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First-line panitumumab plus docetaxel and cisplatin in advanced gastric and gastro-oesophageal junction adenocarcinoma: results of a phase II trial

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Abstract

Purpose

Panitumumab is extensively used for RAS-WT metastatic colorectal cancer. This study assessed the efficacy and safety of panitumumab plus first-line chemotherapy [docetaxel (DOC) and cisplatin (CIS)] in treatment-naïve advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma (ADC) patients.

Methods

Phase II, open-label, single-arm study includes treatment-naïve advanced gastric or GEJ-ADC patients from ten Spanish centres. Patients received panitumumab (6 mg/kg) plus DOC and CIS (50 mg/m2 both) every 2 weeks until disease progression, unacceptable toxicity, or patient withdrawal. Primary endpoint: objective response rate (ORR); main secondary endpoints: disease control rate (DCR), duration of response (DoR), time to progressive disease (TTP), progression-free-survival (PFS), overall survival (OS), and safety.

Results

Forty-four patients were included; median age: 67.8 (range 43.3–82.7) years, 68.2% male. The ORR was 27.3% (95% CI 15.0, 42.8); median PFS and OS: 5.0 (95% CI 3.6, 6.9) and 7.2 (5.5, 9.0) months, respectively. Median TTP, DCR and DoR: 5.3 (range 3.8–7.0) months, 70.5% (95% CI 54.8, 83.2%), and 4.8 (1.8, NE) months. Median panitumumab treatment duration: 11.9 (range 0.1–34.9) weeks; 25.0% patients had a dose reduction and 40.9% discontinued treatment. Grade 3–4 adverse events (AEs): 68.2%/22.2% patients. Most common AEs: asthenia (75.0%) and mucosal inflammation (54.5%). Serious AEs were experienced by 54.6% patients; 9.1%, 13.6%, and 15.9% related to panitumumab, DOC, and CIS, respectively. Three (6.8%) patients died due to AEs not related to study treatment.

Conclusions

The addition of panitumumab to standard chemotherapy as the first-line treatment in advanced gastric or GEJ-ADC does not appear to improve the efficacy outcomes.

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Acknowledgements

Writing assistance was supported by Amgen and provided by Cristina Ceballos, MSc, Nerea Gallastegui, PhD, and Neus Valveny, PhD, from TFS Develop. The authors wish to thank to all the investigators of the SPIGA Study.

Funding

This work was supported by Amgen S.A. Amgen did not have any role in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication.

Author information

Authors and Affiliations

  1. Department of Medical Oncology, Hospital Universitario Lucus Augusti, Calle Doctor Ulises Romero, 1, 27003, Lugo, Spain

    G. Quintero Aldana, M. Covela & M. Carmona

  2. Department of Medical Oncology, Complejo Hospitalario Universitario de Ourense, Ourense, Spain

    M. Salgado & A. Fernández Montes

  3. Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain

    S. Candamio, Y. Vidal Insua & R. López

  4. Department of Medical Oncology, Centro Oncologico de Galicia, A Coruña, Spain

    J. C. Méndez

  5. Department of Medical Oncology, Complejo Hospitalario Xeral Cíes, Vigo, Spain

    M. Jorge

  6. Department of Medical Oncology, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

    M. Reboredo

  7. Department of Medical Oncology, Complejo Hospitalario de Pontevedra, Pontevedra, Spain

    L. Vázquez Tuñas

  8. Department of Medical Oncology, Hospital POVISA, Vigo, Spain

    C. Romero

  9. CIBERONC, Madrid, Spain

    R. López

Authors
  1. G. Quintero Aldana
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  2. M. Salgado
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  3. S. Candamio
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  4. J. C. Méndez
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  5. M. Jorge
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  6. M. Reboredo
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  7. L. Vázquez Tuñas
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  8. C. Romero
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  9. M. Covela
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  10. A. Fernández Montes
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  11. M. Carmona
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  12. Y. Vidal Insua
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  13. R. López
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the Galician Oncological Research Group (GGIO)

Corresponding author

Correspondence to G. Quintero Aldana.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the Ethic Committee of Reference (Comité Ético de Investigación Clínica SERGAS, Santiago de Compostela, Spain) and the Spanish Health Authorities (AEMPS), and conducted in accordance with the principles of the Declaration of Helsinki.

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Informed consent was obtained from all individual participants included in the study.

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Quintero Aldana, G., Salgado, M., Candamio, S. et al. First-line panitumumab plus docetaxel and cisplatin in advanced gastric and gastro-oesophageal junction adenocarcinoma: results of a phase II trial. Clin Transl Oncol 22, 495–502 (2020). https://doi.org/10.1007/s12094-019-02151-6

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  • DOI: https://doi.org/10.1007/s12094-019-02151-6

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