I. Fernandez Perez (Vigo, Spain)

Hospital Alvaro Cunqueiro. 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 1 Presentation

 On-Demand ePoster Display

60P - Real-Life Use of Oncotype DX Breast Recurrence Score® Test for the Management of Patients with Node-Negative and Node-Positive Breast Cancer in the Autonomous Community of Galicia (Spain).

Abstract

Background

Oncotype DX® is a 21-gene assay to guide adjuvant treatment decisions in HR+, HER2- early stage breast cancer. The aim of the study was to evaluate the impact of Recurrence Score® (RS) on decision-making (% change in treatment recommendation), to assess real-life utilization of Oncotype DX test in node-negative, micrometastases, and 1-3 positive lymph nodes patients.

Methods

Data from 630 patients (N0=401, N1=229) from 9 Institutions in the autonomous community of Galicia between May 2013 and Oct 2018 were collected and retrospectively analyzed in accordance with the study objectives. The majority of these data were collected prior to the publication of TAILORx and/or RxPONDER.

Results

Median age: 56 y; 77% of patients were > 50 years; 31% of patients were premenopausal, 50% postmenopausal, and 19% perimenopausal. Tumor size : pT1a-b 21%, pT1c 59%, pT2 19%, pT3 1%; Grade: G1 23%, G2 68%, G3 9%; Ki 67 <10% 20,7%, 10%-20% 39,2%, >20% 40,1%; Luminal subtype (based on Ki 67 and PR status): luminal A 75% and luminal B 25%. Nodal status: N1: 35.7% and N0: 64.3% Recurrence Score results distribution in N+ population was: RS <17: 63%, RS 17-31: 34.5%, and RS >31: 2.5%), and in N0 population: RS ≤ 25: 82.5% and RS >25: 17.4%. Changes in treatment decision are reported in the table.

Before RS After RS % REDUCTION CT
All patients n=630 HT 317 (50.3%) HT 454 (71.6%)
HT+CT 313 (49.7%) HT+CT 176 (28.4%) 43.8%
N0 n=401 HT 245 (61.0%) HT 284 (70.8%)
HT+CT 156 (39.0%) HT+CT 117 (29.1%) 25.0%
N1 n=229 HT 70 (30.6%) HT 170 (74.2%)
HT+CT 159 (69.4%) HT+CT 59 (25.8%) 63.0%

CT: chemotherapy, HT: hormonotherapy.

Conclusions

Based on RS results, a major change in therapeutic decision occurs in patients diagnosed with breast cancer, and chemotherapy recommendations changed in a substantial proportion of patients. In N0 patients, following the outcome of RS results, the indication of chemotherapy was decreased by 25%. In N1 patients, the chemotherapy indication is dramatically reduced by 63%. Our results confirmed in real clinical life the utility of the Oncotype DX assay to guide chemotherapy treatment decisions, and provided additional support for its use both in N0 and N1 patients based on TAILORx and RxPONDER studies.

Legal entity responsible for the study

The authors.

Funding

Genomic Health International.

Disclosure

I. Fernandez-Perez: Speaker Bureau/Expert testimony: Genomic Health; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: AstraZeneka; Advisory/Consultancy: GSK. L. De Paz Arias: Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Novartis. L. Vazquez Tuñas: Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Clovis; Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: GSK; Advisory/Consultancy: Leo Pharma. S. Varela Ferreiro: Advisory/Consultancy, Speaker Bureau/Expert testimony: GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Pfizer. A.Q. Gonzalez Quintas: Speaker Bureau/Expert testimony: Pfizer. J.F. Cueva Banuelos: Advisory/Consultancy: Clovis; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Palex; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Speaker Bureau/Expert testimony: GSK; Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: Pierre Fabre. C. Hagen: Full/Part-time employment, Officer/Board of Directors: Genomic Health. L. Inglada-Pérez: Full/Part-time employment: Genomic Health. L. Iglesias Rey: Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony: Merck; Advisory/Consultancy: Leo Pharma; Speaker Bureau/Expert testimony: Rovi. All other authors have declared no conflicts of interest.

