IMMUNOSCORE® and COVID-19 Colon Cancer Guidelines

IMMUNOSCORE® and COVID-19 Colon Cancer Guidelines

Find in this page an in-depth analysis of latest COVID-19 recommendations in colorectal cancer published worldwide.

Read how precision medicine with tools such as Immunoscore® can be useful in improving patient triage without impacting their clinical outcomes.

Click on the image below to register now for downloading our Factsheet Immunoscore® & COVID-19 Colon Cancer Guidelines

Expert Perspective

The latest Expert Perspective, published by the Video Journal of Biomedicine, brings together the authors of two recent publications in the journal Colorectal Cancer, who provide valuable insights into the multidisciplinary approaches to colorectal cancer management that are needed in the COVID-19 era.

The authors, Dr Matías Chacón, Dr Juan Manuel O’Connor (both Instituto Alexander Fleming, Buenos Aires, Argentina) and Dr Benjamin Weinberg (Georgetown University, DC, USA), discuss their articles and recount their own personal experiences using precision medicine tools for making treatment sequencing decisions for their patients with colorectal cancer.

Click on the image to see the video

In response to the COVID-19 pandemic, the major international cancer societies and national health authorities have issued a flurry of guidelines for the management of cancer patients. In addition to stressing reinforced hygiene practices and particular ethical considerations, these guidelines recommend reducing exposure of cancer patients to the SARS-Cov-2 virus by reprioritising treatments on the basis of urgency and likelihood of recovery and thereby optimise hospital resources.

Organisation

Date first issued

American College of Surgeons313 March 2020
NCCN618 March 2020
NHS423 March 2020
Official French guidelines525 March 2020
ESMO29 April 2020
ASCO128 April 2020

Although a number of specific guidelines for colorectal cancer (CRC) management in the current context have been published, for example, the ACS 7 and the NCCN 8 these do not cover patient triage using biomarkers in detail. However, the following guidelines include precision medicine in CRC with tumour immune response testing in order to best identify patients likely to respond to treatment and to optimise treatment schedules, and thus minimise hospital visits:

ESMO9

Chemotherapy in early stage (II, III) colon cancer 9

  • Test for MSI – especially for stage II patients for treatment decisions
  • Based on the IDEA trial recommendation, assess whether 3 months of adjuvant treatment will be non-inferior to 6 months of treatment (patient risk and clinical conditions-adapted strategy)

Expert oncology group (Emil Lou, et al.)10

These recommendations were issued by experts from 10 centres across the USA, offering practice tips in gastro-intestinal oncology to minimise patient risk:10

  • Consider delaying or not proceeding with risk-reducing adjuvant chemotherapy for patients with resected high-risk stage II colon carcinomas
  • Consider the same for patients at high risk of COVID-19 infection with resected stage III colon carcinomas versus shortening the duration (3 versus 6 months) and/or instituting oral chemotherapy as alternate tactics for adjuvant treatment approaches

Ruesch Center, Georgetown University (John Marshall, et al.)11

This reference centre for gastro-intestinal cancer, in collaboration with the Colorectal Cancer Alliance has issued comprehensive CRC management guidelines for the COVID-19 era, recommending precision medicine with immune response biomarkers as pragmatic solutions for optimising treatment:11

  • Consider ctDNA for adjuvant decision making. Similarly, Immunoscore® quantifies immune cell infiltration in resected colorectal cancer and if a patient had a high-risk stage II colorectal cancer but with high Immunoscore®, adjuvant chemotherapy has a lower likelihood of benefit and should be avoided

Although it has not yet been validated in a robust clinical trial, circulating tumour DNA (ctDNA) has been shown to be effective in identifying those early stage CRC patients who are likely to relapse.12A positive tumour DNA test should thus compel the initiation of chemotherapy, even during the pandemic.11Conversely, Immunoscore® is effective in identifying early-stage colon patients for whom 3 months of adjuvant treatment will be as effective (non-inferior) as 6 months of treatment,  and has been validated in major clinical study.13

Fleming Institute of Oncology, Argentina(Juan Manuel O’Connor, et AL.21

This is an independent paper published by one of the most renown LATAM cancer centers, located in Argentina.

