BMC Cancer (Mar 2021)

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

  • Mariano Provencio,
  • Josefa Terrasa,
  • Pilar Garrido,
  • Rosario García Campelo,
  • Francisco Aparisi,
  • Pilar Diz,
  • David Aguiar,
  • Carlos García-Giron,
  • Julia Hidalgo,
  • Carlos Aguado,
  • Jorge García González,
  • Emilio Esteban,
  • Lorenzo Gómez-Aldavarí,
  • Teresa Moran,
  • Oscar Juan,
  • Luís Enrique Chara,
  • Juan L. Marti,
  • Rafael López Castro,
  • Ana Laura Ortega,
  • Elia Martínez Moreno,
  • Juan Coves,
  • Ana M. Sánchez Peña,
  • Joaquim Bosch-Barrera,
  • Amparo Sánchez Gastaldo,
  • Natalia Fernández Núñez,
  • Edel del Barco,
  • Manuel Cobo,
  • Dolores Isla,
  • Margarita Majem,
  • Fátima Navarro,
  • Virginia Calvo

DOI
https://doi.org/10.1186/s12885-021-07922-5
Journal volume & issue
Vol. 21, no. 1
pp. 1 – 12

Abstract

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Abstract Background AURA study reported 61% objective response rate and progression-free survival of 9.6 months 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. Methods Post-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. Results 70% 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 11.8 months. 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 9.4 months. 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. Conclusion This 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 registration Clinical trial registration number: NCT03790397 .

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