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Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine and Oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial

  • Fernando RiveraEmail author
  • C. Romero
  • P. Jimenez-Fonseca
  • M. Izquierdo-Manuel
  • A. Salud
  • E. Martínez
  • M. Jorge
  • V. Arrazubi
  • J. C. Méndez
  • P. García-Alfonso
  • M. Reboredo
  • J. Barriuso
  • N. Muñoz-Unceta
  • R. Jimeno
  • C. López
Clinical Trial Report
  • 162 Downloads

Abstract

Purpose

The phase III ToGA trial established cisplatin, fluoropyrimidine and trastuzumab as the standard treatment in HER2-positive advanced gastric cancer (AGC). However, as demonstrated in HER2-negative AGC, oxaliplatin-based regimens could improve tolerance remaining effective. The aim of this trial was to explore the potential activity and safety of capecitabine, oxaliplatin (XELOX) and trastuzumab in patients with HER-2 positive advanced gastric cancer.

Methods

We conducted a multicentre, prospective, non-randomised, non-controlled, open-label and national (Spanish) phase II study. Patients with HER2-positive advanced gastric or gastro-oesophageal junction (EGJ) cancer received XELOX and trastuzumab as first-line treatment. Primary endpoint was objective tumour response rate (ORR).

Results

45 patients from ten hospitals in Spain were included from September 2011 to December 2013. Median age was 65 years, 82.2% were male, 69% had gastric cancer and 31% had EGJ tumours. At a median follow-up of 13.7 months (7.1–20.9), the estimated median progression-free survival and overall survival were 7.1 (95% CI 5.5–8.7) and 13.8 months (95% CI 10.1–17.4), respectively, with 8.9%, 37.8% and 31.1% of patients achieving complete response, partial response and stable disease. Regarding safety, 44.4% of the patients had grade 3 or greater adverse events, being the most frequent diarrhoea (26.6%), fatigue (15.5%), nausea (20%) and vomiting (13.3%). Only two patients (4.4%) developed asymptomatic grade 2 left ventricle ejection fraction reduction.

Conclusions

XELOX-trastuzumab is a promising and effective therapy as first-line treatment for patients with HER2-positive AGC, with comparable results to the ones obtained with other “platinum-based” regimens. This scheme is feasible and tolerable with a low incidence of cardiac toxicity.

Keywords

Advanced gastric cancer HER2 positive Phase II study Oxaliplatin Capecitabine Trastuzumab 

Notes

Acknowledgements

We are indebted to the all patients and investigators who have contributed to this study.

Compliance with ethical standards

Conflict of interest

FR: Advisory boards, conferences, travel expenses and investigational grants from Roche Pharma, Sanofi, MSD, BMS, Merck-Serono, Bayer, Amgen, Servier and Celgene. CL: Advisory boards, conferences, travel expenses and investigational grants from Roche Pharma and Sanofi. JB: Advisory boards, conferences, travel expenses and investigational grants from Roche Pharma, Novartis, Ipsen, Pfizer, AAA and Celgene.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Fernando Rivera
    • 1
    Email author
  • C. Romero
    • 2
  • P. Jimenez-Fonseca
    • 3
  • M. Izquierdo-Manuel
    • 3
  • A. Salud
    • 4
  • E. Martínez
    • 1
  • M. Jorge
    • 5
  • V. Arrazubi
    • 6
  • J. C. Méndez
    • 7
  • P. García-Alfonso
    • 8
  • M. Reboredo
    • 9
  • J. Barriuso
    • 10
  • N. Muñoz-Unceta
    • 1
  • R. Jimeno
    • 1
  • C. López
    • 1
  1. 1.Medical Oncology DepartmentHospital Universitario Marqués de ValdecillaSantanderSpain
  2. 2.Medical Oncology DepartmentPOVISAVigoSpain
  3. 3.Medical Oncology DepartmentHospital Universitario Central de AsturiasOviedoSpain
  4. 4.Medical Oncology DepartmentHospital Arnau de VilanovaLleidaSpain
  5. 5.Medical Oncology DepartmentHospital Xeral CiesVigoSpain
  6. 6.Medical Oncology DepartmentComplejo Hospitalario de NavarraPamplonaSpain
  7. 7.Medical Oncology DepartmentCentro Oncológico de GaliciaCoruñaSpain
  8. 8.Medical Oncology DepartmentHospital Gregorio MarañónMadridSpain
  9. 9.Medical Oncology DepartmentComplejo Hospitalario de A CoruñaCoruñaSpain
  10. 10.Medical Oncology DepartmentHospital La PazMadridSpain

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