A Phase II Trial of Topotecan in Esophageal Carcinoma: A Southwest Oncology Group Study (SWOG 9339)

Background. Chemotherapeutic treatments containingtopoisomerase I inhibitors have shown antitumor activity against anumber of solid tumors. Responses have been seen in Phase I trialsusing topotecan in ovarian, lung, and esophageal cancer. A phase II trial using continuous infusion topotecan was completed toassess activity in esophagus cancer. Methods. Forty-fiveeligible patients with locally-advanced or metastatic squarnouscell carcinoma or adenocarcinoma of the esophagus received a regimen consisting of 24-hour continuous infusion topotecan at 1.5mg/m²/day on Days 1, 8, 15, 22 (of 42-day cycle). Patientscontinued on treatment until evidence of disease progression orunacceptable toxicity. Results. Partial response was demonstrated in 1 patient (2% confirmed response rate). Thirty-sixpatients progressed during the first cycle of treatment. The mediansurvival was 3 months, and the median progression-free survival was1 month. Toxicity was mild with only one Grade 4 toxicity reported.Conclusions. This phase II trial indicates nosignificant anti-neoplastic activity for topotecan administered inthe dose and schedule to patients with squamous cell oradenocarcinoma of the esophagus.