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Single-agent panitumumab in frail elderly patients with advanced RAS and BRAF wild-type colorectal cancer: Challenging drug label to light up new hope

机译:晚期RAS和BRAF野生型结直肠癌的年老体弱患者单药帕尼单抗:具有挑战性的药物标签点亮新希望

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摘要

Background. No prospective trials have specifically addressed the efficacy and safety of panitumumab in elderly patients with metastatic colorectal cancer (CRC). We aimed at assessing the efficacy and safety of single agent panitumumab in "frail" elderly patients diagnosed with metastatic RAS and BRAFwildtype CRC. Materials and Methods. Forty elderly patients (aged $75 years) with metastatic RAS-BRAF wild-type CRC received off-label prescriptions of single-agent panitumumab at seven Italian institutions. Treatment was administered as first line in patients with absolute contraindication to any chemotherapy or as second-line treatment after failure of a fluoropyrimidine-based treatment, in the presence of contraindication to irinotecan. The outcome measures included objective response rate (ORR), as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety. Results. ThemedianPFS andOSwere6.4 months (95% confidence interval [CI]: 4.9-8 months) and 14.3 months (95% CI: 10.9-17.7 months), respectively. ORR was 32.5%, and DCR was 72.5%. Dose reductions related to adverse events (AEs) were reported in 9 (23%) patients, but no permanent treatment discontinuation caused by was reported. The most frequentgrade 3 AE was skin rash, with an incidence of 20%. Conclusion. Panitumumab is effective and well-tolerated in frail elderly patients with RAS-BRAF wild-type metastatic CRC and deemed unfit for chemotherapy. A randomized study is needed to confirm these data.
机译:背景。尚无前瞻性试验专门针对帕尼单抗在老年转移性结直肠癌(CRC)患者中的疗效和安全性。我们旨在评估单药帕尼单抗在诊断为转移性RAS和BRAF野生型CRC的“脆弱”老年患者中的疗效和安全性。材料和方法。 40例患有转移性RAS-BRAF野生型CRC的老年患者(年龄75岁)在意大利的7家机构接受了单药帕尼单抗的非处方处方。对于有绝对禁忌症的任何化疗患者,以一线治疗或在以氟嘧啶为基础的治疗失败后,以伊立替康为禁忌症的情况下,作为二线治疗。结果指标包括客观缓解率(ORR),无进展生存期(PFS),疾病控制率(DCR),总生存期(OS)和安全性。结果。 ThemedianPFS和OS分别为6.4个月(95%置信区间[CI]:4.9-8个月)和14.3个月(95%CI:10.9-17.7个月)。 ORR为32.5%,DCR为72.5%。据报道,有9名患者(23%)出现了与不良事件(AEs)相关的剂量减少,但未报告因引起的永久治疗中断。最常见的3级AE是皮疹,发生率20%。结论。 Panitumumab在年老的RAS-BRAF野生型转移性CRC衰老患者中有效且耐受良好,被认为不适合化疗。需要进行随机研究以确认这些数据。

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