J. De la Haba-Rodríguez (Córdoba, Spain)
Instituto Maimonides de Investigacion Biomedica. Hospital Reina Sofía Hospital. Universidad de Córdoba. GEICAM Breast Cancer Group. CIBERONC-ISCIIIAuthor Of 1 Presentation
94MO - Quality of life (QoL) with fulvestrant (FUL)/palbociclib (PAL) versus FUL/placebo (PBO) in postmenopausal women with hormone receptor (HR)+/HER2- endocrine sensitive advanced breast cancer (ABC): results from GEICAM/2014-12 (FLIPPER) study (ID 258)
Abstract
Background
In the FLIPPER trial, FUL/PAL significantly improved progression-free survival (PFS) compared to FUL/PBO as first-line in patients (pts) with HR+/HER2- endocrine sensitive ABC. Here we present patient-reported outcome (PRO) results including health-related QoL (HRQoL).
Methods
Pts were randomized (1:1); 94 FUL/PAL, 95 FUL/PBO. PROs were evaluated at baseline (BL), every three cycles and at end of treatment using the EORTC QLQ-C30 and QLQ-BR23 questionnaires; 178 pts (94.2%) completed BL and ≥1 post-BL PROs. For functional and global health status (GHS)/QoL scales, higher scores represent better level of functioning or QoL and for symptom scales, worse symptoms. Time to deterioration (TTD) in GHS/QoL score considered ≥ 10points. Changes from BL and TTD were analysed using linear mixed-effect and Cox regression models, respectively.
Results
Questionnaire completion rates were high (>95%) for the first 22 cycles. BL scores were comparable between the two treatment arms. Significant between-arm differences were observed in overall change from BL of GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring FUL/PBO. No other statistically significant differences were found between arms for the remaining functional and symptom scales. Median TTD in GHS/QoL was delayed in FUL/PBOL [30.3 months (mo)] vs. FUL/PAL (11.1 mo) [adjusted HR (aHR) 1.57, 95% CI 1.03-2.39, p=0.036]; TTD in GHS/QoL was delayed in PBO-treated pts without progressive disease (PD) (aHR 2.0, 95% CI 1.1-3.8, p=0.023) but not in pts with PD (aHR 1.2, 95% CI 0.6-2.2, p=0.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales.
Conclusions
The TTD in GHS/QoL was prolonged with FUL/PBO, however, GHS/QoL was improved numerically in both arms. The overall HRQoL differences favouring FUL/PBO were clinically meaningful only for appetite loss. These results together with the improvement of PFS observed with FUL/PAL make of this a beneficial therapeutic option for these patients.
Clinical trial identification
NCT02690480.
Legal entity responsible for the study
GEICAM Breast Cancer Group.
Funding
GEICAM Spanish Breast Cancer Group.
Disclosure
A. Tibau: Honoraria (institution): Roche. M. Ramos: Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Novartis; Honoraria (institution): Roche. L. de la Cruz-Merino: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD-Merck; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bristol-Myers-Squibb; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Celgene. A. Santaballa: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony: Clovis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Research grant/Funding (institution): Pfizer. N. Martinez-Jañez: Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Daiichi; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Eisai. F. Moreno: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca. I. Fernandez-Perez: Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): Clovis. J. Alarcón: Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: GSK; Honoraria (institution), Speaker Bureau/Expert testimony: Clovis; Honoraria (institution), Speaker Bureau/Expert testimony: Roche; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (institution), Advisory/Consultancy: MSD. J. de la Haba-Rodríguez: Honoraria (institution): AstraZeneca; Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): Lilly. C. Bueno: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: AstraZeneca; Travel/Accommodation/Expenses: Pfizer. J. Albanell: Advisory/Consultancy: Genomic Health; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi Sankyo. All other authors have declared no conflicts of interest.
