title: A phase II study of topotecan and cisplatin with sequential thoracic radiotherapy in elderly patients with small-cell lung cancer: Okayama Lung Cancer Study Group 0102.
abstract: OBJECTIVE
  The treatment outcome in elderly patients with limited-disease small-cell lung cancer (LD-SCLC) remains poor. We carried out a phase II trial of split topotecan and cisplatin (TP) therapy and sequential thoracic radiotherapy for elderly LD-SCLC patients as a follow-up to our previous phase I trial.
  
  
  METHODS
  In total, 30 patients aged 76 years or older, with untreated LD-SCLC were enrolled. Four courses of topotecan (1.0 mg/m(2), days 1-3) and cisplatin (20 mg/m(2), days 1-3) were administered, followed by thoracic radiotherapy (1.8 Gy/day, total of 45 Gy). The primary end point was the overall response rate (ORR).
  
  
  RESULTS
  The trial was terminated early with 22 patients because of slow accrual. Their median age was 79 years. The median number of courses of chemotherapy administered was three, and the actual completion rate of the entire treatment course was 41 %. The ORR was 68 % with a 95 % confidence interval of 47-89 % (15/22 cases). The median progression-free survival and overall survival were 9.1 and 22.2 months, respectively. The main toxicity was myelosuppression, with grades 3-4 neutropenia (96 %), thrombocytopenia (50 %), and febrile neutropenia (32 %).
  
  
  CONCLUSIONS
  This regimen produced a favorable survival outcome, despite moderate-to-severe toxicity profiles. Further efforts are necessary to define an optimal regimen for elderly patients with limited SCLC.
authors.affiliation: Center for Clinical Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Department of Respiratory Medicine, Okayama Medical Center, Okayama, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fujiwara
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan. khotta@okayama-u.ac.jp.|Center for Innovative Clinical Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. khotta@okayama-u.ac.jp.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Department of Respiratory Medicine, Fukuyama Medical Center, Fukuyama, Japan.|Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Okada
authors.affiliation: Department of Respiratory Medicine, Iwakuni Medical Center, Iwakuni, Japan.|Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Shoichi
authors.initials: S
authors.lastname: Kuyama
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.|Department of Clinical Oncology, Sumitomo Besshi Hospital, Niihama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ninomiya
authors.affiliation: Department of Clinical Oncology, Sumitomo Besshi Hospital, Niihama, Japan.|Department of Medical Oncology, Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Haruhito
authors.initials: H
authors.lastname: Kamei
authors.affiliation: Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
authors.forename: Shinobu
authors.initials: S
authors.lastname: Hosokawa
authors.affiliation: Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Bessho
authors.affiliation: Department of Medical Oncology, Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Maeda
authors.affiliation: Department of Thoracic Oncology and Medicine, Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.affiliation: Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan.
authors.forename: Nobukazu
authors.initials: N
authors.lastname: Fujimoto
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Kiichiro
authors.initials: K
authors.lastname: Ninomiya
authors.affiliation: Department of Radiotherapy, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.|Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Takemoto
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanazawa
authors.affiliation: Department of General Internal Medicine 4, Kawasaki Medical School, Okayama, Japan.
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.affiliation: Center for Clinical Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.|Department of Medical Oncology, Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D011878:Radiotherapy / Q000379:methods; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan; D002945:Cisplatin
keywords: Chemotherapy; Elderly patient; Lung cancer; Topotecan