Efficacy of nintedanib plus docetaxel in patients with refractory advanced epidermal growth factor receptor mutant lung adenocarcinoma.

Autor: Riudavets M; Medical Oncology Department, Hospital de La Santa Creu I Sant Pau, Sant Quintí, 89, 08041, Barcelona, Spain., Bosch-Barrera J; Medical Oncology Department, Institut Català d'Oncologia (ICO), Hospital Universitari Dr. Josep Trueta, Girona, Spain., Cabezón-Gutiérrez L; Medical Oncology Department, Hospital Universitario de Torrejón, Madrid, Spain., Diz Taín P; Medical Oncology Department, Complejo Asistencial Universitario de León, León, Spain., Hernández A; Medical Oncology Department, Institut Català d'Oncologia (ICO), Badalona Applied Research Group in Oncology (B-ARGO Group), Institut Investigació Germans Trias I Pujol (IGTP), Department of Medicine, Universitat Autònoma de Barcelona (UAB), Campus Can Ruti, Badalona, Barcelona, Spain., Alonso M; Medical Oncology Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Blanco R; Medical Oncology Department, Consorci Sanitari de Terrassa, Barcelona, Spain., Gálvez E; Medical Oncology Department, Hospital General de Elda, Alicante, Spain., Insa A; Medical Oncology Department, Hospital Clínico Universitario de Valencia, Valencia, Spain., Mielgo X; Medical Oncology Department, Fundación Hospital Universitario de Alcorcón, Madrid, Spain., Morán T; Medical Oncology Department, Institut Català d'Oncologia (ICO), Badalona Applied Research Group in Oncology (B-ARGO Group), Institut Investigació Germans Trias I Pujol (IGTP), Department of Medicine, Universitat Autònoma de Barcelona (UAB), Campus Can Ruti, Badalona, Barcelona, Spain., Ponce S; Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain., Roa D; Medical Oncology Department, Hospital de Manacor, Manacor, Spain., Sánchez JM; Medical Oncology Department, Hospital Universitario de la Princesa, Madrid, Spain., Majem M; Medical Oncology Department, Hospital de La Santa Creu I Sant Pau, Sant Quintí, 89, 08041, Barcelona, Spain. mmajem@santpau.cat.
Jazyk: angličtina
Zdroj: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2021 Dec; Vol. 23 (12), pp. 2560-2567. Date of Electronic Publication: 2021 Jul 22.
DOI: 10.1007/s12094-021-02661-2
Abstrakt: Background: Anti-angiogenic agents are reported to exert clinical activity in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). We evaluated the outcomes of the combination of docetaxel plus nintedanib in refractory NSCLC patients harboring EGFR mutations.
Methods: We retrospectively analyzed 19 patients with advanced EGFR-mutant NSCLC who had progressed to EGFR tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy receiving docetaxel and nintedanib at 14 Spanish institutions from January 2013 to December 2019. Kaplan-Meier and log-rank tests were used to evaluate progression-free survival (PFS) and overall survival (OS).
Results: Median age was 58.9 years (range 42.8-81), 73.7% were female. All patients were Caucasian, and 73.7% were never or light smokers. The baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0-1 in 94.7% of patients. All patients had adenocarcinoma. Brain and liver metastases were present in 47.4% and 31.6% of patients, respectively. The most common EGFR mutations were exon 19 deletion (52.6%) and exon 21 L858R mutation (36.8%); 47.4% patients presented the EGFR T790M. 94.8% of the patients had received 2-3 previous treatment lines. Docetaxel was administered at 75 mg/m 2 /3 weeks to 16 patients, at 60 mg/m 2 to 2 patients and at 45 mg/m 2 to one patient. Nintedanib was given until disease progression or unacceptable toxicity at 200 mg twice daily except in 2 patients who received 150 mg twice daily and one patient who received 100 mg/12 h. With a median follow-up of 11.4 months (1-38), the median PFS was 6.1 months [95% confidence interval (CI), 4.9-7.3] and the median OS 10.1 months (95% CI 5.9-14.3). The objective response rate (ORR) was 44.4% (23.7-66.8%) and the disease control rate (DCR) 72.2% (49.4-88.5%). Efficacy tended to be greater in patients with the acquired T790M who had received osimertinib, with a median PFS of 6.3 (95% CI 2.1-10.5) versus (vs.) 4.8 (95% CI 3.5-6.1) and a median OS of 12.3 months (95% CI 8.6-16.0) vs. 6.7 months (95% CI 3.9-9.4), although this tendency was not statistically significant (p = 0.468 and p = 0.159, respectively). Sixteen patients (84.2%) had a total of 34 adverse events (AEs), with a median of two (0-6) AEs per patient. The most frequent AEs were asthenia (20.6%) and diarrhea (20.6%). One treatment-related death due to portal thrombosis was reported.
Conclusions: Our data indicate that the combination of docetaxel and nintedanib can be considered to be an effective treatment for EGFR TKI-resistant EGFR-mutant NSCLC.
(© 2021. Federación de Sociedades Españolas de Oncología (FESEO).)
Databáze: MEDLINE
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