Afinitor获准用于治疗部分晚期乳腺癌患者

圣路易斯(MD Consult)——2012年7月20日，美国食品药品管理局(FDA)与诺华公司宣布Afinitor(依维莫司)片获准用于治疗患激素受体阳性(HR+)、HER2阴性的晚期乳腺癌的绝经后女性。该药适合在来曲唑或阿那曲唑治疗失败后与依西美坦联用。

FDA批准Afinitor的这项适应证是基于一项随机、双盲、设安慰剂对照的多中心试验的结果。该研究纳入了724例患晚期HR+乳腺癌且在来曲唑或阿那曲唑治疗后复发或进展的绝经后女性患者。结果显示，Afinitor治疗组中位无进展生存期(PFS)为7.8个月，而依西美坦单药治疗组为3.2个月。独立的放射学审查委员会的进一步分析显示，接受Afinitor+依西美坦治疗的患者中位PFS为11.0个月，而依西美坦单药治疗组患者为4.1个月。

最常见的不良反应为胃炎、感染、皮疹、疲乏、腹泻及食欲下降。年龄≥65岁的患者接受这项治疗发生严重不良反应的几率高于较年轻的患者，故对前者应进行密切监测。

Afinitor已在逾80个国家获准用于治疗晚期肾细胞癌及转移性或不可切除的进展性胰腺神经内分泌肿瘤，其中包括美国和所有欧盟成员国。

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ST LOUIS (MD Consult) - On July 20, 2012, the US Food and Drug Administration (FDA) and Novartis announced the approval of Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive (HR+), HER2-negative breast cancer. The drug is intended for use in combination with exemestane and after failure of treatment with letrozole or anastrozole.

The approval of Afinitor for this indication was granted on the basis of results from a randomized, double-blind, placebo-controlled, multicenter trial. The study included 724 postmenopausal women with advanced HR+ breast cancer who had experienced recurrence or progression after therapy with letrozole or anastrozole. Median progression-free survival (PFS) for patients in the Afinitor arm was 7.8 months, compared with 3.2 months in patients treated with exemestane alone. An additional analysis by an independent central radiology review showed that patients treated with Afinitor plus exemestane experienced a median PFS of 11.0 months compared with 4.1 months for patients treated with exemestane alone.

The most common adverse reactions were stomatitis, infections, rash, fatigue, diarrhea, and decreased appetite.

Patients aged 65 years and older should be monitored closely because these patients experience a higher rate of serious adverse effects than younger patients receiving the treatment.

Afinitor is approved in more than 80 countries including the United States and throughout the European Union in the oncology settings of advanced renal cell carcinoma and for metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin.