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Palbociclib in adults aged 70 years and older with advanced breast cancer: A phase 2 multicenter trial (Alliance A171601).
Sedrak, Mina S; Lee, Minji K; Ji, Jingran; Satele, Daniel V; Freedman, Rachel A; Poorvu, Philip D; O'Connor, Tracey; Williams, Grant R; Hopkins, Judith O; Muss, Hyman B; Cohen, Harvey Jay; Partridge, Ann H; Carey, Lisa A; Chow, Selina L; Subbiah, Niveditha; Le-Rademacher, Jennifer; Jatoi, Aminah.
Afiliación
  • Sedrak MS; Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, USA. Electronic address: msedrak@mednet.ucla.edu.
  • Lee MK; Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
  • Ji J; Department of Medical Oncology & Therapeutics Research, City of Hope, Duarte, CA, USA.
  • Satele DV; Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
  • Freedman RA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
  • Poorvu PD; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
  • O'Connor T; Department of Breast Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
  • Williams GR; Department of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Hopkins JO; SCOR/NCORP/Novant Health Cancer Institute, Winston-Salem, NC, USA.
  • Muss HB; Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
  • Cohen HJ; Department of Medicine, Duke University School Medical Center, Durham, NC, USA.
  • Partridge AH; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
  • Carey LA; Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
  • Chow SL; Alliance Protocol Operations Office, Chicago, IL, USA.
  • Subbiah N; Alliance Protocol Operations Office, Chicago, IL, USA.
  • Le-Rademacher J; Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
  • Jatoi A; Department of Oncology, Mayo Clinic, Rochester, MN, USA.
J Geriatr Oncol ; 15(6): 101813, 2024 Jul.
Article en En | MEDLINE | ID: mdl-38852379
ABSTRACT

INTRODUCTION:

Palbociclib is a widely used treatment for advanced breast cancer in older adults. However, the existing evidence regarding its safety and tolerability in this age group is inconsistent and limited to retrospective subgroup or pooled analyses. MATERIALS AND

METHODS:

We conducted a prospective single-arm multicenter phase 2 study to evaluate the safety and tolerability of palbociclib in participants aged 70 years or older with advanced hormone receptor-positive breast cancer. Participants were given palbociclib in combination with their physician's choice of endocrine therapy (letrozole or fulvestrant). The primary endpoint was the incidence of grade 3+ adverse events (AEs) by six months. Secondary endpoints included AE-related dose delays, dose reductions, early discontinuations, and hospitalizations. Additionally, we compared these endpoints by age groups (70-74 and ≥ 75 years).

RESULTS:

Of the 90 participants (median age 74 years [70-87]) enrolled, 75.6% (95% confidence interval [CI], 65.4-84.0) had grade 3+ AEs by six months. The most frequent grade 3+ AEs were neutropenia (61%), fatigue (4%), and nausea (3%). Febrile neutropenia was uncommon (1.1%). Due to AEs, 36% had dose delays, 34% had dose reductions, 10% had early discontinuations, and 10% had hospitalizations. Compared to those aged 70-74 years, participants aged ≥75 years had higher rates of early discontinuations (5.9% vs 15.9%, a difference of 9.5% [95% CI 3.5%-22.5%]).

DISCUSSION:

Palbociclib has an overall favorable safety profile in adults aged ≥70 with advanced breast cancer. However, adults ≥75 years had a trend toward higher rates of AE-related early discontinuations compared to those 70-74 years. Further research is needed to evaluate tolerability and improve the delivery of palbociclib in older adults. CLINICALTRIALS govNCT03633331.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Piridinas / Neoplasias de la Mama Límite: Aged / Aged80 / Female / Humans Idioma: En Revista: J Geriatr Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Piridinas / Neoplasias de la Mama Límite: Aged / Aged80 / Female / Humans Idioma: En Revista: J Geriatr Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos