Second-line treatment with a combination of continuous 5-fluorouracil, doxorubicin, and mitomycin-C (conti-FAM) in gemcitabine-pretreated pancreatic and biliary tract cancer.
BACKGROUND
Gemcitabine-based chemotherapy is a commonly used first-line treatment for patients with pancreatic and biliary tract cancer. However, a standard second-line chemotherapy regimen has yet to be developed after gemcitabine treatment. We attempted to evaluate the efficacy and safety of a combination of continuous 5-fluorouracil, doxorubicin, and mitomycin-C (conti-FAM) as a second-line treatment in pancreatic and biliary tract cancer.


METHODS
Patients with advanced pancreatic or biliary tract cancer who were previously treated with gemcitabine-based chemotherapy were enrolled in the study. Chemotherapy was administered as follows: 5-fluorouracil, 800 mg/m2 on days 1 to 5 over 10 hours; mitomycin-C, 8 mg/m2 on day 1; and doxorubicin, 30 mg/m2 on day 1 every 4 weeks.


RESULTS
A total of 31 patients received 95 cycles of chemotherapy. Fifteen of the patients had pancreatic cancer. Eleven of the patients had cholangiocarcinoma. Gallbladder cancer was observed in 5 patients. Four (12.9%) patients evidenced partial responses. Eight patients (25.8%) had stable disease. The median time to progression and overall survival time were 2.3 (95% CI: 1.0-3.6) months and 6.7 (95% CI: 4.4-9.0) months, respectively. Major hematologic toxicities included grade 1 to 2 anemia (64.2%), neutropenia (32.6%), thrombocytopenia (20%), and grade 3 to 4 neutropenia (10.5%). The most frequently detected nonhematological toxicities were grade 2 and 3 nausea/vomiting (35.5%). One patient was diagnosed with hemolytic uremic syndrome after 8 cycles of treatment.


CONCLUSIONS
The conti-FAM regimen seems to constitute a safe and feasible salvage therapy in patients with advanced bilio-pancreatic cancer who had been treated previously via gemcitabine-based chemotherapy.
Lee
Suee
S
Department of Internal Medicine, Dong-A University College of Medicine, Busan 602-715, Korea.
Oh
Sung Yong
SY
Kim
Byung Geun
BG
Kwon
Hyuk-Chan
HC
Kim
Sung-Hyun
SH
Rho
Myung Hwan
MH
Kim
Young-Hoon
YH
Rho
Mee-Sook
MS
Jeong
Jin-Sook
JS
Kim
Hyo-Jin
HJ
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016009:Chi-Square Distribution; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011336:Probability; D016016:Proportional Hazards Models; D012074:Remission Induction / Q000379:methods; D018570:Risk Assessment; D016019:Survival Analysis; D000093542:Gemcitabine
D003841:Deoxycytidine; D016685:Mitomycin; D004317:Doxorubicin; D005472:Fluorouracil; D000093542:Gemcitabine