N. Martinez-Jañez (Madrid, Spain)

Hospital Universitario Ramón y Cajal. GEICAM Breast Cancer Group

Author Of 1 Presentation

 Conference Calendar
Mini Oral session 1 Mini oral

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)

Presentation Number
94MO
Lecture Time
12:55 - 13:00
Speakers
Session Name
Mini Oral session 1
Room
Channel 2
Date
Fri, 07.05.2021
Time
12:45 - 13:45

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.

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Author Of 2 Presentations

 On-Demand ePoster Display

121P - Impact of HER2 Low (H2L) expression on prognosis in luminal locally advanced or metastatic breast cancer (BC): A retrospective study.

Abstract

Background

HER2 expression assessment is mandatory for the management of BC due to its predictive and prognosis value. So far, antiHER2 therapies only showed benefit in HER2 positive BC, rather, when immunohistochemistry (IHC) score 3+ and/or ERBB2 gene is amplified by ISH techniques. However, H2L expression (IHC score 1+ or 2+ without ERBB2 amplification) has gained value since the promising results of HER2-directed antibody-drug conjugates in that context. Our aim is to assess the potential prognostic value of H2L expression.

Methods

We performed a retrospective observational study in selected patients treated in our centre in 2012 - 2018. Inclusion criteria: irresectable locally advanced or metastatic BC, hormonal receptors expression, H2L or negative (score 0+). Exclusion criteria: incomplete information, antiHER2 therapy. Data about diagnosis and treatment were collected. Stata 14.0 was employed for statistical analyses.

Results

94 women were included, mean age 61 years. 75% BC were ductal, 100% with oestrogen receptor expression and 66% with progesterone positivity. HER2 expression scored 0+ in 27% of patients versus (vs) 73% H2L, of which 55% were 2+ and 45%, 1+. 67% were treated with hormonal-based therapies (HT) in the first line (1L) setting. Median of follow up and overall survival (OS) were 71.7 and 52 months, respectively. No statistically significant differences are observed between the HER2-low and HER2 0+ in OS (hazard ratio (HR) 1.09, confidence interval (CI) 0.61-1.93, p 0.78), neither are between score 1+ or 2+ (HR 1.16, CI 0.61-2.21, p 0.66). H2L BC does not show differences in progression-free survival (PFS) to 1L therapy (HR 1.43, CI 0.84-2.44, p 0.19), but PFS is worse in BC with HER2 score 2+ vs 1+ (HR 2.28, CI 1.22-4.24, p 0.010). This only remains significant in patients receiving HT (HR 2.04, CI 1.01-4.13, p 0.046).

Conclusions

H2L expression does not show a prognosis value but deeper research in the impact on 1L therapy efficacy will be promising. However, due to the retrospective design of the study, conclusions should be drawn with caution. Molecular profiles will provide more information about this subgroup of tumours, in the line of new investigations already opened.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

C. Saavedra Serrano: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Speaker Bureau/Expert testimony: Roche; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Pierre Fabre. M. Gion Cortes: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche. M. Fernández Abad: Advisory/Consultancy: Daiichi. N. Martinez-Jañez: Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: Daiichi; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: GSK; Advisory/Consultancy: Seagen. M. Soriano: Travel/Accommodation/Expenses: MSD. E.M. Guerra: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: GSK-Tesaro; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Clovis Oncology. E. Lopez Miranda: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Pfizer; Speaker Bureau/Expert testimony: Eisai. All other authors have declared no conflicts of interest.

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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.

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