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A phase I study of combination S-1 plus cisplatin chemotherapy with concurrent thoracic radiation for locally advanced non-small cell lung cancer.

Abstract
A combination of S-1, a newly developed oral 5-fluorouracil derivative, and cisplatin is reported to show anti-tumour activity against advanced non-small cell lung cancer (NSCLC). Because S-1 shows synergistic effects with radiation, we conducted a phase I study to evaluate the maximum tolerated doses (MTDs), recommended doses (RDs), and dose-limiting toxicities (DLTs) of cisplatin and S-1 when combined with concurrent thoracic radiation (total dose of 60 Gy with 2 Gy per daily fraction) in patients with locally advanced NSCLC. Chemotherapy consisted of two 4-week cycles of cisplatin administered on days 1 and 8, and S-1 administered on days 1-14. S-1/cisplatin dosages (mg/m(2)/day) were escalated as follows: 60/30, 60/40, 70/40, 80/40 and 80/50. Twenty-two previously untreated patients were enrolled. The MTDs and RDs for S-1/cisplatin were 80/50 and 80/40, respectively. DLTs included febrile neutropaenia, thrombocytopaenia, bacterial pneumonia and delayed second cycle of chemotherapy. No patient experienced radiation pneumonitis>grade 2 and only one patient experienced grade 3 radiation oesophagitis. The overall response rate was 86.4% with a median survival time of 24.4 months. These results indicate that combination cisplatin-S-1 chemotherapy with concurrent thoracic radiation would be a feasible treatment option and a phase II study is currently under way.
AuthorsKenichi Chikamori, Daizo Kishino, Nagio Takigawa, Katsuyuki Hotta, Naoyuki Nogami, Haruhito Kamei, Shoichi Kuyama, Kenichi Gemba, Mitsuhiro Takemoto, Susumu Kanazawa, Hiroshi Ueoka, Yoshihiko Segawa, Saburo Takata, Masahiro Tabata, Katsuyuki Kiura, Mitsune Tanimoto,
JournalLung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 65 Issue 1 Pg. 74-9 (Jul 2009) ISSN: 1872-8332 [Electronic] Ireland
PMID19056143 (Publication Type: Clinical Trial, Phase I, Journal Article)
Chemical References
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid
  • Cisplatin
Topics
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
  • Carcinoma, Non-Small-Cell Lung (drug therapy, radiotherapy)
  • Cisplatin (administration & dosage, adverse effects)
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Dose-Response Relationship, Radiation
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • Humans
  • Lung Neoplasms (drug therapy, radiotherapy)
  • Male
  • Middle Aged
  • Oxonic Acid (administration & dosage, adverse effects)
  • Tegafur (administration & dosage, adverse effects)

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