联合应用沙利度胺和脂质体阿霉素治疗复发性卵巢上皮性癌和腹膜癌的初步研究

目的:评价联合应用沙利度胺与脂质体阿霉素治疗复发性卵巢上皮性癌和腹膜癌的疗效和毒副作用。方法:将9例经手术和术后泰素+卡铂化疗后复发患者纳入本研究。每4周予以脂质体阿霉素30~50mg/m2化疗,共3~8个疗程;同时每日予以沙利度胺100~300mg,其剂量从100mg/d开始,此后每2周增加50~100mg。通过体检、影像学检查和测定CA125水平评价治疗效果。结果:9例患者的中位年龄为56岁(35~81岁),FIGO分期为ⅢB~Ⅳ期。本次化疗的中位疗程数是6个疗程。中位随访时间为18.5个月。最常见的不良反应为疲劳(55.6%)和神经系统症状(55.6%)。3例患者出现Ⅲ度副反应,1例为无力、1例过敏性皮疹和1例末梢神经感觉异常。根据RECIST标准评价有病灶的6例患者疗效,2例部分缓解,2例治疗中疾病无进展,1例病情进展,1例失访。另有2例CA125升高的患者,在联合化疗3~4个疗程后CA125水平降低50%以上。1例二次肿瘤细胞减灭术后化疗的患者治疗后随访36个月无肿瘤复发迹象。在随访的8例患者中,中位疾病无进展时间为6.5个月(0~36个月);中位总的生存时间为20.5个月(8~36个月)。结论:联合应用沙利度胺与脂质体阿霉素治疗复发性卵巢上皮性癌具有可接受的毒副作用,同时具有一定的治疗效果。

Combined oral thafidomide with liposomal doxorubicin in the treatment of recurrent epithelial ovarian and primary peritoneal cancers

Objective：To evaluate the toxicity and clinical activity of combined oral thalidomide and liposomal doxorubicin in the treatment of patients with recurrent epithelial ovarian or primary peritoneal carcinoma. Methods：All of the nine patients underwent primary debulking followed by adjuvant chemotherapy with Paclitaxel and Carboplatin. Upon relapse, patients were treated with liposomal doxorubicin 30 -50mg/m^2 every four weeks combined with escalating doses of thalidomide about 100 -300mg/d, starting at 100mg/day, increasing by 50 100mg every two weeks. Patients were evaluated with physical exam,imaging studies, and CA125 levels. Results ：Nine patients （median age 56） with recurrent epithelial ovarian cancer or peritoneal cancer were evaluated ; of which, one had FIGO stage ⅢB, six had stageⅢ c, and two had stage IV disease. The median number of cycles of combination of oral thalidomide and liposomal doxorubicin was six with a median follow-up time of 18.5 months. The most common adverse effects were fatigue （55.6%） and neuropathy （55.6%）. Grade 3 events included one with fatigue, one with an allergic rash and one with neuropathy. Based on the RECIST criteria/ evaluation of the six patients with measurable disease, two had a partial response, two had stable disease, one had progressive disease, and one was lost to follow-up. Of the the other two women with chemical recurrence based on CA125 levels, all had at least 50% reduction in CA125 after 3 - 4 cycles of combined treatment of thalidomide and liposomal doxorubicin. One patient was undertaken a secondary tumor debulking before the chemotherapy was-given and in the 36 months follow-up no evidence of tumor recurrence. The median progression-free survival time was 6.5 months with a median overall survival of 20.5 months. Conclusion： The combination of oral thalidomide and liposomal doxorubicin has an acceptable toxicity. Future studies are needed to determine the clinical activity of oral thalidomide combined with cytotoxic chemotherapy.