Castellano D, Lianes P, Paz-Ares L, Hidalgo M, Guerra J A, Gómez-Martín C, Gómez H, Calzas J, Cortés-Funes H
Division of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Ann Oncol. 1998 Apr;9(4):457-9. doi: 10.1023/a:1008276507236.
The aim of this study was to determine the clinical activity and toxicity of a novel chemotherapy combination regimen of gemcitabine plus cisplatin, administered every three weeks, in patients with advanced non-small-cell lung cancer (NSCLC).
Twenty-six previously untreated stages III (14) and IV (12) patients were included. Gemcitabine was administered on days 1 and 8 at a dose of 1250 mg/m2 and cisplatin was administered at a dose of 100 mg/m2 on day 1, every 21 days.
Twenty-five patients were evaluable for response. One patient achieved a complete response, and 16 patients partial responses. The overall response rate was 65.3% (95% CI: 45%-82%). The main toxicity was hematological: neutropenia NCIC-CTC grade 3-4 in 54% of the patients, and thrombocytopenia grade 3-4 in 23%. The non-hematological toxicity was mild and tolerable. Only 13% of gemcitabine injections were dose-reduced or omitted due to toxicity. The actual dose-intensity of gemcitabine was 715 mg/m2/week, and 31 mg/m2/week for cisplatin. These figures represent the 86% and 93% of the theoretical dose intensity of both drugs, respectively. With a median follow-up of 10 months (range 7-13), 17 patients are still alive and nine have died. The median overall survival is 12 months.
This novel combination of gemcitabine and cisplatin administered every three weeks is well tolerated and induces a remarkably high response rate. The regimen proves more interesting than the four-week schedules, particularly regarding patients who are candidates for local therapy.
本研究旨在确定每三周给药一次的吉西他滨联合顺铂新型化疗方案对晚期非小细胞肺癌（NSCLC）患者的临床活性和毒性。
纳入26例既往未接受过治疗的III期（14例）和IV期（12例）患者。吉西他滨于第1天和第8天给药，剂量为1250mg/m²，顺铂于第1天给药，剂量为100mg/m²，每21天重复一次。
25例患者可评估疗效。1例患者达到完全缓解，16例患者部分缓解。总缓解率为65.3%（95%CI：45%-82%）。主要毒性为血液学毒性：54%的患者出现3-4级中性粒细胞减少，23%的患者出现3-4级血小板减少。非血液学毒性较轻且可耐受。仅13%的吉西他滨注射因毒性而减量或停药。吉西他滨的实际剂量强度为715mg/m²/周，顺铂为31mg/m²/周。这些数字分别代表两种药物理论剂量强度的86%和93%。中位随访10个月（范围7-13个月），17例患者仍存活，9例患者死亡。中位总生存期为12个月。
每三周给药一次的吉西他滨和顺铂新型联合方案耐受性良好，诱导出非常高的缓解率。该方案比四周方案更具优势，特别是对于适合局部治疗的患者。
