Treatment decisions for metastatic colorectal cancer (mCRC) require patients to balance survival benefits, health-related quality of life (HRQoL), and potential risks of side effects while also factoring in their own preferences for different treatment options. Despite growing interest, quantitative patient preferences are not yet integrated into health technology assessments (HTAs) for drug reimbursement recommendations. The Colorectal Cancer Canada’s Patient Values Project aims to explore approaches to incorporate quantitative patient preferences into cancer treatment HTA decision-making processes. As a first step, we elicited the treatment preferences and risk tolerance of patients with mCRC in Canada using a multi-method approach. We developed a preference survey that included two discrete choice experiments (DCEs) and case 1 best–worst scaling (BWS-1) to estimate preferences for mCRC treatments. DCE1 included change in HRQoL and overall survival as attributes, and treatment attributes in DCE2 were administration and frequency, side effects (nausea, pain, diarrhea), and progression-free survival. The BWS-1 included 25 attributes of potential mCRC treatment side effects based on the cancer-specific quality-of-life questionnaire. The survey was administered across Canada to patients with mCRC aged ≥ 18 years with a self-reported diagnosis of mCRC through patient organizations, cancer centers, and an online panel. Data were analyzed using mixed logit and latent class models (DCEs) and count-based analysis (BWS-1). Overall, 127 patients with mCRC completed the full survey (n = 143 fully completed DCE1, n = 108 fully completed DCE2, n = 127 fully completed BWS-1). Relative preferences for the treatment attributes in the study were consistent with the expectation that better clinical outcomes were preferred over worse clinical outcomes. In DCE1, patients valued both overall survival (24 vs. 12 months) and HRQoL (improvement to 90 vs. worsens to 50 out of 100) as almost equally important. In DCE2, patients preferred better outcomes (longer progression-free survival and no side effects) over worse outcomes, with a disutility for oral capsules/pills compared with intravenous infusions. Significant preference heterogeneity was observed depending on experiences with CRC treatments, treatment side effects, and health status. In the BWS-1, “need help with eating, dressing, washing yourself or using the toilet”, “vomiting”, and “pain” were ranked as the least and “need to rest”, “trouble doing strenuous activities”, and “feel tired” as the most tolerable side effects. This study highlights the value of a multi-method approach in comprehensively assessing treatment preferences and risk tolerance in mCRC. By triangulating multiple preference-elicitation methods, our findings offer a more robust foundation for integrating patient perspectives into Canada’s HTA framework. These results will inform the next step of the Colorectal Cancer Canada’s Patient Values Project, which aims to explore approaches to explicitly incorporate patient preferences alongside clinical and economic evidence into the cancer treatment HTA decision-making process in Canada.
The Supplemental Materials and Methods file depicts a representative graphical report provided to participants at Visits 1 and 2 that illustrates the participant’s estimated 5-year, 10-year, and remaining lifetime breast cancer risk (determined by NCI-BCRAT and IBIS with and without PRS).
Supplemental Figure 1: The Study Schema Defines Information Collected During Each Patient Visit and at Each Follow-Up Time Point. Visit 1 consisted of a baseline breast cancer risk assessment (NCI-BCRAT and IBIS BC risk scores without PRS) and discussion of risk-reducing options, including ET, with a participating physician or nurse practitioner. During Visit 2, NCI-BCRAT and IBIS BC risk scores, with and without PRS, were presented and explained to participants, and ET risks, benefits, and potential adverse effects were discussed again. ET prescriptions were provided to those who wished to proceed. The participants completed the same survey as was completed after Visit 1. Follow-up assessments were performed 1 and 2 years after Visit 2 and evaluated QOL with the FACT-GP/ES questionnaire.
