title: Treatment of advanced oesophagogastric cancer with FOLFOX-4 regimen followed by leucovorin/bolus and continuous infusion 5-FU as maintenance chemotherapy in patients aged ≥ 75 years with impaired performance status.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of FOLFOX-4 combination chemotherapy, followed by leucovorin (LV)/bolus and continuous infusion 5-fluorouracil (5-FU) as maintenance chemotherapy in elderly (≥ 75 years) patients with advanced oesophagogastric cancer with impaired performance status (PS).
  
  
  METHODS
  Patients with a PS score >1 were included in this study. PS evaluations were performed by a geriatrician and two medical oncologists. FOLFOX-4 consisted of oxaliplatin concurrently with LV/bolus and continuous infusion 5-FU every 2 weeks. After a maximum of six FOLFOX-4 cycles, patients with no evidence of disease progression received maintenance treatment with LV/bolus and continuous infusion 5-FU every 2 weeks until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Thirty-eight patients were enrolled in this study. Of these, 32 (84.2%) patients had a PS score of 2 and six (15.7%) patients had a PS score of 3. After completion of FOLFOX-4, 18 (47.3%) patients achieved a partial response and 14 (36.8%) patients had stable disease. Thirty-two patients (84.2%) received maintenance chemotherapy for a median of eight cycles (range one to 26 cycles). The 6-month disease-control rate was 47.3% [95% confidence interval (CI) 30.9-64.1]. The median progression-free survival was 5.9 months (95% CI 4.7-6.8) and the median overall survival was 9.6 months (95% CI 8.1-11.7). Grade 3 neutropenia occurred in six patients (15.7%), and Grade 3 anaemia and thrombocytopenia occurred in two patients (5.2%).
  
  
  CONCLUSIONS
  FOLFOX-4 followed by LV/bolus and continuous infusion 5-FU as maintenance chemotherapy seems to be an active and well-tolerated first-line treatment strategy for elderly patients with advanced oesophagogastric cancer and impaired PS.
authors.affiliation: Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy. Electronic address: r.petrioli@ao-siena.toscana.it.
authors.forename: Roberto
authors.initials: R
authors.lastname: Petrioli
authors.affiliation: Medical Oncology Unit, Policlinico Umberto I Hospital, University of Rome, Rome, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Francini
authors.affiliation: Unit of General and Minimally Invasive Surgery, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Roviello
authors.affiliation: Unit of Surgical Oncology, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Marrelli
authors.affiliation: Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Salvatora Tindara
authors.initials: ST
authors.lastname: Miano
authors.affiliation: Pharmacology Unit, Department of Medicine, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Anna Ida
authors.initials: AI
authors.lastname: Fiaschi
authors.affiliation: Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Letizia
authors.initials: L
authors.lastname: Laera
authors.affiliation: Ambulatory Chronic Polipathology of Siena, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Marco Antonio
authors.initials: MA
authors.lastname: Bellini
authors.affiliation: Medical Oncology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Giandomenico
authors.initials: G
authors.lastname: Roviello
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects*; D003072:Cognition Disorders / Q000175:diagnosis / Q000523:psychology*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007262:Infusions, Intravenous; D007558:Italy / Q000453:epidemiology; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D011594:Psychometrics / Q000379:methods; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage
chemical_list: D007166:Immunosuppressive Agents; D009944:Organoplatinum Compounds; D014803:Vitamin B Complex; D002955:Leucovorin; D005472:Fluorouracil
keywords: Capecitabine; Elderly; FOLFOX; Gastric cancer; Performance status