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Cost-effective management of breast cancer: The reply
Letters to the Editor / The American Journal of Surgery 182 (2001) 434 – 436
Cost-effective management of breast cancer To the Editor: I read with interest the cost comparisons of different local treatments in the curative management of early breast cancer [1]. The authors correctly point to the data being charges and not reimbursements. As surgical billing is a single all-inclusive cost, it is likely that the charges and reimbursement are closer than occurs in radiation therapy. Radiation charges are billed as itemized costs with ensuing lower reimbursements. The challenge to the medical communities is to reduce unnecessary costs and procedures without increasing patient morbidity or reducing cure rates. The surgical community has performed this task well by utilizing needle biopsies and other outpatient diagnostic procedures prior to the definitive treatment. Similarly, sentinel lymph node dissection (SLND) instead of axillary dissection (ALND) [2] may transform breast conservation surgery to an ambulatory setting, while decreasing false node negative (pNo) rates. Cost effectiveness of radiation therapy can be improved by maximizing its technology and benefit. Radioactive implant to the tumor bed (performed in a few institutions) can be done at the time of lumpectomy instead of as a separate procedure. With HDR (high-dose rate) brachytherapy, treatment is delivered in an outpatient setting. Brachytherapy reduces the dose (treatments) of external radiation to the breast or may eliminate external radiation entirely. Nodal radiation at the time of breast radiation may eliminate the need for axillary dissection in many cases without increasing the cost of radiation therapy. Systemic adjuvant therapy is the standard of care when the primary tumor exceeds 1 cm and risk of nodal disease (pN⫹) is significant. Hence, SLND is most valuable in T1b, high-grade T1a, and DCTS tumors where pN⫹ will make a difference in adjuvant therapy. Most DCIS and T1a tumors do not need nodal evaluation or nodal irradiation. Clinical T1cNoMo tumors have a 28% risk of pN⫹ [2] without factoring the false pNo rates. These patients need optimal adjuvant radiation to the lymph node chain along with systemic therapy, without SLND or ALND. There are increasing data from several randomized trials and a metaanalysis that nodal radiation improves local-regional tumor control, and disease-free and overall survival with a reduction in cancer mortality [3–5]. Clinical T2, 3, NoMo tumors have a 52% and 71% risk of pN⫹, respectively [2]. These patients would best be treated with breast conservation (without SLND or ALND) with neoadjuvant or adjuvant chemotherapy and locoregional radiation. Radiation treats the interpectoral nodes, the entire chain of axillary, subclavicular and supraclavicular nodes. When indicated, the internal mammary nodes can also be included in the radiation field. ALND deters radia-
435
tion therapy to the nodes because of increased risks of breast and arm lymphedema. However, ALND is indicated and therapeutic for palpable nodal disease. The test for the oncology community is to tailor various treatment approaches to each patient’s cancer to increase the patient’s probability of cure while reducing her physical and psychological morbidity. We may need to reconsider the belief that all early invasive breast cancers are the same and need identical locoregional treatment. Gilbert A. Lawrence, MD The Regional Cancer Center Radiation Oncology Faxton-St. Luke’s Healthcare Utica, New York PII: S0002-9610(01)00643-2
References [1] Palit TK, Miltenburg DM, Brunicardi CF. Cost analysis of breast conservation surgery compared with modified radical mastectomy without and without reconstruction. Am J Surg. 2000;179:441–5. [2] McMasters K, Tuttle, TM, Carlson DJ. et al. Sentinel lymph node biopsy for breast cancer: A suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol 2000;18:2560 –2566. [3] Whelan TJ, Julian J, Wright J. et al. Does locoregional radiation therapy improve survival in breast cancer? A Met-Analysis. J Clin Oncol 2000;18:1220 –1229. [4] Lawrence GA, Castro P, and Collins B. Breast Cancer: Systemic benefits of locoregional treatment. J Clin Oncol 1996;14:1403–1404. [5] Cuzick J, Stewart H. Rutqvist L et al. Cause-Specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy. J Clin Oncol 1994;12:447–53.
