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Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer
| Indexado |
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| DOI | 10.1016/J.ANNONC.2020.05.001 | ||||
| Año | 2020 | ||||
| Tipo | artículo de investigación |
Citas Totales
Autores Afiliación Chile
Instituciones Chile
% Participación
Internacional
Autores
Afiliación Extranjera
Instituciones
Extranjeras
Abstract
Conclusions: Hyperglycemia and rash occurred early during alpelisib treatment, while diarrhea occurred at a later time point. Early identification, prevention, and intervention, including concomitant medications and alpelisib dose modifications, resulted in less severe toxicities. Reductions in treatment discontinuations and improved progressionfree survival at higher alpelisib dose intensities support the need for optimal AE management. ClinicalTrials. gov Id: NCT02437318.
| Ord. | Autor | Género | Institución - País |
|---|---|---|---|
| 1 | Rugo, Hope S. | Mujer |
UNIV CALIF SAN FRANCISCO - Estados Unidos
UCSF Helen Diller Family Comprehensive Cancer Center - Estados Unidos |
| 2 | Andre, F. | Hombre |
Univ Paris Sud - Francia
Biomarqueurs prédicteurs et nouvelles stratégies moléculaires en thérapeutique anti-cancéreuse - Francia Prédicteurs Moléculaires et Nouvelles Cibles en Oncologie - Francia |
| 3 | Yamashita, T. | - |
Kanagawa Canc Ctr Hosp - Japón
Kanagawa Cancer Center Research Institute - Japón |
| 4 | Cerda, H. | Hombre |
Clin RedSalud Vitacura - Chile
clínica Redsalud Vitacura - Chile Clínica Red Salud Santiago - Chile Clínica Red Salud Vitacura - Chile |
| 5 | Toledano, I. | - |
Inst Curie - Francia
Institut Curie - Francia |
| 6 | Stemmer, S. M. | - |
Tel Aviv Univ - Israel
Tel Aviv University - Israel |
| 7 | Cruz Jurado, J. | - |
Hosp Univ Canarias - España
Hospital Universitario de Canarias - España |
| 8 | Juric, D. | - |
MASSACHUSETTS GEN HOSP - Estados Unidos
Massachusetts General Hospital Cancer Center - Estados Unidos |
| 9 | Mayer, I. | - |
Vanderbilt Univ - Estados Unidos
Vanderbilt University - Estados Unidos |
| 10 | Ciruelos, E. M. | - |
Hosp Univ 12 Octubre - España
Hospital Universitario 12 de Octubre - España |
| 11 | Iwata, Hiroji | Hombre |
Aichi Canc Ctr Hosp - Japón
Aichi Cancer Center Hospital and Research Institute - Japón |
| 12 | Conte, P. | - |
Univ Padua - Italia
IRCCS - Italia Università degli Studi di Padova - Italia |
| 13 | Campone, M. | - |
Inst Cancerol Ouest - Francia
Institut de Cancérologie de l'Ouest - Francia |
| 14 | Wilke, C. | - |
Novartis Pharma AG - Suiza
Novartis International AG - Suiza |
| 15 | Mills, D. | - |
Novartis Pharma AG - Suiza
Novartis International AG - Suiza |
| 16 | Lteif, A. | - |
Novartis Pharmaceut - Estados Unidos
Novartis International AG - Suiza |
| 17 | Miller, M. | - |
Novartis Pharmaceut - Estados Unidos
Novartis International AG - Suiza |
| 18 | Gaudenzi, F. | - |
Novartis Pharma AG - Suiza
Novartis International AG - Suiza |
| 19 | Loibl, Sibylle | Mujer |
Neu Isenburg Ctr Haematol & Oncol Bethanien - Alemania
Centre for Haematology and Oncology Bethanien - Alemania |
| Fuente |
|---|
| Novartis |
| Eisai |
| Sanofi |
| AbbVie |
| Pfizer |
| AstraZeneca |
| Amgen |
| Merck |
| Eli Lilly and Company |
| Genentech |
| EMD Serono |
| Celgene |
| Bayer Corporation |
| North Carolina GlaxoSmithKline Foundation |
| Roche |
| Astra Zeneca |
| Kyowa Hakko Kirin |
| Novartis Pharmaceuticals Corporation |
| Astellas Pharma US |
| Chugai Pharmaceutical |
| PharmaMar |
| Ipsen Biopharmaceuticals |
| OBI Pharma |
| Agradecimiento |
|---|
| This work was supported by Novartis Pharmaceuticals Corporation. No grant number is applicable. |
| The authors thank the patients who participated in SOLAR-1, their families, and the staff members at each study site. The authors would also like to thank the faculty involved with the advisory board that provided guideline management for the protocol amendment. Medical writing support was provided by Tara Wabbersen, PhD, at MediTech Media, Ltd, funded by Novartis Pharmaceuticals Corporation. This work was supported by Novartis Pharmaceuticals Corporation. No grant number is applicable. HSR reports personal fees from Genomic Health, Novartis, Roche/Genentech, OBI Pharma, Bayer, Pfizer, during the conduct of the study; grants from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Eli Lilly, GlaxoSmithKline, Genentech, Celsion, Merck, outside