PDF(Pubmed)
Abstract：
UNASSIGNED: Routine blood tests are prognostic tests for patients with cholangiocarcinoma. New drug regimens may produce a median overall survival of 2 years or more.
UNASSIGNED: This single practice, IRB-approved, phase II trial examines prognostic tests, Kaplan-Meier survival, and univariate Cox regression analyses. Eligibility requires: intent-to-treat; signed consent; advanced measurable intrahepatic cholangiocarcinoma, with or without resistance to the test drugs; any adult age; performance status 0-2; and expected survival of ≥ 6 weeks. Biweekly treatment, with 1/3 of standard dosages in mg/M2, includes: Gemcitabine 500; 5-Fluorouracil 1200 over 24 hours; Leucovorin 180; Irinotecan 80; and on day 2, Oxaliplatin 40. On progression, drugs are added on day 2: first, Docetaxel 25 precedes Oxaliplatin, with or without Mitomycin C 6 after Oxaliplatin. The next sequential additions are day 1, Cetuximab 400 total mg, then 200 mg weekly, and then Bevacizumab 10 mg/kg is substituted for Cetuximab (FDA IND# 119005).
UNASSIGNED: For 35 patients, 19 with 1-2 lines of prior therapy, resistant tumors, and 16 no prior therapy, survival at 24-months is ≥ 72 and ≥ 58%, respectively. For 14 patients aged ≥ 70 years, ≥ 63% survive 24 months, P = 0.28. Validated tests that predict ≤ 6-month survivals find median survival times of 17-months through > 2-years when compared to patients with favorable tests: Neutrophils lymphocyte ratio > 3.0, HR = 6.54, P < 6.4x10-3; absolute neutrophil count > 8000/μl, HR = 4.95, P < 6.5x10-3; serum albumin < 3.5 g/dl, HR = 4.10, P < 0.03; and lymphocyte monocyte ratio< 2.1, HR = 1.6, P = 0.50. Overall, the 76 (60-90)% of patients with 0-2 out of 4 high risk tests survive ≥ 24 months, (P = 7.1x10-3). Treatments produce neither hospitalization, neutropenic fever, severe enteritis, nor severe neuropathies.
UNASSIGNED: Two-year survival is replicable and predictable. Findings warrant phase III validation tests of sequential regimens, re-challenge with recombination, low dosages, and blood tests that are associated with lethal mechanisms that impair response and survival.
UNASSIGNED: This single practice, IRB-approved, phase II trial examines prognostic tests, Kaplan-Meier survival, and univariate Cox regression analyses. Eligibility requires: intent-to-treat; signed consent; advanced measurable intrahepatic cholangiocarcinoma, with or without resistance to the test drugs; any adult age; performance status 0-2; and expected survival of ≥ 6 weeks. Biweekly treatment, with 1/3 of standard dosages in mg/M2, includes: Gemcitabine 500; 5-Fluorouracil 1200 over 24 hours; Leucovorin 180; Irinotecan 80; and on day 2, Oxaliplatin 40. On progression, drugs are added on day 2: first, Docetaxel 25 precedes Oxaliplatin, with or without Mitomycin C 6 after Oxaliplatin. The next sequential additions are day 1, Cetuximab 400 total mg, then 200 mg weekly, and then Bevacizumab 10 mg/kg is substituted for Cetuximab (FDA IND# 119005).
UNASSIGNED: For 35 patients, 19 with 1-2 lines of prior therapy, resistant tumors, and 16 no prior therapy, survival at 24-months is ≥ 72 and ≥ 58%, respectively. For 14 patients aged ≥ 70 years, ≥ 63% survive 24 months, P = 0.28. Validated tests that predict ≤ 6-month survivals find median survival times of 17-months through > 2-years when compared to patients with favorable tests: Neutrophils lymphocyte ratio > 3.0, HR = 6.54, P < 6.4x10-3; absolute neutrophil count > 8000/μl, HR = 4.95, P < 6.5x10-3; serum albumin < 3.5 g/dl, HR = 4.10, P < 0.03; and lymphocyte monocyte ratio< 2.1, HR = 1.6, P = 0.50. Overall, the 76 (60-90)% of patients with 0-2 out of 4 high risk tests survive ≥ 24 months, (P = 7.1x10-3). Treatments produce neither hospitalization, neutropenic fever, severe enteritis, nor severe neuropathies.
