Buxton E J, Blackledge G, Mould J J, Monaghan J, Paterson M, Tobias J, Alcock C, Spooner D, Meanwell C A
West Midlands Cancer Research Campaign Clinical Trials Unit, Queen Elizabeth Hospital, Birmingham, England.
Semin Oncol. 1989 Feb;16(1 Suppl 3):60-7.
A series of phase II studies using ifosfamide as a single agent and in combination with cisplatin and bleomycin (BIP) in advanced and recurrent cervical cancer were coordinated at the West Midlands Cancer Research Campaign Clinical Trials Unit, Birmingham, UK. The aim of these studies was to identify single agents and combination regimens that might be of value for palliation and have potential for neoadjuvant and adjuvant therapy in primary treatment. Ninety-eight patients were studied. Seventy-nine patients with disease not amenable to radical local therapy were treated with single-agent ifosfamide or the BIP combination. In 30 patients treated with single-agent ifosfamide, ten objective responses (33%) were seen, with one complete response. In 49 patients treated with BIP, 34 objective responses (69%) were seen, with ten complete responses (20%). Eleven (79%) of 14 patients with primary inoperable disease had at least a 50% reduction in tumor bulk before radical local radiotherapy. Toxicity resulted in alopecia, nausea and vomiting, myelosuppression, infection, reduction in renal function, and disturbance of consciousness. There was no evidence that neoadjuvant chemotherapy enhanced the acute toxic effects of pelvic radiotherapy. These data indicate that ifosfamide is highly active in cervical cancer and that in combination with bleomycin and cisplatin, it can be used for effective palliation and cytoreduction in around 70% of patients. Ifosfamide-containing regimens have potential for use as neoadjuvant and adjuvant therapy in patients at high risk of recurrence with conventional treatment. These hypotheses are currently being tested in prospective randomized trials.
英国伯明翰西米德兰兹癌症研究运动临床试验单位协调了一系列二期研究，这些研究将异环磷酰胺作为单一药物，并与顺铂和博来霉素联合使用（BIP方案），用于治疗晚期和复发性宫颈癌。这些研究的目的是确定可能对缓解症状有价值、并在原发性治疗中具有新辅助和辅助治疗潜力的单一药物和联合治疗方案。共研究了98例患者。79例不适于进行根治性局部治疗的患者接受了异环磷酰胺单一药物治疗或BIP联合治疗。在接受异环磷酰胺单一药物治疗的30例患者中，观察到10例客观缓解（33%），其中1例完全缓解。在接受BIP治疗的49例患者中，观察到34例客观缓解（69%），其中10例完全缓解（20%）。14例原发性无法手术的患者中有11例（79%）在根治性局部放疗前肿瘤体积至少缩小了50%。毒性反应包括脱发、恶心和呕吐、骨髓抑制、感染、肾功能减退和意识障碍。没有证据表明新辅助化疗会增强盆腔放疗的急性毒性作用。这些数据表明，异环磷酰胺在宫颈癌中具有高度活性，与博来霉素和顺铂联合使用时，可用于约70%患者的有效缓解症状和肿瘤细胞减灭。含异环磷酰胺的治疗方案有潜力用于常规治疗后复发风险高的患者的新辅助和辅助治疗。目前正在前瞻性随机试验中对这些假设进行检验。
