Gemcitabine and protracted 5-FU for advanced pancreatic cancer. A phase II study.
OBJECTIVE
Although chemotherapy in advanced pancreatic cancer procures dismal results, both 5-fluorouracil and gemcitabine have shown a modest activity. We report a phase II study of gemcitabine combined with protracted 5-fluorouracil.


METHODS
Gemcitabine was given at 1000 mg/m2/week intravenously, in combination with concomitant 5-fluorouracil 200 mg/m2/day as a protracted venous infusion, both 3 out of 4 weeks in patients with locally advanced or metastatic pancreatic adenocarcinoma. Twenty-nine patients were enrolled, among whom 27 were metastatic. Response rate, overall and progression-free survival were endpoints, as well as tolerance and clinical benefit.


RESULTS
We observed 3 (10%) partial responses, and 12 (42%) stabilizations within which the median disease control was 5.6 months. The median progression-free and overall survivals were 2.8 and 4 months, respectively. A clinical benefit was observed in 39% of patients. Myelosuppression was the main toxicity, but no grade 4 was observed. Other toxicities were mild.


CONCLUSIONS
This combination chemotherapy was well tolerated in advanced pancreatic cancer patients.
Kurtz
J E
JE
Département d'Onco-Hématologie, Hôpitaux Universitaires de Strasbourg, France. jean-emmanuel.kurtz@chru-strasbourg.fr
Kohser
F
F
Négrier
S
S
Trillet-Lenoir
V
V
Walter
S
S
Limacher
J M
JM
Untereiner
M
M
Kayitalire
L
L
Jaeck
D
D
Dufour
P
P
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine