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This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as ‘partial response’, with 3.9% reporting ‘complete response’. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.

BACKGROUND: While the COVID-19 pandemic has reshaped how oncology is practiced, we sought to understand itseffects on treatment decision-making and care experiences amongst cancer patients at the Tom BakerCancer Centre in Calgary, Canada. METHODS: A 24 item, cross-sectional survey was developed based on literature review and iterative feedback fromoncology physicians, nurses, and a patient advisor. Survey domains included fear of COVID-19 andperceived risk, uptake of COVID-19 public health measures, cancer treatment decision-making duringthe pandemic, and cancer care experiences during the pandemic. Demographic, cancer and treatment-related information was obtained from the electronic medical record for patients who consented andcompleted the survey. In the first quarter of 2021, 161 patients accrued including 44 breast cancerpatients. The cohort characteristics and survey responses were summarized using descriptive statistics. RESULTS: For the 44 participants with breast cancer, all were female and the median age was 59 years (range 35-83 years). Our breast cancer cohort was almost evenly split between those with stage I-III (45.5%) andthose with metastatic disease (54.5%). Time since diagnosis was as follows: less than 1 year (17patients), 1-3 years (10 patients), 3-5 years (5 patients), and more than 5 years (9 patients). Treatmentsreceived since declaration of the pandemic included: surgery (21 patients), radiation (17 patients),chemotherapy (25 patients), endocrine therapy (25 patients), and other systemic therapies such as boneand anti-HER2 agents (15 patients). Just over half of the participants (54.5%) agreed or strongly agreedthat they were at increased risk of contracting COVID19; however, fewer patients expressed beinguncomfortable thinking about COVID-19 (45.4%), afraid of COVID-19 (38.6%), or fearful of dying fromCOVID19 (31.8%). The vast majority (>93%) of patients followed public health recommendations formitigating the risk of contracting COVID-19 (i.e. masking, frequent hand washing/sanitization, and socialdistancing) and 70.4% expressed a willingness to receive the vaccine when available. Of therespondents, 19 had undergone testing for COVID-19 at least once and 3 tested positive. Only 2 patientsreported that their surgical course was altered due to the pandemic and no patients declinedtreatments or perceived delays or modifications in therapies otherwise. Of 25 breast participants whohad experienced a cancer-related telehealth appointment during the pandemic, 21 (84%) agreed orstrongly agreed with being satisfied with the encounter. CONCLUSION: The COVID-19 pandemic caused minimal perceived disruption to care amongst a small cohort of breastcancer patients being treated at our centre. While experience with a cancer-related telehealthappointment was not universal, our findings support acceptability of its use. Citation Format: Noura Alsafar, Desiree Hao, Nimira Alimohamed, Sunil Samnani, Sasha Lupichuk. Assessing the impact of the COVID-19 pandemic on cancer treatment decision-making and care experiences [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-12-12.

On behalf of the Canadian Association of Medical Oncologists, we are pleased to present the Abstracts of the 2021 Annual Meeting. The National CAMO Residents Research Day was held virtually on 1 April 2021 and the CAMO Virtual Annual Scientific Meeting (ASM) & Annual General Meeting (AGM) took place on 22 April 2021. Twenty (20) abstracts were selected for presentation as oral presentations and rapid-fire presentations. Awards for the top three (3) abstracts were presented during the ASM and AGM. All of them were marked as “Award Recipient”. We congratulate all the presenters on their research work and contribution.

Purpose: Early phase clinical studies are ongoing to evaluate the role of immune checkpoint inhibitors in adenoid cystic carcinoma (ACC) despite a paucity of information on the immune microenvironment. This study aims to better characterize the immune microenvironment of ACC tumours and evaluate survival outcomes based on tumour infiltrating lymphocyte (TIL) and programmed death-ligand 1 (PD-L1) expression. Methods: Patient characteristics, treatment and outcome data were collected for 24 ACC patients. The CD8+(cluster of differentiation 8) TIL and PD-L1 expression were quantified by immunohistochemistry. Marker expression and survival outcomes were evaluated by Kaplan-Meier analysis. Results: All cases were negative for PD-L1 expression; four cases had focal high, eight cases had focal moderate and 12 cases had low TIL expression. Based on TIL expression, there was no difference in disease-free or overall survival. Conclusion: Adenoid cystic carcinoma tumours were found to be associated with a poor immunogenic microenvironment, with absent PD-L1 expression and low CD8+ TILs. There was no association between TIL expression and survival. These data suggest that PD-L1 and TIL expression are unlikely to be useful as predictive biomarkers for response to immunotherapy.

Introduction: MEK inhibition combined with PD-1 axis inhibition may achieve a greater clinical response than either inhibitor alone due to increased T-cell infiltration of tumours. We combined binimetinib with pembrolizumab in patients with stage IV advanced non-small cell lung cancer (NSCLC) and PD-L1 tumor proportion score>=50%. Methods: A 3 + 3 dose escalation design was used. Binimetinib at a dose level 1 (DL1; 45 mg) or dose level -1 (DL-1; 30 mg) twice daily orally continuously was given with pembrolizumab 200 mg IV q 21 days. The primary objective was to define the recommended phase II dose (RP2D) of the combination. Secondary outcomes included safety of the combination and response (RECIST 1.1) with a planned Phase Ib expansion in patients with RAS/RAF/MEK dysregulated tumours via next generation gene sequencing. Genomic markers are being explored in tissue and plasma. Results: Eleven patients (3 DL1, 8 DL-1) were enrolled with the following mutations: 7 with KRAS (3 G12C, 2 G12D, 1 G12V, 1 G12A), 2 BRAF (1 G409A, 1 V600E) and 1 STK11 which acts as a tumor suppressor gene encoding for LKB1. Two of 3 patients at DL1 experienced dose limiting toxicity (DLT) including grade 3 elevated amylase, grade 3 diarrhea, grade 4 elevated lipase and severe grade 2 rash requiring dose reduction. Of 8 patients treated at DL-1, 1 progressed in cycle 1, another was noncompliant with treatment. Of the remaining 6 patients, 1 experienced DLT with grade 3 rash with inability to administer binimetinib for >75% of cycle 1. The most common toxicities across all cycles (n=11 patients) were: rash (82%), diarrhea (36%) and pruritis (36%). Nine patients were evaluated for response with partial response in 3 (33%), stable disease in 4 (44%) and progressive disease in 2 (22%). All 3 responding patients had RAS or RAF alterations (KRASG12C, KRASG12V, BRAFV600E) while the patient with STK11 mutant disease had early disease progression. Conclusion: The RP2D of the combination in patients with advanced NSCLC is binimetinib 30 mg BID plus pembrolizumab 200 mg IV q21 days. Updated data from cohort expansion including response and molecular correlates of treatment response and resistance will be presented. Citation Format: Christopher F. Theriau, Jamie Feng, Lawson Eng, Frances A. Shepherd, Mary DeCarolis, Vivian Glenns, Swati Kulkarni, Rachel VanderMeer, Urszula Zurawska-Fortin, Desiree Hao, Lisa Le, Isabel Wozniczka, Aida Al-Kindy, Danny Xie, Tong Zhang, Vasanth Subramanian, Tracy Stockley, Penelope A. Bradbury, Geoffrey Liu, Natasha B. Leighl. A phase I study of binimetinib, a MEK inhibitor, in combination with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT206.

