Abstract 24P
Background
Despite contributions provided by recent clinical trials, several issues and challenges remain unsolved in the adjuvant setting of colon cancer (CC). Future studies should therefore be better planned to refine risk assessment as well as to establish the optimal treatment strategy in the adjuvant setting. However, it is necessary to request adequate, contemporary and relevant variables and report them homogeneously in order to obtain maximal information when analyzing their prognostic value.
Methods
The project was devised to gain a consensus from experts engaged in the planning, accrual and analyses of stage II and III CC clinical trials, to identify mandatory and recommended baseline variables in order to i) harmonize future data collection worldwide in clinical trials dedicated to adjuvant treatment of CC; ii) propose guidance for Case Report Forms to be used for clinical trials in this setting. The expert panelists considered a total of 72 questions on what variables should be reported in adjuvant clinical trials, and in what format. Afterwards panelists voted to reach a final consensus.
Results
Variables on patient-related factors, histopathological features, molecular profile, circulating biomarkers and blood analyses were analyzed and discussed by the whole expert panel. For each variable, we report data supporting the acquired consensus and the relevant issues that were discussed. Twenty-one variables were deemed to be mandatory for resected stage III patients and 24 for resected stage II disease. In addition, 7 and 4 variables were judged as recommended for stage III and II, respectively.
Conclusions
Here we describe 28 variables which should be collected and uniformly reported in more comprehensive CRFs as research groups design future clinical trials in the field of adjuvant colon cancer.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
J. Seligmann: Financial Interests, Personal, Other, Travel: Bristol Myers Squibb; Financial Interests, Personal, Other, CME activities: GI Connect; Financial Interests, Personal, Invited Speaker: Merck Serono, Pierre Fabre, Servier, tacked, GSK; Financial Interests, Personal, Advisory Board: Pierre Fabre, Ventana, Zentalis, AstraZeneca, Elevate Oncology, Merck Serono, Takeda, GSK, Sanofi; Financial Interests, Institutional, Other, Research Funding: Pierre Fabre Medicament; Financial Interests, Personal, Other, REview of guidelines, consultancy: Roche Diagnostics; Financial Interests, Personal, Expert Testimony: Seagan; Financial Interests, Personal, Other, travel: Servier. T. André: Financial Interests, Personal, Advisory Board, Advisory Board on February 12, 2021: Astellas pharma; Financial Interests, Personal, Advisory Board, Advisory Board on February 2021: Kaleido Biosciences; Financial Interests, Personal, Invited Speaker, and advisory board 2021: Amgen; Financial Interests, Personal, Invited Speaker in a symposuim December 2020: AstraZeneca; Financial Interests, Personal, Advisory Board, and consultant fees and consultant contract 2021 and 2022: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board, Advisory board in January 2020: Clovis; Financial Interests, Personal, Advisory Board, Advisory board in January 2020: Gritstone Oncology; Financial Interests, Personal, Advisory Board, Advisory board 2020: HalioDX; Financial Interests, Personal, Advisory Board, and consultant fees/consultant contract and invited speaker: MSD Oncology; Financial Interests, Personal, Invited Speaker, and other: Pierre Fabre; Financial Interests, Personal, Invited Speaker, in an symposium in 2020: Roche; Financial Interests, Personal, Invited Speaker, in a meeting in 2019: Ventana; Financial Interests, Personal, Invited Speaker, In an educational meeting in 2019: Sanofi; Financial Interests, Personal, Advisory