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Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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Gynecologic Oncology 110 (2008) 7 – 12 www.elsevier.com/locate/ygyno
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care SGO Breast Cancer Task Force Mission Statement “To promote the provision of comprehensive breast health and cancer care of women, including education, research, screening, prevention and treatment.” Approved by SGO Council July 2007 The problem Breast cancer is the most common female malignancy, representing 31% of all cancer diagnoses (compared to ovary 4% or corpus cancer 6%) in the U.S. This year approximately 77,250 women will be diagnosed with a gynecologic malignancy; however, it is estimated that in 2007 there will be 178,480 new female breast cancers diagnosed and 40,460 cancer-related deaths [1]. An additional 60,000 women will be diagnosed with DCIS. The estimated lifetime cumulative risk of developing breast cancer remains 12.8% (1/8 women). Despite a decreasing trend in incidence and overall mortality, breast cancer remains the second most common cause of cancer death in women. In fact, the chance that breast cancer will be responsible for a woman's death is about 3% (1 in 33). According to the World Health Organization, more than 1.2 million individuals will be diagnosed with breast cancer each year worldwide. The natural history of breast cancer and the need, role, and success of multimodality therapy coupled with the continued large variations in breast cancer treatment suggest that a comprehensive disease management approach could offer women a therapeutic advantage. An important part of this strategy would focus on promoting physician excellence, which should improve survival and quality of life, lessen treatment- and disease-related morbidity, and decrease overall costs [2]. Existing quality of breast cancer care Despite the plea for increased subspecialty training to assist in the development of a comprehensive or multidisciplinary care model [2,3], the bulk of surgical breast cancer care remains under the domain of the general surgeon. Currently a general surgeon is “qualified” to perform breast care by the RRC if he or she has performed N 25 breast cases during residency. Clearly, survival is the ultimate goal. However, optimal breast cancer treatment must address initial diagnosis with specific attention to all of the other important outcomes, including cosmesis, functionality, and appropriate initiation of adjuvant therapy [3,4]. While the importance of surgical technique and management cannot be underestimated, it is apparent that the critical impact of “technical precision” is poorly defined [4]. Appropriate training is essential, as a significant portion of breast cancer care begins with initial diagnosis, informed consent, and surgical care but continues with appropriate postsurgical referral, which significantly impacts overall survival and quality of care. Therefore, it is imperative that breast surgeons acquire a broad base of knowledge that allows them to offer best care along the entire continuum of the disease. Despite the recognized advantage associated with specialized surgical training, currently there is no certification examination for individuals completing one of the 33 Breast Fellowship Programs or the 19 Surgical Oncology Fellowship Programs. In an attempt to standardize fellowship training requirements, the Society of Surgical Oncology (SSO) has recently instituted a match program for breast fellowship positions. In 2006, 39 individuals matched in 26 SSO-approved breast fellowships and 46 individuals matched in 18 approved SSO surgical oncology fellowships The SSO, working in conjunction with the American Society of Breast Surgeons (2400 members worldwide), and the American Society of Breast Diseases (founded in 1976 by a group of gynecologists who recognized that proper treatment of breast disease requires comprehensive management) have established core requisites for the training of breast fellows (available at www.surgonc.org). 0090-8258/$ - see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.ygyno.2008.04.009
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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Breast fellowships currently require rotations through surgery (2 months) and 1 month in each of the following: medical oncology, radiation oncology, pathology, radiology, and plastic and reconstructive surgery during the 1-year fellowship (total 7 months). In contrast, gynecologic oncology training programs are 3 to 4 years and provide a greater emphasis in all primary and peripheral aspects of oncologic and multidisciplinary care. The current topography of breast cancer care suggests it to be an uneven terrain, fragmented with wide variations in care as suggested in the selected literature review detailed below. Many of these issues are analogous to the quality of care that was offered to women with ovarian cancer 15 years ago, prior to the development of a comprehensive model of care. Some pertinent points: 1. Proper surgical education and training are paramount in assuring appropriate selection and delivery of surgical procedure [5]. 2. Specialized breast cancer care equals an 18% reduction in mortality [6]. 3. Treatment by a surgical oncologist results in a 33% reduction in the risk of death at 5 years and cannot be entirely attributed to volume effects [7]. 4. Survival is improved (RR 0.85) in women treated by surgeons seeing N30 new cases annually [8]. 5. After adjustment for patient characteristics, 43.3% of the treatment variation was due to the hospital and 56.7% to the surgeon [9]. 6. High-volume surgeons more frequently endorsed current clinical guidelines that favor BCS compared with mastectomy [10]. 7. Specialist surgeons improve 5-year survival (9% higher) and 10-year survival (8% higher). Multifactional analyses suggest a 16% decrease in death risk [11]. 8. Breast cancer patients treated in specialist compared to nonspecialist units have half the risk of inadequate treatment of the breast (24% vs 47%, P b 0.001), a fivefold lower risk of inadequate axillary staging (8% vs 40%, P b 0.001), and nine times lower risk of inadequate definitive axillary treatment (4% vs 38%, P b 0.001). Local recurrence rates are 57% lower (13% vs 23% at 8 years, P b 0.001) and the risk of death from breast cancer is 20% lower for women treated in specialist units, after allowing for case mix and adjuvant therapies [12]. 9. A significant percentage of women with early-stage breast cancer fail to undergo LND, which is associated with a significant decrease (85% vs 66%) in survival [13]. 10. Practicing physicians failed to recognize the impact of adjuvant radiation following lumpectomy (55%) or the role of adjuvant chemotherapy (67%) [14]. 