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Background: Current guidelines note a gap in high-quality evidence regarding utility of kidney ultrasonography (KUS) during initial evaluation of nephrotic syndrome (NS) due to presumed minimal change disease (pMCD). However, KUS is frequently obtained at our institution. This retrospective chart review assessed incidence and impact of abnormal sonographic findings in these patients. Methods: Patients 1–18 years, newly diagnosed at our institution with NS from pMCD between 2011 and 2021, were identified. Hypertension, urinalysis, kidney function, and steroid responsiveness data were collected. Imaging findings were abstracted from radiology reports. Clinical impact of KUS was defined by actions taken in response to KUS. Results: A total of 173 patients identified with new NS; 98 met inclusion criteria. Of these, 54% had KUS during the initial encounter. Demographic and laboratory data did not differ between those with and without KUS. KUS were abnormal in 70% of studies: increased kidney echogenicity (39.6%) and nephromegaly (35.8%) were the most common abnormal findings. Other findings included decreased corticomedullary differentiation, lobular kidney contour, solitary simple kidney cyst, and mild unilateral hydronephrosis. Steroid resistance was not associated with either nephromegaly or abnormal echogenicity. Conclusions: Our data showed no clinically relevant ultrasound findings causing deviations from the standard of care for pMCD. There was no association between KUS findings and steroid resistance. These data suggest there is little to no benefit from routine KUS imaging in patients with pMCD upon initial presentation. [ABSTRACT FROM AUTHOR]

Simple Summary: The treatment of elderly patients with breast cancer often deviates from guideline recommendations due to comorbidities, expected side effects, and patient preference. We investigated the standard of care of postoperative radiotherapy after breast-conserving surgery in elderly patients (≥65 years) treated outside of clinical trials, potential factors related to the omission of radiotherapy, and the interaction with endocrine therapy. Overall, three thousand one hundred seventy-one women treated at two major breast centers were evaluated. Postoperative radiotherapy was performed in 82% of these cases. The irradiated patients were younger and more likely to receive additional endocrine therapy and chemotherapy. Patients who did not receive radiotherapy were significantly more likely to have non-invasive DCIS tumors and did not undergo axillary surgery. Radiotherapy was associated with improved locoregional tumor control, even in patients receiving endocrine therapy. Patients treated with radiotherapy alone had significantly better locoregional control than with endocrine therapy alone. In conclusion, the present work confirms the efficacy of postoperative radiotherapy in the elderly, even in patients receiving endocrine therapy. We aimed to evaluate the standard of care of adjuvant radiotherapy (RT) after breast-conserving surgery (BCS) in elderly female patients (≥65 years) treated outside of clinical trials and to identify potential factors related to the omission of RT and the interaction with endocrine therapy (ET). All women treated with BCS at two major breast centers between 1998 and 2014 were evaluated. Data were provided by the Tumor Registry Munich. Survival analyses were conducted using the Kaplan–Meier method. Prognostic factors were identified using multivariate Cox regression analysis. The median follow-up was 88.4 months. Adjuvant RT was performed in 82% (2599/3171) of patients. Irradiated patients were younger (70.9 vs. 76.5 years, p < 0.001) and were more likely to receive additional chemotherapy (p < 0.001) and ET (p = 0.014). Non-irradiated patients more often had non-invasive DCIS tumors (pTis: 20.3% vs. 6.8%, p < 0.001) and did not undergo axillary surgery (no axillary surgery: 50.5% vs. 9.5%, p < 0.001). Adjuvant RT was associated with improved locoregional tumor control after BCS in invasive tumors (10-year local recurrence-free survival (LRFS): 94.0% vs. 75.1%, p < 0.001, 10-year lymph node recurrence-free survival (LNRFS): 98.1% vs. 93.1%, p < 0.001). Multivariate analysis confirmed significant benefits for local control with postoperative RT. Furthermore, RT led to increased locoregional control even in patients who received ET (10-year LRFS 94.8% with ET + RT vs. 78.1% with ET alone, p < 0.001 and 10-year LNRFS: 98.2% vs. 95.0%, p = 0.003). Similarly, RT alone had significantly better locoregional control rates compared to ET alone (10-year LRFS 92.6% with RT alone vs. 78.1% with ET alone, p < 0.001 and 10-year LNRFS: 98.0% vs. 95.0%, p = 0.014). The present work confirms the efficacy of postoperative RT for breast carcinoma in elderly patients (≥65 years) treated in a modern clinical setting outside of clinical trials, even in patients who receive ET. [ABSTRACT FROM AUTHOR]

Simple Summary: The COVID-19 pandemic has resulted in unprecedented changes to the life of patients with cancer. In this study, we aim to evaluate the impact of the COVID-19 pandemic on the mental health and general well-being of patients with colorectal cancer by carrying out a prospective longitudinal questionnaire. We found that around one in four participants reported symptoms of anxiety and poor well-being, with 15% at risk of moderate to severe depression. Amongst others, those who were worried that the COVID-19 pandemic would have an effect on their mental health were most at risk of anxiety, depression, and poor well-being. Screening for the mental health impact of the COVID-19 pandemic on patients is essential to allow timely action from all key stakeholders in order to avoid potentially longer-term detrimental consequences. The COVID-19 pandemic has resulted in unprecedented changes to the lives of patients with cancer. To evaluate the impact of the COVID-19 pandemic on the mental health and well-being of patients with colorectal cancer, we conducted a prospective longitudinal questionnaire study at a UK tertiary cancer centre. In total, 216 participants were included: mean age 65 years, 57% (n = 122) male, 92% (n = 198) of white ethnicity. Amongst participants who completed the screening psychometric questionnaire, 24% (n = 48/203) reported anxiety (GAD-7 ≥ 5), 15% (n = 31/204) depressive symptoms (PHQ-9 ≥ 10), 3% (n = 5/190) probable post-traumatic stress disorder (PC-PTSD-5 ≥ 4), and 31% (n = 66/213) poor well-being (WHO-5 < 50). In the subgroup (n = 95/216, 44%) who consented to and completed a follow-up survey 6 months later, there was a significant increase in the number of participants at risk of depression (4% vs. 13%, p = 0.021). Self-reported concern about the COVID-19 pandemic impacting one's mental health is associated with increased likelihood of anxiety, depression, and poor well-being, in respective multivariate analyses. In conclusion, screening for the mental health impact of the COVID-19 pandemic is essential to ensure timely action from all key stakeholders and to avoid potentially longer-term detrimental consequences. [ABSTRACT FROM AUTHOR]

Objective To evaluate effectiveness and safety of computed tomography (CT)-guided cyst rupture with intraarticular contrast-enhanced injection of steroid and local anesthetic as first choice therapy in patients with facet joint cyst-induced radicular pain. Design Retrospective data set analysis. Setting University hospital. Subjects One hundred and twenty-one patients suffering from radicular pain attributable to facet joint cysts were included. Methods The rate of patients without following surgery was assessed and defined as surrogate to measure effectiveness. Patients' characteristics, procedure-associated complications, technical aspects, and imaging findings on magnetic resonance imaging (MRI) were analyzed. A subgroup of 65 patients (54%) underwent telephone interview to assess pain relief and clinical outcome measured by Numeric Rating Scale and Oswestry Disability Index. Analyses between the groups with and without surgery were performed by Fisher exact test and two-sample unpaired t -test, respectively. Results The effectiveness of CT-guided cyst rupture was found to be 66.1%. Procedure-induced pain yielded in premature abort in two cases (1.7%). The detection of epidural contrast agent was statistically significantly associated with no need for surgery (P  =  .010). The cyst level was associated with the status of following surgery (P  =  .026), that is, cysts at lower lumbar spine were easier to rupture than cysts at other locations (cervical, thoracic, or upper lumbar spine). No further significant association was found. Conclusions CT-guided cyst rupture as the first-choice therapy in patients with cyst-induced radicular pain was safe and effective. Successful cyst rupture was associated with no need for surgery. Cysts at lower lumbar spine revealed the highest success rate. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the present study was to analyze the performance of Oncotype DX® multigene assay (ODX®) in patients with 0–3 lymph nodes in a high-volume community hospital. Methods: Patients with non-metastatic HR+/HER2– EBC and 0–3 positive lymph nodes, who underwent primary surgery at the Red Cross Hospital Munich, Germany and consecutively had ODX® testing were included in this retrospective study. The distribution of clinicopathologic characteristics, recurrence score (RS) risk, and use of systemic therapy were compared among patients without positive lymph nodes (N0) and patients with micrometastases or 1 to 3 positive lymph nodes (N1). Disease-free survival (DFS) and overall survival (OS) were estimated. Results: From 2012 to 2017 ODX® was consecutively performed in 575 (16.4%) of 3,492 women with HR+/HER– EBC, of which 553 were eligible for this analysis (N0: 60.8%; N1: 39.2%). Among the patients included, 441 (79.7%) had an RS of 0 to 25 and 112 (20.3%) had an RS of 26 or higher. In patients with RS 0 to 25 the rate of chemotherapy use was low, independent from nodal status (N0: 17.1% and N1: 19.1%) and 5-year DFS was 90.5% and 91.7% for N0 and N1 patients, respectively. There was no significant difference in DFS (90.5% vs. 93.3%; p = 0.101) or OS (97.2% vs. 96.0%; p = 0.737) for patients with an RS of 0 to 25 when treated with chemo-endocrine therapy or endocrine therapy alone, independent from nodal status. Conclusions: The results of the study confirm the observations from randomized studies on the use of the ODX® in a real-world population in terms of risk distribution and patient outcome. Adjuvant chemotherapy could be safely omitted in patients with HR+/HER2– breast cancer with 0–3 positive lymph nodes and RS <25. [ABSTRACT FROM AUTHOR]