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Presenter Of 1 Presentation

 On-Demand ePoster Display

60P - Real-Life Use of Oncotype DX Breast Recurrence Score® Test for the Management of Patients with Node-Negative and Node-Positive Breast Cancer in the Autonomous Community of Galicia (Spain).

Abstract

Background

Oncotype DX® is a 21-gene assay to guide adjuvant treatment decisions in HR+, HER2- early stage breast cancer. The aim of the study was to evaluate the impact of Recurrence Score® (RS) on decision-making (% change in treatment recommendation), to assess real-life utilization of Oncotype DX test in node-negative, micrometastases, and 1-3 positive lymph nodes patients.

Methods

Data from 630 patients (N0=401, N1=229) from 9 Institutions in the autonomous community of Galicia between May 2013 and Oct 2018 were collected and retrospectively analyzed in accordance with the study objectives. The majority of these data were collected prior to the publication of TAILORx and/or RxPONDER.

Results

Median age: 56 y; 77% of patients were > 50 years; 31% of patients were premenopausal, 50% postmenopausal, and 19% perimenopausal. Tumor size : pT1a-b 21%, pT1c 59%, pT2 19%, pT3 1%; Grade: G1 23%, G2 68%, G3 9%; Ki 67 <10% 20,7%, 10%-20% 39,2%, >20% 40,1%; Luminal subtype (based on Ki 67 and PR status): luminal A 75% and luminal B 25%. Nodal status: N1: 35.7% and N0: 64.3% Recurrence Score results distribution in N+ population was: RS <17: 63%, RS 17-31: 34.5%, and RS >31: 2.5%), and in N0 population: RS ≤ 25: 82.5% and RS >25: 17.4%. Changes in treatment decision are reported in the table.

Before RS After RS % REDUCTION CT
All patients n=630 HT 317 (50.3%) HT 454 (71.6%)
HT+CT 313 (49.7%) HT+CT 176 (28.4%) 43.8%
N0 n=401 HT 245 (61.0%) HT 284 (70.8%)
HT+CT 156 (39.0%) HT+CT 117 (29.1%) 25.0%
N1 n=229 HT 70 (30.6%) HT 170 (74.2%)
HT+CT 159 (69.4%) HT+CT 59 (25.8%) 63.0%

CT: chemotherapy, HT: hormonotherapy.

Conclusions

Based on RS results, a major change in therapeutic decision occurs in patients diagnosed with breast cancer, and chemotherapy recommendations changed in a substantial proportion of patients. In N0 patients, following the outcome of RS results, the indication of chemotherapy was decreased by 25%. In N1 patients, the chemotherapy indication is dramatically reduced by 63%. Our results confirmed in real clinical life the utility of the Oncotype DX assay to guide chemotherapy treatment decisions, and provided additional support for its use both in N0 and N1 patients based on TAILORx and RxPONDER studies.

Legal entity responsible for the study

The authors.

Funding

Genomic Health International.

Disclosure

I. Fernandez-Perez: Speaker Bureau/Expert testimony: Genomic Health; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: AstraZeneka; Advisory/Consultancy: GSK. L. De Paz Arias: Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Novartis. L. Vazquez Tuñas: Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Clovis; Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: GSK; Advisory/Consultancy: Leo Pharma. S. Varela Ferreiro: Advisory/Consultancy, Speaker Bureau/Expert testimony: GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Pfizer. A.Q. Gonzalez Quintas: Speaker Bureau/Expert testimony: Pfizer. J.F. Cueva Banuelos: Advisory/Consultancy: Clovis; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Speaker Bureau/Expert testimony: Palex; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Speaker Bureau/Expert testimony: GSK; Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: Pierre Fabre. C. Hagen: Full/Part-time employment, Officer/Board of Directors: Genomic Health. L. Inglada-Pérez: Full/Part-time employment: Genomic Health. L. Iglesias Rey: Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony: Merck; Advisory/Consultancy: Leo Pharma; Speaker Bureau/Expert testimony: Rovi. All other authors have declared no conflicts of interest.

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