INTRODUCTION: Treatment intensification beyond androgen deprivation therapy (ADT) has shown survival benefit in patients with metastatic castration-sensitive prostate cancer (mCSPC). There is a need to better understand how these novel treatments fit in real-world practice. METHODS: Using electronic medical records and administrative data, a population-based, retrospective cohort study of patients diagnosed with de novo mCSPC between 2010 and 2020 in Alberta, Canada, and initiated on ADT was conducted. Treatment intensification was defined as the receipt of apalutamide, abiraterone acetate, enzalutamide, or chemotherapy (e.g., docetaxel) within 180 days of ADT initiation. RESULTS: A total of 2515 de novo mCSPC were identified, with 2098 (83%) patients initiating ADT post-diagnosis. Of those, 525 (25%) received intensification beyond ADT. Three percent of patients were intensified in 2010-2013; this increased to 67% in 2020. From 2014-2017, docetaxel was the most used approach, although it was supplanted by abiraterone acetate, apalutamide, and enzalutamide from 2018 onwards. In multivariable logistic regression analyses of patients diagnosed from 2014-2020, significant predictors of intensification were younger age at diagnosis, lower Charlson comorbidity index, greater number of metastatic sites, shorter time to ADT initiation, referral to a medical oncologist, transurethral resection of the prostate or radiation prior to ADT, and more recent year of diagnosis (all p<0.05). CONCLUSIONS: There has been a considerable increase in the use of ADT intensification therapies that correspond with the timing of clinical trial data and approvals of novel agents.

BACKGROUND:Data are needed to improve the current understanding of the epidemiology of patients with high-risk, HER2-negative, early breast cancer (eBC) (hormone receptor positive [HR+]/HER2-negative BC and triple-negative BC [TNBC]). PATIENTS AND METHODS:This retrospective longitudinal cohort study used real-world, population-level data that included all individuals newly diagnosed with high-risk, HER2-negative eBC in Alberta, Canada, between 2010 and 2019. Data on treatment, laboratory results and pathology findings were collected through electronic health records and administrative databases. RESULTS:The annual cumulative incidence of high-risk, HER2-negative eBC ranged from 6% to 9% of all incident BC cases. Individuals with TNBC were more likely to be younger, had stage II disease, grade 3 histology and received systemic therapy at a community centre (P < .05) compared to individuals with HR+/HER2-negative eBC. Only 14% of individuals diagnosed in 2010-2017 underwent germline BRCA testing postdiagnosis. Neoadjuvant systemic therapy was given to 37% of individuals. Adjuvant systemic therapy use increased from 77% (2012-2015) to 84% (2019). The 5-year overall survival (OS) from initiation of adjuvant systemic therapy or date of surgery (for individuals who did not receive adjuvant systemic therapy) was 77% (95% CI: 75-79). OS was significantly worse among individuals who were older, had grade 3 histology, had stage III disease, or had nodal involvement (P < .05). OS among individuals with TNBC between 2016 and 2019 who initiated adjuvant capecitabine was markedly worse compared to the overall cohort (2-year OS: 70% vs. 89%). CONCLUSION:Outcomes analyses in this high-risk, HER2-negative eBC population suggest a continued unmet clinical need.

BACKGROUND AND OBJECTIVE:While the benefit of cabozantinib in metastatic renal cell carcinoma (mRCC) is well established post-tyrosine kinase inhibitor therapy, its comparative effectiveness versus sunitinib after first-line (1L) nivolumab-ipilimumab is uncertain. METHODS:A target trial emulation was designed using data from the IMDC to estimate the effect of second-line (2L) cabozantinib versus sunitinib within 18 months of discontinuing 1L nivolumab-ipilimumab on overall survival (OS). Patients diagnosed after January 1, 2017 were followed from initiation of 2L until death or last known contact. Inverse-probability of treatment weighting was used to adjust for hemoglobin, calcium, platelets, and neutrophils at 2L, Karnofsky performance score (KPS) at 2L, time from diagnosis to initiation of 2L, and response to 1L nivolumab-ipilimumab. Treatments were compared using adjusted Kaplan-Meier curves and adjusted hazard ratios (HR) from a Cox regression model. Missing data were addressed with multiple imputation by chained equations. E-values were used to assess the likelihood findings could be explained by residual confounding. KEY FINDINGS AND LIMITATIONS:A total of 120 and 121 patients who received cabozantinib or sunitinib after 1L nivolumab-ipilimumab were included. The proportion with a KPS < 80% at 2L (21% vs. 46% P = .001) and the overall response rate to first line therapy (12.7% vs. 17.9% P = .002) differed significantly between cabozantinib and sunitinib. The objective response was 27% for cabozantinib versus 20% for sunitinib with a median time to treatment failure of 8.5 (95% CI: 6.9-12.9) and 4.5 (95% CI: 3.7-5.8) months. Median OS was 21.4 (95% CI: 17.9-NA) months from initiation of cabozantinib and 10.1 (95% CI: 7.6-17.7) months for sunitinib (Adjusted HR 0.44 (95% CI: 0.22-0.86)). The E-value was 2.92, suggesting a low likelihood of findings being due to residual confounding alone. CONCLUSIONS:These data provide real-world evidence supporting cabozantinib as a second-line treatment option in mRCC following 1L nivolumab-ipilimumab.