The Reply Once it becomes apparent that breast conservation surgery is more expensive than modified radical mastectomy with or without reconstruction, and that the increased cost appears to be due to radiation therapy charges, the next logical question is how to reduce those charges. Dr Lawrence has suggested that brachytherapy may be the answer. He points out that a high-dose radioactive implant placed in the tumor bed at the time of lumpectomy may eliminate or reduce the number of external radiation treatments and therefore reduce costs. Unfortunately, he does not provide any evidence to support the claim. Nor does he mention how this would help mastectomy patients. He goes on to describe how surgical evaluation of the axilla is unnecessary in most patients and that the clinically negative axilla can be treated with radiation, but fails to mention how axillary radiation will reduce costs. Does he mean to say that radioactive implants in the tumor bed treat the axilla as well? Dr. Lawrence brings up the very important issue of sentinel lymph node dissection (SLND). In our paper, which compared the cost of breast conservation surgery with that of modified radical mastectomy with and without immediate
436
Letters to the Editor / The American Journal of Surgery 182 (2001) 434 – 436
reconstruction, all patients underwent standard level 1 and 2 axillary lymph node dissection (ALND) and not SLND [1]. It would be interesting to see how SLND affects the cost of breast cancer surgery. However, since surgical evaluation of the axilla is still the standard of care in all cases of invasive breast cancer, regardless of whether the patient undergoes lumpectomy or mastectomy, the use of SLND is unlikely to affect the overall findings of our study. Recently there have been suggestions to omit axillary lymph node dissection in certain situations, and Dr. Lawrence addresses these. He suggests that the axillary lymph nodes need not be evaluated surgically in most cases of DCIS and T1a tumors and in all cases of T1c, T2 and T3 lesions where the axilla is clinically negative. He recommends SLND in high-grade T1a and DCIS tumors where a positive lymph node will make a difference in adjuvant therapy and in all T1b lesions. It must be pointed out that axillary lymph node dissection is still part of the standard surgical management of invasive breast cancer. Although it does not appear to affect survival, it has been shown to significantly reduce the risk of axillary recurrence [2]. In patients with a clinically negative axilla, SLND may well replace ALND. At present there does not appear to be sufficient evidence to omit surgical evaluation of the axilla, even if axillary radiation is planned, based on tumor size alone. In fact, with the emergence of SLND, the indications for surgical evaluation of the axilla have increased to include patients found to have DCIS on core biopsy who are considered to be at increased risk for occult lymph node metastases (extensive disease, high histological grade, or architectural distortion). As for patients with larger tumors, recent data show that SLND had an unacceptably high (33%) false-negative rate in patients who underwent preoperative chemotherapy [3].
In summary, there appear to be two issues here: (1) Can surgical evaluation of the axilla be eliminated in patients with stage T1cNOMO and higher breast cancer? At this point in time, I think one might consider eliminating axillary dissection only in the situation where the axilla is clinically negative and knowledge of the pathological status of the axilla would not change management, as in the case of patients with severe comorbid conditions such as advanced age. (2) is radiation therapy less expensive than axillary surgery? Given that radiation therapy appears to be the factor that makes breast conservation surgery more expensive than modified radical mastectomy with or without immediate reconstruction, I think one needs to see convincing cost data before assuming that radiation therapy is more cost effective than axillary dissection. Darlene M. Miltenburg, MD Department of Surgery Bayln College of Medicine Houston, Texas PII: S0002-9610(01)00693-6
References [1] Palit TK, Miltenburg DM, Brunicardi FC. Cost analysis of breast conservation surgery compared with modified radical mastectomy with and without reconstruction. Am J Surg 2000;179:441–5. [2] Fisher B, Redmond C, Fisher ER, et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med 1985;312:674 – 81. [3] Nason KS, Anderson BO, Byrd DR, et al. Increased false negative sentinel node biopsy rates after preoperative chemotherapy for invasive breast cancer. Cancer 2000;89:2187–94.
