ESMO-MCBS early colon cancer toxicity adjuvant chemotherapy quality of life

Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1

by Daan Geert Knapen, Nathan I. Cherny, Panagiota Zygoura, Nicola Jane Latino, Jean-Yves Douillard, Urania Dafni, Elisabeth G.E. de Vries, Derk Jan de Groot

Sep 6^th 2020
17 mins
ESMO Open 2020;5:e000681

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Summary

Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is used to grade therapies with curative intent.
The study aimed to evaluate the applicability and reasonableness of the ESMO-MCBS scores in early colon cancer.
Adjuvant studies were sourced from various medical and regulatory databases and guidelines, then graded using ESMO-MCBS V.1.1.
In stage III colon cancer, certain chemotherapy trials scored high (grade A), while others showed more modest benefits (grades A and B).
For stage II colon cancer, fluoropyrimidine trials had 'no evaluable benefit', but a recent meta-analysis showed a 5.4% survival advantage (grade A).
RCTs and a meta-analysis adding oxaliplatin showed no added benefit.
Challenges included inconsistent toxicity reporting and limited late toxicity results.
Field testers largely confirmed the scores' reasonableness but noted the inability to credit improved convenience in non-inferiority trials as a shortcoming.
Overall, ESMO-MCBS V.1.1 provided very reasonable grading for adjuvant colon cancer studies.

Colorectal cancer is the third most common tumour in men, the second in women and second place in cancer-related cause of death in the world. Mortality has declined over the years for several reasons, including colorectal cancer screening and more effective systemic therapies in both the adjuvant setting and metastatic disease.

Adjuvant therapies for colon cancer have evolved over the past 40 years. Early studies failed to show overall survival (OS) benefit of single agent therapy including 5-fluorouracil (5-FU) monotherapy compared with surgery alone. Adjuvant leucovorin modulated 5-FU (5-FU/LV) did, however, improve relative OS, but not absolute OS due to the increased incidence, and has been the standard of care since the mid-nineties. As of 2004, standard adjuvant therapy consists of a 5-FU/LV-based backbone to which oxaliplatin was added. Oxaliplatin did improve disease-free survival (DFS) and OS in stage III patients but it commonly caused substantial late toxicity (LT) with peripheral sensory neurotoxicity (PSN). Other agents including irinotecan, cetuximab and bevacizumab tested in the adjuvant setting, failed to show additional OS benefit.

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ESMO-MCBS, early colon cancer, toxicity, adjuvant chemotherapy, quality of life

Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1

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