Narayanaswamy Rajesh Kar, Potharaju Mahadev, Vaidhyswaran A N, Perumal Karthikeyan
Senior Resident, Department of Radiation Oncology, Apollo Speciality Hospital , Chennai, India .
Senior Consultant, Department of Radiation Oncology, Apollo Speciality Hospital , Chennai, India .
J Clin Diagn Res. 2015 Jun;9(6):XC14-XC18. doi: 10.7860/JCDR/2015/11593.6102. Epub 2015 Jun 1.
Radiation plays a major role in treatment of locoregional control of Head and Neck Squamous cell carcinoma (HNSCC). Anaemia is considered a contributor to intra-tumour hypoxia and tumour resistance to ionizing radiation and most evidences are from developed world, we prospectively investigated the exact role of anaemia in treatment outcome of Stage III/IVA HNSCC in our patient population.
Primary end point: To analyse the Pre-Radiotherapy haemoglobin level and early response of treatment in stage III/IVA HNSCC and to determine the relationship of Pre-Radiotherapy haemoglobin level with other prognostic factors.
This non-interventional single blinded randomized study enrolled patients attending the OPD consecutively, who met our eligibility criteria.
HNSCC patients of Stage III/IVA aged ≥18 years and ≤ 70 years with ECOG status of 1or 2 and willing for concurrent chemoradiation and at least 6 weeks of follow up.
Ninety one patients enrolled had mean age of 55.63 (range: 32-69), a median of 56 and mode of 60. Seventy one were males (78%) and 20 females (22%) with a performance status of ECOG 1 in 43 (47%) patients and ECOG 2 in 48 (53%); Pre-RT Hb level of <10.7 g/dl in 38 (42%) patients and ≥10.7 in 53 (58%) patients; Pre-RT Hb level was <12 g/dl in 67 (74%) patients and ≥12 in 24 (26%) patients. Tumour sites were - Nasopharynx 7 (8 %), Oral Cavity 18 (20 %), Oropharynx 32 (35 %), Hypopharynx 23 (25 %) and Larynx 11 (12 %). Twenty five (27%) had Grade 2 mucositis and 66 (73%) had Grade 3 mucositis. Fifty eight (64%) patients completed treatment with NO breaks and 33 (36%) with treatment breaks for ≥5 days. Pre-radiotherapy haemoglobin ≥ 10.7 g/dl (p < 0.001), ECOG performance status (p = 0.0002), Treatment interruptions for > 5 days (p = <0.0001), Mucositis reaction (p = <0.0001) showed statistical significance with outcome of response.
The study found that performance status, pre-RT haemoglobin level, radiotherapy interruptions > 5 days and non-development of grade III mucositis was found to be significantly associated with good loco-regional control. Haemoglobin level ≥10.7 g/dl was associated with better treatment outcome, higher performance status, fewer treatment interruptions and lesser degree of mucositis. Transfusion did not affect the outcome. Definitive conclusions and recommendations need further expansion of our study for better statistical power.
放射治疗在头颈部鳞状细胞癌(HNSCC)的局部区域控制治疗中起着重要作用。贫血被认为是导致肿瘤内缺氧和肿瘤对电离辐射产生抗性的一个因素,且大多数证据来自发达国家,我们前瞻性地研究了贫血在我们患者群体中对III/IVA期HNSCC治疗结果的确切作用。
主要终点:分析III/IVA期HNSCC放疗前血红蛋白水平及治疗的早期反应,并确定放疗前血红蛋白水平与其他预后因素的关系。
本非干预性单盲随机研究连续纳入符合我们纳入标准的门诊患者。
年龄≥18岁且≤70岁、ECOG状态为1或2、愿意接受同步放化疗且至少随访6周的III/IVA期HNSCC患者。
1)头颈部既往有恶性肿瘤治疗史或放疗史。2)患有其他可能影响结果或总生存期的致命和非致命的病前或共病情况的患者。放疗前血红蛋白水平<10 g/dl的患者给予补血支持和/或输血。所有患者接受同步化疗(每周顺铂)和66Gy常规分割剂量的放疗。使用修订后的RECIST 1.1版评估早期治疗反应,并使用SPSS 17.版本进行数据分析。
纳入的91例患者平均年龄为55.63岁(范围:32 - 69岁),中位数为56岁,众数为60岁。71例为男性(78%),20例为女性(22%),43例(47%)患者的ECOG表现状态为1,48例(53%)为ECOG 2;38例(42%)患者放疗前血红蛋白水平<10.7 g/dl,53例(58%)患者≥10.7 g/dl;67例(74%)患者放疗前血红蛋白水平<12 g/dl,24例(26%)患者≥12 g/dl。肿瘤部位为 - 鼻咽7例(8%),口腔18例(20%),口咽32例(35%),下咽23例(25%),喉癌11例(12%)。25例(27%)发生2级黏膜炎,66例(73%)发生3级黏膜炎。58例(64%)患者无中断完成治疗,33例(36%)患者治疗中断≥5天。放疗前血红蛋白≥10.7 g/dl(p < 0.001)、ECOG表现状态(p = 0.0002)、治疗中断>5天(p = <0.0001)、黏膜炎反应(p = <0.0001)与反应结果具有统计学意义。
研究发现,表现状态、放疗前血红蛋白水平、放疗中断>5天以及未发生III级黏膜炎与良好的局部区域控制显著相关。血红蛋白水平≥10.7 g/dl与更好的治疗结果、更高的表现状态、更少的治疗中断和较轻的黏膜炎程度相关。输血不影响结果。明确的结论和建议需要进一步扩大我们的研究以获得更好的统计效力。