Abstract
AimTo develop a decision model for the population-level evaluation of strategies to improve the selection of stage II colon cancer (CC) patients who benefit from adjuvant chemotherapy.MethodsA Markov cohort model with a one-month cycle length and a lifelong time horizon was developed. Five health states were included; diagnosis, 90-day mortality, death other causes, recurrence and CC death. Data from the Netherlands Cancer Registry were used to parameterize the model. Transition probabilities were estimated using parametric survival models including relevant clinical and pathological covariates. Subsequently, biomarker status was implemented using external data. Treatment effect was incorporated using pooled trial data. Model development, data sources used, parameter estimation, and internal and external validation are described in detail. To illustrate the use of the model, three example strategies were evaluated in which allocation of treatment was based on (A) 100% adherence to the Dutch guidelines, (B) observed adherence to guideline recommendations and (C) a biomarker-driven strategy.ResultsOverall, the model showed good internal and external validity. Age, tumor growth, tumor sidedness, evaluated lymph nodes, and biomarker status were included as covariates. For the example strategies, the model predicted 83, 87 and 77 CC deaths after 5 years in a cohort of 1000 patients for strategies A, B and C, respectively.ConclusionThis model can be used to evaluate strategies for the allocation of adjuvant chemotherapy in stage II CC patients. In future studies, the model will be used to estimate population-level long-term health gain and cost-effectiveness of biomarker-based selection strategies.
Highlights
With around 10,500 new cases and 4000 deaths in 2016, colon cancer is a major disease in the Netherlands leading to a substantial burden for patients, health care and society [1]
A Markov cohort model was developed for the future population-level evaluation of different strategies to improve the selection of stage II colon cancer patients for adjuvant chemotherapy
The decision model describes the influence of pT stage, number of lymph nodes evaluated, tumor sidedness, microsatellite stability (MSS) status, BRAF mutation status, and KRAS mutation status on relevant outcomes, such as the recurrence rate and disease-specific survival
Summary
With around 10,500 new cases and 4000 deaths in 2016, colon cancer is a major disease in the Netherlands leading to a substantial burden for patients, health care and society [1]. In stage II colon cancer, surgical resection is the curative treatment option of choice, followed by adjuvant therapy in a subgroup of patients. The benefit of adjuvant chemotherapy after surgical resection remains a matter of debate. Adjuvant chemotherapy is often recommended for stage II patients with a high risk of recurrence. There is no consensus on which factors predict the benefit from adjuvant chemotherapy. The correct identification of prognostic and predictive parameters is essential to optimize survival without inducing the harms of overtreatment in patients who will not benefit
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