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Annals of Oncology 15:1204-1209, 2004
© 2004 European Society for Medical Oncology

Combination of irinotecan (CPT-11) plus oxaliplatin (L-OHP) as first-line treatment in locally advanced or metastatic gastric cancer: a multicentre phase II trial

Background: The purpose of this study was to evaluate the efficacy and tolerance of irinotecan (CPT-11) in combination with oxaliplatin (L-OHP) as first-line treatment in patients with locally advanced or metastatic gastric cancer (AGC).

Patients and methods: Thirty-two patients with AGC who had not received previous therapy for metastatic disease were enrolled. The median age was 62.5 years and the World Health Organization performance status was 0–1 in 29 patients; 13 (40.6%) patients had previous surgery and three (9.4%) had adjuvant chemotherapy. L-OHP (85 mg/m2 as a 2-h i.v. infusion) followed by CPT-11 (200 mg/m2 as a 30-min i.v. infusion) was given on day 1, in cycles of 21 days.

Results: All patients were evaluable for toxicity and 31 were evaluable for response. Complete response was achieved in one (3.1%) patient and a partial response was achieved in 15 (46.9%) [overall response rate = 50% (95% confidence interval 38.7–72.4%)]. Eight (25%) patients had stable disease, and eight (25%) had progressive disease. The median duration of response was 5 months and the median time to disease progression was 5.5 months. After a median follow-up period of 16 months, the median survival time was 8.5 months. Grade 3–4 neutropenia occurred in six (18.6%) patients, febrile neutropenia in two (6.2%) and grade 3 anaemia in one (3.1%). Grade 3 diarrhoea was observed in two (6.2%) patients, grade 1 neurotoxicity in five (15.6%) and grade 3 asthenia in two (6.2%). There was no treatment-related death.

Conclusions: The combination of CPT-11/L-OHP is an active regimen as front-line treatment in AGC with a favourable toxicity profile and deserves further evaluation in randomised studies.

J. Souglakos1, K. Syrigos2, A. Potamianou3, A. Polyzos4, I. Boukovinas5, N. Androulakis1, Ch. Kouroussis1, N. Vardakis1, Ch. Christophilakis6, A. Kotsakis1 and V. Georgoulias1,*

1 Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete; 2 Medical Oncology Unit, 3rd Department of Internal Medicine and 4 Medical Oncology Unit, Propedeutic Department, University of Athens, Athens; 3 First Department of Medical Oncology, ‘Metaxa’ Hospital of Athens, Athens; 5 2nd Department of Medical Oncology, ‘Theagenion’ Anticancer Hospital of Thessaloniki, Thessaloniki; 6 Medical Oncology Unit, Department of Medical Oncology, 401 Military Hospital of Athens, Athens, Greece

* Correspondence to: Dr Vassilis Georgoulias, MD, PhD, Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, Heraklion 71110, Crete, Greece. Tel: +30-2810392747; Fax: +30-2810392802; Email: georgsec{at}med.uoc.gr

Key words: gastric cancer, irinotecan, oxaliplatin


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