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Observational Study
. 2024 Jul;206(2):317-328.
doi: 10.1007/s10549-024-07287-w. Epub 2024 Apr 1.

First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN

N Martínez-Jañez  1 , M Bellet Ezquerra  2 , L M Manso Sanchez  3 , F Henao Carrasco  4 , A Anton Torres  5 , S Morales  6 , P Tolosa Ortega  3 , V L Obadia Gil  7 , T Sampedro  8 , R Andrés Conejero  9 , L Calvo-Martinez  10 , E Galve-Calvo  11 , R López  12 , F Ayala de la Pena  13 , S Lopez-Tarruella  14 , B A Hernando Fernandez de Araguiz  15 , L Boronat Ruiz  16 , T Martos Cardenas  17 , J I Chacon  18 , F Moreno Antón  19
Affiliations
Observational Study

First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN

N Martínez-Jañez et al. Breast Cancer Res Treat. 2024 Jul.

Abstract

Purpose: To evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval.

Methods: PALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any menopausal status) with advanced HR+/HER2- BC diagnosed between November 2017 and November 2019. The primary endpoint was real-world progression-free survival (rw-PFS). Secondary endpoints included overall survival (OS), the real-world response rate (rw-RR), the clinical benefit rate, palbociclib dose reduction, and safety.

Results: A total of 762 patients were included. The median rw-PFS and OS were 24 months (95% CI 21-27) and 42 months (40-not estimable [NE]) in the whole population, respectively. By cohort, the median rw-PFS and OS were as follows: 28 (95% CI 23-39) and 44 (95% CI 38-NE) months in patients with de novo metastatic disease, 13 (95% CI 11-17) and 36 months (95% CI 31-41) in patients who experienced relapse < 12 months after the end of ET, and 31 months (95% CI 26-37) and not reached (NR) in patients who experienced relapse > 12 months after the end of ET. rw-PFS and OS were longer in patients with oligometastasis and only one metastatic site and those with non-visceral disease. The most frequent hematologic toxicity was neutropenia (72%; grade ≥ 3: 52.5%), and the most common non-hematologic adverse event was asthenia (38%).

Conclusion: These findings, consistent with those from clinical trials, support use of palbociclib plus ET as 1 L for advanced BC in the real-world setting, including pre-menopausal women and men.

Trial registration number: NCT04874025 (PALBOSPAIN). Date of registration: 04/30/2021 retrospectively registered.

Keywords: Advanced breast cancer; First-line treatment; HR+/HER2−; Overall survival; Palbociclib; Progression-free survival.

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Conflict of interest statement

N. Martínez-Jañez: Advisory board from Roche, Daiichi Sankyo AstraZeneca, Pfizer, Novartis and Eisai.

L. M. Manso Sanchez: LM reports of personal fees for advisory boards from Pfizer, travel and accommodation from Pfizer and, for speaker engagements from Pfizer.

A. Anton Torres: Financial Interests: AstraZeneca-Daiichi Sankyo, Advisory Board, Personal. AstraZeneca-Daiichi-Sankyo, Invited Speaker, Personal. Eli Lilly, Expert Testimony, Personal. Eli Lilly, Advisory Board, Personal. Eli Lilly, Invited Speaker, Personal. Gilead, Advisory Board, Personal. Pfizer, Expert Testimony, Personal. Seagen, Invited Speaker, Personal.

P. Tolosa Ortega: Consultant or Advisory Role: AstraZeneca, Daiichi Sankyo, Novartis and Seagen. Speaking: Pfizer, Novartis, Lilly, AstraZeneca, Daiichi-Sankyo, Gilead and Seagen. Research Funding: Novartis.

