米托坦辅助治疗肾上腺皮质癌。

Adjuvant mitotane treatment for adrenocortical carcinoma.

作者信息

Terzolo Massimo, Angeli Alberto, Fassnacht Martin, Daffara Fulvia, Tauchmanova Libuse, Conton Pier Antonio, Rossetto Ruth, Buci Lisa, Sperone Paola, Grossrubatscher Erika, Reimondo Giuseppe, Bollito Enrico, Papotti Mauro, Saeger Wolfgang, Hahner Stefanie, Koschker Ann-Cathrin, Arvat Emanuela, Ambrosi Bruno, Loli Paola, Lombardi Gaetano, Mannelli Massimo, Bruzzi Paolo, Mantero Franco, Allolio Bruno, Dogliotti Luigi, Berruti Alfredo

机构信息

Università di Torino, Turin, Italy.

出版信息

N Engl J Med. 2007 Jun 7;356(23):2372-80. doi: 10.1056/NEJMoa063360.

DOI:10.1056/NEJMoa063360

PMID:17554118

Abstract

BACKGROUND

Adrenocortical carcinoma is a rare neoplasm characterized by a high risk of recurrence after radical resection. Whether the use of mitotane is beneficial as an adjuvant treatment has been controversial. Our aim was to evaluate the efficacy of adjuvant mitotane in prolonging recurrence-free survival.

METHODS

We performed a retrospective analysis involving 177 patients with adrenocortical cancer who had undergone radical surgery at 8 centers in Italy and 47 centers in Germany between 1985 and 2005. Adjuvant mitotane was administered to 47 Italian patients after radical surgery (mitotane group), whereas 55 Italian patients and 75 German patients (control groups 1 and 2, respectively) did not receive adjuvant treatment after surgery.

RESULTS

Baseline features in the mitotane group and the control group from Italy were similar; the German patients were significantly older (P=0.03) and had more stage I or II adrenocortical carcinomas (P=0.02) than did patients in the mitotane group. Recurrence-free survival was significantly prolonged in the mitotane group, as compared with the two control groups (median recurrence-free survival, 42 months, as compared with 10 months in control group 1 and 25 months in control group 2). Hazard ratios for recurrence were 2.91 (95% confidence interval [CI], 1.77 to 4.78; P<0.001) and 1.97 (95% CI, 1.21 to 3.20; P=0.005), respectively. Multivariate analysis indicated that mitotane treatment had a significant advantage for recurrence-free survival. Adverse events associated with mitotane were mainly of grade 1 or 2, but temporary dose reduction was needed in 13% of patients.

CONCLUSIONS

Adjuvant mitotane may prolong recurrence-free survival in patients with radically resected adrenocortical carcinoma.

摘要

背景

肾上腺皮质癌是一种罕见肿瘤，其特征为根治性切除术后复发风险高。米托坦作为辅助治疗是否有益一直存在争议。我们的目的是评估辅助使用米托坦在延长无复发生存期方面的疗效。

方法

我们进行了一项回顾性分析，纳入了1985年至2005年间在意大利的8个中心和德国的47个中心接受根治性手术的177例肾上腺皮质癌患者。47例意大利患者在根治性手术后接受了辅助米托坦治疗（米托坦组），而55例意大利患者和75例德国患者（分别为对照组1和对照组2）术后未接受辅助治疗。

结果

米托坦组与意大利对照组的基线特征相似；德国患者比米托坦组患者年龄显著更大（P = 0.03），且I期或II期肾上腺皮质癌更多（P = 0.02）。与两个对照组相比，米托坦组的无复发生存期显著延长（中位无复发生存期，42个月，而对照组1为10个月，对照组2为25个月）。复发的风险比分别为2.91（95%置信区间[CI]，1.77至4.78；P < 0.001）和1.97（95%CI，1.21至3.20；P = 0.005）。多变量分析表明，米托坦治疗在无复发生存期方面具有显著优势。与米托坦相关的不良事件主要为1级或2级，但13%的患者需要暂时降低剂量。