PMID- 31303965 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200225 IS - 1949-2553 (Electronic) IS - 1949-2553 (Linking) VI - 10 IP - 42 DP - 2019 Jul 2 TI - Contribution of trastuzumab to the prognostic improvement of HER2-positive early breast cancer in Spain: an estimation of life years and disease-free life years gained since its approval. PG - 4321-4332 LID - 10.18632/oncotarget.27039 [doi] AB - INTRODUCTION: Trastuzumab has become the standard treatment for both HER2-positive early and metastatic breast cancer (HER2+ eBC or mBC) since its approval. The objective of the study is to estimate the benefit of adjuvant trastuzumab in the treatment of patients with HER2+ eBC in terms of life years gained (LYG) and disease-free life years gained (DFLYG) since its approval in Spain in 2006. RESULTS: 35,851 women make up the cohorts from 2006 to 2017. In the T (trastuzumab)+CT (chemotherapy) scenario, the sum of life years was 605,358 (525,964 disease-free) versus 564,137 (489,916 disease-free) in the CT scenario, resulting in 41,221 LYG (36,048 disease-free) due to trastuzumab. The general population for the same age range would have generated 704,331 LY. The estimated incremental cost was 880.43 millioneuro (euro24,558.13 per patient) from 2006 to 2035. The incremental cost-effectiveness ratios obtained were euro20,644 and euro23,960 per LYG and DFLYG, respectively. METHODS: An epidemiological model was developed with a time horizon until 2035 and a 3% discount rate. The model compared two scenarios, with and without trastuzumab as adjuvant therapy. The effectiveness data to model the survival curves were obtained from BCIRG 006 study and direct costs were included. CONCLUSIONS: Adjuvant trastuzumab has substantially improved the survival of patients with HER2+ eBC, contributing over 41,000 LYG to Spanish society (over 36,000 DFLYG) in a cost-effective manner. However, the sum of LYG with trastuzumab is still far from the LY estimated for the general population, supporting the need of further advances in HER2+ eBC. FAU - Ciruelos, Eva AU - Ciruelos E AD - Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain. FAU - Alba, Emilio AU - Alba E AD - Clinical Oncology Unit, Hospitales Universitarios Regional y Virgen de la Victoria; Instituto de Investigacion Biomedica de Malaga (IBIMA), Malaga, Spain. FAU - Lopez, Rafael AU - Lopez R AD - Department of Medical Oncology, Hospital Clinico Universitario e Instituto de Investigacion Sanitaria-CIBERONC, Santiago de Compostela, Spain. FAU - Lluch, Anna AU - Lluch A AD - Department of Medical Oncology, Hospital Clinico Universitario de Valencia, Health Research Institute INCLIVA, University of Valencia, The Centre of Networked Biomedical Cancer Research (CIBERONC), Valencia, Spain. FAU - Martin, Miguel AU - Martin M AD - Medical Oncology Service, Instituto de Investigacion Sanitaria Gregorio Maranon, Universidad Complutense, GEICAM, CIBERONC, Madrid, Spain. FAU - Arroyo, Isabel AU - Arroyo I AD - Department of Payer Evidence and Health Economics, Roche Pharma, Madrid, Spain. FAU - Navarro, Beatriz AU - Navarro B AD - Medical Department, Roche Pharma, Madrid, Spain. FAU - Carcedo, David AU - Carcedo D AD - Oblikue Consulting, Barcelona, Spain. FAU - Colomer, Ramon AU - Colomer R AD - Medical Oncology Service, Hospital Universitario La Princesa, Madrid, Spain. FAU - Albanell, Joan AU - Albanell J AD - Medical Oncology Service, Hospital del Mar, IMIM, Universitat Pompeu Fabra, The Centre of Networked Biomedical Cancer Research (CIBERONC), and Centro Oncologico Clara Campal-HM Delfos, Barcelona, Spain. LA - eng PT - Journal Article DEP - 20190702 PL - United States TA - Oncotarget JT - Oncotarget JID - 101532965 PMC - PMC6611514 OTO - NOTNLM OT - Spain OT - early breast cancer OT - economics OT - life-years OT - trastuzumab COIS- CONFLICTS OF INTEREST Dra. Eva Ciruelos has received honoraria for participation in Advisory Boards and Speakers Bureau from Novartis, Pfizer, Lilly and Roche. Dr. Emilio Alba has received honoraria for participation in Advisory Boards from Roche, Novartis, Pfizer and Lilly, and research grants from Roche and Sysmex. Dr. Rafael Lopez has received honoraria for participation in Advisory Boards from Roche, AstraZeneca, Merck, MSD, Bayer, BMS, Novartis, Janssen, Lilly, Pfizer and Leo; travel, accommodations and expenses from Pharmamar, Roche, BMS and Pierre Fabre; research funding from Roche and Merck; and is co-founder and shareholder in Nasasbiotech, S.L., Mtrap Inc. Dra. Ana Lluch has received research funding (paid to INCLIVA) from Amgen, Astra Zeneca, Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Celgene and Pierre Fabre; and honoraria for participation in Advisory Boards and Consulting from Novartis, Pfizer, Roche/Genentech, Eisai, Celgene. Dr. Miguel Martin has received speaker's honoraria from Pfizer and Lilly, honoraria for participation in Advisory Boards from AstraZeneca, Novartis, Roche-Genentech, Pfizer, Glaxo, Pharmamar, Taiho Oncology and Lilly, and research grants from Novartis and Roche. Arroyo I and Navarro B are employees of Roche which is the developer of the studio. Carcedo D works for the consultancy Oblikue Consulting, who received a grant from Roche for the realization of the study. Dr. Ramon Colomer has received speaker's honoraria from BMS, Pfizer, MSD, Janssen and Novartis, honoraria for participation as consultant or in Advisory Boards from Lilly, MSD, Roche and Servier, research funding from BMS, MSD, Roche, Pfizer, Astrazeneca and Astellas, and has participated in other activities from Instituto Roche, Sanofi and Pfizer. Dr. Joan Albanell has participated in advisory boards and industry sponsored meeting by Roche, Pfizer, Amgen and Novartis. EDAT- 2019/07/16 06:00 MHDA- 2019/07/16 06:01 PMCR- 2019/07/02 CRDT- 2019/07/16 06:00 PHST- 2019/02/12 00:00 [received] PHST- 2019/06/05 00:00 [accepted] PHST- 2019/07/16 06:00 [entrez] PHST- 2019/07/16 06:00 [pubmed] PHST- 2019/07/16 06:01 [medline] PHST- 2019/07/02 00:00 [pmc-release] AID - 27039 [pii] AID - 10.18632/oncotarget.27039 [doi] PST - epublish SO - Oncotarget. 2019 Jul 2;10(42):4321-4332. doi: 10.18632/oncotarget.27039. eCollection 2019 Jul 2.