ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®.
CSRA
Chemosensitivity
Colorectal cancer
Functional assay
Metastatic
ONCOGRAM
Oncogramme®
Personalized medicine
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
21 Aug 2021
21 Aug 2021
Historique:
received:
10
12
2020
accepted:
09
08
2021
entrez:
22
8
2021
pubmed:
23
8
2021
medline:
25
8
2021
Statut:
epublish
Résumé
Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year survival barely surpassing 11%. Conventional chemotherapies against this disease proved their efficiency and remain essential in first-line treatment. However, the large number of authorized protocols complexifies treatment decision. In common practice, such decision is made on an empirical basis, by assessing benefits and risks for the patient. In other words, there is currently no efficient means of predicting the efficacy of any chemotherapy protocol for metastatic colorectal cancer. The use of a chemosensitivity assay, the Oncogramme®, should help clinicians administer the best chemotherapy regimen to their patients. We hypothesize it would ultimately improve their survival. In this multicentred, prospective trial (ONCOGRAM), eligible patients with metastatic colorectal cancer are randomized to determine whether they will receive an Oncogramme®. For clinicians whose patients benefited from the assay (arm A), results are used as a decision support tool. Patients not undergoing the Oncogramme® procedure are treated according to current practice, without the assistance of the assay (arm B). Primary outcome is 1-year progression-free survival. Secondary outcomes include response rates, as well as 6-month and 1-year survival rates. This study aims at investigating the clinical utility of the Oncogramme® as a decision support tool for the treatment of patients with metastatic colorectal cancer. If the Oncogramme® positively influenced patient overall survival and/or progression-free survival, it would be of great value for clinicians to implement this assay within the current landscape of personalized medicine tools, which include genomics and biomarker assays. ClinicalTrials.gov identifier NCT03133273 . Registered on April 28, 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year survival barely surpassing 11%. Conventional chemotherapies against this disease proved their efficiency and remain essential in first-line treatment. However, the large number of authorized protocols complexifies treatment decision. In common practice, such decision is made on an empirical basis, by assessing benefits and risks for the patient. In other words, there is currently no efficient means of predicting the efficacy of any chemotherapy protocol for metastatic colorectal cancer.
METHODS/DESIGN
METHODS
The use of a chemosensitivity assay, the Oncogramme®, should help clinicians administer the best chemotherapy regimen to their patients. We hypothesize it would ultimately improve their survival. In this multicentred, prospective trial (ONCOGRAM), eligible patients with metastatic colorectal cancer are randomized to determine whether they will receive an Oncogramme®. For clinicians whose patients benefited from the assay (arm A), results are used as a decision support tool. Patients not undergoing the Oncogramme® procedure are treated according to current practice, without the assistance of the assay (arm B). Primary outcome is 1-year progression-free survival. Secondary outcomes include response rates, as well as 6-month and 1-year survival rates.
DISCUSSION
CONCLUSIONS
This study aims at investigating the clinical utility of the Oncogramme® as a decision support tool for the treatment of patients with metastatic colorectal cancer. If the Oncogramme® positively influenced patient overall survival and/or progression-free survival, it would be of great value for clinicians to implement this assay within the current landscape of personalized medicine tools, which include genomics and biomarker assays.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov identifier NCT03133273 . Registered on April 28, 2017.
