416 Background: Patients (pts) presenting with de novo metastatic renal cell carcinoma (mRCC) have a poor prognosis. The role of cytoreductive nephrectomy (CN) is uncertain in these pts. Stereotactic body radiation therapy (SBRT) provides a convenient method for cytoreduction of the primary kidney lesion and may induce an enhanced systemic anti-tumor immune response. The efficacy and safety of primary SBRT in combination with ipilimumab and nivolumab (I/N) in pts with previously untreated mRCC are unknown. Methods: A randomized phase II trial was conducted at sites in Canada (6) and Australia (1). Inclusion criteria were: previously untreated, biopsy-proven, IMDC intermediate or poor risk de novo clear cell mRCC. Pts with a primary kidney lesion > 20cm, previous abdominal radiation precluding SBRT, or with a contraindication to I/N were excluded. Randomization was 2:1 to I/N plus SBRT (30-40 Gy in 5 fractions) to the primary kidney mass between cycles 1 and 2 (experimental arm), versus I/N alone. The primary endpoint was progression free survival (PFS). Target sample size was 78 pts. Secondary objectives included safety, overall survival (OS), objective response rate (ORR), health-related quality of life (QOL), and correlative biomarker analyses. Results: Pts were recruited between February 2020 and July 2024, with accrual paused for 8 months during COVID-19 pandemic. Median follow-up is 23.5 months. A total of 67 pts were randomized: 43 pts to I/N+SBRT, 24 to I/N alone. Median age was 65 years, 73% were male, IMDC risk groups were 58% intermediate and 42% poor. Pts in the experimental arm had larger renal tumours (T3/T4 stage 70% vs 46%), primary target lesion (95 mm vs 87.5 mm), and more likely to have liver sites of metastasis (23% vs 8%) compared to the I/N alone arm. Three pts died prior to any SBRT. PFS rate at 12-months was 35% (95% CI 21-49%) for I/N+SBRT vs 48% (27-66%) for I/N alone (HR 1.29, 0.69-2.40). The ORR was 33% vs 42% and 18-month OS was 59% vs 70%, for I/N+SBRT vs I/N alone. In per protocol analysis of pts who received 4 cycles of I/N +/- SBRT, 12-month PFS was 46% vs 56%, ORR was 50% vs 44%, and 18-month OS was 74% vs 79%, for I/N+SBRT (n = 24) vs I/N alone (n = 16). Grade 3/4 treatment related adverse events were 23% vs 29%, respectively, with no new safety signals related to I/N or SBRT toxicity noted. Conclusions: CYTOSHRINK is the first randomized trial testing the addition of early cytoreductive SBRT to first-line immune checkpoint blockade for patients with de novo mRCC. While 12-month PFS was not improved compared to I/N alone, there were notable baseline imbalances. The addition of SBRT to I/N was considered safe. Further follow up of OS, QOL and correlative biomarker analyses are ongoing. Clinical trial information: NCT04090710 .

TPS628 Background: Currently, the standard of care for patients undergoing neoadjuvant chemotherapy (NAC) and breast conserving surgery (BCS) is adjuvant radiation (RT). However, high rates of pathologic complete response (pCR) after NAC have raised questions regarding the necessity of WBRT in these cases. A meta-analysis of 9 German NAC trials demonstrated a 5-year locoregional recurrence (LRR) of only 4% in patients with pCR who underwent BCS with radiation therapy. Data from two large National Surgical Adjuvant Breast and Bowel Project (NSABP) neoadjuvant trials (B.18 and B.27) demonstrated a local recurrence risk of 5.1% at 10 years (2.5% at 5 years) in patients >50 years with node negative breast cancer who had a pCR and were treated with BCS and RT. With such low rates of recurrence, we postulated that the absolute benefit that RT can offer is limited. Radiation therapy is not without side effects, which include both short-term and long-term toxicity. As such, a trial of de-escalation of RT is warranted. Methods: This study is a prospective, multi-center, single arm cohort study of omission of WBRT following BCS in patients with a pCR following NAC. Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer age >50 years with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. Negative lymph node involvement at initial presentation must be documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy. Marker clip must have been placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. Study participants will not receive adjuvant RT, the current standard of care. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. Any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. A local recurrence of 5% without RT was felt to be acceptable. Based on a postulated 5-year IBTR risk of 3.0%, 4 years of accrual plus an additional 3 years of follow-up, a 90% two-sided CI for a postulated LR rate of 3.0% at 5 years would have an upper bound of <5% with 300 patients. To account for a 5% potential loss to follow-up and 10% receiving RT contrary to protocol, a sample size of 352 patients will be required. The trial opened in March 2024. Clinical trial information: NCT05866458 .

