title: Concurrent chemoradiotherapy with tomotherapy in locally advanced Non-Small Cell Lung Cancer: a phase I, docetaxel dose-escalation study, with hypofractionated radiation regimen.
abstract: BACKGROUND
  Concurrent chemo-radiotherapy is demonstrately superior to sequential chemo-radiotherapy in the treatment of advanced Non-Small-Cell Lung Cancer not suitable for surgery. Docetaxel is considered to enhance the cytotoxic effect of radiotherapy on the tumour cells. Tomotherapy (HT) is a novel radiotherapeutic technique, which allows the delivery of Image Guided-IMRT (IG-IMRT), with a highly conformal radiation dose distribution.The goal of the study was to estimate tolerability of Docetaxel concurrent with IMRT and to find the maximum tolerated dose of weekly Docetaxel concurrent with IMRT delivered with HT Tomotherapy after induction chemotherapy with Cisplatin and Docetaxel in patients affected with stage III Non-Small Cell Lung Cancer.
  
  
  METHODS
  We designed a phase I, dose-finding study to determine the dose of weekly Docetaxel concurrent with Tomotherapy after induction chemotherapy, in patients affected by Non-Small Cell Lung Cancer with Stage III disease, not suitable for surgery.
  
  
  RESULTS
  Concurrent weekly Docetaxel and Tomotherapy are feasible; we did not reach a maximum tolerated dose, because no life-threatening toxicity was observed, stopping the accrual at a level of weekly docetaxel 38 mg/m2, a greater dose than in previous assessments, from both phase-I studies with weekly docetaxel alone and with Docetaxel concomitant with standard radiotherapy.
  
  
  CONCLUSIONS
  Concurrent weekly Docetaxel and Tomotherapy are feasible, and even with Docetaxel at 38 mg/m2/week we did not observe any limiting toxicity. For those patients who completed the combined chemo-radio treatment, median progression-free survival (PFS) was 20 months and median overall survival (OS) was 24 months.
authors.affiliation: Medical Oncology Department, National Cancer Institute of Aviano (PN), Aviano (PN), Italy. abearz@cro.it.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bearz
authors.forename: Emilio
authors.initials: E
authors.lastname: Minatel
authors.forename: Imad Abu
authors.initials: IA
authors.lastname: Rumeileh
authors.forename: Eugenio
authors.initials: E
authors.lastname: Borsatti
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Franchin
authors.forename: Carlo
authors.initials: C
authors.lastname: Gobitti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Del Conte
authors.forename: Marco
authors.initials: M
authors.lastname: Trovò
authors.forename: Tanja
authors.initials: T
authors.lastname: Baresic
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel