Stock R G, Dottino P, Jennings T S, Terk M, DeWyngaert J K, Beddoe A M, Cohen C
Department of Radiation Oncology, Mount Sinai School of Medicine, New York, New York 10029, USA.
Gynecol Oncol. 1997 Dec;67(3):309-15. doi: 10.1006/gyno.1997.4879.
To evaluate the efficacy and toxicity of interferon-alpha-2b (IFN-alpha) and cisplatin given concomitantly with radiation therapy (RT) in the treatment of locally advanced cervical carcinoma.
Twenty-one patients with stage bulky Ib-IIIb (Ib, 2; IIa, 2; IIb, 8; IIIb, 9) cervical carcinoma were treated with combined IFN-alpha (5 million IU) subcutaneously three times per week and cisplatin (25 mg/m2) i.v. infusion over 2 h weekly for 7 weeks, given concomitantly with RT (4500 cGy of external beam plus 2 brachytherapy procedures). Total radiation doses delivered ranged from 7500 to 9960 cGy (median, 9300 cGy). Follow-up ranged from 16 to 33 months (median, 25 months).
The 2-year local control rate was 100%. The only sites of disease recurrence were distant. Freedom from distant metastases, disease-free survival, and overall survival at 2 years was 76%. Late complication rates were high. Grade 4 rectosigmoid, bladder, and small bowel complication rates were 49, 18, and 23% at 2 years. Late toxicity was seen earlier than expected with rectosigmoid complications observed 5 to 11.5 months (median, 8 months) after completion of treatment.
Combination IFN-alpha and cisplatin produced a marked effect of enhanced radiosensitization as evidenced by 100% local tumor control and high late normal tissue complication rates. Due to the unacceptable late toxicity, its routine clinical use cannot be recommended. Further investigation is needed to determine whether a therapeutic window exists such that the use of lower doses of IFN-alpha, cisplatin, or RT can increase tumor control with more acceptable normal tissue toxicity.
评估α-2b干扰素（IFN-α）和顺铂同步放疗（RT）治疗局部晚期宫颈癌的疗效及毒性。
21例Ib-IIIb期（Ib期2例；IIa期2例；IIb期8例；IIIb期9例）巨块型宫颈癌患者接受联合治疗，皮下注射IFN-α（500万国际单位），每周3次，同时静脉输注顺铂（25mg/m²），2小时内输完，每周1次，共7周，同步进行放疗（体外照射4500cGy加2次近距离放疗）。总放疗剂量为7500至9960cGy（中位剂量930０cGy）。随访时间为16至33个月（中位时间25个月）。
2年局部控制率为100%。疾病复发仅发生在远处部位。2年无远处转移生存率、无病生存率和总生存率为76%。晚期并发症发生率较高。2年时乙状结肠、膀胱和小肠4级并发症发生率分别为49%、18%和23%。晚期毒性出现时间早于预期，乙状结肠并发症在治疗结束后5至11.5个月（中位时间8个月）出现。
IFN-α与顺铂联合产生了显著的放射增敏作用，局部肿瘤控制率达100%，但晚期正常组织并发症发生率高。由于晚期毒性难以接受，不推荐其常规临床应用。需要进一步研究以确定是否存在治疗窗，即使用较低剂量的IFN-α、顺铂或放疗能否在正常组织毒性更可接受的情况下提高肿瘤控制率。
