Cappuzzo Federico, Selvaggi Giovanni, Gregorc Vanesa, Mazzoni Francesca, Betti Maura, Rita Migliorino Maria, Novello Silvia, Maestri Antonio, De Marinis Filippo, Darwish Samir, De Angelis Verena, Nelli Fabrizio, Bartolini Stefania, Scagliotti Giorgio V, Tonato Maurizio, Crinò Lucio
Division of Medical Oncology, Bellaria Hospital, Bologna, Italy.
Cancer. 2003 Jul 1;98(1):128-34. doi: 10.1002/cncr.11460.
The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC).
From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m(2) on Days 1 and 8 and cisplatin, 70 mg/m(2) on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach.
After induction chemotherapy, 80 patients (62%; 95% confidence interval, 53.6-70.4%) achieved a partial response, 43 patients (33%) had stable disease, and 6 patients (5%) had disease progression during chemotherapy. Forty patients (31%), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29%), with 2% of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74%. The lungs (33%) and the brain (21%) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27%).
GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.
本试验的目的是评估一种新型铂类双联方案作为不可切除的IIIA期（肿大N2）和IIIB期非小细胞肺癌（NSCLC）患者新辅助治疗方案的活性和安全性。
从1996年6月至2000年4月，129例连续的局部晚期NSCLC患者接受吉西他滨治疗，在21天治疗周期的第1天和第8天给予1000mg/m²，顺铂在第2天给予70mg/m²（GC），共4个周期，作为综合治疗方法的一部分。
诱导化疗后，80例患者（62%；95%置信区间，53.6 - 70.4%）达到部分缓解，43例患者（33%）疾病稳定，6例患者（5%）在化疗期间疾病进展。40例患者（31%）被认为可切除并接受了开胸手术。38例患者（29%）实现了完全切除，2%的患者达到病理完全缓解。术后，9例IIIA期NSCLC患者和9例IIIB期NSCLC患者接受了根治性辅助放疗。52例IIIB期疾病患者中的46例和37例IIIA期疾病患者中不适合手术的24例接受了根治性放疗。疾病进展的中位时间为11.4个月，中位生存期为19.4个月（范围，1.2 - 55.2 +个月），1年生存率为74%。肺（33%）和脑（21%）是主要的复发部位。主要毒性包括3 - 4级血小板减少症，34例患者（27%）发生该毒性。
按照3周方案给予的GC在原发性、不可切除、局部晚期NSCLC患者中是一种活性高且安全的方案。
