Phase II trial of biweekly paclitaxel plus infusional 5-fluorouracil and leucovorin in patients with advanced or recurrent inoperable gastric cancer.
OBJECTIVE
To investigate the efficacy and safety of combination chemotherapy with biweekly paclitaxel plus infusional 5-fluorouracil and leucovorin in the treatment of patients with advanced or metastatic gastric cancer.


METHODS
Chemonaive patients with histologically confirmed advanced or recurrent inoperable gastric cancer were enrolled in the present study. Treatment consisted of paclitaxel (75 mg/m(2)) and leucovorin (40 mg/m(2)) as a 2-h intravenous infusion, followed by 5-fluorouracil (2,400 mg/m(2)) as a 46-h continuous infusion. Cycles were repeated every 2 weeks.


RESULTS
Thirty patients were enrolled in this study. There were 12 partial responses, giving an overall response rate of 40.0%. At a median follow-up of 10.6 months, the median time to progression and median overall survival were 3.9 and 8.8 months, respectively. The most common hematological toxicity was grade 1-2 anemia, which was seen in 83.3% of patients. No grade 4 leukopenia, thrombocytopenia, or anemia was noted. The most common non-hematological toxicity was anorexia, which was seen in 70% of patients, although grade 3 anorexia was noted in only 10% of cases. There was no severe treatment-related morbidity or death.


CONCLUSIONS
Combination chemotherapy consisting of biweekly paclitaxel plus infusional 5-fluorouracil and leucovorin was effective and well tolerated in patients with advanced gastric cancers.
Lee
Hyo Jin
HJ
Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University Hospital, Jung-gu, Daejeon, South Korea.
Cho
Do Yeun
DY
Park
Ji Chan
JC
Bae
Sang Byung
SB
Lee
Kyu Taek
KT
Cho
In Sung
IS
Han
Chang Soon
CS
Park
Suk Young
SY
Yun
Hwan Jung
HJ
Kim
Samyong
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis
D017239:Paclitaxel; D002955:Leucovorin; D005472:Fluorouracil