Abstract Refinement of breast cancer risk estimates with a polygenic-risk score (PRS) may improve uptake of risk-reducing endocrine therapy (ET). A previous clinical trial assessed the influence of adding a PRS to traditional risk estimates on ET use. We stratified participants according to PRS-refined breast cancer risk and evaluated ET use and ET-related quality of life (QOL) at 1-year (previously reported) and 2-year follow-ups. Of 151 participants, 58 (38.4%) initiated ET, and 22 (14.6%) discontinued ET by 2 years; 42 (27.8%) and 36 (23.8%) participants were using ET at 1- and 2-year follow-ups, respectively. At the 2-year follow-up, 39% of participants with a lifetime breast cancer risk of 40.1% to 100.0%, 18% with a 20.1% to 40.0% risk, and 16% with a 0.0% to 20.0% risk were taking ET (overall P = 0.01). Moreover, 40% of participants whose breast cancer risk increased by 10% or greater with addition of the PRS to a traditional breast cancer-risk model were taking ET versus 0% whose risk decreased by 10% or greater (P = 0.004). QOL was similar for participants taking or not taking ET at 1- and 2-year follow-ups, although most who discontinued ET did so because of adverse effects. However, these QOL results may have been skewed by the long interval between QOL surveys and lack of baseline QOL data. PRS-informed breast cancer prevention counseling has a lasting, but waning, effect over time. Additional follow-up studies are needed to address the effect of PRS on ET adherence, ET-related QOL, supplemental breast cancer screening, and other risk-reducing behaviors. Prevention Relevance: Risk-reducing medications for breast cancer are considerably underused. Informing women at risk with precise and individualized risk assessment tools may substantially affect the incidence of breast cancer. In our study, a risk assessment tool (IBIS-polygenic-risk score) yielded promising results, with 39% of women at highest risk starting preventive medication.
12116 Background: Pancreatic cancer (PDAC) is an aggressive, deadly disease. Chemotherapy (CT) can improve survival by months, but symptom burden is heavy and quality of life (QOL) is poor. Early palliative care (EPC) alongside standard oncologic care improves QOL and survival in other types of cancer; however, the impact on QOL and symptom burden in advanced PDAC is not known. The primary objective of this study was to test for improvement in QOL between baseline (BL) and 16 weeks (wks) among patients receiving EPC. A secondary objective was to test for decreased symptom burden between BL and 16 wk. Methods: In this prospective case-crossover study, patients >18 years with advanced PDAC received EPC provided by a subspecialist palliative care physician and advanced practice nurse plus standard oncologic care. Ambulatory EPC visits occurred every 2 wks for the first month, then every 4 wks until wk 16, and then as needed. The Functional Assessment of Cancer Therapy – hepatobiliary (FACT-hep) and Edmonton Symptom Assessment System (ESAS) questionnaires were completed at enrollment and every 4 wks until wk 16. Least square means and 95% confidence intervals were computed. A generalized linear mixed model was used to test for statistically significant change in scores between BL and wk 16. A sample size of 20 patients provides 80% power after controlling for covariates; 40 patients were enrolled to account for anticipated attrition and missing data. Results: Of 40 patients, 25 (62.5%) were male, 28 (70%) had metastatic disease, 31 (77.5%) had an ECOG performance status of 0-1, 17 (42.5%) had a body mass index (BMI) >25, 35 (89.7%) had an elevated CA19-9 and 31 (77.5%) received CT. Median age was 70.2 (range 63.0-77.5). BL and wk 16 questionnaires were completed by 100% and 70% of patients, respectively. The mean FACT-hep score at BL was 118.8, compared to 125.7 at wk 16, for a mean change of 6.89, [95%CI (-1.69-15.6); p = 0.11]. The mean change from BL to wk 16 for FACT-hep was statistically significant in patients receiving CT, 10.1 [95%CI (0.32-19.8); p = 0.04], patients with metastatic disease, 14.7 [95%CI (5.30-24.1); p = 0.0030] and patients with a BMI >25, 12.5 [95%CI (1.29-23.7); p = 0.03]. The mean ESAS total symptom score at BL was 25.3, compared to 22.7 at wk 16 (p = 0.28). In those with metastatic disease the mean change was statistically significant, -5.73 [95%CI (-11.21 to -0.24); p = 0.04]. Conclusions: EPC resulted in improved QOL in pts with PDAC receiving CT and those with a BMI >25, and improved QOL and symptom burden in patients with metastatic disease. Given minimal attrition and high rates of questionnaire completion, our sample size was robust, resulting in strong power. Providing palliative care alongside standard oncologic care results in clinically meaningful improvements. Access to palliative care, shortly after diagnosis, should be available for patients with advanced PDAC. Clinical trial information: NCT03837132.
