Kaira Kyoichi, Sunaga Noriaki, Yanagitani Noriko, Kawata Tadayoshi, Utsugi Mitsuyoshi, Shimizu Kimihiro, Ebara Takeshi, Kawamura Hidemasa, Nonaka Tetsuo, Ishikawa Hitoshi, Sakurai Hideyuki, Suga Tatsuo, Hara Kenichiro, Hisada Takeshi, Ishizuka Tamotsu, Nakano Takashi, Mori Masatomo
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):109-14. doi: 10.1016/j.ijrobp.2008.06.1938. Epub 2008 Oct 15.
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).
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(-2)/day(-1)]/cisplatin [mg/m(-2)/day(-1)]). Thoracic radiation therapy was administered in 2 Gy fractions five times weekly to a total dose of 60 Gy.
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 >or=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.
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.
确定S-1联合顺铂及胸部放疗用于不可切除的Ⅲ期非小细胞肺癌（NSCLC）患者时的最大耐受剂量（MTD）和推荐剂量（RD）。
S-1每日口服2次，共14天，顺铂在每个周期的第1天和第8天给药；每3周重复一次。每种药物的剂量计划如下：0级，50/40；1级，60/40；2级，70/40；3级，80/40（S-1[毫克/平方米/天]/顺铂[毫克/平方米/天]）。胸部放疗每周5次，每次2Gy，总剂量60Gy。
10例患者入组本研究。所有患者均接受了60Gy的胸部放疗，7例（70%）患者接受了4个周期的化疗。在1级剂量时，3例患者中有2例在第29天顺铂给药时出现延迟超过10天的情况。4级中性粒细胞减少和3级发热分别发生在1例患者中。非血液学毒性较轻。无一例发生≥3级食管炎或肺部毒性。在0级剂量时，7例患者中有2例出现剂量限制性毒性。因此，1级剂量被认为是MTD，0级剂量被选为RD。所有患者均观察到客观缓解。
RD为0级剂量，该方案是治疗Ⅲ期NSCLC患者的一种可行且耐受性良好的方案。
