[Evaluation of efficacy and safety of bevacizumab combined with chemotherapy for Chinese patients with advanced non-small cell lung cancer]

Zhongguo Fei Ai Za Zhi. 2012 Jan;15(1):6-10. doi: 10.3779/j.issn.1009-3419.2012.01.02.
[Article in Chinese]

Abstract

Background and objective: The current study reported the result of bevacizumab treatment administered to 25 Chinese patients with advanced non-small cell lung cancer (NSCLC) who were treated at the Peking Union Medical College Hospital as a part of the SAiL (MO19390) trial. This trial is an open, international multicenter, single-arm clinical study that assesses the safety and efficacy of first-line bevacizumab-based therapy in advanced NSCLC.

Methods: Twenty-five Chinese patients with advanced non-squamous NSCLC received bevacizumab (15 mg/kg) combined with chemotherapy (carboplatin plus paclitaxel) treatment from August 2007 to February 2008. Adverse effects (AEs), objective response rate (ORR), median time to progression (TTP), and overall survival (OS) were measured.

Results: AEs were generally mild and reversible. The most frequent AEs were alopecia, peripheral neuropathy, rash, proteinuria, nausea/vomitting, fatigue, myalgia, bleeding, and hypertension. The partial remission and stable disease rates were 68% and 28%, respectively. The median TTP and OS of all patients were 11.2 and 19.3 months, respectively.

Conclusion: Bevacizumab combined with carboplatin-based chemotherapy may be well tolerated and beneficial for Chinese patients with non-squamous NSCLC.

背景与目的: SAiL(MO19390)研究是一项开放性、国际多中心、单组的临床试验,旨在评价一线使用贝伐珠单抗为基础的治疗在临床上的安全性及疗效。本文25例患者来自本研究中心入组SAiL试验的患者。

方法: 2007年8月-2008年2月在北京协和医院治疗的25例晚期非鳞非小细胞肺癌(non-squamous non-small cell lung cancer, NSNSCLC)患者,接受贝伐珠单抗联合紫杉醇/卡铂治疗,贝伐珠单抗剂量15 mg/kg。评价不良反应、客观有效率(objective response rate, ORR)、中位疾病进展时间(time to progression, TTP)和总生存期(overall survival, OS)。

结果: 最多见的不良反应为脱发、外周神经病变、皮疹、蛋白尿、恶心/呕吐、乏力、肌肉酸痛、鼻粘膜出血和高血压。17例(68%)评估为部分缓解(partial remission, PR),7例(28%)评估为疾病稳定(stable disease, SD),1例(4%)评估为疾病进展(progressive disease, PD),中位TTP为11.2个月,中位OS为19.3个月。

结论: 中国晚期NSNSCLC患者接受贝伐珠单抗治疗的耐受性好,可明显延长TTP和OS。

Publication types

  • Clinical Trial, Phase IV
  • English Abstract
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Bevacizumab
  • Carboplatin / administration & dosage
  • Carboplatin / adverse effects*
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects*

Substances

  • Antibodies, Monoclonal, Humanized
  • Bevacizumab
  • Carboplatin
  • Paclitaxel