Care Of Colorectal Cancer Patients Research Articles

Postoperative outcomes after prehabilitation for colorectal cancer patients undergoing surgery: a systematic review and meta-analysis of randomized and nonrandomized studies.

Prehabilitation (PH) is purported to improve patients' preoperative functional status. This systematic review and meta-analysis sought to compare short-term postoperative outcomes between patients who underwent a protocolized PH program and the existing standard of care among colorectal cancer patients awaiting surgery. A search in MEDLINE/PubMed, the Cochrane Library, Embase, Scopus, and CINAHL was conducted to identify relevant articles. Repetitive and exhaustive combinations of MeSH search terms ("prehabilitation," "colorectal cancer," "colon cancer," and "rectal cancer") were used to identify randomized and nonrandomized studies comparing PH versus standard of care for colorectal cancer patients awaiting surgery. The primary outcomes included postoperative morbidity, length of hospital stay, and readmission rates. Seven studies including 1,042 colorectal cancer patients (PH, 382) were included. No significant differences were found in intraoperative outcomes. The postoperative complication rates were comparable between groups (Clavien-Dindo grades I and II: risk ratio, 0.82; 95% confidence interval, 0.62-1.07; P=0.15; Clavien-Dindo grades ≥III: risk ratio, 1.02; 95% confidence interval, 0.72-1.44; P=0.92). There were also no significant differences in length of hospital stay (P=0.21) or the risk of 30-day readmission (P=0.68). Although PH does not appear to improve short-term postoperative outcomes following colorectal cancer surgery, the quality of evidence is impaired by the limited trials and heterogeneity. Thus, further large-scale trials are warranted to draw definitive conclusions and establish the long-term effects of PH.

Anxiety among colorectal cancer patient: A concept analysis

Background: Despite the prevalence of anxiety among individuals with colorectal cancer, there is a lack of clarity regarding the definition of anxiety in this population. Moreover, research on the impact of care interventions on anxiety in colorectal cancer patients is limited. Objective: This concept analysis aimed to clarify the concept of anxiety among colorectal cancer patients. Methods: The concept analysis was conducted following the Walker and Avant methodology. The utilization of the concept was investigated across three databases (PubMed, Scopus, and Google Scholar), resulting in the identification of 12 relevant studies for in-depth analysis. Results: The identified attributes of anxiety in colorectal cancer include distress related to body image changes, uncertainty during social role reintegration, and fear of disease recurrence or mortality. Genetic factors, psychological elements, and stressful life events were recognized as antecedents of this anxiety. Additionally, the consequences of anxiety exhibited both positive and negative impacts on colorectal cancer patients. Conclusion: The findings of this concept analysis enhance the understanding of the concept of anxiety among colorectal cancer patients. This has the potential to improve the quality of care for colorectal cancer patients.

The effects of a nurse-led discharge planning on the health outcomes of colorectal cancer patients with stomas: A randomized controlled trial

BackgroundNursing care of colorectal cancer patients with stomas presents unique challenges, particularly during the transition from hospital to home. Early discharge programs can assist patients during this critical period. However, the effects of delivering a nurse-led discharge planning program remain under-studied. ObjectiveEvaluate the effects of a nurse-led discharge planning on the quality of discharge education, stoma self-efficacy, readiness for hospital discharge, stoma quality of life, incidence of stoma complications, unplanned readmission rate, and length of stays. DesignAssessor-blind parallel-arm randomized controlled trial with a repeated-measures design. Setting(s)Participants were recruited from inpatients in the colorectal surgery unit of a university-affiliated hospital in Fujian, China. ParticipantsA total of 160 patients with colorectal cancer who received enterostomy surgery and were scheduled to be discharged to their homes. MethodParticipants were randomly allocated to the experimental and control groups. The former received nurse-led discharge planning in addition to the usual discharge education, while the control group received only the usual discharge education. The program included an assessment, health education, stoma care, stoma support, discharge review, discharge medication and checklist integration, discharge referral, and post-hospital follow-up. Baseline data were collected prior to the intervention (T0). Data on the quality of discharge teaching, readiness for hospital discharge, stoma self-efficacy, and stoma quality of life were measured on the day of discharge from the hospital (T1). Patients' stoma self-efficacy and quality of life were repeat-measured 30 (T2) and 90 days post-discharge (T3). Data on stoma complications (T1, T2, T3), length of stays (T1), and unplanned readmission (T2, T3) were collected from medical records. ResultsParticipants in the intervention group showed significant improvement in the quality of discharge teaching, readiness for hospital discharge, stoma self-efficacy, stoma quality of life, complications, and unplanned readmission, compared to the control group (p < 0.001). However, no statistically significant differences were observed in length of stays (p > 0.05). ConclusionsThe program was effective for improving quality of discharge teaching, readiness for hospital discharge, stoma self-efficacy, and stoma quality of life, as well as for reducing complications and unplanned readmission among stoma patients. Integration of discharge planning into the usual process of care is recommended for clinical practice to facilitate a successful transition from hospital to home. RegistrationThis study was registered at the Chinese clinical trial registry (ChiCTR2200058756) on April 16, 2022, and participant recruitment was initiated in May 2022.