11. Risk of local recurrence for DCIS following breast-conserving therapy is influenced by quality of initial procedures. Large treatment variations occur in multicenter trials, which may influence the effect of initial procedures [15]. 12. Patient clinical factors and surgeon volume together explain approximately one-third of the between-surgeon variation in mastectomy. Patient factors and surgeon demographics explain approximately 60% of between-surgeon variation in reconstruction, and surgeon referral propensity explains an additional 15% [16]. 13. Only 30% of women at risk receive N 85% of referenced target dose chemotherapy [17]. 14. Nearly two-thirds of patients received relative dose intensity less than 85% when adjusted for differences in regimen dose intensity [18]. 15. Twenty to thirty percent of breast cancer patients experience longstanding psychic stress [19] frequently in excess of 5 years [20,21]. 16. Fewer than half (45%) of women with early breast cancer had ever discussed genetic testing with their physician and/or been referred to see a genetic counselor [22]. These compelling data are from but a few of the peer-reviewed studies that clearly suggest the potential benefit for a comprehensive model of care from subspecialty-trained physicians who can encompass all physical and psychological aspects of diagnosis, initial and adjuvant treatment, and surveillance. The potential impact of these quality of care issues becomes more relevant given that the readily available “treatment guidelines” are not used by many physicians [23–25]. Despite numerous similar reports, some have argued that there is no shortage of competent, highly trained people to do the breast work. To the contrary, during her address at the 2005 SGO Annual Meeting, Dr. Monica Morrow (one of the most noted breast surgeons in this country), clearly and emphatically stated that this was not the case, citing data reflecting the continued fragmentation of care as well as the significant number of “less than optimal” procedures that continue to be performed in this country. It should be noted that despite the much higher incidence and prevalence of breast cancer, the annual “output” of breast fellowship-trained surgeons is essentially equal to the number of physicians completing gynecologic oncology fellowships. Necessary surgical training It is axiomatic that a prerequisite for breast cancer care requires adequate surgical training in the diagnostic and therapeutic aspects of breast disease. While the exact number of necessary surgical procedures needed to acquire adequate skills for lumpectomy or mastectomy is unknown, available data from a more recently described breast procedure (sentinel lymph node biopsy, or SLN) suggest:
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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1. Surgeons performing b3 SLNs yearly have success rates of 86%, while those performing N65 SLNs have success rates N 98% [26]. 2. Individual surgeon performance is the most significant factor in determining institutional mapping success [27]. 3. Excluding the first 6 cases, the false-negative rate of SLN falls to 5.2% [28]. 4. Surgeons should perform at least 20 SLNs before abandoning routine axillary dissection [29]. Average experiences to attain 90% success are 23 cases. Ninety-five percent success is reached at 53 cases [30]. It would appear that when this information is combined with other available scientific data regarding surgical learning curves [31,32], surgical competence should be attainable at approximately 20 to 30 cases, provided continued surgical experience is maintained. It should be noted that SLN is a procedure that is currently routinely performed by most gynecologic oncologists in the management of vulvar cancer. Why gynecologic oncologists? Gynecologists have always been involved with clinical breast care and were the founding members of the American Society of Breast Diseases in 1976. The first article published in Gynecologic Oncology [33] was related to gynecologic aspects of breast disease. A number of American College of Obstetrics and Gynecology publications regarding the responsibility for screening and management of breast abnormalities have been published. The current American Board of Obstetrics and Gynecology Guidelines to learning (www.abog) indicate that the gynecologic oncology fellow should be familiar with the assessment and performance of fine needle aspiration or biopsy of breast lesions (p. 3); understand molecular, genetic, and hormone receptors (p. 4); and understand and describe breast/ovary genetic syndromes (p. 29) and the use of anti estrogens (p. 49). A specific section on breast (pp. 62, 63) addresses the precise requirements: 8. Breast — The fellow should have knowledge of breast diseases and should be able to advise patients regarding: a. the frequency of breast carcinoma b. high-risk sub-populations c. benign breast lesions which predispose to subsequent breast carcinoma d. mammography and breast self exam in screening and diagnosis e. the significance of estrogen and progesterone receptors in breast carcinoma f. staging breast cancer g. the indications for lumpectomy, modified radical mastectomy, sentinel node biopsy, and axillary node dissection in the treatment of breast carcinoma h. the role of radiotherapy and chemotherapy in primary treatment i. breast reconstructive techniques j. the role of tamoxifen and aromatase inhibitor therapy k. appropriate follow up l. the pros and cons of hormone replacement therapy for breast cancer survivors. Thus gynecologic oncologists in training are currently responsible for a significant knowledge base as it relates to the understanding of breast cancer. Seemingly, it would not be a giant leap to add the words “treat” breast cancer if appropriate training were available to this group of individuals, already in the midst of broad-based oncology training. Importantly, gynecologic oncologists typically have a specific philosophy for and commitment to total care and are thoroughly trained to address women's cancer care with a comprehensive approach. They desire and strive for excellence in overall patient care, not simply to execute an exercise in surgical technique. The ability to treat the “entire spectrum” of disease is evidenced by the comprehensive disease-based model developed by gynecologic oncologists in the care of women with ovarian cancer. This dedication to continuity of care has resulted in a higher level of individual care and improved outcomes (when compared to non-gynecologic oncologists). Gynecologic oncologists already enjoy many attributes necessary for breast care, as they are specifically trained in reproductive medicine, endocrinology, genetics, and hormonal replacement. They possess the necessary acumen and comprehension of the fundamentals of tumor biology, cancer screening, diagnostic procedures, and essential surgical skills, as