Phase II trial of docetaxel, cisplatin and fluorouracil followed by carboplatin and radiotherapy in locally advanced oesophageal cancer.
Phase II trial of docetaxel, cisplatin and fluorouracil followed by carboplatin and radiotherapy in locally advanced oesophageal cancer.
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DOI：
10.1038/sj.bjc.6603585
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发表时间：
2007-02-12
影响因子：
8.8
通讯作者：
Ancona, E.
中科院分区：
文献类型：
--
作者：
Chiarion-Sileni, V.;Corti, L.;Ruol, A.;Innocente, R.;Boso, C.;Del Bianco, P.;Pigozzo, J.;Mazzarotto, R.;Tomassi, O.;Ancona, E.
本研究旨在评估多西他赛、顺铂和氟尿嘧啶联合治疗不可切除的局部晚期食管鳞状细胞癌患者的疗效和安全性。治疗包括多西他赛60 mg m−2、顺铂75 mg m−2（第1天）和氟尿嘧啶750 mg m−2（第2-5天），每3周一次重复，持续3个周期，随后卡铂100 mg m−2周−1，持续5周，同时进行放疗（45戈伊，分25次，5天，周−1）。放疗后，符合条件的患者要么接受食管切除术，要么接受高剂量率腔内近距离放射治疗（HDR-EBT）。37例入组患者中有31例完成了计划的化疗，30例完成了放化疗。完成化疗后，49%（95% CI：32.2-66.2）患者出现临床缓解。12名患者（32%）接受了切除术，其中60%为根治性切除（术后死亡率：0%）。4例患者（11%的入组患者，30%的切除患者）记录了病理学完全缓解。中位生存期为10.8个月（95%CI：8.1-12.4），1年和2年生存率分别为35.1%和18.9%。3-4级毒性为贫血32%，贫血11%，非贫血性感染18%，腹泻6%和食管炎5%。9名患者（24%）在治疗期间发生了气管食管瘘。即使多西他赛加顺铂和5-氟尿嘧啶（5-FU）似乎比顺铂和5-FU联合治疗更有效，也未观察到生存率的增量改善，并且在该研究人群中观察到的毒性值得关注。为了改善这些患者的预后，需要确定具有更好治疗指数的新药物、组合和策略。
This study was performed to assess the efficacy and safety of docetaxel, cisplatin and fluorouracil combination in patients with unresectable locally advanced oesophageal squamous cell carcinoma. Treatment consisted of docetaxel 60 mg m−2, cisplatin 75 mg m−2 on day 1 and fluorouracil 750 mg m−2 day−1 on days 2–5, repeated every 3 weeks for three cycles, followed by carboplatin 100 mg m−2 week−1 for 5 weeks and concurrent radiotherapy (45 Gy in 25 fractions, 5 days week−1). After radiotherapy, eligible patients either underwent an oesophagectomy or received high dose rate endoluminal brachytherapy (HDR-EBT). Thirty-one out of 37 enrolled patients completed the planned chemotherapy and 30 completed chemoradiation. After completion of chemotherapy, 49% (95% CI: 32.2–66.2) had a clinical response. Twelve patients (32%) underwent a resection, which was radical in 60% (postoperative mortality: 0%). A pathological complete response was documented in four patients (11% of enrolled, 30% of resected). The median survival was 10.8 months (95% CI: 8.1–12.4), and the 1- and 2-year survival rates were 35.1 and 18.9%, respectively. Grade 3–4 toxicities were neutropoenia 32%, anaemia 11%, non-neutropoenic infections 18%, diarrhoea 6% and oesophagitis 5%. Nine patients (24%) developed a tracheo-oesophageal fistula during treatment. Even if the addition of docetaxel to cisplatin and 5-fluorouracil (5-FU) seems to be more active than the cisplatin and 5-FU combination, an incremental improvement in survival is not seen, and the toxicity observed in this study population is of concern. In order to improve the prognosis of these patients, new drugs, combinations and strategies with a better therapeutic index need to be identified.
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影响因子：
45.3
作者：
Adelstein, DJ;Rice, TW;Zuccaro, G
通讯作者：
Zuccaro, G
影响因子：
3.4
作者：
Einzig, AI;Neuberg, D;Benson, AB
通讯作者：
Benson, AB
影响因子：
8.8
作者：
GROEN, HJM;VANDERLEEST, AHD;MULDER, NH
通讯作者：
MULDER, NH
DOI：
10.1093/jnci/86.14.1086
发表时间：
1994-07-20
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
AJANI, JA;ILSON, DH;KELSEN, DP
通讯作者：
KELSEN, DP
影响因子：
45.3
作者：
Colevas, AD;Busse, PM;Posner, MR
通讯作者：
Posner, MR