Retrospective analysis of preoperative application of triple-modal pre-rehabilitation on postoperative recovery of colorectal cancer patients.

To retrospectively analyze the difference between triple-modal pre-rehabilitation and common treatment in patients with colorectal cancer (CRC). A total of 145 patients with CRC diagnosed by pathology and admitted to our hospital for surgery between June 2020 and June 2022 were included in the study. All patients were divided into two groups: the triple-modal pre-rehabilitation group (pre-rehabilitation group) and the common treatment group. The triple-modal pre-rehabilitation strategy included exercise (3-5 times per week, with each session lasting more than 50min), nutritional support, and psychological support. The study was designed to assess the potential of the pre-rehabilitation intervention to accelerate postoperative recovery by assessing the 6-min walk test, nutritional indicators, and HADS score before and after surgery. The pre-rehabilitation intervention did not reduce the duration of initial postoperative recovery or the incidence of postoperative complications, but it did increase the patients' exercise capacity (as determined by the 6-min walk test), with the pre-rehabilitation group performing significantly better than the common group (433.0 (105.0) vs. 389.0 (103.5), P < 0.001). The study also found that triple-modal pre-rehabilitation was beneficial for the early recovery of nutritional status in surgical patients and improved anxiety and depression in patients after surgery, especially in those who had not received neoadjuvant therapy. The triple-modal pre-rehabilitation strategy is of significant importance for reducing stress and improving the functional reserve of patients with colorectal cancer (CRC) during the perioperative period. The results of our study provide further support for the integration of the triple-modal pre-rehabilitation strategy into the treatment and care of CRC patients.

Factors associated with sexual dysfunction in patients with colorectal cancer in Iran: a cross-sectional study

Sexual dysfunction is a prevalent issue among individuals diagnosed with colorectal cancer (CRC), significantly impacting their quality of life. However, limited research has explored the factors associated with sexual dysfunction in CRC patients in Iran. This cross-sectional study aimed to identify the demographic factors that may contribute to sexual dysfunction in this population. A cross-sectional study involving CRC patients was conducted from April 1, 2022, to May 1, 2022, in Tabriz, Iran. Ethical approvals were obtained, and convenience sampling was employed at outpatient chemotherapy centers in five Tabriz hospitals. Validated questionnaires, including participants characteristics form, the Female Sexual Function Index (FSFI) for females and International Index of Erectile Function (IIEF) for males, were utilized. Data were analyzed using IBM SPSS Statistics version 24, employing descriptive statistics and stepwise linear regression to assess association between mentioned factors and sexual function. Among 256 participants, 50.4% were males, 49.6% were females, and 80.5% were married. The predominant age range was 50–60 years. The study findings revealed a high prevalence of sexual dysfunction among both female (Mean ± SD: 10.91 ± 8.67, Min–Max: 3.20–33.00) and male (Mean ± SD: 27.64 ± 16.28, Min–Max: 11–62) CRC patients. Factors such as the presence of a colostomy for FSFI (P < 0.001), type of treatment received for both FSFI and IIEF (P < 0.001), type of housing for both FSFI and IIEF (P < 0.001), occupation for FSFI (P < 0.001), presence of other diseases for FSFI (P = 0.047), and time since the last chemotherapy session for FSFI (P = 0.018), Education for IIEF (P = 0.026), and Age for IIEF (P = 0.002) were identified as significant factors of sexual dysfunction. These demographic factors demonstrated varying effects on sexual function, underscoring the complexity of this issue. The results underscore the significance of addressing sexual health concerns in CRC patients and highlight the necessity for tailored interventions to enhance their overall well-being. Healthcare providers should recognize the influence of demographic factors on sexual function and contemplate integrating sexual health assessments and interventions into the care of CRC patients. Further research is needed to comprehend better the underlying mechanisms and devise effective strategies for managing sexual dysfunction in this population.

Reliability and validity of the Turkish version of the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire.