Author Of 1 Presentation
- E. Ciruelos (Madrid, Spain)
- J. Ponce (Hospital General Universitario de Alicante, Spain)
- J. Cortes Castan (Barcelona, Spain)
- S. Pernas Simon (Hospitalet de Llobregat, Spain)
- E. Garate (Bilbao, Spain)
- M. Melé (Reus, Spain)
- Á. Montaño (Sevilla, Spain)
- N. Martinez-Jañez (Madrid, Spain)
- M. Oliveira (Barcelona, Spain)
- J. De la Haba-Rodríguez (Córdoba, Spain)
- E. Vega (Madrid, Spain)
- A. Perello Martorell (Palma de Mallorca, Spain)
- B. Bermejo De Las Heras (Valencia, Va, Spain)
- B. Cantos Sanchez De Ibarguen (Majadahonda, Spain)
- E. Martínez (Castellón de la Plana, Spain)
- E. Vila Navarro (Barcelona, Spain)
- T. Pascual (Barcelona, Spain)
- X. González-Farré (Sant Cugat del Vallés, Spain)
- P. Villagrasa (Barcelona, Spain)
- A. Prat (Barcelona, Spain)
130TiP - SOLTI-1303 PATRICIA II randomized phase II trial of palbociclib plus trastuzumab and endocrine therapy (ET) versus treatment of physician's choice (TPC) in metastatic HER2-positive and hormone receptor-positive (HER2+/HR+) breast cancer (BC) with PAM50 luminal intrinsic subtype
Abstract
Background
PATRICIA phase II trial showed that Palbociclib in combination with trastuzumab is safe and exhibits promising survival outcomes in trastuzumab pretreated HER2+/HR+ advanced breast cancer with a PAM50 Luminal A or B subtype (Ciruelos E. et al, CCR 2020). Based on these results, PATRICIA II was designed to include only patients with HER2+/HR+, PAM50 Luminal A/B tumors to receive palbociclib, trastuzumab and ET versus treatment of physician’s choice (TPC).
Trial design
PATRICIA II is a randomized open-label, adaptive design, phase II study. Patients must have centrally confirmed HER2+/HR+ and PAM50 Luminal A or B tumors and have received at least 1 (and no more than 4) prior lines of anti-HER2 regimens for locally advanced or metastatic BC. Patients are randomized 1:1 to receive trastuzumab plus palbociclib at a standard dose of 125 mg/day orally 3 weeks on/ 1 week off and ET (Cohort C1) or TPC (cohort C2). ET options in cohort 1 are either an aromatase inhibitor, fulvestrant or tamoxifen +/- ovarian suppression. TPC options in cohort C2 are T-DM1 or chemotherapy (gemcitabine, vinorelbine, capecitabine, eribulin, paclitaxel or docetaxel) plus trastuzumab. Stratification factors include number of previous regimens for advanced or metastatic BC (1-2 vs 3-4) and the presence of visceral disease (yes vs no). Primary endpoint is to compare the progression-free survival between two arms. The study has an 80% power with two-sided alpha=0.05 to detect a HR of 0.62 in favor of the palbociclib cohort. Secondary endpoints include response rate, overall survival, safety, and quality of life. Tumor tissue and blood samples will be collected for biomarker analyses. An estimated total of 516 patients will be screened to include 232 patients with HER2+/HR+ PAM50 Luminal A or B tumors. The recruitment is ongoing in 20 sites in Spain and as of February 3rd, 2021, 107 patients were screened and 30 were enrolled in the trial.
Clinical trial identification
NCT02448420.
Legal entity responsible for the study
SOLTI.
Funding
Pfizer.
Disclosure
E.M. Ciruelos: Advisory/Consultancy, Non-remunerated activity/ies: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Novartis; Advisory/Consultancy: MSD. S. Pernas Simon: Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Polyphor; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Roche. M. Oliveira: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Philips Healthcare; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Research grant/Funding (institution): Immunomedics; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy, Research grant/Funding (institution): GSK; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Puma Biotechnology; Research grant/Funding (institution): Zenith Epigenetics; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Puma Biotechnology; Travel/Accommodation/Expenses: Pierre Fabre; Travel/Accommodation/Expenses: Eisai. B. Bermejo De Las Heras: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Palex; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer. X. González-Farré: Advisory/Consultancy: SOLTI Breast Cancer Group; Advisory/Consultancy, Non-remunerated activity/ies: Roche; Advisory/Consultancy: Eisai. P. Villagrasa: Honoraria (self): NanoString. A. Prat: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy: MSD Oncology; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy, Research grant/Funding (self): NanoString Technologies; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: Amgen; Advisory/Consultancy: Puma. All other authors have declared no conflicts of interest.