Ke Qing-Hua, Zhou Shi-Qiong, Yang Ji-Yuan, Du Wei, Liang Gai, Lei Yong, Luo Fei
Qing-Hua Ke, Shi-Qiong Zhou, Ji-Yuan Yang, Wei Du, Gai Liang, Yong Lei, Fei Luo, Department of Chemoradiotherapy, Oncology Hospital of Jingzhou, Jingzhou 434000, Hubei Province, China.
World J Gastroenterol. 2014 Oct 14;20(38):13987-92. doi: 10.3748/wjg.v20.i38.13987.
To investigate the feasibility and efficacy of the combination of S-1 with gemcitabine followed by oral S-1 with concurrent radiotherapy (intensity modulated radiotherapy, IMRT) and maintenance therapy with S-1 for locally advanced pancreatic cancer.
Subjects selected in the study were patients who had unresectable and locally advanced pancreatic cancer without distant metastases, adequate organ and marrow functions, an Eastern Cooperative Oncology Group performance status of 0-1 and no prior anticancer therapy. Initially the subjects received two cycles of chemotherapy, oral administration of S-1 40 mg/m(2) twice daily from day 1 to day 14 of a 21-d cycle, with 30-min intravenous infusions of gemcitabine 1000 mg/m(2) on day 1 and day 8. Two weeks after the completion of chemotherapy, S-1 was administered orally with concurrent IMRT. Oral S-1 was administered at a dose of 80 mg/m(2) per day twice daily from day 1 to day 14 and from day 22 to day 35. Radiation was concurrently delivered at a dose of 50.4 Gy (1.8 Gy/d, 5 times per week, 28 fractions). One month after the completion of chemotherapy and radiotherapy, S-1 was administered orally at a dose of 80 mg/m(2) per day twice daily for 14 d, followed by a 14-d rest period. This cycle was repeated as maintenance therapy, until unacceptable toxicity occurred or the disease worsened. Thirty-two patients were involved in this study. The median follow-up was 15.6 mo (range: 8.6-32.3 mo).
Thirty-two patients completed the scheduled course of chemotherapy, while 30 patients (93.8%) received chemoradiotherapy with two patients ceasing to continue with radiotherapy. The major toxic effects were nausea and leukopenia. There was no grade 4 toxicity or treatment-related death. According to the Response Evaluation Criteria in Solid Tumors criteria, the objective tumor response was partial response in 17 (53.1%) patients, stable disease in 9 (28.1%), and progressive disease in 6 (18.8%). The median overall survival and median progression-free survival were 15.2 mo and 9.3 mo, respectively. The survival rates at 1 year and 2 years were 75% and 34.4%, respectively.
The combination of S-1 with gemcitabine followed by oral S-1 with IMRT and maintenance therapy with S-1 alone in patients with locally advanced pancreatic cancer may be considered a well-tolerated, promising treatment regimen.
探讨S-1与吉西他滨联合应用，随后口服S-1同步放疗（调强放疗，IMRT）及S-1维持治疗用于局部晚期胰腺癌的可行性和疗效。
本研究选取的受试者为不可切除的局部晚期胰腺癌患者，无远处转移，器官和骨髓功能良好，东部肿瘤协作组体能状态为0-1，且既往未接受过抗癌治疗。受试者最初接受两个周期的化疗，在21天周期的第1天至第14天口服S-1，40mg/m²，每日两次，在第1天和第8天静脉输注吉西他滨1000mg/m²，持续30分钟。化疗完成两周后，口服S-1同步IMRT。口服S-1剂量为80mg/m²，每日两次，从第1天至第14天以及从第22天至第35天。放疗剂量为50.4Gy（1.8Gy/天，每周5次，共28次分割）。化疗和放疗完成1个月后，口服S-1，剂量为80mg/m²，每日两次，持续14天，随后休息14天。此周期重复作为维持治疗，直至出现不可接受的毒性或疾病进展。本研究纳入32例患者。中位随访时间为15.6个月（范围：8.6-32.3个月）。
32例患者完成了预定的化疗疗程，30例患者（93.8%）接受了放化疗，2例患者停止继续放疗。主要毒性反应为恶心和白细胞减少。无4级毒性反应或与治疗相关的死亡。根据实体瘤疗效评价标准，客观肿瘤反应为部分缓解17例（53.1%），疾病稳定9例（28.1%），疾病进展6例（18.8%）。中位总生存期和中位无进展生存期分别为15.2个月和9.3个月。1年和2年生存率分别为75%和34.4%。
对于局部晚期胰腺癌患者，S-1与吉西他滨联合应用，随后口服S-1同步IMRT及单独S-1维持治疗，可被认为是一种耐受性良好、有前景的治疗方案。
