Istituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Fondazione IRCCS Istituto Nazionale Tumori, Dipartimento di Oncologia Medica, Via Venezian, 1, 20133, Milan, Italy.
BMC Cancer. 2018 Jan 25;18(1):98. doi: 10.1186/s12885-018-4001-x.
Few data are available regarding the treatment of metastatic colorectal cancer elderly patients with anti-EGFR agents in combination with chemotherapy. FOLFOX plus panitumumab is a standard first-line option for RAS wild-type metastatic colorectal cancer. Slight adjustments in chemo-dosage are commonly applied in clinical practice to elderly patients, but those modified schedules have never been prospectively tested. Clinical definition of elderly (≥70 years old) patients that may deserve a more or less intensive combination therapy is still debated. Several geriatric screening tools have been developed to predict survival and risk of toxicity from treatment. Among those, the G8 screening tool has been tested in cancer patients showing the strongest prognostic value for overall survival, while the CRASH score can stratify patients according to an estimated risk of treatment-related toxicities.
The PANDA study is a prospective, open-label, multicenter, randomized phase II trial of first-line therapy with panitumumab in combination with dose-adjusted FOLFOX or with 5-fluorouracil monotherapy, in previously untreated elderly patients (≥70 years) with RAS and BRAF wild-type unresectable metastatic colorectal cancer. RAS and BRAF analyses are centralized. Geriatric assessment by means of G8 and CRASH score is planned at baseline and G8 will be re-evaluated at disease progression. The primary endpoint is duration of progression-free survival in both arms. Secondary endpoints include prospective evaluation of the prognostic role of G8 score and the correlation of CRASH risk categories with toxicity.
The PANDA study aims at exploring safety and efficacy of panitumumab in combination with FOLFOX or with 5FU/LV in elderly patients affected by RAS and BRAF wild-type metastatic colorectal cancer, to identify the most promising treatment strategy in this setting. Additionally, this is the first trial in which the prognostic role of the G8 score will be prospectively evaluated. Results of this study will drive further experimental developments for one or both combinations.
PANDA is registered at Clinicaltrials.gov : NCT02904031 , July 11, 2016. PANDA is registered at EudraCT-No.: 2015-003888-10, September 3, 2015.
关于抗 EGFR 药物联合化疗治疗转移性结直肠癌老年患者的数据很少。FOLFOX 加 panitumumab 是 RAS 野生型转移性结直肠癌的标准一线治疗选择。在临床实践中，通常会对老年患者进行化疗剂量的轻微调整，但这些修改后的方案从未经过前瞻性测试。对于可能需要更密集或更不密集联合治疗的老年（≥70 岁）患者的临床定义仍存在争议。已经开发了几种老年综合评估工具来预测生存和治疗毒性风险。其中，G8 筛查工具已在癌症患者中进行了测试，显示出对总生存期最强的预后价值，而 CRASH 评分可以根据治疗相关毒性的估计风险对患者进行分层。
PANDA 研究是一项前瞻性、开放标签、多中心、随机 II 期试验，旨在评估 panitumumab 联合剂量调整的 FOLFOX 或 5-氟尿嘧啶单药治疗未经治疗的 RAS 和 BRAF 野生型不可切除转移性结直肠癌老年患者（≥70 岁）的一线治疗。RAS 和 BRAF 分析是集中进行的。计划在基线时进行 G8 老年综合评估，并在疾病进展时重新评估 G8。主要终点是两个治疗组的无进展生存期。次要终点包括前瞻性评估 G8 评分的预后作用以及 CRASH 风险类别与毒性的相关性。
PANDA 研究旨在探索 panitumumab 联合 FOLFOX 或 5FU/LV 治疗 RAS 和 BRAF 野生型转移性结直肠癌老年患者的安全性和有效性，以确定该人群中最有前途的治疗策略。此外，这是第一个前瞻性评估 G8 评分预后作用的试验。该研究的结果将为这两种联合治疗方法中的一种或两种方法的进一步实验开发提供依据。
PANDA 于 2016 年 7 月 11 日在 Clinicaltrials.gov 注册：NCT02904031。PANDA 于 2015 年 9 月 3 日在 EudraCT-No.：2015-003888-10 注册。
