Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109, USA.
Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29.
The purpose of this study was to evaluate preoperative treatment with full-dose gemcitabine, oxaliplatin, and radiation therapy (RT) in patients with localized pancreatic cancer.
Eligibility included confirmation of adenocarcinoma, resectable or borderline resectable disease, a performance status ≤2, and adequate organ function. Treatment consisted of two 28-day cycles of gemcitabine (1 g/m(2) over 30 minutes on days 1, 8, and 15) and oxaliplatin (85 mg/m(2) on days 1 and 15) with RT during cycle 1 (30 Gray [Gy] in 2-Gy fractions). Patients were evaluated for surgery after cycle 2. Patients who underwent resection received 2 cycles of adjuvant chemotherapy.
Sixty-eight evaluable patients received treatment at 4 centers. By central radiology review, 23 patients had resectable disease, 39 patients had borderline resectable disease, and 6 patients had unresectable disease. Sixty-six patients (97%) completed cycle 1 with RT, and 61 patients (90%) completed cycle 2. Grade ≥3 adverse events during preoperative therapy included neutropenia (32%), thrombocytopenia (25%), and biliary obstruction/cholangitis (14%). Forty-three patients underwent resection (63%), and complete (R0) resection was achieved in 36 of those 43 patients (84%). The median overall survival was 18.2 months (95% confidence interval, 13-26.9 months) for all patients, 27.1 months (95% confidence interval, 21.2-47.1 months) for those who underwent resection, and 10.9 months (95% confidence interval, 6.1-12.6 months) for those who did not undergo resection. A decrease in CA 19-9 level after neoadjuvant therapy was associated with R0 resection (P = .02), which resulted in a median survival of 34.6 months (95% confidence interval, 20.3-47.1 months). Fourteen patients (21%) are alive and disease free at a median follow-up of 31.4 months (range, 24-47.6 months).
Preoperative therapy with full-dose gemcitabine, oxaliplatin, and RT was feasible and resulted in a high percentage of R0 resections. The current results are particularly encouraging, because the majority of patients had borderline resectable disease.
本研究旨在评估局部胰腺癌患者术前接受吉西他滨、奥沙利铂和放疗（RT）全剂量治疗的效果。
纳入标准包括组织学证实为腺癌、可切除或边界可切除疾病、体力状态评分≤2 分、以及足够的器官功能。治疗包括两个 28 天周期的吉西他滨（1g/m2 静滴 30 分钟，第 1、8 和 15 天）和奥沙利铂（85mg/m2，第 1 和 15 天），第 1 周期同时进行 RT（30Gy 分 2Gy 剂量）。第 2 周期后评估患者是否可接受手术。接受手术的患者接受 2 个周期的辅助化疗。
4 个中心共 68 例患者可评估。根据中心影像学评估，23 例患者为可切除疾病，39 例为边界可切除疾病，6 例为不可切除疾病。66 例（97%）患者完成了第 1 周期的 RT，61 例（90%）患者完成了第 2 周期。术前治疗期间出现的≥3 级不良事件包括中性粒细胞减少症（32%）、血小板减少症（25%）和胆道阻塞/胆管炎（14%）。43 例患者接受了手术（63%），其中 43 例患者中的 36 例（84%）获得了完全（R0）切除。所有患者的中位总生存期为 18.2 个月（95%置信区间，13-26.9 个月），接受手术的患者为 27.1 个月（95%置信区间，21.2-47.1 个月），未接受手术的患者为 10.9 个月（95%置信区间，6.1-12.6 个月）。新辅助治疗后 CA19-9 水平降低与 R0 切除相关（P=.02），中位生存时间为 34.6 个月（95%置信区间，20.3-47.1 个月）。14 例（21%）患者在中位随访 31.4 个月（范围，24-47.6 个月）时仍存活且无疾病。
吉西他滨、奥沙利铂和 RT 的术前治疗是可行的，并且可以获得很高的 R0 切除率。目前的结果尤其令人鼓舞，因为大多数患者患有边界可切除疾病。