Identifiants
pubmed: 34419125
doi: 10.1186/s13063-021-05531-y
pii: 10.1186/s13063-021-05531-y
pmc: PMC8379769
doi:
Banques de données
ClinicalTrials.gov
['NCT03133273']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
556Investigateurs
B Marin
(B)
S Bouvier
(S)
S Durand-Fontanier
(S)
A Fabre
(A)
D Valleix
(D)
T Rivaille
(T)
F Fredon
(F)
S Derbal
(S)
P Carrier
(P)
R Daloko Lonfo
(RD)
R Legros
(R)
S Lavau-Denes
(S)
V Lebrun-Ly
(V)
F Thuillier
(F)
P Engel
(P)
A Chaunavel
(A)
M Pradel
(M)
D Pezet
(D)
A Dubois
(A)
C Pétorin
(C)
O Antomarchi
(O)
A Aboukassem
(A)
A Vimal-Baguet
(A)
B Gillet
(B)
B Mathieu
(B)
J Joubert-Zakeyh
(J)
S Evrard
(S)
Y Becouarn
(Y)
D Béchade
(D)
M Fonk
(M)
G Desolneux
(G)
N Dauriat
(N)
M Agbo
(M)
M Louty
(M)
F Borie
(F)
S Lyubimova
(S)
V Phoutthasang
(V)
B Brunaud-Gagniard
(B)
Y Benadjaoud
(Y)
N Rolland
(N)
L Letournoux
(L)
P Roger
(P)
L Chen
(L)
Z Amadou
(Z)
C Christopoulous
(C)
G Nakahl
(G)
Y Souliman
(Y)
M N Cirt
(MN)
D Ducoux
(D)
P A Boisseau
(PA)
P Pardies
(P)
L Mesturoux
(L)
L Vayre
(L)
A Abdeh
(A)
F Teboul
(F)
R Landraud
(R)
M Ouaissi
(M)
E Salamé
(E)
N Tabchouri
(N)
T Lecomte
(T)
G Proutheau
(G)
S Guyetant
(S)
D Tougeron
(D)
A de Singly
(A)
A Ferru
(A)
R El Fadel
(R)
T Courvoisier
(T)
A Junca
(A)
E Frouin
(E)
L Rouleau
(L)
S Rafaert
(S)
A Rocher
(A)
J-M Regimbeau
(JM)
C Sabbagh
(C)
E Dumange
(E)
E Chive
(E)
D Lignier
(D)
N Siembida
(N)
B Chauffert
(B)
V Hautefeuille
(V)
D Chatelain
(D)
E Rivkine
(E)
Informations de copyright
© 2021. The Author(s).
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. https://doi.org/10.3322/caac.21492 .
doi: 10.3322/caac.21492
pubmed: 30207593
Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017;66(4):683–91. https://doi.org/10.1136/gutjnl-2015-310912 .
doi: 10.1136/gutjnl-2015-310912
pubmed: 26818619
Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016;7(3):105–14.
pubmed: 27766137
pmcid: 5069274
Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014;383(9927):1490–502. https://doi.org/10.1016/S0140-6736(13)61649-9 .
doi: 10.1016/S0140-6736(13)61649-9
pubmed: 24225001
Lee JJ, Chu E. An update on treatment advances for the first-line therapy of metastatic colorectal cancer. Cancer J. 2007;13(5):276–81. https://doi.org/10.1097/PPO.0b013e3181570062 .
doi: 10.1097/PPO.0b013e3181570062
pubmed: 17921724
Holch J, Stintzing S, Heinemann V. Treatment of metastatic colorectal cancer: Standard of care and future perspectives. Visc Med. 2016;32(3):178–83. https://doi.org/10.1159/000446052 .
doi: 10.1159/000446052
pubmed: 27493945
pmcid: 4945779
Ikoma N, Raghav K, Chang G. An Update on Randomized Clinical Trials in Metastatic Colorectal Carcinoma. Surg Oncol Clin N Am. 2017;26(4):667–87. https://doi.org/10.1016/j.soc.2017.05.007 .
doi: 10.1016/j.soc.2017.05.007
pubmed: 28923224
pmcid: 5648005
Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017;18(9):1182–91. https://doi.org/10.1016/S1470-2045(17)30422-9 .
doi: 10.1016/S1470-2045(17)30422-9
pubmed: 28734759
pmcid: 6207072
Marcus L, Lemery SJ, Keegan P, Pazdur R. FDA approval summary: Pembrolizumab for the treatment of microsatellite instability-high solid tumors. Clin Cancer Res. 2019;25(13):3753–8. https://doi.org/10.1158/1078-0432.CCR-18-4070 .
doi: 10.1158/1078-0432.CCR-18-4070
pubmed: 30787022
Neugut AI, Lin A, Raab GT, Hillyer GC, Keller D, O’Neil DS, et al. FOLFOX and FOLFIRI Use in Stage IV Colon Cancer: Analysis of SEER-Medicare Data. Clin Colorectal Cancer. 2019;18(2):133–40. https://doi.org/10.1016/j.clcc.2019.01.005 .
doi: 10.1016/j.clcc.2019.01.005
pubmed: 30878317
pmcid: 7379162
Ychou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, et al. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. the METHEP trial. Ann Surg Oncol. 2013. https://doi.org/10.1245/s10434-013-3217-x .
