紫杉醇与贝伐单抗联合治疗高度预处理的非小细胞肺癌（NSCLC）患者：15例患者的病例系列研究

Combination of paclitaxel and bevacizumab in heavily pre-treated non-small-cell lung cancer (NSCLC) patients: a case series study on 15 patients.

作者信息

Le Moulec Sylvestre, Hadoux Julien, Gontier Eric, Chargari Cyrus, Helissey Carole, Lamand Virginie, Tanz Rachid, Farace Françoise, Vedrine Lionel, Bonardel Gérald, Soria Jean-Charles, Besse Benjamin

机构信息

Hôpital du Val-de-Grâce, service d'oncologie médicale, 74, boulevard de Port-Royal, 75005 Paris, France.

Gustave-Roussy Campus Cancer, 94805 Villejuif, France.

出版信息

Bull Cancer. 2013 Dec;100(12):30-7. doi: 10.1684/bdc.2013.1864.

DOI:10.1684/bdc.2013.1864

PMID:24316967

Abstract

BACKGROUND

The combination of paclitaxel and bevacizumab was EMA-approved as first-line therapy in metastatic breast cancer. Moreover, in vitro studies showed a potential antiangiogenic synergistic effect of paclitaxel and bevacizumab.

METHODS

Between November 2008 and March 2010, this case series study included 15 patients with metastatic non squamous-cell lung carcinoma (NSCLC). Those were bevacizumab eligible and received the same regimen used in metastatic breast cancer with weekly paclitaxel (80 mg/m(2), days 1, 8 and 15) and bevacizumab (10 mg/kg at days 1 and 15) after at least one prior line of chemotherapy. Efficacy was evaluated by CT-scan and PET-FDG every two months. Circulating endothelial progenitor cells (CEP) and circulating endothelial cells (CEC) levels were explored in a subset of patients.

RESULTS

Median age 56 (36-75), female: 47%, never smokers: 27%, adenocarcinoma: 100%, PS 0-1: 87% and PS 3: 13%. All patients were treated with a first-line platinum-based doublet with or without bevacizumab and 70% of them with erlotinib in the second-line. No major toxicity was observed. Partial response (PR) rate was 44% (31-63%) using RECIST criteria on CT-scan, and 65% (29-88%) with PET FDG. PS improved in 33% of the cases. Median progression free survival was 4.6 months. An increase of CEC and CEP was observed in patients with NSCLC treated with paclitaxel and bevacizumab.

CONCLUSION

In this retrospective series, our results suggest efficacy signal in pre-treated metastatic NSCLC and warrant further assessment in a randomized clinical trial.

摘要

背景

紫杉醇与贝伐单抗联合用药已获欧洲药品管理局（EMA）批准，可作为转移性乳腺癌的一线治疗方案。此外，体外研究显示紫杉醇与贝伐单抗具有潜在的抗血管生成协同效应。

方法

2008年11月至2010年3月期间，该病例系列研究纳入了15例转移性非鳞状细胞肺癌（NSCLC）患者。这些患者符合使用贝伐单抗的条件，在至少接受过一线化疗后，接受与转移性乳腺癌相同的治疗方案，即每周使用紫杉醇（80mg/m²，第1、8和15天）和贝伐单抗（第1天和第15天为10mg/kg）。每两个月通过CT扫描和PET-FDG评估疗效。在部分患者中检测循环内皮祖细胞（CEP）和循环内皮细胞（CEC）水平。

结果

中位年龄56岁（36 - 75岁），女性占47%，从不吸烟者占27%，腺癌占100%，体能状态（PS）为0 - 1级的占87%，PS为3级的占13%。所有患者均接受过含铂双药一线治疗，部分患者联合使用贝伐单抗，70%的患者在二线治疗时使用厄洛替尼。未观察到严重毒性反应。根据CT扫描的实体瘤疗效评价标准（RECIST），部分缓解（PR）率为44%（31% - 63%），PET-FDG检测的PR率为65%（29% - 88%）。33%的病例PS得到改善。中位无进展生存期为4.6个月。在用紫杉醇和贝伐单抗治疗的NSCLC患者中观察到CEC和CEP增加。