Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial-Reference-Cited by-同舟云学术

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

Published:2023-11-20 Issue:33 Volume:41 Page:5118-5130
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Pfeiler Georg¹^ORCID,Hlauschek Dominik²^ORCID,Mayer Erica L.³^ORCID,Deutschmann Christine¹^ORCID,Kacerovsky-Strobl Stephanie⁴,Martin Miguel⁵^ORCID,Meisel Jane Lowe⁶,Zdenkowski Nicholas⁷^ORCID,Loibl Sibylle⁸⁹¹⁰^ORCID,Balic Marija¹¹^ORCID,Park Haeseong¹²^ORCID,Prat Aleix¹³,Isaacs Claudine¹⁴^ORCID,Bajetta Emilio¹⁵¹⁶,Balko Justin M.¹⁷^ORCID,Bellet-Ezquerra Merixtell¹⁸,Bliss Judith¹⁹^ORCID,Burstein Harold²⁰^ORCID,Cardoso Fatima²¹^ORCID,Fohler Hannes²,Foukakis Theodoros²²²³^ORCID,Gelmon Karen A.²⁴^ORCID,Goetz Matthew²⁵^ORCID,Haddad Tufia C.²⁶^ORCID,Iwata Hiroji²⁷^ORCID,Jassem Jacek²⁸^ORCID,Lee Soo-Chin²⁹³⁰³¹^ORCID,Linderholm Barbro³²³³,Los Maartje³⁴,Mamounas Eleftherios P.³⁵^ORCID,Miller Kathy D.³⁶^ORCID,Morris Patrick G.³⁷³⁸,Munzone Elisabetta³⁹^ORCID,Gal-Yam Einav Nili⁴⁰^ORCID,Ring Alistair⁴¹,Shepherd Lois⁴²^ORCID,Singer Christian¹⁴³^ORCID,Thomssen Christoph⁴⁴^ORCID,Tseng Ling-Ming⁴⁵^ORCID,Valagussa Pinuccia⁴⁶^ORCID,Winer Eric P.⁴⁷^ORCID,Wolff Antonio C.⁴⁸^ORCID,Zoppoli Gabriele⁴⁹⁵⁰^ORCID,Machacek-Link Jana²,Schurmans Celine⁵¹^ORCID,Huang Xin⁵²^ORCID,Gauthier Eric⁵²^ORCID,Fesl Christian²^ORCID,Dueck Amylou C.⁵³^ORCID,DeMichele Angela⁵⁴^ORCID,Gnant Michael²⁴³^ORCID,Cameron David,El-Abed Sarra,Rugo Hope S.,Steger Guenther G.,Traina Tiffany,Werutsky Gustavo,Wolmark Norman,

Affiliation:

1. Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria

2. Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria

3. Dana-Farber/Partners Cancer Care, Boston, MA

4. Breast Health Center, St Francis Hospital, Vienna, Austria

5. Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain

6. Winship Cancer Institute, Emory University, Atlanta, GA

7. University of Newcastle, Newcastle, NSW, Australia

8. German Breast Group, Neu-Isenburg, Germany

9. Goethe University Frankfurt/M, Frankfurt/M, Germany

10. Centre for Haematology and Oncology/Bethanien, Frankfurt/M, Germany

11. Division of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria

12. Siteman Cancer Center, Washington University, St Louis, MO

13. Department of Medical Oncology, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain

14. Georgetown University, Washington, DC

15. Gruppo I.T.M.O., Monza, Italy

16. Fondazione Policlinico di Monza, Monza, Italy

17. Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN

18. Hospital Universitari Son Espases, Palma de Mallorca, Spain

19. The Institute of Cancer Research, London, United Kingdom

20. Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA

21. Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal

22. Breast Center, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden

23. Department of Oncology/Pathology, Karolinska Institute, Stockholm, Sweden

24. BC Cancer, Vancouver, BC, Canada

25. Mayo Clinic, Rochester, MN

26. Mayo Clinic College of Medicine and Science, Rochester, MN

27. Aichi Cancer Center Hospital, Nagoya, Japan

28. Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland

29. Department of Haematology-Oncology, National University Cancer Institute (NCIS), Singapore, Singapore

30. Cancer Science Institute (CSI), Singapore, Singapore

31. National University of Singapore (NUS), Singapore, Singapore

32. Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden

33. Department of Oncology, Institution of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden

34. St Antonius Ziekenhuis Nieuwegein, Utrecht, the Netherlands

35. Orlando Health Cancer Institute, Orlando, FL

36. Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN

37. Cancer Trials Ireland, Dublin, Ireland

38. Beaumont RCSI Cancer Centre, Dublin, Ireland

39. European Institute of Oncology IRCCS, Milan, Italy

40. The Talpiot Medical Leadership Program, Breast Oncology Institute, Sheba Medical Center, Ramat-Gam, Israel

41. Royal Marsden Hospital, NHS Foundation Trust, London, United Kingdom

42. Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada

43. Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria

44. Martin-Luther-University Halle-Wittenberg, Halle/S, Germany

45. Taipei-Veterans General Hospital, National Yang Ming Chiao Tung University, Taipei, Taiwan

46. Fondazione Michelangelo, Milano, Italy

47. Yale Cancer Center, Smilow Cancer Network, Yale University, New Haven, CT

48. Johns Hopkins University, Baltimore, MD

49. Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Università degli Studi di Genova, Genoa, Italy

50. IRCCS Ospedale Policlinico San Martino, Genoa, Italy

51. Breast International Group (BIG), Brussels, Belgium

52. Pfizer, Inc, San Francisco, CA

53. Alliance Statistics and Data Center, Mayo Clinic, Phoenix, AZ

54. University of Pennsylvania, Philadelphia, PA

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Link

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.23.00126

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