This study aims to adapt and validate the Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire (CCF-CaQL) in Turkish, addressing the significant need for reliable, language-specific QoL measures for colorectal cancer (CRC) in Turkiye. This effort fills a critical gap in CRC patient care, enhancing both patient-provider communication and disease-specific QoL assessment. The CCF-CaQL was translated into Turkish, verified for accuracy, and reviewed for clarity and relevance. Eligible patients who underwent colorectal surgery for cancer between July 2021 and July 2022 from six hospitals completed the CCF-CaQL and SF-36 questionnaires. For analysis, confirmatory factor analysis using Smart PLS 4 and descriptive statistics were employed. The questionnaire's reliability and validity were assessed using Cronbach alpha, composite reliability, and the heterotrait-monotrait (HTMT) ratio, along with multicollinearity checks and factor loadings. Nonparametric resampling was used for precise error and confidence interval calculations, and the Spearman coefficient and split-half method were applied for reliability testing. In the study involving 244 colorectal cancer patients, confirmatory factor analysis of the CCF-CaQL indicated effective item performance, with one item removed due to lower factor loading. The questionnaire exhibited high internal consistency, evidenced by a Cronbach alpha value of 0.909. Convergent validity was strong, with all average variance extracted (AVE) values exceeding 0.4. Discriminant validity was confirmed with HTMT coefficients below 0.9, and no significant multicollinearity issues were observed (VIF values < 10). Parallel testing with the SF-36 scale demonstrated moderate to very strong correlations, affirming the CCF-CaQL's comparability in measuring quality of life. The Turkish version of the CCF-CaQL was validated for assessing quality of life in colorectal cancer patients. This validation confirms its reliability and cultural appropriateness for use in Turkiye. The disease-specific nature of the CCF-CaQL makes it a useful tool in clinical and research settings, enhancing patient care by accurately monitoring treatment effects and interventions in the Turkish colorectal cancer patient population.

The PaCES Study: Cost effectiveness of an early palliative care intervention in patients with advanced colorectal cancer.

20 Background: An early palliative care (PC) pragmatic trial conducted in outpatient cancer clinics for patients living with advanced colorectal cancer (CRC), led to a 17% increase in early referrals (more than 3 months before death). This study evaluates the cost effectiveness of this trial. A lack of timely palliative care is associated with poorer quality of life, poorer symptom control and fewer days spent at home. Improving on this time toxicity is an important part of early palliative care. Methods: This pragmatic controlled before-and-after study was performed in 18 outpatient cancer clinics in two tertiary cancer centers in neighboring metropolitan cities. Baseline phase was from April 2017 to December 2018 with intervention phase only occurring in 1 of the cities, from April 2019 to December 2020. Intervention consisted of systematically screening patients for unmet PC needs, adding a community-based PC nurse specialist and templated ‘shared care’ letters sent from oncologists to primary care providers. Effectiveness was defined as the number of days spent at home in the last 90 days of life, by subtracting days in hospital, residential hospice, emergency department and clinic. A healthcare system perspective was used to calculate total costs in all sectors including hospital, cancer care, home care, palliative care and physician visits. Healthcare outcomes and costs were analysed using a difference-in-differences (DID) method, while accounting for geographic variations and other covariates. Results: A total of 695 decedents were included. There was a 15% decrease in hospital stay and 18% decrease in chemotherapy days in last 90 days of life. The intervention was cost dominant with an overall DID increase of 2.3 community days with an average cost reduction of C$1,942.17 per patient day in the community. Adjusted analysis showed that this difference was not statistically significant. A non-parametric random resampling of the population with 1,000 reiterations (bootstrapping) showed that the likelihood of the program remaining dominant was 69%. The biggest cost contributors were inpatient acute care (53.6%) and residential hospice (33.6%). Conclusions: Integrating early palliative care services into the care of CRC patients’ shows potential for cost savings and more days spent in the community in the last 90 days of life. Measuring time toxicity is a potentially important outcome in early palliative care trials while examining impact on cost.

Whole-course care in photodynamic therapy of colorectal cancer: A short communication

Photodynamic therapy is now widely used in different oncologic fields. It is feasible for the treatment of early, non-surgical and non-obstructive cancers. Also, in gastroenterology, where it was a few attempts to treat both the premalignant lesion and advanced colorectal cancer. Photodynamic therapy provides a new treatment option for advanced colon cancer patients with severe obstruction and elderly patients whose cardiopulmonary function cannot tolerate surgery, and effective nursing support throughout the treatment is the key to ensure successful treatment. This study reported the effect of whole-course care for colorectal cancer patients undergoing photodynamic therapy in the Department of Surgical Oncology, Lanzhou University Second Hospital, Lanzhou, China.

Deep learning imaging reconstruction of reduced-dose 40 keV virtual monoenergetic imaging for early detection of colorectal cancer liver metastases