The urgent cancer care (UCC) clinic at CancerCare Manitoba (CCMB) opened in 2013 to provide care to individuals diagnosed with cancer and serious blood disorders experiencing complications from the underlying disorder or its treatment. This study examined the impact of the UCC clinic on other health care utilization in Winnipeg, Manitoba, Canada. An interrupted time series study design was used to compare the rates of emergency department (ED) visits, primary care clinician (PCC) visits, and hospitalizations from 1 January 2010 to 31 December 2015. Rates of ED visits were also stratified by ED location, severity, and cancer type. We found a 6% (95% CI 1.00–1.13, p-value = 0.0389) increase in PCC visits, a 7% (95% CI 0.99–1.15, p-value = 0.0737) increase in hospitalizations, a 4% (95% CI 0.86–1.08, p-value = 0.5053) decrease in the rate of ED visits, and a 3% (95% CI 0.92–1.17, p-value = 0.5778) increase in the rate of ED visits during the UCC clinic hours after the UCC clinic opened. The implementation of the UCC clinic had minimal impact on health care utilization. Future work should examine the impact of the UCC clinic on other aspects of healthcare utilization (e.g., number of tests ordered and time spent waiting in CCMB’s main clinics) and patient quality of life and patient and health care provider experience.
The modern management of rectal cancers continues to evolve. With the release of data from new landmark randomized controlled trials (RAPIDO, PRODIGE-23), total neoadjuvant therapy (TNT) has moved to the forefront of locally advanced rectal cancer treatment and is considered a standard option in selected patients. Total neoadjuvant therapy promises enhanced systemic disease control, better treatment adherence and less time with an ostomy. However, TNT as currently described encompasses a number of different potential treatment options that differ significantly in terms of their radiation dosage, chemotherapy regimen and order of treatments administered. Being familiar with TNT regimens will be important for rectal cancer surgeons to appropriately advocate for their patients and optimize their outcomes. This article serves as a primer for the general surgeon and offers a pragmatic overview of the indications, realistic expected benefits and potential downsides of each TNT regimen.
Abstract Background: Preventive endocrine therapy (ET) has been proven extensively to decrease breast cancer (BC) risk by 50-65%. Despite this significant reduction, a small proportion of high risk women take ET, due to attitudes toward medications, inaccurate risk perception and drug side-effects. The addition of a polygenic risk score (PRS), comprised of 77 BC genetic susceptibility loci (Single Nucleotide Polymorphisms (SNP)), to the standard risk calculator estimates, can be used to improve BC risk estimation. We previously reported on the influence of the PRS-adjusted BC risk estimates on the intent to use ET (Abstract, SABCS, 2019). Here we report on the influence of PRS-adjusted BC risk estimates on ET adherence at 1 and 2 year follow –up. We also report on ET side effects over this same time period. Methods: Women older than age 35 were eligible if they were deemed at high risk for BC by either a 5 year Gail Model risk of ≥3% or 10 year Tyrer-Cuzick risk (IBIS) of ≥5%. We excluded women with a personal history of BC or hereditary BC syndromes. At baseline, participants were counseled on their BC risk using standard risk calculators: Gail and IBIS risk scores (5 yr, 10 yr, & lifetime) and ET options were discussed, including benefits and risks. Blood samples were obtained and genotyped for 77 SNPs, and an updated BC -PRS risk report was shared with study participants that reflected the IBIS and Gail risk predictions for 5 yr, 10 yr, & lifetime BC risk with and without the PRS. A baseline self-reported questionnaire assessed understanding of BC risk and decision to take ET. Follow-up questionnaires at 1 and 2 years assessed self-reported ET adherence and ET side effects (vasomotor symptoms, vaginal symptoms, sexual dysfunction, weight gain, GI symptoms, headaches, breast sensitivity, mood changes, and joint pain). Adherence to ET at 1 and 2 year follow-up was stratified by three categories of lifetime PRS-BC risk: 0-20%; 20-40%; 40-100%. Results: 151 women at Mayo Clinic Rochester and CancerCare Manitoba were enrolled in the study from 2016 to 2017. Of the 149 participants with evaluable data at 1 and 2 year follow-up, 57 (38%) started on ET therapy, all within 1 year of the baseline visit; 43 (29%) were taking ET at 1 year and 33 (22%) were