Department of Radiation Oncology, Fudan University, Shanghai Cancer Center, 270 Dong'An Road, Shanghai, 200032, China.
Department of Radiation Oncology, Fudan University, Shanghai Cancer Center Minhang Branch, 106 RuiLi Road, Shanghai, 200240, China.
Int J Clin Oncol. 2018 Jun;23(3):458-465. doi: 10.1007/s10147-018-1240-4. Epub 2018 Feb 12.
This study was performed to assess the efficacy and feasibility of definitive chemoradiotherapy consisting of weekly doses of combined paclitaxel and carboplatin concurrent with radiation therapy, followed by 2 cycles of consolidation chemotherapy for advanced esophageal carcinoma.
Eligibility criteria included local, advanced, newly diagnosed and postoperative local regional lymph node metastasis; Eastern Cooperative Oncology Group (ECOG) score ≤ 2; and adequate organ function. Patients received concurrent chemoradiation therapy consisting of radiotherapy (50.4 Gy/28 Fx or 61.2 Gy/34 Fx) and concurrent paclitaxel (50 mg/m) and carboplatin (area under the curve, AUC = 2) on days 1, 8, 15, 22 and 29. The two-cycle consolidation chemotherapy protocol was paclitaxel (175 mg/m) plus carboplatin (AUC = 5) administered on days 57 and 85, after concurrent chemoradiotherapy.
Between August 2013 and February 2015, 65 patients with oesophageal carcinoma were enrolled in the study; 34 (52.3%) were newly diagnosed and 31 (47.6%) had postoperative local regional lymph node metastasis. The median overall survival time was 21.7 months (95% confidence interval [CI] 16.7-26.6), and the median progression-free survival time was 12.1 months (95% CI 9.0-15.3). A total of 96.9% (63/65) and 67.6% (44/65) patients completed ≥5 cycles and all 7 cycles of chemotherapy, respectively. A total of 93.8% (61/65) patients completed radiation therapy. The 1- and 2-year overall survival rates were 73.7 and 42.0%, respectively. The 1- and 2-year progression-free survival rates were 50.6 and 31.1%, respectively. Grade 3-4 toxicity during chemoradiotherapy included neutropenia (24.5%), thrombocytopenia (4.6%), fatigue (1.5%), anaemia (1.5%), radiation dermatitis (1.5%), pneumonitis (1.5%), oesophagitis (4.6%) and vomiting (1.5%).
In patients with locally advanced oesophageal cancer, the combination of weekly doses of paclitaxel and carboplatin was well tolerated and produced comparable results. A three-arm randomised phase III trial (NCT02459457) comparing paclitaxel in combination with cisplatin, carboplatin or 5-fluorouracil with concurrent radiotherapy is on-going at our hospital.
本研究旨在评估每周剂量紫杉醇和卡铂联合放化疗联合放疗后进行 2 周期巩固化疗治疗晚期食管癌的疗效和可行性。
入选标准包括局部晚期、新诊断和术后局部区域淋巴结转移的食管癌；东部肿瘤协作组（ECOG）评分≤2；以及足够的器官功能。患者接受放化疗联合治疗，包括放疗（50.4Gy/28Fx 或 61.2Gy/34Fx）和同期紫杉醇（50mg/m）和卡铂（曲线下面积，AUC=2），于第 1、8、15、22 和 29 天给药。两周期巩固化疗方案为紫杉醇（175mg/m）联合卡铂（AUC=5），于放化疗后第 57 和 85 天给药。
2013 年 8 月至 2015 年 2 月，共有 65 例食管癌患者入组本研究；34 例（52.3%）为新诊断患者，31 例（47.6%）为术后局部区域淋巴结转移患者。中位总生存期为 21.7 个月（95%可信区间[CI]为 16.7-26.6），中位无进展生存期为 12.1 个月（95%CI 为 9.0-15.3）。共有 96.9%（63/65）和 67.6%（44/65）的患者完成了≥5 个周期和所有 7 个周期的化疗。共有 93.8%（61/65）的患者完成了放疗。1 年和 2 年总生存率分别为 73.7%和 42.0%。1 年和 2 年无进展生存率分别为 50.6%和 31.1%。放化疗期间 3-4 级毒性包括中性粒细胞减少症（24.5%）、血小板减少症（4.6%）、乏力（1.5%）、贫血（1.5%）、放射性皮炎（1.5%）、肺炎（1.5%）、食管炎（4.6%）和呕吐（1.5%）。
在局部晚期食管癌患者中，每周剂量紫杉醇和卡铂联合治疗耐受性良好，疗效相当。我院正在进行一项三臂随机 III 期试验（NCT02459457），比较紫杉醇联合顺铂、卡铂或 5-氟尿嘧啶与同期放化疗的疗效。
