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Type II Radical Hysterectomy: Evaluating Its Role in Cervical Cancer
Gynecologic Oncology 80, 1–2 (2001) doi:10.1006/gyno.2000.6077, available online at http://www.idealibrary.com on
EDITORIAL Type II Radical Hysterectomy: Evaluating Its Role in Cervical Cancer Peter G. Rose, M.D. Case Western Reserve University School of Medicine, University Hospitals of Cleveland, MacDonald Women’s Hospital, 11100 Euclid Avenue, Cleveland, Ohio 44106
frequently used in this study, with 54 and 55% of Type II and III radical hysterectomy patients, respectively, receiving adjuvant radiation. Eligible patients could have any size cervical tumor and even radiologic evidence of nodal metastasis. In view of this high rate of adjuvant postoperative radiation therapy, the effect of the extent of surgical resection may only truly be determined in 46 and 45% of study patients, respectively, who did not receive radiation. Is this trial large enough to prove equivalence? The study was powered to detect a 20% difference in death and morbidity. In view of the relatively high cure rate for early cervical cancer treated by radical hysterectomy, a larger trial would have been needed to detect small differences of this magnitude. An analagous situation occurred with the replacement of carboplatin in combination with paclitaxel for cisplatin and paclitaxel in ovarian cancer. Neijt et al. performed a randomized trial of 190 patients and compared these different regimens [11]. No statistical difference in outcome was evident. However, confirming equivalence required larger studies of almost 800 patients per trial. Therefore, before the initial results of Neijt et al. were accepted, two large randomized trials, GOG 158 and the Austrian-German Oncology trial, were performed [12, 13]. Both of these larger trials confirmed the initial results of Neijt et al. and the regimen of paclitaxel administered over 3 h and carboplatin has uniformly replaced former regimens. An identical sequence of trials is required before we can accept the current results of Landoni et al. as the new standard of care. We have too much at stake for the management of our young cervical cancer patients to accept anything less. The authors should be commended for the foresight in the planning, execution, and analysis of their trial. We hope it will stimulate larger trials with a more select patient population (Stage IB 1) to address this question further.
How radical a radical hysterectomy should be has been controversial. As the operating surgeon, in the absence of strong data, one is hesitant to be too conservative and possibly increase the risk of recurrence. Cervical cancer affects women at a younger age than any other cancer, and careful attention to the details of treatment can make the difference between life and death [1]. Although the Type II radical hysterectomy was described many years ago, its precise role in the management of cervical cancer was not well defined [2]. Over the past decade papers have begun to address the potential role of Type II radical hysterectomy. Photopolous et al. reported its use in patients with microinvasion (Stage IA 1) or cervical cancers where the extent of invasion was uncertain [3]. Furthermore, Magrina et al. reported decreased morbidity with Type II compared to Type III radical hysterectomy [4]. However, we now accept Type I hysterectomy as definitive treatment of microinvasive carcinoma (Stage IA 1) and even accept a cone biopsy if the patient desires fertility and is aware of the need for close surveillance [5, 6]. Perhaps Type II hysterectomy could be used for patients with Stage IA 2 cervical cancer? Burghardt et al. reported a 17% recurrence rate and 5.5% death rate with cone biopsy alone for patients with Stage IA 2 (defined by the 1985 staging system as ⱕ5 mm in depth and ⱕ7 mm in width of invasion) [7]. However, for a small cohort of a patients with Stage IA 2 treated by extrafascial (simple) hysterectomy, Yaegashi et al. reported no recurrences at a median follow-up of 66 months [8]. Additionally, Creasman et al. found no nodal metastasis or recurrences among 51 patients with Stage IA 2 squamous carcinoma treated by radical hysterectomy, confirming the excellent prognosis for this cohort of patients [9]. Landoni et al. in this issue provide a significantly higher level of evidence supporting the use of the Type II hysterectomy [10]. In a randomized trial with 243 patients with Stage IB 1–IIA cervical cancer, treatment by Type II or Type III hysterectomy had a similar recurrence-free and overall survival. The benefit of the Type II radical hysterectomy was a statistical decrease in the length of the operation and postoperative morbidity, particularly bladder dysfunction. Operative blood loss and transfusion requirements were not statistically less. However, adjuvant postoperative radiation therapy was
REFERENCES 1. SEER Cancer Statistics Review. 1973–1996 (NCI 1999) 2. Piver MS, Rutledge F, Smith JP: Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol 44:265–272, 1974 3. Photopolos GJ, Zwaag RV: Class II radical hysterectomy shows less morbidity and good treatment efficacy compared to class III. Gynecol Oncol 40:21–24, 1991 1
0090-8258/01 $35.00 Copyright © 2001 by Academic Press All rights of reproduction in any form reserved.
