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多西他赛节拍给药治疗晚期复发性非小细胞肺癌的疗效与安全性。

Efficacy and safety of metronomic administration of paclitaxel for advanced recurrent non-small-cell lung cancer.

作者信息

Noronha V, Patil V M, Joshi A, Prabhash K

机构信息

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.

出版信息

Indian J Cancer. 2013 Apr-Jun;50(2):122-7. doi: 10.4103/0019-509X.117032.

DOI:10.4103/0019-509X.117032
PMID:23979203
Abstract

CONTEXT

There are limited effective therapeutic options in the relapsed setting for non-small cell lung cancer (NSCLC) or in the first line for platinum-ineligible patients.

AIM

To evaluate the safety and efficacy of a metronomic schedule of paclitaxel administered weekly in relapsed refractory NSCLC or upfront in patients not eligible for platinum-based chemotherapy.

SETTINGS AND DESIGN

Retrospective analysis of a prospectively collected database from the medical oncology department at Tata Memorial Hospital in Mumbai, India.

MATERIALS AND METHODS

Patients with recurrent and treatment-naïve platinum-ineligible advanced NSCLC were treated with weekly paclitaxel at 80 mg/m 2 with palliative intent. Restaging scans were obtained every two months. Chemotherapy was continued until progressive disease, intolerable side effects, or decision of the patient.

STATISTICAL ANALYSIS USED

SPSS version 16 was used for analysis. Simple percentages were used for descriptive statistics. Progression-free survival (PFS) was calculated from date of start of paclitaxel till the date of progression, change of therapy due to any reason, or death due to any cause. Overall survival (OS) was calculated from date of start of paclitaxel to death. The Kaplan Meier method was used for estimation of survival.

RESULTS

There were 37 patients over eight months. The median age was 59 years, with a male-to-female ratio of 5:1. Two patients received paclitaxel in the first line, 18 patients in second line, nine in third line, five in fourth line, and three were in fifth line. 73% patients had received prior platinum and 48.6% patients had Eastern Cooperative Oncology Group performance status (ECOG PS) >2. The median number of weekly cycles delivered was 14. The response rate was 35% [complete remission (CR): 2.7%, partial remission (PR): 32.4%, stable disease (SD): 32.4%, progressive disease (PD): 27%], the median PFS was four months, and the estimated median OS was seven months. Chemotherapy was well tolerated. The most frequent grade 3 toxicities included anemia: 8%, neutropenia: 5.4%, and sensory neuropathy: 8%. There were no grade 4 toxicities and no episodes of febrile neutropenia.

CONCLUSIONS

Weekly low-dose continuous metronomic-type scheduling of paclitaxel is safe and effective for relapsed refractory NSCLC and in the first line in platinum-ineligible patients.

摘要

背景

对于复发的非小细胞肺癌(NSCLC)患者或一线治疗中不符合铂类化疗条件的患者,有效的治疗选择有限。

目的

评估每周一次节拍器式紫杉醇给药方案在复发难治性NSCLC患者中的安全性和有效性,以及在不符合铂类化疗条件的患者一线治疗中的安全性和有效性。

设置与设计

对印度孟买塔塔纪念医院医学肿瘤科前瞻性收集的数据库进行回顾性分析。

材料与方法

复发且未接受过治疗的不符合铂类化疗条件的晚期NSCLC患者接受每周一次的紫杉醇治疗,剂量为80mg/m²,旨在缓解症状。每两个月进行一次重新分期扫描。化疗持续进行,直至疾病进展、出现无法耐受的副作用或患者做出决定。

所用统计分析方法

使用SPSS 16版进行分析。简单百分比用于描述性统计。无进展生存期(PFS)从紫杉醇开始给药日期计算至疾病进展日期、因任何原因改变治疗方案日期或因任何原因死亡日期。总生存期(OS)从紫杉醇开始给药日期计算至死亡日期。采用Kaplan-Meier方法估计生存期。

结果

8个月内共有37例患者。中位年龄为59岁,男女比例为5:1。2例患者一线接受紫杉醇治疗,18例二线治疗,9例三线治疗,5例四线治疗,3例五线治疗。73%的患者曾接受过铂类治疗,48.6%的患者东部肿瘤协作组体能状态(ECOG PS)>2。每周给药周期的中位数为14个。缓解率为35%[完全缓解(CR):2.7%,部分缓解(PR):32.4%,疾病稳定(SD):32.4%,疾病进展(PD):27%],中位PFS为4个月,估计中位OS为7个月。化疗耐受性良好。最常见的3级毒性反应包括贫血:8%,中性粒细胞减少:5.4%,感觉神经病变:8%。无4级毒性反应,也无发热性中性粒细胞减少事件。

结论

每周低剂量持续节拍器式紫杉醇给药方案对于复发难治性NSCLC患者以及不符合铂类化疗条件的一线患者是安全有效的。

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