Cobo Dols Manuel, Villar Chamorro Esther, Alés Díaz Inmaculada, Gil Calle Silvia, Alcalde García Julia, Gutiérrez Calderón Vanesa, Carabantes Ocón Francisco, Montesa Pino Alvaro, Bretón García Juan J, Benavides Orgaz Manuel
Medical Oncology Section, Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Clin Transl Oncol. 2006 Oct;8(10):742-9. doi: 10.1007/s12094-006-0121-x.
Objective. We conducted this phase II trial to evaluate the efficacy and toxicity of the sequential nonplatinum combination chemotherapy consisting of gemcitabine (GEM) and vinorelbine (VNR) followed by weekly docetaxel (DOC) in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods.
stage IV NSCLC, Performance status =/< 2, adequate renal, hepatic and bone marrow function. Treatment consisted on: VNR 25 mg/m(2) plus gemcitabine 1000 mg/m(2), on days 1 and 8 of each 21-day cycle, followed by docetaxel 36 mg/m(2) weekly until progression or unacceptable toxicity. Results. 21 stage IV patients were enrolled. All patients are evaluable for treatment response and toxicity profile. The mean age of the patients was 63 years (range: 51 to 72) with 18 (86%) males and 3 (14%) females. Histology types were: adenocarcinoma in 8 patients (38%), large cell carcinoma in 1 patients (5%) and squamous cell carcinoma in 12 patients (57%). The majority of the patients had and ECOG PS of 1. Eight patients (38%) did not complete six cycles of gemcitabine-navelbine. The median number of cycles of gemcitabine-navelbine was 4 (range 2-6) Of the 13 patients (61%) who completed six cycles of gemcitabine-navelbine, all of them went on to receive weekly docetaxel and received at least 3 cycles, with a median number of 8 cycles (range 3- 16). The overall response rate was 33%. Respect survival, the minimum follow-up was 6 months (range, 6-25 months). The median survival time (MST) was 7.9 months, and the 1-year survival was 30%, and the median progression-free survival was 4.7 months. Toxicity was mild, well tolerated and mostly hematologic. In the GEM/VNR cycle, grade 3/4 neutropenia occurred in 14%, two patients with febrile neutropenia. Grade 3 anaemia in 1 patients (5%) and grade 3 thrombocytopenia in 1 patient (5%). Nonhematologic toxicity was also mild: 1 patient with Grade 3 skin toxicity with docetaxel, 1 patient with grade 3 infection, 2 patients with grade 3 astenia and 1 patient with a mild allergic reaction postchemotherapy treatment with docetaxel. Conclusion. The sequential triplet nonplatinum chemotherapy consisted of GEM/VNR followed by weekly DOC is active and can be administered safely in advanced NSCLC. Our results are similar with other sequential regimens and did not represent a significant improvement in the treatment of this disease.
目的。我们开展了这项II期试验，以评估吉西他滨（GEM）和长春瑞滨（VNR）序贯非铂类联合化疗，随后每周使用多西他赛（DOC）治疗晚期非小细胞肺癌（NSCLC）患者的疗效和毒性。患者与方法。
IV期NSCLC，体能状态≤2，肾功能、肝功能和骨髓功能良好。治疗方案为：在每21天周期的第1天和第8天，给予长春瑞滨25mg/m²加吉西他滨1000mg/m²，随后每周给予多西他赛36mg/m²，直至疾病进展或出现不可接受的毒性。结果。21例IV期患者入组。所有患者均可评估治疗反应和毒性情况。患者的平均年龄为63岁（范围：51至72岁），其中男性18例（86%），女性3例（14%）。组织学类型为：腺癌8例（38%），大细胞癌1例（5%），鳞状细胞癌12例（57%）。大多数患者的东部肿瘤协作组体能状态评分为1。8例患者（38%）未完成6个周期的吉西他滨 - 长春瑞滨化疗。吉西他滨 - 长春瑞滨的中位周期数为4（范围2 - 6）。在完成6个周期吉西他滨 - 长春瑞滨化疗的13例患者（61%）中，所有患者均继续接受每周一次的多西他赛治疗，且至少接受了3个周期，中位周期数为8个周期（范围3 - 16）。总缓解率为33%。关于生存情况，最短随访时间为6个月（范围，6 - 25个月）。中位生存时间（MST）为7.9个月，1年生存率为30%，中位无进展生存期为4.7个月。毒性较轻，耐受性良好，主要为血液学毒性。在吉西他滨/长春瑞滨周期中，3/4级中性粒细胞减少症发生率为14%，2例患者发生发热性中性粒细胞减少症。1例患者发生3级贫血（5%），1例患者发生3级血小板减少症（5%）。非血液学毒性也较轻：1例患者接受多西他赛治疗时出现3级皮肤毒性，1例患者发生3级感染，2例患者出现3级乏力，1例患者在多西他赛化疗后出现轻度过敏反应。结论。由吉西他滨/长春瑞滨序贯每周使用多西他赛组成的三联非铂类化疗方案具有活性，可安全用于晚期NSCLC。我们的结果与其他序贯方案相似，在该疾病的治疗中未显示出显著改善。