taking ET at 2 year follow-up, representing a discontinuation rate of 26% at 1 year and 42% at 2 year follow-up. Adherence to ET use at 1 year and 2 year follow-ups correlated significantly with the category of PRS-BC risk estimation: at 1 year follow up, 17% of those in the lowest PRS-IBIS risk category, 23% in the middle risk category and 50% of those in the highest risk category were taking ET (p=0.001). At 2 year follow up, 12% of those in the lowest PRS-IBIS risk category, 18% in the middle risk category and 38% of those in the highest risk category were taking ET (p=0.008). At 1 year follow up, participants taking ET reported significantly more bothersome symptoms of vaginal itching (p=0.010), weight gain (p=0.015) and joint pain (p=0.044), compared with those not on ET. There was a trend towards increased irritability and mood swings on those taking ET (p=0.059). At year 2 there was no significant difference in side effects between those taking and not taking ET. Conclusion: Adherence to ET in a population of women at high risk for BC decreased overtime and strongly correlated with the level of risk, with 38% of those at highest risk of breast cancer taking ET at 2 year follow up. Side effects of vaginal itching, weight gain and body aches were more common on those taking ET versus not taking ET at the 1 year follow-up, but did not differ at 2 year follow-up, possibly due to the fact that those with the most bothersome symptoms have discontinued ET by the 2 year follow up. Citation Format: Daniela Stan, Julian Kim, Daniel Schaid, Erin Carlson, Andrew Cooke, Christina A. Kim, Benjamin Goldenberg, Jason Sinnwell, Debjani Grenier, Amy Degnim, Fergus Couch, Celine Vachon, Sandhya Pruthi. Influence of a breast cancer polygenic risk score on adherence to preventive endocrine therapy in high risk women at 1 and 2 year follow-up: The genetic risk estimate (GENRE) trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS8-02.
AbstractBackgroundCapecitabine is a pyrimidine antimetabolite that inhibits thymidylate synthase and is commonly used in the treatment of colorectal cancer. Adverse cardiac side effects are reported in 1–18% of patients receiving Capecitabine. The most commonly proposed mechanism of cardiotoxicity in the setting of Capecitabine use is vasospasm of the coronary arteries. However, cardiotoxicity can also present as an acute coronary syndrome, arrhythmia, hypertension, and/or sudden cardiac death. Profound non-vasospastic cardiotoxicity is rare.Case summaryWe describe two cases of acute heart failure leading to cardiogenic shock in patients shortly after exposure to Capecitabine. Both patients did not demonstrate the characteristic transient ST elevation seen in patients with coronary artery vasospasms secondary to Capecitabine. Both patients required admission to the Acute Cardiac Care Unit requiring vasopressor and inotropic support. Thorough diagnostic investigations including echocardiography, cardiac magnetic resonance imaging, and cardiac computed tomography did not identify infarction, myocarditis, or any infiltrative process to explain their symptoms. Both patients had complete resolution of cardiac function, with no long-term sequalae.DiscussionIn patients receiving Capecitabine, reversible heart failure leading to cardiogenic shock should be considered as a potential cardiotoxic side effect.
In 2013, CancerCare Manitoba (CCMB) launched an urgent cancer care clinic (UCC) to meet the needs of individuals diagnosed with cancer experiencing acute complications of cancer or its treatment. This retrospective cohort study compared the characteristics of individuals diagnosed with cancer that visited the UCC to those who visited an emergency department (ED) and determined predictors of use. Multivariable logistic mixed models were run to predict an individual’s likelihood of visiting the UCC or an ED. Scaled Brier scores were calculated to determine how greatly each predictor impacted UCC or ED use. We found that UCC visits increased up to 4 months after eligibility to visit and then decreased. ED visits were highest immediately after eligibility and then decreased. The median number of hours between triage and discharge was 2 h for UCC visits and 9 h for ED visits. Chemotherapy had the strongest association with UCC visits, whereas ED visits prior to diagnosis had the strongest association with ED visits. Variables related to socioeconomic status were less strongly associated with UCC or ED visits. Future studies would be beneficial to planning service delivery and improving clinical outcomes and patient satisfaction.