well as an understanding of primary and adjuvant radiation and chemotherapy, immunotherapy, counseling (psycho-oncology), and posttreatment surveillance. Much of our subspecialty research already incorporates specific aspects of breast disease (i.e., BRCA, risk reduction surgery) and gynecologic oncologists have faced and will continue to face all of the issues related to developing quality state-of-the-art care [34]. Thus, it seems natural and appropriate for gynecologic oncologists to evaluate their potential role in breast disease as an opportunity to develop or assist in the development of a comprehensive treatment model that could improve women's care. Additionally, the results from the 2007 SGO Strategic Planning Survey indicate that 67% of respondents see N 5 patients with a personal history of breast cancer per month (26% see N 11/month). Furthermore 73% think that gynecologic oncology programs should have the option of incorporating breast cancer training and 61% would hire a breast-trained surgeon. Notably, the vast majority (83%) felt
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Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
that a properly trained gynecologic oncologist should be able to perform diagnostic techniques (33%), complete surgical management (15%), and administer endocrine or chemotherapy (10%) and 53% believed that they perform all of the previously mentioned tasks. While some vocally object to gynecologic oncologists being involved in breast cancer care, we must all be reminded that despite training and certification not every gynecologic oncologist offers chemotherapy, constructs conduits, performs bowel surgery, or manages their TPN. Our subspecialty offers many different options for practice preference and the Task Force believes that breast cancer care could be another option, given the availability and opportunity for proper training. Nearly every gynecologic oncologist would agree that our specialty's strongest asset is our model of care. The disease management model championed by our founding members is powerful. By maintaining focus, it creates disease-specific volume. Simultaneously its multimodality approach develops comprehensive depth and expertise. The combined effects of these factors over time consistently build quality. As simple as this model is, other cancer specialists outside SGO seem averse to accepting or developing such a model. Although there is a definite role for other cancer specialists within this model, we believe it is extremely unlikely that such a precedent for breast cancer care will be initiated outside our specialty. Because this model is second nature to all of us, gynecologic oncologists are the ideal champions of a model that is destined to improve breast cancer care wherever it is implemented. It seems only appropriate that SGO assume a leadership role in an effort to develop alternative methods for offering appropriate, quality breast training during fellowship and assisting in the development of post-fellowship training programs to ensure satisfactory training. It is axiomatic that the SGO should support those gynecologic oncologists currently caring for women with breast cancer. The issues facing gynecologic oncologists becoming involved in breast cancer care are no different from our forefather's struggles that occurred during the birth and evolution of the specialty, when a determined group of dedicated individuals worked diligently in an effort to establish a subspecialty that offered a comprehensive approach to female pelvic cancer at a time when it was unthinkable! It would appear that we have ACOG's support as the recent Committee Opinion (#334, May 2006) addresses guidelines for the early diagnosis of breast cancer and specifically states: “Institutions that grant privileges to perform breast surgery should apply the same criteria for privileging to obstetricians–gynecologists as to other physicians.” It is obvious that any move to incorporate broad-based breast training would necessitate enlisting support from ACOG as well as tactical discussions with ABOG and all of the other organizations involved with breast cancer care, including but not limited to the SSO, American College of Surgeons, and American Society of Clinical Oncology. Finally, if the SGO and gynecologic oncologists become more involved with breast cancer, it would strategically place us in a favorable position to strengthen relationships with referring gynecologists, potentially increase research funding, dramatically enlarge our potential advocacy groups, greatly improve our standing with our industry partners, and provide additional clinical opportunity to our members as the patterns/methods of care of the “customary” gynecologic malignancies change. Strategies for implementing breast surgery training Proposed strategies for implementing breast surgery training can be divided into two areas. Those related to: 1. Primary surgical training. 2. Administration of chemotherapy and hormonal therapy. Surgical training strategy planning must focus on potential methods for best integrating breast surgery training into fellowship training and developing a process to provide additional training for post-fellowship-trained gynecologic oncologists who may desire to retool and add breast cancer care to their practices. It is not unreasonable to consider a year of breast surgery fellowship within the current curriculum of gynecologic oncology training, as many gynecologic oncology fellowships exist in academic centers that also include a breast fellowship program. For those fellows interested in pursuing breast surgery training, the possibility of exchanging a basic science research year for a fellowship year dedicated to breast surgery is a simple, logical, but perhaps controversial approach. Our society is nearly equally divided between those in private practice and those in an academic setting. Thus, the majority of gynecologic oncologists are not engaged in basic science research, despite having spent one or two years in the lab. Importantly, incorporating a full year of breast surgery fellowship training would negate or minimize the “turf” battles and ease the path to obtaining credentials to practice breast surgery. Credentialing must be based on the satisfactory completion of a recognized training program. One must be reminded that there are an ever increasing number of “breast-trained” gynecologic oncologists who have successfully traversed these issues and are actively practicing breast surgery in both the private and the academic sector. They serve as a great resource to SGO in the development of breast training options. An alternative strategy involves the provision of training in breast surgery concurrently during gynecologic oncology training, as is done at Women's and Infants Hospital/Brown University. Regardless of process, the fellowship must be committed to providing excellent breast surgery training, which would encompass all the core requirements as set forth by the Society of Surgical Oncology, which in essence covers a total of only 7 months. The greatest criticism of this approach is the argument that our fellows are already overcommitted and pulled in many directions, given the current requirements of the board. It is recognized that all gynecologic
