Rothenberg M L, Ozols R F, Glatstein E, Steinberg S M, Reed E, Young R C
Medicine Branch, National Cancer Institute, Bethesda, MD.
J Clin Oncol. 1992 May;10(5):727-34. doi: 10.1200/JCO.1992.10.5.727.
The primary goal of this trial was to evaluate the clinical activity of a high-dose cisplatin-based induction regimen for women with advanced-stage ovarian cancer. A secondary goal was to assess the use of whole-abdominal radiation as consolidative therapy in the subset of women left with less than 5 mm residual disease after completion of chemotherapy.
Fifty consecutive patients with newly diagnosed, advanced-stage ovarian cancer received cisplatin 40 mg/m2/d and cyclophosphamide 200 mg/m2/d intravenously (IV) for 5 days, every 4 to 6 weeks. After three to four cycles of chemotherapy, patients who still had residual disease less than 5 mm in greatest diameter at second-look surgery were given whole-abdominal radiotherapy.
The overall response rate in 49 patients assessable for response was 61.3% (24.5% pathologic complete responses [pCRs], 32.7% pathologic partial responses [pPRs], and 4.1% clinical partial responses [cPRs]). Median survival for all patients was 23.4 months, and actuarial 4-year survival was 33.7% (95% confidence interval [CI], 21.8% to 48.1%). Multivariate analysis showed stage III and serous histology as independent favorable prognostic factors for survival. Median survival for stage III patients was 36.5 months, with an actuarial 4-year survival of 41.6% (95% CI, 25.5% to 59.6%). Median survival for stage IV patients was 12.0 months, with actuarial 4-year survival of 22.9% (95% CI, 9.5% to 45.5%). The major acute toxicities encountered were myelosuppression and peripheral neuropathy. Patients who received consolidative radiotherapy were at increased risk of developing late-onset enteropathy.
This regimen is active against advanced-stage ovarian cancer, but the associated toxicity is severe. Consolidative whole-abdominal radiation did not appear to prolong survival in the subset of women left with less than 5 mm residual disease after chemotherapy.
本试验的主要目标是评估以大剂量顺铂为基础的诱导方案对晚期卵巢癌女性患者的临床活性。次要目标是评估在化疗完成后残留病灶小于5 mm的女性亚组中，全腹放疗作为巩固治疗的应用情况。
50例新诊断的晚期卵巢癌患者，每4至6周静脉注射顺铂40 mg/m²/天和环磷酰胺200 mg/m²/天，持续5天。在三至四个周期的化疗后，二次探查手术时最大直径残留病灶仍小于5 mm的患者接受全腹放疗。
49例可评估反应的患者的总体反应率为61.3%（24.5%为病理完全缓解[pCR]，32.7%为病理部分缓解[pPR]，4.1%为临床部分缓解[cPR]）。所有患者的中位生存期为23.4个月，4年精算生存率为33.7%（95%置信区间[CI]，21.8%至48.）。多因素分析显示III期和浆液性组织学是生存的独立有利预后因素。III期患者的中位生存期为36.5个月，4年精算生存率为41.6%（95%CI，25.5%至59.6%）。IV期患者的中位生存期为12.0个月，4年精算生存率为22.9%（95%CI，9.5%至45.5%）。主要的急性毒性反应为骨髓抑制和周围神经病变。接受巩固性放疗的患者发生迟发性肠病的风险增加。
该方案对晚期卵巢癌有活性，但相关毒性严重。在化疗后残留病灶小于5 mm的女性亚组中，巩固性全腹放疗似乎并未延长生存期。
