Abstract 218P
Background
Palbociclib plus an aromatase inhibitor is approved for the treatment of HR+/HER2– ABC. In the PALOMA-2 trial, adding PAL to LET maintained quality-of-life outcomes in predominantly White, treatment-naive, postmenopausal women with HR+/HER2– ABC. We evaluated patient-reported outcomes (PROs) in Asian women with HR+/HER2– ABC receiving PAL + LET or placebo (PBO) + LET from the PALOMA-4 trial.
Methods
PALOMA-4 is a randomized, double-blind, phase III trial of PAL + LET vs PBO + LET in treatment-naive, postmenopausal Asian women with HR+/HER2– ABC. PROs were assessed at baseline, day 1 of cycles 2 and 3, then every other cycle from cycle 5 onward using the Functional Assessment of Cancer Therapy–Breast (FACT-B; included the FACT-G [General] and was also collected at follow-up visits) and EuroQoL 5-dimension 3-level (EQ-5D-3L; included the visual analog scale [VAS]) questionnaires. Group comparisons were analyzed using a longitudinal, mixed-effects model.
Results
Patients were assigned to PAL + LET (n=169) and PBO + LET (n=171). There were no significant between-arm differences in change from baseline in the FACT-B Total, FACT-G Total, Breast Cancer Subscale, FACT-G subscales or EQ-5D-3L index. A significant difference in change from baseline in mean VAS score favoring the PAL + LET arm was observed (3.36 [95% CI, 0.88–5.83]; P=0.008). When patients from both arms were combined, there were significant differences in the mean change from baseline for the Breast Cancer Subscale favoring patients who did not progress vs those who did (0.972 [95% CI, 0.05–1.89]; P=0.038) and for FACT-B Total score favoring patients who responded vs those who did not (3.84 [95% CI, 0.33–7.36]; p=0.032). No difference in FACT or EQ-5D-3L scores were observed in patients with vs without neutropenia.
Conclusions
The PROs demonstrate that quality of life is maintained in treatment-naive, postmenopausal Asian women with HR+/HER2– ABC treated with PAL + LET. Findings are consistent with PROs in the PALOMA-2 cohort and support the use of PAL as first-line treatment in Asian patients with HR+/HER2– ABC.
Clinical trial identification
Pfizer NCT02297438.
Editorial acknowledgement
Editorial support was provided by John Teiber, PhD, of ICON plc (Blue Bell, PA, USA) and was funded by Pfizer Inc. Funded by Pfizer Inc.
Legal entity responsible for the study
Pfizer.
Funding
Pfizer.
Disclosure
E. Broughton, H. Bhattacharyya, H. Zhao, J. Shen: Financial Interests, Personal, Other, Employee: Pfizer Inc. C. Huang: Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Lilly, Novartis, Pfizer Inc, Roche; Financial Interests, Personal, Sponsor/Funding: Amgen, AstraZeneca, Daiichi Sankyo, EirGenix, Lilly, MSD, Novartis, OBI, Pfizer, Roche; Financial Interests, Personal, Speaker’s Bureau: Roche. V. Sriuranpong: Financial Interests, Personal, Sponsor/Funding: Roche, MSD, Novartis, Pfizer Inc, AstraZeneca ; Financial Interests, Personal, Advisory Role: Roche, Novartis, Boehringer Ingelheim, Pfizer Inc, Amgen. K.C.R. Ngan: Financial Interests, Personal, Sponsor/Funding: Pfizer Inc; Financial Interests, Personal, Advisory Role: Pfizer Inc, Novartis, Sanofi, AstraZeneca, Lilly, MSD, Zai Lab, Roche, Eisai; Financial Interests, Personal, Speaker’s Bureau: Novartis, AstraZeneca, Sanofi, Pfizer Inc, Zai Lab, Eisai, Lilly, MSD. B. Xu: Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca. All other authors have declared no conflicts of interest.