吉西他滨与卡铂联合方案对比丝裂霉素、异环磷酰胺和顺铂或丝裂霉素、长春碱和顺铂用于晚期非小细胞肺癌患者的Ⅲ期试验
Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma.
作者信息
Danson Sarah, Middleton Mark R, O'Byrne Kenneth J, Clemons Mark, Ranson Malcolm, Hassan Jurjees, Anderson Heather, Burt Paul A, Fairve-Finn Corrine, Stout Ronald, Dowd Isabel, Ashcroft Linda, Beresford Cheryl, Thatcher Nicholas
机构信息
Department of Medical Oncology, Christie Hospital National Health Service Trust, Manchester, United Kingdom.
出版信息
Cancer. 2003 Aug 1;98(3):542-53. doi: 10.1002/cncr.11535.
BACKGROUND
The authors compared gemcitabine and carboplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) or mitomycin, vinblastine, and cisplatin (MVP) in patients with advanced nonsmall cell lung carcinoma (NSCLC). The primary objective was survival. Secondary objectives were time to disease progression, response rates, evaluation of toxicity, disease-related symptoms, World Health Organization performance status (PS), and quality of life (QoL).
METHODS
Three hundred seventy-two chemotherapy-naïve patients with International Staging System Stage III/IV NSCLC who were ineligible for curative radiotherapy or surgery were randomized to receive either 4 cycles of gemcitabine (1000 mg/m(2) on Days 1, 8, and 15) plus carboplatin (area under the serum concentration-time curve, 5; given on Day 1) every 4 weeks (the GC arm) or MIC/MVP every 3 weeks (the MIC/MVP arm).
RESULTS
There was no significant difference in median survival (248 days in the MIC/MVP arm vs. 236 days in the GC arm) or time to progression (225 days in the MIC/MVP arm vs. 218 days in the GC arm) between the 2 treatment arms. The 2-year survival rate was 11.8% in the MIC/MVP arm and 6.9% in the GC arm. The 1-year survival rate was 32.5% in the MIC/MVP arm and 33.2% in the GC arm. In the MIC/MVP arm, 33% of patients responded (4 complete responses [CRs] and 57 partial responses [PRs]) whereas in the GC arm, 30% of patients responded (3 CRs and 54 PRs). Nonhematologic toxicity was comparable for patients with Grade 3-4 symptoms, except there was more alopecia among patients in the MIC/MVP arm. GC appeared to produce more hematologic toxicity and necessitated more transfusions. There was no difference in performance status, disease-related symptoms, or QoL between patients in the two treatment arms. Fewer inpatient stays for complications were required with GC.
CONCLUSIONS
The results of the current study failed to demonstrate any difference in efficacy between the newer regimen of GC and the older regimens of MIC and MVP. Cancer 2003;98:542-53.
背景
作者比较了吉西他滨联合卡铂（GC方案）与丝裂霉素、异环磷酰胺和顺铂（MIC方案）或丝裂霉素、长春碱和顺铂（MVP方案）用于晚期非小细胞肺癌（NSCLC）患者的疗效。主要研究目的是生存期。次要研究目的包括疾病进展时间、缓解率、毒性评估、疾病相关症状、世界卫生组织体能状态（PS）和生活质量（QoL）。
方法
372例未接受过化疗、国际分期系统为Ⅲ/Ⅳ期且不适合根治性放疗或手术的NSCLC患者被随机分为两组，一组每4周接受4个周期的吉西他滨（第1、8和15天，1000mg/m²）联合卡铂（血清浓度 - 时间曲线下面积为5，第1天给药）（GC组），另一组每3周接受MIC/MVP方案。
结果
两个治疗组之间的中位生存期（MIC/MVP组为248天，GC组为236天）或疾病进展时间（MIC/MVP组为225天，GC组为218天）无显著差异。MIC/MVP组的2年生存率为11.8%，GC组为6.9%。MIC/MVP组的1年生存率为32.5%，GC组为33.2%。在MIC/MVP组，33%的患者有反应（4例完全缓解[CR]和57例部分缓解[PR]），而在GC组，30%的患者有反应（3例CR和54例PR）。3 - 4级症状患者的非血液学毒性相当，但MIC/MVP组患者的脱发更多。GC方案似乎产生更多血液学毒性，需要更多输血。两个治疗组患者的体能状态、疾病相关症状或生活质量无差异。GC方案因并发症所需的住院天数更少。
结论
本研究结果未能显示GC新方案与MIC和MVP旧方案在疗效上有任何差异。《癌症》2003年；98：542 - 53。
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