Gatzemeier U, Jagos U, Kaukel E, Koschel G, von Pawel J
Department of Thoracic Oncology, Hospital Grosshansdorf, Hamburg, Germany.
Semin Oncol. 1997 Aug;24(4 Suppl 12):S12-149-S12-152.
Carboplatin/etoposide is an active regimen in the treatment of small cell lung cancer. This phase II trial evaluated whether adding paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) to this two-drug combination might increase its efficacy. Since April 1996, 55 patients were entered into the ongoing protocol. To date, 35 patients are evaluable for efficacy and toxicity. Most of the evaluable patients are male (28). The patients' median age is 60 years (range, 36 to 74 years); 32 patients have Eastern Cooperative Oncology Group performance status ratings of 1, and the balance are Eastern Cooperative Oncology Group performance status 0. All patients had limited-stage disease. Patients received paclitaxel 175 mg/m2 via 1-hour intravenous infusion on day 1, carboplatin dosed to an area under the concentration-time curve of 5, also on day 1, and oral etoposide 100 mg on days 2 through 8. Overall, 31 patients responded to paclitaxel/carboplatin/etoposide therapy, including complete response in 13 patients (37.1%) and partial response in 18 patients (51.4%). Disease was stable in three patients (8.6%) and disease progressed in one (2.0%). Hematologic toxicity included neutropenia (World Health Organization grade 3 in 24.1% of patients, grade 4 in 31.3%), anemia (4% grade 3, no grade 4), and thrombocytopenia (3.2% grade 3, 2.1% grade 4). Nonhematologic adverse events included minor nausea/vomiting (1.5% grade 3, 9.2% grade 2), polyneuropathy (2.3% grade 2, 17.5% grade 1), and myalgia/arthralgia (8.2% grade 2, 16.4% grade 1). Paclitaxel/carboplatin/etoposide is active in small cell lung cancer with moderate toxicity and good subjective tolerance. There were no life-threatening hematologic or nonhematologic complications in this phase II trial.
卡铂/依托泊苷是治疗小细胞肺癌的一种有效方案。这项II期试验评估了在这种两药联合方案中加入紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）是否可能提高其疗效。自1996年4月以来，55例患者进入了正在进行的方案。迄今为止，35例患者可进行疗效和毒性评估。大多数可评估患者为男性（28例）。患者的中位年龄为60岁（范围36至74岁）；32例患者东部肿瘤协作组体能状态评分为1，其余为东部肿瘤协作组体能状态0。所有患者均为局限期疾病。患者在第1天接受175mg/m²紫杉醇1小时静脉输注，第1天也接受卡铂，剂量使浓度-时间曲线下面积达到5，第2至8天接受口服依托泊苷100mg。总体而言，31例患者对紫杉醇/卡铂/依托泊苷治疗有反应，包括13例患者完全缓解（37.1%）和18例患者部分缓解（51.4%）。3例患者疾病稳定（8.6%），1例患者疾病进展（2.0%）。血液学毒性包括中性粒细胞减少（世界卫生组织3级，占患者的24.1%，4级占31.3%）、贫血（4%为3级，无4级）和血小板减少（3.2%为3级，2.1%为4级）。非血液学不良事件包括轻微恶心/呕吐（1.5%为3级，9.2%为2级）、多发性神经病变（2.3%为2级，17.5%为1级）和肌痛/关节痛（8.2%为2级，16.4%为1级）。紫杉醇/卡铂/依托泊苷对小细胞肺癌有效，毒性中等，主观耐受性良好。在这项II期试验中没有危及生命的血液学或非血液学并发症。
