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Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma

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Abstract

Purpose

The prognosis of patients with unresectable M0 gastric cancer remains very poor. We performed a phase II trial to explore the efficacy and toxicity of induction irinotecan-cisplatin (IC) followed by concurrent irinotecan-cisplatin and radiotherapy (IC/RT) in this setting.

Methods and materials

Patients with unresectable M0 gastric (GC) or oesophageal-gastric junction (EGJC) adenocarcinomas were treated with two courses of IC (irinotecan, 65 mg/m2; cisplatin, 30 mg/m2 on days 1 and 8 every 21 days) followed by IC/RT (daily radiotherapy—45 Gy—with concurrent IC: irinotecan, 65 mg/m2, and cisplatin, 30 mg/m2, on days 1, 8, 15, and 22). Resectability was reassessed after this treatment, and surgical resection was performed if feasible. The primary endpoint was the R0 resection rate after induction treatment.

Results

Seventeen patients were included in the study (EGJC: 6; GC: 11). An R0 resection was achieved in only 5 patients (29%), and according to the design of the trial (Simon’s optimal two-stage) accrual of patients was terminated after the first stage. No patient died during IC, whereas 3 patients (24%) died during IC/RT and one of 5 resected patients (20%) died during the first 30 days after resection. The median survival was 10.5 months, and the actuarial 2-year survival rate was 27%.

Conclusions

Induction IC followed by IC/RT showed poor efficacy and significant toxicity in patients with unresectable GC/EGJC.

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Acknowledgments

We thank the patients and the medical and nursing staff of all the participating institutions. We also thank David Asensio, Julita Ocaña, Matilde Salcedo, Noelia Vega, Yolanda Blanco and Inmaculada Ruiz de Mena for their helpful comments on the manuscript. This work was supported by an unrestricted grant from Laboratorios Almirall, Barcelona, Spain.

Conflict of interest

Fernando Rivera served on the advisory board and received travel and research grants from Roche, Sanofi –Aventis and Merck-Serono. Maica Galán served on the advisory board for Roche. No conflicts of interest pertain to the remaining authors.

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Authors and Affiliations

  1. Medical Oncology Department, H. U. Marqués de Valdecilla, Santander, Spain

    Fernando Rivera & Mª Eugenia Vega-Villegas

  2. Medical Oncology Department, ICO L′Hospitalet, Barcelona, Spain

    Maica Galán & Berta Laquente

  3. Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain

    Josep Tabernero

  4. Hematology and Medical Oncology Department, University Hospital, University of Valencia, Valencia, Spain

    Andres Cervantes & Edith Rodríguez

  5. Medical Oncology Department, H. General U, Elche, Alicante, Spain

    Javier Gallego & Alfredo Carrato

  6. Medical Oncology Department, H. Clínico U, Lozano Blesa, Zaragoza, Spain

    Pilar Escudero & Alberto Sáenz

  7. Medical Oncology Department, H. General U, Alicante, Spain

    Bartomeu Massutí & Ana Lucia Yuste

  8. Medical Oncology Department, H. Miguel Servet, Zaragoza, Spain

    Vicente Alonso-Orduña & Antonio Antón

  9. Radiotherapy Department, H.U. Marqués de Valdecilla, Santander, Spain

    Adelaida Cardenal

  10. Radiotherapy Department, Vall d’Hebron University Hospital, Barcelona, Spain

    Jordi Giralt

  11. Medical Oncology Department, H.U. Reina Sofía, Córdoba, Spain

    Enrique Aranda

  12. Medical Oncology Department, Marqués de Valdecilla University Hospital, Avda, Valdecilla s/n, 39008, Santander, Spain

    Fernando Rivera

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  1. Fernando Rivera
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On Behalf of the Spanish Cooperative Group for Digestive Tumour Therapy (TTD)

Corresponding author

Correspondence to Fernando Rivera.

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Rivera, F., Galán, M., Tabernero, J. et al. Phase II trial of induction irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for unresectable, locally advanced gastric and oesophageal-gastric junction adenocarcinoma. Cancer Chemother Pharmacol 67, 75–82 (2011). https://doi.org/10.1007/s00280-010-1285-1

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  • DOI: https://doi.org/10.1007/s00280-010-1285-1

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