ObjectiveTo explore whether reduced-dose (RD) gemstone spectral imaging (GSI) and deep learning image reconstruction (DLIR) of 40 keV virtual monoenergetic image (VMI) enhanced the early detection and diagnosis of colorectal cancer liver metastases (CRLM). MethodsThirty-five participants with pathologically confirmed colorectal cancer were prospectively enrolled from March to August 2022 after routine care abdominal computed tomography (CT). GSI mode was used for contrast-enhanced CT, and two portal venous phase CT images were obtained [standard-dose (SD) CT dose index (CTDIvol) = 15.51 mGy, RD CTDIvol = 7.95 mGy]. The 40 keV-VMI were reconstructed via filtered back projection (FBP) and iterative reconstruction (ASIR-V 60 %, AV60) of both SD and RD images. RD medium-strength deep learning image reconstruction (DLIR-M) and RD high-strength deep learning image reconstruction (DLIR-H) were used to reconstruct the 40 keV-VMI. The contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR) of the liver and the lesions were objectively evaluated. The overall image quality, lesion conspicuity, and diagnostic confidence were subjectively evaluated, to compare the differences in evaluation results among the different images. ResultsAll 35 participants (mean age: 59.51 ± 11.01 years; 14 females) underwent SD and RD GSI portal venous-phase CT scans. The dose-length product of the RD GSI scan was reduced by 49–53 % lower than that of the SD GSI scan (420.22 ± 31.95) vs (817.58 ± 60.56). A total of 219 lesions were identified, including 55 benign lesions and 164 metastases, with an average size of 7.37 ± 4.14 mm. SD-FBP detected 207 lesions, SD-AV60 detected 201 lesions, and DLIR-M and DLIR-H detected 199 and 190 lesions, respectively. For lesions ≤ 5 mm, there was no statistical difference between SD-FBP vs DLIR-M (χ2McNemar = 1.00, P = 0.32) and SD-AV60 vs DLIR-M (χ2McNemar = 0.33, P = 0.56) in the detection rate. The CNR, SNR, and noise of DLIR-M and DLIR-H 40 keV-VMI images were better than those of SD-FBP images (P < 0.01) but did not differ significantly from those of SD-AV60 images (P > 0.05). When the lesions ≤ 5 mm, there were statistical differences in the overall diagnostic sensitivity of lesions compared with SD-FBP, SD-AV60, DLIR-M and DLIR-H (P＜0.01). There were no statistical differences in the sensitivity of lesions diagnosis between SD-FBP, SD-AV60 and DLIR-M (both P＞0.05). However, the DLIR-M subjective image quality and lesion diagnostic confidence were higher for SD-FBP (both P < 0.01). ConclusionReduced dose DLIR-M of 40 keV-VMI can be used for routine follow-up care of colorectal cancer patients, to optimize evaluations and ensure CT image quality. Meanwhile, the detection rate and diagnostic sensitivity and specificity of small lesions, early liver metastases is not obviously reduced.

International study on the prevalence of malnutrition in centralized care for colorectal cancer patients.

Patients with different diseases may show signs of malnutrition both before and during the hospital stay. The presence of malnutrition may impact the recovery and length of stay and consequently the costs. Early identification of malnutrition is thus a critical factor. The objective of this multicenter study is to determine the prevalence of malnutrition in colorectal cancer centers. Another objective is to investigate possible consequences, such as complications or length of stay. In addition, the study aims to demonstrate the relevance of nutrition management in colorectal cancer centers. At the same time, relevant requirements clearly demanded by the Certification Commission for Certified Colorectal Cancer Centers are met through implementation of the study. Between 2019 and 2021, patients incolorectal cancer centers were examined in the preoperative phase. In addition to questions about patients' state of health and nutrition, the validated screening forms-Subjective Global Assessment (SGA) and Nutritional Risk Screening Tool 2002 (NRS 2002)-were used to assess malnutrition. The data were processed by univariate analysis. In total, data records of 3,102 patients were evaluated. The mean age of the participants was 68.5 ± 11.9 years, and their average body mass index (BMI) was 26.8 ± 5.3 kg/m2. The SGA questionnaire indicated that 23 % of the participants suffered from malnutrition and 38 % were at risk of malnutrition (NRS≥3). Malnutrition was found more frequently in patients with colorectal carcinomas than in patients with rectal carcinomas (53.1 vs. 32.1 %). The length of stay in hospital and the rate of complications were significantly higher when malnutrition was identified. Approximately one in three to four patients with a colorectal carcinoma has an increased risk of malnutrition. The two screening methods calculated a different prevalence (23 and 38 %). Any malnutrition that is present demonstrably has a significant impact both on the rate of complications and the length of stay and may therefore have a decisive influence on the costs. The results of this multicenter study underscore the need for systematic screening for malnutrition and at the same time should increase clinics awareness of the importance of establishing a nutrition management policy.

Cancer incidence and mortality and state of cancer care for colorectal cancer patients in the Russian Far East.

The aim of the study was to estimate the incidence and mortality rates in patients with colorectal cancer in the Russian Far east in the time period from 2008 to 2020. Material and methods. Cancer incidence and mortality data collected from population-based cancer registries were used. Results. In 2020, the average rate of colorectal cancer incidence in the Russian Far east was 15.29 ± 0.33 per 100,000 men (2019: 15.35 ± 0.36) with an annual percent decrease of 5.40% since 2008. The corresponding rate increased to 12.92 ± 0.23 (2019: 12.98 ± 0.25) per 100,000 women with an annual percent increase of 5.95 %. By the end of the study period the number of new cancer cases increased to 13.2 % (2008: 1.3 %). The percent of morphological confirmation of the diagnosis was lower than in the Russian Federation as a whole (93.4 % versus 96.0; 2008: 84.3 %). The number of patients followed-up for 5 and more years was lower than in the Russian Federation as a whole (52.7 % versus 55.0 %; 2008: 41.9 %). The quality of the cancer service activity was marked by the index of reliability of registration, which was not lower than 0.40 in any of the territories of the district. The average colorectal cancer mortality rate in men was 8.73 ± 0.12 per 100,000 population (2019: 8.72 ± 0.13), which exceeded that in women (6.83 ± 0.10; 2019: 7.37 ± 0.53). The death rate within the first year after diagnosis decreased to 25.0 % (2008: 34.3 %). Conclusion. Unfortunately, the work of primary healthcare organizations responsible for early detection of cancer has not led to significant changes in the incidence rates. (2020: 13.02 0/0000; 2008: 12.9858 0/0000) and mortality rates (2020: 7.4558 0/0000; 2008: 7.6158 0/0000). Cancer screening programs aimed not only at the early cancer detection, but also at the formation of groups being at high risk of cancer are necessary for improving cancer care in the Russian Far east region. These programs should be accompanied by the training of professional staff and the development of modern diagnostic and treatment regimens.

Furthering the clinical development of navicixizumab in advanced epithelial ovarian cancer patients with a population pharmacokinetic model and exploratory exposure-safety-efficacy response analyses (225)

Objectives: Cumulative data from navicixizumab clinical trials were analyzed to establish a population pharmacokinetic model, which was further used to characterize the relationships of navicixizumab exposure with safety and efficacy parameters. Methods: A population pharmacokinetic model was developed using data from clinical trials with navicixizumab in advanced cancer patients (B83-001), in combination with paclitaxel in advanced ovarian cancer patients (B83-002) and combination with standard of care in colorectal cancer patients (B83-003). Exposure-safety analyses focused on the relationship between navicixizumab exposures and systemic hypertension as measured with mean arterial pressure data and incidence of pulmonary hypertension assessed using peak tricuspid velocity data. For the purposes of this analysis, pulmonary hypertension was defined as peak tricuspid velocities >3.4 m/s. Exposure-efficacy analyses focused on objective response rates collected using RECIST version 1.1 and sum of the longest diameters of the target lesion. Results: The overall pharmacokinetic profile of navicixizumab was best described by a 2-compartment model with dose-proportional pharmacokinetics observed at doses ≥ 2.5 mg/kg. The effects of patient weight and patient antidrug antibody (ADA) status were identified as significant covariates in the model, where ADA positivity was associated with reduced clearance values. Changes in mean arterial pressure were concentration-dependent, where both Stage III/IV and ADA positive patients had lesser changes in mean arterial pressures. While peak tricuspid velocities were not related to navicixizumab concentrations, dose, disease stage, or disease indication, pulmonary hypertension was observed as being related to cumulative navicixizumab exposures as measured by AUC and total dose. Navicixizumab exposures were not significantly related to objective response rates. Ovarian stage III/IV cancer patients demonstrated a significant relationship between higher exposure and significantly greater reductions in target tumor size. Conclusions: A robust pharmacokinetic model was developed, demonstrating linear navicixizumab pharmacokinetics at doses ≥ 2.5 mg/kg. While the impact of ADA on navicixizumab clearance was statistically significant, the impact at therapeutically relevant doses was not clinically meaningful. Changes in mean arterial pressures with navicixizumab concentrations support a favorable adverse event profile in the ovarian patient population, while cumulative dose and exposures are associated with peak tricuspid velocities ≥ 3.4 m/s. When both ORR and changes in target tumor size were considered, cumulative navicixizumab exposures were associated with increased efficacy in ovarian cancer patients. Cumulative data reported herein support continued clinical development of navicixizumab, especially in ovarian cancer patients. Objectives: Cumulative data from navicixizumab clinical trials were analyzed to establish a population pharmacokinetic model, which was further used to characterize the relationships of navicixizumab exposure with safety and efficacy parameters. Methods: A population pharmacokinetic model was developed using data from clinical trials with navicixizumab in advanced cancer patients (B83-001), in combination with paclitaxel in advanced ovarian cancer patients (B83-002) and combination with standard of care in colorectal cancer patients (B83-003). Exposure-safety analyses focused on the relationship between navicixizumab exposures and systemic hypertension as measured with mean arterial pressure data and incidence of pulmonary hypertension assessed using peak tricuspid velocity data. For the purposes of this analysis, pulmonary hypertension was defined as peak tricuspid velocities >3.4 m/s. Exposure-efficacy analyses focused on objective response rates collected using RECIST version 1.1 and sum of the longest diameters of the target lesion. Results: The overall pharmacokinetic profile of navicixizumab was best described by a 2-compartment model with dose-proportional pharmacokinetics observed at doses ≥ 2.5 mg/kg. The effects of patient weight and patient antidrug antibody (ADA) status were identified as significant covariates in the model, where ADA positivity was associated with reduced clearance values. Changes in mean arterial pressure were concentration-dependent, where both Stage III/IV and ADA positive patients had lesser changes in mean arterial pressures. While peak tricuspid velocities were not related to navicixizumab concentrations, dose, disease stage, or disease indication, pulmonary hypertension was observed as being related to cumulative navicixizumab exposures as measured by AUC and total dose. Navicixizumab exposures were not significantly related to objective response rates. Ovarian stage III/IV cancer patients demonstrated a significant relationship between higher exposure and significantly greater reductions in target tumor size. Conclusions: A robust pharmacokinetic model was developed, demonstrating linear navicixizumab pharmacokinetics at doses ≥ 2.5 mg/kg. While the impact of ADA on navicixizumab clearance was statistically significant, the impact at therapeutically relevant doses was not clinically meaningful. Changes in mean arterial pressures with navicixizumab concentrations support a favorable adverse event profile in the ovarian patient population, while cumulative dose and exposures are associated with peak tricuspid velocities ≥ 3.4 m/s. When both ORR and changes in target tumor size were considered, cumulative navicixizumab exposures were associated with increased efficacy in ovarian cancer patients. Cumulative data reported herein support continued clinical development of navicixizumab, especially in ovarian cancer patients.

