Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan.
Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):163-9. doi: 10.1016/j.ijrobp.2012.03.059. Epub 2012 Jun 5.
The aim of this trial was to evaluate the efficacy and toxicity of S-1 and concurrent radiation therapy for locally advanced pancreatic cancer (PC).
Locally advanced PC patients with histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma, who had no previous therapy were enrolled. Radiation therapy was delivered through 3 or more fields at a total dose of 50.4 Gy in 28 fractions over 5.5 weeks. S-1 was administered orally at a dose of 80 mg/m2 twice daily on the day of irradiation during radiation therapy. After a 2- to 8-week break, patients received a maintenance dose of S-1 (80 mg/m2/day for 28 consecutive days, followed by a 14-day rest period) was then administered until the appearance of disease progression or unacceptable toxicity. The primary efficacy endpoint was survival, and the secondary efficacy endpoints were progression-free survival, response rate, and serum carbohydrate antigen 19-9 (CA19-9) response; the safety endpoint was toxicity.
Of the 60 evaluable patients, 16 patients achieved a partial response (27%; 95% confidence interval [CI], 16%-40%). The median progression-free survival period, overall survival period, and 1-year survival rate of the evaluable patients were 9.7 months (95% CI, 6.9-11.6 months), 16.2 months (95% CI, 13.5-21.3 months), and 72% (95%CI, 59%-82%), respectively. Of the 42 patients with a pretreatment serum CA19-9 level of ≥100 U/ml, 34 (81%) patients showed a decrease of greater than 50%. Leukopenia (6 patients, 10%) and anorexia (4 patients, 7%) were the major grade 3-4 toxicities with chemoradiation therapy.
The effect of S-1 with concurrent radiation therapy in patients with locally advanced PC was found to be very favorable, with only mild toxicity.
本试验旨在评估 S-1 联合放疗治疗局部晚期胰腺癌（PC）的疗效和毒性。
入组的局部晚期 PC 患者均经组织学或细胞学证实为腺癌或腺鳞癌，且无既往治疗。放疗采用 3 个或更多野，总剂量为 50.4 Gy，分 28 次，5.5 周完成。放疗期间，S-1 口服，剂量为 80mg/m2，每日 2 次，于放疗日给药。2-8 周后，患者接受维持剂量 S-1（80mg/m2/天，连续 28 天，然后休息 14 天）治疗，直至疾病进展或出现不可耐受的毒性。主要疗效终点为生存，次要疗效终点为无进展生存期、缓解率和血清肿瘤标志物（CA19-9）应答；安全性终点为毒性。
在 60 例可评价患者中，16 例患者获得部分缓解（27%；95%置信区间[CI]，16%-40%）。可评价患者的中位无进展生存期、总生存期和 1 年生存率分别为 9.7 个月（95%CI，6.9-11.6 个月）、16.2 个月（95%CI，13.5-21.3 个月）和 72%（95%CI，59%-82%）。42 例治疗前血清 CA19-9 水平≥100U/ml 的患者中，34 例（81%）患者下降超过 50%。白细胞减少症（6 例，10%）和厌食症（4 例，7%）是主要的 3-4 级放化疗毒性。
S-1 联合放疗治疗局部晚期 PC 的疗效非常显著，毒性轻微。