Background Population-based data from real-world sources on metastatic breast cancer (mBC) patient outcomes by HER2 status are limited, particularly in Canada. To meet this need, we examined treatment patterns, outcomes, and healthcare resource utilization in HER2-positive (HER2+) mBC in a real-world Canadian setting. Patients and Methods This retrospective longitudinal cohort consisted of all patients in Alberta, Canada diagnosed with de novo metastatic or recurrent HER2+ breast cancer between 2010 and 2019. Patient data were obtained from the provincial cancer registry, electronic medical records, and other administrative databases. Results 758 patients with HER2+ mBC were included, of which 461 (60.8 %) were recurrent cases. Taxane + trastuzumab + pertuzumab was the most frequent (61.7 %) first-line regimen, trastuzumab emtansine (T-DM1) was the most frequent (74.8 %) second-line regimen, and capecitabine + lapatinib was the most frequent (52.9 %) third-line regimen. Median overall survival from first-, second-, and third-line chemotherapy was 41.9 months (95 % CI: 36.9–51.2), 18.8 months (95 % CI: 15.4–24.3), and 12.9 months (95 % CI: 11.0–16.8), respectively, with no meaningful differences between de novo and recurrent patients. Conclusion Uptake of guideline-recommended regimens in each line of therapy was lower in recurrent patients although survival was similar to de novo patients. These findings highlight the need for consensus on treatment regimens for de novo and recurrent HER2+ patients, effective first-and second-line management, and novel therapies to improve outcomes.MICROABSTRACTOur study evaluated real-world treatment patterns, clinical outcomes, and healthcare utilization in HER2-positive metastatic breast cancer (mBC) in Alberta, Canada. Among 758 patients, survival was similar between new diagnoses and recurrent cases, despite lower uptake of guideline-recommended therapies in recurrent patients. Our findings highlight the need for consensus on treatment strategies and novel therapies to improve mBC outcomes.

4580 Background: Overall survival (OS) is the gold-standard efficacy measure in oncology; however, it can take several years for OS data to mature, particularly in the clinically localized setting in patients undergoing curative intent treatment. To accelerate patient access to novel therapies, surrogate endpoints can be used to accelerate the assessment of new treatments when an early measure is reasonably likely or known to predict the clinical benefit for a target outcome such as OS. MIBC is a potentially curative disease with a complex and evolving treatment landscape involving radical cystectomy with or without systemic therapies, and bladder sparing strategies. Despite the need for surrogate endpoints in MIBC, there is limited research on their validity in this patient population. Methods: This study evaluated the trial-level surrogacy of event-free survival (EFS), progression-free survival (PFS), and disease-free survival (DFS) with respect to OS in MIBC. A systematic literature review (SLR) was conducted to identify randomized controlled trials (RCTs) that evaluated anti-cancer treatments (neoadjuvant, adjuvant, perioperative, and bladder sparing therapies) in MIBC and reported results for OS and ≥1 surrogate endpoint of interest. Studies published between Jan 1, 2000 and Jun 26, 2024 were identified by searching the MEDLINE, EMBASE, and CENTRAL databases. Grey-literature sources included recent conference proceedings and clinical trial registries. Study quality was assessed using the Cochrane Risk of Bias v2 tool. Data from studies with comparable outcome definitions for EFS, PFS, and DFS were combined into a broad composite outcome definition (cEFS). Trial-level surrogacy between the hazard ratio (HR) for cEFS and OS was evaluated. Analyses were conducted using a weighted linear regression (WLR) model and the bivariate Daniel & Hughes (D&H) model. Measures of surrogacy included the Pearson correlation coefficient (r) to measure the strength of association and the surrogate threshold effect (STE) to estimate the minimum HR for cEFS needed to reliably predict a HR for OS < 1. Results: 32 RCTs across 71 publications were included in the SLR; 14 were included in the cEFS analyses based on a feasibility assessment. Trials with a high-risk of bias (n = 1) or that evaluated the initiation of systemic therapy after disease progression (n = 4) were excluded. The HR for cEFS was strongly correlated with the HR for OS (r = 0.94; 95% CI: 0.72-0.99). Based on the STE, a HR <0.88 for cEFS would be needed to reliably predict a HR < 1 for OS. Results from the D&H model were consistent with these findings. Conclusions: These results suggest that at the trial level, the HR for cEFS is highly correlated with the HR for OS in MIBC across various treatment settings. cEFS may assist clinicians, regulatory agencies, and reimbursement bodies in contextualizing the benefits of novel treatment strategies in MIBC.

