BACKGROUND: We evaluated the effect of adding secondary cytoreductive surgery to postoperative chemotherapy on progression-free survival and overall survival among patients who had advanced ovarian cancer and residual...BACKGROUND: We evaluated the effect of adding secondary cytoreductive surgery to postoperative chemotherapy on progression-free survival and overall survival among patients who had advanced ovarian cancer and residual tumor exceeding 1 c m in diameter after primary surgery. METHODS: Women were enrolled within six wee ks after primary surgery. If, after three cycles of postoperative paclitaxel plu s cisplatin, a patient had no evidence of progressive disease, she was randomly assigned to undergo secondary cytoreductive surgery followed by three more cycle s of chemotherapy or three more cycles of chemotherapy alone. RESULTS: We enroll ed 550 women. After completing three cycles of postoperative chemotherapy, 216 e ligible patients were randomly assigned to receive secondary surgical cytoreduct ion followed by chemotherapy and 208 to receive chemotherapy alone. Surgerywas d eclined by or medically contraindicated in 15 patients who were assigned to seco ndary surgery (7 percent). As of March 2003, 296 patients had died and 82 had pr ogressive disease. The likelihood of progression-free survival in the group ass igned to secondary surgery plus chemotherapy, as compared with the chemotherapy -alone group, was 1.07 (95 percent confidence interval, 0.87 to 1.31; P=0.54), and the relative risk of death was 0.99 (95 percent confidence interval, 0.79 to 1.24; P=0.92). CONCLUSIONS: For patients with advanced ovarian carcinoma in who m primary cytoreductive surgery was considered to be maximal, the addition of se condary cytoreductive surgery to postoperative chemotherapy with paclitaxel plus cisplatin does not improve progression-free survival or overall survival.展开更多
文摘BACKGROUND: We evaluated the effect of adding secondary cytoreductive surgery to postoperative chemotherapy on progression-free survival and overall survival among patients who had advanced ovarian cancer and residual tumor exceeding 1 c m in diameter after primary surgery. METHODS: Women were enrolled within six wee ks after primary surgery. If, after three cycles of postoperative paclitaxel plu s cisplatin, a patient had no evidence of progressive disease, she was randomly assigned to undergo secondary cytoreductive surgery followed by three more cycle s of chemotherapy or three more cycles of chemotherapy alone. RESULTS: We enroll ed 550 women. After completing three cycles of postoperative chemotherapy, 216 e ligible patients were randomly assigned to receive secondary surgical cytoreduct ion followed by chemotherapy and 208 to receive chemotherapy alone. Surgerywas d eclined by or medically contraindicated in 15 patients who were assigned to seco ndary surgery (7 percent). As of March 2003, 296 patients had died and 82 had pr ogressive disease. The likelihood of progression-free survival in the group ass igned to secondary surgery plus chemotherapy, as compared with the chemotherapy -alone group, was 1.07 (95 percent confidence interval, 0.87 to 1.31; P=0.54), and the relative risk of death was 0.99 (95 percent confidence interval, 0.79 to 1.24; P=0.92). CONCLUSIONS: For patients with advanced ovarian carcinoma in who m primary cytoreductive surgery was considered to be maximal, the addition of se condary cytoreductive surgery to postoperative chemotherapy with paclitaxel plus cisplatin does not improve progression-free survival or overall survival.
