AGITG MONARCC: A Randomized Phase 2 Study of Panitumumab Monotherapy and Panitumumab Plus 5-Fluorouracil as First-Line Therapy for Older Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer. A Study by the Australasian Gastro-Intestinal Trials Group (AGITG)

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2024-12-12 DOI:10.1016/j.clcc.2024.11.003

Matthew E. Burge , David Espinoza , Katrin Marie Sjoquist , Derrick Ho Siu , Rebecca Mercieca-Bebber , Lorraine A. Chantrill , Christos Stelios Karapetis , Christopher B. Steer , Sonia Yip , Jeff Cuff , Stephanie Winata , Jeanne Tie , Darshit Arunbhai Thaker , Ratnesh Srivastav , Ehtesham Abdi , Andrew Strickland , Eva Segelov , Alessandra Francesconi , Timothy Price , Rahul Ladwa , Niall C. Tebbutt

{"title":"AGITG MONARCC: A Randomized Phase 2 Study of Panitumumab Monotherapy and Panitumumab Plus 5-Fluorouracil as First-Line Therapy for Older Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer. A Study by the Australasian Gastro-Intestinal Trials Group (AGITG)","authors":"Matthew E. Burge , David Espinoza , Katrin Marie Sjoquist , Derrick Ho Siu , Rebecca Mercieca-Bebber , Lorraine A. Chantrill , Christos Stelios Karapetis , Christopher B. Steer , Sonia Yip , Jeff Cuff , Stephanie Winata , Jeanne Tie , Darshit Arunbhai Thaker , Ratnesh Srivastav , Ehtesham Abdi , Andrew Strickland , Eva Segelov , Alessandra Francesconi , Timothy Price , Rahul Ladwa , Niall C. Tebbutt","doi":"10.1016/j.clcc.2024.11.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Panitumumab (pan) plus chemotherapy is a preferred first-line therapy for unresectable RAS and BRAF wild type metastatic colorectal cancer (mCRC). Older patients may not be suitable for combination regimens. We investigated 2 lower intensity pan-containing regimens.</div></div><div><h3>Methods</h3><div>Prospective, noncomparative, randomized (1:1) phase 2 study of pan alone (Arm A) or pan plus FU (Arm B). Previously untreated mCRC were ≥70 years; RAS/BRAF wild type. Primary endpoint: 6-month progression-free survival (PFS). Secondary endpoints included: overall survival (OS), response rate (RR), feasibility of geriatric assessments and overall treatment utility (OTU)—a composite measure based on radiological response, clinical progress, toxicity and patient-reported treatment worth. Planned sample size was 40 patients per arm.</div></div><div><h3>Results</h3><div>36 patients (Arm A n <em>=</em> 19, Arm B n <em>=</em> 17) were randomized between June 2018 and June 2021. Median age was 79 and 80 years respectively. 6-month PFS 63% (95% CI 38%-80%) arm A 82% (95%CI 55%-94%) Arm B. Median OS 21 months Arm A (95%CI 13-31) 28 (95%CI 14-39) months Arm B. RR 47% and 65% Arms A and B respectively. Baseline comprehensive geriatric assessments were completed in >80% of patients. At week 16, OTU was categorized as good in 92% (Arm A) and 90% (Arm B). No unexpected adverse events were seen.</div></div><div><h3>Conclusions</h3><div>Six-month PFS in both arms was consistent with that achieved with FU/bev, whilst the rate was numerically higher for Arm B. Baseline comprehensive geriatric assessments were feasible and OTU was high. Both treatment arms might be suitable in appropriately selected patients.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 120-128"},"PeriodicalIF":3.3000,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical colorectal cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1533002824001129","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Panitumumab (pan) plus chemotherapy is a preferred first-line therapy for unresectable RAS and BRAF wild type metastatic colorectal cancer (mCRC). Older patients may not be suitable for combination regimens. We investigated 2 lower intensity pan-containing regimens.

Methods

Prospective, noncomparative, randomized (1:1) phase 2 study of pan alone (Arm A) or pan plus FU (Arm B). Previously untreated mCRC were ≥70 years; RAS/BRAF wild type. Primary endpoint: 6-month progression-free survival (PFS). Secondary endpoints included: overall survival (OS), response rate (RR), feasibility of geriatric assessments and overall treatment utility (OTU)—a composite measure based on radiological response, clinical progress, toxicity and patient-reported treatment worth. Planned sample size was 40 patients per arm.

Results

36 patients (Arm A n = 19, Arm B n = 17) were randomized between June 2018 and June 2021. Median age was 79 and 80 years respectively. 6-month PFS 63% (95% CI 38%-80%) arm A 82% (95%CI 55%-94%) Arm B. Median OS 21 months Arm A (95%CI 13-31) 28 (95%CI 14-39) months Arm B. RR 47% and 65% Arms A and B respectively. Baseline comprehensive geriatric assessments were completed in >80% of patients. At week 16, OTU was categorized as good in 92% (Arm A) and 90% (Arm B). No unexpected adverse events were seen.

Conclusions

Six-month PFS in both arms was consistent with that achieved with FU/bev, whilst the rate was numerically higher for Arm B. Baseline comprehensive geriatric assessments were feasible and OTU was high. Both treatment arms might be suitable in appropriately selected patients.

查看原文本刊更多论文

AGITG MONARCC：帕尼单抗单药和帕尼单抗加5-氟尿嘧啶作为RAS和BRAF野生型转移性结直肠癌老年患者一线治疗的随机2期研究澳大利亚胃肠试验组（AGITG）的研究。

背景：帕尼珠单抗（Panitumumab, pan）联合化疗是不可切除的RAS和BRAF野生型转移性结直肠癌（mCRC）的首选一线治疗方法。老年患者可能不适合联合用药。我们研究了2种低强度的泛含方案。方法：前瞻性，非比较，随机（1:1）2期研究，pan单独（A组）或pan加FU （B组）。先前未治疗的mCRC≥70年；RAS/BRAF野生型。主要终点：6个月无进展生存（PFS）。次要终点包括：总生存期（OS）、缓解率（RR）、老年评估的可行性和总治疗效用（OTU）——一种基于放射反应、临床进展、毒性和患者报告的治疗价值的综合指标。计划样本量为每组40例患者。结果：在2018年6月至2021年6月期间，36例患者（A组n = 19， B组n = 17）被随机分组。中位年龄分别为79岁和80岁。6个月PFS 63% (95%CI 38%-80%) A组82% (95%CI 55%-94%) B组中位OS 21个月A组（95%CI 13-31） 28个月（95%CI 14-39） B组RR分别为47%和65% A组和B组。80%的患者完成了基线综合老年评估。在第16周，92% （A组）和90% （B组）的OTU被归类为良好。未见意外不良事件。结论：两个组的6个月PFS与FU/bev组一致，而b组的比率更高。基线综合老年评估是可行的，OTU很高。两种治疗方法可能都适用于适当选择的患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.