A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer.
A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer.
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DOI：
10.1002/cncr.28117
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发表时间：
2013-08-01
期刊：
影响因子：
6.2
通讯作者：
Zalupski, Mark M.
中科院分区：
文献类型：
--
作者：
Kim, Edward J.;Ben-Josef, Edgar;Herman, Joseph M.;Bekaii-Saab, Tanios;Dawson, Laura A.;Griffith, Kent A.;Francis, Isaac R.;Greenson, Joel K.;Simeone, Diane M.;Lawrence, Theodore S.;Laheru, Daniel;Wolfgang, Christopher L.;Williams, Terence;Bloomston, Mark;Moore, Malcolm J.;Wei, Alice;Zalupski, Mark M.
本研究的目的是评估术前全剂量吉西他滨、奥沙利铂和放疗（RT）治疗局限性胰腺癌的效果。合格性包括确认腺癌、可切除或边缘性可切除疾病、PS≤2和充分的器官功能。治疗包括两个28天周期的吉西他滨（1 g/m2，30分钟，第1、8、15天）和奥沙利铂（85 mg/m2，第1、15天），第1周期采用RT（30 Gy，2 Gy分次）。在第2周期后对患者进行手术评价。切除患者接受2个周期的辅助化疗。68例可评价患者在4家临床试验机构接受治疗。通过中心放射学审查，23例患者可切除，39例可边缘切除，6例不可切除。66例患者（97%）完成了第1周期/RT，61例患者（90%）完成了第2周期。术前治疗期间≥ 3级的不良事件包括中性粒细胞减少症（32%）、血小板减少症（25%）和胆道梗阻/胆管炎（14%）。43例患者接受了切除术（63%），其中36例患者接受了R 0切除术（84%）。所有患者的中位总生存期为18.2个月（95%CI 13-26.9），切除组为27.1个月（95%CI 21.2-47.1），未切除组为10.9个月（95%CI 6.1-12.6）。新辅助治疗后CA 19 -9的降低与R 0切除相关（p=0.02），导致中位生存期为34.6个月（95% CI 20.3-47.1）。中位随访时间为31.4个月（范围：24-47.6）时，14例患者（21%）存活且无疾病。术前全剂量吉西他滨、奥沙利铂和RT治疗是可行的，R 0切除率较高。结果是特别令人鼓舞的，因为大多数患者的边缘切除疾病。
The purpose of this study was to evaluate preoperative treatment with full-dose gemcitabine, oxaliplatin and radiation (RT) in localized pancreatic cancer. Eligibility included confirmation of adenocarcinoma, resectable or borderline resectable disease, PS≤2, and adequate organ function. Treatment consisted of two, 28 day cycles of gemcitabine (1g/m2 over 30 minutes days 1, 8, 15) and oxaliplatin (85mg/m2 days 1, 15) with RT during cycle 1 (30Gy in 2Gy fractions). Patients were evaluated for surgery following cycle 2. Resected patients received 2 cycles of adjuvant chemotherapy. Sixty-eight evaluable patients were treated at 4 centers. By central radiology review, 23 patients were resectable, 39 borderline resectable, and 6 unresectable. Sixty-six patients (97%) completed cycle 1/RT and 61 patients (90%) cycle 2. Adverse events ≥ grade 3 during preoperative therapy included neutropenia (32%), thrombocytopenia (25%), and biliary obstruction/cholangitis (14%). Forty-three patients were resected (63%) with R0 resection in 36 (84%). Median overall survival for all patients was 18.2 months (95%CI 13–26.9), those resected 27.1 months (95%CI 21.2–47.1) and those not resected 10.9 months (95%CI 6.1–12.6). A decrease in CA19-9 following neoadjuvant therapy was associated with R0 resection (p=0.02) which resulted in a median survival of 34.6 months (95% CI 20.3–47.1). Fourteen patients (21%) are alive and disease-free at a median follow-up time of 31.4 months (range, 24–47.6). Preoperative therapy with full dose gemcitabine, oxaliplatin and RT was feasible and resulted in a high percentage of R0 resections. Results are particularly encouraging given a majority of patients with borderline resectable disease.
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影响因子：
45.3
作者：
Evans, Douglas B.;Varadhachary, Gauri R.;Wolff, Robert A.
通讯作者：
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