AbstractEndocrine therapy is underutilized to reduce breast cancer incidence among women at increased risk. Polygenic risk scores (PRSs) assessing 77 breast cancer genetic susceptibility loci personalizes risk estimates. We examined effect of personalized PRS breast cancer risk prediction on intention to take and endocrine therapy uptake among women at increased risk. Eligible participants had a 10-year breast cancer risk ≥5% by Tyrer–Cuzick model [International Breast Cancer Intervention Study (IBIS)] or ≥3.0 % 5-year Gail Model risk with no breast cancer history or hereditary breast cancer syndrome. Breast cancer risk was estimated, endocrine therapy options were discussed, and endocrine therapy intent was assessed at baseline. After genotyping, PRS-updated breast cancer risk estimates, endocrine therapy options, and intent to take endocrine therapy were reassessed; endocrine therapy uptake was assessed during follow-up. From March 2016 to October 2017, 151 patients were enrolled [median (range) age, 56.1 (36.0–76.4 years)]. Median 10-year and lifetime IBIS risks were 7.9% and 25.3%. Inclusion of PRS increased lifetime IBIS breast cancer risk estimates for 81 patients (53.6%) and reduced risk for 70 (46.4%). Of participants with increased breast cancer risk by PRS, 39 (41.9%) had greater intent to take endocrine therapy; of those with decreased breast cancer risk by PRS, 28 (46.7%) had less intent to take endocrine therapy (P < 0.001). On multivariable regression, increased breast cancer risk by PRS was associated with greater intent to take endocrine therapy (P < 0.001). Endocrine therapy uptake was greater among participants with increased breast cancer risk by PRS (53.4%) than with decreased risk (20.9%; P < 0.001). PRS testing influenced intent to take and endocrine therapy uptake. Assessing PRS effect on endocrine therapy adherence is needed.Prevention Relevance: Counseling women at increased breast cancer risk using polygenic risk score (PRS) risk estimates can significantly impact preventive endocrine therapy uptake. Further development of PRS testing to personalize breast cancer risk assessments and endocrine therapy counselling may serve to potentially reduce the incidence of breast cancer in the future.
Abstract Background: Studies demonstrate breast cancer risk reduction of 50-65% with the use of endocrine therapy (ET) and yet drug uptake and adherence in this setting is suboptimal even among high risk women. A Polygenic Risk Score (PRS) comprised of 77 BC genetic susceptibility loci (Single Nucleotide Polymorphisms (SNP)) can provide a personalized risk assessment and potentially influence ET adherence. We assessed ET adherence at 1 year comparing women whose risk estimate increased due to PRS versus women whose risk estimate decreased due to PRS. The effect of ET use on quality of life (hot flashes, night sweats, vaginal dryness, weight gain, joint pain) was evaluated. Methods: Eligible women required either a 5 year Gail Model risk of ≥3% or 10 year IBIS ( International Breast Intervention Study or Tyrer-Cuzick model) of ≥5%. Women with a history of breast cancer (BC) or hereditary BC syndrome were excluded. High risk women were counseled at baseline using their Gail and IBIS risk scores and ET options were discussed including benefits and risks. Participants completed a self-reported questionnaire at baseline to assess their understanding of breast cancer risk and decision to take preventive ET. Blood samples were obtained and genotyped for 77 SNPs, and the odds ratio from the SNPs were used to modify the IBIS and Gail risk estimates. The BC -PRS risk estimate information was shared with study participants that reflected the IBIS and Gail risk estimates for 5 year, 10 year, & lifetime BC risk with and without the PRS. Follow up questionnaires at year 1 were administered to assess drug adherence and ET usage on quality of life. Results: 151 women were enrolled at Mayo Clinic Rochester and CancerCare Manitoba from 2016 to 2017. The median age was 56.1 (range 36-76.4), 35.6% were premenopausal, 98.7% were Caucasian and 64.7% had>1 family member with BC. Median 5yr, 10yr, & lifetime IBIS- PRS risk estimates were 3.8% (2.0-11.5), 7.9% (5.0-23.1), and 25.3% (5.5 to 92.2). At year 1 (n=112 women) 46 % of those with an increase in risk when considering the BC-PRS score and 16 % with a decrease in risk were taking ET ( p< 0.001). Types of ET taken: tamoxifen-18, raloxifene- 3, exemestane -14 and missing-1. Women taking ET