A PHASE-II TRIAL OF 5-FLUOROURACIL AND HIGH-DOSE LEUCOVORIN IN PATIENTS WITH RECURRENT SQUAMOUS-CELL CARCINOMA OF THE CERVIX - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY
Ky. Look et al., A PHASE-II TRIAL OF 5-FLUOROURACIL AND HIGH-DOSE LEUCOVORIN IN PATIENTS WITH RECURRENT SQUAMOUS-CELL CARCINOMA OF THE CERVIX - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY, American journal of clinical oncology, 19(5), 1996, pp. 439-441
The addition of leucovorin to 5-fluorouracil (5-FU) has been shown to
improve the response rate in recurrent colon cancer. The combination o
f low-dose leucovorin and 5-FU was previously tested by the Gynecologi
c Oncology Group (GOG) and did not produce response rates greater than
rates using 5-FU alone. From June 1990 to April 1992, 55 patients wit
h unresectable recurrent squamous cervical cancer received high-dose l
eucovorin at 200 mg/m(2) IV bolus, followed by 5-FU at 370 mg/m(2) IV
bolus daily for 5 days every 4 weeks for the first two courses. Subseq
uent courses were given every 5 weeks. The median number of courses de
livered was two (range 1-15). Fifty patients were evaluable for toxici
ty and 45 for response. Prior radiotherapy had been given to 43 patien
ts and prior chemotherapy to 38. The overall response rate was 8.8% (9
5% confidence interval, 2.5-21.2%). There were two complete responses
(4.4%) and two partial responses (4.4%). One response was in the pelvi
s and three were outside the pelvis. None of the extrapelvic responses
had received irradiation at the site of measurable disease. The major
adverse effect was granulocytopenia, with 15/50 (30%) experiencing GO
G grade 3 or 4 granulocytopenia. The median white blood count for pati
ents experiencing leukopenia was 2,000 (range 400-3,800). Grade 3 or 4
gastrointestinal toxicity was seen in 12 patients (24%). In this pret
reated population, patients receiving high-dose leucovorin with 5-FU h
ad moderate toxicity but only minimal activity.