Ezzat Mohamad, Shouman Tarek, Zaza Khaled, Safwat Akmal, El-Khoudary Ahmad, El-Senosi Mohamad, Ezzat Ibrahim
The Department of Radiation Oncology, National Cancer Institute, Cairo University.
J Egypt Natl Canc Inst. 2005 Jun;17(2):85-92.
This single-institution study evaluates the feasibility of accelerated fractionation radiotherapy (AF) with and without mitomycin C (MMC) in the treatment of locally advanced head and neck cancer.
Between May 1998 and October 2001, sixty patients with locally advanced stage III and IV of head and neck cancer were randomized into three treatment arms: (1) conventional fractionation radiotherapy (CF) (5 fractions per week); (2) accelerated fractionation radiotherapy (AF) (6 fractions per week); and (3) AF plus Mitomycin C (MMC).
The 2-year overall survival (OS) of the whole group was 21%. The OS according to treatment arm was 23%, 20%, and 28% in CF, AF, and AF+MMC arms respectively (p<0.19). The 2-year loco-regional control (LC) rate was 22% for the whole group of patients. The LC was 10%, 25%, and 30% for the CF, AF, and AF+MMC respectively (p=0.27). The only significant parameters for OS and LC were performance status and pre-treatment hemoglobin level. Mucositis grades 3 & 4 occurred in 70% and 90% of the patients in the AF and AF+MMC arm respectively compared to 55% of patients in the CF arm (p=0.04). However the addition of MMC did not significantly increase the incidence or severity of mucositis between AF and AF+MMC (p=0.13). Hematological toxicity grades 3 & 4 were significantly higher after MMC (occurred in 40% of patients versus 10% and 5% in CF and AF arms respectively, p=0.04). There was no statistically significant difference in the incidence of grade 3 dryness of mouth (p=0.06), fibrosis (p=0.6), or lymphoedema (p=0.39) among the three arms.
There was a trend for improvement of LC and OS rates with the use of AF and the addition of MMC to AF compared to CF radiotherapy, although the difference was not statistically significant. The small number of the patients in each treatment arm and the inclusion of multiple tumor sites may contribute to these statistically insignificant results. Accordingly we advise 85 to continue the trial with inclusion of a larger number of patients and restrict tumor sites to one major site.
本单机构研究评估了加速分割放疗（AF）联合或不联合丝裂霉素C（MMC）治疗局部晚期头颈癌的可行性。
1998年5月至2001年10月期间，60例局部晚期III期和IV期头颈癌患者被随机分为三个治疗组：（1）常规分割放疗（CF）（每周5次分割）；（2）加速分割放疗（AF）（每周6次分割）；（3）AF联合丝裂霉素C（MMC）。
全组患者的2年总生存率（OS）为21%。CF组、AF组和AF + MMC组的OS分别为23%、20%和28%（p < 0.19）。全组患者的2年局部区域控制（LC）率为22%。CF组、AF组和AF + MMC组的LC分别为10%、25%和30%（p = 0.27）。OS和LC的唯一显著参数是体能状态和治疗前血红蛋白水平。AF组和AF + MMC组分别有70%和90%的患者发生3级和4级黏膜炎，而CF组为55%（p = 0.04）。然而，添加MMC并未显著增加AF组和AF + MMC组之间黏膜炎的发生率或严重程度（p = 0.13）。MMC治疗后3级和4级血液学毒性明显更高（分别发生在40%的患者中，而CF组和AF组分别为10%和5%，p = 0.04）。三组之间3级口干（p = 0.06）、纤维化（p = 0.6）或淋巴水肿（p = 0.39）的发生率无统计学显著差异。
与CF放疗相比，使用AF以及在AF中添加MMC有提高LC和OS率的趋势，尽管差异无统计学意义。每个治疗组的患者数量较少以及纳入多个肿瘤部位可能导致这些结果无统计学意义。因此，我们建议继续进行试验，纳入更多患者并将肿瘤部位限制在一个主要部位。