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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oncology fellows would require or desire full breast training, as some will not be interested in pursuing a career that includes breast surgery. However, it should be made available for those fellows who are potentially interested. A logical starting approach may be to initially establish and develop 5 to 10 pilot programs in existing fellowships and build upon their outcomes. The particulars for implementing breast surgery training to retool those already in practice are more complex. These individuals should begin their breast training already possessing all of the surgical acumen and comprehension of chemotherapy, radiation therapy, and psycho-oncology as outlined in the guidelines to learning. Theoretically, there are numerous superb, respected annual courses related to all aspects of breast cancer care as well as specific topics such as radiologic evaluation and pathology. Obviously it would be necessary to align with academic or private partners to facilitate their acquiring the necessary surgical experience (≥50 cases). With the current guidelines for breast surgery fellowship, it may be necessary for them to pursue formal training, which would circumvent issues related to obtaining practice credentials. The appropriate length of time necessary for this additional training will need to be determined. It is anticipated that as more gynecologic oncologists enter the field of breast cancer care, the “uniqueness” of this idea and plan will dissipate and move to become an accepted norm. The development of this alternative training tract could become a hybrid of existing programs using available online sources to fulfill a portion of the necessary didactic training as long as some form of testing or privileging standards are in place. The issues surrounding the administration of breast cancer chemotherapy are a difficult dilemma. Most practicing gynecologic oncologists already administer a wide variety of complex chemotherapeutic regimens. This is not an unreasonable step given our expertise and historical perspective with respect to our subspecialty's involvement in chemotherapy administration. Those opposed to gynecologic oncologists administering breast chemotherapy cite the complexity of the protocols for breast cancer treatment and the heavy involvement of cooperative groups (such as CALGB) in recruiting patients for studies. This question can only be answered with time and appropriate training on an individual basis. However, the guiding principles of gynecologic oncology practice encompass comprehensive care of women with cancer. We strongly believe this must encompass the care of women at risk for and diagnosed with breast cancer. There is little doubt that gynecologic oncologists are currently in an excellent position to successfully enter and contribute to breast cancer care. There are many avenues for entrance, and there are currently many gynecologic oncologists who are interested in treating the most common cancer in women. It is logical that the doctor that treats the majority of women's cancers should also be able to treat the most common cancer. Because of our multidisciplinary training, adding the treatment of breast cancer in our armamentarium is a reasonable next step. Our specialty provides many different niches, including surgical treatment with or without chemotherapy, bench research, public health, and screening. Our Task Force believes that women would benefit from a comprehensive model of breast cancer care, and SGO members warrant a concerted opportunity to develop the tools necessary to offer it. It would seem appropriate that our SGO and our subspecialty (in whole or part) embrace breast disease and assume a greater role in breast cancer care by becoming the facilitator for the development of appropriate training programs for those interested individuals entering as well as those who have completed fellowship programs. The Task Force has extensively evaluated the SSO training guidelines and has submitted what the members believe to be an acceptable version with the incorporation of the attributes of the trained (or in training gynecologist) and elicits Council's support in continuing the endeavor to develop the role of our specialty in breast care. Conflict of interest statement The authors have no conflicts of interest to declare.
References [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]
Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007;57:43–66. Kolb GR. Disease management is the future: breast cancer is the model. Surg Oncol Clin N Am 2000;9:217–32. Bickell NA, Mendez J, Guth AA. The quality of early-stage breast cancer treatment: what can we do to improve? Surg Oncol Clin N Am Jan 2005;14(1): 103–17. Cady B, Falkenberry S, Chung M. The surgeon's role in outcome in contemporary breast cancer. Surg Oncol Clin 2000;9:119–32. Giacomentonio CA, Temple WJ. Quality of cancer surgery: challenges and controversies. Surg Oncol Clin N Am 2000;9:51–60. Grilli R, Minozzi S, Tinazzi A, Labianca R, Sheldon TA, Liberati A. Do specialists do it better? The impact of specialization on the processes and outcomes of care for cancer patients. Ann Oncol 1998;9:365–74. Skinner KA, Helsper JT, Deapen D, Ye W, Sposto R. Breast cancer: do specialists make a difference? Ann Surg Oncol 2003;10:606–15. Sainsbury R, Haward B, Rider L, Johnston C, Round C. Influence of clinician workload and patterns of treatment on survival from breast cancer. Lancet 1995;345:1265–70. Gort M, Broekhuis M, Otter R, Klazinga NS. Improvement of best practice in early breast cancer: actionable surgeon and hospital factors. Breast Cancer Res Treat 2007;102:219–26. Katz SJ, Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Salem B, Lakhani I, Morrow M. Surgeon perspectives about local therapy for breast carcinoma. Cancer 2005;104:1854–61. Gillis CR, Hole DJ. Survival outcome of care by specialist surgeons in breast cancer: a study of 3786 patients in the west of Scotland. BMJ 1996;312:145–8. Kingsmore D, Hole D, Gillis C. Why does specialist treatment of breast cancer improve survival? The role of surgical management. Br J Cancer 2004;90:1920–5. Bland KI, Scott-Conner CE, Menck H, Winchester DP. Axillary dissection in breast conserving surgery for stage I and II breast cancer: a National Cancer Data Base study of patterns of omission and implications for survival. J Am Coll Surg 1999;188:586–95.