Cost-effective management of breast cancer To the Editor: I read with interest the cost comparisons of different local treatments in the curative management of early breast cancer [1]. The authors correctly point to the data being charges and not reimbursements. As surgical billing is a single all-inclusive cost, it is likely that the charges and reimbursement are closer than occurs in radiation therapy. Radiation charges are billed as itemized costs with ensuing lower reimbursements. The challenge to the medical communities is to reduce unnecessary costs and procedures without increasing patient morbidity or reducing cure rates. The surgical community has performed this task well by utilizing needle biopsies and other outpatient diagnostic procedures prior to the definitive treatment. Similarly, sentinel lymph node dissection (SLND) instead of axillary dissection (ALND) [2] may transform breast conservation surgery to an ambulatory setting, while decreasing false node negative (pNo) rates. Cost effectiveness of radiation therapy can be improved by maximizing its technology and benefit. Radioactive implant to the tumor bed (performed in a few institutions) can be done at the time of lumpectomy instead of as a separate procedure. With HDR (high-dose rate) brachytherapy, treatment is delivered in an outpatient setting. Brachytherapy reduces the dose (treatments) of external radiation to the breast or may eliminate external radiation entirely. Nodal radiation at the time of breast radiation may eliminate the need for axillary dissection in many cases without increasing the cost of radiation therapy. Systemic adjuvant therapy is the standard of care when the primary tumor exceeds 1 cm and risk of nodal disease (pN⫹) is significant. Hence, SLND is most valuable in T1b, high-grade T1a, and DCTS tumors where pN⫹ will make a difference in adjuvant therapy. Most DCIS and T1a tumors do not need nodal evaluation or nodal irradiation. Clinical T1cNoMo tumors have a 28% risk of pN⫹ [2] without factoring the false pNo rates. These patients need optimal adjuvant radiation to the lymph node chain along with systemic therapy, without SLND or ALND. There are increasing data from several randomized trials and a metaanalysis that nodal radiation improves local-regional tumor control, and disease-free and overall survival with a reduction in cancer mortality [3–5]. Clinical T2, 3, NoMo tumors have a 52% and 71% risk of pN⫹, respectively [2]. These patients would best be treated with breast conservation (without SLND or ALND) with neoadjuvant or adjuvant chemotherapy and locoregional radiation. Radiation treats the interpectoral nodes, the entire chain of axillary, subclavicular and supraclavicular nodes. When indicated, the internal mammary nodes can also be included in the radiation field. ALND deters radia-
435
tion therapy to the nodes because of increased risks of breast and arm lymphedema. However, ALND is indicated and therapeutic for palpable nodal disease. The test for the oncology community is to tailor various treatment approaches to each patient’s cancer to increase the patient’s probability of cure while reducing her physical and psychological morbidity. We may need to reconsider the belief that all early invasive breast cancers are the same and need identical locoregional treatment. Gilbert A. Lawrence, MD The Regional Cancer Center Radiation Oncology Faxton-St. Luke’s Healthcare Utica, New York PII: S0002-9610(01)00643-2
References [1] Palit TK, Miltenburg DM, Brunicardi CF. Cost analysis of breast conservation surgery compared with modified radical mastectomy without and without reconstruction. Am J Surg. 2000;179:441–5. [2] McMasters K, Tuttle, TM, Carlson DJ. et al. Sentinel lymph node biopsy for breast cancer: A suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol 2000;18:2560 –2566. [3] Whelan TJ, Julian J, Wright J. et al. Does locoregional radiation therapy improve survival in breast cancer? A Met-Analysis. J Clin Oncol 2000;18:1220 –1229. [4] Lawrence GA, Castro P, and Collins B. Breast Cancer: Systemic benefits of locoregional treatment. J Clin Oncol 1996;14:1403–1404. [5] Cuzick J, Stewart H. Rutqvist L et al. Cause-Specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy. J Clin Oncol 1994;12:447–53.