Background The IND.226 study was a phase Ib study to determine the recommended phase II dose of durvalumab + tremelimumab in combination with standard platinum-doublet chemotherapy. Sequential administration of multiple agents increases total chair time adding costs overall and inconvenience for patients. This cohort of the IND.226 study evaluated the safety and tolerability of durvalumab + tremelimumab given either sequentially (SEQ) or concurrently (CON). Methods Patients with advanced solid tumours were enrolled and randomised to either SEQ tremelimumab 75 mg IV over 1 h followed by durvalumab 1500 mg IV over 1 h q4wks on the same day, or CON administration over 1 h. The serum pharmacokinetic profile of SEQ versus CON of durvalumab and tremelimumab administration was also evaluated. Results 14 patients either received SEQ (n = 7pts) or CON (n = 7 pts). There were no infusion related reactions. Drug related adverse events (AEs) were mainly low grade and manageable, and comparable in frequency between SEQ/CON- fatigue (43%/57%), rash (43%/43%), pruritus (43%/29%) and nausea (14%/29%). One patient in each cohort discontinued treatment due to toxicity. The PK profiles of durvalumab and tremelimumab were similar between CON and SEQ, and to historical reference data. Conclusions Concurrent administration of durvalumab and tremelimumab over 1 h is safe with a comparable PK profile to sequential administration.

AIM To determine factors associated with survival in de novo stage IV, non-small cell lung cancer (NSCLC) patients possessing epidermal growth factor receptor mutations (EGFRmut+ ) receiving tyrosine kinase inhibitors (TKI) in the first-line setting. METHODS The Glans-Look Lung Cancer Database was used to retrospectively review stage IV EGFRmut+ NSCLC patients diagnosed 2010-2016 receiving first-line TKI. Patients with overall survival times in the upper quartile (≥34 months) were designated "long-term survivors" (LTS), the remaining deemed "average-term survivors" and characteristics between these groups were compared in univariate analysis, and multivariable models constructed to determine predictors of outcome. RESULTS Of 170 eligible patients, median overall survival was 21 months. LTS were significantly more likely to be of Asian ethnicity, be never-smokers and not possess brain or bone metastases at diagnosis. Asian and non-Asian patients were comparable, save for an increased propensity of Asian patients to be never smokers and have normal-range BMI. Multivariable analysis revealed Asian ethnicity [hazard ratio (HR) = 0.65; P = 0.016] and never-smoking history (HR = 0.65; P = 0.034) as indicators of improved outcome, and presence of brain metastasis at diagnosis an indicator of poor outcome (HR = 2.21; P

Background Adenoid cystic carcinoma (ACC) is a slow growing salivary gland malignancy that is molecularly characterized by t(6:9)(q22–23;p23–24) translocations which predominantly result in MYB-NFIB gene fusions in nearly half of tumours. Detection of MYB-NFIB transcripts is typically performed with fresh ACC tissue using conventional RT-PCR fragment analysis or FISH techniques, which are prone to failure when only archival formalin fixed paraffin embedded (FFPE) tissue is available. The purpose of this pilot study was to evaluate the utility of NanoString probe technology for the detection of MYB-NFIB transcripts in archival ACC tissue. Methods A NanoString probeset panel was designed targeting the junctions of three currently annotated MYB-NFIB fusion genes as well as 5′/3′ MYB probesets designed to detect MYB gene expression imbalance. RNA isolated from twenty-five archival ACC specimens was profiled and analyzed. RT-qPCR and sequencing were performed to confirm NanoString results. MYB protein expression was analyzed by immunohistochemistry. Results Of the 25 samples analyzed, 11/25 (44%) expressed a high degree of MYB 5′/3′ imbalance and five of these samples were positive for at least one specific MYB-NFIB variant in our panel. MYB-NFIB variant detection on NanoString analysis was confirmed by direct cDNA sequencing. No clinical correlations were found to be associated with MYB fusion status. Conclusion We conclude that the application of NanoString digital probe counting technology is well suited for the detection and quantification of MYB-NFIB fusion transcripts in archival ACC specimens. Electronic supplementary material The online version of this article (10.1186/s13000-019-0855-8) contains supplementary material, which is available to authorized users.

11022 Background: Despite extensive literature on the value of mentorship in academic medicine, little evidence exists to inform mentorship practices in MO. In 2021, the Canadian Association of Medical Oncologists (CAMO) piloted a national, 6-month virtual mentorship program consisting of 2 group mentoring events and additional 1-on-1 mentoring activities, to better support the needs of MO trainees. Feedback was obtained from participants to gain insight into how virtual mentorship might impact physician wellness and formation of professional identity, and to inform future iterations of CAMO’s virtual mentorship strategy. Methods: All Canadian MO residents/fellows were invited to participate in the program. Electronic surveys were completed by participants at baseline, after each group event, and at program completion. Surveys evaluated the program content and format, and used validated questionnaires for evaluating physician wellness/burnout (Stanford Professional Fulfillment Index [SPFI]), and professional identity (Macleod Clark Professional Identity Scale [MCPIS]). Cohort characteristics and survey responses were summarized using descriptive statistics. Procedures for survey data collection and analysis were ethics approved. Results: At baseline, respondents (n = 38) were predominantly female (63%), and < 35 years (76%). 50% were married. On average, 78% of respondents ranked the virtual group mentoring events as meeting expectations. Program strengths identified by participants included meeting mentors outside of their own centre, meeting other trainees from across the country, and learning more about work-life balance/physician wellness. The main critique was insufficient time for interaction. Of the 34 MCPIS respondents, 94% were pleased to belong to the profession of MO, 91% identified positively with members of their profession and 77% felt like a member of the profession themselves. The average score on the SPFI scale was 2.73±0.71 (n = 34). Although 85% of respondents found their work meaningful, 71% satisfying, and 50% felt they were contributing professionally in valued ways, only 38% met criteria for professional fulfilment (score ≥3.00). 27% met criteria for burnout (score ≥1.33), 15% found their work physically exhausting and 9% found their work emotionally exhausting. Conclusions: CAMO’s pilot virtual mentorship program highlights that technology can be successfully leveraged to facilitate mentoring. The majority of MO trainees identified positively with their profession, yet only 38% reached the threshold for professional fulfillment and nearly a third met criteria for burnout. Longitudinal follow-up among mentored trainees is needed to provide insight into whether mentorship may influence physician wellness and professional identity over time.