They are experienced with Immunoscore®. They requested the test for covid period and regarding the ability of the test in chemotherapy descalation and triage, they consider that Immunoscore® helps achieve the official guidelines’ objectives for covid. The paper is written in the same journal where a previous American paper was published about precision medicine tools including IS® and covid times requirements.

Patient risk assessment and prognosis can be sharpened by using biomarkers: Colorectal Cancer: Proposed Treatment Guidelines for the COVID-19 Era 14
•    Testing microsatellite status9
•    Using ctDNA analysis in early-stage CRC to guide treatment escalation12
•    Assessing the Immunoscore® in stage III colon cancer to guide treatment de-escalation13

Prognosis for patients with resectable colon cancer has traditionally depended on histological sample examination, but the advent of individualised precision medicine and particularly, digitised analysis of biomarkers offers a new paradigm in the management of CRC.15Indeed, the World Health Organization (WHO) in the latest edition of Digestive System Tumours (5th edition) has introduced immune response as an essential and desirable diagnostic criteria for colorectal cancer in addition to traditional histological parameters.16 This inclusion as a gold standard by this international authority is a recognition of the value of precision medicine in the management of colorectal cancers.

Immunoscore®

Immunoscore® is an in vitro diagnostic assay to assess the risk of relapse in colon cancer patients, and, used in conjunction with TNM staging, it helps to guide treatment strategies.17 Immunoscore® assesses immune response at the site of the tumour using a digital pathology-based methodology involving measurement of CD3+ and CD8+ T-lymphocytes in defined regions of the tumour. An “immunoscore” is then generated, which is strongly correlated with the patient’s risk of recurrence.17

Immunoscore® – Improving risk assessment for better patient management.17


Validated for prognosis in stage II and III colon cancer

The ability of Immunoscore® to identify which patients are most likely to experience a recurrence has been shown to be reproducible, reliable and robust.18 In the large SITC-led study involving more than 3,000 stage I-III colon cancer patients, Immunoscore® was strongly predictive of patient outcomes, and to a greater degree than established indicators such as TNM classification or microsatellite instability (MSI).18  These findings have been confirmed in two prospective-retrospective studies of over 1,500 stage III colon cancer patients.13,19

Immunoscore® – Independent and stronger ability to predict survival than MSI.18, 19


Validated for treatment adjustment

In addition to more accurate prognostication, Immunoscore® has been demonstrated to be a predictive factor for facilitating treatment adjustment. In high-risk stage II colon cancer patients, Immunoscore® identified patients for whom adjuvant treatment could be avoided.20 This was shown in a sub-group analysis of the SITC study data of stage II patients (n = 1,130).20
Immunoscore® has also been demonstrated to be a predictive factor for identifying stage III patients who benefit from longer FOLFOX treatment. In an analysis of the prospective IDEA French cohort data (n = 1,322), comparing 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy in stage III colon cancer patients, Immunoscore® identified those patients who benefitted from a longer duration of treatment.13

Facilitating a 70% reduction in adjuvant chemotherapy in high-risk stage II patients, and around a 50% reduction from 6 to 3 months of FOLFOX therapy in patients with stage III colon cancer.13,20

Immunoscore® – Identifying patients eligible for chemotherapy de-escalation.13

Precision medicine with Immunoscore® allows documentation of:
•    Risk assessment profiling of stage II patients18
•    Optimisation of treatment duration in stage III patients13

 

Individualised precision medicine in early-stage colon cancer facilitates putting the patient at the centre of their treatment,15 with a digital process enabling rapid and contactless triage to optimise treatment schedules and avoid overtreatment, minimising risk and maximising outcomes.13,17,18
Implementation of more precise diagnostic tools will ensure better patient outcomes, heralding the widespread use of these tools and the beginning of a new era in precision medicine post-COVID-19.


