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晚期非鳞状非小细胞肺癌患者在接受顺铂、吉西他滨和贝伐单抗诱导化疗后,改用口服长春瑞滨和贝伐单抗进行维持治疗:一项II期研究。

Switch maintenance treatment with oral vinorelbine and bevacizumab after induction chemotherapy with cisplatin, gemcitabine and bevacizumab in patients with advanced non-squamous non-small cell lung cancer: a phase II study.

作者信息

Petrioli Roberto, Francini Edoardo, Fiaschi Anna Ida, Laera Letizia, Luzzi Luca, Paladini Piero, Ghiribelli Claudia, Voltolini Luca, Bianco Vincenzo, Roviello Giandomenico

机构信息

Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Viale Bracci, 53100, Siena, Italy,

出版信息

Med Oncol. 2015 Apr;32(4):134. doi: 10.1007/s12032-015-0587-x. Epub 2015 Mar 22.

DOI:10.1007/s12032-015-0587-x
PMID:25796503
Abstract

The present study evaluated the efficacy and safety of cisplatin (Cis), gemcitabine (Gem) and bevacizumab (Bev), followed by maintenance treatment with Bev and oral vinorelbine (Vnb), in patients with advanced non-squamous non-small cell lung cancer (NSCLC). The patients were administered six cycles of induction chemotherapy consisting of intravenously (i.v.) Cis 70 mg/m(2) on day 1 plus i.v. Gem 1000 mg/m(2) on days 1 and 8, plus i.v. Bev 7.5 mg/kg on day 1, every 3 weeks. Patients who did not experience tumor progression remained on maintenance treatment with Bev combined with oral Vnb 60 mg/m(2) weekly until occurrence of disease progression or unacceptable toxicity. Thirty-seven patients were enrolled: The median age was 67 years (range 38-81); 22 patients were male, and 30 patients had stage IV tumors. The response rate was 32.4 % (95 % CI 18-49.7). The 9-month disease-control rate was 45.9 %. The median PFS was 8.4 months (95 % CI 4.4-10.7), and the median OS was 18.1 months (95 % CI 15.3-20.8 months). Grade 3-4 neutropenia occurred in 6 (16.2 %) patients and grade 3-4 thrombocytopenia in four (10.8 %) patients during induction chemotherapy. Bev- or Vnb-associated toxicities were mild. Switch maintenance treatment with Bev and oral Vnb after first-line Cis, Gem and Bev is feasible in patients with non-squamous NSCLC and may achieve encouraging results in terms of PFS and OS.

摘要

本研究评估了顺铂(Cis)、吉西他滨(Gem)和贝伐单抗(Bev)的疗效及安全性,随后采用贝伐单抗和口服长春瑞滨(Vnb)进行维持治疗,用于晚期非鳞状非小细胞肺癌(NSCLC)患者。患者接受六个周期的诱导化疗,具体方案为第1天静脉注射(i.v.)顺铂70mg/m²,第1天和第8天静脉注射吉西他滨1000mg/m²,第1天静脉注射贝伐单抗7.5mg/kg,每3周重复一次。未出现肿瘤进展的患者继续接受贝伐单抗联合口服长春瑞滨60mg/m²每周一次的维持治疗,直至疾病进展或出现不可接受的毒性反应。共纳入37例患者:中位年龄为67岁(范围38 - 81岁);22例为男性,30例为IV期肿瘤患者。缓解率为32.4%(95%CI 18 - 49.7)。9个月疾病控制率为45.9%。中位无进展生存期(PFS)为8.4个月(95%CI 4.4 - 10.7),中位总生存期(OS)为18.1个月(95%CI 15.3 - 20.8个月)。诱导化疗期间,6例(16.2%)患者出现3 - 4级中性粒细胞减少,4例(10.8%)患者出现3 - 4级血小板减少。与贝伐单抗或长春瑞滨相关的毒性反应较轻。对于非鳞状NSCLC患者,一线使用顺铂、吉西他滨和贝伐单抗后换用贝伐单抗和口服长春瑞滨进行维持治疗是可行的,且在PFS和OS方面可能取得令人鼓舞的结果。

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