A pilot study of irinotecan (CPT-11) as single-agent therapy in patients with locally advanced or metastatic esophageal carcinoma.
OBJECTIVE
This study assessed the efficacy and safety of irinotecan (CPT-11) in the treatment of patients with unresectable esophageal carcinoma.


METHODS
Ten patients with esophageal squamous cell carcinoma (SCC) and three with adenocarcinoma (AC) were treated with CPT-11. Eight of the 13 patients were pretreated by surgery, radio-, or chemotherapy. CPT-11 was administered in repeated 6-week cycles consisting of CPT-11 once weekly for 4 weeks, followed by a 2-week rest. The starting dose of CPT-11 was 125 mg/m(2) given intravenously over 60 min; subsequent doses were adjusted based on tolerance and toxicity. Nine patients were evaluable for response.


RESULTS
Two patients showed a partial response (one SCC, one AC) and two others disease stabilization (one SCC, one AC). The mean time to progression was 3.8 months. Mean survival since study entry was 6.1 months. In the 103 administrations we observed grade 3 or 4 toxicity on six occasions with diarrhea, five with neutropenia, and one with nausea and vomiting. Toxicity required dose reductions in five patients; in two of these patients treatment was stopped because of severe toxicity. No treatment related deaths occurred.


CONCLUSIONS
CPT-11 as single-agent therapy is modestly effective against squamous cell cancer of the esophagus.
Mühr-Wilkenshoff
F
F
Medical Clinic I, University Hospital Benjamin Franklin, Hindenburgdamm 30, 12200, Berlin, Germany.
Hinkelbein
W
W
Ohnesorge
I
I
Wolf
K J
KJ
Riecken
E-O
EO
Zeitz
M
M
Scherübl
H
H
D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis
D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin