Panitumumab in Japanese patients with unresectable colorectal cancer: a post-marketing surveillance study of 3085 patients.
Panitumumab in Japanese patients with unresectable colorectal cancer: a post-marketing surveillance study of 3085 patients.
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DOI：
10.1093/jjco/hyt196
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发表时间：
2014-03
影响因子：
2.4
通讯作者：
Ohtsu A
中科院分区：
文献类型：
--
作者：
Boku N;Sugihara K;Kitagawa Y;Hatake K;Gemma A;Yamazaki N;Muro K;Hamaguchi T;Yoshino T;Yana I;Ueno H;Ohtsu A
帕尼单抗于2010年4月在日本获批用于治疗Kirsten大鼠肉瘤-2病毒癌基因野生型不可切除和复发性结直肠癌。我们进行了一项上市后监测研究，以评估帕尼单抗的安全性和有效性。帕尼单抗在日本上市后，所有接受帕尼单抗治疗的患者均入组。收集基线特征、治疗结果、药物不良反应的发生率和严重程度的数据。共登记了3091名患者。在安全性分析集中（n = 3085），帕尼单抗作为单药治疗（40.7%）或联合治疗（59.4%）给药。中位治疗持续时间为113天（范围：1-559天），451例（14.6%）患者接受帕尼单抗治疗≥10个月。药物不良反应总发生率为84.1%，最常见的药物不良反应为皮肤病（78.4%）。间质性肺病、输液反应、电解质异常和心脏疾病的发生率（所有级别）分别为1.3%（死亡率：0.6%）、1.5%、19.3%和0.2%。接受帕尼单抗单药治疗作为三线或更高治疗的患者的中位生存时间为10.3个月。这项临床实践中的上市后调查证实了帕尼单抗的安全性和有效性。帕尼单抗在不可切除结直肠癌日本患者中的获益/风险平衡仍然有利。
Panitumumab was approved in Japan in April 2010 for the treatment of Kirsten rat sarcoma-2 virus oncogene wild-type unresectable and recurrent colorectal cancer. We conducted a post-marketing surveillance study to evaluate the safety and effectiveness of panitumumab. After panitumumab was commercially available in Japan, all patients to be treated with panitumumab were enrolled. Data on baseline characteristics, treatment outcome, and incidence and severity of adverse drug reactions were collected. In total, 3091 patients were registered. In the safety analysis set (n = 3085), panitumumab was administered as monotherapy (40.7%) or combination therapy (59.4%). The median treatment duration was 113 days (range: 1–559 days), and 451 (14.6%) patients received panitumumab for ≥10 months. The overall incidence rate of adverse drug reactions was 84.1%, and the most common adverse drug reaction was skin disorders (78.4%). The incidence rates (all grades) of interstitial lung disease, infusion reaction, electrolyte abnormalities and cardiac disorders were 1.3% (mortality rate: 0.6%), 1.5, 19.3 and 0.2%, respectively. The median survival time of patients treated with panitumumab monotherapy as the third-line, or later, therapy was 10.3 months. This post-marketing survey in clinical practice confirmed the safety and effectiveness of panitumumab. The benefit/risk balance for panitumumab in Japanese patients with unresectable colorectal cancer remains favorable.
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