Improved understanding of the biological heterogeneity of breast cancer (BC) has facilitated the development of more effective and personalized approaches to treatment. This study describes real-world evidence on treatment patterns and outcomes for a population-based cohort of patients with human epidermal growth factor receptor (HER2) IHC0 and -low BC with de novo or recurrent disease from Alberta, Canada. Patients 18+ years old diagnosed with HER2 IHC0/-low, de novo/recurrent BC from 2010 to 2019 were identified using Alberta’s cancer registry. Analyses of these patients’ existing electronic medical records and administrative claims data were conducted to examine patient characteristics, treatment patterns, and survival outcomes. A total of 3413 patients were included in the study, of which 72.10% initiated first line hormonal and non-hormonal systemic therapy. The 1-year overall survival (OS) was 81.09% [95% CI, 79.52–82.69]. Recurrent patients had a higher OS compared to de novo patients: 54.30 months [95% CI, 47.80–61.90] vs. 31.5 months [95% CI, 28.40–35.90], respectively. Median OS was 43.4 months [95% CI, 40.70–47.10] and 35.80 months [95% CI, 29.00–41.70] among patients with HER2-low and HER2 IHC0 cancer, respectively. The study results provide real-world evidence regarding the clinical outcomes of HER2 IHC0/-low and de novo/recurrent disease.

A better understanding of the clinical and economic burden of ES-SCLC across lines of treatment is required. We investigated baseline characteristics, treatment patterns, HCRU, real-world overall survival (rwOS), and time-to-next treatment or death (TTNT/D) of patients with ES-SCLC in Alberta, Canada.

Background Laboratory data can provide great value to support research aimed at reducing the incidence, prolonging survival and enhancing outcomes of cancer. Data is characterized by the information it carries and the format it holds. Data captured in Alberta’s biomarker laboratory repository is free text, cluttered and rouge. Such data format limits its utility and prohibits broader adoption and research development. Text analysis for information extraction of unstructured data can change this and lead to more complete analyses. Previous work on extracting relevant information from free text, unstructured data employed Natural Language Processing (NLP), Machine Learning (ML), rule-based Information Extraction (IE) methods, or a hybrid combination between them. Methods In our study, text analysis was performed on Alberta Precision Laboratories data which consisted of 95,854 entries from the Southern Alberta Dataset (SAD) and 6944 entries from the Northern Alberta Dataset (NAD). The data covers all of Alberta and is completely population-based. Our proposed framework is built around rule-based IE methods. It incorporates topics such as Syntax and Lexical analyses to achieve deterministic extraction of data from biomarker laboratory data (i.e., Epidermal Growth Factor Receptor (EGFR) test results). Lexical analysis compromises of data cleaning and pre-processing, Rich Text Format text conversion into readable plain text format, and normalization and tokenization of text. The framework then passes the text into the Syntax analysis stage which includes the rule-based method of extracting relevant data. Rule-based patterns of the test result are identified, and a Context Free Grammar then generates the rules of information extraction. Finally, the results are linked with the Alberta Cancer Registry to support real-world cancer research studies. Results Of the original 5512 entries in the SAD dataset and 5017 entries in the NAD dataset which were filtered for EGFR, the framework yielded 5129 and 3388 extracted EGFR test results from the SAD and NAD datasets, respectively. An accuracy of 97.5% was achieved on a random sample of 362 tests. Conclusions We presented a text analysis framework to extract specific information from unstructured clinical data. Our proposed framework has shown that it can successfully extract relevant information from EGFR test results.

