Kim Hyeong Su, Kim Ho Young, Zang Dae Young, Oh Ho Suk, Jeon Jang Yong, Cho Ji Woong, Park Choong Kee, Kim Jong Hyeok, Kim Min-Jeong, Ha Hong Il, Kim Jung Han, Han Boram, Song Hunho, Kwon Jung Hye, Choi Dae Ro, Jung Joo Young
Department of Internal Medicine, Division of Hematology-Oncology, Hallym University Medical Center, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil Dongan-gu, Anyang-Si, 431-796, South Korea.
Cancer Chemother Pharmacol. 2015 Apr;75(4):711-8. doi: 10.1007/s00280-015-2687-x. Epub 2015 Jan 29.
A phase II study was conducted to evaluate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with metastatic biliary tract cancer (BTC).
Patients with pathologically confirmed, unresectable, recurrent, or metastatic adenocarcinoma that originated from the intrahepatic or extrahepatic biliary ducts or gallbladder were assessed for eligibility. The primary end point was the overall response rate (ORR). The treatment consisted of 1,000 mg/m(2) intravenous gemcitabine administered over 30 min on days 1 and 8, and 80 mg/m(2) oral S-1 on days 1-14 of each cycle. The treatment was repeated every 3 weeks.
Thirty-eight patients were enrolled between November 2005 and 2010. All patients had metastatic disease, and the primary sites of cancer were as follows: gallbladder in 12 (31.6%), intrahepatic and extrahepatic bile ducts in 23 (60.5%), and the ampulla of Vater in 3 (7.9%) patients. One patient achieved a complete response, and six experienced a partial response. The ORR was 20.6% (95% CI 8.5-36.7] in the per-protocol (PP) population, and 18.4% (95%CI 6.1-30.7) in the intention-to-treat (ITT) population; the median response duration was 10.8 months. Nineteen patients had stable disease, and the disease control rate was 76.5% (95%CI 60.6-87.6) in the PP population. The median progression-free survival was 4.4 months (95%CI 1.8-6.9), and the median overall survival was 9.0 months (95%CI 4.0-13.9) with a 1-year survival rate of 44.7% (95%CI 29.0-61.5) in the ITT population. Grade 3/4 hematologic toxicities, neutropenia, anemia, and thrombocytopenia were observed in 13 (37.1%), 9 (25.7%), 2 (5.7%), and 2 (5.7%) patients, respectively. One patient experienced a grade 3 febrile neutropenia without any documented infection. The grade 3/4 non-hematologic toxicities were hepatic toxicity (11.4%), anorexia (2.9%), and renal toxicity (2.9%).
Gemcitabine and S-1 combination chemotherapy showed acceptable efficacy and favorable toxicity profiles. Therefore, it might offer an alternative therapeutic strategy in patients with BTC.
开展一项II期研究，以评估吉西他滨与S-1联合化疗对转移性胆管癌（BTC）患者的疗效和安全性。
评估病理确诊、不可切除、复发或转移性腺癌起源于肝内或肝外胆管或胆囊的患者是否符合入组条件。主要终点为总缓解率（ORR）。治疗方案为在每个周期的第1天和第8天静脉输注1000mg/m²吉西他滨，持续30分钟，第1 - 14天口服80mg/m² S-1。每3周重复一次治疗。
2005年11月至2010年期间共入组38例患者。所有患者均有转移性疾病，癌症原发部位如下：胆囊12例（31.6%），肝内和肝外胆管23例（60.5%），壶腹3例（7.9%）。1例患者达到完全缓解，6例患者部分缓解。符合方案（PP）人群的ORR为20.6%（95%CI 8.5 - 36.7]，意向性治疗（ITT）人群的ORR为18.4%（95%CI 6.1 - 30.7）；中位缓解持续时间为10.8个月。19例患者病情稳定，PP人群的疾病控制率为76.5%（95%CI 60.6 - 87.6）。ITT人群的中位无进展生存期为4.4个月（95%CI 1.8 - 6.9），中位总生存期为9.0个月（95%CI 4.0 - 13.9），1年生存率为44.7%（95%CI 29.0 - 61.5）。分别有13例（37.1%）、9例（25.7%）、2例（5.7%）和2例（5.7%）患者出现3/4级血液学毒性，即中性粒细胞减少、贫血和血小板减少。1例患者出现3级发热性中性粒细胞减少，无任何感染记录。3/4级非血液学毒性为肝毒性（11.4%）、厌食（2.9%）和肾毒性（2.9%）。
吉西他滨与S-1联合化疗显示出可接受的疗效和良好的毒性特征。因此，它可能为BTC患者提供一种替代治疗策略。
