Cancer Res Treat. 2003 Aug;35(4):330-4. doi: 10.4143/crt.2003.35.4.330.
The outcomes of a surgical approach for patients with an esophageal carcinoma remain unsatisfactory despite its high complication rates. We conducted a phase II trial, using combined FP (5-fluorouracil and cisplatin) chemotherapy and concurrent radiotherapy, as a definitive therapy for patients with esophageal cancer.
Patients with histologically proven esophageal cancer were enrolled onto this study. The treatment consisted of four courses of chemotherapy and six and a half weeks of radiotherapy. The patients received chemotherapy in weeks 1, 5, 12 and 16 (5-fluorouracil 1, 000 mg/m2 on days 1 to 4 and cisplatin 75 mg/m2 on day 1). Radiotherapy was administered at a dose of 59.4 Gy, in five 1.8 Gy fractions a week.
A total of 22 eligible patients entered the study. Of the 19 evaluable patients, a complete response occurred in 7 (37%), and a partial response in 8 (42%). After a median follow-up of 35 months, the overall survival rate was 32% at three years and the median survival was 11 months. Fourteen (64%) received planned dose of radio-therapy and 13 (59%) received more than three courses of chemotherapy. However, there was no difference in three-year survival rates between the patients that received less than three courses of chemotherapy and those that received three or more courses (31% vs. 32%). The major treatment related toxicity was mucositis, which developed in every patient, with grades III or IV in thirteen (59%) patients. During the treatment, the patients lost, on average, 3.8% of their body weight. The mean hospital stay was 23 days, with a total duration of treatment of 74 days.
S: Concurrent FP chemoradiotherapy was effective as a definitive therapy for patients with esophageal cancer. The major toxicity was mucositis. Although the treatment was relatively feasible, a randomized trial of reduced courses of chemotherapy is warranted.
尽管手术治疗食管癌的并发症发生率较高,但患者的治疗效果仍不理想。我们进行了一项 II 期临床试验,采用 FP(氟尿嘧啶和顺铂)联合化疗和同期放疗作为食管癌患者的确定性治疗。
本研究纳入了经组织学证实的食管癌患者。治疗包括 4 个疗程的化疗和 6 个半星期的放疗。患者在第 1、5、12 和 16 周接受化疗(第 1 至 4 天给予氟尿嘧啶 1,000mg/m2,第 1 天给予顺铂 75mg/m2)。放疗剂量为 59.4Gy,每周 5 次,每次 1.8Gy。
共有 22 名符合条件的患者入组该研究。19 名可评估的患者中,完全缓解 7 例(37%),部分缓解 8 例(42%)。中位随访 35 个月后,3 年总生存率为 32%,中位生存期为 11 个月。14 例(64%)患者接受了计划剂量的放疗,13 例(59%)患者接受了超过 3 个疗程的化疗。然而,接受少于 3 个疗程化疗的患者与接受 3 个或更多疗程化疗的患者的 3 年生存率无差异(31%vs.32%)。主要治疗相关毒性为黏膜炎,所有患者均出现,其中 13 例(59%)患者为 III 或 IV 级。治疗期间,患者平均体重减轻 3.8%。平均住院时间为 23 天,总治疗时间为 74 天。
同期 FP 放化疗作为食管癌患者的确定性治疗是有效的。主要毒性为黏膜炎。尽管治疗相对可行,但需要进行减少化疗疗程的随机试验。