title: Phase I results of vinorelbine with concurrent radiotherapy in elderly patients with unresectable, locally advanced non-small-cell lung cancer: West Japan Thoracic Oncology Group (WJTOG3005-DI).
abstract: OBJECTIVE
  To investigate the safety and efficacy of concurrent vinorelbine and thoracic radiotherapy in elderly patients with locally advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients were 71 years of age or older with unresectable Stage III NSCLC. Patients were treated with thoracic radiotherapy (60 Gy) and concurrent vinorelbine (20 mg/m(2) in Level 1 and 25 mg/m(2) in Level 2) on Days 1 and 8 every 3 weeks for two cycles, followed by adjuvant vinorelbine (25 mg/m(2)) on Days 1 and 8 every 3 weeks for two cycles.
  
  
  RESULTS
  Four patients were enrolled at Level 1. One patient experienced Grade 3 febrile neutropenia at Level 1 and the dose was escalated to Level 2. At Level 2, 2 of 6 patients experienced dose-limiting toxicities (Grade 4 neutropenia in 1 patient and Grade 3 infection in another). Three of 6 patients developed late Grade 2 or 3 pneumonitis. Therefore, the dose was de-escalated to Level 1. An additional 6 patients were enrolled at Level 1, 4 of whom experienced dose-limiting toxicities (incomplete radiotherapy because of Grade 2 pneumonitis in 1 patient and Grade 3 infection in 1, Grade 3 febrile neutropenia in 1, and Grade 3 esophagitis in 1). Moreover, late Grade 3 pneumothorax and Grade 5 pneumonitis occurred in 1 and 1 patient, respectively. Overall, Grade 2, 3 and 5 pneumonitis occurred in 3, 3, and 1 among 16 patients, respectively.
  
  
  CONCLUSIONS
  Concurrent vinorelbine and thoracic radiotherapy resulted in a high incidence of severe pneumonitis when the standard dose of this agent was used for elderly patients. We therefore recommend caution in the use of this regimen and schedule for elderly patients.
authors.affiliation: Division of Radiation Oncology, Shizuoka Cancer Center Hospital, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan. h.harada@scchr.jp
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Harada
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Igawa
authors.forename: Asuka
authors.initials: A
authors.lastname: Tsuya
authors.forename: Mayuko
authors.initials: M
authors.lastname: Wada
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.forename: Tateaki
authors.initials: T
authors.lastname: Naito
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nishimura
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Masuda
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods; D004334:Drug Administration Schedule; D004941:Esophagitis / Q000209:etiology; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007239:Infections / Q000209:etiology; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D017564:Radiation Pneumonitis / Q000209:etiology*; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects* / Q000627:therapeutic use; D011879:Radiotherapy Dosage; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011838:Radiation-Sensitizing Agents; D014747:Vinblastine; D000077235:Vinorelbine