Study Protocol for a Randomised Controlled Trial on Pulmonary Metastasectomy vs. Standard of Care in Colorectal Cancer Patients With ≥ 3 Lung Metastases (PUCC-Trial).

This is a multicentre prospective randomised controlled trial for patients with 3 or more resectable pulmonary metastases from colorectal carcinoma. The study investigates the effects of pulmonary metastasectomy in addition to standard medical treatment in comparison to standard medical treatment plus possible local ablative measures such as SBRT. This trial is intended to demonstrate an overall survival difference in the group undergoing pulmonary metastasectomy. Further secondary and exploratory endpoints include quality of life (EORTC QLQ-C30, QLQ-CR29 and QLQ-LC29 questionnaires), progression-free survival and impact of mutational status. Due to the heterogeneity and complexity of the disease and treatment trajectories in metastasised colorectal cancer, well powered trials have been very challenging to design and execute. The goal of this study is to create a setting which allows treatment as close to the real life conditions as possible but under well standardised conditions. Based on previous trials, in which patient recruitment in the given setting hindered successful study completion, we decided to (1) restrict inclusion to patients with 3 or more metastases (since in case of lesser, surgery will probably be the preferred option) and (2) allow for real world standard of care (SOC) treatment options before and after randomisation including watchful waiting (as opposed to a predefined treatment protocol) and (3) possibility that patient can receive SOC externally (to reduce patient burden). Moreover, we chose to stipulate 12 weeks of systemic treatment prior to possible resection to further standardize treatment response and disease course over a certain period of time. Hence, included patients will be in the disease state of oligopersistence rather than primary oligometastatic. The trial was registered in the German Clinical Trials Register (DRKS-No.: DRKS00024727).

Real-world utilization of ctDNA in the management of colorectal cancer.

3075 Background: The utilization of circulating tumor DNA (ctDNA) as a non-invasive biomarker for the detection of minimal residual disease, prediction of recurrence in the post-operative setting, and real-time monitoring of treatment efficacy has the potential to vastly improve the care and outcomes of patients with colorectal cancer (CRC). In August of 2020, ctDNA testing first gained approval for use in solid tumors and its prognostic benefit after curative intent surgery has been demonstrated to exceed that of prior standard of care clinicopathological criteria in CRC patients. The comprehensive integration of validated ctDNA approaches into the routine clinical care of patients with CRC would not only fundamentally change how risk of recurrence is assessed but could also reduce treatment with unneeded/unwarranted toxic therapies and allow for earlier recognition and treatment in cases with a high risk of relapse. This survey-based study aimed to evaluate the utilization of ctDNA testing in the management of CRC among practicing community oncologists in the U.S. Methods: Questions related to ctDNA utilization for patients with CRC were presented to community oncologists during a virtual meeting held in July 2021. Descriptive statistics were used to analyze the results. Results: Of 55 participating oncologists geographically distributed across the U.S., 49% indicated not using ctDNA to make treatment decisions in CRC. A proportion of physicians reported using ctDNA to detect recurrence (27% of physicians); make decisions around post-resection adjuvant therapy (25%); monitor disease progression/relapse (18%); and track tumor resistance during treatment (9%). The most frequently cited barriers to ordering ctDNA testing for patients with metastatic CRC were reimbursement issues (reported by 56% of oncologists), insufficient clinical evidence (46%), and limited familiarity with ctDNA use (28%). Oncologists reported that the following would increase their utilization of ctDNA testing: more clinical evidence of the utility of ctDNA (reported by 66% of physicians), increased education on methodology (60%), more education on the use of ctDNA (57%), more financial aid and reimbursement support for patients (49%), more decision support tools (47%), and better communication between physicians and vendors (26%). Conclusions: These findings demonstrate limited adoption of ctDNA testing by community oncologists in the care of CRC patients. Insufficient demonstration of clinical utility, limited familiarity with methodology, and reimbursement issues were cited as barriers to uptake. Education for community oncology providers about ctDNA testing and its demonstrated clinical utility, and increased financial support for patients may improve its utilization and adoption in CRC to improve patient outcomes and care.

