TY - JOUR
T1 - Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
AU - Puglisi, Fabio
AU - Gerratana, Lorenzo
AU - Lambertini, Matteo
AU - Ceppi, Marcello
AU - Boni, Luca
AU - Montemurro, Filippo
AU - Russo, Stefania
AU - Bighin, Claudia
AU - De Laurentiis, Michelino
AU - Giuliano, Mario
AU - Bisagni, Giancarlo
AU - Durando, Antonio
AU - Turletti, Anna
AU - Garrone, Ornella
AU - Ardizzoni, Andrea
AU - Gamucci, Teresa
AU - Colantuoni, Giuseppe
AU - Gravina, Adriano
AU - De Placido, Sabino
AU - Cognetti, Francesco
AU - Del Mastro, Lucia
N1 - Funding Information:
reports non-financial support from Menarini Silicon Biosystems, personal fees from Lilly, outside the submitted work; M.L. reports personal fees from Roche, Takeda, Theramex, Lilly, Pfizer, outside the submitted work; F.M. reports personal fees from Roche, Lilly, Novartis, Pfizer, Pierre Fabre, Daiichi Sankyo, outside the submitted work; C.B. reports research grant/funding from Roche, Novartis, personal fees from Roche, Novartis, Lilly, outside the submitted work; M.D.L. reports personal fees from Novartis, Pfizer, AstraZeneca, Roche, Pierre Fabre, Amgen, Lilly, MSD, Celgene, Eisai, outside the submitted work; M.G. reports reports non-financial support from Roche, Pfizer, Novartis, Amgen, personal fees from Novartis, Lilly, Pfizer, Eisai, Celgene, AstraZeneca, Roche, outside the submitted work; A.T. reports personal fees from Eisai, Roche, Pfizer, outside the submitted work; O.G. reports personal fees from Pfizer, Novartis, Eisai, Lilly, non-financial support from Roche, outside the submitted work; T.G. reports non-financial support from Pfizer, Novartis, Roche, Lilly, personal fees from Eisai, Pfizer, Novartis, Roche, Lilly, outside the submitted work; G.T. research grant/funding from Roche, Novartis, personal fees from Roche, Novartis, outside the submitted work; A.G. reports non-financial support from Pfizer, personal fees from Istituto Gentili, outside the submitted work; S.D.P. reports personal fees from GSK, Novartis, Roche, Celgene, AstraZeneca, Amgen, Teva,Eisai, Pfizer, Lilly, outside the submitted work; C.F. reports non-financial support from Novartis, Roche, MSD, BMS, personal fees from ABBOTT, CELGENE, GSK, Roche, Bayer, Novartis, Amgen, Pfizer, AstraZeneca, EISAI, Vifor Pharma, Merck—Serono, Boheringer Ingelheim, MSD, BMS, Takeda, Astellas Oncology, Lilly, Genomic Health, outside the submitted work; L.D.M. reports non-financial support from Roche, Celgene, Pfizer, personal fees from Genomic Health, Pfizer, Seattle Genetics, Pierre Fabre, Lilly, Roche, Novartis, MSD, Eisai, Ipsen, Takeda, outside the submitted work. The remaining authors declare no competing interests.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.
AB - The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.
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U2 - 10.1038/s41523-021-00286-w
DO - 10.1038/s41523-021-00286-w
M3 - Article
AN - SCOPUS:85111295242
SN - 2374-4677
VL - 7
SP - 82
JO - npj Breast Cancer
JF - npj Breast Cancer
IS - 1
ER -