Abstract 317MO
Background
Some studies suggest that older patients have reduced or no benefit from the addition of oxaliplatin to fluoropyrimidines as adjuvant chemotherapy for stage III colon cancer (CC).
Methods
We studied the prognostic impact of age and treatment adherence/toxicity patterns according to age in patients with stage III CC who participated in 12 clinical trials from the ACCENT and IDEA databases and received 3 or 6 months (mo) of FOLFOX/CAPOX. Associations between age and time to recurrence (TTR), disease-free survival (DFS), overall survival (OS), survival after recurrence (SAR) and cancer-specific survival (CSS) were assessed by Cox model or a competing risk model, stratified by studies and adjusted for gender, performance status, T and N stage, and year of enrollment.
Results
17,608 patients were included. The age of 24% of patients was > 70 (N=4,278). Patients >70 were more often included in newer trials (29% in the period 2010-2015 vs 17% for 1998-2003, p<0.0001) and had higher rates of early treatment discontinuation (ETD). The rates of grade ≥3 adverse events were similar between the 2 groups, except for diarrhea for 6-mo CAPOX (18% vs 14%, p=0.03) and neutropenia for 3-mo FOLFOX (24% vs 18%, p=0.08) for patients < and >70 respectively). Comparing patients <70 and >70, TTR, DFS, OS, SAR and CSS were significantly shorter (except for TTR in patients treated with 6-mo regimens) although absolute differences were small (Table1).
Conclusions
In patients >70 with stage III CC enrolled in clinical trials, oxaliplatin-based adjuvant chemotherapy was well tolerated. Outcomes were inferior to those of patients under 70, but still provided clinically relevant benefit. Increased deaths from other causes and less intensive management at relapse may account for some of the differences in OS. Table: 317MO
CAPOX/FOLFOX 6 mo | CAPOX/FOLFOX 3 mo | ||||
≥ 70y | <70y | ≥ 70y | <70y | ||
ETD | 29% | 19% | 12% | 8% | |
p | <0.001 | <0.001 | |||
TTR | 3-year | 77% | 77% | 76% | 78% |
HR | 1.0 | 1.1 | |||
p | 0.4 | 0.04 | |||
DFS | 3-year | 75% | 77% | 76% | 78% |
HR | 1.2 | 1.3 | |||
p | <0.001 | <0.001 | |||
OS | 5-year | 78% | 83% | 79% | 85% |
HR | 1.4 | 1.5 | |||
p | <0.001 | <0.001 | |||
SAR | median (y) | 1.7 | 2.4 | 2.0 | 2.8 |
HR | 1.4 | 1.3 | |||
p | <0.001 | <0.001 | |||
Cancer-specific mortality | 5-year | 14% | 10% | 15% | 11% |
HR | 1.2 | 1.2 | |||
p | 0.02 | 0.04 |
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Gallois: Financial Interests, Institutional, Invited Speaker: Sanofi Genzyme; Financial Interests, Institutional, Advisory Board: Servier. Q. Shi: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc.; Financial Interests, Institutional, Research Grant: Genetech, BMS, Novartis, Johnson & Johnson. 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: Amgen; Financial Interests, Personal, Invited Speaker, Invited speaker in a symposium December 2020: AstraZeneca; Financial Interests, Personal, Advisory Board, and consultant fees and consultant contract: 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: 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 an 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, Expert Testimony, consultant contract: Seagen; Financial Interests, Personal, Invited Speaker, Virtual symposium Lecture: 1 MSI-H CRC: Implementation of Immunotherapy in clinical practice (30 minutes) – (this will be pre-recorded)Q&A – Live Q&A – (10 minutes) (on July 2, 2021): MSD Oncology; Financial Interests, Personal, Invited Speaker, June 2022: Sanofi; Financial Interests, Personal, Expert Testimony, Contract: Merck & Co., Inc, Gritstone Oncologie; Financial Interests, Personal, Advisory Board, Contrat: BMS; Financial Interests, Institutional, Other, Investigator and Scientific Committee President: Gercor Academic group; Financial Interests, Institutional, Invited Speaker, PI Garnet study: GSK; Financial Interests, Institutional, Invited Speaker, Keynote 164 and 171 and 811: 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: Servier; Non-Financial Interests, Invited Speaker, Vice President: Gercor group; Non-Financial Interests, Invited Speaker, Member of Scientific Sommittee: ARCADFoundation. A.F. Sobrero: Financial Interests, Personal, Advisory Board: Servier, BMS, MSD, Incyte; Financial