Board, in a symposium in 2020: Servier; Financial Interests, Personal, Expert Testimony, Consultant with personal fees and invited speaker: Servier; Financial Interests, Personal, Advisory Board, in 2019: GSK; Financial Interests, Personal, Invited Speaker, in 2020 and 2021: GSK; Financial Interests, Personal, Invited Speaker, Virtual symposium, Lecture 1, MSI-H CRC: Implementation of Immunotherapy in clinical practice (on July 2, 2021): MSD Oncology; Financial Interests, Personal, Invited Speaker, June 2022: Sanofi; Financial Interests, Personal, Advisory Board, Contract 2021, 2022, 2023: Merck & Co., Inc; Financial Interests, Personal, Advisory Board, Contract 2019, 2020, 2021, 2022: BMS; Financial Interests, Personal, Advisory Board, Contract 2021: Gritstone Oncologie; Financial Interests, Personal, Invited Speaker, June 2022 and June 2023 during ESMO GI meeting: Seagen; Financial Interests, Personal, Invited Speaker, Contract of consulting 2021 and 2022 and 2023: MSD Oncology; Financial Interests, Personal, Advisory Board, September 2022: GSK, Seagen; Financial Interests, Personal, Invited Speaker, Contract of consulting 2022 and 2023: GSK; Financial Interests, Personal, Invited Speaker, Contract of consulting 2022: Nordic Pharma; Financial Interests, Personal, Invited Speaker, October 2022: Merck Serono; Financial Interests, Personal, Other, Educational in 2022: Roche; Financial Interests, Personal, Other, Contract of consulting 2020, 2021, 2022,2023: Servier; Financial Interests, Personal, Advisory Board, Gilead Sciences Global GI Advisory Board on January 18, 2023: Aptitude Health, Gilead; Financial Interests, Personal, Other, Consultant like member of the SGNTUC-029 Steering Committee (the “Steering Committee”) Services related to the Company’s Study titled “An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer” (collectively, the “Services”).Including teleconferences and board preparation before the board (6h)Participation of the Board on September 2022 in Paris, September 10, 2022 MOUNTAINEER-03 Steering Committee Meeting during ESMO: Seagen; Financial Interests, Personal, Other, Consultant like member of the Colorectal Program Scientific Advisory Committee (SAC). In charges for reviewing V940 Pembro on Engagezone (as per your contract in ref) and also an interview about Pembrolizumab for MSI/dMMR Metastatic colo-rectal 2023: MSD Oncology; Financial Interests, Personal, Advisory Board, but also formation for the Takeda team, and consultant for Takeda Contract between 1 sept 2023 and 15 October 2024: Takeda; Financial Interests, Personal, Advisory Board, Board Meeting (October 19, 2023): AbbVie; Financial Interests, Personal, Invited Speaker, Emerging Role of Biomarkers in Gastrointestinal Cancers Webcast Engagement reference: Webinar: MSD; Financial Interests, Personal, Invited Speaker, Preparation and presentation at the Seagen ESMO GI 2023 Scientific Exchange HER2 as an emerging target for the treatment of mCRC in the context MOUNTAINEER03: Seagen; Financial Interests, Personal, Advisory Board, Fruquitinib: Takeda; Financial Interests, Personal, Invited Speaker, Oral speaker in a Symposium 2 and 3 February 2024, GI cancer MSI: MSD; Financial Interests, Personal, Invited Speaker, Management of CRC: Aptitude Health; Financial Interests, Personal, Invited Speaker, symposium JFHOD GI CancerPARIS15 03-2024: Servier; Financial Interests, Institutional, Invited Speaker, PI Garnet study: GSK; Financial Interests, Institutional, Invited Speaker, Keynote 164 and 171 and 811 and C08: MSD; Financial Interests, Institutional, Invited Speaker, BMS CA209-8HW, BMS CA209-142, BMS CA209-577: BMS; Financial Interests, Institutional, Invited Speaker, SPOTLIGHT study: Astellas; Financial Interests, Personal, Invited Speaker, and international PI (trial chair Solstice