Found 1 Presentation For Request "141P"
141P - Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple negative breast cancer
- Peter Schmid (London, United Kingdom)
- Peter Schmid (London, United Kingdom)
- Amin Haiderali (Kenilworth, United States of America)
- Jaime Mejia (North Wales, United States of America)
- Zifang Guo (North Wales, United States of America)
- Xuan Zhou (North Wales, United States of America)
- Allison Martin-Nguyen (Kenilworth, United States of America)
- Javier Cortés (Barcelona, Spain)
- Eric Winer (Boston, MA, United States of America)
Abstract
Background
KEYNOTE-119 (NCT02555657), an open-label, randomized, phase 3 trial for metastatic triple-negative breast cancer (mTNBC), evaluated IV pembrolizumab (P) 200 mg Q3W for up to 2 years vs investigator’s choice of chemotherapy (CT) as second-line or third-line treatment. In the primary analysis populations (all-comers, PD-L1 CPS≥1, PD-L1 CPS≥10), OS was not significantly different between P and CT. We present results of prespecified health-related quality of life (HRQoL) analyses in this study.
Methods
The EORTC QLQ-C30 and QLQ-BR23 were completed at baseline, various time points during treatment cycles up to 2 years or until end of treatment, and 30-day safety follow-up visit. Data were analyzed from patients receiving ≥1 dose of study treatment and completing ≥1 HRQoL assessment. Least-squares mean (LSM) change from baseline, 95% CIs, and nominal P values were calculated. Time to deterioration (TTD; ≥10-point worsening from baseline) was assessed by Kaplan-Meier method and Cox regression model. No formal hypothesis testing was performed.
Results
The HRQoL population included all-comers (P, n = 306; CT, n = 288), subjects with PD-L1 positive CPS≥1 tumors (P, n = 188; CT, n = 183), and subjects with PD-L1 positive CPS≥10 tumors (P, n = 86; CT, n = 91). Compliance for QLQ-C30 and QLQ-BR23 at week 6 was ≥90% in both arms for all patient populations. The benefit of P vs CT was observed in nearly all pre-specified PRO endpoints, particularly in CPS≥10 population. In this CPS-enriched population, the difference in LSM between arms in pre-specified systemic therapy side effects scale (-9.14; 95%CI, -13.16, -5.11; p<0.0001) and the nausea and vomiting scale (-6.19; 95%CI, -11.29, -1.09; p=0.0177) favored the P arm. There were differences between arms in the CPS≥10 population that favored P for the pre-specified LSM change from baseline in global health status (GHS)/QoL (4.21 (95% CI: -1.38, 9.80). Importantly, TTD in the GHS/QoL scale was longer for P compared to CT (4.3 months vs 1.7 months; HR 0.70; 95%CI; 0.46, 1.05) in the CPS-enriched population.
Conclusions
In this CPS-enriched population of patients with mTNBC receiving second and third-line treatments, HRQoL was better for patients receiving P than those receiving CT.
Clinical trial identification
NCT02555657; 2015-00100-27.
Legal entity responsible for the study
MSD-Merck, Sharp & Dohme.
Funding
MSD-Merck, Sharp & Dohme.
Disclosure
P. Schmid: Honoraria (self), Research grant/Funding (institution), Spouse/Financial dependant: Roche; Honoraria (self), Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Oncogenex; Honoraria (institution), Research grant/Funding (self): Novartis; Research grant/Funding (self): Astellas; Honoraria (self): Merck; Honoraria (self): Pfizer; Honoraria (self): Eisai; Honoraria (self): Bayer. A. Haiderali: Full/Part-time employment: MSD-Merck Sharp & Dohme. J. Mejia: Full/Part-time employment: MSD-Merck Sharp & Dohme. Z. Guo: Full/Part-time employment: MSD-Merck Sharp & Dohme. X. Zhou: Full/Part-time employment: MSD-Merck Sharp & Dohme. A. Martin-Nguyen: Full/Part-time employment: MSD-Merck Sharp & Dohme. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self): Eisai; Honoraria (self): Pfizer; Advisory/Consultancy: Samsung; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy: AstraZeneca; Shareholder/Stockholder/Stock options, Licensing/Royalties: MedSIR. E. Winer: Honoraria (self), Advisory/Consultancy: Genentech/Roche; Honoraria (institution), Advisory/Consultancy: Carrick Therapeutics; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy: Jounce; Honoraria (self), Advisory/Consultancy: Leap; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Seattle Genetics.