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Longitudinal effects of adjuvant chemotherapy and related neuropathy on health utility in stage II and III colon cancer patients: A prospective cohort study

6 april 2021

Patient's quality of life should be included in clinical decision making regarding the administration of adjuvant chemotherapy (ACT) in stage II/III colon cancer. Therefore, quality of life, summarized as health utility (HU), was evaluated for patients treated with and without ACT. Furthermore, the role of chemotherapy–induced peripheral neuropathy (CIPN) on HU was evaluated. Patients diagnosed with stage II/III colon cancer between 2011 and 2019 and participating in the Prospective Dutch ColoRectal Cancer cohort were included (n = 914). HU scores were assessed with the EQ‐5D‐5L at baseline, 3, 6, 12, 18, and 24 months. Patients treated with ACT received mainly capecitabine and oxaliplatin (57%) or capecitabine monotherapy (40%) (average duration: 3.5 months). HU 3 to 18 months after diagnosis (potential ACT period + 12 months follow‐up) was compared between patients treated with and without ACT using a mixed model adjusted for age, sex and education level. Subsequently, the CIPN sensory, motor and autonomy scales, measured using the EORTC QLQ‐CIPN20, were independently included in the model to evaluate the impact of neuropathy. Using a mixed model, a significant difference of −0.039 (95% confidence interval: −0.062; −0.015) in HU was found between patients treated with and without ACT. Including the CIPN sensory, motor and autonomy scales decreased the difference with 0.019, 0.015 and 0.02, respectively. HU 3 to 18 months after diagnosis is significantly lower in patients treated with ACT vs without ACT. This difference is on the boundary of clinical relevance and appears to be partly related to the sensory and motor neuropathy‐related side effects of ACT.

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The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real‑world data facilitating research and clinical care

18 februari 2021

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate
treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort,
linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research
collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on
cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and
demographic characteristics of PLCRC participants were compared with the general Dutch CRC
population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between
PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability
to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation
independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016
and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744
patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to
2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability
to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in
the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the
Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to
represent the Dutch CRC population and will ultimately meet the current demand for high-quality
RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s
representativeness and its contribution to a learning healthcare system.

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