study): Servier; Financial Interests, Personal, Invited Speaker, MOUNTAINEER and MOUNTAINEER-03 study (PI for France) 2022, 2023: Seagen; Financial Interests, Institutional, Invited Speaker, A randomized, open-label, phase 2 study of botensilimab (agen1181) as monotherapy and in combination with balstilimab (agen2034) or investigator’s choice standard of care (regorafenib or trifluridine and tipiracil) for the treatment of refractory metastatic colorectal cancer: Agenus; Financial Interests, Institutional, Invited Speaker, Study with traztuzumab derxtecan in mCRC C study: Daiichi; Non-Financial Interests, Member of Board of Directors, Investigator: Gercor Group; Non-Financial Interests, Member of Board of Directors, President since October 2022: ARCAD Foundation; Other, DMC Meeting by Teleconference on November 7, 2023 5member of steering committee of A randomized Phase 2 Study of ompenaclid versus placebo in combination with FOLFIRI plus bevacizumab in patients with previously treated RAS mutant advanced or metastatic colorectal cancer (RGX-202-002): Inspira. C. Gallois: Financial Interests, Institutional, Invited Speaker: Sanofi Genzyme; Financial Interests, Institutional, Advisory Board: Servier, Pierre Fabre, Merck; Financial Interests, Institutional, Other, French congress invitation: MSD; Financial Interests, Institutional, Other, Congress invitation: Amgen. R.M. Goldberg: Financial Interests, Personal, Other, DMC: AstraZeneca, Bayer, Inspirna, Sorrento; Financial Interests, Personal, Advisory Board, new drug development advice: Compass Therapeutics; Financial Interests, Personal, Other, New drug development advice: AbbVie; Financial Interests, Personal, Expert Testimony, expert witness in patent law trial: Taiho; Financial Interests, Personal, Advisory Board, Device development advice: Focal Medical; Financial Interests, Personal, Other, DMS: IQVIA; Financial Interests, Personal, Other, Drug development advice: Eisai, Innovative Cellular Therapeutics, Merck, Modulation Therapeutics, Takeda; Financial Interests, Personal, Advisory Board, drug development advice: GSK; Financial Interests, Personal, Advisory Board, genetic testing advice: Haystack Oncology; Financial Interests, Personal, Other, DMC and drug development advice: G1 Therapeutics; Financial Interests, Personal, Stocks/Shares, stock options: Compass Therapeutics, Focus Medical, Haystack Oncology; Non-Financial Interests, Other, Board member of an advocacy group: Fight Colorectal Cancer; Non-Financial Interests, Leadership Role, Associate Group Chair, NCI funded cooperative oncology group: Alliance for Clinical Trials in Oncology. A. Sobrero: Financial Interests, Personal, Invited Speaker: Servier, Bayer, Amgen, Pierre Fabre; Financial Interests, Personal, Advisory Board: BMS, MSD, Hutchmed, Astellas; Financial Interests, Personal, Stocks/Shares: Amgen. I. Souglakos: Financial Interests, Institutional, Invited Speaker: Amgen, Servier, Roche; Financial Interests, Institutional, Advisory Board: Takeda, BMS, MSD, AstraZeneca; Financial Interests, Institutional, Research Grant: Servier. D. Arnold: Financial Interests, Personal, Invited Speaker: AstraZeneca, Sanofi (Genzyme), Boston Scientific, Amgen, Merck (Serono), Servier, Ipsen, Boehringer Ingelheim, Eisai, GSK, Viatris, Amgen, Sirtex, PeerMD (China); Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Pierre Fabre Pharma, Boston Scientific, AstraZeneca, Gilead, Janssen Cilag; Financial Interests, Personal, Advisory Board, Advisory Board participations and Invited Speaker roles: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Advisory Board participation and Invited Speaker role: Terumo, Seagen, Amgen, Takeda; Financial Interests, Personal, Invited Speaker, CME Provider: PRMA Consulting, Tactics MD LLC, WebMD Health Corp, From Research to