title: A phase I study of split-dose cisplatin and etoposide with concurrent accelerated hyperfractionated thoracic radiotherapy in elderly patients with limited-disease small cell lung cancer.
abstract: OBJECTIVE
  The optimal treatment for elderly patients with limited-disease small cell lung cancer has not been defined. We therefore performed a Phase I study for split-dose cisplatin plus etoposide combined with early concurrent accelerated hyperfractionated thoracic radiotherapy in elderly (70 years of age or older) patients with limited-disease small cell lung cancer.
  
  
  METHODS
  Chemotherapy consisted of cisplatin at 20 or 25 mg/m(2) and etoposide at 80 mg/m(2), both administered on Days 1-3 of a 28-day cycle. Radiotherapy was initiated at the onset of chemotherapy and administered at a dose of 1.5 Gy twice daily over 3 weeks up to a total dose of 45 Gy.
  
  
  RESULTS
  Twelve patients with a median age of 76 years (range, 70-85) were enrolled. Dose-limiting toxicities occurred in two (hyponatremia of Grade 4 or cardiac ischemia of Grade 3) of the six patients treated at dose Level 1 as well as in three (perforation of the sigmoid colon of Grade 3, febrile neutropenia of Grade 3, or hyponatremia of Grade 3) of the six patients treated at dose Level 2. The most frequent non-hematologic adverse events included anorexia, fatigue, esophagitis and pneumonitis, but most of these events were of Grade 1 or 2.
  
  
  CONCLUSIONS
  The recommended dose for cisplatin and etoposide chemotherapy administered on Days 1-3 was determined to be 20 and 80 mg/m(2), respectively. Our results indicate that split-dose cisplatin plus etoposide chemotherapy combined with early concurrent accelerated hyperfractionated thoracic radiotherapy is well tolerated by elderly patients with limited-disease small cell lung cancer.
  UMIN Clinical Trials Registry (UMIN-CTR) C000000143.
authors.affiliation: Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka.
authors.forename: Kunio
authors.initials: K
authors.lastname: Okamoto
authors.affiliation: Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka okamotoi@kokyu.med.kyushu-u.ac.jp.
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.affiliation: Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takeda
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, Osaka.
authors.forename: Shinya
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, Osaka.
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.affiliation: Department of Radiation Oncology, Kinki University Faculty of Medicine, Osaka, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Nakamatsu
authors.affiliation: Department of Radiation Oncology, Kinki University Faculty of Medicine, Osaka, Japan.
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Nishimura
authors.affiliation: Department of Medical Oncology, Kinki University Faculty of Medicine, Osaka.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005047:Etoposide / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005720:Gamma Rays; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D011829:Radiation Dosage; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D013909:Thorax / Q000528:radiation effects
chemical_list: D000970:Antineoplastic Agents; D005047:Etoposide; D002945:Cisplatin
keywords: chemoradiotherapy; elderly; feasibility; lung cancer; small cell lung cancer