Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey. 实际世界中的指南应用:意大利多机构基础的胰腺导管腺癌辅助和一线治疗的调查。 GARIBALDI调查的主要分析。
Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey.
发表日期:2023 Jan 31
作者:
M Reni, E Giommoni, F Bergamo, M Milella, L Cavanna, M C Di Marco, M Spada, S Cordio, G Aprile, G G Cardellino, E Maiello, I Bernardini, M Ghidini, S Bozzarelli, M Macchini, G Orsi, I De Simone, Er Rulli, L Porcu, V Torri, C Pinto,
来源:
ESMO Open
摘要:
关于肿瘤患者实际治疗管理中遵循科学协会指南的信息缺乏。此项多中心前瞻性调查旨在提高对意大利医学肿瘤协会(AIOM)2017-2018建议的认识,征集了胰腺腺癌的治疗未经过的成年患者。A组接受辅助治疗,B组接受初级化疗,C组有转移性疾病。在2021年3月31日之前收集的患者结果及其随访显示:自2017年7月以来,在44个意大利中心共有923名符合条件的患者中,有833名患者参与了该研究(90%)。其中,中位年龄为69岁(范围36-89岁;24%> 75岁);48%为女性;93%的患者的ECOG(东部合作组织肿瘤学小组)表现评分为0或1;A组:16%,B组:30%;C组:54%;72%北部,13%中部,15%南部。其中,A组指南遵从率为68%(95%置信区间[CI] 59%至76%);53%的患者接受了吉西他滨治疗,15%的患者接受了吉西他滨+卡培他滨治疗;中位CA19.9为29(范围0-7300;15%未报告);中位生存期为36.4个月(95% CI 27.5-47.3个月)。B组指南遵从率为96%(95% CI 92%至98%);55%的患者接受了nab-紫杉醇+吉西他滨治疗,27%的患者接受了FOLFIRINOX治疗,12%的患者接受了吉西他滨治疗,3%的患者参与了临床试验;中位CA19.9为337(范围0-20220;9%未报告);中位生存期为18.1个月(95% CI 15.6-19.9个月)。C组指南遵从率为96%(95% CI 94%至98%);71%的患者接受了nab-紫杉醇+吉西他滨治疗,16%的患者接受了吉西他滨治疗,8%的患者接受了FOLFIRINOX治疗,4%的患者参与了临床试验;76%的患者报道有肝转移,23%的患者报道有肺转移;中位CA19.9值为760(范围0-1374500;9%未报告);中位生存期为10.0个月(95% CI 9.1-11.1个月)。GARIBALDI调查显示了遵循指南的极高比例和与文献相符的生存结果。应增强CA19.9测试;还存在未满足的营养和心理咨询需求。目前在进行加入更新后AIOM指南的遵循评估的招募工作。版权所有© 2023 Elsevier Ltd.,授权转载。
Information about the adherence to scientific societies guidelines in the 'real-world' therapeutic management of oncological patients are lacking. This multicenter, prospective survey was aimed to improve the knowledge relative to 2017-2018 recommendations of the Italian Association of Medical Oncology (AIOM).Treatment-naive adult patients with pancreatic adenocarcinoma were enrolled. Group A received adjuvant therapy, group B received primary chemotherapy, and group C had metastatic disease. The results on patients accrued until 31 October 2019 with a mature follow-up were presented.Since July 2017, 833 eligible patients of 923 (90%) were enrolled in 44 Italian centers. The median age was 69 years (range 36-89 years; 24% >75 years); 48% were female; 93% had Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; group A: 16%, group B: 30%; group C: 54%; 72% Nord, 13% Center, 15% South. In group A, guidelines adherence was 68% [95% confidence interval (CI) 59% to 76%]; 53% of patients received gemcitabine and 15% gemcitabine + capecitabine; median CA19.9 was 29 (range 0-7300; not reported 15%); median survival was 36.4 months (95% CI 27.5-47.3 months). In group B, guidelines adherence was 96% (95% CI 92% to 98%); 55% of patients received nab-paclitaxel + gemcitabine, 27% FOLFIRINOX, 12% gemcitabine, and 3% clinical trial; median CA19.9 was 337 (range 0-20220; not reported 9%); median survival was 18.1 months (95% CI 15.6-19.9 months). In group C, guidelines adherence was 96% (95% CI 94% to 98%); 71% of patients received nab-paclitaxel + gemcitabine, 16% gemcitabine, 8% FOLFIRINOX, and 4% clinical trial; liver and lung metastases were reported in 76% and 23% of patients, respectively; median CA19.9 value was 760 (range 0-1374500; not reported 9%); median survival was 10.0 months (95% CI 9.1-11.1 months).The GARIBALDI survey shows a very high rate of adherence to guidelines and survival outcome in line with the literature. CA19.9 testing should be enhanced; nutritional and psychological counseling represent an unmet need. Enrollment to assess adherence to updated AIOM guidelines is ongoing.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.