Vadell C, Seguí M A, Giménez-Arnau J M, Morales S, Cirera L, Bestit I, Batiste E, Blanco R, Jolis L, Boleda M, Antón I
Hospital del Mar, Barcelona, Spain.
Am J Clin Oncol. 1998 Aug;21(4):347-51. doi: 10.1097/00000421-199808000-00006.
Anorexia and cachexia are present in the majority of patients with advanced-stage cancer. Several agents have been tested for their ability to reverse weight loss in these patients. Megestrol acetate has been demonstrated to improve appetite and weight, independent of tumor response, when used in the treatment of metastatic breast cancer. Several trials have studied the ability of megestrol acetate to stimulate weight gain in patients with non-hormone-sensitive tumors. One hundred fifty patients with a weight lost of more than 5% in the 3 previous months were randomized between double-blind megestrol acetate 160 mg daily (LMA), megestrol acetate 480 mg daily (HMA), or placebo (P). Weight, mid-arm circumference, triceps skinfold thickness (TST), performance status (Karnofsky index), and a quality-of-life status by seven linear analogic self-assessment scales were assessed before the start of treatment and at 4, 8, and 12 weeks thereafter. One hundred seven patients were assessable at 4 weeks, 79 at 8 weeks, and 64 at 12 weeks. Sixty-eight percent of patients treated with HMA increased their weights during their permanence on study, versus 37% and 38% of patients treated with P or LMA (p < 0.03). The mean weight gain after 12 weeks of treatment with HMA was 5.41 kg. A significant increase on TST was observed in the HMA group versus the LMA and P groups. There was no gain in performance status or quality of life in any group of treatment. The toxicity registered was mild. There were no thromboembolic events. This trial supports the efficacy of megestrol acetate at 480 mg/day in the treatment of cancer-related cachexia and anorexia, with mild toxicity. However, performance status and quality of life were not influenced by this treatment.
晚期癌症患者大多存在厌食和恶病质。已有多种药物被测试用于逆转这些患者的体重减轻情况。醋酸甲地孕酮用于治疗转移性乳腺癌时，已被证明可改善食欲和体重，且与肿瘤反应无关。多项试验研究了醋酸甲地孕酮促使非激素敏感性肿瘤患者体重增加的能力。150名在过去3个月体重下降超过5%的患者被随机分为三组，分别每日服用160毫克醋酸甲地孕酮（LMA）、每日服用480毫克醋酸甲地孕酮（HMA）或服用安慰剂（P），采用双盲法。在治疗开始前以及之后的第4、8和12周，对体重、上臂中部周长、肱三头肌皮褶厚度（TST）、体能状态（卡诺夫斯基指数）以及通过七个线性模拟自我评估量表得出的生活质量状态进行评估。在第4周有107名患者可进行评估，第8周有79名，第12周有64名。接受HMA治疗的患者中有68%在研究期间体重增加，而接受P或LMA治疗的患者这一比例分别为37%和38%（p < 0.03）。HMA治疗12周后的平均体重增加为5.41千克。与LMA组和P组相比，HMA组的TST有显著增加。任何治疗组的体能状态或生活质量均未提高。记录到的毒性较轻。未发生血栓栓塞事件。该试验支持每日480毫克醋酸甲地孕酮治疗癌症相关性恶病质和厌食的疗效，且毒性较轻。然而，这种治疗对体能状态和生活质量没有影响。