59 Background: mCSPC treatment is rapidly evolving with androgen deprivation therapy (ADT) plus ARPIs viewed as the standard of care for most pts. Data are needed to understand the real-world characteristics and treatment patterns of mCSPC (PC) pts in this dynamic field. This study aimed to define clinical features of mCSPC pts, estimate the proportion of pts receiving ARPIs, and evaluate clinical and demographic features associated with ARPI use. Methods: This retrospective cohort study used data from electronic health records and administrative databases in the province of Alberta, Canada. All newly diagnosed metastatic PC pts between 2017-2020 were identified. Pts were considered to have mCSPC if they initiated ADT within 30 days prior to, or at any time after diagnosis. ARPI exposure was defined as receiving ARPI within 180 days of initiating ADT. ARPI-naïve pts may have received ADT alone or other non-ARPI therapy (i.e., docetaxel) within 180 days of initiating ADT. Multivariable logistic regression was used to evaluate pt characteristics related to the receipt of ARPI. Overall survival (OS) was defined as the date of diagnosis to death from any cause or last known contact. Results: Of the 976 mCSPC pts identified, 33.5% received an ARPI. In ARPI exposed pts, the median time from ADT to ARPI start was 7.9 weeks and median time on ARPI was 13.1 months (mos). In multivariable analyses, ARPI use was associated with younger pt age, more recent diagnosis, fewer comorbidities, a higher metastatic burden, treatment centre, referral to a medical oncologist, and prior local therapy (all p<0.05). The median time to next therapy was 24.6 mos (95%CI=19.5-33.0) vs. 18.5 mos (95%CI+16.9-21.1), and median OS was 38.5 mos (95%CI=32.8-NA) vs. 34.2 mos (95%CI=33.3-38.8) for APRI exposed vs. ARPI-naive pts, respectively (p=0.03). Conclusions: This study identified factors associated with ARPI use in mCSPC, potentially allowing targeted efforts to improve ARPI uptake for pts in whom use is low. These findings are important as they reflect outcomes seen in real world pts.

The prognosis of early non-small-cell lung cancer (eNSCLC) remains poor. An understanding of current therapies and outcomes can provide insights into how novel therapies can be integrated into clinics. We conducted a large, retrospective, population-based cohort study of patients with de novo eNSCLC (stages IB, IIA, IIB, and IIIA) diagnosed in Alberta, Canada, between 2010 and 2019. The primary objectives were to describe treatment patterns and survival outcomes among patients with eNSCLC. A total of 5126 patients with eNSCLC were included. A total of 45.3% of patients were referred to a medical oncologist, ranging from 23.7% in stage IB to 58.3% in IIIA. A total of 23.6% of patients initiated systemic therapy (ST), ranging from 3.5% in stage IB to 38.5% in IIIA. For stage IIB and IIIA individuals who received surgery, adjuvant ST was associated with a decreased likelihood of death (hazard ratios (HR) of 0.77 (95% CI: 0.56–1.07) and 0.69 (95% CI: 0.54–0.89), respectively). In a Canadian real-world setting, stage IIB and IIIA patients who received adjuvant ST tended to have better survival than patients who did not, but future studies that provide adjustment of additional confounders are warranted. Examining referral pathways that account for disparities based on age, sex, and comorbidities in the real world would also provide further insights.

