Phase I Study of Oral S-1 Plus Cisplatin With Concurrent Radiotherapy for Locally Advanced Non-Small-Cell Lung Cancer

Journal Article · Tue Sep 01 00:00:00 EDT 2009 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2008.06.1938· OSTI ID:21282000

Kaira, Kyoichi ^[1]; Sunaga, Noriaki; Yanagitani, Noriko; Kawata, Tadayoshi; Utsugi, Mitsuyoshi ^[1]; Shimizu, Kimihiro ^[2]; Ebara, Takeshi; Kawamura, Hidemasa; Nonaka, Tetsuo; Ishikawa, Hitoshi; Sakurai, Hideyuki ^[3]; Suga, Tatsuo; Hara, Kenichiro ^[4]; Hisada, Takeshi; Ishizuka, Tamotsu ^[1]; Nakano, Takashi ^[3]; Mori, Masatomo ^[1]

---

1. Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma (Japan)
2. Department of Thoracic and Visceral Organ Surgery, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma (Japan)
3. Department of Radiation Oncology, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma (Japan)
4. Department of Medicine and Biological Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma (Japan)

Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with cisplatin and thoracic radiotherapy in patients with unresectable Stage III non-small-cell lung cancer (NSCLC). Methods and Materials: S-1 was administered orally twice daily for 14 days and cisplatin on Days 1 and 8 of each cycle; this was repeated every 3 weeks. Doses of each drug were planned as follows: level 0, 50/40; level 1, 60/40; level 2, 70/40; level 3, 80/40 (S-1 [mg/m{sup -2}/day{sup -1}]/cisplatin [mg/m{sup -2}/day{sup -1}]). Thoracic radiation therapy was administered in 2 Gy fractions five times weekly to a total dose of 60 Gy. Results: Ten patients were enrolled in this study. All patients received 60 Gy of thoracic radiotherapy and 7 (70%) patients received four cycles of chemotherapy. At level 1, 2 of 3 patients experienced a delay exceeding 10 days in the cisplatin administration of Day 29. Grade 4 neutropenia and Grade 3 fever occurred in 1 and 1 patients, respectively. Nonhematologic toxicities were mild. None developed {>=}Grade 3 esophagitis or lung toxicity. At level 0, 2 of 7 patients developed dose-limiting toxicity. Thus, level 1 was considered the MTD and Level 0 was selected as the RD. Objective responses were seen in all patients. Conclusions: The RD is the level 0 dose, and this regimen is a feasible and well-tolerated regimen for the treatment of patients with Stage III NSCLC.

• OSTI ID: 21282000
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 75, Issue 1; Other Information: DOI: 10.1016/j.ijrobp.2008.06.1938; PII: S0360-3016(08)03054-X; Copyright (c) 2009 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CHEMOTHERAPY
COMBINED THERAPY
DOSES
DRUGS
FEVER
LUNGS
NEOPLASMS
PATIENTS
RADIOTHERAPY
TOXICITY