A phase II trial of weekly irinotecan in cisplatin-refractory esophageal cancer.
BACKGROUND
This study investigated the efficacy and toxicity of weekly single-agent irinotecan in patients with metastatic disease relapsing after cisplatin-based chemotherapy.


METHODS
Fourteen patients were enrolled. A total number of 29 cycles (one cycle consisted of CPT-11 100 mg/m2 on days 1, 8, 15, qd 28) were applied. Irinotecan was continued until disease progression or unacceptable toxicity occurred. Where toxicity was less than WHO grade 3, the dose of irinotecan was escalated in 20 mg steps in subsequent cycles up to a maximum dose of 140 mg/m2. Patients were assessed for response according to WHO criteria every second cycle.


RESULTS
Of the 13 evaluable patients, 2 achieved a partial response (PR) and 3 disease stabilisation (NC); progressive disease (PD) was noted in 8 patients. Median time to progression was 2 months (range: 1-8 months) and median survival from start of study treatment was 5 months (range: 2-16 months). Grade 3 toxicity consisted of diarrhea (n=3), fever (n=1) and pain (n=1).


CONCLUSIONS
Single-agent irinotecan has moderate activity in cisplatin-refractory esophageal cancer.
Burkart
Christof
C
Departments of Medical Oncology, Hematology, Immunology, Rheumatology, Pulmology, Medical Center II, Tübingen, Germany.
Bokemeyer
Carsten
C
Klump
Bodo
B
Pereira
Philippe
P
Teichmann
Reinhard
R
Hartmann
Jörg Thomas
JT
D000230:Adenocarcinoma / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D002945:Cisplatin / Q000494:pharmacology; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged
D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin