TY - JOUR
T1 - Impact of BMI in Patients with Early Hormone Receptor-Positive Breast Cancer Receiving Endocrine Therapy with or Without Palbociclib in the PALLAS Trial
AU - PALLAS groups and investigators
AU - Pfeiler, Georg
AU - Hlauschek, Dominik
AU - Mayer, Erica L.
AU - Deutschmann, Christine
AU - Kacerovsky-Strobl, Stephanie
AU - Martin, Miguel
AU - Meisel, Jane Lowe
AU - Zdenkowski, Nicholas
AU - Loibl, Sibylle
AU - Balic, Marija
AU - Park, Haeseong
AU - Prat, Aleix
AU - Isaacs, Claudine
AU - Bajetta, Emilio
AU - Balko, Justin M.
AU - Bellet-Ezquerra, Merixtell
AU - Bliss, Judith
AU - Burstein, Harold
AU - Cardoso, Fatima
AU - Fohler, Hannes
AU - Foukakis, Theodoros
AU - Gelmon, Karen A.
AU - Goetz, Matthew
AU - Haddad, Tufia C.
AU - Iwata, Hiroji
AU - Jassem, Jacek
AU - Lee, Soo Chin
AU - Linderholm, Barbro
AU - Los, Maartje
AU - Mamounas, Eleftherios P.
AU - Miller, Kathy D.
AU - Morris, Patrick G.
AU - Munzone, Elisabetta
AU - Gal-Yam, Einav Nili
AU - Ring, Alistair
AU - Shepherd, Lois
AU - Singer, Christian
AU - Thomssen, Christoph
AU - Tseng, Ling Ming
AU - Valagussa, Pinuccia
AU - Winer, Eric P.
AU - Wolff, Antonio C.
AU - Zoppoli, Gabriele
AU - Machacek-Link, Jana
AU - Schurmans, Celine
AU - Huang, Xin
AU - Gauthier, Eric
AU - Fesl, Christian
AU - Dueck, Amylou C.
AU - Demichele, Angela
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/11/20
Y1 - 2023/11/20
N2 - PURPOSEBMI 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.METHODSPatients 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.RESULTSOf 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).CONCLUSIONThis 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.
AB - PURPOSEBMI 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.METHODSPatients 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.RESULTSOf 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).CONCLUSIONThis 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.
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U2 - 10.1200/JCO.23.00126
DO - 10.1200/JCO.23.00126
M3 - Article
C2 - 37556775
AN - SCOPUS:85173772318
SN - 0732-183X
VL - 41
SP - 5118
EP - 5130
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -