Maruyama Y, van Nagell J R, Yoneda J, Donaldson E S, Gallion H H, Powell D, Kryscio R J
Department of Radiation Medicine, University of Kentucky Medical Center, Lexington 40536-0084.
Cancer. 1991 Sep 15;68(6):1189-97. doi: 10.1002/1097-0142(19910915)68:6<1189::aid-cncr2820680602>3.0.co;2-f.
Since 1976 a clinical trial has been conducted to test the feasibility, the potential, and to develop methods for using the neutron-emitting radioactive isotope, californium-252 (Cf-252), for the treatment of cervical cancer. A total of 218 patients were treated in the initial study period from 1976 until 1983. The trials initially treated advanced (Stages III and IV) cervical cancer patients using different doses and schedules; they were extended to include unfavorable presentations of Stages I and II because of favorable results in the initial trials. The authors began to treat patients with Stage IB bulky or barrel-shaped tumors and the majority were treated with both radiation and hysterectomy. Actuarial survival was determined for Stage IB disease and was 87% at 5 years and 82% at 10 years. For those tested with preoperative radiation it was 92% at 5 and 87% at 10 years. For Stage II, it was 62% 5 years and 61% at 10. Survival 5 years after combined radiation and surgical therapy for Stage II disease was 68%. For Stage III, it was 33% at 5 years and 25% at 10. However, 5-year survival using the early neutron implant was 46% versus approximately 19% for delayed Cf-252 or cesium 137. Different schedules and sequences of neutrons and photons greatly altered outcome. Neutron treatment before external photon therapy was better for all stages of disease. Only about 5% of all patients developed complications after neutron therapy. No hematologic or mesenchymal second tumors were observed. Neutron brachytherapy was found to be very effective for producing rapid response and greatly improved local control of bulky, barrel, or advanced cervical cancers. The clinical trial identified and evolved schedules, doses, doses per session, and developed methods different from standard photon therapy but highly effective for local control and cure of cervical cancers of all stages. Clinical and radiobiologic understanding for the use of neutron therapy was greatly advanced by this trial. Future trials will focus on patients with advanced disease and will require evaluation of adjuvant chemotherapy studies and neutron-enhancing chemicals.
自1976年以来，一直在进行一项临床试验，以测试使用发射中子的放射性同位素锎-252（Cf-252）治疗宫颈癌的可行性、潜力并开发相关方法。在1976年至1983年的初始研究阶段，共治疗了218例患者。该试验最初使用不同的剂量和方案治疗晚期（III期和IV期）宫颈癌患者；由于初始试验结果良好，后来扩展至包括I期和II期的不良表现患者。作者开始治疗IB期体积较大或桶状肿瘤的患者，大多数患者接受了放疗和子宫切除术。确定了IB期疾病的精算生存率，5年时为87%，10年时为82%。对于术前接受放疗的患者，5年时为92%，10年时为87%。II期患者，5年生存率为62%，10年生存率为61%。II期疾病联合放疗和手术治疗后5年生存率为68%。III期患者，5年生存率为33%，10年生存率为25%。然而，早期中子植入的5年生存率为46%，而延迟使用Cf-252或铯137的生存率约为19%。中子和光子的不同方案和顺序极大地改变了治疗结果。外部光子治疗前进行中子治疗对所有疾病阶段都更好。所有患者中只有约5%在中子治疗后出现并发症。未观察到血液学或间充质第二肿瘤。发现中子近距离治疗对于产生快速反应非常有效，并且极大地改善了对体积较大、桶状或晚期宫颈癌的局部控制。该临床试验确定并改进了方案、剂量、每次治疗剂量，并开发了不同于标准光子治疗但对所有阶段宫颈癌的局部控制和治愈非常有效的方法。该试验极大地推进了对中子治疗应用的临床和放射生物学理解。未来的试验将聚焦于晚期疾病患者，并且需要评估辅助化疗研究和中子增强化学物质。
