Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark.
Acta Oncol. 2011 Oct;50(7):1006-14. doi: 10.3109/0284186X.2011.592650. Epub 2011 Jul 26.
Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect of transfusion by the results from the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients.
Patients were randomized to treatment in the DAHANCA 5 and 7 study (nimorazole vs. placebo and five fx/week vs. six fx/week), and in addition, patients with "low" pre-irradiation hemoglobin values (females <13 g/dl; males <14.5 g/dl) were subrandomized to plus or minus transfusion. Transfusion was given with packed red blood cells with the aim to achieve a hemoglobin level in the "high" value range.
A total of 1166 patients were included, 701 patients had high hemoglobin levels and 465 had low hemoglobin levels. Among the low hemoglobin patients, 235 were randomized to receive transfusion. Patient characteristics and treatment arms were well balanced. In the majority of patients, transfusion resulted in increased hemoglobin levels although this decreased slightly throughout treatment as in the non-transfused patients. Overall, the patients with low hemoglobin level had a significant reduced probability of locoregional control, disease-specific and overall survival. In the low hemoglobin group, transfusion did not improve the outcome in locoregional control, disease-specific or overall survival. In multivariate analyses, HPV/p16 status, T and N classification were significant factors for all outcome measures, whereas there was no significant influence of transfusion or hemoglobin level on endpoints.
Transfusion prior to and during radiation treatment did not improve the outcome in patients with HNSCC and low hemoglobin values, but may have a negative impact on survival.
患有头颈部鳞状细胞癌（HNSCC）且血红蛋白水平较低的患者通常对放疗反应不佳，这可能与缺氧诱导的放疗抵抗有关。我们之前曾根据随机 DAHANCA 5 试验的结果发表过血红蛋白水平和输血的重要性，该试验共纳入了 414 例患者进行分析。本分析旨在通过增加继续进行的 DAHANCA 7 试验中的患者来获得额外的效力，现在总共纳入了近 1200 例患者。
患者被随机分配到 DAHANCA 5 和 7 研究（尼莫佐胺与安慰剂以及每周 5 次与每周 6 次放疗）中进行治疗，此外，还将“低”放疗前血红蛋白值（女性<13 g/dl；男性<14.5 g/dl）的患者进行亚随机分组，分别接受输血或不输血。输血采用浓缩红细胞，目的是使血红蛋白水平达到“高”值范围。
共纳入 1166 例患者，701 例患者血红蛋白水平较高，465 例患者血红蛋白水平较低。在低血红蛋白患者中，235 例患者被随机分配接受输血。患者特征和治疗组之间平衡良好。在大多数患者中，输血导致血红蛋白水平升高，尽管与未输血患者相比，在整个治疗过程中血红蛋白水平略有下降。总体而言，低血红蛋白水平的患者局部区域控制、疾病特异性和总体生存率显著降低。在低血红蛋白组中，输血并没有改善局部区域控制、疾病特异性或总体生存率。多变量分析显示，HPV/p16 状态、T 和 N 分类是所有终点的重要因素，而输血或血红蛋白水平对终点没有显著影响。
在放疗前和放疗期间输血并没有改善 HNSCC 和低血红蛋白值患者的结局，但可能对生存产生负面影响。
