title: Phase I/II study of altered schedule of cisplatin and etoposide administration and concurrent accelerated hyperfractionated thoracic radiotherapy for limited-stage small-cell lung cancer.
abstract: To improve the efficacy of a combination of cisplatin and etoposide and concurrent accelerated twice-daily thoracic radiotherapy against limited-stage small-cell lung cancer, we conducted a phase I/II study using an altered schedule of chemotherapy administration. Chemotherapy consisted of four cycles of cisplatin (days 1 and 8) and etoposide (days 1, 2, 8, and 9) every 4 weeks. Accelerated hyperfractionated thoracic radiation (1.5 Gy twice daily x 30 fractions, total dose of 45 Gy) was concurrently given with the first cycle of chemotherapy. The recommended doses of cisplatin and etoposide determined in the phase I study were 40 and 80 mg/m(2), respectively. In the phase II study, the overall response rate was 100% (complete response: 32%, partial response: 68%). By a median follow-up time of 29 months, median radiation-outfield progression-free survival was 13.4 months, while radiation-infield progression-free survival did not reach median value. The median overall survival time was 22.9 months, with survival rate of 48.4% at 2 years. Major toxicities were leukopenia and neutropenia (>/=grade 3, 92% each). The local control and overall survival demonstrated in this study were excellent. However, the insufficient distant control suggests a need for development of more active chemotherapy regimens.
authors.affiliation: Department of Internal Medicine, National Shikoku Cancer Center, 13 Horinouchi, Matsuyama, Ehime 790-0007, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Segawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Hiraki
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Toshiro
authors.initials: T
authors.lastname: Yonei
authors.forename: Tomonori
authors.initials: T
authors.lastname: Moritaka
authors.forename: Junichiro
authors.initials: J
authors.lastname: Hiyama
authors.forename: Shunkichi
authors.initials: S
authors.lastname: Hiraki
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.forename: Mine
authors.initials: M
authors.lastname: Harada
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use / Q000633:toxicity; D015331:Cohort Studies; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage* / Q000627:therapeutic use / Q000633:toxicity; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide; D002945:Cisplatin