title: Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer.
abstract: OBJECTIVE
  Previous studies have shown that docetaxel and cisplatin, as single agents, are effective and relatively well tolerated in patients with advanced gastric cancer. The aim of this study was to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer.
  
  
  METHODS
  Fifty-five patients with histologically proven advanced gastric cancer with at least 1 measurable lesion and ECOG PS ≤ 2 were enrolled. Patients received docetaxel 50 mg/m(2) and cisplatin 50 mg/m(2) every 2 weeks until progression disease, unbearable toxicity or a maximum of 12 cycles.
  
  
  RESULTS
  In total, 426 cycles were administered (median 8.5 cycles) to 52 evaluable patients. One patient (1.9 %) showed a complete response, while 21 (40.4 %) had partial responses. The objective response rate was 42.3 % (95 % CI 28.9-55.7), the median time to progression was 5.5 months (95 % CI 4.0-7.0), and the median overall survival was 8.9 months (95 % CI 6.0-11.9). The most common grade 3-4 toxicities per cycle were haematological [neutropenia (5.9 %)].
  
  
  CONCLUSIONS
  Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable toxicity profile and shows a promising antitumour activity as a first-line therapy.
authors.affiliation: Hospital Universitario Lucus, Augusti, Lugo, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Quintero-Aldana
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Jorge
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Grande
authors.affiliation: Complejo Hospitalario de Ourense, CHOU, Ourense, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Salgado
authors.affiliation: Complejo Hospitalario Universitario de Santiago, CHUS, Santiago de Compostela, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Gallardo
authors.affiliation: Hospital Universitario Lucus, Augusti, Lugo, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Varela
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: C
authors.initials: C
authors.lastname: López
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Villanueva
authors.affiliation: Complejo Hospitalario de Ourense, CHOU, Ourense, Spain. afm1003@hotmail.com.
authors.forename: A
authors.initials: A
authors.lastname: Fernández
authors.affiliation: Hospital Universitario Lucus, Augusti, Lugo, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Alvarez
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: P
authors.initials: P
authors.lastname: González
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Castellanos
authors.affiliation: Complejo Hospitalario Universitario de Vigo, CHUVI, Vigo, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Casal
authors.affiliation: Complejo Hospitalario Universitario de Santiago, CHUS, Santiago de Compostela, Spain.
authors.forename: R
authors.initials: R
authors.lastname: López
authors.affiliation: Hospital Universitario Lucus, Augusti, Lugo, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Campos Balea
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010166:Palliative Care; D013030:Spain; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin
keywords: Advanced gastric cancer; Cisplatin; Combination chemotherapy; Docetaxel