e13526 Background: It is unclear whether the Canadian medical oncology workforce has kept pace with the country’s rising cancer incidence over the last three decades. This study sought to characterize the national and provincial trends in the medical oncologist (MO) and MO trainee workforce during the last 27 years and explore the relationship between workforce and cancer incidence. Methods: Publicly available databases from the Canadian Medical Association (CMA; 1994-2019) and Canadian Institute of Health Information (CIHI) database (1994-2020) were utilized to estimate the number, demographics, and regional distribution of practicing MOs in Canada from 1994 to 2020. Cancer incidence by province was obtained from Statistics Canada for the period 1990 to 2018, except for Quebec where only 1990-2010 data was available, and then projected to 2020 across five regions (The West Coast, The Prairies, Ontario, Quebec and Atlantic Canada) using Canadian population statistics from Statistics Canada and age-period-cohort modeling. To estimate changes in demand for, and supply of, medical oncology services over time, annual cancer incidence to MO provider ratios were calculated. Finally, the Canadian Post MD Education Registry (CAPER) database (1994-2020) was used to characterize the number of MO trainees. Results: Between 1994 and 2020, annual cancer incidence nationally rose from 120,255 cases to 225,800 cases (88%), while the number of MOs increased from 161 to 642 (298%). Incident cancer cases to medical oncologist (MO) ratio dropped from 749:1 in 1994 to 352:1 in 2020. This ratio fell in all five analyzed regions from 1994 to 2020 (Atlantic Canada 1836:1 to 447:1, The Prairies 1257:1 to 377:1, The West Coast 909 to 261:1, Ontario 682:1 to 411:1 and Quebec 543:1 to 300:1). In 1994, 24% of MO providers were ≥ 50 years old compared with 40% in 2020. Nationally, the MO workforce has nearly reached gender parity with 46% female in 2020 versus 25% in 1994. Trends in Canadian MO trainees have largely mirrored MO trends with a 203% increase in the annual trainee cohort from 34 in 1994 to 103 in 2020. In 1994, 34% of trainees were female compared with 63% in 2020. The largest proportion of the country's MOs (34% in 2020) and MO trainees (49%) are located in Canada’s most populous province, Ontario. Conclusions: Although the Canadian MO workforce has shown considerable growth between 1994-2020, a higher proportion of MO providers are nearing retirement age and may influence future workforce trends. Moreover, our study was not able to take into consideration referral patterns or the increasing number and complexity of systemic therapies that also influence MO workload. Ongoing monitoring of human resource levels in medical oncology and cancer incidence data are key metrics to meaningfully inform MO training programs of an appropriately sized trainee cohort and ensure future demands for MO services in cancer care are met.

e24097 Background: Timely palliative care interventions can help to alleviate the distress people experience after a diagnosis of an incurable, life-threatening cancer. However, referrals to palliative care continue to be late due to various provider and patient barriers. The Palliative Care Early and Systematic (PaCES)-Automatic study was co-designed with patients and providers and implemented an early palliative care intervention for newly diagnosed stage IV non-small lung cancer (NSCLC). The objective of this study was to determine patient/caregiver-reported acceptability of a phone call from a supportive and palliative care (SPC) nurse offering consultation, automatically (without referral) after first oncologist appointment. Methods: Two SPC specialist nurses screened out-patient clinic lists at a tertiary cancer center weekly and called all eligible patients offering an in-home consultation. Eligibility: > 18 years, newly diagnosed/suspected Stage IV NSCLC and had first medical/radiation oncologist visit. Patients/caregivers were surveyed about the acceptability (5-point Likert scale) of the automatic phone call offering a palliative care consult, using Sekhon’s Framework of Acceptability domains. Results: Among the 113 patients screened, 81 patients/caregivers were contacted and offered SPC consultation and 72% accepted the in-home consult. Of 70 patients/caregivers that agreed to be contacted for the survey: 4 did not recall the call offering SPC, 3 declined participating in the survey, and 15 were not reached. Of 48 respondents, 93.6% rated overall acceptability of the automatic call offering SPC consultation somewhat/completely acceptable, with the other 6.4% rating it as neither acceptable nor unacceptable. Of 35 patients/caregivers that completed the full survey: 31% caregivers, 63% female, 57% ≤65 years, 29% ≤high school education, 67% (n = 27) < $60,000 household income, 80% spoke only English/French, and 71% Caucasian. Within the domains of acceptability, 94.7% were comfortable receiving the call, 91.9% understood why they received it; 86.5% thought the call was a valuable; 69.5% thought the call helped them; 65.7% learned about SPC from the call; no one expressed concern that the SPC nurse had access to their contact/health information; 97.2% thought the call didn’t take much physical/emotional effort and were confident in their ability to participate (ask questions/make decisions). Conclusions: Nearly all patients/caregivers found the automatic SPC call offering consultation to be acceptable. Most patients agreed to the consultation offer. Routine calls offering SPC consultation may be a timely alternative to awaiting conventional referral by oncologists.

The metabolic requirements of metastatic non-small cell lung (mNSCLC) tumors from patients receiving first-line platinum-doublet chemotherapy are hypothesized to imprint a blood signature suitable for survival prediction. Pre-treatment samples prospectively collected at baseline from a randomized phase III trial were assayed using nuclear magnetic resonance (NMR) spectroscopy (n = 341) and ultra-high performance liquid chromatography &ndash, mass spectrometry (UPLC-MS) (n = 297). Distributions of time to event outcomes were estimated by Kaplan-Meier analysis, and baseline characteristics adjusted Cox regression modeling was used to correlate markers&rsquo, levels to time to event outcomes. Sixteen polar metabolites were significantly correlated with overall survival (OS) by univariate analysis (p &lt, 0.025). Formate, 2-hydroxybutyrate, glycine and myo-inositol were selected for a multivariate model. The median OS was 6.6 months in the high-risk group compared to 11.4 months in the low risk group HR (Hazard Ratio) = 1.99, 95% C.I. (Confidence Interval) 1.45&ndash, 2.68, p &lt, 0.0001). Modeling of lipids by class (sphingolipids, acylcarnitines and lysophosphatidylcholines) revealed a median OS = 5.7 months vs. 11. 9 months for the high vs. low risk group. (HR: 2.23, 95% C.I. 1.55&ndash, 3.20, 0.0001). These results demonstrate that metabolic profiles from pre-treatment samples may be useful to stratify clinical outcomes for mNSCLC patients receiving chemotherapy. Genomic and longitudinal measurements pre- and post-treatment may yield addition information to personalize treatment decisions further.

