Surgery Versus Radiochemotherapy for Resectable Locally Invasive Pancreatic Cancer: Final Results of a Randomized Multi-Institutional Trial
Surgery Versus Radiochemotherapy for Resectable Locally Invasive Pancreatic Cancer: Final Results of a Randomized Multi-Institutional Trial
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DOI：
10.1007/s00595-007-3745-8
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发表时间：
2008-11-01
期刊：
影响因子：
2.5
通讯作者：
Yoshida, Shigeaki
中科院分区：
文献类型：
--
作者：
Doi, Ryuichiro;Imamura, Masayuki;Yoshida, Shigeaki
目的.虽然局部晚期胰腺癌的手术结果仍然很差，但它正在改善，在日本5年生存率高达约10%。我们的多机构随机对照试验的初步结果显示，手术后的生存率高于放疗后。我们报告的最终结果，这项研究经过5年的随访。术前发现胰腺癌侵犯胰腺被膜而未累及上级肠系膜动脉或肝总动脉或远处转移的患者，在征得其同意的情况下纳入本随机对照试验。如果剖腹手术结果符合这些标准，患者被随机分配到手术组或放化疗组（5-氟尿嘧啶200 mg/m2/d，5040戈伊放疗）。我们比较了平均生存时间、3年和5年生存率以及风险比。手术组20例，放化疗组22例。患者随访5年或更长时间，或直到发生事件以排除这种情况。手术组生存率明显高于放化疗组（P < 0.03）。手术使生存时间和3年生存率分别平均增加11.8个月和20%，并使瞬时死亡率（危险）减半。没有远处转移或主要动脉侵犯的局部浸润性胰腺癌最有效的治疗方法是手术切除。
Purpose. Although the outcome of surgery for locally advanced pancreatic cancer remains poor, it is improving, with 5-year survival up to about 10% in Japan. The preliminary results of our multi-institutional randomized controlled trial revealed better survival after surgery than after radiochemotherapy. We report the final results of this study after 5 years of follow-up.Methods. Patients with preoperative findings of pancreatic cancer invading the pancreatic capsule without involvement of the superior mesenteric or common hepatic arteries, or distant metastasis, were included in this randomized controlled trial, with their consent. If the laparotomy findings were consistent with these criteria, the patient was randomized to a surgery group or a radiochemotherapy group (5-fluorouracil 200 mg/m(2) stop/day and 5040 Gy radiotherapy). We compared the mean survival time, 3-and 5-year survival rates, and hazard ratio.Results. The surgery and radiochemotherapy groups comprised 20 and 22 patients, respectively. Patients were followed up for 5 years or longer, or until an event occurred to preclude this. The surgery group had significantly better survival than the radiochemotherapy group (P < 0.03). Surgery increased the survival time and 3-year survival rate by an average of 11.8 months and 20%, respectively, and it halved the instantaneous mortality (hazard) rate.Conclusions. Locally invasive pancreatic cancer without distant metastases or major arterial invasion is treated most effectively by surgical resection.