title: Phase II trial of low-dose paclitaxel and cisplatin in patients with advanced gastric cancer.
abstract: BACKGROUND
  Paclitaxel has shown promising activity in gastric cancer and has synergism with cisplatin. This study was performed to evaluate the efficacy and toxicity of low-dose paclitaxel (145 mg/m(2)) plus cisplatin chemotherapy in metastatic or relapsed gastric cancer.
  
  
  METHODS
  Chemotherapy-naïve patients with metastatic or relapsed gastric cancer were enrolled. Paclitaxel 145 mg/m(2) was administered intravenously over 3 h, followed by cisplatin 60 mg/m(2) on Day 1 every 3 weeks in the outpatient setting.
  
  
  RESULTS
  Of 39 patients enrolled, 17 (44%) had partial responses. Twelve (31%) had stable disease and eight (21%) progressive disease. Two patients (5%) were not evaluable because of early drop-out. The median time to progression was 4.7 months and the median overall survival was 12.1 months. The most common hematologic toxicity was anemia (41%). Grade 3/4 neutropenia and thrombocytopenia developed in 14 and 3%, respectively. The most common non-hematologic toxicities were peripheral neuropathy (43%) and emesis (43%). Grade 3/4 non-hematologic toxicities included emesis (11%), peripheral neuropathy (3%), diarrhea (3%) and hepatotoxicity (3%).
  
  
  CONCLUSIONS
  Low-dose paclitaxel and cisplatin chemotherapy was active and well-tolerated in chemotherapy-naïve gastric cancer patients. This regimen seems to have comparable efficacy to previously reported higher-dose paclitaxel plus cisplatin-containing regimens and fewer toxicities.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Chongno-Gu, Seoul 110-744, Republic of Korea.
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Seock-Ah
authors.initials: SA
authors.lastname: Im
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: In Sil
authors.initials: IS
authors.lastname: Choi
authors.forename: Do-Youn
authors.initials: DY
authors.lastname: Oh
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Kim
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* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000556:secondary; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014840:Vomiting, Anticipatory / Q000139:chemically induced
chemical_list: D017239:Paclitaxel; D002945:Cisplatin