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EDITORIAL
4. Magrina JF, Goodrich MA, Wlaver AL, Podratz KC: Modified radical hysterectomy: morbidity and mortality. Gynecol Oncol 59:277–282, 1995 5. Sevin BU, Lu Y, Bloch DA, Nadji M, Koechli OR, Averette HE: Surgically defined prognostic parameters in patients with early cervical carcinoma: a multivariate survival tree analysis. Cancer 78:1438 –1443, 1996 6. Morris M: Management of Stage IA cervical carcinoma. J Natl Cancer Inst Monogr 21:47–52, 1996 7. Burghardt E, Girardi F, Lahousen M, Pickel H, Tamussino K: Microinvasive carcinoma of the uterine cervix (International Federation of Gynecology and Obstetrics Stage IA). Cancer 67:1037–1045, 1991 8. Yaegashi N, Sato S, Inoue Y, Noda K, Yajima A: Conservative surgical treatment in cervical cancer with 3 to 5 mm stromal invasion in the absence of confluent invasion and lymph–vascular space involvement. Gynecol Oncol 54:333–337, 1994 9. Creasman WT, Zaino RJ, Major FJ, DiSaia PJ, Hatch KD, Homesley HD: Early invasive carcinoma of the cervix (3 to 5 mm Invasion): Risk factors and prognosis. A Gynecologic Oncology Group Study. Am J Obstet Gynecol 178:62– 65, 1998
10. Landoni F, Maneo A, Cormio G, Patrizia P, Milani R, Caruso O, Mangioni C: Class II versus Class III radical hysterectomy in stage IB–IIA cervical cancer. A prospective randomized study. Gynecol Oncol 80:3–12 2001 11. Neijt JP, Hansen M, Hansen SW, Sorensen PG, Sessa C, Witteveen PO, Engelholm SA, Stigaard L, Roer O, Lund B: Randomized phase III study in previously untreated epithelial ovarian cancer FIGO stage IIB, IIC, III, IV, comparing paclitaxel-cisplatin and paclitaxel-carboplatin. Proc Am Soc Clin Oncol 16:352a, 1997 (abstract 1259) 12. Ozols RF, Bundy BN, Fowler J, Clarke-Pearson D, Mannel R, Hartenbach EM, Baergen R: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) vs carboplatin (Carbo)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group Trial (GOG 158). Proc Am Soc Clin Oncol 18:356a, 1999 (abstract 1373) 13. DuBois A, Lueck HJ, Meier W, Moebus V, Costa SD, Bauknecht T, Richter B, Warm M, Schroeder W, Olbricht S, Nitz U. Jackisch C: Cisplatin/paclitaxel vs carboplatin/paclitaxel in ovarian cancer: update of an Arbeitsgemeinschaft Gynakologische Okologie (AGO) study group trial. Proc Am Soc Clin Oncol 18:356a, 1999 (abstract 1374)
EDITORIAL Type II Radical Hysterectomy: Evaluating Its Role in Cervical Cancer Peter G. Rose, M.D. Case Western Reserve University School of Medicine, University Hospitals of Cleveland, MacDonald Women’s Hospital, 11100 Euclid Avenue, Cleveland, Ohio 44106
frequently used in this study, with 54 and 55% of Type II and III radical hysterectomy patients, respectively, receiving adjuvant radiation. Eligible patients could have any size cervical tumor and even radiologic evidence of nodal metastasis. In view of this high rate of adjuvant postoperative radiation therapy, the effect of the extent of surgical resection may only truly be determined in 46 and 45% of study patients, respectively, who did not receive radiation. Is this trial large enough to prove equivalence? The study was powered to detect a 20% difference in death and morbidity. In view of the relatively high cure rate for early cervical cancer treated by radical hysterectomy, a larger trial would have been needed to detect small differences of this magnitude. An analagous situation occurred with the replacement of carboplatin in combination with paclitaxel for cisplatin and paclitaxel in ovarian cancer. Neijt et al. performed a randomized trial of 190 patients and compared these different regimens [11]. No statistical difference in outcome was evident. However, confirming equivalence required larger studies of almost 800 patients per trial. Therefore, before the initial results of Neijt et al. were accepted, two large randomized trials, GOG 158 and the Austrian-German Oncology trial, were performed [12, 13]. Both of these larger trials confirmed the initial results of Neijt et al. and the regimen of paclitaxel administered over 3 h and carboplatin has uniformly replaced former regimens. An identical sequence of trials is required before we can accept the current results of Landoni et al. as the new standard of care. We have too much at stake for the management of our young cervical cancer patients to accept anything less. The authors should be commended for the foresight in the planning, execution, and analysis of their trial. We hope it will stimulate larger trials with a more select patient population (Stage IB 1) to address this question further.
