A phase II trial of topotecan in esophageal carcinoma: a Southwest Oncology Group study (SWOG 9339).
BACKGROUND
Chemotherapeutic treatments containing topoisomerase I inhibitors have shown antitumor activity against a number of solid tumors. Responses have been seen in Phase I trials using topotecan in ovarian, lung, and esophageal cancer. A phase II trial using continuous infusion topotecan was completed to assess activity in esophagus cancer.


METHODS
Forty-five eligible patients with locally-advanced or metastatic squamous cell carcinoma or adenocarcinoma of the esophagus received a regimen consisting of 24-hour continuous infusion topotecan at 1.5 mg/m2/day on Days 1, 8, 15, 22 (of 42-day cycle). Patients continued on treatment until evidence of disease progression or unacceptable toxicity.


RESULTS
Partial response was demonstrated in 1 patient (2% confirmed response rate). Thirty-six patients progressed during the first cycle of treatment. The median survival was 3 months, and the median progression-free survival was 1 month. Toxicity was mild with only one Grade 4 toxicity reported.


CONCLUSIONS
This phase II trial indicates no significant anti-neoplastic activity for topotecan administered in the dose and schedule to patients with squamous cell or adenocarcinoma of the esophagus.
Macdonald
J S
JS
Saint Vincents Comprehensive Cancer Center, New York, NY, USA.
Jacobson
J L
JL
Ketchel
S J
SJ
Weiss
G
G
Taylor
S
S
Mills
G
G
Kuebler
J P
JP
Rivkin
S
S
Conrad
M
M
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D019772:Topotecan / Q000009:adverse effects / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D019772:Topotecan