多西他赛和 5-FU 同期放疗联合治疗不可切除局部晚期胰腺癌患者：FNCLCC-ACCORD/0201 随机 II 期试验的预设分析及 5.5 年无病生存病例报告。
Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival.
机构信息
Institut Gustave Roussy, Villejuif, France.
出版信息
Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.
BACKGROUND
To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC) we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued.
METHODS
Forty (40) chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1) to either continuous fluorouracil (5-FU) 200 mg/m(2)/day (protracted IV) and docetaxel (DCT) 20 mg/m(2)/week or DCT 20 mg/m2 and cisplatin (CDDP) 20 mg/m(2), plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR). Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients.
RESULTS
Eighteen (18) progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23). Six and 12-month survivals were 85% (95%CI: 64-95) and 40% (95%CI: 22-61); median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR) for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%), abdominal pain (10%) and fatigue (10%).
CONCLUSIONS
Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT00112697.
背景
为了探索局部晚期胰腺癌（LAPC）治疗的可能改善，我们进行了一项随机、非对照的 II 期研究，评估多西他赛联合每日持续 5-FU 或每周顺铂与放疗同时应用。我们在此报告根据中期分析停止的多西他赛加 5-FU 方案的结果。多西他赛加顺铂组继续进行。
方法
40 例（40 例）初治不可切除 LAPC 患者被随机分配（1:1）接受持续氟尿嘧啶（5-FU）200mg/m2/天（持续 IV）和多西他赛（DCT）20mg/m2/周或 DCT 20mg/m2和顺铂（CDDP）20mg/m2，同时接受 6 周放疗。原发肿瘤的放射剂量为 54Gy，分 30 个剂量。该试验的主要终点是 6 个月时未经治疗的无进展率（NPR）。次要终点为耐受性、客观缓解率和总生存率。如果在 6 个月时，20 例患者中有超过 13 例疾病进展，则停止入组。
结果
在 5-FU-DCT 组中，18 例患者在 6 个月时出现进展。6 个月 NPR 为 10%（95%CI：0-23）。6 个月和 12 个月的生存率分别为 85%（95%CI：64-95）和 40%（95%CI：22-61）；中位总生存期为 10.1 个月。中位无进展生存期为 4.3 个月。我们报告了 1 例患者的病例，该患者可手术治疗，5.5 年来完全缓解（CR）。≥3 级毒性反应见于 75%的患者；无治疗相关死亡。严重毒性主要为呕吐（35%）、腹痛（10%）和乏力（10%）。
结论
尽管 5-FU-DCT 方案的耐受性良好，但 5-FU、多西他赛和放疗联合应用治疗 LAPC 的疗效不足。
试验注册
ClinicalTrials.gov：NCT00112697。
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