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A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study

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Abstract

Purpose

This single arm, phase II study aims to evaluate the role of epidermal growth factor receptor–tyrosine-kinase inhibitor erlotinib as maintenance therapy following concurrent chemoradiotherapy (cCRT) in unresectable locally advanced non-small-cell lung cancer (NSCLC).

Methods

Patients with unresectable stage IIIA o dry IIIB NSCLC with no evidence of tumor progression after receiving a standard cCRT regimen with curative intent were included. Oral erlotinib 150 mg/day was administered within 4–6 weeks after the end of the cCRT for a maximum of 6 months if no disease progression or intolerable toxicity occurred. Primary end point was the progression-free rate (PFR) at 6 months. Secondary end points included time to progression (TTP) and overall survival (OS).

Results

Sixty-six patients were enrolled and received maintenance treatment with erlotinib [average: 4.5 months (95 % CI 4.0–5.0)]. PFR at 6 months was 63.5 % (41/66). With a median follow-up of 22.7 months (95 % CI 13.5–37.1), the median TTP was 9.9 months (95 % CI 6.2–12.1), and the median OS was 24.0 months (95 % CI 17.3–48.6). Most common adverse events (AEs) related to erlotinib were rash (78.8 %; 16.7 % grade 3), diarrhea (28.8 %; 1.5 % grade 3), fatigue (15.2 %; 1.5 % grade 3), anorexia (7.6 %; 1.5 % grade 3) and vomiting (4.6 %; none grade 3). Five patients (7.6 %) were withdrawn due to AEs.

Conclusions

Erlotinib as maintenance therapy is an active treatment after cCRT in unselected patients with stage III NSCLC, reaching a 6-month PFR of 63.5 % and a median OS of 24 months. The safety profile of maintenance erlotinib was as expected and manageable.

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Acknowledgments

This study was supported by Roche Farma S.A., Madrid, Spain.

Conflict of interest

The authors declare not having conflict of interest regarding this study.

Author information

Authors and Affiliations

  1. Medical Oncology Department, Complexo Hospitalario Universitario de Vigo (CHUVI), Vigo, Spain

    J. Casal Rubio, M. Lázaro-Quintela & G. Huidobro

  2. Medical Oncology Department, Complexo Hospitalario de Ourense (CHOU), Ourense, Spain

    J. L. Fírvida-Pérez

  3. Medical Oncology Department, Complexo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela, Spain

    F. J. Barón-Duarte

  4. Medical Oncology Department, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain

    G. Alonso-Jáudenes

  5. Medical Oncology Department, Hospital Povisa, Vigo, Spain

    L. Santomé

  6. Medical Oncology Department, Complexo Hospitalario Arquitecto Marcide-Novoa Santos, Ferrol, Spain

    F. J. Afonso-Afonso

  7. Centro Regional Oncológico de Galicia, A Coruña, Spain

    M. Amenedo

  8. Medical Oncology Department, Hospital Universitario Lucus Augusti (HULA), Lugo, Spain

    B. Campos-Balea & S. Vázquez

  9. Radiation Oncology Department, Complexo Hospitalario de Ourense (CHOU), Ourense, Spain

    M. D. López-Vázquez

  10. Medical Oncology Service, Complexo Hospitalario Universitario de Vigo, Avda. Camelias, 106—Hospital Nicolás Peña, 36211, Vigo, Spain

    J. Casal Rubio

Authors
  1. J. Casal Rubio
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  2. J. L. Fírvida-Pérez
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  3. M. Lázaro-Quintela
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  5. G. Alonso-Jáudenes
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  6. L. Santomé
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  7. F. J. Afonso-Afonso
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  8. M. Amenedo
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  9. G. Huidobro
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  10. B. Campos-Balea
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  11. M. D. López-Vázquez
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  12. S. Vázquez
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Corresponding author

Correspondence to J. Casal Rubio.

Additional information

This study is conducted on behalf of the Galician Lung Cancer Group (GGCP).

ClinicalTrials.gov Identifier: NCT00466284.

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Casal Rubio, J., Fírvida-Pérez, J.L., Lázaro-Quintela, M. et al. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol 73, 451–457 (2014). https://doi.org/10.1007/s00280-013-2370-z

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  • DOI: https://doi.org/10.1007/s00280-013-2370-z

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