reported weight gain ( 19.4% vs 6.7%, p=0.04) and more joint pain ( 27.8 % vs 12%, p=0.04) when compared to women not taking ET. Conclusion: In high risk women, BC-PRS risk estimates in addition to standard BC risk calculators had a significant impact on preventive ET adherence. ET use was associated with weight gain and joint pain. Citation Format: Sandhya Pruthi, Julian O Kim, Daniel Schaid, Andrew Cooke, Christina Kim, Benjamin Goldenberg, Jason Sinnwell, Debjani Grenier, Fergus Couch, Celine Vachon. Impact of the breast cancer polygenic risk score on preventive endocrine therapy adherence and endocrine therapy usage on quality of life - The Genetic Risk Estimate (GENRE) trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD3-03.
Purpose Many patients with cancer are interested in complementary therapies, including strategies such as reduced carbohydrate diets. Guidelines regarding the use of these diets during cancer treatment are lacking; therefore, we aimed to explore the perceptions and practices of medical oncologists in Canada regarding low-sugar and ketogenic diets. Method A cross-sectional, online multiple-choice survey was distributed to 206 Canadian medical oncologists. Questions explored frequency of patient interactions, oncologist perceptions of efficacy, advice given to patients, and concerns about side effects related to reduced carbohydrate diets. Results Responses were received from 57 medical oncologists in seven of thirteen provinces and territories, with an overall response rate of 28%. Forty-nine percent of respondents were asked at least weekly about a low-sugar diet, and 9% about the ketogenic diet. Eighty-five percent supported the use of a low-added sugar diet in patients with diabetes or hyperglycemia, while conversely 87% did not support the use of a ketogenic diet for any of their patients undergoing active cancer treatment. Respondents felt either that a ketogenic diet was not effective (31%) or that the effect on cancer outcomes was unknown (69%). Ninety-six percent of respondents had concerns about a ketogenic diet for patients receiving active cancer treatment. Conclusion The role of reduced carbohydrate diets during cancer treatment is topical. Canadian oncologists are particularly reluctant to support a ketogenic diet for patients on active cancer treatment, with concerns about side effects and unknown efficacy. There may be a role for continuing medical education and institutional guidelines to inform these discussions with patients.
PURPOSE:Cancer survivors transitioning between academic comprehensive cancer systems and community general practice settings are vulnerable to discontinuity, inconsistency and variation in care, inappropriate surveillance testing, and a sense of isolation and loss. Though these issues have been well recognized for over a decade and a half in the survivorship, oncologic, and health services literature, there remains a dearth of positive examples of models that have been well received by both the transitioned patient and the providers on either side of the handoff. We herein describe a sustained positive example of a transitions program. This program centers on standardized and personalized survivorship care plans (SCP) to guide follow-up care and recovery.METHODS:Following the province-wide introduction of a transitions program for treated stages II and III colorectal cancer (CRC) patients, a post-implementation survey was mailed to transitioned patients with the primary outcome evaluated the patients' perception of improved continuity of care and the main instrument used the Patient Continuity of Care Questionnaire. This was compared against a previously published pre-implementation historical control.RESULTS:The data presented comparing pre- and post-implementation patient cohorts reflect significantly improved patient-reported perceptions regarding the enhanced continuity and coordination of their follow-up and survivorship care after the province-wide introduction of a formal transitions process. This SCP intervention has been sustained post implementation.CONCLUSIONS:Using, as a starting-point, a standardized electronically SCP, CancerCare Manitoba has successfully facilitated a jurisdiction-wide implementation of a scalable, reproducible, and adaptable transitions program.IMPLICATIONS FOR CANCER SURVIVORS:This intervention at the time of transition back to the community has enhanced CRC survivor perception of continuity and coordination of follow-up care.
