Impact of BMI in Patients With Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial.

Autor:	Pfeiler G; Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria., Hlauschek D; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria., Mayer EL; Dana-Farber/Partners Cancer Care, Boston, MA., Deutschmann C; Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria., Kacerovsky-Strobl S; Breast Health Center, St Francis Hospital, Vienna, Austria., Martin M; Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain., Meisel JL; Winship Cancer Institute, Emory University, Atlanta, GA., Zdenkowski N; University of Newcastle, Newcastle, NSW, Australia., Loibl S; German Breast Group, Neu-Isenburg, Germany.; Goethe University Frankfurt/M, Frankfurt/M, Germany.; Centre for Haematology and Oncology/Bethanien, Frankfurt/M, Germany., Balic M; Division of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria., Park H; Siteman Cancer Center, Washington University, St Louis, MO., Prat A; Department of Medical Oncology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain., Isaacs C; Georgetown University, Washington, DC., Bajetta E; Gruppo I.T.M.O., Monza, Italy.; Fondazione Policlinico di Monza, Monza, Italy., Balko JM; Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN., Bellet-Ezquerra M; Hospital Universitari Son Espases, Palma de Mallorca, Spain., Bliss J; The Institute of Cancer Research, London, United Kingdom., Burstein H; Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA., Cardoso F; Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal., Fohler H; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria., Foukakis T; Breast Center, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.; Department of Oncology/Pathology, Karolinska Institute, Stockholm, Sweden., Gelmon KA; BC Cancer, Vancouver, BC, Canada., Goetz M; Mayo Clinic, Rochester, MN., Haddad TC; Mayo Clinic College of Medicine and Science, Rochester, MN., Iwata H; Aichi Cancer Center Hospital, Nagoya, Japan., Jassem J; Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland., Lee SC; Department of Haematology-Oncology, National University Cancer Institute (NCIS), Singapore, Singapore.; Cancer Science Institute (CSI), Singapore, Singapore.; National University of Singapore (NUS), Singapore, Singapore., Linderholm B; Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.; Department of Oncology, Institution of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden., Los M; St Antonius Ziekenhuis Nieuwegein, Utrecht, the Netherlands., Mamounas EP; Orlando Health Cancer Institute, Orlando, FL., Miller KD; Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN., Morris PG; Cancer Trials Ireland, Dublin, Ireland.; Beaumont RCSI Cancer Centre, Dublin, Ireland., Munzone E; European Institute of Oncology IRCCS, Milan, Italy., Gal-Yam EN; The Talpiot Medical Leadership Program, Breast Oncology Institute, Sheba Medical Center, Ramat-Gam, Israel., Ring A; Royal Marsden Hospital, NHS Foundation Trust, London, United Kingdom., Shepherd L; Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada., Singer C; Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria.; Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Thomssen C; Martin-Luther-University Halle-Wittenberg, Halle/S, Germany., Tseng LM; Taipei-Veterans General Hospital, National Yang Ming Chiao Tung University, Taipei, Taiwan., Valagussa P; Fondazione Michelangelo, Milano, Italy., Winer EP; Yale Cancer Center, Smilow Cancer Network, Yale University, New Haven, CT., Wolff AC; Johns Hopkins University, Baltimore, MD., Zoppoli G; Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Università degli Studi di Genova, Genoa, Italy.; IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Machacek-Link J; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria., Schurmans C; Breast International Group (BIG), Brussels, Belgium., Huang X; Pfizer, Inc, San Francisco, CA., Gauthier E; Pfizer, Inc, San Francisco, CA., Fesl C; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria., Dueck AC; Alliance Statistics and Data Center, Mayo Clinic, Phoenix, AZ., DeMichele A; University of Pennsylvania, Philadelphia, PA., Gnant M; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.; Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Nov 20; Vol. 41 (33), pp. 5118-5130. Date of Electronic Publication: 2023 Aug 09.
DOI:	10.1200/JCO.23.00126
Abstrakt:	Purpose: BMI affects breast cancer risk and prognosis. In contrast to cytotoxic chemotherapy, CDK4/6 inhibitors are given at a fixed dose, irrespective of BMI or weight. This preplanned analysis of the global randomized PALLAS trial investigates the impact of BMI on the side-effect profile, treatment adherence, and efficacy of palbociclib. Methods: Patients were categorized at baseline according to WHO BMI categories. Neutropenia rates were assessed with univariable and multivariable logistic regression. Time to early discontinuation of palbociclib was analyzed with Fine and Gray competing risk models. Unstratified Cox models were used to investigate the association between BMI category and time to invasive disease-free survival (iDFS). 95% CIs were derived. Results: Of 5,698 patients included in this analysis, 68 (1.2%) were underweight, 2,082 (36.5%) normal weight, 1,818 (31.9%) overweight, and 1,730 (30.4%) obese at baseline. In the palbociclib arm, higher BMI was associated with a significant decrease in neutropenia (unadjusted odds ratio for 1-unit change, 0.93; 95% CI, 0.91 to 0.94; adjusted for age, race ethnicity, region, chemotherapy use, and Eastern Cooperative Oncology Group at baseline, 0.93; 95% CI, 0.92 to 0.95). This translated into a significant decrease in treatment discontinuation rate with higher BMI (adjusted hazard ratio [HR] for 10-unit change, 0.75; 95% CI, 0.67 to 0.83). There was no significant improvement in iDFS with the addition of palbociclib to ET in any weight category (normal weight HR, 0.84; 95% CI, 0.63 to 1.12; overweight HR, 1.10; 95% CI, 0.82 to 1.49; and obese HR, 0.95; 95% CI, 0.69 to 1.30) in this analysis early in follow-up (31 months). Conclusion: This preplanned analysis of the PALLAS trial demonstrates a significant impact of BMI on side effects, dose reductions, early treatment discontinuation, and relative dose intensity. Additional long-term follow-up will further evaluate whether BMI ultimately affects outcome.
Databáze:	MEDLINE
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