Health-Related Quality of Life Impact of Bevacizumab When Combined with Irinotecan, 5-Fluorouracil, and Leucovorin or 5-Fluorouracil and Leucovorin for Metastatic Colorectal Cancer
Health-Related Quality of Life Impact of Bevacizumab When Combined with Irinotecan, 5-Fluorouracil, and Leucovorin or 5-Fluorouracil and Leucovorin for Metastatic Colorectal Cancer
复制标题
DOI：
10.1634/theoncologist.2008-0003
复制
发表时间：
2008-01-01
期刊：
影响因子：
5.8
通讯作者：
Hurwitz, Herbert I.
中科院分区：
文献类型：
--
作者：
Kabbinavar, Fairooz F.;Wallace, Joel F.;Hurwitz, Herbert I.
目的.在两项随机、安慰剂对照研究中，比较既往未经治疗的转移性结直肠癌患者接受5-氟尿嘧啶（5-FU）为基础的化疗方案（加或不加贝伐单抗（BV））后至健康相关生活质量（HRQoL）恶化的时间。II期（研究2192）和III期（研究2107）研究中预先规定的HRQoL终点为至HRQoL恶化的时间，通过癌症治疗功能评估-结直肠（FACT-C）结直肠癌子量表（CCS）、试验结局指数（TOI-C）和FACT-C总分测量。使用分层对数秩检验，评估基线和基线后评估患者HRQoL恶化的时间。在关键III期试验中，127例接受伊立替康、5-FU和亚叶酸（LV）（IFL）治疗的患者和122例接受IFL + BV治疗的患者的HRQoL基线和基线后CCS评分可用。根据CCS、TOI-C或FACT-C总分测量，治疗组间至HRQoL恶化的时间无显著差异。在II期研究中，分别有77例和89例接受5-FU和LV以及5-FU和LV + BV治疗的患者的基线和基线后CCS评分可用。在该研究中，根据CCS和TOI-C评分测量的至HRQoL恶化的时间在两组之间相似，但5-FU和LV + BV组的FACT-C总评分显著长于5-FU和LV+安慰剂组。当加入5-FU化疗时，BV显著延长了总生存期和无进展生存期，而不影响HRQoL。肿瘤学家2008; 13：1021-1029
Purpose. To compare the time to deterioration in health-related quality of life (HRQoL) in patients with previously untreated metastatic colorectal cancer receiving a 5-fluorouracil (5-FU)-based chemotherapy regimen with or without the addition of bevacizumab (BV) in two randomized, placebo-controlled studies.Patients and Methods. Prespecified HRQoL endpoints in the phase II (Study 2192) and phase III (Study 2107) studies were time to deterioration in HRQoL, measured by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Colorectal Cancer Subscale (CCS), Trial Outcome Index (TOI-C), and FACT-C total score. Time to deterioration in HRQoL was evaluated for patients with baseline and postbaseline assessments, using the stratified log-rank test.Results. In the pivotal phase III trial, HRQoL baseline and postbaseline CCS scores were available for 127 patients receiving irinotecan, 5-FU, and leucovorin (LV) (IFL) and 122 patients receiving IFL plus BV. The time to deterioration in HRQoL did not differ significantly between treatment groups as measured by the CCS, TOI-C, or FACT-C total score. In the phase II study, baseline and postbaseline CCS scores were available for 77 and 89 patients receiving 5-FU and LV and 5-FU and LV plus BV, respectively. In that study, the time to deterioration in HRQoL was similar between groups as measured by the CCS and TOI-C scores, but was significantly longer in the 5-FU and LV plus BV arm than in the 5-FU and LV plus placebo arm for the FACT-C total score.Conclusions. When added to 5-FU chemotherapy, BV significantly prolonged overall survival and progression-free survival without compromising HRQoL. The Oncologist 2008; 13: 1021-1029