Marion T van Mackelenbergh1, Fenja Seither2, Volker Möbus3, Joyce O'Shaughnessy4, Miguel Martin5, Heikki Joensuu6, Michael Untch7, Ulrike Nitz8, Guenther G Steger9, Juan J Miralles10, Carlos H Barrios11, Masakazu Toi12, Harry D Bear13, Hyman Muss14, Toralf Reimer15, Valentina Nekljudova2, Sibylle Loibl2. 1. German Breast Group, Neu-Isenburg, Germany; Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein, Kiel, Germany. Electronic address: marion.vanmackelenbergh@gbg.de. 2. German Breast Group, Neu-Isenburg, Germany. 3. University Hospital Frankfurt, Frankfurt, Germany. 4. US Oncology Research, Inc., The Woodlands, TX, USA; Texas Oncology/Baylor University Medical Center, Dallas, TX, USA. 5. Instituto de Investigacion Sanitaria Gregorio Marañon, CIBERONC, Universidad Complutense, Madrid, Spain; Spanish Breast Cancer Group, GEICAM, Madrid, Spain. 6. Helsinki University Hospital, University of Helsinki, Helsinki, Finland. 7. Helios Kliniken Berlin-Buch, Berlin, Germany. 8. Breast Center Niederrhein, Evangelical Hospital Johanniter Bethesda, Mönchengladbach, Germany. 9. Department of Internal Medicine I and Gaston H. Glock Research Centre, Medical University of Vienna, Vienna, Austria. 10. Spanish Breast Cancer Group, GEICAM, Madrid, Spain. 11. Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil; Grupo Oncoclinicas, Porto Alegre, Brazil. 12. Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 13. NRG Oncology and Division of Surgical Oncology, Massey Cancer Center, Virginia Commonwealth University, VCU Health, Richmond, VA, USA. 14. University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. 15. Breast Center, University of Rostock, Rostock, Germany.
Abstract
BACKGROUND: Despite the large number of patients with early breast cancer (EBC) who have been treated with capecitabine in randomised trials, no individual patient data meta-analysis has been conducted. The primary objective was to examine the effect of capecitabine on disease-free survival (DFS), and the secondary objectives were to analyse distant DFS (DDFS), overall survival (OS), pathological complete response (for neoadjuvant studies) and the interaction between capecitabine-related toxicity and treatment effect. METHODS: www. CLINICALTRIALS: gov and www.pubmed.ncbi.nlm.nih.gov were searched using the following criteria: use of capecitabine for EBC as adjuvant or neoadjuvant therapy; multicentre randomised trial with >100 patients; recruitment completed, and outcomes available. Required data were available for 13 trials. RESULTS: Individual data from 15,993 patients were collected. Cox regression analyses of all included patients revealed that the addition of capecitabine did not alter DFS significantly compared with treatment without capecitabine (hazard ratio [HR] 0.952; 95% CI 0.895-1.012; P value = 0.115). There was also no effect on DFS in the subset of studies where capecitabine was given instead of another drug (HR 1.035; 95% CI 0.945-1.134; P = 0.455). However, capecitabine administered in addition to the standard systemic treatment improved DFS (HR 0.888; 95% CI 0.817-0.965; P = 0.005). An OS improvement was observed in the entire cohort (HR 0.892; 95% CI 0.824-0.965, P = 0.005) and in the subset of capecitabine addition (HR 0.837; 95% CI 0.751, 0.933, P = 0.001). Subgroup analyses revealed that triple-negative breast cancer (TNBC) patients benefitted from treatment with capecitabine overall and in addition to other systemic treatments in terms of DFS and OS. CONCLUSION: Capecitabine was able to improve DFS and OS in patients with TNBC and in all patients with EBC when administered in addition to systemic treatment.
BACKGROUND: Despite the large number of patients with early breast cancer (EBC) who have been treated with capecitabine in randomised trials, no individual patient data meta-analysis has been conducted. The primary objective was to examine the effect of capecitabine on disease-free survival (DFS), and the secondary objectives were to analyse distant DFS (DDFS), overall survival (OS), pathological complete response (for neoadjuvant studies) and the interaction between capecitabine-related toxicity and treatment effect. METHODS: www. CLINICALTRIALS: gov and www.pubmed.ncbi.nlm.nih.gov were searched using the following criteria: use of capecitabine for EBC as adjuvant or neoadjuvant therapy; multicentre randomised trial with >100 patients; recruitment completed, and outcomes available. Required data were available for 13 trials. RESULTS: Individual data from 15,993 patients were collected. Cox regression analyses of all included patients revealed that the addition of capecitabine did not alter DFS significantly compared with treatment without capecitabine (hazard ratio [HR] 0.952; 95% CI 0.895-1.012; P value = 0.115). There was also no effect on DFS in the subset of studies where capecitabine was given instead of another drug (HR 1.035; 95% CI 0.945-1.134; P = 0.455). However, capecitabine administered in addition to the standard systemic treatment improved DFS (HR 0.888; 95% CI 0.817-0.965; P = 0.005). An OS improvement was observed in the entire cohort (HR 0.892; 95% CI 0.824-0.965, P = 0.005) and in the subset of capecitabine addition (HR 0.837; 95% CI 0.751, 0.933, P = 0.001). Subgroup analyses revealed that triple-negative breast cancer (TNBC) patients benefitted from treatment with capecitabine overall and in addition to other systemic treatments in terms of DFS and OS. CONCLUSION: Capecitabine was able to improve DFS and OS in patients with TNBC and in all patients with EBC when administered in addition to systemic treatment.
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
Authors: Elisabeth K Trapp; Peter A Fasching; Tanja Fehm; Andreas Schneeweiss; Volkmar Mueller; Nadia Harbeck; Ralf Lorenz; Claudia Schumacher; Georg Heinrich; Fabienne Schochter; Amelie de Gregorio; Marie Tzschaschel; Brigitte Rack; Wolfgang Janni; Thomas W P Friedl Journal: Cancers (Basel) Date: 2022-08-16 Impact factor: 6.575