A phase III study of recombinant interleukin-2, 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in patients with unresectable or metastatic colorectal carcinoma.
135 patients with locally advanced or metastatic colorectal cancer were entered into a phase III trial evaluating the efficacy of chemoimmunotherapy [recombinant interleukin 2 (rIL2)/5-fluorouracil (5-FU) and leucovorin (LV)] versus chemotherapy alone (5-FU/LV). A cycle of chemoimmunotherapy comprised a constant intravenous infusion of rIL2 at a dose of 18 x 10(6) U/m2/24 h for 120 h, followed by three bolus injections of 5-FU (600 mg/m2) and LV (25 mg/m2) at weekly intervals. Patients receiving chemotherapy alone received 5-FU/LV at the same dose at weekly intervals for 6 weeks followed by a rest period of 2 weeks, constituting one cycle of therapy. A maximum of 6 months therapy was given in both arms of the study. The response rates (complete and partial responses) were 17% in patients receiving rIL2/5-FU/LV versus 16% in those in the 5-FU/LV arm of the study. Median survival and progression-free survival were comparable for the two groups of patients, although there was a trend for a prolongation of survival in patients receiving chemoimmunotherapy compared with chemotherapy alone, beyond 12 months. Retrospective subgroup analyses revealed a significantly increased survival in poor prognosis patients (ECOG 1) treated with rIL2/5-FU/LV when compared to those receiving chemotherapy alone. Therefore, further studies evaluating the dose and duration of chemoimmunotherapy in patients with metastatic colorectal cancer seem warranted.
Heys
S D
SD
University Department of Surgery, Aberdeen, U.K.
Eremin
O
O
Ruggeri
E M
EM
Pein
F
F
Rainer
H
H
Oskam
R
R
de Peuter
R A
RA
Palmer
P A
PA
Franks
C R
CR
D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000401:mortality / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins / Q000627:therapeutic use; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D007376:Interleukin-2; D011994:Recombinant Proteins; D002955:Leucovorin; D005472:Fluorouracil