Background: In critically ill children with acute kidney injury (AKI), continuous kidney replacement therapy (CKRT) enables nutrition provision. The magnitude of amino acid loss during continuous venovenous hemodiafiltration (CVVHDF) is unknown and needs accurate quantification. We investigated the mass removal and clearance of amino acids in pediatric CVVHDF. Methods: This is a prospective observational cohort study of patients receiving CVVHDF from August 2014 to January 2016 in the pediatric intensive care unit (PICU) of a tertiary children's hospital. Results: Fifteen patients (40% male, median age 2.0 (IQR 0.7, 8.0) years) were enrolled. Median PICU and hospital lengths of stay were 20 (9, 59) and 36 (22, 132) days, respectively. Overall survival to discharge was 66.7%. Median daily protein prescription was 2.00 (1.25, 2.80) g/kg/day. Median daily amino acid mass removal was 299.0 (174.9, 452.0) mg/kg body weight, and median daily amino acid mass clearance was 18.2 (13.5, 27.9) ml/min/m2, resulting in a median 14.6 (8.3, 26.7) % protein loss. The rate of amino acid loss increased with increasing dialysis dose and blood flow rate. Conclusion: CVVHDF prescription and related amino acid loss impact nutrition provision, with 14.6% of the prescribed protein removed. Current recommendations for protein provision for children requiring CVVHDF should be adjusted to compensate for circuit-related loss. [ABSTRACT FROM AUTHOR]

Purpose: Hazardous alcohol consumption among university students represents a prime health risk for this population. Due to a lack of appropriate German-language (online) prevention programs, an existing U.S.-American program was transferred to the German higher education area and then evaluated. Method: For this purpose, both qualitative focus groups and a quantitative evaluation were undertaken. The guided focus groups allowed a further adaptation of the prevention program: An improved frequency–quantity questionnaire for the drinking behavior of German-speaking students was developed, and thresholds for hazardous consumption were included. Results: The additional quantitative verification of the adaptation found that 65.9% of the surveyed students found the adapted program suitable for the higher education context and 62.6% stated that every university should provide such a program. Discussion: The adaptation process described here made it possible to develop an online prevention program tailored to the lifeworld of students in the German-speaking region. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to identify predictors of 'intrauterine fetal renal failure' in fetuses with severe congenital lower urinary tract obstruction (LUTO). Methods: We undertook a retrospective study of 31 consecutive fetuses with a diagnosis of LUTO in a tertiary Fetal Center between April 2013 and April 2015. Predictors of 'intrauterine fetal renal failure' were evaluated in those infants with severe LUTO who had either a primary composite outcome measure of neonatal death in the first 24 h of life due to severe pulmonary hypoplasia or a need for renal replacement therapy within 7 days of life. The following variables were analyzed: fetal bladder re-expansion 48 h after vesicocentesis, fetal renal ultrasound characteristics, fetal urinary indices, and amniotic fluid volume. Results: Of the 31 fetuses included in the study, eight met the criteria for 'intrauterine fetal renal failure'. All of the latter had composite poor postnatal outcomes based on death within 24 h of life ( n = 6) or need for dialysis within 1 week of life ( n = 2). The percentage of fetal bladder refilling after vesicocentesis at time of initial evaluation was the only predictor of 'intrauterine fetal renal failure' (cut-off <27 %, area under the time-concentration curve 0.86, 95 % confidence interval 0.68-0.99; p = 0.009). Conclusion: We propose the concept of 'intrauterine fetal renal failure' in fetuses with the most severe forms of LUTO. Fetal bladder refilling can be used to reliably predict 'intrauterine fetal renal failure', which is associated with severe pulmonary hypoplasia or the need for dialysis within a few days of life. [ABSTRACT FROM AUTHOR]

Background: Maintaining hemoglobin (Hgb) levels within a target range is difficult. Non-invasive hematocrit monitoring (NIVH) continuously monitors both the hematocrit and percent change in intravascular blood volume in real time. Based on the data reported here, NIVH can be utilized as a tool for anemia management in pediatric hemodialysis patients. Methods: Monthly, mid-week pre-dialysis, Hgb levels were obtained for 12 consecutive months. Concurrent with monthly Hgb, hematocrit was recorded at the start of the dialysis treatment using NIVH. Hgb (oHgb) was calculated using the adult equation Hgb = 0.3112*HCT + 0.71, and a linear regression model was used to derive a pediatric specific equation (pHgb = 0.28*CRIT Hct + 2.5). Results: A total of 310 observations were obtained from 47 patients. The mean actual hemoglobin (mHgb) was 11.14 ± 1.4, and the mean derived hemoglobin from the adult equation, oHgb, was 10.3 ± 1.3 ( p = 0.0001). For the target hemoglobin of 10-12 gm/dl, the adult equation was 72 % sensitive and 63 % specific, whereas the pediatric equation was 93 % sensitive and 70 % specific. Conclusions: The newly derived pediatric equation (pHgb = 0.28*CRIT Hct + 2.5) improved the prediction capability compared to the standard equation with lower false-negative and false-positive rates. [ABSTRACT FROM AUTHOR]

Our purpose was to compare objective and subjective measures of energy exertion during caregiving tasks. Participants were primary caregivers ( N = 19) of children and young adults (aged 3 -22 years) with cerebral palsy (CP) who require assistance for mobility and self-care (67% classified in level V on the Gross Motor Function Classification System). Measures of exertion were collected during two caregiving tasks: (1) transfers and (2) dressing. Objective measures included volume of oxygen (V02), heart rate (HR), and the subjective measure was a rating of perceived exertion (Borg RPE). Controlling for baseline status, perceived exertion correlated with VO2 (0.43, p < .01) and HR (0.29, p < .01) during the tasks. Caregivers with high baseline HR and VO2, had high Borg RPE scores following a task. Correlations were found between HR and VO2 during caregiving tasks (0.63, p < .01). Patterns of association with caregiver and child characteristics were similar for VO2 and Borg RPE. Subjective measures of exertion appear to capture the strain of caregiving. Understanding a caregiver's perception of exertion can guide therapists in assessing the need for equipment, pharmacological, or respite interventions. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with "HER2-positive" early breast cancer are treated with antibodies to the HER2 protein along with chemotherapy, regardless of whether their cancer also has hormone receptors, or of its molecular features. Because patients with HER2-positive/hormone receptor-positive disease tend to live longer than those with HER2-positive/hormone receptor-negative disease, there may be some patients who are being overtreated under current guidelines. The aim of our exploratory translational analysis of the ADAPT HER2-positive/hormone receptor-positive trial was to investigate the potential of several prognostic (outcome regardless of therapy) and predictive (effect of therapy) biomarkers as early predictors of response to treatment before surgery. Comparison of these biomarkers before and after one treatment cycle, and their effects on whether patients' cancers were completely removed at surgery, suggest that certain patients (those with treatment-induced CD8 protein-expressing cells infiltrating the cancer; without PIK3CA mutation; those with HER2-enriched tumors) may be candidates for less intensive treatment following pre-surgical therapy. Prognostic or predictive biomarkers in HER2-positive early breast cancer (EBC) may inform treatment optimization. The ADAPT HER2-positive/hormone receptor-positive phase II trial (NCT01779206) demonstrated pathological complete response (pCR) rates of ~40% following de-escalated treatment with 12 weeks neoadjuvant ado-trastuzumab emtansine (T-DM1) ± endocrine therapy. In this exploratory analysis, we evaluated potential early predictors of response to neoadjuvant therapy. The effects of PIK3CA mutations and immune (CD8 and PD-L1) and apoptotic markers (BCL2 and MCL1) on pCR rates were assessed, along with intrinsic BC subtypes. Immune response and pCR were lower in PIK3CA-mutated tumors compared with wildtype. Increased BCL2 at baseline in all patients and at Cycle 2 in the T-DM1 arms was associated with lower pCR. In the T-DM1 arms only, the HER2-enriched subtype was associated with increased pCR rate (54% vs. 28%). These findings support further prospective pCR-driven de-escalation studies in patients with HER2-positive EBC. [ABSTRACT FROM AUTHOR]

Simple Summary: The decision to provide adjuvant treatment in lower grade glioma (LGG) is often based on presence of residual tumor after surgery. Differentiating tumor remnants and surgically induced artifacts can be challenging. Postoperative MRI performed 24 or 48 h after the surgery overestimates residual tumor volume. MRI scan in the first hour after surgery (ultra-early), or an intraoperative MRI after final resection, correlated best with residual tumor at 3 months follow up. The timing of MRI imaging after surgical resection may have an important role in assessing the extent of resection (EoR) and in determining further treatment. The aim of our study was to evaluate the time dependency of T2 and FLAIR changes after surgery for LGG. The Log-Glio database of patients treated at our hospital from 2016 to 2021 was searched for patients >18a and non-enhancing intra-axial lesion with complete MR-imaging protocol. A total of 16 patients matched the inclusion criteria and were thus selected for volumetric analysis. All patients received an intraoperative scan (iMRI) after complete tumor removal, an ultra-early postoperative scan after skin closure, an early MRI within 48 h and a late follow up MRI after 3–4 mo. Detailed volumetric analysis of FLAIR and T2 abnormalities was conducted. Demographic data and basic characteristics were also analyzed. An ultra-early postoperative MRI was performed within a median time of 30 min after skin closure and showed significantly lower FLAIR (p = 0.003) and T2 (p = 0.003) abnormalities when compared to early postoperative MRI (median 23.5 h), though no significant difference was found between ultra-early and late postoperative FLAIR (p = 0.422) and T2 (p = 0.575) images. A significant difference was calculated between early and late postoperative FLAIR (p = 0.005) and T2 (p = 0.019) MRI scans. Additionally, we found no significant difference between intraoperative and ultra-early FLAIR/T2 (p = 0.919 and 0.499), but we found a significant difference between iMRI and early MRI FLAIR/T2 (p = 0.027 and p = 0.035). Therefore, a postoperative MRI performed 24 h or 48 h might lead to false positive findings. An MRI scan in the first hour after surgery (ultra-early) correlated best with residual tumor at 3 months follow up. An iMRI with open skull, at the end of resection, was similar to an ultra-early MRI with regard to residual tumor. [ABSTRACT FROM AUTHOR]

• 798 youth in mental health residential treatment centers were involved in 13,339 restraint incidents over the course of 3 years. • African-American youth experienced more restraints compared to White youth. • Younger youth experienced more restraints compared to older youth. • Restraints were more likely to occur earlier in the week and in the evening. • Most restraint incidents involved only 1 physical hold, but a sizeable number involved the use of multiple holds. • A majority of youth ever restrained are restrained within their first 5 weeks of treatment. Youth are physically restrained in residential treatment centers to prevent them from harming themselves or others, and this practice is common in treatment settings. Consequences from restraint (including clinical, emotional, and physical harm; even death) demonstrate the necessity of reducing restraint use. These consequences may be more severe for youth who have experienced trauma, a population that is disproportionately represented in residential treatment facilities. Using a large dataset (798 youth in residential treatment centers in the Midwest involved in 13,339 restraint incidents over three years), this paper explores the characteristics of the youth who were restrained (including age, race, sex, and primary diagnosis), the reasons why restraints occurred, when restraints occurred during the day, week, and course of the youth's treatment, and the techniques used to restrain youth. African-American youth were more likely to be restrained, as were younger youth. There were no differences between sex or primary diagnosis. Restraints are more likely to occur early in the week and in the evening hours. A majority of youth ever restrained are restrained within their first five weeks of treatment, including a fifth of youth restrained in their first week. Standing holds are the most common restraint technique, and most youth are restrained using only one hold; a disturbing minority of incidents, however, involve the use of multiple holds, including 7% of incidents involving four or more holds. These exploratory results are discussed in terms of how they may be used to reduce restraints and spur future research. [ABSTRACT FROM AUTHOR]

