title: Phase II study of low-dose paclitaxel and cisplatin as a second-line therapy after 5-fluorouracil/platinum chemotherapy in gastric cancer.
abstract: This study was performed to evaluate the efficacy and toxicity of low-dose paclitaxel/cisplatin chemotherapy in patients with metastatic or recurrent gastric cancer that had failed 5-fluorouracil/platinum-based chemotherapy. Thirty-two patients with documented progression on or within 6 months after discontinuing 5-fluorouracil/platinum-based chemotherapy were enrolled. As a second-line treatment, paclitaxel (145 mg/m(2)) and cisplatin (60 mg/m(2)) was administered on day 1 every 3 weeks. Among 32 patients enrolled, 8 (25%) responded partially to paclitaxel/cisplatin, 8 (25%) had stable disease, and 14 (44%) had progressive disease. Two patients (6%) were not evaluable. The median time to progression (TTP) and overall survival for all patients were 2.9 months and 9.1 months, respectively. The most common hematologic toxicity was anemia (47%). Grade 3 neutropenia developed in three patients (9%), but no other grade 3/4 hematologic toxicity occurred. The most common non-hematologic toxicities were emesis (31%) and peripheral neuropathy (38%). Three cases (9%) of grade 3/4 emesis and 2 cases (6%) of grade 3 peripheral neuropathy developed. In conclusion, low-dose paclitaxel and cisplatin chemotherapy showed moderate activity with favorable toxicity profiles. However, relatively short TTP of this regimen warrants the development of more effective paclitaxel-based regimens other than combination with cisplatin in these patients as second-line therapies.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Keun Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Tak
authors.initials: T
authors.lastname: Yun
authors.forename: Eun Kee
authors.initials: EK
authors.lastname: Song
authors.forename: Im Il
authors.initials: II
authors.lastname: Na
authors.forename: Hyunchoon
authors.initials: H
authors.lastname: Shin
authors.forename: So Yeon
authors.initials: SY
authors.lastname: Oh
authors.forename: In Sil
authors.initials: IS
authors.lastname: Choi
authors.forename: Do Youn
authors.initials: DY
authors.lastname: Oh
authors.forename: Dong Wan
authors.initials: DW
authors.lastname: Kim
authors.forename: Seock Ah
authors.initials: SA
authors.lastname: Im
authors.forename: Tae You
authors.initials: TY
authors.lastname: Kim
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Dae Seog
authors.initials: DS
authors.lastname: Heo
authors.forename: Yung Jue
authors.initials: YJ
authors.lastname: Bang
authors.forename: Noe Kyeong
authors.initials: NK
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D017211:Treatment Failure
chemical_list: D009944:Organoplatinum Compounds; D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil