丝裂霉素C和博来霉素同步放疗与单纯放疗治疗不可切除头颈部癌的比较：最终报告

Concomitant radiotherapy with mitomycin C and bleomycin compared with radiotherapy alone in inoperable head and neck cancer: final report.

作者信息

Zakotnik B, Smid L, Budihna M, Lesnicar H, Soba E, Furlan L, Zargi M

机构信息

Department of Medical Oncology, Institute of Oncology, Ljubljana, Slovenia.

出版信息

Int J Radiat Oncol Biol Phys. 1998 Jul 15;41(5):1121-7. doi: 10.1016/s0360-3016(98)00157-6.

DOI:10.1016/s0360-3016(98)00157-6

PMID:9719123

Abstract

PURPOSE

To compare the efficacy of concomitant irradiation with mitomycin C and bleomycin in patients with inoperable head and neck carcinoma with radiotherapy alone.

METHODS AND MATERIALS

Between March 1991 and December 1993, 64 patients with inoperable head and neck carcinoma (41 with oropharyngeal site) were randomized to radiotherapy alone (group A) or radiotherapy combined with simultaneous application of mitomycin C and bleomycin (group B). In both groups patients were irradiated five times weekly with 2 Gy to a total dose of 66-70 Gy. The planned concomitant treatment in group B was: bleomycin 5 units twice a week i.m., total dose 70 units, mitomycin C 15 mg/m2 i.v. after delivery of 10 Gy, and 10 mg/m2 i.v. on the last day of radiotherapy. To enhance the effect of these two drugs, patients received also nicotinamide, chlorpromazine, and dicoumarol. Because significantly better results were achieved in arm B for patients with inoperable oropharyngeal carcinoma, the study was closed and such patients were after December 1993 routinely treated with the combined therapy (as in arm B). Until October 1996, we treated and followed up 48 such consecutive patients.

RESULTS

Median follow-up of our study patients is 42 months. Complete remission (CR) rate in group A was 31% and in group B 59% (p = 0.04); disease-free survival (DFS) in group A was 8% and in group B 37% (P = 0.01); and overall survival (OS) was 7% in group A and 26% in group B (p = 0.08). CR rate for patients with oropharyngeal carcinoma was 29% in group A (N = 21) and 75% in group B (N = 20) (p = 0.007); DFS in group A was 10% and in group B 48% (p = 0.001); and the OS was 10% in group A and 38% in group B (p = 0.019). In patients with inoperable oropharyngeal carcinoma treated after December 1993, complete remission was achieved in 32/48 (67%, 95% CI: 52%-80%). DFS at the median follow-up of 14 months was 60% (95% CI 43-77%) and OS 58% (95% CI 42-74%).

CONCLUSION

From the results of our study it seems that the concomitant treatment significantly improves CR rate, DFS, and OS in patients with inoperable oropharyngeal carcinoma in comparison with radiotherapy alone.

摘要

目的

比较丝裂霉素C和博来霉素同步放疗与单纯放疗对不可切除的头颈部癌患者的疗效。

方法和材料

1991年3月至1993年12月期间，64例不可切除的头颈部癌患者（41例为口咽癌）被随机分为单纯放疗组（A组）或放疗联合丝裂霉素C和博来霉素同步应用组（B组）。两组患者均每周放疗5次，每次2 Gy，总剂量66 - 70 Gy。B组的同步治疗方案为：博来霉素5单位，每周肌肉注射2次，总剂量70单位；丝裂霉素C 15 mg/m²，在照射10 Gy后静脉注射，放疗最后一天静脉注射10 mg/m²。为增强这两种药物的效果，患者还接受了烟酰胺、氯丙嗪和双香豆素治疗。由于B组中不可切除口咽癌患者取得了显著更好的结果，该研究提前结束，1993年12月后此类患者常规采用联合治疗（如B组）。至1996年10月，我们对48例此类连续患者进行了治疗和随访。

结果

本研究患者的中位随访时间为42个月。A组的完全缓解（CR）率为31%，B组为59%（p = 0.04）；A组的无病生存率（DFS）为8%，B组为37%（P = 0.01）；总生存率（OS）A组为7%，B组为26%（p = 0.08）。口咽癌患者的CR率在A组（N = 21）为29%，在B组（N =

20）为75%（p = 0.007）；A组的DFS为10%，B组为48%（p = 0.001）；OS在A组为10%，B组为38%（p = 0.019）。1993年12月后接受治疗的不可切除口咽癌患者中，32/48（67%，95%CI：52% - 80%）实现了完全缓解。在中位随访14个月时的DFS为60%（95%CI 43 - 77%），OS为58%（95%CI 42 - 74%）。