Interests, Personal, Invited Speaker: Bayer, Pierre Fabre, Merck, Amgen, Sanofi; Financial Interests, Personal, Stocks/Shares: Bayer. S. Lonardi: Financial Interests, Personal, Advisory Board: Amgen, Merck Merono, Lilly, Servier, AstraZeneca, MSD, Incyte, Daiichi Sankyo, Bristol-Myers Squibb; Financial Interests, Personal, Invited Speaker: Pierre-Fabre, GlaxoSmithKline; Financial Interests, Institutional, Invited Speaker: Amgen, Merck Serono, Bayer, Roche, Lilly, AstraZeneca, Bristol-Myers Squibb. G. Yothers: Financial Interests, Personal, Other, Data monitoring Committee member for the agent Elflornithine: Orbus Theraputics, Inc.; Financial Interests, Institutional, Other, Deputy Group Statistician: NRG Oncology Foundation; Financial Interests, Personal, Other, Group Statistician: NSABP Foundation; Non-Financial Interests, Other, Executive Committee Member: Olympia Trial; Non-Financial Interests, Other, GI Cancer Steering Committee Member: NCI Cancer Therapy Evaluation Program (CTEP); Non-Financial Interests, Member: ASCO. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai, Merck Biopharma, Bayer, Ono, MSD; Financial Interests, Institutional, Invited Speaker: Ono, Sanofi, Daiichi Sankyo, Chugai, Pfizer; Financial Interests, Institutional, Research Grant: Taiho, MSD, Ono, Amgen, Genomedia, Sysmex, Daiichi Sankyo, Chugai, Boehringer Ingelheim. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Roche, Merck, Servier, Pierre Fabre, Amgen, BMS, Novartis; Financial Interests, Personal, Invited Speaker: Amgen, BMS, Merck, MSD, Novartis, Pierre Fabre, Roche, Servier; 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). D. Papamichael: Financial Interests, Institutional, Advisory Board, Ad Board participation: Merck Serono; Financial Interests, Institutional, Advisory Board: Ipsen; Financial Interests, Institutional, Invited Speaker: Ipsen, Amgen; Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Advisory Role, IDMC member in one of their clinical trials: Servier; Non-Financial Interests, Advisory Role, Member of the Editorial Board: European Journal Of Surgery; Non-Financial Interests, Invited Speaker: Cyprus Cancer Research Institute; Non-Financial Interests, Advisory Role, Member of the Scientific Committee: European School of Oncology; Non-Financial Interests, Member, National Representatives Committee: SIOG - International Society of Geriatric Oncology. All other authors have declared no conflicts of interest.
Resources from the same session
LBA26 - BREAKWATER safety lead-in (SLI): Encorafenib (E) + cetuximab (C) + chemotherapy (chemo) for BRAFV600E metastatic colorectal cancer (mCRC)
Presenter: Josep Tabernero
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
LBA27 - Additional analyses of MOUNTAINEER: A phase II study of tucatinib and trastuzumab for HER2-positive mCRC
Presenter: John Strickler
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
Invited Discussant LBA26 and LBA27
Presenter: Per Pfeiffer
Session: Mini Oral session: GI, lower digestive
Resources:
Slides
Webcast
318MO - Circulating tumour DNA (ctDNA) dynamics, CEA and sites of recurrence for the randomised DYNAMIC study: Adjuvant chemotherapy (ACT) guided by ctDNA analysis in stage II colon cancer (CC)
Presenter: Jeanne Tie
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
319MO - Real-world monitoring of circulating tumor DNA reliably predicts cancer recurrence in patients with resected stages I-III colorectal cancer
Presenter: Stacey Cohen
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
Invited Discussant 317MO, 318MO and 319MO
Presenter: Clara Montagut Viladot
Session: Mini Oral session: GI, lower digestive
Resources:
Slides
Webcast
320MO - A phase I clinical trial of regorafenib, ipilimumab, and nivolumab (RIN) in chemotherapy resistant MSS metastatic colorectal cancer (mCRC)
Presenter: Marwan Fakih
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
LBA28 - Prognostic effect of imaging and CEA follow-up in resected colorectal cancer (CRC): Final results and relapse free survival (RFS) - PRODIGE 13 a FFCD phase III trial
Presenter: Come Lepage
Session: Mini Oral session: GI, lower digestive
Resources:
Abstract
Slides
Webcast
Invited Discussant 320MO and LBA28
Presenter: Pia Osterlund
Session: Mini Oral session: GI, lower digestive
Resources:
Slides
Webcast