1501 Background: Despite BC risk reduction of 50-65% by preventive endocrine therapy (ET), very few at-risk women choose to take them. A woman’s perceived BC risk correlates with uptake of ET. A PRS comprised of 77 BC genetic susceptibility loci (Single Nucleotide Polymorphisms (SNP) improves the accuracy of risk prediction for BC. We examined the impact of the addition of individualized PRS BC risk prediction to standard risk calculator estimates on intent to take BC prevention medication. Methods: Eligible women had ≥5% 10 yr BC Tyrer-Cuzick risk (IBIS) or 5 year Gail score ≥3%, with no history of BC or hereditary BC syndrome. Standard BC risk estimates (IBIS or Gail) were incorporated into the counselling on BC preventive ET. A self-reported questionnaire at baseline quantified intention to take ET and explored factors associated with this decision. Blood samples were obtained and genotyped for 77 SNPs, individualized PRS were calculated then incorporated into IBIS and Gail predictions for 5 yr, 10 yr, & lifetime BC risk. At a second visit, PRS risk & prevention recommendations were revisited. Post visit questionnaires assessed change in intent to take ET. Multivariable linear regression was performed to assess impact of baseline variables on change in intent to take medication. Results: From 2016 to 2017, 151 women in Canada & USA were enrolled, median age: 56.1 (range 36-76.4), 35.6% were premenopausal, 98.7% were Caucasian. Median 5yr, 10yr, & lifetime IBIS risk estimates were 3.8% (2.0-11.5), 7.9% (5.0-23.1), and 25.3% (5.5 to 92.2). PRS increased BC risk estimates in 84 (55.6%) and reduced BC risk estimates in 67 (44%) women. After PRS risk counselling, intention to take ET significantly changed (p<0.001): 41.9% of those with increased PRS were more inclined, and 46.7% of women with decreased PRS were less inclined to take ET. On multivariable regression, increase in PRS (p<0.0001) and less concern about ET side effects (p<0.0001) were associated with greater intent to take ET. Conclusions: In high risk women, PRS significantly changed BC risk estimates & intent to take preventive ET. Further assessments of the impact of PRS scores on compliance with ET are warranted. Clinical trial information: NCT02517593.
The rectum has distinctive anatomic and physiologic features, which increase the risk of local spread and recurrence among rectal cancers as compared to colon cancers. Essential to the management of rectal cancers is accurate endoscopic localization as well as preoperative imaging assessment of local and distant disease. Successful oncologic care is multidisciplinary including input from Gastroenterologists, Surgeons, Medical and Radiation Oncologists, Radiologists, and Pathologists. Extensive planning of curative intent is mandatory as failures of upfront treatment present great long-term difficulty for patients and caregivers. Local recurrences are frequently associated with major morbidity including bowel and urinary obstruction, severe pain, and significantly diminished quality of life. Distant recurrence is associated with lower survival. Over the last two decades, there have been many advances in diagnostic imaging techniques as well as surgical techniques including transanal endoscopic microsurgery for very early stage cancers. Progress in curative management paradigms includes shorter courses of preoperative radiotherapy and chemotherapy doublet paradigms for perioperative treatment. This review describes the diagnosis, workup, and multimodality curative intent treatment of rectal cancers. It is emphasized that success begins in the hands and eyes of the gastroenterologist.
