122MO - Quality of life from the Penelope-B study on high-risk HR+/HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib

Background

The PENELOPE-B trial did not demonstrate improved invasive disease-free survival with the addition of one year of palbociclib to endocrine therapy (ET) compared to placebo plus ET in high risk HR+/HER2- early breast cancer patients with residual invasive breast cancer following neoadjuvant therapy. This analysis compared patient-reported outcomes (PROs) between the two treatment groups.

Methods

Patients were randomized 1:1 to receive palbociclib 125 mg/day (n=631) or placebo (n=619) orally for 3 weeks followed by 1 week off plus ET per standard of care. PROs were assessed during screening, on day 1 of cycles 1, 3, 5, 7, 9, 11, then, every 6 months after end of treatment visit using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) and its breast cancer (BR23) and fatigue (FA13) modules. Higher scores of C30 and FA13 (range 0-100) indicate better functioning and global health status/quality of life (GHS/QoL) or worse symptom severity, respectively. Repeated-measures mixed-effects models were used to evaluate differences in PRO between treatment groups, changes of PRO over time, and treatment-by-time interactions.

Results

Overall, 924 of 1250 patients (73.9%) completed the baseline and at least one post baseline questionnaire of all PRO instruments. GHS/QoL by the EORTC QLQ-C30 was generally high in both treatment arms (mean [SD]: palbociclib 70.1 [19.3], placebo 71.4 [18.8]) and was slightly higher in the placebo arm (LeastSquare mean difference: 0.82, p<0.001), especially during the active treatment phase of the study. Higher fatigue was reported in the palbociclib compared to placebo arm (mean [SD]: 30.3 [23.8] vs. 28.3 [22.7]; p<0.001). In contrast, no statistically significant differences were observed among the FA13 physical, cognitive, and emotional fatigue subscales.

Conclusions

In general, patient-reported QoL and fatigue was maintained during the study in both treatment arms. Statistically significant differences were observed between treatments in favor of the placebo arm; however, none were clinically relevant.

Clinical trial identification

NCT01864746

Editorial acknowledgement

Legal entity responsible for the study

German Breast Group.

Funding

Pfizer Inc.

Disclosure

J.A. García-Saenz: Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Seagen; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Funding: MSD; Financial Interests, Other: Roche. F. Marmé: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK/Tesaro; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Myriad; Financial Interests, Personal, Other: PharmaMar; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Janssen-Cilag. H.S. Rugo: Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Odonate; Financial Interests, Institutional, Research Grant: Daiichi; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Sermonix; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Polyphor; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Personal, Advisory Role: Puma; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Samsung. 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Untch: Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AbbVie; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Amgen GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AstraZeneca; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: BMS; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Celgene GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Daiji Sankyo; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Eisai GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Deutschland; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Int.; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: MSD Merck; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Mundipharma; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Myriad Genetics; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Pfizer GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Roche Pharma AG; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: TEVA Pharmaceuticals Ind Ltd; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Novartis; Financial Interests, Institutional, Funding, All fees to the institution/employer: Pierre Fabre; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Clovis Oncology; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seattle Genetics; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seagen. 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McCarthy: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Specialised Therapeutics; Financial Interests, Personal, Advisory Role: Easai; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Novartis. K. 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Toi: Financial Interests, Personal, Member of the Board of Directors: JBCRG association, Organisation for Oncology and Translational Research, Kyoto Breast Cancer Research Network; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Chugai; Financial Interests, Personal, Research Grant: Takeda; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Pfizer; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Kyowa-Kirin; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Taiho; Financial Interests, Personal, Research Grant, Research grant: JBCRG association; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Eisai; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Daiichi-Sankyo; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, Lecture Honoraria, An advisory role: Eli Lilly; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: MSD; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Exact Science; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Novartis; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: Konica Minolta; Financial Interests, Institutional, Research Grant, Research grant: Astellas; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: BMS; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Shimadzu; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Yakult; Financial Interests, Personal, Research Grant, Research Fund and Honoraria for lecture: Nippon Kayaku; Financial Interests, Institutional, Research Grant, Research grant: AFI technologies; Financial Interests, Personal, Advisory Role, An advisory role: Athenex Oncology; Financial Interests, Personal, Advisory Board, An advisory role: Bertis; Financial Interests, Personal, Advisory Board, An advisory role: Terumo; Financial Interests, Institutional, Research Grant, Research grant, an advisory role: Luxonus; Financial Interests, Institutional, Research Grant, Research grant: Shionogi; Financial Interests, Institutional, Research Grant, Research grant: GL Science; Financial Interests, Personal, Advisory Board, An advisory role: Kansai Medical Net. 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All other authors have declared no conflicts of interest.