Background: The covid-19 pandemic has presented unprecedented professional and personal challenges for the oncology community. Under the auspices of the Canadian Association of Medical Oncologists, we conducted an online national survey to better understand the impact of the pandemic on the medical oncology community in Canada. Methods: An English-language multiple-choice survey, including questions about demographics, covid-19 risk, use of personal protective equipment (ppe), personal challenges, and chemotherapy management was distributed to Canadian medical oncologists. The survey was open from 30 March to 4 April 2020, and attracted 159 responses. Results: More than 70% of medical oncologists expressed moderate-to-extreme concern about personally contracting covid-19 and about family members or patients (or both) contracting covid-19 from them. Despite that high level of concern, considerable variability in the use of ppe in direct cancer care was reported at the time of this survey, with 33% of respondents indicating no routine ppe use at their institutions and 69% indicating uncertainty about access to adequate ppe. Of the respondents, 54% were experiencing feelings of nervousness or anxiety on most days, and 52% were having feelings of depression or hopelessness on at least some days. Concern about aging parents or family and individual wellness represented the top personal challenges identified. The management of cancer patients has been affected, with adoption of telemedicine reported by 82% of respondents, and cessation of clinical trial accrual reported by 54%. The 3 factors deemed most important for treatment decision-making were (1) cancer prognosis and anticipated benefit from treatment, (2) risk of treatment toxicity during scarce health care access, and (3) patient risk of contracting covid-19. Conclusions: This report describes the results of the first national survey assessing the impact of the covid-19 on Canadian medical oncologists and how they deliver systemic anticancer therapies. We hope that these data will provide a framework to address the challenges identified.

Background This population-based retrospective study compares the efficacy of cisplatin (cis-RT) vs cetuximab (cetux-RT) with concurrent radiation as definitive treatment in patients with oropharyngeal carcinoma (OPC). Methods Patients with OPC treated in Alberta with cis-RT or cetux-RT between 2006 and 2016 were evaluated. Median disease-free survival (DFS) and overall survival (OS) were assessed using the Kaplan-Meier method. Multivariable analysis (MVA) was completed with a Cox proportional hazards model. Results Among 546 patients with OPC, 431 (78.9%) received cis-RT and 115 (21.1%) cetux-RT. Patients treated with cetux-RT were more likely to develop a recurrence after treatment compared to cis-RT (25% vs 15%, P = .01). On MVA, current smoking, human papillomavirus (HPV)-negative status, higher Charlson comorbidity index (CCI), T-stage, and cetux-RT predicted for worse DFS and OS. Outcomes in older patients with a higher CCI still favored cis-RT. Conclusions Our data reaffirm results from randomized studies showing better survival outcomes with cis-RT compared to cetux-RT even among those who are >65 with CCI ≥3.

This multicenter phase Ib study aimed to establish a recommended phase II dose for durvalumab (Du) ± tremelimumab (Tr) in combination with standard platinum-doublet chemotherapy. Eligible patients were enrolled into one of six dose levels (DL) of Du ± Tr which included concomitant treatment with standard platinum-doublet regimens; (pemetrexed, gemcitabine, etoposide, (each with cisplatin or carboplatin) or nab-paclitaxel (with carboplatin)). Dose escalation was according to a Rolling Six type design. Both weight-based and fixed dosing of Du and Tr were explored. Du was continued until progression. Tr dosing was finite (up to 6 doses) with increasing dose and/or frequency by DL. 136 patients were enrolled. The majority of drug-related adverse events (AEs) were ≤ grade 2 and attributable to chemotherapy. AEs considered related to immunotherapy were mainly ≤ grade 2; the most frequent (occurring ≥10 %) were colitis/diarrhea, skin, and thyroid dysfunction. Seven patients had DLTs including pneumonitis, myocarditis, diarrhea, encephalitis, motor neuropathy, and enterocolitis. There were 2 treatment-related deaths. Tr and Du exposures did not appear affected by chemotherapy. Among the 73 non-small cell lung cancer (NSCLC) patients treated, the objective response rate was 51 % (95 %CI = 38.7-62.6 %) with a median progression-free and overall survival of 6.5 months (95 % CI = 5.5-9.4 months) and 19.8 months (95 % CI = 14.8 months - not yet reached) respectively. Anti-tumour activity was observed across PD-L1 subtypes. Du 1500 mg q3w and Tr 75 mg q3wx5 can be safely combined with platinum-doublet chemotherapy. Efficacy among NSCLC patients appears comparable to results from other immunotherapy and chemotherapy combination trials. NCT02537418.

Purpose: We developed a workforce-planning model to predict Canadian medical oncologist (MO) supply and clinical demand during the next 10 years. Materials and Methods: A forward calculation model was created to forecast the balance of MO supply and demand. MO supply was estimated by using Canadian Institute for Health Information, Canadian Medical Association, and Canadian Post-MD Education Registry data. Care demand was estimated by using data from Canadian Cancer Statistics and Alberta Cancer Registry. The Canadian Royal College MO Committee confirmed its face validity. Results: The MO workforce is expected to grow from 541 staff in 2016 to 830 staff in 2026. During this period, new hires will increase from 39 to 56 per year, and departures will increase from 15 to 24 per year. Although cancer incidence rates will grow from 202,149 to 257,497, a projected increase in MO supply will mean fewer initial consultations, from an average of 168.5 consultations per MO in 2016 to 129.2 consultations per MO in 2026. The initiation of systemic therapy is projected to remain stable at 102.3 new systemic therapy starts per MO per year. Conclusion: We have developed a forward calculation MO workforce model that predicts a growing Canadian MO workforce and redefines MO workload dynamics. MO providers will increasingly support more follow-up care with the initiation of multiple lines of systemic therapy relative to the medical management of patients at the time of initial cancer diagnosis. Workload metrics, including follow-up and new therapy initiation rates, must be measured to appropriately to meet increasingly complex and growing care demands.

Background: The pandemic has presented professional and personal challenges for the MO workforce. CAMO sought to examine the temporal effects of C19 on MOs and care practices across Canada. Methods: Three serial multiple-choice, web-based surveys were conducted in 2020 – from Mar 30th to April 4th (S1), May 6th to May 15th (S2) and Dec 10th to 18th (S3). The surveys were distributed by email to MOs identified through CAMO and the Royal College of Physicians and Surgeons directory (n=618). Participation was voluntary with no compensation. Descriptive analyses with frequency distributions are reported. Results: The timing for S1 and S3 coincided with the 1st and 2nd C19 waves in Canada. Response rates decreased slightly: 26% S1, 25% S2 and 20% S3. Per table, demographics were similar across surveys: majority of respondents were from a comprehensive cancer centre and in practice for < 15 years. Concerns regarding PPE access and C19 personal risk decreased over time. A high rate of telemedicine was observed in S1 but this notably decreased by S3, despite the 2nd wave. A similar decreasing trend was observed in the proportion of altered chemotherapy plans due to C19. Similar levels of anxiety, depression, lack of focus and concerns for personal wellness were maintained over time. In S3, respondents noted delayed cancer diagnoses and oncologist burnout as the top 2 post-pandemic challenges, and 87% believed their workload would increase. [Formula presented] Conclusions: As the pandemic continues, positive trends can be observed in concerns around PPE access and C19 risk. A high level of telemedicine adoption was observed early in the pandemic but is decreasing, and chemotherapy plans remained unchanged for most patients. Concerns regarding personal wellness remained high across all 3 surveys. Proactive strategies to support physician wellness, mitigate burnout and manage MO workload are needed. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Human papillomavirus (HPV)-related cancers have been associated with different demographic profiles and disease characteristics than HPV-unrelated cancers in head and neck patients, but distress and other symptoms have not been compared. The aim of this study was to assess whether distress levels, fatigue, pain, anxiety, depression, and common psychological and practical problems differ between head and neck cancer patients with HPV-related vs. HPV-unrelated carcinomas (using oropharyngeal carcinoma (OPC) and non-OPC cancers as surrogates for HPV status). Distress, depression, anxiety, fatigue, pain, and common problems were examined in 56 OPC and 90 non-OPC patients at 4 timepoints during the first year following diagnosis. Two-level hierarchical linear modeling was used to examine effects. The HPV-related OPC group was more likely to be younger (p = 0.05), Caucasian (p = 0.001), non-smokers (p = 0.01), earn more (p = 0.04), and present with more advanced stage (p

Ataxia-telangiectasia mutated (ATM) is critical in maintaining genomic integrity. In response to DNA double-strand breaks, ATM phosphorylates downstream proteins involved in cell-cycle checkpoint arrest, DNA repair, and apoptosis. Here we investigate the frequency, and influence of ATM deficiency on outcome, in early-resected non-small cell lung cancer (NSCLC). Tissue microarrays, containing 165 formalin-fixed, paraffin-embedded resected NSCLC tumours from patients diagnosed at the Tom Baker Cancer Centre, Calgary, Canada, between 2003 and 2006, were analyzed for ATM expression using quantitative fluorescence immunohistochemistry. Both malignant cell-specific ATM expression and the ratio of ATM expression within malignant tumour cells compared to that in the surrounding tumour stroma, defined as the ATM expression index (ATM-EI), were measured and correlated with clinical outcome. ATM loss was identified in 21.8% of patients, and was unaffected by clinical pathological variables. Patients with low ATM-EI tumours had worse survival outcomes compared to those with high ATM-EI (p < 0.01). This effect was pronounced in stage II/III patients, even after adjusting for other clinical co-variates (p < 0.001). Additionally, we provide evidence that ATM-deficient patients may derive greater benefit from guideline-recommended adjuvant chemotherapy following surgical resection. Taken together, these results indicate that ATM loss seems to be an early event in NSCLC carcinogenesis and is an independent prognostic factor associated with worse survival in stage II/III patients.

Objectives Following failure of a platinum-antifolate combination regimen, there is no standard therapy for advanced malignant pleural mesothelioma (MPM). The fibroblast growth factor receptor (FGFR) signaling pathways may be a relevant target in MPM. Dovitinib inhibits multiple tyrosine receptor kinases, predominantly the vascular endothelial growth factor receptors (VEGFR), but also FGFRs, and could be active in MPM. Methods This open-label multicentre phase II trial [NCT01769547] enrolled fit, consenting adult patients with advanced MPM who had previously received platinum-antifolate combination chemotherapy and up to one additional line of systemic therapy. Dovitinib was administered orally at 500 mg/day for 5 days on, 2 days off, in 28-day cycles. Response was assessed every 2 cycles using RECIST 1.1 criteria modified for MPM. Correlative studies included FGFR-1 amplification on archival tumour and serum samples for circulating angiogenesis factors. The primary end-point was the proportion of patients progression-free at 3 months (PF3) using a two-stage design. Results 12 patients (10 males, median age 67) were enrolled. The median number of cycles administered was 2.5 (range 1–8). One unconfirmed partial response was observed. PF3 was 50% (95% confidence interval 28.4% to 88.0%); although the criterion for proceeding to stage II accrual was met, the trial was halted due to a combination of minimal activity with several early progression events and poor tolerability in this patient population. One of 12 tumour specimens had low amplification of FGFR-1. Conclusions Dovitinib has minimal activity in previously-treated MPM. The role of the FGFR pathway in MPM remains unclear.

Background: Little evidence has been generated for how best to manage patients with non-small-cell lung cancer (NSCLS) presenting with rarer clinical scenarios, including oligometastases, oligoprogression, and pseudoprogression. In each of those scenarios, oncologists have to consider how best to balance efficacy with quality of life, while maximizing the duration of each line of therapy and ensuring that patients are still eligible for later options, including clinical trial enrolment. Methods: An expert panel was convened to define the clinical questions. Using case-based presentations, consensus practice recommendations for each clinical scenario were generated through focused, evidence-based discussions. Results: Treatment strategies and best-practice or consensus recommendations are presented, with areas of consensus and areas of uncertainty identified. Conclusions: In each situation, treatment has to be tailored to suit the individual patient, but with the intent of extending and maximizing the use of each line of treatment, while keeping treatment options in reserve for later lines of therapy. Patient participation in clinical trials examining these issues should be encouraged.

