Annals of Oncology Advance Access originally published online on May 8, 2009
Annals of Oncology 2009 20(7):1242-1248; doi:10.1093/annonc/mdn787
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gastrointestinal tumors |
Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer
1 Division of Medical Sciences, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA
2 Department of Internal Medicine, Section of Medical Oncology, University of Pittsburgh, Pittsburgh
3 Division of Population Sciences, Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA
4 School of Nuring, Yale Cancer Center, New Haven, CT
5 Department of Internal Medicine, Yale University School of Medicine, New Haven, CT
6 Anne Arundel Medical Center, Annapolis, MD, USA
7 Sidney Kimmel Cancer Center, Johns Hopkins University School of Medicine, Baltimore,USA
* Correspondence to: Dr B. Burtness, Division of Medical Sciences, Department of Medical Oncology, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA. Tel: +1-215-728-3023; Fax: +1-215-728-3639; E-mail: barbara.burtness{at}fccc.edu
Background: Preclinical evidence suggests synergy between docetaxel and irinotecan, two drugs active in esophagogastric cancer. We previously demonstrated the safety of docetaxel 35 mg/m2 and irinotecan 50 mg/m2 given on days 1 and 8 of a 21-day schedule.
Materials and methods: Patients who had unresectable/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus, measurable disease, Eastern Cooperative Oncology Group performance status of zero to two, and normal bilirubin were eligible. Tumor assessment was carried out every three cycles.
Results: We enrolled 29 chemotherapy-naive (CN) and 15 chemotherapy-exposed (CE) eligible patients. Principal toxic effects were diarrhea, neutropenia, and hyperglycemia. There were no toxic deaths. There was one early death, from myocardial infarction. Among 26 CN and assessable patients, there were seven (26.9%) with a partial response (PR) and one (3.8%) with a complete response (CR). There were two PRs and one CR among the patients with CE disease. Median time to progression for CN patients was 4.0 months and for CE patients 3.5 months. Median survival for CN eligible patients was 9.0 months and for CE patients 11.4 months.
Conclusions: Docetaxel–irinotecan combination given on a weekly x 2 of 3 schedule is promising in the treatment of advanced esophageal cancer.
Key words: chemotherapy, docetaxel, esophageal cancer, irinotecan
Present address: Department of Internal Medicine, Section of Medical Oncology, University of Pittsburgh, Pittsburgh, PA, USA. 
Posthumous. Received for publication October 13, 2008. Revision received December 11, 2008. Accepted for publication December 12, 2008.