Cappuzzo Federico, De Marinis Filippo, Nelli Fabrizio, Calandri Cesare, Maestri Antonio, Benedetti Giovanni, Migliorino Maria Rita, Cortesi Enrico, Rastelli Francesca, Martelli Olga, Andruccetti Michele, Bartolini Stefania, Crinò Lucio
Division of Medical Oncology, Bellaria Hospital, Via Altura 3, 40139 Bologna, Italy.
Lung Cancer. 2003 Dec;42(3):355-61. doi: 10.1016/s0169-5002(03)00365-9.
Our objective was to determine the activity in terms of response rate, surgical resectability, and the tolerability of the new three-drug combination gemcitabine-cisplatin-paclitaxel (GCP) in unresectable stage IIIA(N2) and IIIB non-small cell lung cancer (NSCLC).
Forty-two chemo-naive patients with stage IIIA(N2)-IIIB NSCLC, median age of 59 years, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the ability to tolerate pneumectomy, received gemcitabine (Gem) 1000 mg/m(2) IV days 1 and 8, cisplatin (CDDP) 50 mg/m(2) IV days 1 and 8, paclitaxel 125 mg/m(2) 1h infusion IV days 1 and 8, every 21 days for 3 cycles. After induction chemotherapy, patients were evaluated for surgery or definitive radiotherapy.
Grade 3-4 neutropenia was the main hematologic toxicity, occurring in 28% of patients. Grade 3-4 thrombocytopenia was observed in only 11% of cases. No neutropenic fever or bleeding episodes were recorded. Severe non-hematologic toxicity was uncommon. Thirty (71%, 95% CI: 57.2-84.7%) of the 42 eligible patients had objective responses (1 complete and 29 partial responses). After induction chemotherapy, 21 patients (50%) went to surgery. Complete resection was obtained in 16 patients (38%). Viable tumor was present in 18 of 21 resection specimens. In three cases only necrotic tumor cells were identified, for a pathological complete response of 7%. With a median follow-up of 13.9 months, median time to progression was 17.4 months, median survival 21.7 months and estimated 1-year survival 92%.
GCP combination is active and well tolerated in locally-advanced, non-resectable NSCLC. The activity profile, in terms of response and surgical resection rate, is comparable to that obtained with standard doublets.
我们的目标是确定新的三联药物组合吉西他滨 - 顺铂 - 紫杉醇（GCP）在不可切除的IIIA（N2）期和IIIB期非小细胞肺癌（NSCLC）中的缓解率、手术可切除性及耐受性方面的活性。
42例初治的IIIA（N2）-IIIB期NSCLC患者，中位年龄59岁，东部肿瘤协作组（ECOG）体能状态为0或1，且能够耐受肺切除术，接受吉西他滨（Gem）1000mg/m²静脉滴注，第1天和第8天；顺铂（CDDP）50mg/m²静脉滴注，第1天和第8天；紫杉醇125mg/m²静脉滴注1小时，第1天和第8天，每21天为1个周期，共3个周期。诱导化疗后，对患者进行手术或根治性放疗评估。
3 - 4级中性粒细胞减少是主要的血液学毒性，发生在28%的患者中。仅11%的病例观察到3 - 4级血小板减少。未记录到中性粒细胞减少性发热或出血事件。严重的非血液学毒性不常见。42例符合条件的患者中有30例（71%，95%CI：57.2 - 84.7%）有客观缓解（1例完全缓解和29例部分缓解）。诱导化疗后，21例患者（50%）接受了手术。16例患者（38%）实现了完全切除。21份切除标本中有18份存在存活肿瘤。3例仅发现坏死肿瘤细胞，病理完全缓解率为7%。中位随访13.9个月，中位进展时间为17.4个月，中位生存期为21.7个月，估计1年生存率为92%。
GCP组合在局部晚期、不可切除的NSCLC中具有活性且耐受性良好。在缓解率和手术切除率方面的活性情况与标准双联方案相当。
