A Phase I Dose Escalation Study of Weekly Docetaxel and Carboplatin in Elderly Patients With Nonsmall Cell Lung Cancer
A Phase I Dose Escalation Study of Weekly Docetaxel and Carboplatin in Elderly Patients With Nonsmall Cell Lung Cancer
复制标题
每周多西紫杉醇和卡铂治疗老年非小细胞肺癌患者的 I 期剂量递增研究
DOI：
--
复制
发表时间：
2007
期刊：
影响因子：
--
通讯作者：
M. Mori
中科院分区：
文献类型：
--
作者：
K. Kaira;S. Tsuchiya;N. Sunaga;N. Yanagitani;Satoru Watanabe;H. Imai;T. Hisada;T. Ishizuka;R. Saito;M. Mori
目的：我们进行了一项I期剂量递增研究，以确定每周多西他赛和卡铂联合治疗老年晚期非小细胞肺癌（NSCLC）患者的最大耐受剂量（MTD）、推荐剂量（RD）和安全性。患者和方法：首次化疗的IIIB期和IV期非小细胞肺癌患者，年龄60 ~ 70岁，ECOG 0 ~ 2，骨髓、肾、肝、心功能正常，采用多西他赛和卡铂治疗。多西他赛在第1天、第8天和第15天以20 mg/m2/周的递增剂量给药，随后以5 mg/m2的递增剂量给药，卡铂也从AUC 4至6 （mg/ml/min）开始递增剂量给药；每4周给药一次。在第一个化疗周期评估该方案的剂量限制毒性（DLT）。结果：有25名患者入组，并进行了安全性评估。中性粒细胞减少是该方案的主要DLT；3/4级中性粒细胞减少5例（20%）。血液学毒性较轻，包括1例3级血小板减少症（4%）和1例3级贫血（4%）。非血液学毒性一般较轻，包括1例3级便秘（4%）和1例3级肾病（4%）。客观缓解9例（有效率36%）。结论：MTD为卡铂AUC 5（第1天）和多西他赛30mg /m2（第1、8、15天）；因此，II期研究的RD为卡铂AUC 5和多西他赛30mg /m2。多西他赛联合卡铂治疗老年晚期NSCLC是一种可行且耐受性良好的方案。该方案值得在II期试验中进一步研究。
Objective:We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD), and the safety profile of a weekly docetaxel and carboplatin combination regimen in the treatment of elderly patients with advanced nonsmall cell lung cancer (NSCLC). Patients and methods:Chemotherapy-naive patients with stage IIIB and IV NSCLC, >70 years of age, performance status (ECOG) 0–2, with adequate bone marrow, renal, liver and cardiac function, were treated with docetaxel and carboplatin. Docetaxel was given at escalated doses starting from 20 mg/m2/wk on days 1, 8, and 15, with an increment of 5 mg/m2 followed by carboplatin also administered at escalated doses starting from AUC 4 to 6 (mg/ml/min); the regimen was administered every 4 weeks. The dose limiting toxicity (DLT) of the regimen was assessed during the first chemotherapy cycle. Results:There were 25 patients enrolled in this study and assessed for safety. Neutropenia was the main DLT of the regimen; grade 3/4 neutropenia occurred in 5 patients (20%). Hematologic toxicities were mild, and included grade 3 thrombocytopenia in 1 patient (4%) and grade 3 anemia in 1 patient (4%). Nonhematologic toxicities were generally mild, and included grade 3 constipation in 1 patient (4%) and grade 3 renal disorder in 1 patient (4%). Objective responses were seen in 9 patients (response rate 36%). Conclusions:The MTD was carboplatin AUC 5 on day 1 and docetaxel 30 mg/m2 on days 1, 8, and 15; therefore, the RD for the phase II study is carboplatin AUC 5 and docetaxel 30 mg/m2. The combination of docetaxel and carboplatin is a feasible and well-tolerated regimen for the treatment of elderly patients with advanced NSCLC. This regimen merits further investigation in phase II trials.
DOI：
10.1093/jnci/94.3.173
发表时间：
2002-02
期刊：
Journal of the National Cancer Institute
影响因子：
--
作者：
C. Langer;J. Manola;P. Bernardo;J. Kugler;P. Bonomi;D. Cella;David H. Johnson
通讯作者：
C. Langer;J. Manola;P. Bernardo;J. Kugler;P. Bonomi;D. Cella;David H. Johnson
影响因子：
158.5
作者：
Hutchins, LF;Unger, JM;Albain, KS
通讯作者：
Albain, KS
影响因子：
158.5
作者：
Schiller, JH;Harrington, D;Johnson, DH
通讯作者：
Johnson, DH