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[14] Hatzell TA, Ricketts TC, Tropman SE, Paskett ED, Cooper MR. Rural physicians' understanding of the state-of-the-art in breast, colon and rectum cancer treatment. Cancer Causes Control 1999;10:261–7. [15] Bijker N, Rutgers EJ, Peters JL, Fentiman IS, Julien JP, Duchateau L, et al. Variations in diagnostic and therapeutic procedures in a multicenter, randomized clinical trial (EORTC 10853) investigating breast-conserving treatment for DCIS. Eur J Surg Oncol 2001;27:135–40. [16] Hawley ST, Hofer TP, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Morrow M, Katz SJ. Correlates of between-surgeon variation in breast cancer treatments. Med Care 2006;44:609–16. [17] Link BK, Budd GT, Scott S, Dickman E, Paul D, Lawless G, et al. Delivering adjuvant chemotherapy to women with early-stage breast carcinoma: current patterns of care. Cancer 2001;92:1354–67. [18] Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol Dec 15 2003;21(24):4524–31. [19] Keller M. Psychosocial care of breast cancer patients. Anticancer Res 1998;18:2257–9. [20] Holzner B, Kemmler G, Kopp M, Moschen R, Schweigkofler H, Dunser M, et al. Quality of life in breast cancer patients—not enough attention for long-term survivors? Psychosomatics 2001;42:117–23. [21] Broeckel JA, Jacobsen PB, Balducci L, Horton J, Lyman GH. Quality of life after adjuvant chemotherapy for breast cancer. Breast Cancer Res Treatment 2000;62:141–50. [22] Brown KL, Hutchison R, Zinberg RE, McGovern MM. Referral and experience with genetic testing among women with early onset breast cancer. Genet Test Winter 2005;9(4):301–5. [23] Adjuvant therapy for breast cancer. NIH Consensus Statement 2000;17: 1–35. [24] Carlson RW, Brown E, Burstein HJ, Gradishar WJ, Hudis CA, Loprinzi C, Mamounas EP, Perez EA, Pritchard K, Ravdin P, Recht A, Somlo G, Theriault RL, Winer EP, Wolff AC, National Comprehensive Cancer Network. NCCN Task Force Report: adjuvant therapy for breast cancer. J Natl Compr Canc Netw 2006;4 (Suppl 1):S1–2. [25] J Natl Compr Canc Netw. Mar 2006;4(Suppl 1):S1–S26. [26] Cox CE, Salud CJ, Cantor A, Bass SS, Peltz ES, Ebert MD. Learning curves for breast cancer sentinel lymph node mapping based on surgical volume analysis. J Am Coll Surg 2001;193:593–600. [27] Dupont E, Cox C, Shivers S, Falud C, Nguyen K, Cantor A, Reintgen D. Learning curves and breast cancer lymphatic mapping: institutional volume index. J Surg Res 2001;97:92–6. [28] Cody III HS, Hill AD, Tran KN, Brennan MF, Borgen PI. Credentialing for breast lymphatic mapping: how many cases are enough? Ann Surg 1999;229:723–6; discussion 726–8. [29] Simmons RM. Review of sentinel lymph node credentialing: how many cases are enough? Am Coll Surgeons 2001:206–9. [30] Cox CE, Bass SS, Boulware D, Ky NK, Berman C, Reintgen DS. Implementation of new surgical technology: outcome measures for lymphatic mapping of breast carcinoma. Ann Surg Oncol 1999;6: 520–1. [31] Eltabbakh GH. Effect of surgeon's experience on the surgical outcome of laparoscopic surgery for women with endometrial cancer. Gynecol Oncol 2000;78:58–61. [32] Melendez TD, Childers JM, Nour M, Harrigill K, Surwit EA. Laparoscopic staging of endometrial cancer: the learning experience. JSLS 1997;1:45–9. [33] Gray L. Gynecologic aspects of breast disease. Gynecol Oncol 1972;1: 1–12. [34] Gershenson DM. Why American women are not receiving state-of-the art gynecologic cancer care. Cancer J 2001;7:450–7.
Breast Cancer Task Force: James Orr, Jr. MD, Chair Joseph Kelley, III MD, Vice-Chair Don Dizon, MD Pedro Escobar, MD Evelyn Fleming, MD Mary Gemignani, MD David Hetzel, MD William Hoskins, MD Dirk Kieback, MD, PhD Larry Kilgore, MD James LaPolla, MD Sharyn Lewin, MD Joseph Lucci, MD Maurie Markman, MD Bhavana Pothuri, MD C. Bethan Powell, MD Trevor Tejada-Berges, MD 18 March 2008
Gynecologic Oncology 110 (2008) 7 – 12 www.elsevier.com/locate/ygyno
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care SGO Breast Cancer Task Force Mission Statement “To promote the provision of comprehensive breast health and cancer care of women, including education, research, screening, prevention and treatment.” Approved by SGO Council July 2007 The problem Breast cancer is the most common female malignancy, representing 31% of all cancer diagnoses (compared to ovary 4% or corpus cancer 6%) in the U.S. This year approximately 77,250 women will be diagnosed with a gynecologic malignancy; however, it is estimated that in 2007 there will be 178,480 new female breast cancers diagnosed and 40,460 cancer-related deaths [1]. An additional 60,000 women will be diagnosed with DCIS. The estimated lifetime cumulative risk of developing breast cancer remains 12.8% (1/8 women). Despite a decreasing trend in incidence and overall mortality, breast cancer remains the second most common cause of cancer death in women. In fact, the chance that breast cancer will be responsible for a woman's death is about 3% (1 in 33). According to the World Health Organization, more than 1.2 million individuals will be diagnosed with breast cancer each year worldwide. The natural history of breast cancer and the need, role, and success of multimodality therapy coupled with the continued large variations in breast cancer treatment suggest that a comprehensive disease management approach could offer women a therapeutic advantage. An important part of this strategy would focus on promoting physician excellence, which should improve survival and quality of life, lessen treatment- and disease-related morbidity, and decrease overall costs [2]. Existing quality of breast cancer care Despite the plea for increased subspecialty training to assist in the development of a comprehensive or multidisciplinary care model [2,3], the bulk of surgical breast cancer care remains under the domain of the general surgeon. Currently a general surgeon is “qualified” to perform breast care by the RRC if he or she has performed N 25 breast cases during residency. Clearly, survival is the ultimate goal. However, optimal breast cancer treatment must address initial diagnosis with specific attention to all of the other important outcomes, including cosmesis, functionality, and appropriate initiation of adjuvant therapy [3,4]. While the importance of surgical technique and management cannot be underestimated, it is apparent that the critical impact of “technical precision” is poorly defined [4]. Appropriate training is essential, as a significant portion of breast cancer care begins with initial diagnosis, informed consent, and surgical care but continues with appropriate postsurgical referral, which significantly impacts overall survival and quality of care. Therefore, it is imperative that breast surgeons acquire a broad base of knowledge that allows them to offer best care along the entire continuum of the disease. Despite the recognized advantage associated with specialized surgical training, currently there is no certification examination for individuals completing one of the 33 Breast Fellowship Programs or the 19 Surgical Oncology Fellowship Programs. In an attempt to standardize fellowship training requirements, the Society of Surgical Oncology (SSO) has recently instituted a match program for breast fellowship positions. In 2006, 39 individuals matched in 26 SSO-approved breast fellowships and 46 individuals matched in 18 approved SSO surgical oncology fellowships The SSO, working in conjunction with the American Society of Breast Surgeons (2400 members worldwide), and the American Society of Breast Diseases (founded in 1976 by a group of gynecologists who recognized that proper treatment of breast disease requires comprehensive management) have established core requisites for the training of breast fellows (available at www.surgonc.org). 0090-8258/$ - see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.ygyno.2008.04.009
