title: Neoadjuvant carboplatin and vinorelbine followed by chemoradiotherapy in locally advanced head and neck or oesophageal squamous cell carcinoma: a phase II study in elderly patients or patients with poor performance status.
abstract: BACKGROUND
  The purpose of this study was to evaluate the efficacy and toxicity of neo-adjuvant carboplatin and vinorelbine followed by concomitant chemoradiotherapy in patients > or =70 years of age or with Karnofsky performance status (PS) 70-80, diagnosed with locally advanced head and neck (H&N) or oesophageal carcinoma.
  
  
  METHODS
  The treatment plan consisted of three courses of carboplatin AUC4 on day 1 and vinorelbine 25 mg/m2 on day 1 and 8, every 21 days, followed by chemoradiotherapy. Carboplatin 100 mg/m2 was delivered weekly for the duration of the radiation therapy (70 Gy, 2 Gy/daily).
  
  
  RESULTS
  Thirty-five patients with an average age of 68 years (range 42-85, 16 patients > or =70 years) were treated. Twenty-seven patients (77.1%) responded to neo-adjuvant chemotherapy (2 complete and 25 partial responses). Haematological toxicity was grade 3-4 in 13 patients (37.2%), while gastrointestinal toxicity was grade 3-4 in 20 patients (57.1%). All the patients completed the chemoradiotherapy plan, with grade 4 mucositis plus febrile neutropenia in 3 patients (8.5%). Median time to progression (TTP) was 10.2 months, with 31.5% of patients being alive at two years.
  
  
  CONCLUSIONS
  The regimen of neo-adjuvant carboplatin and vinorelbine followed by chemoradiotherapy is feasible and active in older (> or =70 years) or low PS (Karnofsky 70-80) patients, although toxicity is not negligible and long-term outcome remains poor.
authors.affiliation: Department of Medical Oncology, Istituto Oncologico Veneto IRCCS, Padova, Italy. drbabis@libero.it
authors.forename: Haralabos
authors.initials: H
authors.lastname: Koussis
authors.forename: Annamaria
authors.initials: A
authors.lastname: Scola
authors.forename: Francesca
authors.initials: F
authors.lastname: Bergamo
authors.forename: Stefano
authors.initials: S
authors.lastname: Tonello
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.forename: Paraskevi
authors.initials: P
authors.lastname: Karahontzitis
authors.forename: Vanna
authors.initials: V
authors.lastname: Chiarion-Sileni
authors.forename: Lara
authors.initials: L
authors.lastname: Pasetto
authors.forename: Alberto
authors.initials: A
authors.lastname: Ruol
authors.forename: Lucio
authors.initials: L
authors.lastname: Loreggian
authors.forename: Ornella
authors.initials: O
authors.lastname: Lora
authors.forename: Raffaele
authors.initials: R
authors.lastname: Bottin
authors.forename: Gino
authors.initials: G
authors.lastname: Marioni
authors.forename: Martin
authors.initials: M
authors.lastname: Donach
authors.forename: Antonio
authors.initials: A
authors.lastname: Jirillo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine