Quality of life and clinical outcomes in rectal cancer patients treated on a 1.5T MR-Linac within the MOMENTUM study.

Background and purpose: This study assessed quality of life (QoL) and clinical outcomes in rectal cancer patients treated with magnetic resonance (MR) guided short-course radiation therapy (SCRT) on a 1.5 Tesla (T) MR-Linac during the first 12 months after treatment. Materials and methods: Rectal cancer patients treated with 25 Gy SCRT in five fractions with curative intent in the Netherlands (2019-2022) were identified in MOMENTUM (NCT04075305). Toxicity (CTCAE v5) and QoL (EORTC QLQ-C30 and -CR29) was primarily analyzed in patients without metastatic disease (M0) and no other therapies after SCRT. Patients who underwent tumor resection were censored from surgery. A generalized linear mixed-model was used to investigate clinically meaningful (≥10) and significant (P < 0.05) QoL changes. Clinical and pathological complete response (cCR and pCR) rates were calculated in patients in whom response was documented. Results: A total of 172 patients were included, of whom 112 patients were primarily analyzed. Acute and late radiation-induced high-grade toxicity were reported in one patient, respectively. CCR was observed in 8/64 patients (13 %), 14/37 patients (38 %) and 13/16 patients (91 %) at three, six and twelve months; pCR was observed in 3/69 (4 %) patients. After 12 months, diarrhea (mean difference [MD] -17.4 [95 % confidence interval [CI] -31.2 to -3.7]), blood and mucus in stool (MD -31.1 [95 % CI -46.4 to -15.8]), and anxiety (MD -22.4 [95 % CI -34.0 to -10.9]) were improved. Conclusion: High-field MR-guided SCRT for the treatment of patients with rectal cancer is associated with improved disease-related symptom management and functioning one year after treatment.

Population-based study of morbidity risk associated with pathological complete response after chemoradiotherapy for rectal cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) for locally advanced rectal cancer may induce a pathological complete response (pCR) but increase surgical morbidity due to radiation-induced fibrosis. In this study the association between pCR and postoperative surgical morbidity was investigated. METHODS: Patients in the Netherlands with rectal cancer who underwent nCRT followed by total mesorectal excision between 2009 and 2017 were included. Data were stratified into patients who underwent resection with creation of a primary anastomosis and those who had a permanent stoma procedure. The association between pCR and postoperative morbidity was investigated in univariable and multivariable logistic regression analyses. RESULTS: pCR was observed in 976 (12·2 per cent) of 8003 patients. In 3472 patients who had a primary anastomosis, the presence of pCR was significantly associated with surgical complications (122 of 443 (27·5 per cent) versus 598 of 3029 (19·7 per cent) in those without pCR) and anastomotic leak (35 of 443 (7·9 per cent) versus 173 of 3029 (5·7 per cent) respectively). Multivariable analysis also showed associations between pCR and surgical complications (adjusted odds ratio (OR) 1·53, 95 per cent c.i. 1·22 to 1·92) and pCR and anastomotic leak (adjusted OR 1·41, 1·03 to 2·05). Of 4531 patients with a permanent stoma, surgical complications were observed in 120 (22·5 per cent) of 533 patients with a pCR, compared with 798 (20·0 per cent) of 3998 patients with no pCR (adjusted OR 1·17, 0·94 to 1·46). CONCLUSION: Patients with a pCR in whom an anastomosis was created were at increased risk of developing an anastomotic leak.