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
8
Breast fellowships currently require rotations through surgery (2 months) and 1 month in each of the following: medical oncology, radiation oncology, pathology, radiology, and plastic and reconstructive surgery during the 1-year fellowship (total 7 months). In contrast, gynecologic oncology training programs are 3 to 4 years and provide a greater emphasis in all primary and peripheral aspects of oncologic and multidisciplinary care. The current topography of breast cancer care suggests it to be an uneven terrain, fragmented with wide variations in care as suggested in the selected literature review detailed below. Many of these issues are analogous to the quality of care that was offered to women with ovarian cancer 15 years ago, prior to the development of a comprehensive model of care. Some pertinent points: 1. Proper surgical education and training are paramount in assuring appropriate selection and delivery of surgical procedure [5]. 2. Specialized breast cancer care equals an 18% reduction in mortality [6]. 3. Treatment by a surgical oncologist results in a 33% reduction in the risk of death at 5 years and cannot be entirely attributed to volume effects [7]. 4. Survival is improved (RR 0.85) in women treated by surgeons seeing N30 new cases annually [8]. 5. After adjustment for patient characteristics, 43.3% of the treatment variation was due to the hospital and 56.7% to the surgeon [9]. 6. High-volume surgeons more frequently endorsed current clinical guidelines that favor BCS compared with mastectomy [10]. 7. Specialist surgeons improve 5-year survival (9% higher) and 10-year survival (8% higher). Multifactional analyses suggest a 16% decrease in death risk [11]. 8. Breast cancer patients treated in specialist compared to nonspecialist units have half the risk of inadequate treatment of the breast (24% vs 47%, P b 0.001), a fivefold lower risk of inadequate axillary staging (8% vs 40%, P b 0.001), and nine times lower risk of inadequate definitive axillary treatment (4% vs 38%, P b 0.001). Local recurrence rates are 57% lower (13% vs 23% at 8 years, P b 0.001) and the risk of death from breast cancer is 20% lower for women treated in specialist units, after allowing for case mix and adjuvant therapies [12]. 9. A significant percentage of women with early-stage breast cancer fail to undergo LND, which is associated with a significant decrease (85% vs 66%) in survival [13]. 10. Practicing physicians failed to recognize the impact of adjuvant radiation following lumpectomy (55%) or the role of adjuvant chemotherapy (67%) [14]. 11. Risk of local recurrence for DCIS following breast-conserving therapy is influenced by quality of initial procedures. Large treatment variations occur in multicenter trials, which may influence the effect of initial procedures [15]. 12. Patient clinical factors and surgeon volume together explain approximately one-third of the between-surgeon variation in mastectomy. Patient factors and surgeon demographics explain approximately 60% of between-surgeon variation in reconstruction, and surgeon referral propensity explains an additional 15% [16]. 13. Only 30% of women at risk receive N 85% of referenced target dose chemotherapy [17]. 14. Nearly two-thirds of patients received relative dose intensity less than 85% when adjusted for differences in regimen dose intensity [18]. 15. Twenty to thirty percent of breast cancer patients experience longstanding psychic stress [19] frequently in excess of 5 years [20,21]. 16. Fewer than half (45%) of women with early breast cancer had ever discussed genetic testing with their physician and/or been referred to see a genetic counselor [22]. These compelling data are from but a few of the peer-reviewed studies that clearly suggest the potential benefit for a comprehensive model of care from subspecialty-trained physicians who can encompass all physical and psychological aspects of diagnosis, initial and adjuvant treatment, and surveillance. The potential impact of these quality of care issues becomes more relevant given that the readily available “treatment guidelines” are not used by many physicians [23–25]. Despite numerous similar reports, some have argued that there is no shortage of competent, highly trained people to do the breast work. To the contrary, during her address at the 2005 SGO Annual Meeting, Dr. Monica Morrow (one of the most noted breast surgeons in this country), clearly and emphatically stated that this was not the case, citing data reflecting the continued fragmentation of care as well as the significant number of “less than optimal” procedures that continue to be performed in this country. It should be noted that despite the much higher incidence and prevalence of breast cancer, the annual “output” of breast fellowship-trained surgeons is essentially equal to the number of physicians completing gynecologic oncology fellowships. Necessary surgical training It is axiomatic that a prerequisite for breast cancer care requires adequate surgical training in the diagnostic and therapeutic aspects of breast disease. While the exact number of necessary surgical procedures needed to acquire adequate skills for lumpectomy or mastectomy is unknown, available data from a more recently described breast procedure (sentinel lymph node biopsy, or SLN) suggest:
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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1. Surgeons performing b3 SLNs yearly have success rates of 86%, while those performing N65 SLNs have success rates N 98% [26]. 2. Individual surgeon performance is the most significant factor in determining institutional mapping success [27]. 3. Excluding the first 6 cases, the false-negative rate of SLN falls to 5.2% [28]. 4. Surgeons should perform at least 20 SLNs before abandoning routine axillary dissection [29]. Average experiences to attain 90% success are 23 cases. Ninety-five percent success is reached at 53 cases [30]. It would appear that when this information is combined with other available scientific data regarding surgical learning curves [31,32], surgical competence should be attainable at approximately 20 to 30 cases, provided continued surgical experience is maintained. It should be noted that SLN is a procedure that is currently routinely performed by most gynecologic oncologists in the management of vulvar cancer. Why gynecologic oncologists? Gynecologists have always been involved with clinical breast care and were the founding members of the American Society of Breast Diseases in 1976. The first article published in Gynecologic Oncology [33] was related to gynecologic aspects of breast disease. A number of American College of Obstetrics and Gynecology publications regarding the responsibility for screening and management of breast abnormalities have been published. The current American Board of Obstetrics and Gynecology Guidelines