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Efficacy of nintedanib and docetaxel in patients with advanced lung adenocarcinoma treated with first-line chemotherapy and second-line immunotherapy in the nintedanib NPU program

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Abstract

Purpose

Both nintedanib/docetaxel and anti‐PD‐1/PD‐L1 immunotherapies have demonstrated efficacy as second‐line treatment of patients with advanced lung adenocarcinoma. This is the first report on the efficacy of the nintedanib/docetaxel combination following first‐line platinum‐based chemotherapy and subsequent immunotherapy in a real-world setting.

Methods/patients

From May 2014 to December 2015, 390 patients in 108 Spanish centres enrolled in the nintedanib named patient use program. Inclusion criteria were advanced lung adenocarcinoma with progressive disease following at least one line of platinum‐based doublet chemotherapy. The objective was to evaluate the efficacy of the nintedanib/docetaxel combination in patients who also received immunotherapy.

Results

Eleven patients met the inclusion criteria; with a median age of 67 years. PD‐L1 expression was positive in six patients. Median progression‐free survival (PFS) of first‐line platinum‐based chemotherapy was 3.3 months (95% CI 1.9–4.6). Second‐line immunotherapy was pembrolizumab (36.5%), atezolizumab (36.5%) or nivolumab (27%). Median PFS of second‐line immunotherapy was 2.3 months (95% CI 0–6.1). The overall response rate (ORR) to second‐line immunotherapy was 18% with a disease‐control rate (DCR) of 45%. Median PFS of nintedanib/docetaxel was 3.2 months (95% CI 1.9–4.5). Best response was partial response in four patients (36%), stable disease in five patients (46%), and progressive disease in two patients (18%), for an ORR of 36% and a DCR of 82%.

Conclusion

Our experience suggests an encouraging efficacy of nintedanib/docetaxel in patients with adenocarcinoma NSCLC pretreated with platinum‐based doublet chemotherapy and immunotherapy, reinforcing the importance of an optimal therapeutic sequence for managing advanced lung adenocarcinoma.

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Funding

The nintedanib NPU was funded by Boehringer Ingelheim.

Author information

Authors and Affiliations

  1. Clinica Universidad de Navarra, Calle Marquesado de Santa Marta nº1, 28027, Madrid, Spain

    J. Corral

  2. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

    M. Majem

  3. Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain

    D. Rodríguez-Abreu

  4. Catalan Institute of Oncology- Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

    E. Carcereny

  5. Hospital Universitario Miguel Servet, Saragossa, Spain

    Á. A. Cortes

  6. Hospital General Universitario de Elda, Elda, Alicante, Spain

    M. Llorente

  7. Clínica Universidad de Navarra, Pamplona, Spain

    J. M. López Picazo

  8. Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain

    Y. García

  9. Hospital Universitario- Fundación Jiménez Díaz, Madrid, Spain

    M. Domine

  10. M.D. Anderson Cancer Center, Madrid, Spain

    M P. López Criado

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  1. J. Corral
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Correspondence to J. Corral.

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The authors declare that they have not conflict of interest.

Ethical approval

This study was approved by the Ethics Committees of the participating hospitals and the procedures were performed in accordance with ethical standards of the Institutions′ Research Committees and with the 1964 Declaration of Helsinki and its later amendments.

Informed consent

All patients provided written informed prior to their inclusion in the study. Data that might disclose the identity of the patient has been omitted and the confidentiality of the patient data has been maintained throughout the study and the analyses.

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Corral, J., Majem, M., Rodríguez-Abreu, D. et al. Efficacy of nintedanib and docetaxel in patients with advanced lung adenocarcinoma treated with first-line chemotherapy and second-line immunotherapy in the nintedanib NPU program. Clin Transl Oncol 21, 1270–1279 (2019). https://doi.org/10.1007/s12094-019-02053-7

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