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
| Autor: | David Cella, Kathleen J. Yost, Jing Yi, Herbert Hurwitz, Joel F. Wallace, Fairooz F. Kabbinavar, Eric Holmgren |
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| Rok vydání: | 2008 |
| Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Bevacizumab Leucovorin Phases of clinical research Antibodies Monoclonal Humanized Irinotecan Disease-Free Survival law.invention Randomized controlled trial Quality of life law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Neoplasm Metastasis Prospective cohort study business.industry Antibodies Monoclonal Chemotherapy regimen Treatment Outcome Fluorouracil Disease Progression Quality of Life Camptothecin Female Colorectal Neoplasms business medicine.drug |
| Zdroj: | The Oncologist. 13:1021-1029 |
| ISSN: | 1549-490X 1083-7159 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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