ANTECEDENTES: La quimiorradioterapia neoadyuvante (neoadjuvant chemoradiotherapy, nCRT) para el cáncer de recto localmente avanzado puede inducir una respuesta patológica completa (pathological complete response, pCR), pero también puede aumentar la morbilidad quirúrgica debido a la fibrosis inducida por la radiación. En este estudio se investigó la asociación entre pCR y morbilidad quirúrgica postoperatoria. MÉTODOS: Se incluyeron los pacientes con cáncer de recto que recibieron nCRT seguida de resección total del mesorrecto entre 2009 y 2017 en los Países Bajos. Los datos se estratificaron en pacientes en los que se realizó una resección con anastomosis primaria y en los que se realizó una resección con estoma permanente. La asociación entre pCR y morbilidad postoperatoria se investigó mediante análisis de regresión logística univariable y multivariable. RESULTADOS: Se observó una pCR en 976 (12,2%) de 8.003 pacientes. En el grupo de pacientes con anastomosis primaria (n = 3472), la presencia de pCR se asoció significativamente con complicaciones quirúrgicas (n = 122; 27,5% versus n = 598; 19,7% sin pCR) y fuga anastomótica (n = 35; 7,9 % versus n = 173; 5,7% sin pCR). Las asociaciones entre la pCR y las complicaciones quirúrgicas y la pCR y la fuga anastomótica también se confirmaron en los análisis multivariables (razón de oportunidades ajustada, odds ratio, OR ajustado: 1,53; i.c. del 95%: 1,22-1,92; OR ajustado: 1,41; i.c. del 95%: 1,03-2,05, respectivamente). En el grupo con estoma permanente (n = 4.531), se observaron complicaciones quirúrgicas en 120 pacientes (22,5%) en los casos con presencia de pCR en comparación con 798 pacientes (20%) en ausencia de pCR (OR ajustado: 1,17; i.c. del 95%: 0,94-1,46). CONCLUSIÓN: Los pacientes con pCR en los que se realizó una anastomosis tenían mayor riesgo de presentar una fuga anastomótica.

Self-reported work ability in breast cancer survivors; a prospective cohort study in the Netherlands.

PURPOSE: To evaluate patient-reported work ability of breast cancer patients, to compare scores with the Dutch general population, and to identify determinants of reduced work ability in breast cancer patients. METHODS: In a prospective cohort study, we identified 939 patients <67 years. Employed patients filled out the Work Ability Index (WAI) questionnaire before the start of radiotherapy treatment (baseline) and at 6, 18, and 30 months. Work ability was compared with a matched Dutch cancer-free population (n=3,641). The association between (clinical) characteristics and work ability over time was assessed using mixed-effects models. RESULTS: At baseline, 68% (n=641) of the respondents were employed and 64% (n=203) were employed at 30 months. Moderate or poor work ability was reported by 71% of patients at baseline, by 24% of the patients at 30 months and by 14% of the general population. Axillary lymph node dissection, (neo)adjuvant chemotherapy and locoregional radiotherapy were associated with reduced work ability. After 30 months, 18% of employed patients reported to have reduced their working hours, made substantial modifications to their work or were unable to work. CONCLUSION: Patient-reported work ability is strongly reduced during breast cancer treatment. Thirty months after treatment the proportion of women reporting poor or moderate work ability remains higher compared to the general population. Even though the proportion of women with paid employment is rather stable over time, substantial amendments in work are needed in 18% of patients. These findings emphasize the importance of informing patients on potential changes in work ability to allow shared decision making.

Assessment of a fully automated, high-throughput mammographic density measurement tool for use with processed digital mammograms.

PURPOSE: The ImageJ model is a recently developed automated breast density measurement tool based on analysis of Cumulus outcomes. It has been validated on digitized film-screen mammograms. In this study, the ImageJ model was assessed on processed full-field digital mammograms and correlated with the Breast Imaging Reporting and Data System (BI-RADS) density classification. Also, the association with breast cancer risk factors is observed. METHODS: Women with mammographies between 2001 and 2011 at the University Medical Center Utrecht, The Netherlands were included. We composed a training set, read with Cumulus, for building the ImageJ model [n = 100 women, 331 images; craniocaudal (CC) and mediolateral oblique (MLO) views, left and right] and a validation set for model assessment and correlation with the BI-RADS classification [n = 530 women, 1,977 images; average of available CC and MLO views, left and right]. Pearson product-moment correlation coefficient was used to compare Cumulus with ImageJ, Spearman correlation coefficient for ImageJ with BI-RADS density, and generalized linear models for association with breast cancer risk factors. RESULTS: The correlation between ImageJ and Cumulus in the training set was 0.90 [95 % confidence interval (CI) 0.86-0.93]. After application to the validation set, we observed a high correlation between ImageJ and the BI-RADS readings (Spearman r = 0.86, 95 % CI 0.84-0.88). Women with higher density were significantly younger, more often premenopausal, had lower parity, more often a benign breast lesion or family history of breast cancer. CONCLUSIONS: The ImageJ model can be used on processed digital mammograms. The measurements strongly correlate with Cumulus, the BI-RADS density classification, and breast cancer risk factors.