Practice, Aptitude Health, art tempi media, Imedex, streamitup Germany, Clinical Care Options (CCO), MCI, iOMEDICO (Germany); Financial Interests, Personal, Advisory Board, Consulting Agency: CRA International; Financial Interests, Personal, Advisory Board, CME Provider, App Producer: Onkowissen; Financial Interests, Personal, Other, Roles as Assoc. Editor for ESMO Open and Ann Oncol: Elsevier; Financial Interests, Personal, Other, Role as Associate Editor Clin Colorect Cancer: Elsevier; Financial Interests, Institutional, Other, DSMB chair: Sanofi (Genzyme); Financial Interests, Institutional, Invited Speaker: OncoLytics; Financial Interests, Institutional, Funding, Educational Grant: AbbVie; Non-Financial Interests, Project Lead, non-compensated Scientific Advisory Board member: OncoLytics; Non-Financial Interests, Advisory Role, non-compensated Scientific Advisory Board member: Phanes Therapeutics Inc.; Non-Financial Interests, Leadership Role, GI Group Steering Committee: EORTC; Non-Financial Interests, Leadership Role, Steering Committee Member: AIO (German Cancer Society); Non-Financial Interests, Member: ASCO, ESO, DGHO. S. Gill: Financial Interests, Personal, Advisory Board: Roche Canada, Eisai, Taiho Canada, Merck Canada, Pfizer, Bristol Myers Squibb, Ipsen Canada, AstraZeneca, Takeda; Non-Financial Interests, Leadership Role, President: Canadian association of medical oncologists; Non-Financial Interests, Project Lead, Chair, GI Disease Site Committee: Canadian Clinical Trials Group. P. Laurent-Puig: Financial Interests, Personal, Invited Speaker: Amgen, Sanofi; Financial Interests, Personal, Advisory Board: Biocartis, Pierre Fabre; Financial Interests, Personal, Ownership Interest: Methys DX; Financial Interests, Institutional, Research Grant, PI of translational research: Federation Francophone de Cancerologie Digestive; Non-Financial Interests, Leadership Role: President of Canceropole Ile de France. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co., Ltd.; Financial Interests, Personal, Other, Consultancy: Sumitomo Corp.; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical Co., Ltd., Sanofi K.K., MSD K.K., Taiho Pharmaceutical Co., Ltd., Molecular Health GmbH, Amgen K.K., Pfizer Japan Inc., Genomedia Inc., Sysmex Corp., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., Roche Diagnostics K.K., Falco Biosystems Ltd., Merus N.V., Bristol Myers Squibb K.K., Medical & Biological Laboratories Co., LTD., Takeda Pharmaceutical Co., Ltd. S. Lonardi: Financial Interests, Personal, Advisory Board: Amgen, Merck Serono, Lilly, Servier, AstraZeneca, MSD, Incyte, Daiichi Sankyo, Bristol Myers Squibb, Astellas, GSK, Takeda, Bayer; Financial Interests, Personal, Invited Speaker: Pierre Fabre, GSK, Roche, Servier, Amgen, Bristol Myers Squibb, Incyte, Lilly, Merck Serono, MSD; Financial Interests, Institutional, Invited Speaker: Amgen, Merck Serono, Bayer, Roche, Lilly, AstraZeneca, Bristol Myers Squibb; Non-Financial Interests, Member of Board of Directors, Italian No-Profit Oncology Research Foundation supporting academic Clinical trials: GONO Foundation. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Merck, Servier, Pierre Fabre, Amgen, BMS, Novartis, Pfizer, Sanofi, Rottapharm, Takeda; Financial Interests, Personal, Expert Testimony: Astellas, Takeda; Financial Interests, Personal, Invited Speaker: Amgen, BMS, Merck, MSD, Novartis; Financial Interests, Personal, Invited Speaker, symposia: Astellas; Financial Interests, Personal, Other, steering committee of clinical trial: Novartis; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the prodige intergroup: Federation Francophone de Cancerologie Digestive (FFCD); Non-Financial Interests, Other, steering committee of clinical trials: Pfizer, Servier. All other authors have declared no conflicts of interest.