Phase II trial of weekly docetaxel/irinotecan combination in advanced pancreatic cancer.
BACKGROUND
Docetaxel and irinotecan have activity in pancreatic cancer. The combination of docetaxel and irinotecan is attractive because of preclinical evidence of synergy between the two drugs. We have previously demonstrated the safety of docetaxel 35 mg/m(2) and irinotecan 50 mg/m(2) given on days 1, 8, 15, and 21 of a 35-day schedule.


METHODS
Patients who had unresectable or metastatic adenocarcinoma of the pancreas, bidimensionally measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and normal bilirubin levels were eligible. Tumor assessment was performed with computed tomography, computed tomographic angiography, or magnetic resonance imaging every 2 cycles. Response was graded according to World Health Organization criteria.


RESULTS
We enrolled 37 eligible patients. Principal grade 3/4 toxicities were diarrhea (21%), neutropenia (30%), and hyperglycemia (30%). There were 3 patients with febrile neutropenia and no toxic deaths. There were 4 early deaths. Among 36 evaluable patients, 9 (24%) attained a partial response and 1 (3%) attained a complete response for an objective response rate of 27%. One patient enrolled because she had been deemed to have unresectable disease but then underwent resection with negative margins after attaining a confirmed partial response. Median survival for all eligible patients is 9.4 months (range 0-68+ months) with minimum follow-up for surviving patients of 23.4 months. One-year survival is 43%. The patient who attained a complete response is alive with recurrent disease at 68 months.


CONCLUSIONS
The docetaxel/irinotecan combination given on a weekly schedule is an active treatment for advanced pancreatic cancer.
Burtness
Barbara
B
Fox Chase Cancer Center, Philadelphia, PA 19111, USA. barbara.burtness@fccc.edu
Thomas
Laurie
L
Sipples
Rebecca
R
McGurk
Meghan
M
Salikooti
Saritha
S
Christoforou
Maryanne
M
Mirto
Gayle
G
Salem
Ronald
R
Sosa
Julieann
J
Kloss
Robert
R
Rahman
Zia
Z
Chung
Gina
G
Lacy
Jill
J
Murren
John R
JR
D000230:Adenocarcinoma / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000627:therapeutic use; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology
D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin