Phase II Trial of Docetaxel Chemotherapy in Patients with Incurable Adenocarcinoma of the Esophagus

Abstract

Background: Chemotherapy remains theprimary mode of treatment for metastaticcarcinoma of the esophagus. The efficacyof various chemotherapeutic regimens hasbeen studied predominantly in patients withsquamous cell carcinoma of the esophagus. In light of the increasing incidence ofadenocarcinoma of the esophagus, studiesevaluating newer chemotherapy agents, suchas docetaxel, in this patient populationare necessary. The objective of this trialwas to determine the complete and partialresponse rate of docetaxel in patients withincurable adenocarcinoma of theesophagus.

Patients and methods: Eligiblepatients had histologically confirmedmetastatic adenocarcinoma of the esophagusor locally extensive disease not curablewith surgery or radiation therapy. Patients were either chemotherapy naive orpreviously treated with chemotherapy(including paclitaxel). Docetaxel wasadministered at a dose of 75 mg/m²every three weeks intravenously.Appropriate imaging studies/examinationswere obtained after every two cycles toevaluate response.

Results: A total of 22 patients wereenrolled in the trial. Chemotherapy-naivepatients achieved a response rate of 18%(95% CI = 2.3 to 51.8) while patients whoreceived prior chemotherapy achieved a 0%response rate (95% CI = 0 to 25). Therewere no complete responses. The overallmedian survival time is 3.4 months and theone-year survival rate is 21%. Thetoxicities included febrile neutropenia(32%) as well as grade 3 and 4 fatigue(14%) and anorexia (9%).

Conclusions: Although chemotherapy naivepatients achieved an 18% response rate andno responses were seen in previouslytreated patients, the limitations of thistrial does not allow for any definitiveconclusions to be made about the efficacyof single agent docetaxel chemotherapy inpatients with incurable esophagealcancer.