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晚期非鳞状非小细胞肺癌患者在顺铂、培美曲塞和贝伐珠单抗诱导治疗后行多西他赛和贝伐珠单抗维持治疗的 II 期研究。

Switch maintenance therapy with docetaxel and bevacizumab after induction therapy with cisplatin, pemetrexed, and bevacizumab in advanced non-squamous non-small cell lung cancer: a phase II study.

机构信息

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.

Department of Clinical Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.

出版信息

Med Oncol. 2018 Jun 16;35(7):108. doi: 10.1007/s12032-018-1172-x.

Abstract

Switch maintenance therapy, using alternative agents that were not administered during induction chemotherapy, is a treatment option for advanced non-squamous non-small cell lung cancer (NSCLC). Bevacizumab is known to increase the efficacy of other chemotherapeutic agents; however, switch maintenance therapy with docetaxel and bevacizumab has not been adequately studied. The goal of this study was to evaluate the efficacy and safety of switch maintenance therapy with docetaxel and bevacizumab following induction therapy with cisplatin, pemetrexed, and bevacizumab. Chemotherapy-naïve non-squamous NSCLC patients received induction therapy of four cycles of cisplatin (75 mg/m), pemetrexed (500 mg/m), and bevacizumab (15 mg/kg). Patients who achieved disease control after induction therapy then received maintenance therapy with docetaxel (50 mg/m) and bevacizumab (15 mg/kg) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival from enrollment. This study enrolled 49 NSCLC patients, among which 38 (77.6%) completed the four cycles of induction therapy and received maintenance therapy. The median progression-free survival from enrollment was 7.8 months (95% confidence interval: 4.7-11.0 months). The most common toxicities of grade 3 or higher were neutropenia (68.4%), leukopenia (50.0%), febrile neutropenia (31.8%), and hypertension. Switch maintenance therapy with docetaxel and bevacizumab following induction therapy with cisplatin, pemetrexed, and bevacizumab demonstrated modest efficacy and frequent hematologic toxicity in non-squamous NSCLC patients.

摘要

切换维持治疗,使用诱导化疗期间未给予的替代药物,是晚期非鳞状非小细胞肺癌(NSCLC)的一种治疗选择。贝伐珠单抗已知能提高其他化疗药物的疗效;然而,多西他赛和贝伐珠单抗的切换维持治疗尚未得到充分研究。本研究的目的是评估顺铂、培美曲塞和贝伐珠单抗诱导治疗后,多西他赛和贝伐珠单抗切换维持治疗的疗效和安全性。化疗初治非鳞状 NSCLC 患者接受四个周期的顺铂(75mg/m)、培美曲塞(500mg/m)和贝伐珠单抗(15mg/kg)诱导治疗。诱导治疗后达到疾病控制的患者随后接受多西他赛(50mg/m)和贝伐珠单抗(15mg/kg)维持治疗,直至疾病进展或出现不可接受的毒性。主要终点是从入组开始的无进展生存期。本研究共纳入 49 例 NSCLC 患者,其中 38 例(77.6%)完成了四个周期的诱导治疗并接受了维持治疗。从入组开始的中位无进展生存期为 7.8 个月(95%置信区间:4.7-11.0 个月)。最常见的 3 级或以上毒性为中性粒细胞减少症(68.4%)、白细胞减少症(50.0%)、发热性中性粒细胞减少症(31.8%)和高血压。顺铂、培美曲塞和贝伐珠单抗诱导治疗后,多西他赛和贝伐珠单抗切换维持治疗在非鳞状 NSCLC 患者中显示出适度疗效和频繁的血液学毒性。

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