The Reply Once it becomes apparent that breast conservation surgery is more expensive than modified radical mastectomy with or without reconstruction, and that the increased cost appears to be due to radiation therapy charges, the next logical question is how to reduce those charges. Dr Lawrence has suggested that brachytherapy may be the answer. He points out that a high-dose radioactive implant placed in the tumor bed at the time of lumpectomy may eliminate or reduce the number of external radiation treatments and therefore reduce costs. Unfortunately, he does not provide any evidence to support the claim. Nor does he mention how this would help mastectomy patients. He goes on to describe how surgical evaluation of the axilla is unnecessary in most patients and that the clinically negative axilla can be treated with radiation, but fails to mention how axillary radiation will reduce costs. Does he mean to say that radioactive implants in the tumor bed treat the axilla as well? Dr. Lawrence brings up the very important issue of sentinel lymph node dissection (SLND). In our paper, which compared the cost of breast conservation surgery with that of modified radical mastectomy with and without immediate
436
Letters to the Editor / The American Journal of Surgery 182 (2001) 434 – 436
reconstruction, all patients underwent standard level 1 and 2 axillary lymph node dissection (ALND) and not SLND [1]. It would be interesting to see how SLND affects the cost of breast cancer surgery. However, since surgical evaluation of the axilla is still the standard of care in all cases of invasive breast cancer, regardless of whether the patient undergoes lumpectomy or mastectomy, the use of SLND is unlikely to affect the overall findings of our study. Recently there have been suggestions to omit axillary lymph node dissection in certain situations, and Dr. Lawrence addresses these. He suggests that the axillary lymph nodes need not be evaluated surgically in most cases of DCIS and T1a tumors and in all cases of T1c, T2 and T3 lesions where the axilla is clinically negative. He recommends SLND in high-grade T1a and DCIS tumors where a positive lymph node will make a difference in adjuvant therapy and in all T1b lesions. It must be pointed out that axillary lymph node dissection is still part of the standard surgical management of invasive breast cancer. Although it does not appear to affect survival, it has been shown to significantly reduce the risk of axillary recurrence [2]. In patients with a clinically negative axilla, SLND may well replace ALND. At present there does not appear to be sufficient evidence to omit surgical evaluation of the axilla, even if axillary radiation is planned, based on tumor size alone. In fact, with the emergence of SLND, the indications for surgical evaluation of the axilla have increased to include patients found to have DCIS on core biopsy who are considered to be at increased risk for occult lymph node metastases (extensive disease, high histological grade, or architectural distortion). As for patients with larger tumors, recent data show that SLND had an unacceptably high (33%) false-negative rate in patients who underwent preoperative chemotherapy [3].
In summary, there appear to be two issues here: (1) Can surgical evaluation of the axilla be eliminated in patients with stage T1cNOMO and higher breast cancer? At this point in time, I think one might consider eliminating axillary dissection only in the situation where the axilla is clinically negative and knowledge of the pathological status of the axilla would not change management, as in the case of patients with severe comorbid conditions such as advanced age. (2) is radiation therapy less expensive than axillary surgery? Given that radiation therapy appears to be the factor that makes breast conservation surgery more expensive than modified radical mastectomy with or without immediate reconstruction, I think one needs to see convincing cost data before assuming that radiation therapy is more cost effective than axillary dissection. Darlene M. Miltenburg, MD Department of Surgery Bayln College of Medicine Houston, Texas PII: S0002-9610(01)00693-6
References [1] Palit TK, Miltenburg DM, Brunicardi FC. Cost analysis of breast conservation surgery compared with modified radical mastectomy with and without reconstruction. Am J Surg 2000;179:441–5. [2] Fisher B, Redmond C, Fisher ER, et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med 1985;312:674 – 81. [3] Nason KS, Anderson BO, Byrd DR, et al. Increased false negative sentinel node biopsy rates after preoperative chemotherapy for invasive breast cancer. Cancer 2000;89:2187–94.