IMPORTANCE With the growing use of oral chemotherapy, there is an urgent need to develop safe and effective systems to administer and manage these agents. A comprehensive synthesis of literature on oral chemotherapy care delivery programs to which clinicians can look for best practices is lacking. OBJECTIVE To summarize the peer-reviewed and gray literature on interventions to improve oral chemotherapy care delivery toward describing best practices and identifying current gaps. EVIDENCE REVIEW Using search terms pertaining to the concepts of oral chemotherapy, cancer, and interventions and outcomes, we performed a systematic review of PubMed, EMBASE, and CINAHL from January 1995 to May 24, 2016, to identify oral chemotherapy intervention programs. We searched the gray literature from January 1995 through February 2016 and contacted gray literature authors for further information. Four physician abstractors reviewed the titles, abstracts, and articles. Quality of the articles was assessed using SQUIRE2 guidelines. Interventions were evaluated in the categories of prescribing, preparation/dispensing, education, administration, monitoring, and storage/disposal. The population of interest included all ages and was limited to traditional cytotoxic and targeted anticancer oral agents. FINDINGS From 7984 abstracts identified in the peer-reviewed literature search, 16 full-text articles met inclusion criteria representing 3612 patients. Interventions focused on prescribing (n = 1), preparation/dispensing (n = 2), education (n = 11), administration (n = 5), monitoring (n = 14), and storage/disposal (n = 1). In the 10 articles with adherence as the primary outcome, 4 evaluation methods were used. Most improvements were seen in toxic effects/safety compared with adherence. Of the 7 interventions with statistically significant improvement in the primary outcome, 3 nursing phone calls to contact patients within the first few days after treatment initiation, 2 of them with standardized toxic effects management protocols. Interventions using technology to increase touch points between care teams and patients (including video directly observed therapy, automated voice response, and text messages) were not effective. CONCLUSIONS AND RELEVANCE A framework for the oral chemotherapy management process with standardized outcome definitions is needed to ensure constructive research. Existing data suggest that a monitoring program should include personal contact with patients within the first weeks of treatment. Whether such contact can be enhanced by technology is uncertain.
365 Background: Resection of isolated metastases in good performance status patient (pts) has increasingly become an accepted standard of care. While resection of hepatic and pulmonary metastases from selected cancers such as CRC and RCC have supportive evidence, the safety and effectiveness of pancreatic resections for metastases from these same tumour sites is not as well established. We aim to identify the optimal assessment and selection criteria which would best predict a favourable outcome from pancreatic metastatectomy. Methods: A prospective pathology database was used to identify pts who underwent partial or total pancreatectomy for solid tumour metastases to the pancreas between Sept 2000 to May 2013. Demographic, histologic, surgical and survival data was collected and analyzed using descriptive statistics. Results: 19 pts were identified and included. Follow-up time ranged from 5 months to 8 years. Most common primary sites were RCC (42%,) CRC (11%) and GIST (11%). Favourable outcome, defined as an event-free survival greater than 12 mos from pancreatectomy, was observed in 63% (12/19) and was associated with a higher proportion of RCC (50% vs 14%), pancreas as M1 presentation (58% vs 43%), longer time from presentation to resection (median 5mos vs 2mos), multidisciplinary conference (MDC) review (33% vs 14%) and preop PET (42% vs 14%). No differences were observed by age or gender. Median postoperative length of stay was 22.1 days. Conclusions: Resection of pancreatic metastases remains a rare indication. Given the morbidity and extended LOS associated with pancreatectomy, careful patient selection is required. In this small retrospective series, favourable outcomes were more frequently associated with RCC primary, delayed resection, pre-op MDC and PET staging. Multicentre surgical registries would enhance future analysis and better guide patient selection.
OBJECTIVES:We explored whether iron deficiency in the absence of anemia is associated with fatigue in inflammatory bowel disease (IBD). METHODS:We assessed iron deficiency and anemia in 280 participants from the population-based Manitoba IBD Cohort Study. RESULTS:Iron deficiency was identified in 20% with Crohn's disease and 27% with ulcerative colitis. Anemia was identified overall in 50 (18%), with 230 who were nonanemic. In the nonanemic subgroup, there were no significant differences between iron-deficient and -sufficient groups in mean fatigue levels or proportions with problematic fatigue. There was no unique contribution of iron deficiency to problematic fatigue after adjustment for active disease and anemia. CONCLUSIONS:There was no evidence of an association between iron deficiency and fatigue in the absence of anemia, suggesting that iron deficiency is not a clinically relevant contributor to fatigue in IBD.