How radical a radical hysterectomy should be has been controversial. As the operating surgeon, in the absence of strong data, one is hesitant to be too conservative and possibly increase the risk of recurrence. Cervical cancer affects women at a younger age than any other cancer, and careful attention to the details of treatment can make the difference between life and death [1]. Although the Type II radical hysterectomy was described many years ago, its precise role in the management of cervical cancer was not well defined [2]. Over the past decade papers have begun to address the potential role of Type II radical hysterectomy. Photopolous et al. reported its use in patients with microinvasion (Stage IA 1) or cervical cancers where the extent of invasion was uncertain [3]. Furthermore, Magrina et al. reported decreased morbidity with Type II compared to Type III radical hysterectomy [4]. However, we now accept Type I hysterectomy as definitive treatment of microinvasive carcinoma (Stage IA 1) and even accept a cone biopsy if the patient desires fertility and is aware of the need for close surveillance [5, 6]. Perhaps Type II hysterectomy could be used for patients with Stage IA 2 cervical cancer? Burghardt et al. reported a 17% recurrence rate and 5.5% death rate with cone biopsy alone for patients with Stage IA 2 (defined by the 1985 staging system as ⱕ5 mm in depth and ⱕ7 mm in width of invasion) [7]. However, for a small cohort of a patients with Stage IA 2 treated by extrafascial (simple) hysterectomy, Yaegashi et al. reported no recurrences at a median follow-up of 66 months [8]. Additionally, Creasman et al. found no nodal metastasis or recurrences among 51 patients with Stage IA 2 squamous carcinoma treated by radical hysterectomy, confirming the excellent prognosis for this cohort of patients [9]. Landoni et al. in this issue provide a significantly higher level of evidence supporting the use of the Type II hysterectomy [10]. In a randomized trial with 243 patients with Stage IB 1–IIA cervical cancer, treatment by Type II or Type III hysterectomy had a similar recurrence-free and overall survival. The benefit of the Type II radical hysterectomy was a statistical decrease in the length of the operation and postoperative morbidity, particularly bladder dysfunction. Operative blood loss and transfusion requirements were not statistically less. However, adjuvant postoperative radiation therapy was
REFERENCES 1. SEER Cancer Statistics Review. 1973–1996 (NCI 1999) 2. Piver MS, Rutledge F, Smith JP: Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol 44:265–272, 1974 3. Photopolos GJ, Zwaag RV: Class II radical hysterectomy shows less morbidity and good treatment efficacy compared to class III. Gynecol Oncol 40:21–24, 1991 1
0090-8258/01 $35.00 Copyright © 2001 by Academic Press All rights of reproduction in any form reserved.
2
EDITORIAL
4. Magrina JF, Goodrich MA, Wlaver AL, Podratz KC: Modified radical hysterectomy: morbidity and mortality. Gynecol Oncol 59:277–282, 1995 5. Sevin BU, Lu Y, Bloch DA, Nadji M, Koechli OR, Averette HE: Surgically defined prognostic parameters in patients with early cervical carcinoma: a multivariate survival tree analysis. Cancer 78:1438 –1443, 1996 6. Morris M: Management of Stage IA cervical carcinoma. J Natl Cancer Inst Monogr 21:47–52, 1996 7. Burghardt E, Girardi F, Lahousen M, Pickel H, Tamussino K: Microinvasive carcinoma of the uterine cervix (International Federation of Gynecology and Obstetrics Stage IA). Cancer 67:1037–1045, 1991 8. Yaegashi N, Sato S, Inoue Y, Noda K, Yajima A: Conservative surgical treatment in cervical cancer with 3 to 5 mm stromal invasion in the absence of confluent invasion and lymph–vascular space involvement. Gynecol Oncol 54:333–337, 1994 9. Creasman WT, Zaino RJ, Major FJ, DiSaia PJ, Hatch KD, Homesley HD: Early invasive carcinoma of the cervix (3 to 5 mm Invasion): Risk factors and prognosis. A Gynecologic Oncology Group Study. Am J Obstet Gynecol 178:62– 65, 1998
10. Landoni F, Maneo A, Cormio G, Patrizia P, Milani R, Caruso O, Mangioni C: Class II versus Class III radical hysterectomy in stage IB–IIA cervical cancer. A prospective randomized study. Gynecol Oncol 80:3–12 2001 11. Neijt JP, Hansen M, Hansen SW, Sorensen PG, Sessa C, Witteveen PO, Engelholm SA, Stigaard L, Roer O, Lund B: Randomized phase III study in previously untreated epithelial ovarian cancer FIGO stage IIB, IIC, III, IV, comparing paclitaxel-cisplatin and paclitaxel-carboplatin. Proc Am Soc Clin Oncol 16:352a, 1997 (abstract 1259) 12. Ozols RF, Bundy BN, Fowler J, Clarke-Pearson D, Mannel R, Hartenbach EM, Baergen R: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) vs carboplatin (Carbo)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group Trial (GOG 158). Proc Am Soc Clin Oncol 18:356a, 1999 (abstract 1373) 13. DuBois A, Lueck HJ, Meier W, Moebus V, Costa SD, Bauknecht T, Richter B, Warm M, Schroeder W, Olbricht S, Nitz U. Jackisch C: Cisplatin/paclitaxel vs carboplatin/paclitaxel in ovarian cancer: update of an Arbeitsgemeinschaft Gynakologische Okologie (AGO) study group trial. Proc Am Soc Clin Oncol 18:356a, 1999 (abstract 1374)