ACS: American College of Surgeons; ASCO: American Society of Clinical Oncology; COVID-19: coronavirus 19; ctDNA: circulating tumour DNA; IDEA: International Duration Evaluation of Adjuvant Chemotherapy; ESMO: European Society of Clinical Oncology; MSI: microsatellite instability; NCCN: National Comprehensive Cancer Network; NHS: National Health Service; SARS-Cov-19: severe acute respiratory syndrome-related coronavirus 19; SITC: Society for the Immunotherapy of Cancer.

  1.  Marron JM, Joffe S, Jagsi R, Spence RA, Hlubocky FJ. Ethics and resource scarcity: ASCO recommendations for the oncology community during the COVID-19 pandemic. J Clin Oncol 2020:JCO.20.00960.

  2. Cancer patient management during the COVID-19 pandemic. Guides for patients on cancer care. European Society of Clinical Oncology, 2020.

  3. COVID-19: Recommendations for management of elective surgical procedures. American College of Surgeons, 2020.

  4. Specialty guides for patient management during the coronavirus pandemic: Clinical guide for the management of non-coronavirus patients requiring acute treatment: Cancer. Version 2. National Health Service, 2020.

  5. You B, Ravaud A, Canivet A, et al. The official French guidelines to protect patients with cancer against SARS-CoV-2 infection. Lancet Oncol 2020.

  6. JNCCN: How to manage cancer care during COVID-19 pandemic. National Comprehensive Cancer Network, 2020.

  7. COVID-19: Elective case triage guidelines for surgical care. Colorectal cancer surgery. American College of Surgeons, 2020.

  8. Principles for management of colorectal cancer patients during the COVID-19 pandemic. National Comprehensive Cancer Network, 2020.

  9. ESMO management and treatment adapted recommendations in the Covid-19 era: colorectal cancer (CRC). Cancer patient prioritisation. European Society of Medical Oncology, 2020.

  10. Lou E, Beg S, Bergsland E, et al. Modifying practices in GI oncology in the face of COVID-19: recommendations from expert oncologists on minimizing patient risk. JCO Oncol Pract 2020:Op2000239.

  11. Marschall JL, Yarden RI, Weinberg BA. Colorectal cancer care in the age of coronavirus: strategies to reduce risk and maintain benefit. Colorect Cancer 2020;9.

  12. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with Stages I to III colorectal cancer. JAMA Oncol 2019;5:1124-31.

  13. Pagès F, André T, Taieb J, et al. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol 2020.

  14. Colorectal cancer: proposed treatment guidelines for the COVID-19 era. Medscape, 2020.

  15. La Thangue NB, Kerr DJ. Predictive biomarkers: a paradigm shift towards personalized cancer medicine. Nat Rev Clin Oncol 2011;8:587-96.

  16. Digestive System Tumours. 5th ed. Geneva: World Health Organization; 2019.

  17. Blair HA. Immunoscore®: a diagnostic assay for clinical management of colon cancer. Mol Diagn Ther 2020.

  18. Pagès F, Mlecnik B, Marliot F, et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet 2018;391:2128-39.

  19. Sinicrope FA, Shi Q, Hermitte F, et al. Contribution of immunoscore and molecular features to survival prediction in stage lll colon cancer. JNCI Cancer Spectrum 2020.

  20. Galon J, Hermitte F, Mlecnik B, et al. Immunoscore clinical utility to identify good prognostic colon cancer stage II patients with high-risk clinico-pathological features for whom adjuvant treatment may be avoided. J Clin Oncol 2019;37:487.

  21. Juan Manuel O’Connor , Federico Esteso , Matías Chacón. Official French SARS-CoV-2 guidelines for cancer patients, a triage solution with precision medicine



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