title: A feasibility study of carboplatin plus irinotecan treatment for elderly patients with extensive disease small-cell lung cancer.
abstract: OBJECTIVE
  The role of platinum agents plus irinotecan has been unclear for elderly patients with extensive disease small-cell lung cancer. We conducted a feasibility study to evaluate the safety and efficacy of carboplatin plus irinotecan in preparation for a planned Phase III study.
  
  
  METHODS
  Based on another Phase I study, carboplatin area under the curve of four Day 1 plus irinotecan 50 mg/m(2) Days 1 and 8 every 3 weeks for four courses was administered. Patients aged ≥70 years with a performance status of 0-2 were eligible. The primary endpoint was feasibility, defined as the percentage of patients who have received three or more courses of chemotherapy. If the feasibility was ≥60% in the first 10 patients, this endpoint would be considered to be met.
  
  
  RESULTS
  Eleven patients were registered. The median age was 77 years, and nine patients had a performance status of 1. Ten patients completed four courses of treatment, and neither dose omission nor modification was required. The feasibility was 91% (10/11) and the relative dose intensity was 76.9%. Because neutropenia was frequently prolonged, the next course was delayed in 53% of all courses. Other toxicities were generally mild, and the only Grade 4 toxicity was hyponatremia. The overall response rate was 90% (9/10), and the progression-free survival and the overall survival were 5.1 and 10.9 months, respectively.
  
  
  CONCLUSIONS
  This regimen appears to be feasible and effective. Based on these results, a Phase II/III trial comparing carboplatin plus etoposide with carboplatin plus irinotecan for elderly patients with extensive disease small-cell lung cancer is being planned by the Japan Clinical Oncology Group.
authors: *Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, Japan. yu00-misumi@city.yokohama.jp.
authors: Yuki
authors: Y
authors: Misumi
authors: Makoto
authors: M
authors: Nishio
authors: Toshiaki
authors: T
authors: Takahashi
authors: Fumiyoshi
authors: F
authors: Ohyanagi
authors: Atsushi
authors: A
authors: Horiike
authors: Haruyasu
authors: H
authors: Murakami
authors: Hirotsugu
authors: H
authors: Kenmotsu
authors: Nobuyuki
authors: N
authors: Yamamoto
authors: Mari
authors: M
authors: Ishii
authors: Tsuneo
authors: T
authors: Shimokawa
authors: Naoya
authors: N
authors: Hida
authors: Hiroaki
authors: H
authors: Okamoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008279:Magnetic Resonance Imaging; D008297:Male; D009367:Neoplasm Staging; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin
keywords: chemo-Phase I–III; chemo-respiratory tract; clinical trials; lung medicine