CONCLUSIONS Chronic lymphocytic leukemia (CLL) is the most common lymphoproliferative disorder in North America. Treatment of CLL is currently indicated only for patients with disease-related symptoms or organ compromise, such as cytopenias, with no evidence of survival benefit for the treatment of asymptomatic patients. Patients with CLL are not cured with conventional therapy and typically require repeated treatments over their lifetime. Median overall survival (OS) is difficult to estimate given recent advances in therapy options but is dependent upon disease features, patient characteristics, and treatment choice. Since the recent introduction of targeted therapy for CLL, there has been limited Canadian data on the evolution of management approaches in a real-world setting. Data are needed to improve the current understanding of the treatment landscape of CLL. This retrospective observational cohort study used real-world, population-level data to describe the baseline characteristics, treatment patterns, clinical outcomes, and healthcare resource use of individuals diagnosed with CLL in Alberta, Canada. The study cohort included all individuals in Alberta over 18 diagnosed with CLL between 2010-2020 and who subsequently initiated systemic therapy. Data were collected through electronic health records and administrative databases. OS was defined as the date of diagnosis to death from any cause or last known contact with the health care system. A total of 890 individuals diagnosed with CLL between 2010-2020 who initiated first-line (1L) systemic therapy were included in the analyses. The mean age at initiation of 1L therapy was 69 years, and 68% were male. Among individuals who initiated 1L therapy in 2020+, the primary form of 1L systemic therapy was ibrutinib monotherapy (IBR) (29%), followed by bendamustine plus rituximab (BR) (21%). A considerable number of individuals did not initiate subsequent lines of therapy, with a drop of approximately 40-45% between each successive line. The treatment landscape changed over time, particularly with respect to decreased use of 1L fludarabine, cyclophosphamide, and rituximab (FCR; 40% in 2010-2013 vs. 9% in 2020+) and increased use of 1L IBR (6% in 2014-2017 vs. 29% in 2020+). Individuals treated at an academic centre were more likely to receive 1L IBR than those treated at a community centre. The median duration of 1L therapy was considerably longer for patients treated with targeted therapy (IBR: 9.8 months) compared to chemoimmunotherapy (BR: 5.6 months, FCR: 5.6 months). The majority of individuals did not initiate therapy immediately after diagnosis, with a median time from diagnosis to initiation of 1L therapy of 24 months (recognizing that the population described includes only those who initiated 1L therapy such that time to first therapy would be much longer for the entire CLL population). The time to next line of therapy (from the start of each line to the start of the subsequent line) was 17 months from 1L to second-line (2L), 14 months from 2L to third-line (3L), and 12 months from 3L to fourth-line. Median OS from initiation of 1L was 104 months, 2L was 70 months, and 3L was 64 months. On average, individuals had 39 healthcare encounters within the first year of initiating 1L systemic therapy, with an average of one hospitalization, six ambulatory care encounters, 25 non-cancer practitioner encounters, and seven cancer physician visits. The mean number of healthcare encounters within the first year of front-line therapy tended to decrease over time, which may be attributable to the changing treatment landscape. These findings highlight the rapid changes in CLL therapy that have occurred over the last decade. Our results demonstrate the significantly smaller cohorts of real-world patients receiving 2L or later therapies compared to 1L and highlight declining survival with subsequent lines of therapy, and a decreasing trend of healthcare resource use over time.

e18798 Background: Little epidemiological data characterizing the mTNBC population in Canada exist, limiting the understanding of treatment patterns, attrition rates, and unmet need for CAN patients (pts) with R/R mTNBC. This study examined real-world outcomes and palliative treatment patterns for CAN pts with 1L+ R/R mTNBC, stratified by early vs late recurrence. Methods: This retrospective study used real-world, population-based data from the Oncology Outcomes database in Alberta to identify pts diagnosed with early stage (I to III) TNBC between 2010-2019 who progressed to mTNBC. Algorithms reliably identified recurrent pts as those who received 2+ cycles of systemic therapy > 240 days from the initiation of adjuvant treatment or surgery. Clinical outcomes from 1L+ treatment of mTNBC, including time to next treatment (TTNT) or death and overall survival (OS), were ascertained. Diagnosis, demographics, treatment patterns, and attrition rates were stratified by treatment-free interval (TFI), early (8-12 mo TFI) or late ( > 12 mo TFI). Results: Data from 181 CAN pts with R/R mTNBC (recurred early, n = 59; recurred late, n = 122) were analyzed. Baseline characteristics were generally comparable between groups. Pts who recurred late were on average older at recurrence (59 y vs 55 y, P= 0.03) and less likely to be stage III (21% vs 51%, P< 0.001) at initial diagnosis. The median time to recurrence was 17 mo. The most common 1L therapies were capecitabine monotherapy (35%), other chemotherapy combinations (16%), and taxane monotherapy (12%), with a median duration of therapy (DOT) of 4.9 mo, 3.5 mo, and 4.5 mo, respectively. Rates of attrition between lines of therapy (LOT) were relatively high, with 96 pts (53%) initiating 2L therapy (among the 85 pts who did not start 2L treatment, 63 had died). Median DOT was 3.6 mo for 1L, 3.0 mo for 2L, and 3.0 mo for 3L. Stratifying by early or late recurrence did not show differences in TTNT (4 mo vs 4 mo; HR, 0.94; 95% CI, 0.64-1.38; P= 0.75) or OS (10 mo vs 11 mo; HR, 0.96; 95% CI, 0.64-1.44; P= 0.84). Exploratory analyses showed improved OS (23 mo vs 10 mo; HR, 0.60; 95% CI, 0.40-0.92; P= 0.02) in pts with TFI ≥24 mo (n = 61) but not in pts with TFI 12-24 mo (11 vs 10 mo; HR: 0.96; 95% CI: 0.64-1.44; P= 0.84) vs pts with TFI of 8-12 mo. Conclusions: This retrospective study showed higher than expected rates of early recurrence and high attrition between LOT in a CAN breast cancer population that progressed to mTNBC. The short DOT across lines was similar and consistent with CAN practice. OS for 1L+ R/R mTNBC were similar for individuals who recurred between 8-12 vs 12-24 mo. These findings confirmed the poor prognosis of pts with R/R mTNBC and the need for improved therapies especially in 1L, where the most common treatments, including capecitabine, may not deliver the most meaningful impact.

