Spiridonidis C H, Laufman L R, Jones J J, Gray D J, Cho C C, Young D C
Hematology/Oncology Consultants Inc., Columbus, Ohio 43215, USA.
Cancer. 1996 Nov 15;78(10):2070-7.
In patients with advanced esophageal adenocarcinoma, the efficacy and palliative role of systemic chemotherapy are not well defined. The primary objective of this Phase II trial was to evaluate the antitumor activity and toxicity of a multiday chemotherapy schedule of high dose cisplatin and etoposide in patients with unresectable or metastatic esophageal adenocarcinoma. A secondary objective was to assess the efficacy of this regimen in palliating dysphagia.
Twenty-seven eligible patients with unresectable locoregional or metastatic esophageal adenocarcinoma were treated with cisplatin, 30 mg/m2/day, and etoposide, 60 mg/m2/day, intravenously daily for 5 days, every 3 weeks. After three cycles of chemotherapy, all patients were assessed for response. Patients with responding metastatic disease were given one additional cycle of chemotherapy, and patients with locoregional disease received radiation and concurrent continuous infusion of 5-fluorouracil at 300 mg/m2/day for the duration of radiation therapy. Patients were questioned about dysphagia symptoms initially and then weekly during chemotherapy.
The major toxicities included myelosuppression, nausea and vomiting, and peripheral sensory neuropathy, with one treatment-related death. Major responses were observed in 13 patients (48%; 95% confidence intervals, 36-74%), including 5 complete and 8 partial responses. Dysphagia relief occurred in 89% of 18 symptomatic patients within a median time of 16 days. The median survival duration for all patients was 9.8 months, and the actuarial 3-year survival rate was 22%.
Multiday chemotherapy with high dose cisplatin and etoposide is active in patients with advanced esophageal adenocarcinoma. Toxicities associated with this regimen are substantial but manageable.
在晚期食管腺癌患者中，全身化疗的疗效和姑息作用尚不明确。本II期试验的主要目的是评估高剂量顺铂和依托泊苷多日化疗方案对不可切除或转移性食管腺癌患者的抗肿瘤活性和毒性。次要目的是评估该方案缓解吞咽困难的疗效。
27例符合条件的不可切除的局部区域或转移性食管腺癌患者接受顺铂30mg/m²/天和依托泊苷60mg/m²/天静脉滴注，每日1次，共5天，每3周重复。化疗三个周期后，评估所有患者的反应。有反应的转移性疾病患者再接受一个周期的化疗，局部区域疾病患者接受放疗并在放疗期间同时持续静脉滴注5-氟尿嘧啶，剂量为300mg/m²/天。最初询问患者吞咽困难症状，然后在化疗期间每周询问一次。
主要毒性包括骨髓抑制、恶心和呕吐以及周围感觉神经病变，有1例与治疗相关的死亡。13例患者（48%；95%置信区间，36 - 74%）观察到主要反应，包括5例完全缓解和8例部分缓解。18例有症状患者中89%在中位时间16天内吞咽困难得到缓解。所有患者的中位生存时间为9.8个月，3年精算生存率为22%。
高剂量顺铂和依托泊苷多日化疗对晚期食管腺癌患者有活性。该方案相关的毒性较大但可控制。