e24009 Background: Early utilization of specialist palliative care (SPC) in cancer patients may reduce healthcare resource use, aggressive interventions, and costs at end-of-life. We evaluated the impact of SPC on healthcare resource utilization and aggressive interventions at end-of-life in patients who have died from lung cancer. Methods: Descriptive and multivariable logistic regression analyses were conducted on lung cancer decedents in the Calgary Zone, Alberta Health Services from 2008 to 2015. The primary exposure was timing of SPC (Early: receipt of SPC > = 90 days before death; Late: < 90 days before death; No SPC). The primary outcome was end-of-life healthcare resource use (defined as any of: hospital death, > 1 emergency department visit, > 1 hospital admission, > 14 days of hospitalization, ≥1 intensive care unit admission, ≥1 new chemotherapy program (or any chemotherapy in the last 14 days of life) in the 30 days prior to death. Results: There were 3300 patients of which the majority (51.6%) of decedents were male. More female versus male lung cancer decedents (36.4% vs 28.7%) received early SPC. After adjusting for confounders, a strong association was found between early, late or no SPC and end-of-life healthcare resource use (ORno exposure 3.25 (95% CI 2.41-4.40) vs ORlate exposure 2.44 (95% CI 2.03-2.92) compared to those with early SPC; p < 0.001). Males had 1.53 the odds of aggressive care at end-of-life compared to females (p < 0.001). Stratified analysis by sex revealed a strong association between the absence of SPC utilization and end-of-life healthcare resource use. Young age ( < 50 at death) was a strong driver of aggressive care at end-of-life in females versus males [OR 5.44 vs 2.53]. Conclusions: Early specialist palliative care was significantly associated with less end-of-life healthcare resource use in both male and female lung cancer decedents, with less early specialist palliative care use in males. Keywords: palliative care, early palliative care, cancer, end-of-life, healthcare resource use, lung cancer.

Introduction: This study explored the use, safety, and efficacy of initial use of an ALK-inhibiting targeted therapy (ALK tyrosine kinase inhibitor [TKI]) in patients with ALK-rearranged NSCLC in a population-based, real-world clinical population within the province of Alberta, Canada. Methods: Demographic, clinical, treatment, and outcome data of the patients with advanced or metastatic ALK-rearranged NSCLC receiving their first ALK TKI between 2014 and 2019 were included in the analysis. Results: A total of 92 patients with ALK-rearranged NSCLC treated with ALK TKI (78% crizotinib, 22% alectinib) were identified. In the ALK-rearranged cohort, 1-year survival rate was 73% and median overall survival (OS) and progression-free survival (PFS) were 48.5 months and 17.0 months, respectively. An objective response rate of 49% was observed, and adverse events were reported in 70% of the patients, primarily of low grade (84%). Case-matched comparison to patients with ALK-wildtype disease treated with cytotoxic chemotherapy revealed the benefit of ALK TKI in the context of an ALK rearrangement (ALK-rearranged versus ALK-wildtype) (median post-treatment initiation OS: 46.8 versus 14.2 mo, p < 0.001). Outcomes, measured from the time of ALK TKI initiation, differed by Eastern Cooperative Oncology Group (ECOG) (ECOG < 2 versus ECOG ≥ 2) (median OS: not reached versus 6.8 mo, p < 0.001; median PFS 17.6 versus 7.4 mo, p = 0.02), disease presentation (relapsed versus de novo) (median PFS: 30.8 versus 15.0 mo, p = 0.04), and brain metastasis onset (brain metastases development during ALK TKI versus baseline brain metastases) (not reached versus 12.8 mo, p = 0.04). Conclusions: Clinical trials have firmly established that ALK TKIs are safe, well tolerated, and effective; these findings reveal that their impact in a real-world setting is just as profound. The availability and use of ALK TKI therapies contribute to the impressive gains in survival experienced by contemporary patients with ALK-rearranged disease, rendering patients with this oncodriven form of NSCLC among the longest surviving patients with lung cancer.

Introduction Evidence suggests that the expression of certain cytokine receptors increases with lung cancer evolution. Overexpression of the cytokine receptor CXCR4 is associated with poor outcomes in stage IV non-small cell lung cancer (NSCLC), with shorter survival in females with high CXCR4 expression. This study quantifies CXCR4 expression in early stage disease and evaluates its association with gender-specific recurrence-free (RFS) and overall survival (OS) in resected stage I-III NSCLC patients. Methods Patient characteristics and clinical outcomes were obtained from the Glans-Look Lung Cancer (G-LLC) database for early stage NSCLC patients diagnosed between 2003–2006 at the Tom Baker Cancer Centre (TBCC). CXCR4 expression was quantified on tissue microarrays (TMA). Median RFS and OS were evaluated by gender using Kaplan-Meier analyses. CXCR4 expression and outcome data were analyzed using Cox proportional hazards (PH) and multi-state models (MSM). Results 176 stage I-III NSCLC patients were identified. CXCR4 expression was lower in early stage NSCLC patients, with a mean CXCR4 expression of 1729 (SD 1083) compared to 2640 (SD 1541) in stage IV patients. On Kaplan-Meier, median RFS by gender was similar (male 52.8 months vs. female 54.5 months) as was median OS (male 80.9 months vs. female 89.0 months), and there was no significant difference in RFS (p = 0.60) or OS (p = 0.30) by gender and CXCR4 groups over follow-up. By multivariable analysis, CXCR4 expression was not prognostic for RFS (Hazard Ratio (HR) = 1.00, p = 0.73) or OS (HR = 1.00, p = 0.44), and no gender difference was observed. Conclusions CXCR4 expression increases with stage progression in NSCLC but is not prognostic in early stage NSCLC patients of either gender. Mechanisms by which CXCR4 expression increases during lung carcinogenesis warrant further exploration and testing in clinical trials.

Purpose Erlotinib is an epidermal growth factor receptor inhibitor approved for patients with advanced non–small-cell lung cancer (NSCLC) whose epidermal growth factor receptor expression status is positive or unknown. Although it is efficacious, erlotinib can cause skin toxicity. This prospective, randomized phase III trial examined the effect of prophylactic treatment of erlotinib-induced skin rash. Patients and Methods Patients receiving erlotinib in the second- or third-line setting for advanced NSCLC were randomly assigned to prophylactic minocycline (100 mg twice per day for 4 weeks), reactive treatment (after rash developed, per grade of rash), or no treatment unless severe (grade 3). Rash incidence and severity, time to maximal rash, time to resolution, and overall survival (OS) were compared among treatment groups. Results In all, 150 patients were randomly assigned, 50 to each of three treatment arms. The incidence of skin toxicity was 84% regardless of treatment arm. Prophylactic treatment with minocycline significantly lengthened the time to the most severe grade of rash. Grade 3 rash was significantly higher in the no-treatment arm. OS was not significantly different among treatment arms, but patients receiving prophylactic or reactive treatments had a longer OS (7.6 and 8 months, respectively) than those who received no rash treatment (6 months). Rash was not self-limiting. Conclusion The incidence of all grades of rash did not differ statistically among the three arms, so the trial was negative. The incidence of grade 3 skin toxicities was reduced in patients who were treated with prophylactic minocycline or reactive treatment. Efficacy was not compromised. Prophylactic minocycline and reactive treatment are both acceptable options for the necessary treatment of erlotinib-induced rash in the second- or third-line setting of metastatic NSCLC.

