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肿瘤协作组0122试验(东部肿瘤协作组PE - 289,放射肿瘤学组90 - 12)最终报告:食管癌新辅助化疗联合同步化疗及高剂量放疗的II期试验。

Final report of Intergroup Trial 0122 (ECOG PE-289, RTOG 90-12): Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus.

作者信息

Minsky B D, Neuberg D, Kelsen D P, Pisansky T M, Ginsberg R J, Pajak T, Salter M, Benson A B

机构信息

Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.

出版信息

Int J Radiat Oncol Biol Phys. 1999 Feb 1;43(3):517-23. doi: 10.1016/s0360-3016(98)00463-5.

DOI:10.1016/s0360-3016(98)00463-5
PMID:10078631
Abstract

PURPOSE

To determine the outcome of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus.

METHODS AND MATERIALS

Forty-five patients with clinical Stage T1-4N0-1M0 squamous cell carcinoma were entered on a prospective single-arm study, of which 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (100 mg/m2 day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m2/24 h x 5 days) and cisplatin (75 mg/m2 day 1) plus concurrent 6480 cGy (combined modality segment). The median follow-up in surviving patients was 59 months.

RESULTS

For the 38 eligible patients, the primary tumor response rate was 47% complete, 8% partial, and 3% stable disease. The first site of clinical failure was 39% local/regional and 24% distant. For the total patient group, there were 6 deaths during treatment, of which 9% (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years was 30%, and at 5 years, 20%.

CONCLUSION

This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modality therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123.

摘要

目的

确定新辅助化疗后序贯同步化疗加高分次放疗治疗局部/区域食管鳞状细胞癌患者的疗效。

方法与材料

45例临床分期为T1-4N0-1M0的食管鳞状细胞癌患者进入一项前瞻性单臂研究,其中38例符合条件。患者接受3个周期的5-氟尿嘧啶(1000mg/m²/24小时×5天)和顺铂(第1天100mg/m²;新辅助治疗阶段),随后再接受2个周期的5-氟尿嘧啶(1000mg/m²/24小时×5天)和顺铂(第1天75mg/m²)加同步6480cGy放疗(综合治疗阶段)。存活患者的中位随访时间为59个月。

结果

38例符合条件的患者中,原发肿瘤完全缓解率为47%,部分缓解率为8%,病情稳定率为3%。临床首次失败部位为局部/区域的占39%,远处转移的占24%。在整个患者组中,治疗期间有6例死亡,其中9%(4/45)与治疗相关。中位生存期为20个月。3年精算生存率为30%,5年为20%。

结论

与传统剂量和综合治疗技术相比,这种强化新辅助治疗方法似乎未显示出优势。然而,高分次放疗(6480cGy)似乎耐受性良好,正在组间试验INT 0123中进一步测试。

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