Departments of Oncology.
Pathology, Danish Colorectal Cancer Group South, Vejle Hospital, Vejle and University of Southern Denmark, Odense, Denmark.
Ann Oncol. 2012 Sep;23(9):2341-2346. doi: 10.1093/annonc/mds008. Epub 2012 Feb 23.
Combination chemotherapy has proven beneficial in biliary tract cancer and further improvements may be achieved by individualizing treatment based on biomarkers and by adding biological agents. We report the effect of chemotherapy with panitumumab as first-line therapy for KRAS wild-type irresectable biliary tract cancer.
Patients were treated with gemcitabine 1000 mg/m(2), oxaliplatin 60 mg/m(2), and panitumumab 6 mg/kg i.v. every 2 weeks followed by two daily administrations of capecitabine 1000 mg/m(2) in 7 days.
During 22 months, 46 patients were included in a single institution. The primary end point, fraction of progression-free survival (PFS) at 6 months, was 31/42 [74%; 95% confidence interval (CI) 58% to 84%]. Forty-two patients had measurable disease. Response rate was 33% and disease control rate 86%. Median PFS was 8.3 months (95% CI 6.7-8.7 months) and median overall survival was 10.0 months (95% CI 7.4-12.7 months). Toxicity was manageable including eight cases of epidermal growth factor receptor-related skin adverse events of grade 2 or more.
Marker-driven patient selection is feasible in the systemic treatment of biliary tract cancer. Combination chemotherapy with panitumumab in patients with KRAS wild-type tumors met the efficacy criteria for future testing in a randomized trial.
联合化疗已被证明对胆道癌有益，通过基于生物标志物的个体化治疗和添加生物制剂，可能会进一步改善。我们报告了帕尼单抗作为 KRAS 野生型不可切除胆道癌一线治疗的化疗效果。
患者接受吉西他滨 1000mg/m²、奥沙利铂 60mg/m²和帕尼单抗 6mg/kg 静脉注射，每 2 周 1 次，随后连续 2 天给予卡培他滨 1000mg/m²，每 7 天 1 次。
在 22 个月期间，46 例患者在一家机构中接受了治疗。主要终点为 6 个月时无进展生存（PFS）的比例，为 31/42[74%；95%置信区间（CI）58%-84%]。42 例患者有可测量的疾病。缓解率为 33%，疾病控制率为 86%。中位 PFS 为 8.3 个月（95%CI 6.7-8.7 个月），中位总生存期为 10.0 个月（95%CI 7.4-12.7 个月）。毒性可管理，包括 8 例表皮生长因子受体相关皮肤不良事件为 2 级或以上。
在胆道癌的系统治疗中，标志物驱动的患者选择是可行的。在 KRAS 野生型肿瘤患者中联合使用帕尼单抗的化疗达到了未来随机试验的疗效标准。