Background: Available data suggest that cancer patients who contract COVID-19 may have worse outcomes, including a higher mortality compared to noncancer patients. In an effort to inform and guide our clinicians in the ongoing management of cancer patients during the COVID-19 pandemic, CancerControl Alberta (CCA) implemented targeted fast-track testing for symptomatic, immunocompromised cancer patients in the ambulatory setting. We report the results of the first 7 weeks of testing at the Tom Baker Cancer Centre (TBCC), a comprehensive tertiary cancer center serving southern Alberta (population approximately 2 million). Methods: Referral for prioritized COVID-19 testing (results within 24 hours) was intended for ambulatory cancer patients who were identified to have symptoms consistent with an influenza-like illness and confirmed to meet at least one of the following criteria: stem cell transplant recipient, hematologic malignancy, cancer diagnosis receiving >0.5 mg/kg/day of prednisone or equivalent, patients on immunotherapy treatment, patients on active chemotherapy within the last 3 weeks, neutropenia (ANC Results: Between April 15th and June 1st, 2020, 80 patients received prioritized testing at the Tom Baker Cancer Centre. Patients who were tested for COVID-19 had the following characteristics: median age of 60.5 years (range 19, 85) and 31% were male. The majority of tested patients (80%) met the criteria as outlined to prioritize testing. Patients with the following tumor types comprised over 80% of those tested: breast (n=22), hematologic (n=16), lung (n=9), gynecologic (n=9), and GI (n=9). The average time from screening to testing was 26.5 hours, and the average time from test to result was 12.8 hours. At the time of reporting, only one breast cancer patient, who just finished chemotherapy, tested positive via the fast-track testing process; this patient received repeat clearance testing, undergoing a total of 6 tests over one month before achieving 2 negative tests. Conclusions: Our experience demonstrates that prioritized testing for COVID-19 among those who are potentially the most susceptible, namely immunocompromised cancer patients, is feasible. Very few (1%) positive cases of COVID-19 were identified, among 80 patients tested in the first 47 days of operationalizing the fast-track testing process. Expedited testing should be considered as an ongoing strategy to provide guidance to clinicians in managing cancer patients during the COVID-19 pandemic. Citation Format: April A. Hildebrand, Desiree Hao, Safiya Karim, Winson Y. Cheung, Don Morris, Daniel Y. C. Heng. Operationalizing a prioritized COVID-19 testing strategy at a Canadian tertiary care cancer center [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-029.

Background: The first case of COVID-19 (SARS-CoV-2, C19) was reported to Health Canada on Jan 25th, 2020. By March 18th, states of emergency were declared across multiple provinces. The pandemic has presented professional and personal challenges for the medical oncology workforce and cancer care. Under the auspices of the Canadian Association of Medical Oncology (CAMO), we sought to examine the temporal effects of C19 on medical oncologists and care practices across Canada. Methods: Two serial multiple-choice, web-based national surveys were conducted in 2020—from March 30th to April 4th (S1) and May 6th to May 15th, 2020 (S2). The surveys were distributed by email to medical oncologists identified through CAMO and the Royal College of Physicians and Surgeons Medical Oncology directory (n=618). Participation was voluntary with no compensation. Descriptive analyses with frequency distributions are reported. Results: A total of 157 completed responses were received for S1 and 159 responses for S2 (25% response rate). Demographics were similar between S1/S2: from comprehensive cancer centre (87%/86%), greater than 15 years in practice (41%/46%), CAMO member (60%/65%). Moderate to extreme concern of C19 exposure decreased over time for self (79%/54%), for family (82%/65%), and for patient (pt) (71%/54%). Routine use of PPE increased (67%/100%) with less concern around PPE access (69%/28%). Frequent anxiety (54%/32%) and depression (19%/14%) lessened while frequent lack of interest (18%/17%) and lack of focus (33%/31%) were unchanged. Use of telemedicine for >50% of pts remained high (82%/86%), and confidence in adequate health care access for pts increased (39%/59%). Centre accrual activity to clinical trials increased (46%/67%). Change in chemotherapy for >20% of pts was reported infrequently (33%/23%). Cancer prognosis and treatment benefit remained the primary determinant in treatment decision-making (rank score: 7.50/7.95) while resource access (6.19/5.68) and pt risk of C19 (6.05/5.72) became less important. Conclusions: As the pandemic curve flattens and Canadian medical oncologists adjust to a new normal, positive trends can be observed in concerns around C19 exposure, frequency of anxiety and depression, concerns about PPE access, confidence in health care access, and accrual to clinical trials. Chemotherapy plans remained unchanged for the majority of pts. A high rate of early adoption of telemedicine was observed and maintained. Serial follow-up is valuable to understand changing perceptions and practices. Citation Format: Sharlene Gill, Bruce Colwell, Hal Hirte, Welch Stephen, Alexi Campbell, Desiree Hao. Evaluating the impact of COVID-19 on medical oncology workforce and cancer care in Canada: A serial survey study [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-016.