To date, there has been little systematic assessment of the quality of care associated with systemic anti-cancer therapy (SACT) delivery across national healthcare systems. We evaluated hospital-level toxicity rates during SACT treatment as a means of identifying variation in care quality. All colorectal cancer (CRC) patients receiving SACT within 106 English National Health Service (NHS) hospitals between 2016 and 2019 were included. Severe acute toxicity rates were derived from hospital administrative data using a validated coding framework. Variation in hospital-level toxicity rates was assessed separately in the adjuvant and metastatic settings. Toxicity rates were adjusted for age, sex, comorbidity, performance status, tumour site, and TNM staging. Eight thousand one hundred and seventy three patients received SACT in the adjuvant setting, and 7,683 patients in the metastatic setting. Adjusted severe acute toxicity rates varied between hospitals from 11% to 49% for the adjuvant cohort, and from 25% to 67% for the metastatic cohort. Compared to the national mean toxicity rate in the adjuvant cohort, six hospitals were more than two standard deviations (2SD) above, and four hospitals were more than 2SD below. In the metastatic cohort, six hospitals were more than 2SD above, and seven hospitals were more than 2SD below the national mean toxicity rate. Overall, 12 hospitals (12%) had toxicity rates more than 2SD above the national mean, and 11 (10%) had rates more than 2SD below. There is substantial variation in hospital-level severe acute toxicity rates in both the adjuvant and metastatic settings, despite risk-adjustment. Ongoing reporting of this performance indicator can be used to focus further investigation of toxicity rates and stimulate quality improvement initiatives to improve care. • Quality of SACT delivery was evaluated in adjuvant and metastatic colorectal cancer patients. • Variation in toxicity rates across 106 English NHS hospitals was used to explore this. • Adjusted toxicity rates varied from 11% to 49% (adjuvant) and from 25% to 67% (metastatic). • Twelve hospitals had toxicity rates >2SD above the national average, and 11 >2SD below. • Ongoing reporting of this performance indicator can be used for quality improvement. [ABSTRACT FROM AUTHOR]

Purpose This randomised phase II trial aimed to compare efficacy of the irreversible ErbB family blocker, afatinib, with cetuximab in patients with KRAS wild-type metastatic colorectal adenocarcinoma (mCRC) with progression following oxaliplatin- and irinotecan-based regimens. Efficacy in patients with KRAS mutations was also evaluated. Patients and methods Patients with KRAS wild-type tumours were randomised 2:1 to afatinib (40 mg/day, increasing to 50 mg/day if minimal toxicity) or cetuximab weekly (400 mg/m 2 loading dose, then 250 mg/m 2 /week) according to number of previous chemotherapy lines. All patients with KRAS-mutated tumours received afatinib. Primary end-points were objective response (OR) for the wild-type group and disease control for the KRAS-mutated group. Secondary end-points were progression-free survival (PFS) and overall survival (OS). Results Patients with KRAS wild-type tumours ( n = 50) received afatinib ( n = 36) or cetuximab ( n = 14). Unconfirmed and confirmed ORs were 3% and 0% for afatinib versus 20% and 13% for cetuximab (odds ratio: 0.122 [ P = 0.0735] and <0.001, respectively). Median PFS was 46.0 and 144.5 days for afatinib and cetuximab, respectively. Median OS was 355 days with afatinib but not reached for cetuximab. In the KRAS - mutated group ( n = 41), five (12%) patients achieved confirmed disease control (stable disease; P = 0.6394 [comparison versus 10%]); no ORs were reported. Median PFS and OS were 41.0 and 173 days, respectively. Most frequent treatment-related adverse events were diarrhoea and rash across groups. Conclusions The efficacy of afatinib was inferior to cetuximab in patients with KRAS wild-type mCRC. In patients with KRAS-mutated tumours, disease control was modest with afatinib. Afatinib had a manageable safety profile. [ABSTRACT FROM AUTHOR]