A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma
A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma
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DOI：
10.1245/aso.2006.03.039
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发表时间：
2006-02-01
影响因子：
3.7
通讯作者：
McGinn, CJ
中科院分区：
文献类型：
--
作者：
Talamonti, MS;Small, W;McGinn, CJ
背景：我们报告了一项多机构II期试验的结果，该试验使用术前全剂量吉西他滨和放疗治疗潜在可切除的胰腺癌患者。方法：术前给予全剂量吉西他滨（1000mg /m(2)静脉注射）3个周期，第二个周期放疗（36gy，每日2.4 Gy分次）。患者在最后一次吉西他滨输注后4至6周接受手术。结果：男10例，女10例，中位年龄58岁（范围50 ~ 80岁）。19例患者（95%）完成了治疗，没有中断，1例出现3级胃肠道毒性。治疗后平均体重减轻4.0%。在20例接受手术的患者中，17例（85%）接受了切除术（16例胰十二指肠切除术和1例远端胰腺切除术）。并发症发生率24%，平均住院时间13.5天。无手术死亡病例。病理分析显示17例标本中16例（94%）边缘清晰，11例（65%）未受累淋巴结。一个标本未发现残留肿瘤，三个标本仅显示残留病变的显微灶。在18个月的中位随访中，17例切除疾病患者中有7例（41%）存活且无复发，3例（18%）存活并有远处转移，7例（41%）死亡。结论：术前吉西他滨/放疗在多机构环境下耐受良好且安全。该方案术后切除率高，发病率可接受。阴性切缘和未受累淋巴结的高发生率提示有显著的肿瘤反应。初步的生存数据令人鼓舞。在未来胰腺癌的新辅助试验中应考虑该方案。
Background: We report the results of a multi-institutional phase II trial that used preoperative full-dose gemcitabine and radiotherapy for patients with potentially resectable pancreatic carcinoma.Methods: Patients were treated before surgery with three cycles of full-dose gemcitabine (1000 mg/m(2) intravenously), with radiation during the second cycle (36 Gy in daily 2.4-Gy fractions). Patients underwent surgery 4 to 6 weeks after the last gemcitabine infusion.Results: There were 10 men and 10 women, with a median age of 58 years (range, 50-80 years). Nineteen patients (95%) completed therapy without interruption, and one experienced grade 3 gastrointestinal toxicity. The mean weight loss after therapy was 4.0%. Of 20 patients taken to surgery, 17 (85%) underwent resections (16 pancreaticoduodenectomies and 1 distal pancreatectomy). The complication rate was 24%, with an average length of stay of 13.5 days. There were no operative deaths. Pathologic analysis revealed clear margins in 16 (94%) of 17 and uninvolved lymph nodes in 11 (65%) of 17 specimens. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease. With a median follow-up of 18 months, 7 (41%) of the 17 patients with resected disease are alive with no recurrence, 3 (18%) are alive with distant metastases, and 7 (41%) have died.Conclusions: Preoperative gemcitabine/radiotherapy is well tolerated and safe when delivered in a multi-institutional setting. This protocol had a high rate of subsequent resection, with acceptable morbidity. The high rate of negative margins and uninvolved nodes suggests a significant tumor response. Preliminary survival data are encouraging. This regimen should be considered in future neoadjuvant trials for pancreatic cancer.