Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region - Phase III trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group
Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region - Phase III trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group
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DOI：
10.1097/00000658-199912000-00006
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发表时间：
1999-12-01
影响因子：
9
通讯作者：
Wils, J
中科院分区：
文献类型：
--
作者：
Klinkenbijl, JH;Jeekel, J;Wils, J
目的探讨胰头及壶腹周围癌术后辅助放疗联合5-氟尿嘧啶与单纯观察的生存效益。背景资料EORTC胃肠道肿瘤合作小组先前对这些癌症的辅助放疗和化疗进行了研究，随后进行了其他研究，结果相互矛盾。方法将符合条件的T1-2NO-1aMO胰头或T1-3NO-1aMO壶腹周围癌和组织学证实的腺癌患者在切除后随机分组。结果1987 ~ 1995年随机抽取218例患者，其中观察组108例，治疗组110例。11例患者不符合条件（观察组5例，治疗组6例）。两组患者的基线特征具有可比性。114例（55%）患者患有胰腺癌（观察组54例，治疗组60例）。在治疗组，21例（20%）患者因术后并发症或患者拒绝而未接受治疗。治疗组仅见轻微毒性反应。观察组的中位生存期为19.0个月，治疗组的中位生存期为24.5个月（log-rank, p = 0.208）。2年生存率分别为41%和51%。肿瘤部位分层结果显示：胰头癌2年生存率观察组为26%，治疗组为34% (log-rank, p = 0.099)；在壶腹周围癌中，观察组2年生存率为63%，治疗组为67% （log-rank, p = 0.737）。两组局部复发率未见明显降低。结论5-氟尿嘧啶辅助放疗安全、耐受性好。然而，这项研究的益处很小；常规辅助放化疗不能作为胰腺头部或壶腹周围癌的标准治疗。
Objective The survival benefit of adjuvant radiotherapy and 5-fluorouracil versus observation alone after surgery was investigated in patients with pancreatic head and periampullary cancers.Summary Background Data A previous study of adjuvant radiotherapy and chemotherapy in these cancers by the Gastrointestinal Tract Cancer Cooperative Group of EORTC has been followed by other studies with conflicting results.Methods Eligible patients with T1-2NO-1aMO pancreatic head or T1-3NO-1aMO periampullary cancer and histologically proven adenocarcinoma were randomized after resection.Results Between 1987 and 1995, 218 patients were randomized (108 patients in the observation group, 110 patients in the treatment group). Eleven patients were ineligible (five in the observation group and six in the treatment group). Baseline characteristics were comparable between the two groups. One hundred fourteen patients (55%) had pancreatic cancer (54 in the observation group and 60 in the treatment group). In the treatment arm, 21 patients (20%) received no treatment because of postoperative complications or patient refusal. In the treatment group, only minor toxicity was observed. The median duration of survival was 19.0 months for the observation group and 24.5 months in the treatment group (log-rank, p = 0.208). The 2-year survival estimates were 41% and 51%, respectively. The results when stratifying for tumor location showed a 2-year survival rate of 26% in the observation group and 34% in the treatment group (log-rank, p = 0.099) in pancreatic head cancer; in periampullary cancer, the 2-year survival rate was 63% in the observation group and 67% in the treatment group (log-rank, p = 0.737). No reduction of locoregional recurrence rates was apparent in the groups.Conclusions Adjuvant radiotherapy in combination with 5-fluorouracil is safe and well tolerated. However, the benefit in this study was small; routine use of adjuvant chemoradiotherapy is not warranted as standard treatment in cancer of the head of the pancreas or periampullary region.