to learning (www.abog) indicate that the gynecologic oncology fellow should be familiar with the assessment and performance of fine needle aspiration or biopsy of breast lesions (p. 3); understand molecular, genetic, and hormone receptors (p. 4); and understand and describe breast/ovary genetic syndromes (p. 29) and the use of anti estrogens (p. 49). A specific section on breast (pp. 62, 63) addresses the precise requirements: 8. Breast — The fellow should have knowledge of breast diseases and should be able to advise patients regarding: a. the frequency of breast carcinoma b. high-risk sub-populations c. benign breast lesions which predispose to subsequent breast carcinoma d. mammography and breast self exam in screening and diagnosis e. the significance of estrogen and progesterone receptors in breast carcinoma f. staging breast cancer g. the indications for lumpectomy, modified radical mastectomy, sentinel node biopsy, and axillary node dissection in the treatment of breast carcinoma h. the role of radiotherapy and chemotherapy in primary treatment i. breast reconstructive techniques j. the role of tamoxifen and aromatase inhibitor therapy k. appropriate follow up l. the pros and cons of hormone replacement therapy for breast cancer survivors. Thus gynecologic oncologists in training are currently responsible for a significant knowledge base as it relates to the understanding of breast cancer. Seemingly, it would not be a giant leap to add the words “treat” breast cancer if appropriate training were available to this group of individuals, already in the midst of broad-based oncology training. Importantly, gynecologic oncologists typically have a specific philosophy for and commitment to total care and are thoroughly trained to address women's cancer care with a comprehensive approach. They desire and strive for excellence in overall patient care, not simply to execute an exercise in surgical technique. The ability to treat the “entire spectrum” of disease is evidenced by the comprehensive disease-based model developed by gynecologic oncologists in the care of women with ovarian cancer. This dedication to continuity of care has resulted in a higher level of individual care and improved outcomes (when compared to non-gynecologic oncologists). Gynecologic oncologists already enjoy many attributes necessary for breast care, as they are specifically trained in reproductive medicine, endocrinology, genetics, and hormonal replacement. They possess the necessary acumen and comprehension of the fundamentals of tumor biology, cancer screening, diagnostic procedures, and essential surgical skills, as well as an understanding of primary and adjuvant radiation and chemotherapy, immunotherapy, counseling (psycho-oncology), and posttreatment surveillance. Much of our subspecialty research already incorporates specific aspects of breast disease (i.e., BRCA, risk reduction surgery) and gynecologic oncologists have faced and will continue to face all of the issues related to developing quality state-of-the-art care [34]. Thus, it seems natural and appropriate for gynecologic oncologists to evaluate their potential role in breast disease as an opportunity to develop or assist in the development of a comprehensive treatment model that could improve women's care. Additionally, the results from the 2007 SGO Strategic Planning Survey indicate that 67% of respondents see N 5 patients with a personal history of breast cancer per month (26% see N 11/month). Furthermore 73% think that gynecologic oncology programs should have the option of incorporating breast cancer training and 61% would hire a breast-trained surgeon. Notably, the vast majority (83%) felt
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Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
that a properly trained gynecologic oncologist should be able to perform diagnostic techniques (33%), complete surgical management (15%), and administer endocrine or chemotherapy (10%) and 53% believed that they perform all of the previously mentioned tasks. While some vocally object to gynecologic oncologists being involved in breast cancer care, we must all be reminded that despite training and certification not every gynecologic oncologist offers chemotherapy, constructs conduits, performs bowel surgery, or manages their TPN. Our subspecialty offers many different options for practice preference and the Task Force believes that breast cancer care could be another option, given the availability and opportunity for proper training. Nearly every gynecologic oncologist would agree that our specialty's strongest asset is our model of care. The disease management model championed by our founding members is powerful. By maintaining focus, it creates disease-specific volume. Simultaneously its multimodality approach develops comprehensive depth and expertise. The combined effects of these factors over time consistently build quality. As simple as this model is, other cancer specialists outside SGO seem averse to accepting or developing such a model. Although there is a definite role for other cancer specialists within this model, we believe it is extremely unlikely that such a precedent for breast cancer care will be initiated outside our specialty. Because this model is second nature to all of us, gynecologic oncologists are the ideal champions of a model that is destined to improve breast cancer care wherever it is implemented. It seems only appropriate that SGO assume a leadership role in an effort to develop alternative methods for offering appropriate, quality breast training during fellowship and assisting in the development of post-fellowship training programs to ensure satisfactory training. It is axiomatic that the SGO should support those gynecologic oncologists currently caring for women with breast cancer. The issues facing gynecologic oncologists becoming involved in breast cancer care are no different from our forefather's struggles that occurred during the birth and evolution of the specialty, when a determined group of dedicated individuals worked diligently in an effort to establish a subspecialty that offered a comprehensive approach to female pelvic cancer at a time when it was unthinkable! It would appear that we have ACOG's support as the recent Committee Opinion (#334, May 2006) addresses guidelines for the early diagnosis of breast cancer and specifically states: “Institutions that grant privileges to perform breast surgery should apply the same criteria for privileging to obstetricians–gynecologists as to other physicians.” It is obvious that any move to incorporate broad-based breast training would necessitate enlisting support from ACOG as well as tactical discussions with ABOG and all of the other organizations involved with breast cancer care, including but not limited to the SSO, American College of Surgeons, and American Society of Clinical Oncology. Finally, if the SGO and gynecologic oncologists become more involved with breast cancer, it would strategically place us in a favorable position to strengthen relationships with referring gynecologists, potentially increase research funding, dramatically enlarge our potential advocacy groups, greatly improve our standing with our industry partners, and provide additional clinical opportunity to our members as the patterns/methods of care of the “customary” gynecologic malignancies change. Strategies for implementing breast surgery training Proposed strategies for implementing breast surgery training can be divided into two areas. Those related to: 1. Primary surgical training. 