BACKGROUND: There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. METHODS: This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: The study included 101 female patients with median age of 57 (IQR 48-62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5-41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5-43.7) months, median PFS and OS were 5.98 (95%CI 4.96-7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3-4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25-0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20-0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008-0.206, p = 0.000) with OS. CONCLUSION: Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.
BACKGROUND: There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. METHODS: This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: The study included 101 female patients with median age of 57 (IQR 48-62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5-41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5-43.7) months, median PFS and OS were 5.98 (95%CI 4.96-7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3-4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25-0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20-0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008-0.206, p = 0.000) with OS. CONCLUSION:Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.
Authors: Richard S Finn; John P Crown; Istvan Lang; Katalin Boer; Igor M Bondarenko; Sergey O Kulyk; Johannes Ettl; Ravindranath Patel; Tamas Pinter; Marcus Schmidt; Yaroslav Shparyk; Anu R Thummala; Nataliya L Voytko; Camilla Fowst; Xin Huang; Sindy T Kim; Sophia Randolph; Dennis J Slamon Journal: Lancet Oncol Date: 2014-12-16 Impact factor: 41.316
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Authors: Gabriel N Hortobagyi; Salomon M Stemmer; Howard A Burris; Yoon-Sim Yap; Gabe S Sonke; Shani Paluch-Shimon; Mario Campone; Kimberly L Blackwell; Fabrice André; Eric P Winer; Wolfgang Janni; Sunil Verma; Pierfranco Conte; Carlos L Arteaga; David A Cameron; Katarina Petrakova; Lowell L Hart; Cristian Villanueva; Arlene Chan; Erik Jakobsen; Arnd Nusch; Olga Burdaeva; Eva-Maria Grischke; Emilio Alba; Erik Wist; Norbert Marschner; Anne M Favret; Denise Yardley; Thomas Bachelot; Ling-Ming Tseng; Sibel Blau; Fengjuan Xuan; Farida Souami; Michelle Miller; Caroline Germa; Samit Hirawat; Joyce O'Shaughnessy Journal: N Engl J Med Date: 2016-10-07 Impact factor: 91.245
Authors: Akaolisa Samuel Eziokwu; Leticia Varella; Megan Lynn Kruse; Xuefei Jia; Halle C F Moore; George Thomas Budd; Jame Abraham; Alberto J Montero Journal: Clin Breast Cancer Date: 2020-10-02 Impact factor: 3.225