title: A Phase I/II Study of Docetaxel, Oxaliplatin, and Fluorouracil (D-FOX) Chemotherapy in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction.
abstract: A randomized phase III study established docetaxel, cisplatin, and 5-fluorouracil (DCF) as one of the standard treatments for patients with untreated advanced gastric cancer (AGC). However, DCF use is limited due toxicity. With the purpose to evaluate a less toxic regimen, we conducted a single arm, phase I/II trial of modified DCF (oxaliplatin, 5-fluorouracil, and docetaxel [D-FOX]) for untreated AGC patients. The primary objective of the phase I study was to determine the maximum tolerated dose of docetaxel and for the phase II study was to assess the progression-free survival (PFS) at 6 months and overall survival (OS).
  
  
  
  We enrolled a total of 98 patients with AGC. Docetaxel and oxaliplatin were administered intravenously on day 1 and 5-fluorouracil was infused starting on day 1 over 48 hours. Cycles were repeated every 2 weeks and patients were monitored for toxicities. Kaplan-Meir curve was used to estimate unadjusted OS and PFS.
  
  
  
  The maximum tolerated dose of docetaxel was 50 mg/m. In total, 24 (45%) patients experienced grade 2 adverse events, 22 (41%) experienced grade 3, and 1 (1.9%) experienced grade 4 toxicity. The median PFS in the phase II portion of the study was approximately 6.5 (95% confidence interval, 5.5-9.5) months and the median OS was 11.1 (95% confidence interval, 9.4-18.8) months.
  
  
  
  D-FOX administered every 2 weeks is a well-tolerated and active regimen in untreated AGC patients.
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Mariela A
authors.initials: MA
authors.lastname: Blum Murphy
authors.affiliation: Biostatistics, The University of Texas, MD Anderson Cancer Center.
authors.forename: Wei
authors.initials: W
authors.lastname: Qiao
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Nishith
authors.initials: N
authors.lastname: Mewada
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Roopma
authors.initials: R
authors.lastname: Wadhwa
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Elena
authors.initials: E
authors.lastname: Elimova
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Taketa
authors.initials: T
authors.lastname: Takashi
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Linus
authors.initials: L
authors.lastname: Ho
authors.affiliation: Department of Hematology-Oncology, Houston-Methodist Hospital, Houston, TX.
authors.forename: Alexandria
authors.initials: A
authors.lastname: Phan
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Jackie
authors.initials: J
authors.lastname: Baker
authors.affiliation: Departments of GI Medical Oncology.
authors.forename: Jaffer
authors.initials: J
authors.lastname: Ajani
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel / Q000008:administration & dosage; D004943:Esophagogastric Junction / Q000187:drug effects* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077150:Oxaliplatin / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate
chemical_list: D000077150:Oxaliplatin; D000077143:Docetaxel; D005472:Fluorouracil