Cancer Centre of Galicia, A Coruña, Spain.
University Hospital Complex of Ourense, Ourense, Spain.
J Geriatr Oncol. 2020 Nov;11(8):1263-1267. doi: 10.1016/j.jgo.2020.06.003. Epub 2020 Jun 21.
Despite the high morbidity and mortality of metastatic colorectal cancer (mCRC) in older patients, they have been underrepresented in clinical trials and their optimal treatment is yet to be determined. This open-label phase II study evaluated the benefits of panitumumab and capecitabine as a first-line chemotherapy regimen in older patients with wild-type [WT] RAS mCRC.
Patients (≥70 years; ECOG≤2) received 3-week cycles of panitumumab (9 mg/kg on day 1) plus capecitabine (850 mg/m twice daily on days 1-14) until disease progression or unacceptable toxicity. Response was evaluated every 9 weeks according to RECIST_1.1. Outcome measures were: objective response rate (ORR), duration of response (DoR), time to response (TTR), progression (TTP) and treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety.
Twenty-seven patients (11 women; median age: 78 years; ECOG: 0 [26%], 1 [67%], 2 [7%]) were evaluated. Median follow-up was 17.7 months. Confirmed ORR (95%CI) was 44.4% (25.7-63.2), with 25.9% of patients achieving at least stable disease. Median (95%CI) DoR was 8.7 (5.5-10.4) months, and median TTR was 2.2 (1.9-2.8) months. Median TTP was 9.6 (4.8-11.5) months, with a median TTF of 5.2 (2.8-7.2) months. The median PFS was 7.5 (4.4-10.4) months, and the median OS was 23.7 (7.4-27.5) months. Seventeen (63%) patients reported panitumumab and/or capecitabine-related adverse events grade 3-4, with skin toxicity (18.5%) being the most common. Two (7.4%) deaths were treatment-related.
This study suggests that panitumumab plus capecitabine is a safe and effective regimen in older patients with WT RAS mCRC.
转移性结直肠癌（mCRC）在老年患者中的发病率和死亡率都很高，但他们在临床试验中的代表性不足，其最佳治疗方法仍有待确定。本开放标签 II 期研究评估了 panitumumab 和卡培他滨作为野生型[WT]RAS mCRC 老年患者一线化疗方案的疗效。
患者（≥70 岁；ECOG≤2）接受 3 周周期的 panitumumab（第 1 天 9mg/kg）加卡培他滨（第 1-14 天每天 2 次，850mg/m），直至疾病进展或不可接受的毒性。根据 RECIST_1.1 每 9 周评估一次反应。主要终点为客观缓解率（ORR）、缓解持续时间（DoR）、反应时间（TTR）、进展（TTP）和治疗失败（TTF）、无进展生存期（PFS）、总生存期（OS）和安全性。
共 27 例患者（11 例女性；中位年龄：78 岁；ECOG：0[26%]、1[67%]、2[7%]）接受了评估。中位随访时间为 17.7 个月。确认的 ORR（95%CI）为 44.4%（25.7-63.2），25.9%的患者至少达到稳定疾病。中位（95%CI）DoR 为 8.7（5.5-10.4）个月，中位 TTR 为 2.2（1.9-2.8）个月。中位 TTP 为 9.6（4.8-11.5）个月，中位 TTF 为 5.2（2.8-7.2）个月。中位 PFS 为 7.5（4.4-10.4）个月，中位 OS 为 23.7（7.4-27.5）个月。17 例（63%）患者报告了 panitumumab 和/或卡培他滨相关的 3-4 级不良事件，其中皮肤毒性（18.5%）最为常见。2 例（7.4%）死亡与治疗相关。
本研究表明，panitumumab 联合卡培他滨在野生型[WT]RAS mCRC 老年患者中是一种安全有效的治疗方案。
