Hope S Rugo1, Nicholas C Turner2, Richard S Finn3, Anil A Joy4, Sunil Verma5, Nadia Harbeck6, Norikazu Masuda7, Seock-Ah Im8, Xin Huang9, Sindy Kim10, Wan Sun11, Shrividya Iyer12, Patrick Schnell13, Cynthia Huang Bartlett14, Stephen Johnston15. 1. University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 1600 Divisidero St, San Francisco, CA 94115, USA. Electronic address: hope.rugo@ucsf.edu. 2. Institute of Cancer Research and Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK. Electronic address: nick.turner@icr.ac.uk. 3. David Geffen School of Medicine at UCLA, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA 90404, USA. Electronic address: rfinn@mednet.ucla.edu. 4. Cross Cancer Institute, 11560 University Avenue NW, Edmonton, AB T6G1Z2, Canada. Electronic address: dr_a_joy@yahoo.com. 5. University of Calgary, 1403-29 St. N.W., Calgary, AB, Canada. Electronic address: drsunil.verma@ahs.ca. 6. Breast Center, University of Munich (LMU), Marchioninistrasse 15, Munich 81377, Germany. Electronic address: nadia.harbeck@med.uni-muenchen.de. 7. National Hospital Organization Osaka National Hospital, 2 Chome-1-14 Hoenzaka, Chuo, Osaka, Osaka Prefecture 540-0006, Japan. Electronic address: nmasuda@alpha.ocn.ne.jp. 8. Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, 101 Daehak-ro, Jongro-gu, Seoul 03080, South Korea. Electronic address: moisa@snu.ac.kr. 9. Pfizer Inc, 10646 Science Center Dr, San Diego, CA 92121, USA. Electronic address: xin.huang@pfizer.com. 10. Pfizer Inc, 10646 Science Center Dr, San Diego, CA 92121, USA. Electronic address: sindy.kim@pfizer.com. 11. Pfizer Inc, 10646 Science Center Dr, San Diego, CA 92121, USA. Electronic address: wan.sun@pfizer.com. 12. Pfizer Inc, 235 E 42nd St, New York, NY 10017, USA. Electronic address: shrividya.iyer@pfizer.com. 13. Pfizer Inc, 235 E 42nd St, New York, NY 10017, USA. Electronic address: patrick.schnell@pfizer.com. 14. Pfizer Inc, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: cynthia.huang@pfizer.com. 15. Institute of Cancer Research and Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK. Electronic address: stephen.johnston@rmh.nhs.uk.
Abstract
AIM: Because incidence of breast cancer and comorbidities increase with age, it is important to determine treatment benefit in elderly patients. We evaluated outcomes with palbociclib plus endocrine therapy in patients aged ≥65 years. METHODS: Data were pooled from three randomised studies (NCT00721409, NCT01740427 and NCT01942135) of women with HR+/HER2- advanced breast cancer (ABC). In PALOMA-1 (open-label) and PALOMA-2 (double-blind, placebo-controlled), treatment-naïve patients received palbociclib plus letrozole or letrozole alone. In PALOMA-3 (double-blind, placebo-controlled), patients with endocrine-resistant disease receivedpalbociclib plus fulvestrant or fulvestrant alone. RESULTS: Among 528 patients treated withpalbociclib plus letrozole and 347 treated with palbociclib plus fulvestrant, 218 (41.3%) and 86 (24.8%), respectively, were aged ≥65 years. Versus endocrine therapy alone, median progression-free survival was significantly improved in patients aged 65-74 years (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.45-0.97; P = 0.016) and ≥75 years (HR, 0.31; 95% CI, 0.16-0.61; P<0.001) receiving palbociclib plus letrozole and in patients aged 65-74 years (HR, 0.27; 95% CI, 0.16-0.48; P<0.001) receiving palbociclib plus fulvestrant; few patients aged ≥75 years received palbociclib plus fulvestrant (HR, 0.59; 95% CI, 0.19-1.8; P = 0.18). Patient-reported functioning and quality of life was maintained. No clinically relevant differences in palbociclib exposure were observed between age groups. Although myelosuppression was more common among patients aged ≥75 years, incidence of grade ≥III myelosuppression was similar across age groups, and febrile neutropenia was uncommon (≤2.4%); no new safety concerns were identified in older patients. CONCLUSIONS:Palbociclib plus endocrine therapy is an effective, well-tolerated treatment for older patients with ABC.
RCT Entities:
AIM: Because incidence of breast cancer and comorbidities increase with age, it is important to determine treatment benefit in elderly patients. We evaluated outcomes with palbociclib plus endocrine therapy in patients aged ≥65 years. METHODS: Data were pooled from three randomised studies (NCT00721409, NCT01740427 and NCT01942135) of women with HR+/HER2- advanced breast cancer (ABC). In PALOMA-1 (open-label) and PALOMA-2 (double-blind, placebo-controlled), treatment-naïve patients received palbociclib plus letrozole or letrozole alone. In PALOMA-3 (double-blind, placebo-controlled), patients with endocrine-resistant disease received palbociclib plus fulvestrant or fulvestrant alone. RESULTS: Among 528 patients treated with palbociclib plus letrozole and 347 treated with palbociclib plus fulvestrant, 218 (41.3%) and 86 (24.8%), respectively, were aged ≥65 years. Versus endocrine therapy alone, median progression-free survival was significantly improved in patients aged 65-74 years (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.45-0.97; P = 0.016) and ≥75 years (HR, 0.31; 95% CI, 0.16-0.61; P<0.001) receiving palbociclib plus letrozole and in patients aged 65-74 years (HR, 0.27; 95% CI, 0.16-0.48; P<0.001) receiving palbociclib plus fulvestrant; few patients aged ≥75 years received palbociclib plus fulvestrant (HR, 0.59; 95% CI, 0.19-1.8; P = 0.18). Patient-reported functioning and quality of life was maintained. No clinically relevant differences in palbociclib exposure were observed between age groups. Although myelosuppression was more common among patients aged ≥75 years, incidence of grade ≥III myelosuppression was similar across age groups, and febrile neutropenia was uncommon (≤2.4%); no new safety concerns were identified in older patients. CONCLUSIONS:Palbociclib plus endocrine therapy is an effective, well-tolerated treatment for older patients with ABC.
Authors: Danielle B Tometich; Kelly A Hyland; Hatem Soliman; Heather S L Jim; Laura Oswald Journal: Cancers (Basel) Date: 2020-12-08 Impact factor: 6.639
Authors: Harold J Burstein; Mark R Somerfield; Debra L Barton; Ali Dorris; Lesley J Fallowfield; Dharamvir Jain; Stephen R D Johnston; Larissa A Korde; Jennifer K Litton; Erin R Macrae; Lindsay L Peterson; Praveen Vikas; Rachel L Yung; Hope S Rugo Journal: J Clin Oncol Date: 2021-07-29 Impact factor: 44.544