pros and cons

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1 A Gynecologic Oncology Group Study Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: v.s. III GOG Marcus E. Randall, Virginia L. Filiaci, Hyman Muss, Nick M. Spirtos, Robert S. Mannel, Jeffrey Fowler, J. Tate Thigpen, and Jo Ann Benda J Clin Oncol 24, 36-44, pros and cons Purpose To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease. 2cmIII IV (WAI) (AP) Conclusion Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. AP WAI progression-free overall survival ( ( ) 5. 6.

2 To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease. 2cmIII IV (WAI) (AP) III IV Abdominal radiotherapy for cancer of the uterine cervix and endometrium. Potish RA, Int J Radiat Oncol Biol Phys. Jun;16(6):1453-8, (FIGO)III IV 49 open-field 2. surgical stagingwhole abdominal radiotherapy 3. 2cm The 5-year relapse-free rate was 63% in women with stage + CT III/IV endometrial carcinoma. 4. WBC3,000/l granulocyte1,500/l, platelets100,000/l creatinine2mg%, bilirubin1.5x, AST3X (EF) GOG PS:

3 Adjuvant whole abdomino-pelvic irradiation (WAPI) for high risk endometrial carcinoma Gibbons S, et.al. Int J Radiat Oncol Biol Phys. Sep;21(4): , 1991 III IV 56 WAPI The 7-year actuarial survival was 57.8% for Stage III, and 25.0% for Stage IV. Treatment of high-risk uterine cancer with whole abdomino-pelvic radiation therapy Ron S. et.al.int J Radiat Oncol Biol Phys48: , 2000 WAPI is a safe, effective treatment for patients with optimally debulked advanced-stage uterine endometrial carcinoma. DFS of 79% of 89% III IV 22 2cmIII IV ( ) control arm : 30Gy/20 (PALN): 15Gy/8 Phase II trial of adriamycin in the treatment of advanced Phase II trial of cisplatin as first-line chemotherapy in or recurrent endometrial carcinoma: patients with advanced or recurrent endometrial carcinoma: a GOG study. a GOG Study. Thigpen JT, et.al. Cancer Treat Rep. Jan;63(1):21-7, 1979 Thigpen JT, et.al. Gynecol Oncol. 33(1):68-70, mg/m23 43 CR CR (4%) 8 PR (16%) 2 SD (45%) (37.2%) 50% 2 Adriamycin is an active agent in the treatment of advanced or recurrent endometrial carcinoma. Cisplatin has definite activity when given at the dose and schedule tested to patients with endometrial carcinoma who have not received prior chemotherapy. CR PR SD PD 2/49 (4%) 8/49 (8%) 22/49 (45%) 17/49 (35%)

4 Phase III Trial of Doxorubicin With or Without Cisplatin in Advanced Endometrial Carcinoma: A GOG Study Thigpen, J. T. et al. J Clin Oncol; 22: Response (N = 281) Doxorubicin (n = 150) No. of Patients Complete response 12 Partial response 26 No response 112 HR: (95% CI, to 0.939; P =.014) % Doxorubicin + Cisplatin (n = 131) No. of Patients % (AP) (AP) 60mg/m2 50mg/m mg/m granulocyte1,500/l 100,000/l 2. 60mg/m2 15mg/m2 15mg/m G-CSF 5. 20% 2.0mg 6. Primary endpoint: Progression free survival (): Secondary endpoint: Overall survival (): % Hazard ratio33 ( =0.05) Follow-up ( ) ( 222 ) follow-up 74 Intent-to-treat

5 HR:0.71(95%CI,0.55 to 0.91; p=0.007) HR:0.68(95%CI,0.52 to 0.89; p=0.004)

6 Conclusion Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. Nevertheless, further advances in efficacy and reduction in toxicity are clearly needed. AP WAI