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

Byline: John S. Macdonald (1), Joth L. Jacobson (2), Steven J Ketchel (3), Geoffrey Weiss (4), Sarah Taylor (5), Glenn Mills (6), J. Phillip Kuebler (7), Saul Rivkin (8), Marcel Conrad (9) Keywords: esophageal cancer; gastrointestinal cancer; topotecan; topoisomerase-1 inhibitor Abstract: 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/m.sup.2/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. Author Affiliation: (1) Saint Vincents Comprehensive Cancer Center, New York, NY (2) Southwest Oncology Group Statistical Center, Seattle, WA (3) Cancer Care Center of Southern Arizona, Tucson, AZ (4) Division of Medical Oncology, UT Health Science Center, San Antonio, TX (5) Veterans Administration Hospital, Kansas City, MO (6) LSU Medical Center, Shreveport, LA (7) Cancer Services, Columbus, OH (8) Tumor Institute of Swedish Hospital Medical Center, Seattle, WA (9) University of Southern Alabama, Mobile, AL, USA Article History: Registration Date: 09/10/2004