UNASSIGNED: Two-year survival is replicable and predictable. Findings warrant phase III validation tests of sequential regimens, re-challenge with recombination, low dosages, and blood tests that are associated with lethal mechanisms that impair response and survival.
摘要：
■常规血液检查是胆管癌患者的预后检查。新的药物方案可能产生2年或更长时间的中位总生存期。
■这种单一的做法，IRB批准,第二阶段试验检查预后测试，Kaplan-Meier生存,和单变量Cox回归分析。资格要求：意向治疗;签署同意书;晚期可测量肝内胆管癌，对测试药物有或没有耐药性；任何成人年龄；表现状态0-2；预期生存期≥6周。每两周治疗一次,1/3的标准剂量(mg/M2)包括:吉西他滨500;5-氟尿嘧啶1200,超过24小时;亚叶酸180;伊立替康80;和在第2天,奥沙利铂40。关于进展，在第2天添加药物:首先，多西他赛25先于奥沙利铂，奥沙利铂后有或没有丝裂霉素C6。接下来的连续添加是第1天，西妥昔单抗400毫克，然后每周200毫克，然后用10mg/kg的贝伐单抗代替西妥昔单抗(FDAIND#119005)。
■对于35名患者，19与1-2行先前的治疗，耐药肿瘤，16以前没有治疗，24个月生存率≥72，≥58%，分别。对于年龄≥70岁的14名患者，≥63%存活24个月，P=0.28。与具有良好测试的患者相比，预测≤6个月生存率的验证测试发现，中位生存时间为17个月至>2年：中性粒细胞淋巴细胞比率>3.0，HR=6.54，P<6.4x10-3；绝对中性粒细胞计数>8000/μl，HR=4.95,P<6.5x10-3;血清白蛋白<3.5g/dl,HR=4.10,P<0.03;淋巴细胞单核细胞比率<2.1,HR=1.6,P=0.50。总的来说,在4项高风险测试中，有76（60-90）％的0-2例患者存活≥24个月，（P=7.1x10-3）。治疗不会导致住院，中性粒细胞减少症,严重肠炎,也不是严重的神经病。
■两年生存率是可复制和可预测的。研究结果证明了序贯方案的第三阶段验证测试，用重组重新挑战，低剂量,和与损害反应和存活的致命机制相关的血液测试。
■这种单一的做法，IRB批准,第二阶段试验检查预后测试，Kaplan-Meier生存,和单变量Cox回归分析。资格要求：意向治疗;签署同意书;晚期可测量肝内胆管癌，对测试药物有或没有耐药性；任何成人年龄；表现状态0-2；预期生存期≥6周。每两周治疗一次,1/3的标准剂量(mg/M2)包括:吉西他滨500;5-氟尿嘧啶1200,超过24小时;亚叶酸180;伊立替康80;和在第2天,奥沙利铂40。关于进展，在第2天添加药物:首先，多西他赛25先于奥沙利铂，奥沙利铂后有或没有丝裂霉素C6。接下来的连续添加是第1天，西妥昔单抗400毫克，然后每周200毫克，然后用10mg/kg的贝伐单抗代替西妥昔单抗(FDAIND#119005)。
■对于35名患者，19与1-2行先前的治疗，耐药肿瘤，16以前没有治疗，24个月生存率≥72，≥58%，分别。对于年龄≥70岁的14名患者，≥63%存活24个月，P=0.28。与具有良好测试的患者相比，预测≤6个月生存率的验证测试发现，中位生存时间为17个月至>2年：中性粒细胞淋巴细胞比率>3.0，HR=6.54，P<6.4x10-3；绝对中性粒细胞计数>8000/μl，HR=4.95,P<6.5x10-3;血清白蛋白<3.5g/dl,HR=4.10,P<0.03;淋巴细胞单核细胞比率<2.1,HR=1.6,P=0.50。总的来说,在4项高风险测试中，有76（60-90）％的0-2例患者存活≥24个月，（P=7.1x10-3）。治疗不会导致住院，中性粒细胞减少症,严重肠炎,也不是严重的神经病。
■两年生存率是可复制和可预测的。研究结果证明了序贯方案的第三阶段验证测试，用重组重新挑战，低剂量,和与损害反应和存活的致命机制相关的血液测试。