Aim: The purpose of this retrospective, population-based, observational cohort analysis was to assess whether routine patient-reported outcomes (PRO) monitoring alone has an impact on real-world overall survival (OS) and hospitalizations among individuals diagnosed with lung, breast or colorectal cancer. The importance of follow-up care in post-PRO data collection was also discussed. Patients & methods: Administrative databases covering 17 cancer centers from Alberta, Canada were queried and individuals ≥18 years old and diagnosed with lung, breast or colorectal cancer from 1 January 2016 to 31 December 2019 were included and followed until 31 December 2020. Patients were stratified by whether they received routine PRO monitoring initiated within 120 days of diagnosis and matched 1:1 with use of propensity scores based on baseline characteristics. OS was assessed from the index date to death, and the respective Kaplan–Meier curves were estimated along with hazard ratios from Cox Proportional Hazard Models. Linear and logistic regression models were used to estimate mean differences and odds ratios (OR) respectively for healthcare resource utilization events including cancer physician visits, emergency department visits and outpatient ambulatory care encounters. Results: 4800 patients were included in each matched cohort. There was no statistically significant difference between PRO monitoring and non-monitoring cohorts in OS (HR = 1.01; 95% CI: 0.93–1.09; p = 0.836) and treatment discontinuation (OR = 0.98; 95% CI: 0.85–1.12; p = 0.75). Median OS was 51.5 months for unmonitored cohort (95% CI: 47.5–NA) versus 50.6 months for monitored cohort (95% CI: 47.6–55.7). Compared with PRO-monitored patients, unmonitored patients were associated with lower hospitalization risks (OR = 1.12; 95% CI: 1.03–1.22; p = 0.01). However, PRO-monitored patients experienced significantly fewer physician visits in comparison to unmonitored patients (MD = -1.036; 95% CI: -1.288 to -0.784, p < 0.001). Conclusion: Our results show that capturing patient-reported symptoms alone reduced the number of physician visits but neither reduced hospitalizations nor improved OS in this real-world cancer population. To drive more meaningful clinical impact, PRO monitoring programs must be met with rigorous follow-up response to the identified symptoms.

PURPOSE: Patients with colorectal cancer (CRC) experience a range of physical and psychologic symptoms, and supportive care needs throughout the illness trajectory. We used patient-reported outcomes and administrative health data to describe symptom burden and supportive care needs during and after adjuvant treatment and determine factors associated with changes to symptom burden. METHODS: A retrospective population-based cohort study of patients who were newly diagnosed with stage II-III CRC in Alberta, Canada, between January 1, 2016, and January 31, 2019. Adults age 18 years or older who completed a patient-reported outcomes survey (Edmonton Symptom Assessment System) and supportive care needs (Canadian Problem Checklist) within 3 months after starting adjuvant treatment (during treatment) and > 7 months after starting treatment (after treatment) were included. Changes to symptom severity were stratified as stable, improved, or deteriorated. Multivariable logistic regression was used to evaluate factors associated with these changes. RESULTS: We included 303 patients (median age 60 years, 62% male, 84.5% stage III, 51.2% rectal v colon). Prevalent symptoms included tiredness (80.5%), pain (50.8%), and poor well-being (50%) during treatment, and tiredness (71.3%), pain (44.2%), and poor well-being (62.1%) after treatment. The results were heterogeneous with respect to improvements, stability, or deterioration. Pain worsened for 25% of the cohort, tiredness for 28%, and depression, anxiety, and well-being for 21%, 22%, and 31%, respectively. Deterioration of some symptoms was associated with older age, stage II, comorbidities, rural setting, and higher income. CONCLUSION: We demonstrated symptom severity was generally low and most symptoms remained stable or improved after treatment. Particular groups of patients were at greater risk for more severe and/or more persistent symptoms. Ongoing assessments and interventions to address physical and psychologic symptoms, and supportive care needs in patients with CRC during and after treatment are needed.