Background: Genotyping tumor tissue in time for clinical treatment decision-making has been challenging in advanced non-small cell lung cancer (NSCLC). Next-generation sequencing (NGS) of cell-free DNA (cfDNA) obtained from blood samples may improve diagnostic testing, with faster turnaround time (TAT) and potential cost savings. This study defines the added value of cfDNA versus tumor tissue genotyping in patients with advanced NSCLC in the Canadian public health care system. Methods: Patients with advanced non-squamous NSCLC patients at 6 cancer centers across Canada are being recruited (BC, Alberta, Ontario, Quebec). Two cohorts are included: 1) treatment-naïve patients with ≤10 pack year smoking history (N=150) and 2) patients with known oncogenic drivers (e.g., EGFR, ALK, ROS1, BRAF) that have progressed on tyrosine kinase inhibitors (N=60). Consenting patients undergo peripheral blood draw and cfDNA NGS analysis using Guardant360™ (Guardant Health), a validated assay that detects alterations in 74 known cancer-associated genes, prior to starting treatment (Cohort 1) or next line of treatment (Cohort 2). Standard-of-care (SOC) tissue profiling is completed per institutional standards. Endpoints include response, progression-free survival, time-to-treatment failure, as well as time to treatment initiation, number of actionable genomic alterations identified, result TAT, patient-reported quality of life (EQ-5D), and willingness to pay. A decision-analytic model will be developed to perform a cost-consequence analysis of cfDNA versus tissue-based diagnostics. Results: Between February and October 3, 2019, 49 patients (32 female, 17 male) were recruited to Cohort 1 and 31 (21 female, 10 male) to Cohort 2. Forty patients in Cohort 1 (81.6%) had ≥1 alteration detected, with a total of 145 genetic alterations detected in 36 genes. Of these, 68 were actionable with FDA-approved drugs and/or clinical trials available. The most frequent actionable alterations were in EGFR (33.8%), MET Exon 14 Skipping (7.4%), and EML4-ALK fusion (2.9%). Additional alterations included TP53 (29.4%), KRAS (8.8%), PIK3CA (4.4%), and STK11 (2.9%). In Cohort 2, 29 patients (93.5%, 29/31) had ≥1 alteration detected, with a total of 130 alterations in 33 genes. The most frequent alterations were in EGFR (46.0%), TP53 (9.5%), EML4-ALK fusion (6.3%), ALK mutations (4.8%), and BRAF, BRCA2, GNAS, KRAS, MET Exon 14 Skipping, NRAS, and PTEN (each 3.2%). In samples with alterations detected, the median number of alterations/patient was 3 (range 1-17). The median time to Guardant report was 8 days (range 5-27). Mutations detected in tissue, concordance, and time to result for SOC tissue profiling will be updated, along with incremental treatment options for patients. Conclusion: Over 86% of advanced NSCLC patients had detectable cfDNA and at least 61 had actionable mutations. Blood-based testing may be an important cost-efficient addition to tissue-based testing in lung cancer to determine optimal treatment options. Citation Format: Jason Agulnik, Jennifer H. Law, Rosalyn Juergens, Janessa Laskin, Scott Laurie, Desiree Hao, Doreen A. Ezeife, Lisa W. Le, Lesli A. Kiedrowski, Richard B. Lanman, Natasha B. Leighl. Defining VALUE: Routine liquid biopsy in NSCLC diagnosis—a Canadian trial in progress [abstract]. In: Proceedings of the AACR Special Conference on Advances in Liquid Biopsies; Jan 13-16, 2020; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(11_Suppl):Abstract nr A26.

3546 Background: Given the challenges of molecular profiling in patients with advanced lung cancer, this prospective study examines clinical outcomes and utility of liquid biopsy in treatment naive stage IV lung adenocarcinoma patients (Cohort 1) and in the setting of resistance to targeted therapy (Cohort 2; not reported here). Methods: This study is being conducted at 6 Canadian centres (NCT03576937) using Guardant 360 (G360), a validated cell-free DNA next-generation sequencing assay that identifies variants in 74 cancer-associated genes, including fusions and copy number gain. Cohort 1 (N = 150) includes patients with treatment-naïve advanced non-squamous lung carcinoma, ≤10 pack-year smoking history, and measurable disease. Patients received standard of care tumour tissue (TT) molecular profiling ( EGFR, ALK +/- ROS1) and liquid biopsy (LB). The primary endpoint was response rate to first-line therapy (RECIST 1.1); secondary endpoints include incremental targetable alterations identified through G360 ( EGFR, ALK, BRAF, ERBB2, KRAS (G12C), NTRK, MET (amplification, exon 14 skipping), RET, ROS1), turn-around time (TAT) and successful molecular profiling rates. Results: To date, 84 eligible patients with clinical data have been accrued to Cohort 1. Median age is 64 (range 23-91), 64% are female, 85% never smokers, 96% have adenocarcinoma. Actionable targets have been identified in 55% of patients using G360 ( EGFR/ALK in 37%), 39% using standard TT profiling. Eight EGFR/ALK aberrations were identified in TT but not LB, while 6 were identified in LB but not TT. TT profiling for EGFR/ALK was unsuccessful in 8% of patients (insufficient tissue, failed biopsy). Fourteen patients (17%) had no ctDNA alterations detected by G360 (low disease burden vs. non-shedding). Of 75 patients receiving first-line treatment, 57% received targeted therapy, 28% chemotherapy combinations, 11% checkpoint inhibitors and 4% were observed. Treatment decisions were informed by G360 alone in 37% and by G360+TT results in 27% (by physician report). Among 46 evaluable patients, ORR was 54% (25/46). Using G360, ORR was 75% (15/20) in those with actionable alterations and 38.5% (10/26) in those without. Using TT, ORR was 67% (14/21) in those with actionable alterations and 44% (11/25) in those without. Mean TAT was 7.9 days (SD+/-1.7) for LB vs 19.9 days (SD+/- 9.8) for TT. Conclusions: Liquid biopsy using G360 identifies actionable targets beyond tissue profiling alone in newly diagnosed lung cancer patients, has faster TAT and yields similar outcomes with targeted and non-targeted therapy. Clinical trial information: NCT03576937 .

No standardized measures specifically assess cancer survivors&rsquo, and healthcare providers&rsquo, experience of Survivor Care Plans (scps). We sought to develop two care plan evaluation (cpe) measures, one for survivors (cpe-s) and one for healthcare providers (cpe-p), examine initial psychometric qualities in Alberta, and assess generalizability in Manitoba, Canada. We developed the initial measures using convenience samples of breast (n = 35) and head and neck (n = 18) survivors who received scps at the end of active cancer-centre treatment. After assessing Alberta&rsquo, s scp concordance with Institute of Medicine (iom) recommendations using a published coding scheme, we examined psychometric qualities for the cpe-s and cpe-p. We examined generalizability in Manitoba, Canada, with colorectal survivors discharged to primary care providers for follow-up (n = 75). We demonstrated acceptable internal consistency for the cpe-s and cpe-p subscales and total score after eliminating one item per subscale for cpe-s, two for cpe-p, resulting in revised scales with four 7-item and 6-item subscales, respectively. Subscale scores correlated highly indicating that for each measure the total score may be the most reliable and valid. We provide initial cpe-s discriminant, convergent, and predictive validity using the total score. Using the Manitoba sample, initial psychometrics similarly indicated good generalizability across differences in tumour groups, scp, and location. We recommend the revised cpe-s and cpe-p for further use and development. Studies documenting the creation and standardization of scp evaluations are few, and we recommend further development of patient experience measures to improve both clinical practice and the specificity of research questions.