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Effectiveness and safety of aflibercept for metastatic colorectal cancer: retrospective review within an early access program in Spain

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Abstract

Purpose

In the VELOUR study, aflibercept + FOLFIRI regimen resulted in improved survival in metastatic colorectal cancer (mCRC) patients who progressed after oxaliplatin. The use of aflibercept outside the clinical trial framework needs to be further assessed in terms of effectiveness and tolerability.

Methods

Early access to aflibercept through a named patient programme (NPP) was provided to mCRC patients receiving FOLFIRI as second-line treatment in Spain. The effectiveness of aflibercept was assessed as progression-free survival (PFS) achieved within the NPP population. Post hoc analyses on PFS were done according to certain baseline characteristics (K-RAS mutation, prior targeted therapy) or prognostic factors.

Results

Registries from 71 mCRC patients included in the NPP were reviewed retrospectively. The median age for the NPP population was 64 years (19.7 % aged ≥70 years) and 63.4 % patients had ≥2 metastases. A median PFS of 5.3 months (95 % CI, 3.6–8.5 months) was achieved, which did not depend on K-RAS mutation status or prior targeted therapy received. The risk of progression or death increased in patients with a poor prognosis as per the GERCOR score (performance status [PS] 1–2 and increased baseline lactate dehydrogenase [LDH] level) compared with patients with a good prognosis (PS 0 and normal LDH level) (median PFS: 2.6 vs. 8.3 months, respectively; p = 0.0124). Aflibercept was well tolerated, with a manageable toxicity profile.

Conclusions

Bearing in mind the differences in sample size, the PFS achieved with the aflibercept + FOLFIRI regimen in the real-life practice setting is comparable to that observed in the clinical trial setting.

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Acknowledgments

This study was supported by Sanofi. A. Del Campo (Pivotal SL) provided medical writing services on behalf of Sanofi Pharmaceuticals.

Author information

Authors and Affiliations

  1. Medical Oncology Department, Hospital Universitario La Paz, Paseo de la Castellana, 261., 28046, Madrid, Spain

    J. Feliu

  2. Medical Oncology Department, Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain

    I. Díez de Corcuera

  3. Medical Oncology Department, Institut Català d’Oncologia-Hospital Germans Trias i Pujol, Barcelona, Spain

    J. L. Manzano

  4. Medical Oncology Department, H Virgen del Rocio, Seville, Spain

    M. Valladares-Ayerbes

  5. Medical Oncology Department, Hospital Costa del Sol, Marbella, Málaga, Spain

    J. Alcaide

  6. Medical Oncology Department, Hospital General Universitario Morales Meseguer, Murcia, Spain

    T. García García

  7. Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain

    R. Vera

  8. Medical Oncology Department, H. Clínico San Carlos, Madrid, Spain

    J. Sastre

  9. Medical Oncology Department, Center Affiliated to the Red Temática de Investigación Cooperativa (RD06/0020/0021), Instituto Carlos III, Spanish Ministry of Science and Innovation, Madrid, Spain

    J. Sastre

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  1. J. Feliu
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  2. I. Díez de Corcuera
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  3. J. L. Manzano
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  6. T. García García
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  7. R. Vera
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Corresponding author

Correspondence to J. Feliu.

Ethics declarations

Informed consent/research involving human participants

The NPP was performed in accordance with the principles of Good Clinical Practice and the 1964 Helsinki declaration as well as its later amendments, and was approved by the local ethical committees. Patients were informed about their inclusion in the NPP by their treating physician and all gave their informed consent in writing before inclusion. Informed consent was obtained from all individual participants included in the study.

Conflict of interest

JF: Role of advisory or honoraria: Sanofi, Amgen, Bayer, Lilly. MVA: Role of advisory or honoraria: Sanofi, Roche, Amgen, Merck, Bayer. JA: Sanofi, Amgen, Merck, Roche, Novartis. TGG: Role of advisory or honoraria: Sanofi, Roche, Amgen, Merck, Bayer. JS: Role of advisory or honoraria: Sanofi, Roche, Amgen, Merck, Bayer. Research funding: Merck, Bayer. The other authors declare no conflict of interest.

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Feliu, J., Díez de Corcuera, I., Manzano, J.L. et al. Effectiveness and safety of aflibercept for metastatic colorectal cancer: retrospective review within an early access program in Spain. Clin Transl Oncol 19, 498–507 (2017). https://doi.org/10.1007/s12094-016-1556-3

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  • DOI: https://doi.org/10.1007/s12094-016-1556-3

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