Memorial NN Blokhin Russian Cancer Research Center RAMS, Moscow, Russia.
Anticancer Drugs. 2011 Jul;22(6):569-75. doi: 10.1097/CAD.0b013e328342d50a.
This single-arm, multicenter, phase II study examined the objective response rate and toxicity after neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with stage IB-IIIA non-small cell lung cancer. Treatment consisted of three 21-day cycles of gemcitabine (1000 mg/m(2)) on days 1 and 8 and cisplatin (75 mg/m(2)) on day 1 of each cycle. Surgery was performed 4-5 weeks after day 1 of the last cycle of study therapy. A total of 52 patients from five investigative sites in Russia were enrolled in the study, of which 50 (96.2%) received study therapy. Of the 49 patients who were evaluable for response, six (12.2%) had a complete response and 16 (32.7%) had a partial response, resulting in an overall response rate of 44.9%. Disease progression occurred in four out of the 49 (8.2%) patients. Radical tumor resection was performed in 38 out of the 49 (77.6%) patients. A total of 41 patients were assessed for a pathological complete response, of which four (9.8%) patients had pathological complete tumor regression. Postsurgical restaging was performed in 36 out of the 41 (87.8%) patients. Tumor downstaging occurred in 16 out of the 36 (44.4%) patients. Grade 3/4 neutropenia and thrombocytopenia were experienced by 28.0%/6.0% patients and 6.0%/2.0% patients, respectively. Grade 3 anemia occurred in 4.0% of the patients. Nonhematological toxicity was mild. Overall mortality was 30.0% (15 out of 50 patients), predominantly from progressive disease. The 1-year overall survival rate was 74.4% (95% confidence interval: 61.3-87.6%). Neoadjuvant chemotherapy with gemcitabine and cisplatin showed a good safety profile with an encouraging possibility of curative surgery in patients with early-stage non-small cell lung cancer.
这项单臂、多中心、二期研究评估了新辅助化疗中吉西他滨和顺铂治疗 IB-IIIA 期非小细胞肺癌患者的客观缓解率和毒性。治疗包括三个 21 天周期的吉西他滨（1000mg/m2），第 1 天和第 8 天，顺铂（75mg/m2），每个周期的第 1 天。研究治疗最后一个周期的第 1 天 4-5 周后进行手术。共有来自俄罗斯五个研究点的 52 名患者入组该研究，其中 50 名（96.2%）接受了研究治疗。在可评估反应的 49 名患者中，6 名（12.2%）患者完全缓解，16 名（32.7%）患者部分缓解，总缓解率为 44.9%。49 名患者中有 4 名（8.2%）疾病进展。38 名可评估患者（77.6%）进行了根治性肿瘤切除术。共有 41 名患者接受了病理完全缓解评估，其中 4 名（9.8%）患者肿瘤完全消退。36 名可评估患者中的 36 名（87.8%）患者进行了术后重新分期。36 名患者中有 16 名（44.4%）肿瘤降期。3 级/4 级中性粒细胞减少和血小板减少分别见于 28.0%/6.0%的患者和 6.0%/2.0%的患者，4.0%的患者出现 3 级贫血。非血液学毒性较轻。总死亡率为 30.0%（50 名患者中有 15 名），主要死于疾病进展。1 年总生存率为 74.4%（95%置信区间：61.3-87.6%）。新辅助化疗中吉西他滨和顺铂具有良好的安全性，为早期非小细胞肺癌患者提供了有希望的根治性手术机会。
