肛门癌患者接受大剂量放疗联合氟尿嘧啶和顺铂同期治疗的 II 期临床试验的长期随访（ECOG E4292）。
Long-term follow-up of a Phase II trial of high-dose radiation with concurrent 5-fluorouracil and cisplatin in patients with anal cancer (ECOG E4292).
机构信息
Department of Radiation Oncology, Vanderbilt University Medical Center, 2220 Pierce Avenue, Preston Research Building, Room B-1003, Nashville, TN 37232, USA.
出版信息
Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e607-13. doi: 10.1016/j.ijrobp.2011.02.042. Epub 2011 Apr 20.
PURPOSE
Although chemoradiation using 5-fluorouracil (5-FU) and mitomycin-C (MMC) is the standard of care in the treatment of anal cancer, many patients are unable to tolerate MMC. This Phase II clinical trial was performed to determine whether cisplatin could replace MMC in the treatment of anal cancer.
METHODS AND MATERIALS
Thirty-three patients with localized anal cancer were enrolled. One patient registered but never received any assigned therapy and was excluded from all analyses. Between February 1, 1993, and July 21, 1993, 19 patients were accrued to Cohort 1. Radiation consisted of 45 Gy to the primary tumor and pelvic nodes, followed by a boost to the primary and involved nodes to 59.4 Gy. A planned 2-week treatment break was used after 36 Gy. Concurrent chemotherapy consisted of 5-FU 1,000 mg/m(2)/day on Days 1 to 4 and cisplatin 75 mg/m(2) on Day 1. A second course of 5-FU and cisplatin was given after 36 Gy, when the patient resumed radiation therapy. Between April 4, 1996, and September 23, 1996, an additional 13 patients (Cohort 2) were accrued to the study and received the same treatment except without the planned treatment break.
RESULTS
Complete response was seen in 78% (90% CI, 63-89) of patients and was higher in patients who did not get a planned treatment break (92% vs. 68%). The overall Grade 4 toxicity rate was 31%. One treatment-related death (Grade 5) occurred in a patient who developed sepsis. The 5-year overall survival was 69%.
CONCLUSIONS
Radiation therapy, cisplatin, and 5-FU resulted in an overall objective response (complete response + partial response) of 97%. Although the 5-year progression-free survival was only 55%, the overall 5-year survival was 69%. Given the excellent salvage provided by surgery, this study affirms that cisplatin-based regimens may be an alternative for patients who cannot tolerate the severe hematologic toxicities associated with mitomycin-based chemoradiation regimens.
目的
尽管氟尿嘧啶（5-FU）和丝裂霉素 C（MMC）联合放化疗是治疗肛门癌的标准治疗方法，但许多患者无法耐受 MMC。本 II 期临床试验旨在确定顺铂是否可以替代 MMC 治疗肛门癌。
方法和材料
33 例局部肛门癌患者入组。1 例患者登记但从未接受任何指定治疗，被排除在所有分析之外。1993 年 2 月 1 日至 7 月 21 日，19 例患者被纳入队列 1。放疗包括原发肿瘤和盆腔淋巴结 45 Gy，然后对原发和受累淋巴结加量至 59.4 Gy。在 36 Gy 后使用计划的 2 周治疗休息期。同期化疗包括 5-FU 1000 mg/m²/天，连用 4 天，顺铂 75 mg/m² 于第 1 天。在患者恢复放疗后，在 36 Gy 时给予第二疗程的 5-FU 和顺铂。1996 年 4 月 4 日至 9 月 23 日，13 例（队列 2）入组并接受相同治疗，但无计划的治疗休息期。
结果
78%（90%CI，63-89）的患者达到完全缓解，未接受计划治疗休息期的患者缓解率更高（92% vs. 68%）。总体 4 级毒性发生率为 31%。1 例患者发生败血症导致治疗相关死亡（5 级）。5 年总生存率为 69%。
结论
放疗、顺铂和 5-FU 的总体客观缓解率（完全缓解+部分缓解）为 97%。尽管 5 年无进展生存率仅为 55%，但 5 年总生存率为 69%。鉴于手术提供的良好挽救治疗效果，本研究证实，对于不能耐受丝裂霉素 C 联合放化疗方案相关严重血液学毒性的患者，顺铂为基础的方案可能是一种替代选择。
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