the submitted work; FA reports grants from Novartis during the conduct of the study; grants from Astra Zeneca, Pfizer, Lilly, Roche, outside the submitted work; TY reports grants and other from Chugai, Kyowa Kirin; other from Eisai, Novartis, Taiho, Sanofi, AstraZeneca, Pfizer Japan, outside the submitted work; SMS reports non-financial support from Pfizer, Lilly, outside the submitted work. JCJ reports personal fees from GlaxoSmithKline, Roche, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen, Pfizer, during the conduct of the study; other from GlaxoSmithKline, AstraZeneca, Roche, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen, Pfizer, outside the submitted work; DJ reports personal fees from Novartis, Genentech, Eisai, Ipsen, EMD Serono, during the conduct of the study; IM reports personal fees from Novartis, Genentech, during the conduct of the study; grants from Novartis, Pfizer, outside the submitted work; EMC reports personal fees from Pfizer, Novartis, Lilly, Roche, Celgene, during the conduct of the study; PC reports personal fees from Roche, Novartis, AstraZeneca, Celgene, Tesaro, during the conduct of the study; grants from Roche, Novartis, Merck, Bristol-Myers Squibb, outside the submitted work; MC reports personal fees from Novartis, Lilly, during the conduct of the study; grants from Pfizer, AstraZeneca, Sanofi, Pierre Fabre, Takeda, outside the submitted work; CW reports other from Novartis, during the conduct of the study; DM reports other from Novartis, during the conduct of the study; AL reports other from Novartis, during the conduct of the study; MM reports other from Novartis, during the conduct of the study; FG reports other from Novartis, during the conduct of the study; SL reports grants from Pfizer, Celgene, Amgen, Roche, AstraZeneca, AbbVie, outside the submitted work; other from Pfizer, Celgene, Amgen, Roche, AstraZeneca, AbbVie, Lilly, Daiichi Sankyo, EirGenix, outside the submitted work. All other authors have declared no conflicts of interest. |
| This work was supported by Novartis Pharmaceuticals Corporation . No grant number is applicable. |
| HSR reports personal fees from Genomic Health, Novartis, Roche/Genentech, OBI Pharma, Bayer, Pfizer, during the conduct of the study; grants from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Eli Lilly, GlaxoSmithKline, Genentech, Celsion, Merck, outside the submitted work; FA reports grants from Novartis during the conduct of the study; grants from Astra Zeneca, Pfizer, Lilly, Roche, outside the submitted work; TY reports grants and other from Chugai, Kyowa Kirin; other from Eisai, Novartis, Taiho, Sanofi, AstraZeneca, Pfizer Japan, outside the submitted work; SMS reports non-financial support from Pfizer, Lilly, outside the submitted work. JCJ reports personal fees from GlaxoSmithKline, Roche, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen, Pfizer, during the conduct of the study; other from GlaxoSmithKline, AstraZeneca, Roche, Novartis, PharmaMar, Eisai, Lilly, Celgene, Astellas, Amgen, Pfizer, outside the submitted work; DJ reports personal fees from Novartis, Genentech, Eisai, Ipsen, EMD Serono, during the conduct of the study; IM reports personal fees from Novartis, Genentech, during the conduct of the study; grants from Novartis, Pfizer, outside the submitted work; EMC reports personal fees from Pfizer, Novartis, Lilly, Roche, Celgene, during the conduct of the study; PC reports personal fees from Roche, Novartis, AstraZeneca, Celgene, Tesaro, during the conduct of the study; grants from Roche, Novartis, Merck, Bristol-Myers Squibb, outside the submitted work; MC reports personal fees from Novartis, Lilly, during the conduct of the study; grants from Pfizer, AstraZeneca, Sanofi, Pierre Fabre, Takeda, outside the submitted work; CW reports other from Novartis, during the conduct of the study; DM reports other from Novartis, during the conduct of the study; AL reports other from Novartis, during the conduct of the study; MM reports other from Novartis, during the conduct of the study; FG reports other from Novartis, during the conduct of the study; SL reports grants from Pfizer, Celgene, Amgen, Roche, AstraZeneca, AbbVie, outside the submitted work; other from Pfizer, Celgene, Amgen, Roche, AstraZeneca, AbbVie, Lilly, Daiichi Sankyo, EirGenix, outside the submitted work. All other authors have declared no conflicts of interest. |