AbstractPurposeIn a learning health system (LHS), data gathered from clinical practice informs care and scientific investigation. To demonstrate how a novel data and analytics platform can enable an LHS at a regional cancer center by characterizing the care provided to breast cancer patients.MethodsSocioeconomic information, tumor characteristics, treatments and outcomes were extracted from the platform and combined to characterize the patient population and their clinical course. Oncologists were asked to identify examples where clinical practice guidelines (CPGs) or policy changes had varying impacts on practice. These constructs were evaluated by extracting the corresponding data.ResultsBreast cancer patients (5768) seen at the Juravinski Cancer Centre between January 2014 and June 2022 were included. The average age was 62.5 years. The commonest histology was invasive ductal carcinoma (74.6%); 77% were estrogen receptor‐positive and 15.5% were HER2 Neu positive. Breast‐conserving surgery (BCS) occurred in 56%. For the 4294 patients who received systemic therapy, the initial indications were adjuvant (3096), neoadjuvant (828) and palliative (370). Metastases occurred in 531 patients and 495 patients died. Lowest‐income patients had a higher mortality rate. For the adoption of CPGs, the uptake for adjuvant bisphosphonate was very low, 8% as predicted, compared to 64% for pertuzumab, a HER2 targeted agent and 40.2% for CD4/6 inhibitors in metastases. During COVID‐19, the provincial cancer agency issued a policy to shorten the duration of radiation after BCS. There was a significant reduction in the average number of fractions to the breast by five fractions.ConclusionOur platform characterized care and the clinical course of breast cancer patients. Practice changes in response to regulatory developments and policy changes were measured. Establishing a data platform is important for an LHS. The next step is for the data to feedback and change practice, that is, close the loop.

Introduction: Although virtual care (VC) has become an integral part of oncology care and healthcare delivery, clinicians’ perspectives on and satisfaction with this modality are not well understood. Methods: Using a National Network Forum framework and expert panel review, we developed a questionnaire to measure oncologists’ satisfaction with VC. The questionnaire was distributed to Canadian oncologists through medical society email lists (n = 1541). We used a 5-point Likert scale to capture their responses, which included strongly disagree (1), disagree (2), undecided (3), agree (4), and strongly agree (5). Results: A total of 61 oncologists and/or oncology trainees, of 768 (7.9%) who opened their email, completed questionnaires between October 2022 and January 2023. Every questionnaire item had a response rate greater than 98%. Seventy-two percent of the respondents were satisfied with VC. Oncologists who were less comfortable with technology were more likely to report lower levels of satisfaction (p < 0.001, Wilcoxon rank-sum). The questionnaire items that received the highest levels of agreement were related to VC reducing costs and improving access for patients and concerns about missing a diagnosis and assessing patients’ functional status. The questionnaire items that received the greatest disagreement were related to VC improving access for patients with language barriers, VC being associated with time-savings for clinicians, improvements in clinical efficacy, and more readily available lab tests. Conclusions: Most of the oncologists surveyed are satisfied with VC; however, there are some concerns with VC that need to be addressed. Future research on optimizing VC should address clinicians’ concerns, in addition to addressing the patient experience.

INTRODUCTION:As immigrant women face challenges accessing health care, we hypothesized that immigration status would be associated with fewer women with breast cancer receiving surgery for curable disease, fewer undergoing breast conserving surgery (BCS), and longer wait time to surgery.METHODS:A population-level retrospective cohort study, including women aged 18-70 years with Stage I-III breast cancer diagnosed between 2010 and 2016 in Ontario was conducted. Multivariable analysis was performed to assess odds of undergoing surgery, receiving BCS and wait time to surgery.RESULTS:A total of 31,755 patients were included [26,253 (82.7%) Canadian-born and 5502 (17.3%) immigrant women]. Immigrant women were younger (mean age 51.6 vs. 56.1 years) and less often presented with Stage I/II disease (87.4% vs. 89.8%) (both p < .001). On multivariable analysis, there was no difference between immigrant women and Canadian-born women in odds of undergoing surgery [Stage I OR 0.93 (95% CI 0.79-1.11), Stage II 1.04 (0.89-1.22), Stage III 1.22 (0.94-1.57)], receiving BCS [Stage I 0.93 (0.82-1.05), Stage II 0.96 (0.86-1.07), Stage III 1.00 (0.83-1.22)], or wait time [Stage I 0.45 (-0.61-1.50), Stage II 0.33 (-0.86-1.52), Stage III 3.03 (-0.05-6.12)]. In exploratory analysis, new immigrants did not have surgery more than established immigrants (12.9% vs. 10.1%), and refugee women had longer wait time compared with economic-class immigrants (39.5 vs. 35.3 days).CONCLUSIONS:We observed differences in measures of socioeconomic disadvantage and disease characteristics between immigrant and Canadian-born women with breast cancer. Upon adjusting for these factors, no differences emerged in rate of surgery, rate of BCS, and time to surgery. The lack of disparity suggests barriers to accessing basic components of breast cancer care may be mitigated by the universal healthcare system in Canada.

