Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study.
BACKGROUND
Pancreatic carcinoma responds poorly to conventional chemotherapy. To identify potentially useful agents, a sequence of clinical trials were done.


METHODS
A series of Phase II randomized trials were done by the Southwest Oncology Group in which patients with metastatic or advanced pancreatic cancer were randomized to receive single agents (methylglyoxal-bis-guanylhydrazone [MGBG], dihydroxyanthracenedione [DHAD], and aziridinylbenzoquinone [AZQ]) or a combined regimen of 5-fluorouracil, doxorubicin, mitomycin C, and streptozotocin (FAM-S). Toxicity, response, and survival were determined.


RESULTS
Seventy-one patients received FAM-S and 82, the Phase II single agents. Response rates (95% confidence intervals) for the various treatments were: FAM-S, 11% (0%, 21%); MGBG, 6% (0.8%, 21%); DHAD, 0% (0%, 12%); and AZQ, 0% (0%, 16%). The median survival times were: FAM-S Group, 4.8 months and Phase II agent Group, 3.4 months.


CONCLUSIONS
The FAM-S regimen and the Phase II agents tested did not have substantial antitumor activity in pancreatic cancer. The use of new agents as initial therapy is reasonable.
Bukowski
R M
RM
Cleveland Clinic Foundation, Ohio.
Fleming
T R
TR
Macdonald
J S
JS
Oishi
N
N
Taylor
S A
SA
Baker
L H
LH
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D013311:Streptozocin / Q000008:administration & dosage
D016685:Mitomycin; D013311:Streptozocin; D004317:Doxorubicin; D005472:Fluorouracil