A D Seidman1, A Brufsky2, R H Ansari3, L L Hart4, R S Stein5, L S Schwartzberg6, J F Stewart7, C A Russell8, S-C Chen9, L E Fein10, J A De La Cruz Vargas11, S-B Kim12, J Cavalheiro13, L Zhao14, J F Gill14, C K Obasaju14, M Orlando15, D F Tai14. 1. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York. Electronic address: seidmana@mskcc.org. 2. Women's Cancer Center, Magee Women's Hospital, Pittsburgh. 3. Michiana Hematology Oncology, South Bend. 4. Florida Cancer Specialists, Venice. 5. Department of Molecular Physiology and Biophysics, Vanderbilt-Ingram Cancer Center, Nashville. 6. Hematology and Medical Oncology, The West Clinic, Memphis, USA. 7. Calvary Mater Hospital, Waratah, Australia. 8. Department of Clinical Medicine, University of Southern California, Los Angeles, USA. 9. Department of Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan. 10. Centro de Oncologia Rosario, Santa Fe, Argentina. 11. Department of Oncology and Clinical Research, Acapulco Oncology Group, Acapulco, Mexico. 12. Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 13. Hospital de Clinicas, Porto Alegre, Brazil. 14. Lilly USA, LLC, Indianapolis. 15. Eli Lilly and Company, Indianapolis, USA.
Abstract
BACKGROUND:Safety and efficacy of gemcitabine plus docetaxel (GD) and capecitabine plus docetaxel (CD) were compared in patients with metastatic breast cancer, where the alternate crossover monotherapy (GD→C or CD→G) was predetermined. PATIENTS AND METHODS: Patients were randomly assigned to 3-week cycles of either gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 mg/m(2) on day 1 or capecitabine 1000 mg/m(2) twice daily on days 1-14 plus docetaxel 75 mg/m(2) day 1. Upon progression, patients received crossover monotherapy. Primary end point was time to progression (TtP). Secondary end points evaluated overall response rate (ORR), overall survival (OS), and adverse events (AEs). RESULTS: Despite over-accrual of 475 patients, the trial matured with only 324 of 385 planned TtP events due to patient discontinuations. Human epidermal growth factor receptor 2 status was not captured in this study. More CD patients (28%) discontinued due to AEs than GD patients (18.0%, P = 0.009). TtP [hazard ratio (HR) = 1.101, 95% confidence interval (CI) 0.885-1.370, P = 0.387] and OS (HR = 1.031, 95% CI 0.830-1.280, P = 0.785) were not significantly different comparing GD and CD. ORR was not statistically different (P = 0.239) comparing GD (72 of 207, 34.8%) and CD (78 of 191, 40.8%). TtP, OS, and ORR were not significantly different comparing crossover groups. GD caused greater fatigue, hepatotoxicity, neutropenia, and thrombocytopenia but not febrile neutropenia; CD caused more hand-foot syndrome, gastrointestinal toxicity, and mucositis. CONCLUSIONS: GD and CD produced similar efficacy and toxicity profiles consistent with prior clinical experience.
RCT Entities:
BACKGROUND: Safety and efficacy of gemcitabine plus docetaxel (GD) and capecitabine plus docetaxel (CD) were compared in patients with metastatic breast cancer, where the alternate crossover monotherapy (GD→C or CD→G) was predetermined. PATIENTS AND METHODS: Patients were randomly assigned to 3-week cycles of either gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 mg/m(2) on day 1 or capecitabine 1000 mg/m(2) twice daily on days 1-14 plus docetaxel 75 mg/m(2) day 1. Upon progression, patients received crossover monotherapy. Primary end point was time to progression (TtP). Secondary end points evaluated overall response rate (ORR), overall survival (OS), and adverse events (AEs). RESULTS: Despite over-accrual of 475 patients, the trial matured with only 324 of 385 planned TtP events due to patient discontinuations. Humanepidermal growth factor receptor 2 status was not captured in this study. More CDpatients (28%) discontinued due to AEs than GDpatients (18.0%, P = 0.009). TtP [hazard ratio (HR) = 1.101, 95% confidence interval (CI) 0.885-1.370, P = 0.387] and OS (HR = 1.031, 95% CI 0.830-1.280, P = 0.785) were not significantly different comparing GD and CD. ORR was not statistically different (P = 0.239) comparing GD (72 of 207, 34.8%) and CD (78 of 191, 40.8%). TtP, OS, and ORR were not significantly different comparing crossover groups. GD caused greater fatigue, hepatotoxicity, neutropenia, and thrombocytopenia but not febrile neutropenia; CD caused more hand-foot syndrome, gastrointestinal toxicity, and mucositis. CONCLUSIONS:GD and CD produced similar efficacy and toxicity profiles consistent with prior clinical experience.
Authors: Ann H Partridge; R Bryan Rumble; Lisa A Carey; Steven E Come; Nancy E Davidson; Angelo Di Leo; Julie Gralow; Gabriel N Hortobagyi; Beverly Moy; Douglas Yee; Shelley B Brundage; Michael A Danso; Maggie Wilcox; Ian E Smith Journal: J Clin Oncol Date: 2014-09-02 Impact factor: 44.544
Authors: L Schröder; B Rack; H Sommer; J G Koch; T Weissenbacher; W Janni; A Schneeweiss; M Rezai; R Lorenz; B Jäger; A Schramm; L Häberle; P A Fasching; T W P Friedl; M W Beckmann; C Scholz Journal: Geburtshilfe Frauenheilkd Date: 2016-05 Impact factor: 2.915
Authors: Siao-Nge Hoon; Peter Kh Lau; Alison M White; Max K Bulsara; Patricia D Banks; Andrew D Redfern Journal: Cochrane Database Syst Rev Date: 2021-05-26