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Annals of Oncology Advance Access originally published online on January 12, 2009
Annals of Oncology 2009 20(3):475-480; doi:10.1093/annonc/mdn658
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer

P. C. Enzinger1,*, D. P. Ryan2, J. W. Clark2, A. Muzikansky3, C. C. Earle1, M. H. Kulke1, J. A. Meyerhardt1, L. S. Blaszkowsky2, A. X. Zhu2, P. Fidias2, M. M. Vincitore1, R. J. Mayer1 and C. S. Fuchs1,4

1 Department of Medical Oncology, Dana-Farber Cancer Institute
2 Division of Hematology/Oncology
3 Biostatistics Center, Massachusetts General Hospital
4 Channing Laboratory, Brigham and Women's Hospital, Boston, MA, USA

* Correspondence to: Dr P. C. Enzinger, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. Tel: +1 (617) 632-6855; Fax: +1 (617) 632-5370; E-mail: peter_enzinger{at}dfci.harvard.edu

Background: Recent studies have examined the addition of docetaxel to fluorouracil and cisplatin in advanced esophagogastric cancer.

Patients and methods: We carried out a phase I dose-escalation study of weekly docetaxel, cisplatin, and irinotecan (TPC), given on days 1 and 8 every 3 weeks, in patients with chemonaive solid tumors. Subsequently, we completed a multiinstitutional phase II study of TPC in patients with previously untreated, metastatic esophagogastric cancer.

Results: Thirty-nine patients were enrolled in the phase I trial; a weekly schedule of TPC was well tolerated. On that basis, docetaxel 30 mg/m2, cisplatin 25 mg/m2, and irinotecan 65 mg/m2 were selected for the phase II trial, where in the first 18 patients irinotecan 65 mg/m2 caused too much diarrhea and was reduced to 50 mg/m2. Among 56 eligible patients with previously untreated, metastatic esophagogastric cancer enrolled in the phase II trial, three complete and 27 partial responses were observed (overall response rate = 54%), and 15 patients (30%) had stable disease. Median progression-free survival was 7.1 months, and median survival was 11.9 months. At the final irinotecan dose of 50 mg/m2, grade 3 or higher toxicity included diarrhea (26%), neutropenia (21%), nausea (18%), fatigue (16%), anorexia (13%), and thrombosis/embolism (13%).

Conclusions: Weekly TPC is an active and well-tolerated regimen for patients with esophagogastric cancer.

Key words: chemotherapy, cisplatin, docetaxel, esophageal cancer, gastric cancer, irinotecan

Received for publication June 5, 2008. Revision received August 4, 2008. Accepted for publication September 3, 2008.


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