Deyme L, Barbolosi D, Gattacceca F. Population pharmacokinetics of FOLFIRINOX: a review of studies and parameters. Cancer Chemother Pharmacol. 2019;83(1):27–42. https://doi.org/10.1007/s00280-018-3722-5 .
doi: 10.1007/s00280-018-3722-5
pubmed: 30446786
Blom K, Nygren P, Larsson R, Andersson CR. Predictive Value of Ex Vivo Chemosensitivity Assays for Individualized Cancer Chemotherapy: A Meta-Analysis. SLAS Technol. 2017;22(3):306–14. https://doi.org/10.1177/2472630316686297 .
doi: 10.1177/2472630316686297
pubmed: 28378608
Burstein HJ, Mangu PB, Somerfield MR, Schrag D, Samson D, Holt L, et al. American Society of Clinical Oncology clinical practice guideline update on the Use of chemotherapy sensitivity and resistance assays. J Clin Oncol. 2011;29(24):3328–30. https://doi.org/10.1200/JCO.2011.36.0354 .
doi: 10.1200/JCO.2011.36.0354
pubmed: 21788567
Hur H, Kim NK, Kim HG, Min BS, Lee KY, Shin SJ, et al. Adenosine triphosphate-based chemotherapy response assay-guided chemotherapy in unresectable colorectal liver metastasis. Br J Cancer. 2012;106(1):53–60. https://doi.org/10.1038/bjc.2011.469 .
doi: 10.1038/bjc.2011.469
pubmed: 22068817
Cree IA, Kurbacher CM, Lamont A, Hindley AC, Love S, Cree IA, et al. A prospective randomized controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician’s choice in patients with recurrent platinum-resistant ovarian cancer. Anticancer Drugs. 2007;18(9):1093–101. https://doi.org/10.1097/CAD.0b013e3281de727e .
doi: 10.1097/CAD.0b013e3281de727e
pubmed: 17704660
Loum E, Giraud S, Bessette B, Battu S, Mathonnet M, Lautrette C. Oncogramme, a new individualized tumor response testing method: Application to colon cancer. Cytotechnology. 2010;62(5):381–8. https://doi.org/10.1007/s10616-010-9298-5 .
doi: 10.1007/s10616-010-9298-5
pubmed: 20820914
pmcid: 2993861
Giraud S, Loum E, Bessette B, Fermeaux V, Lautrette C. Oncogramme, a new promising method for individualized breast tumour response testing for cancer treatment. Anticancer Res. 2011;31(1):139–45.
pubmed: 21273591
Giraud S. Oncogramme, an Adapted Method for Individualized Tumour Response Testing of Ovary Cancer Treatments. J Cancer Res Ther Oncol. 2014. https://doi.org/10.17303/jcrto.2014.2.303 .
Bounaix Morand du Puch C, Giraud S, Lautrette C, Nouaille M, Labrunie A, Luce S, et al. Chemotherapy outcome predictive effectiveness by the Oncogramme: Pilot trial on stage-IV colorectal cancer. J Transl Med. 2016. https://doi.org/10.1186/s12967-016-0765-4 .
Yoon YS, Kim JC. Recent applications of chemosensitivity tests for colorectal cancer treatment. World J Gastroenterol. 2014;20(44):16398–408. https://doi.org/10.3748/wjg.v20.i44.16398 .
doi: 10.3748/wjg.v20.i44.16398
pubmed: 25469008
pmcid: 4248183
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009. https://doi.org/10.1016/j.ejca.2008.10.026 .
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340(mar23 1):c332. https://doi.org/10.1136/bmj.c332 .
doi: 10.1136/bmj.c332
pubmed: 20332509
pmcid: 20332509
Giraud S, Bounaix Morand du Puch C, Fermeaux V, Guillaudeau A, Lautrette C. Oncogramme responses of breast tumour cells treated with herceptin correlate with HER2/C-ERB B2 pathological status. Anticancer Res. 2012;32:1323–5.
pubmed: 22493365