Adjuvant Intra-Arterial Chemotherapy and Radiotherapy Versus Surgery Alone in Resectable Pancreatic and Periampullary Cancer A Prospective Randomized Controlled Trial
Adjuvant Intra-Arterial Chemotherapy and Radiotherapy Versus Surgery Alone in Resectable Pancreatic and Periampullary Cancer A Prospective Randomized Controlled Trial
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DOI：
10.1097/sla.0b013e318190c53e
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发表时间：
2008-12-01
影响因子：
9
通讯作者：
van Eijck, Casper H. J.
中科院分区：
文献类型：
--
作者：
Morak, Marjolein J. M.;van der Gaast, Ate;van Eijck, Casper H. J.
背景资料：由于局部复发和/或远处转移的发展，胰腺癌和壶腹周围癌手术治疗的成功往往是有限的。目的：研究胰腺癌或壶腹周围癌切除术后腹腔轴灌注（CAI）和放疗（RT）与观察的生存益处。方法：在一项随机对照试验中，120例连续的经组织病理学证实的胰腺癌或壶腹周围癌患者接受了由动脉内米托蒽醌、5-FU、甲酰四氢叶酸和顺铂联合30 × 1.8戈伊放疗（A组）或不加辅助治疗（B组）。根据肿瘤类型（胰腺肿瘤与壶腹周围肿瘤）对各组进行分层。结果：手术后，120例患者被随机分组（治疗组59例，观察组61例）。中位随访时间为17个月。未观察到显著的总生存期获益（中位数分别为19和18个月）。86例患者出现疾病进展：CAI/RT组37例，观察组49例（对数秩P < 0.02）。亚组分析显示壶腹周围肿瘤辅助治疗后肝转移显著减少（对数秩P < 0.03），对局部复发无影响。尽管如此，对这些患者的总生存期没有显著影响（对数秩P = 0.15）。在胰腺癌患者中，CAI/RT对局部复发（对数秩P = 0.12）没有显着影响，也没有对肝转移的发展（对数秩P = 0.76），因此，对总生存率没有影响。结论：这种辅助治疗方案的结果在一个延长的时间进展。对于壶腹周围肿瘤，CAI/RT诱导肝转移的发展显着减少，可能对总生存率产生影响。特别是在这些肿瘤中，CAI/RT可能在更大的群体中证明是有益的，需要进一步研究。
Background: Success of surgical treatment for pancreatic and periampullary cancer is often limited due to locoregional recurrence and/or the development of distant metastases.Objective: The survival benefit of celiac axis infusion (CAI) and radiotherapy (RT) versus observation after resection of pancreatic or periampullary cancer was investigated.Methods: In a randomized controlled trial, 120 consecutive patients with histopathologically proven pancreatic or periampullary cancer received either adjuvant treatment consisting of intra-arterial mitoxantrone, 5-FU, leucovorin, and cisplatinum in combination with 30 x 1.8 Gy radiotherapy (group A) or no adjuvant treatment (group B). Groups were stratified for tumor type (pancreatic vs. periampullary tumors).Results: After surgery, 120 patients were randomized (59 patients in the treatment group, 61 in the observation group). The median follow-up was 17 months. No significant overall survival benefit was seen (median, 19 vs. 18 months resp.). Progressive disease was seen in 86 patients: in 37 patients in the CAI/RT group, and in 49 patients in the observation group (log-rank P < 0.02). Subgroup analysis showed significantly less liver metastases after adjuvant treatment in periampullary tumors (log-rank P < 0.03) without effect on local recurrence. Nonetheless, there was no significant effect on overall survival in these patients (log-rank P = 0.15). In patients with pancreatic cancer, CAI/RT had no significant effect on local recurrence (log-rank P = 0.12) neither on the development of liver metastases (log-rank P = 0.76) and consequently, no effect on overall survival.Conclusion: This adjuvant treatment schedule results in a prolonged time to progression. For periampullary tumors, CAI/RT induced a significant reduction in the development of liver metastases, with a possible effect on overall survival. Especially in these tumors, CAI/RT might prove beneficial in larger groups and further research is warranted.