Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: A gynecologic oncology group study
Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: A gynecologic oncology group study
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DOI：
10.1200/jco.1998.16.2.405
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发表时间：
1998-02-01
影响因子：
45.3
通讯作者：
Homesley, HD
中科院分区：
文献类型：
--
作者：
Rose, PG;Blessing, JA;Homesley, HD
目的：进行了第二阶段的试验，以确定长期口服依托泊苷在铂耐药和铂敏感的卵巢carcinoma.Patients和方法的活动：铂耐药的疾病被定义为进展铂为基础的化疗或复发6个月内完成治疗。起始剂量为50 mg/m2/d（既往放疗为30 mg/m2/d），共21天，每28天一次。剂量递增至最大剂量60 mg/m2/d.Results：99例患者中，97例可评估毒性，82例可评估反应。在41例铂类耐药患者中，缓解率为26.8%（7.3%完全缓解[CR]和19.5%部分缓解[PR]率）。中位缓解持续时间为4.3个月（范围，1.3至8.7），中位无进展间隔（PFI）为5.7个月（范围，0.8至30.8+），中位生存时间为10.8个月（范围，1.9至45.8）。41名铂类耐药患者中有25名既往接受过紫杉醇治疗，其中8名（32%）有反应。在41例铂敏感患者中，有效率为34.1%（CR率为14.6%，PR率为19.5%）。中位缓解持续时间为7.5个月（范围：1.9至15.2+），中位PFI为6.3+个月（范围：0.9至20.4），中位生存时间为16.5+个月（范围：0.9至34.8）。在97例可评估毒性的患者中，3级或4级血液学毒性常见，白细胞减少症发生率为41.2%（3级，29%; 4级，12%），中性粒细胞减少症发生率为45.4%（3级，20%; 4级，25%），血小板减少症发生率为9%（3级，5%; 4级，4%），贫血发生率为13.4%。发生了3例治疗相关死亡：2例死于血供减少性败血症，1例死于药物过量后血供减少性出血。结论：该方案对铂类耐药和铂类敏感的卵巢癌均有较好的疗效。此外，该方案在紫杉醇耐药的卵巢癌中有效。(C)1998年，美国临床肿瘤学会。
Purpose: A phase II trial was conducted to determine the activity of prolonged oral etoposide in platinum resistant and platinum-sensitive ovarian carcinoma.Patients and Methods: platinum-resistant disease was defined as progression on platinum-based chemotherapy or recurrence within 6 months of completing therapy. The starting dose was 50 mg/m(2)/d (30 mg/m(2)/d for prior radiotherapy) for 21 days, every 28 days. A dose escalation to a maximum dose of 60 mg/m(2)/d was prescribed.Results: Of 99 patients entered, 97 were assessable for toxicity and 82 were assessable for response. Among 41 platinum-resistant patients a 26.8% response rate (7.3% complete response [CR] and 19.5% partial response [PR] rate) occurred. The median response duration was 4.3 months (range, 1.3 to 8.7), median progression-free interval (PFI) was 5.7 months (range, 0.8 to 30.8+), and median survival time was 10.8 months (range, 1.9 to 45.8). Twenty five of 41 platinum-resistant patients had also previously received paclitaxel; of which eight (32%) responded. Among 41 platinum-sensitive patients, a 34.1% response rate (14.6% CR and 19.5% PR rate) occurred. The median response duration was 7.5 months (range, 1.9 to 15.2+), median PFI was 6.3+ months (range, 0.9 to 20.4), and median survival time was 16.5+ months (range, 0.9 to 34.8). Of 97 patients assessable For toxicity, grade 3 or 4 hematologic toxicity was common, with leukopenia occurring in 41.2% (grade 3, 29%; grade 4, 12%), neutropenia in 45.4% (grade 3, 20%; grade 4, 25%), thrombocytopenia in 9% (grade 3, 5%; grade 4, 4%), and anemia in 13.4%. Three treatment-related deaths occurred: two from neutropenic sepsis and one from thrombocytopenic bleeding after an overdose. One patient developed leukemia.Conclusion: This regimen is active in platinum-resistant and platinum-sensitive ovarian carcinoma. Additionally, the regimen is active in paclitaxel-resistant ovarian carcinoma. (C) 1998 by American Society of Clinical Oncology.