Article type
Year
Abstract
Background: Breast cancer is the most common cancer diagnosed worldwide. In China, more than one million new cases of breast cancer were diagnosed and around 30 thousand females were dead each year. Vinca alkaloid containing regimens have been widely used in China and other developing counties for advanced breast cancer due to the price and availability.
Objective: To investigate effects of vinca alkaloid containing regimen for advanced breast cancer
Methods: The specialized register maintained by the Editorial Base of Cochrane Breast Cancer Group, Cochrane Central Register of Controlled Trials, Pubmed, Embase and Chinese Biomedical database were searched to March 2003. The published randomized controlled trials comparing vinca alkaloid containing regimen with regimen not containing vinca alkaloid in women with advanced breast cancer would be included. Studies were assessed for eligibility and quality. Treatment response, time-to-event data, quality of life and adverse effects were extracted by intent-to-treat methods, where appropriate. Quality appraisal and data extraction wee performed by two independent reviewers.
Overall effects and effects in subgroups were calculated by using fixed and random effects model. Sensitivity analyses were conducted based on study quality, samples and duration of trials. Subgroups were classified according to types of vinca alkaloid (vinblastine, vincristine, vinorelbine, vindesine), types of regimen (vinca alkaloid alone vs. regimen not containing vinca alkaloid; vinca alkaloid plus regimen A vs. regimen A; vinca alkaloid plus regimen A vs. regimen B), and option of use (first-line therapy and second-line therapy).
Results: Forty trials involving 6,006 patients were included, of which 636 patients were loss of follow up. Generation of randomization and blinding were generally not described. Thirty-nine trials involving 5653 patients assessed the overall effect of treatment response, and there was no statistic significance between vinca alkaloid containing regimen and regimen not containing vinca alkaloid (95% CI=0.90-1.17, P=0.66). All the subgroup analyses also indicated no statistical significance except that vinblastine containing regimen might be less effective for advanced breast cancer (95% CI=0.31-0.99, P =0.05).
Time-to-event data were temporarily unavailable as they were under data synthesis. Thirteen trials involving 2363 patients assessed survival rate, and there was no statistical significance between vinca alkaloid containing regimen and regimen not containing regimen (95% CI=0.85-1.18, P=1.00). Results from subgroup analyses also showed no statistical significance. However, vinca alkaloid alone or vinblastine containing regimen might decrease survival rate (95% CI=0.68-0.99, 0.52-0.86, P=0.04, 0.002).
Two trials involving 466 patients reported quality of life by using EORTC QLQ-C30, and there was no statistical difference in global health status scores.
Total and subgroup adverse effects in vinca alkaloid containing regimen and regimen not containing vinca alkaloid were comparable. Gastrointestinal disorders were lower if vinca alkaloid was administrated alone (95% CI = 0.52-0.98, P=0.04). However, neurological toxicity was higher in vinca alkaloid containing regimen. (95% CI=1.80-3.73, P<0.00001)
Conclusions: Vinca alkaloid containing regimen might be equal or even worse in efficacy than regimen not containing vinca alkaloid, and might increase adverse effects in neurological system. Further report on time-to-event data would be available soon.
Objective: To investigate effects of vinca alkaloid containing regimen for advanced breast cancer
Methods: The specialized register maintained by the Editorial Base of Cochrane Breast Cancer Group, Cochrane Central Register of Controlled Trials, Pubmed, Embase and Chinese Biomedical database were searched to March 2003. The published randomized controlled trials comparing vinca alkaloid containing regimen with regimen not containing vinca alkaloid in women with advanced breast cancer would be included. Studies were assessed for eligibility and quality. Treatment response, time-to-event data, quality of life and adverse effects were extracted by intent-to-treat methods, where appropriate. Quality appraisal and data extraction wee performed by two independent reviewers.
Overall effects and effects in subgroups were calculated by using fixed and random effects model. Sensitivity analyses were conducted based on study quality, samples and duration of trials. Subgroups were classified according to types of vinca alkaloid (vinblastine, vincristine, vinorelbine, vindesine), types of regimen (vinca alkaloid alone vs. regimen not containing vinca alkaloid; vinca alkaloid plus regimen A vs. regimen A; vinca alkaloid plus regimen A vs. regimen B), and option of use (first-line therapy and second-line therapy).
Results: Forty trials involving 6,006 patients were included, of which 636 patients were loss of follow up. Generation of randomization and blinding were generally not described. Thirty-nine trials involving 5653 patients assessed the overall effect of treatment response, and there was no statistic significance between vinca alkaloid containing regimen and regimen not containing vinca alkaloid (95% CI=0.90-1.17, P=0.66). All the subgroup analyses also indicated no statistical significance except that vinblastine containing regimen might be less effective for advanced breast cancer (95% CI=0.31-0.99, P =0.05).
Time-to-event data were temporarily unavailable as they were under data synthesis. Thirteen trials involving 2363 patients assessed survival rate, and there was no statistical significance between vinca alkaloid containing regimen and regimen not containing regimen (95% CI=0.85-1.18, P=1.00). Results from subgroup analyses also showed no statistical significance. However, vinca alkaloid alone or vinblastine containing regimen might decrease survival rate (95% CI=0.68-0.99, 0.52-0.86, P=0.04, 0.002).
Two trials involving 466 patients reported quality of life by using EORTC QLQ-C30, and there was no statistical difference in global health status scores.
Total and subgroup adverse effects in vinca alkaloid containing regimen and regimen not containing vinca alkaloid were comparable. Gastrointestinal disorders were lower if vinca alkaloid was administrated alone (95% CI = 0.52-0.98, P=0.04). However, neurological toxicity was higher in vinca alkaloid containing regimen. (95% CI=1.80-3.73, P<0.00001)
Conclusions: Vinca alkaloid containing regimen might be equal or even worse in efficacy than regimen not containing vinca alkaloid, and might increase adverse effects in neurological system. Further report on time-to-event data would be available soon.