Colorectal cancer presents via multiple different clinical phenotypes that can arise from a variety of different genetic and molecular alterations. The aim of this study was to describe survival outcomes and treatment patterns of metastatic colorectal cancer (mCRC) patients by v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation status. The Alberta Cancer Registry was used to identify all patients >18 years old who had been diagnosed with mCRC in Alberta between 1 January 2017 and 31 December 2019 and had received at least one cycle of systemic therapy. Treatment patterns were compared between wild-type and mutant BRAF mCRC patients. Cox regression models and Kaplan-Meier curves were created to assess survival differences by both treatment pattern and BRAF status. A total of 488 patients were identified with mCRC, of which 42 (11.4%) were confirmed to have a BRAF mutation. The most common first-line treatment regimen was either capecitabine and oxaliplatin (CAPOX) or leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX). The median overall survival for mCRC patients was 20.01 months. Mutant BRAF patients had a median survival of 8.21 months compared to 20.03 months among those with wild-type BRAF. BRAF mutations among mCRC patients are associated with a considerably poor prognosis, reinforcing the need for clinical BRAF testing among newly diagnosed patients to better understand their prognosis.

Determining the prognosis of relapsed follicular lymphoma is challenging. We examined the Follicular Lymphoma International Prognostic Index (FLIPI) risk score and POD24 to see if they could inform prognosis at the time of relapse. In a group of 216 individuals, the FLIPI risk score at initial diagnosis was highly prognostic at the time of relapse which suggests that it may help to stratify risk among individuals with relapsed follicular lymphoma. Background: The Follicular lymphoma international prognostic index (FLIPI) risk score and POD24 have previously been shown to have prognostic value in follicular lymphoma (FL), but the extent to which they can inform prognosis at the time of subsequent relapse is uncertain. Patients and Methods: We conducted a longitudinal cohort study of individuals diagnosed with FL between 2004 and 2010 in Alberta, Canada who received front-line therapy and subsequently relapsed. FLIPI covariates were measured prior to the initiation of front-line therapy. Median overall survival (OS), progression-free survival (PFS2), and time to next treatment (TTNT2) were estimated from the time of relapse. Results: A total of 216 individuals were included. The FLIPI risk score was highly prognostic at the time of relapse for OS (c-statistic = 0.70; HR[High vs. Low] = 7.38; 95% CI: 3.05-17.88), PFS2 (c-statistic = 0.68; HR[High vs. Low] = 5.84; 95% CI: 2.93-11.62) and TTNT2 (c-statistic = 0.68; HR[High vs. Low] = 5.72; 95% CI: 2.87-11.41). POD24 was not prognostic at the time of relapse for either OS, PFS2, or TTNT2 (c-statistic = 0.55). Conclusion: The FLIPI score measured at diagnosis may help with the risk stratification of individuals with relapsed FL.

Background:The COVID-19 pandemic is suspected to have affected cancer care and outcomes among patients in Canada. In this study, we evaluated the impact of the state of emergency period during the COVID-19 pandemic (Mar. 17 to June 15, 2020) on cancer diagnoses, stage at diagnosis and 1-year survival in Alberta. Methods:We included new diagnoses of the 10 most prevalent cancer types from Jan. 1, 2018, to Dec. 31, 2020. We followed patients up to Dec. 31, 2021. We used interrupted time series analysis to examine the impact of the first COVID-19-related state of emergency in Alberta on the number of cancer diagnoses. We used multivariable Cox regression to compare 1-year survival of the patients who received a diagnosis during 2020 after the state of emergency with those who received a diagnosis during 2018 and 2019. We also performed stage-specific analyses. Results:We observed significant reductions in diagnoses of breast cancer (incidence rate ratio [IRR] 0.67, 95% confidence interval [CI] 0.59-0.76), prostate cancer (IRR 0.64, 95% CI 0.56-0.73) and colorectal cancer (IRR 0.64, 95% CI 0.56- 0.74) and melanoma (IRR 0.57, 95% CI 0.47-0.69) during the state of emergency period compared with the period before it. These decreases largely occurred among early-stage rather than late-stage diagnoses. Patients who received a diagnosis of colorectal cancer, non-Hodgkin lymphoma and uterine cancer in 2020 had lower 1-year survival than those diagnosed in 2018; no other cancer sites had lower survival. Interpretation:The results from our analyses suggest that health care disruptions during the COVID-19 pandemic in Alberta considerably affected cancer outcomes. Given that the largest impact was observed among early-stage cancers and those with organized screening programs, additional system capacity may be needed to mitigate future impact.

