Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group
Por:
Provencio, M, Terrasa, J, Garrido, P, Campelo, RG, Aparisi, F, Diz, P, Aguiar, D, Garcia-Giron, C, Hidalgo, J, Aguado, C, Gonzalez, JG, Esteban, E, Gomez-Aldavari, L, Moran, T, Juan, O, Chara, LE, Marti, JL, Castro, RL, Ortega, AL, Moreno, EM, Coves, J, Pena, AMS, Bosch-Barrera, J, Gastaldo, AS, Nunez, NF, del Barco, E, Cobo, M, Isla, D, Majem, M, Navarro, F, Calvo, V
Publicada:
6 mar 2021
Resumen:
BackgroundAURA study reported 61% objective response rate and progression-free survival of 9.6months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.MethodsPost-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016-December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8months. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted.ConclusionThis study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events.Trial registrationClinical trial registration number:NCT03790397.
Filiaciones:
Provencio, M:
Hosp Univ Puerta Hierro, Med Oncol Dept, Madrid, Spain
Hosp Univ Puerta Hierro, Hlth Res Inst, Madrid, Spain
Univ Autonoma Madrid, Madrid, Spain
Terrasa, J:
Hosp Univ Son Espases, Med Oncol Dept, Palma De Mallorca, Spain
Garrido, P:
IRYCIS Hosp Univ Ramon y Cajal, Med Oncol Dept, Madrid, Spain
Campelo, RG:
Hosp Univ A Coruna, Med Oncol Dept, La Coruna, Spain
Inst Invest Biomed A Coruna INIBIC, La Coruna, Spain
Aparisi, F:
Hosp Gen Univ Valencia, Med Oncol Dept Valencia, Madrid, Spain
Diz, P:
Complejo Asistencial Univ Leon, Med Oncol Dept Leon, Madrid, Spain
Aguiar, D:
Hosp Univ Gran Canaria Dr Negrin, Med Oncol Dept, Las Palmas De Gc, Spain
Garcia-Giron, C:
Hosp Univ Burgos, Med Oncol Dept, Burgos, Spain
Hidalgo, J:
Hosp Lluis Alcanyis, Med Oncol Dept, Valencia, Spain
Aguado, C:
Hosp Clin San Carlos, Med Oncol Dept, Madrid, Spain
Gonzalez, JG:
Hosp Clin Univ Santiago, Med Oncol Dept Santiago Compostela, Madrid, Spain
Esteban, E:
Hosp Univ Cent Asturias, Med Oncol Dept, Oviedo, Spain
Gomez-Aldavari, L:
Complejo Hosp Univ Albacete, Med Oncol Dept, Albacete, Spain
Moran, T:
Inst Catala Oncol Badalona, Med Oncol Dept, Barcelona, Spain
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Med, Barcelona, Spain
Badalona Appl Res Grp Oncol, Barcelona, Spain
Fundacio Germans Trias & Pujol, Barcelona, Spain
Juan, O:
Hosp Univ & Politecn La Fe, Med Oncol Dept, Valencia, Spain
Chara, LE:
Hosp Univ Guadalajara, Med Oncol Dept, Guadalajara, Spain
Marti, JL:
Hosp Gen Univ Alicante, Med Oncol Dept, Alicante, Spain
Castro, RL:
Hosp Clin Univ Valladolid, Med Oncol Dept, Valladolid, Spain
Ortega, AL:
Complejo Hosp Jaen, Med Oncol Dept, Jaen, Spain
Moreno, EM:
Hosp Virgen Salud, Med Oncol Dept, Toledo, Spain
Coves, J:
Hosp Son Llatzer, Med Oncol Dept, Palma De Mallorca, Spain
Pena, AMS:
Hosp Univ Getafe, Med Oncol Dept, Madrid, Spain
Bosch-Barrera, J:
Dr Josep Trueta Univ Hosp, Dept Oncol, Catalan Inst Oncol, Girona, Spain
Gastaldo, AS:
Hosp Univ Virgen Rocio, Med Oncol Dept, Seville, Spain
Nunez, NF:
Hosp Univ Lucus Augusti, Med Oncol Dept, Lugo, Spain
del Barco, E:
Hosp Univ Salamanca, Med Oncol Dept, Salamanca, Spain
Cobo, M:
Hosp Univ Reg & Virgen Victoria, Unidad Gest Clin Intercentros Oncol Med, IBIMA, Malaga, Spain
Isla, D:
Hosp Univ Lozano Blesa, Med Oncol Dept, Zaragoza, Aragon, Spain
Majem, M:
Hosp Santa Creu & Sant Pau, Med Oncol Dept, Barcelona, Spain
Navarro, F:
Hosp Univ Principe Asturias, Med Oncol Dept, Alcala De Henares, Spain
Calvo, V:
Hosp Univ Puerta Hierro, Med Oncol Dept, Madrid, Spain
Hosp Univ Puerta Hierro, Hlth Res Inst, Madrid, Spain
Green Published, gold, Green Submitted
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