R. Andrés Conejero: Speaker and have received help to attend conferences from Pfizer in the last two years.

E. Galve-Calvo: Financial Interests: AstraZeneca, Invited Speaker, Personal. AstraZeneca, Expert Testimony, Personal. AstraZeneca, Advisory Board, Personal. Daiichi Sankyo, Expert Testimony, Personal. Daiichi Sankyo, Invited Speaker, Personal. Daiichi Sankyo, Advisory Board, Personal. Eisai, Expert Testimony, Personal. Gilead, Invited Speaker, Personal. Gilead, Expert Testimony, Personal. Gilead, Advisory Board, Personal. Novartis, Expert Testimony, Personal. Pfizer, Invited Speaker, Personal. Pfizer, Expert Testimony, Personal. Pfizer, Advisory Board, Personal. Pierre Fabre, Expert Testimony, Personal. Roche, Expert Testimony, Personal. Other: Pfizer, Other, Travel accommodation.

R. López: Advisory role: Roche, AstraZeneca, Merck, MSD, Bayer, BMS, Novartis, Janssen, Lilly, Pfizer, Leo, Rovi, Daiichi Sankyo, Seattle Genetics. Speaker’s fee: Roche, Novartis, Pharmamar. Research support: Roche, Merck. Co-founder and shareholder: Nasasbiotech, Diversa Technologies.

F. Ayala de la Pena: FAP has received speaker honoraria from AstraZeneca, Novartis, Lilly, Sanofi, Daiichi Sankyo, Celgene, Eisai and Pierre Fabre; has received consultant honoraria from Pfizer, Seagen and Roche; has received educational and research funding from MSD and Daiichi Sankyo.

S. Lopez-Tarruella: Financial Interests AstraZeneca, Advisory Board, Personal Daiichi Sankyo, Advisory Board, Personal Gebro Pharma, Advisory Board, Personal Gilead, Advisory Board, Personal GSK, Advisory Board, Personal Lilly, Advisory Board, Personal Lilly, Invited Speaker, Personal Menarini_Stemline, Advisory Board, Personal MSD, Advisory Board, Personal Novartis, Advisory Board, Personal Pfizer, Advisory Board, Personal Pierre Fabre, Advisory Board, Personal Roche, Advisory Board, Personal Seagen, Advisory Board, Personal Veracyte, Advisory Board, Personal Non-Financial Interests GEICAM, Member of Board of Directors SEOM, Member of Board of Director.

B.A. Hernando Fernandez de Aranguiz: Fees for consultancy or presentations and/or support for travel to conferences from Seagen, Pierre Fabre, Lilly, GSK, MSD, Tesaro, Pharmamar and Pfizer in the last 5 years.

F. Moreno Anton: Consultancy/speaker fees from Novartis, Roche, Pfizer, AstraZeneca, Daiichi Sankyo, Gilead, Exact Sciences, Seagen. Institution research funding from Pfizer. Travel support from Pfizer, Pierre Fabre.

Figures

Fig. 1
Fig. 1
Real-world progression-free survival (rw-PFS) in (A) the whole population (n = 758) and (B) patients with de novo metastatic disease, relapse > 12 months after the end of endocrine therapy (ET), and relapse during ET or within 12 months of ET. CI: confidence interval; m: months
Fig. 2
Fig. 2
Real-world progression-free survival (rw-PFS) in (A) patients with non-visceral vs. visceral metastasis, (B) patients with 1, 2 or 3 or more than 3 metastatic sites, (C) depending on age, (D) depending on menopausal status. CI: Confidence interval; m: months
Fig. 3
Fig. 3
Overall survival in (A) the whole population (n = 750) and in (B) patients with de novo metastatic disease, relapse > 12 months after the end of endocrine therapy (ET), and relapse during ET or within 12 months of ET. CI: confidence interval; m: months; NR: not reached
Fig. 4
Fig. 4
Overall survival (OS) in (A) patients with non-visceral vs. visceral metastasis, (B) patients with 1, 2 or 3 or more than 3 metastatic sites, (C) depending on age, (D) depending on menopausal status. CI: Confidence interval; m: months; NR: not reached
Fig. 5
Fig. 5
Response rate (rw-RR) in the whole population and in some groups of patients with de novo metastasis, relapse > 12 months after the end of the adjuvant endocrine therapy (ET) relapse > 12 months) and relapse during the adjuvant ET or within 12 months of its ending (relapse < 12 months). CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progression of disease; NA: Not assessed
See this image and copyright information in PMC

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