Empowering colorectal cancer patients and caregivers through clinical trials education in COLONTOWN.

e24129 Background: Clinical trials are increasingly part of the continuum of care for colorectal cancer patients, particularly those with metastatic disease. Yet most patients have limited knowledge about clinical trials, and many struggle to navigate the myriad barriers to enrollment. To bridge this gap, PALTOWN supports a broad array of activities in its COLONTOWN online community to help patients and caregivers interested in pursuing clinical trials. The function and impact of these activities is examined here. Methods: A comprehensive inventory of all clinical trial-related activity was conducted across three main sources: 1) resources and activity in COLONTOWN’s nine clinical trial-focused groups; 2) clinical trial materials posted in COLONTOWN UNIVERSITY, an online disease education center; and 3) patient feedback on clinical trial programming. Results: The MSS and MSI-High clinical trial groups in COLONTOWN serve more than 2,200 members, and more than 1,000 members are served by mutation- and location-specific trial groups. These groups have helped at least 187 members enroll in a clinical trial between 2019 and 2022. Among 10 trial-related activities, a majority (6/10) focused on sharing biomedical information, including : 1) patient-friendly descriptions of new trials; 2) explanations of trial results; 3) abstracts, articles, and videos from professional outlets such as ASCO Daily Post and OncLive; 4) patient-created resources on clinical trial basics in COLONTOWN UNIVERSITY; 5) “Doc Talks” by prominent CRC oncologists; and 6) patient advocates serving as information liaisons between patients and NCI Task Forces. A smaller number of activities (3/10) focused on psycho-social support from peers, including 1) accounts of patient experiences while seeking and participating in trials; 2) strategy discussions about how and when to pursue trials; and 3) “Alanna Project” database of members on a trial. COLONTOWN’s Clinical Trial Workshop (1/10) offers a novel approach to integrating biomedical education with psycho-social support via a four-week, peer-led clinical trial navigation program. Assessment of the cognitive and behavioral outcomes of the workshop demonstrate improvements in all four dimensions of health literacy: the ability to access, understand, appraise, and apply relevant information in the search for clinical trials. Conclusions: COLONTOWN's clinical trial programming offers comprehensive clinical trial education to patients and caregivers that leads to enrollment in trials. By embedding that education within a supportive community of peers, it enhances patients' capacity to collaborate with health care professionals in making informed decisions about clinical trials.

Impact of the COVID-19 pandemic on colorectal cancer (CRC) care: Data from 22 German cancer centers (CC) and the Institute of Pathology, Ruhr-University Bochum - the AIO (Working Group for Internal Oncology of the German Cancer Society) CancerCOVID Consortium - AIO-YMO/KRK 520/ass.

3626 Background: CRC still is one of the leading causes of cancer related death though prognosis has improved through guideline based management. The COVID-19 pandemic lead to re-allocation of resources subordinating all sections of care for CRC patients. We present data on changes of CRC care during the pandemic from 22 German AIO CC and our high volume Institute of Pathology (pathology). Methods: Data was collected retrospectively comparing the months (mo) of the first wave (fw) (4-6/2020) and second wave (sw) (11-12/2020) of the pandemic with corresponding periods (cp) in 2019 focusing on the number of precancerous (ICD-O/0+2) and malignant (ICD-O/3+6) colorectal lesions (CRL) diagnosed by our pathology, the number/stage of primary diagnoses (PD) and the number of surgeries (surg) at AIO CC. There, quality criteria of CRC care were also assessed (number of PD discussed within a multidisciplinary tumor board (tb), received social service (soc)/ psychological (psy) counseling or recruited into a clinical trial). Statistical analysis was performed using students t-test for paired data. Results: Numbers of CRL detected upon histology (row 1-3), number of cases, surg and quality criteria from AIO CC (row 4-9) are displayed in the table. We saw a dip in diagnosed CRL and number of surg (p=0.007) only during fw, whereas PD dipped significantly in both waves. A significant reduction in diagnosis of stage III CRC was detected for 2019 vs. 2020 (p=0.001), not for other stages. Quality criteria showed a significant reduction in clinical trial inclusion, a small dip in soc/psy counseling and persistently high tb presentation. Conclusions: We detected a significant decrease of premalignant lesions and primary cancers during the first year of the pandemic which may impact cancer mortality in the future. Certified German CC provided CRC care with significant reduction in clinical trial inclusion only, suggesting high stability of established certified cancer care infrastructure.[Table: see text]

Effectiveness of care transition strategies for colorectal cancer patients: a systematic review and meta-analysis.

