Department of Internal Medicine, Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo 181-8611, Japan.
Jpn J Clin Oncol. 2013 Jan;43(1):2-7. doi: 10.1093/jjco/hys177. Epub 2012 Oct 24.
The Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG) was constituted in April 2008 to develop new standard treatments for hepatobiliary and pancreatic cancer. In pancreatic cancer, the Hepatobiliary and Pancreatic Oncology Group focuses on establishing standard chemotherapy or chemoradiotherapy for unresectable locally advanced disease. The JCOG 0506 study was a Phase II study of gemcitabine alone to examine its efficacy and safety in patients with locally advanced disease. The results in survival significantly exceeded expectations, and gemcitabine monotherapy has come to be regarded as the provisional standard therapy by our group. Following JCOG 0506, the JCOG 1106 study, which is currently under investigation, is a randomized Phase II study to evaluate the efficacy of induction chemotherapy with gemcitabine in combination with S-1 chemoradiotherapy and select a candidate therapeutic agent in a Phase III study comparing with gemcitabine alone. The JCOG 0805 study was a randomized Phase II study comparing S-1 monotherapy with gemcitabine plus S-1 combination therapy for unresectable biliary tract cancer. As a result, gemcitabine plus S-1 combination therapy was considered the more promising candidate in comparison with the gemcitabine plus cisplatin combination therapy in a subsequent Phase III trial. The Hepatobiliary and Pancreatic Oncology Group is planning a Phase III study to compare gemcitabine plus S-1 combination therapy with gemcitabine plus cisplatin combination therapy (JCOG PC1113 study). No standard postoperative adjuvant treatment has been established. We plan to conduct a Phase III study to compare S-1 as adjuvant therapy after surgery with surgery alone in patients with biliary tract cancer (JCOG PC1202).
日本临床肿瘤学会（JCOG）肝胆胰肿瘤组于 2008 年 4 月成立，旨在为肝胆胰肿瘤开发新的标准治疗方法。在胰腺癌方面，肝胆胰肿瘤组专注于为不可切除的局部晚期疾病建立标准的化疗或放化疗。JCOG0506 研究是一项单独使用吉西他滨的 II 期研究，旨在检查其在局部晚期疾病患者中的疗效和安全性。生存结果显著超出预期，吉西他滨单药治疗已成为我们组的暂定标准治疗方法。继 JCOG0506 之后，目前正在进行的 JCOG1106 研究是一项随机 II 期研究，旨在评估吉西他滨联合 S-1 放化疗诱导化疗的疗效，并在 III 期研究中比较与吉西他滨单药治疗的候选治疗药物。JCOG0805 研究是一项比较不可切除胆管癌患者单独使用替吉奥（S-1）与吉西他滨加 S-1 联合治疗的随机 II 期研究。结果表明，与吉西他滨加顺铂联合治疗相比，吉西他滨加 S-1 联合治疗更有前途，随后的 III 期试验也证实了这一点。肝胆胰肿瘤组正在计划一项 III 期研究，比较吉西他滨加 S-1 联合治疗与吉西他滨加顺铂联合治疗（JCOG PC1113 研究）。尚无标准的术后辅助治疗方法。我们计划进行一项 III 期研究，比较替吉奥作为胆管癌患者手术后辅助治疗与单纯手术的疗效（JCOG PC1202）。
