Rowland K M, Loprinzi C L, Shaw E G, Maksymiuk A W, Kuross S A, Jung S H, Kugler J W, Tschetter L K, Ghosh C, Schaefer P L, Owen D, Washburn J H, Webb T A, Mailliard J A, Jett J R
Mayo Clinic, Rochester, MN 55905, USA.
J Clin Oncol. 1996 Jan;14(1):135-41. doi: 10.1200/JCO.1996.14.1.135.
Megestrol acetate has been reported to improve appetite and quality of life and to decrease nausea and vomiting in patients with cancer anorexia/cachexia. The present trial was formulated to evaluate the impact of megestrol acetate on quality of life, toxicity, response, and survival in individuals with extensive-stage small-cell lung cancer who received concomitant chemotherapy.
Patients were randomized to receive megestrol acetate 800 mg/d orally or placebo. In addition, all patients were scheduled to receive a maximum of four cycles of cisplatin and etoposide chemotherapy. Quality of life was self-assessed at entry onto study, with every cycle of chemotherapy, and 4 months thereafter with a linear visual analog scale. Toxicity was evaluated by patient questionnaire and investigator reports.
A total of 243 eligible patients were randomized. Those who received megestrol acetate had increased nonfluid weight gain (P = .004) and significantly less nausea (P = .0002) and vomiting (P = .02). Significant thromboembolic phenomena occurred more often in patients who received megestrol acetate versus placebo (9% v 2%, P = .01). Patients who received megestrol acetate had more edema (30% v 20%, P = .002), an inferior response rate to chemotherapy (68% v 80%, P = .03), and a trend for inferior survival duration (median, 8.2 v 10.0 months, P = .49). These findings may have been influenced by a poorer quality of life of the megestrol acetate group at study initiation. There were no significant changes in quality of life scores over time between either of the study arms.
Megestrol acetate cannot be routinely recommended for all patients with small-cell lung cancer at the time of chemotherapy initiation. Rather, its therapeutic ratio may be more favorable for patients with problematic cancer anorexia/cachexia.
据报道，醋酸甲地孕酮可改善癌症厌食/恶病质患者的食欲和生活质量，并减少恶心和呕吐。本试验旨在评估醋酸甲地孕酮对接受同步化疗的广泛期小细胞肺癌患者的生活质量、毒性、反应和生存的影响。
患者被随机分为口服醋酸甲地孕酮800mg/d或安慰剂组。此外，所有患者计划接受最多四个周期的顺铂和依托泊苷化疗。在进入研究时、每个化疗周期以及此后4个月，使用线性视觉模拟量表进行生活质量的自我评估。通过患者问卷和研究者报告评估毒性。
共有243例符合条件的患者被随机分组。接受醋酸甲地孕酮治疗的患者非液体体重增加更多（P = 0.004），恶心（P = 0.0002）和呕吐（P = 0.02）明显减少。与安慰剂组相比，接受醋酸甲地孕酮治疗的患者发生显著血栓栓塞现象的频率更高（9%对2%，P = 0.01）。接受醋酸甲地孕酮治疗的患者水肿更多（30%对20%，P = 0.002），化疗缓解率较低（68%对80%，P = 0.03），生存持续时间有较差趋势（中位数，8.2对10.0个月，P = 0.49）。这些结果可能受到研究开始时醋酸甲地孕酮组较差生活质量的影响。两个研究组之间生活质量评分随时间均无显著变化。
在化疗开始时，不能常规推荐所有小细胞肺癌患者使用醋酸甲地孕酮。相反，对于有严重癌症厌食/恶病质问题的患者，其治疗效益比可能更有利。
