Erkurt E, Erkisi M, Tunali C
Dept. of Radiation Oncology, Cukurova University Medical Faculty, Balcali-Adana, Turkey.
J Exp Clin Cancer Res. 2000 Dec;19(4):431-9.
The reversal of anorexia and weight loss especially in patients with advanced cancer suffering from radiation treatment (RT) -related complications and debilitated furtherly during RT would be a welcome relief. The purpose of this study is to evaluate the feasibility of supportive treatment with megestrol acetate (MA) in our weight-losing cancer patients increasingly experiencing anorexia, smell, taste, and weight loss due to the additive adverse effects of RT +/- chemotherapy and how MA changes the additive role of the severity of RT reactions on such patients. From June 1997 to October 1998, 100 eligible patients were enrolled on a randomized, placebo-controlled clinical trial. Of the 100 patients, 46 received MA during RT and 4 after the end of the RT, and 50 received placebo for 3 months. Subjective parameters were assessed by a brief questionnaire form based on scoring from 1 to 5, according to the degree of the loss or change for each parameter of malnutrition, appetite, taste and smell developed by us. At the end of the study a statistically significant weight gain was achieved in the patient group receiving MA compared to the placebo group (+3 to +5 kg versus -3.7 to -5.9 kg, p=0.000). Significant improvements were seen in performance status (p=0.000), appetite (p=0.000), malnutrition (p=0.000), loss of taste (p=0.000) and smell qualities (p=0.02) in the MA group compared to the placebo group. In the MA group there was no statistically significant difference related to the weight changes according to the grade of either the acute or late RT effects (p=0.65 and 0.07, respectively). Whereas, in the placebo group a statistically significant additive effect of the acute and late RT effects was detected on weight loss (p=0.008 and 0.007, respectively). We observed no side-effects of MA in a 3-month time follow-up. The use of MA 480 mg/day during RT was effective in reversing anorexia and weight loss in spite of the acute RT effects, and helped most patients to well tolerate specific tumor therapy. Further evaluation of its mechanisms of action on RT-related adverse effects, tumor response relationships, and effect on patient survival are researched.
对于患有晚期癌症且因放疗相关并发症而体重减轻、在放疗期间身体更加虚弱的患者而言,厌食和体重减轻现象的逆转将是一种令人欣慰的缓解。本研究的目的是评估醋酸甲地孕酮(MA)对我们体重减轻的癌症患者进行支持性治疗的可行性,这些患者因放疗±化疗的叠加不良反应而日益出现厌食、嗅觉、味觉和体重减轻的情况,以及MA如何改变放疗反应严重程度对这类患者的叠加作用。1997年6月至1998年10月,100名符合条件的患者参加了一项随机、安慰剂对照的临床试验。在这100名患者中,46名在放疗期间接受MA治疗,4名在放疗结束后接受MA治疗,50名接受3个月的安慰剂治疗。主观参数通过一份简短的问卷形式进行评估,根据我们制定的营养不良、食欲、味觉和嗅觉各参数的丧失或变化程度,从1到5进行评分。在研究结束时,与安慰剂组相比,接受MA治疗的患者组实现了具有统计学意义的体重增加(分别为+3至+5千克与-3.7至-5.9千克,p = 0.000)。与安慰剂组相比,MA组在体能状态(p = 0.000)、食欲(p = 0.000)、营养不良(p = 0.000)、味觉丧失(p = 0.000)和嗅觉质量(p = 0.02)方面有显著改善。在MA组中,根据急性或晚期放疗效应的分级,体重变化没有统计学上的显著差异(分别为p = 0.65和0.07)。然而,在安慰剂组中,检测到急性和晚期放疗效应对体重减轻有统计学上的显著叠加作用(分别为p = 0.008和0.007)。在3个月的随访中,我们未观察到MA有副作用。放疗期间每天使用480毫克MA可有效逆转厌食和体重减轻,尽管存在急性放疗效应,并帮助大多数患者很好地耐受特定的肿瘤治疗。对其对放疗相关不良反应的作用机制、肿瘤反应关系以及对患者生存的影响进行了进一步评估。