Implementing effective strategies to transition care for individuals with colorectal cancer is an important tool to qualify care for affected individuals, as well as contribute to the dispensation of continuous and quality care to patients. To evaluate the effectiveness of strategies to transition from hospital care to the community compared to usual care for colorectal cancer patients to reduce hospital stay, readmissions at 30days, and visit to the emergency department up to 30days. Systematic review and meta-analysis followed the recommendations of PRISMA statement, with protocol registered in PROSPERO (CRD 42,020,162,249). Searches were carried out in May 2020 in the following databases: PubMed/MEDLINE, LILACS, EMBASE, and Cochrane Central. Meta-analysis was performed using a random-effects model. The measure of effect used for dichotomous outcomes was relative risk, and for continuous outcomes, the difference of means was used, with their confidence intervals of 95%. Heterogeneity was evaluated using inconsistency statistics. Of 631 identified studies, seven studies were included. The meta-analysis of the studies showed a reduction in readmissions at 30days of 32% and a significant reduction in hospital stay time of approximately one and a half days, both of which were analyzed in favor of the group of care transition interventions. The findings showed effective care transition strategies for the transition of colorectal cancer patients, such as post-discharge active surveillance program, standardized protocol of improved recovery, and telephone follow-up. CRD42020162249.

Addressing the Quality of Hospital Care of Colorectal Cancer Patients Undergoing Surgery: What Can We Learn From the National Bowel Cancer Audit?

IntroductionThe National Bowel Cancer Audit (NBOCA) is the largest database in the United Kingdom that audits real-world data and allows comparison of the quality of care for colorectal cancer patients. This study aimed to highlight relevant clinical factors in the NBOCA that contribute to variation in the quality of care provided in different hospitals.MethodsData from 36,116 patients with colorectal cancer who had undergone surgery were obtained from the NBOCA. These were patients from 145 and 146 hospitals from the years 2016 and 2017, respectively. A validated multiple linear regression was performed to compare the identified clinical factors with various quality outcomes. The quality outcomes defined in this study were the length of hospital stay of more than five days, two-year mortality, 30-day unplanned readmission rate, 90-day mortality, and 18-month stoma rate.ResultsFour clinical factors (laparoscopy rate, abdominal-perineal-resection-of-rectum, pre-operative radiotherapy, and patients with distant metastases) were shown to have a significant (p < 0.05) impact on the length of hospital stay of more than five days and the 18-month stoma rate. The 18-month stoma rate was also a significant predictor (p < 0.001) with two-year mortality.ConclusionThe NBOCA should consider adjusting for these factors when reporting the quality of care provided in hospitals. Hospitals should monitor the four clinical factors for colorectal cancer patients during perioperative care. When formulating a management plan for patients with colorectal cancer, clinicians should consider these factors along with the individual patient's history.

The impact of the COVID-19 pandemic on colorectal cancer diagnosis and management: a Binational Colorectal Cancer Audit study.

The COVID-19 pandemic has resulted in global disruptions to the delivery of healthcare. The national responses of Australia and New Zealand has resulted in unprecedented changes to the care of colorectal cancer patients, amongst others. This paper aims to determine the impact of COVID-19 on colorectal cancer diagnosis and management in Australia and New Zealand. This is a multicentre retrospective cohort study using the prospectively maintained Binational Colorectal Cancer Audit (BCCA) registry. Data is contributed by over 200 surgeons in Australia and New Zealand. Patients receiving colorectal cancer surgery during the pandemic were compared to averages from the same period over the preceding 3 years. There were fewer operations in 2020 than the historical average. During April to June, patients were younger, more likely to have operations in public hospitals and more likely to have urgent or emergency operations. By October to December, proportionally less patients had Stage I disease, proportionally more had Stage II or III disease and there was no difference in Stage IV disease. Patients were less likely to have rectal cancer, were increasingly likely to have urgent or emergency surgery and more likely to have a stoma created. This study shows that the response to COVID-19 has had measurably negative effects on the diagnosis and management of colorectal cancer in two countries that have had significantly fewer COVID-19 cases than many other countries. The long-term effects on survival and recurrence are yet to be known, but could be significant.

472 Addressing the Quality of Hospital Care of Colorectal Cancer Patients Undergoing Surgery: What Did We Learn from the National Bowel Cancer Audit?

Abstract Aim To identify the most relevant clinical factors in the National Bowel Cancer Audit (NBOCA) that contribute to the variation in the quality of care provided in different hospitals for colorectal cancer patients undergoing surgery. Method Data from 36,116 patients with colorectal cancer who had undergone surgery were retrospectively collected from the NBOCA and analysed from 145 and 146 hospitals over two years. A validated multiple linear regression was performed to compare the identified clinical factors with various quality outcomes. The quality outcomes defined in this study were the length of hospitalisation, 2-year mortality, readmission rate, 90-day mortality, and 18-month stoma rate. Results Four clinical factors (laparoscopy rate, abdominal-perineal-resection-of-rectum (APER), pre-operative radiotherapy and patients with distant metastases) were shown to have a significant (p &amp;lt; 0.05) impact on the length of hospitalisation and 18-month stoma rate. 18-month stoma rate was also significantly associated with 2-year mortality. External validation of the regression model demonstrated the Root-Mean-Square-Error of 0.811 and 4.62 for 18-month stoma rate and 2-year mortality respectively. Conclusions Hospitals should monitor the four clinical factors for patients with colorectal cancer during perioperative care. Clinicians should consider these factors along with the individual patients’ history when formulating a management plan for patients with colorectal cancer.