Real-world evidence has been increasingly used to support evaluations of emerging therapies. These investigations are often conducted in settings that may not be representative of the underlying population. The purpose of this investigation was to empirically quantify the magnitude of this selection bias. Individuals diagnosed with solid metastatic cancer in Alberta, Canada, between 2010–2019 were identified using the provincial cancer registry for 13 common metastatic sites. Two outcomes used to support oncology reimbursement decisions were examined: the proportion of individuals who initiated systemic therapy and median overall survival (OS). These outcomes were assessed in the entire population and in a subset of individuals who were referred to a medical oncologist. Among the 23,152 individuals in the entire population, 40.8% (95% CI: 40.2–41.4) initiated systemic therapy, and the median OS from diagnosis was 5.4 months (95% CI: 5.3–5.6). Among those who were referred to a medical oncologist (n = 13,372; 57.8%), 67.4% (95% CI: 66.6–68.2) initiated systemic therapy, and the median OS from diagnosis was 11.2 months (95% CI: 10.9–11.5). The magnitude of bias varied by cancer site where lower referral rates were associated with greater bias. Non-referral is an important source of selection bias in real-world investigations. Studies that rely on limited-catchment real-world data should be interpreted with caution, particularly in metastatic cancer settings.

Based on findings from a single-arm, phase 2 basket trial (NCT02454972), lurbinectedin may be an effective treatment for individuals with small cell lung cancer (SCLC) who progressed on or after platinum-based chemotherapy. To estimate the comparative effectiveness of lurbinectedin versus the historical standard of care for relapsed SCLC in Canada. A synthetic control arm (SCA) analysis was conducted using real-world data. Population-level data were obtained from real-world databases in Alberta, Canada. Individuals diagnosed with SCLC who initiated post-platinum systemic therapy and met approximated eligibility criteria from the lurbinectedin trial were included in the SCA. Median overall survival (OS) in the SCA was estimated after adjusting for chemotherapy-free interval (CTFI; < 90 versus ≥ 90 days) and stage at initial diagnosis (extensive versus limited). The CTFI-adjusted hazard ratio was estimated using a Cox proportional hazards model. One hundred seventy-four individuals were included in the SCA and 105 in the lurbinectedin trial. The adjusted median OS in the SCA was 6.1 months (95

56 Background: The use of biologics in combination with chemotherapy early in the course of treatment in mCRC improves outcomes, but whether this approach is uniformly adopted in clinical practice is unclear. This study aims to describe biomarker testing, treatment patterns, and survival of RAS WT, left-sided mCRC patients in a real-world population. Methods: We performed deterministic linkages with population-based data sources, including the cancer registry, pharmacy data, electronic medical records, and vital statistics to identify all patients who were diagnosed with RAS WT, left-sided mCRC, and treated with first-line (1L) combination systemic therapy from 2014 to 2019 in Alberta, Canada. Patients were followed until December 31, 2020. Results: Of 2,721 patients with left-sided mCRC, 1,375 were referred and received systemic therapy, 977 underwent RAS testing prior to or within 30 days of initiating 1L treatment, and 420 were found to be RAS WT. Among them, 320 were treated with 1L combination systemic therapy: FOLFOX/CAPOX/FOLFIRI (n=204), panitumumab (pani) with doublet chemotherapy (n=64), or bevacizumab (bev) with doublet chemotherapy (n=52). The interval from diagnosis to RAS test results was 38 (IQR 24-61) days. Only 207 (65%) and 125 (39%) of the 320 1L-treated patients reached 2L and 3L therapy, respectively. Median overall survival based on the different 1L regimens are summarized. Conclusions: Many real-world patients with mCRC were not exposed to biologics as part of their front-line treatment. There is a need to enhance RAS testing in 1L as 29% of patients were not tested, despite recommendations from guidelines. Because attrition across lines of therapy is high in mCRC, the opportunity to receive and benefit from biologics in later lines of therapy may be importantly reduced. [Table: see text]