2. Administration of chemotherapy and hormonal therapy. Surgical training strategy planning must focus on potential methods for best integrating breast surgery training into fellowship training and developing a process to provide additional training for post-fellowship-trained gynecologic oncologists who may desire to retool and add breast cancer care to their practices. It is not unreasonable to consider a year of breast surgery fellowship within the current curriculum of gynecologic oncology training, as many gynecologic oncology fellowships exist in academic centers that also include a breast fellowship program. For those fellows interested in pursuing breast surgery training, the possibility of exchanging a basic science research year for a fellowship year dedicated to breast surgery is a simple, logical, but perhaps controversial approach. Our society is nearly equally divided between those in private practice and those in an academic setting. Thus, the majority of gynecologic oncologists are not engaged in basic science research, despite having spent one or two years in the lab. Importantly, incorporating a full year of breast surgery fellowship training would negate or minimize the “turf” battles and ease the path to obtaining credentials to practice breast surgery. Credentialing must be based on the satisfactory completion of a recognized training program. One must be reminded that there are an ever increasing number of “breast-trained” gynecologic oncologists who have successfully traversed these issues and are actively practicing breast surgery in both the private and the academic sector. They serve as a great resource to SGO in the development of breast training options. An alternative strategy involves the provision of training in breast surgery concurrently during gynecologic oncology training, as is done at Women's and Infants Hospital/Brown University. Regardless of process, the fellowship must be committed to providing excellent breast surgery training, which would encompass all the core requirements as set forth by the Society of Surgical Oncology, which in essence covers a total of only 7 months. The greatest criticism of this approach is the argument that our fellows are already overcommitted and pulled in many directions, given the current requirements of the board. It is recognized that all gynecologic
Society of Gynecologic Oncologists Position Paper: Breast Cancer Care
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oncology fellows would require or desire full breast training, as some will not be interested in pursuing a career that includes breast surgery. However, it should be made available for those fellows who are potentially interested. A logical starting approach may be to initially establish and develop 5 to 10 pilot programs in existing fellowships and build upon their outcomes. The particulars for implementing breast surgery training to retool those already in practice are more complex. These individuals should begin their breast training already possessing all of the surgical acumen and comprehension of chemotherapy, radiation therapy, and psycho-oncology as outlined in the guidelines to learning. Theoretically, there are numerous superb, respected annual courses related to all aspects of breast cancer care as well as specific topics such as radiologic evaluation and pathology. Obviously it would be necessary to align with academic or private partners to facilitate their acquiring the necessary surgical experience (≥50 cases). With the current guidelines for breast surgery fellowship, it may be necessary for them to pursue formal training, which would circumvent issues related to obtaining practice credentials. The appropriate length of time necessary for this additional training will need to be determined. It is anticipated that as more gynecologic oncologists enter the field of breast cancer care, the “uniqueness” of this idea and plan will dissipate and move to become an accepted norm. The development of this alternative training tract could become a hybrid of existing programs using available online sources to fulfill a portion of the necessary didactic training as long as some form of testing or privileging standards are in place. The issues surrounding the administration of breast cancer chemotherapy are a difficult dilemma. Most practicing gynecologic oncologists already administer a wide variety of complex chemotherapeutic regimens. This is not an unreasonable step given our expertise and historical perspective with respect to our subspecialty's involvement in chemotherapy administration. Those opposed to gynecologic oncologists administering breast chemotherapy cite the complexity of the protocols for breast cancer treatment and the heavy involvement of cooperative groups (such as CALGB) in recruiting patients for studies. This question can only be answered with time and appropriate training on an individual basis. However, the guiding principles of gynecologic oncology practice encompass comprehensive care of women with cancer. We strongly believe this must encompass the care of women at risk for and diagnosed with breast cancer. There is little doubt that gynecologic oncologists are currently in an excellent position to successfully enter and contribute to breast cancer care. There are many avenues for entrance, and there are currently many gynecologic oncologists who are interested in treating the most common cancer in women. It is logical that the doctor that treats the majority of women's cancers should also be able to treat the most common cancer. Because of our multidisciplinary training, adding the treatment of breast cancer in our armamentarium is a reasonable next step. Our specialty provides many different niches, including surgical treatment with or without chemotherapy, bench research, public health, and screening. Our Task Force believes that women would benefit from a comprehensive model of breast cancer care, and SGO members warrant a concerted opportunity to develop the tools necessary to offer it. It would seem appropriate that our SGO and our subspecialty (in whole or part) embrace breast disease and assume a greater role in breast cancer care by becoming the facilitator for the development of appropriate training programs for those interested individuals entering as well as those who have completed fellowship programs. The Task Force has extensively evaluated the SSO training guidelines and has submitted what the members believe to be an acceptable version with the incorporation of the attributes of the trained (or in training gynecologist) and elicits Council's support in continuing the endeavor to develop the role of our specialty in breast care. Conflict of interest statement The authors have no conflicts of interest to declare.
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Breast Cancer Task Force: James Orr, Jr. MD, Chair Joseph Kelley, III MD, Vice-Chair Don Dizon, MD Pedro Escobar, MD Evelyn Fleming, MD Mary Gemignani, MD David Hetzel, MD William Hoskins, MD Dirk Kieback, MD, PhD Larry Kilgore, MD James LaPolla, MD Sharyn Lewin, MD Joseph Lucci, MD Maurie Markman, MD Bhavana Pothuri, MD C. Bethan Powell, MD Trevor Tejada-Berges, MD 18 March 2008