Patient-reported outcome measures (PROMs) come directly from the patient, without clinician interpretation, to provide a patient-centered perspective. To understand the association of PROM integration into cancer care with patient-related, therapy-related, and health care utilization outcomes. Searches included MEDLINE and MEDLINE Epub ahead of print, in-process, and other nonindexed citations; Embase databases (OvidSP); PsychINFO; CENTRAL; and CINAHL from January 1, 2012 to September 26, 2022. Randomized clinical trials (RCTs) that enrolled adult patients (ages 18 years and older) with active cancer receiving anticancer therapy using a PROM as an intervention. Pairs of review authors, using prepiloted forms, independently extracted trial characteristics, disease characteristics, and intervention details. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was followed. Random-effects analyses were conducted. Overall mortality, health-related quality of life (HRQoL) measures, and hospital utilization outcomes. From 1996 to 2022, 45 RCTs including 13 661 participants addressed the association of PROMs with outcomes considered important to patients. The addition of a PROM likely reduced the risk of overall mortality (HR, 0.84; 95% CI, 0.72-0.98; moderate certainty), improved HRQoL (range 0-100) at 12 weeks (mean difference [MD], 2.45; 95% CI, 0.42-4.48; moderate certainty). Improvements of HRQoL at 24 weeks were not significant (MD, 1.87; 95% CI, −1.21 to 4.96; low certainty). There was no association between the addition of a PROM and HRQoL at 48 weeks. The addition of a PROM was not associated with reduced ED visits (OR, 0.74; 95% CI, 0.54-1.02; low certainty) or hospital admissions (OR, 0.86; 95% CI, 0.73-1.02; low certainty). The findings of this study suggest that the integration of PROMs into cancer care may improve overall survival and quality of life.

Importance:Stereotactic body radiotherapy (SBRT) is widely used for stage I medically inoperable non-small cell lung cancer (NSCLC), yet varied results from randomized clinical trials (RCTs) and concerns in treating centrally located tumors persist. Objective:To examine whether SBRT would improve local control (LC) compared with hypofractionated conventional radiotherapy (CRT). Design Setting and Participants:This phase 3 RCT was conducted in 16 Canadian centers. Patients with medically inoperable stage I (≤5 cm) NSCLC were randomized 2:1 to SBRT of 48 Gy in 4 fractions (peripheral NSCLC) or 60 Gy in 8 fractions (central NSCLC) vs CRT of 60 Gy in 15 fractions. Data were collected from May 2014 to January 2020, and data were analyzed from July 2022 to July 2023. Interventions:SBRT or CRT. Main Outcomes and Measures:The primary objective was to determine the effectiveness of SBRT compared with CRT based on LC at 3 years. Secondary outcomes included event-free survival, overall survival, and toxic effects. All radiation plans were subject to real-time/final review. Local failures were centrally adjudicated. The study was designed to detect a 3-year LC improvement of SBRT from 75% to 87.5%. The target sample size was 324 patients. Results:Of 233 included patients, 119 (51.1%) were male, and the mean (SD) age was 75.4 (7.7) years; the median (IQR) follow-up was 36.1 (26.4-52.8) months. A total of 154 patients received SBRT and 79 received CRT. The 3-year LC was 87.6% (95% CI, 81.9%-93.4%) for SBRT and 81.2% (95% CI, 71.9%-90.5%) for CRT (hazard ratio [HR], 0.61; 95% CI, 0.31-1.20; P = .15). The HR was 1.02 (95% CI, 0.72-1.45; P = .87) for event-free survival and 1.18 (95% CI, 0.80-1.76; P = .40) for overall survival. Minimal acute toxic effects were observed. Among those randomized to SBRT, late grade 3 or 4 toxic effects occurred in 5 of 45 (11%) with central NSCLC and 2 of 109 (1.8%) with peripheral NSCLC; among those randomized to CRT, in 1 of 19 (5%) with central NSCLC and 1 of 60 (2%) with peripheral NSCLC. One patient who received SBRT for an ultracentral lesion (target overlapping proximal bronchus) experienced a possible treatment-related grade 5 event (hemoptysis). Conclusions and Relevance:This RCT compared lung SBRT with hypofractionated CRT that included central/ultracentral tumors. No difference was detected in LC between groups. Severe toxic effects were limited, including patients with central tumors. The trial provides important prospective data evaluating SBRT; however, further research is necessary to determine if SBRT is more effective than CRT for peripheral and central NSCLC. Trial Registration:ClinicalTrials.gov Identifier: NCT03924869.

PURPOSE:Patients with locally advanced breast cancer (LABC) typically undergo staging tests at presentation. If staging does not detect metastases, treatment consists of curative intent combined modality therapy (neoadjuvant chemotherapy, surgery, and regional radiation). Positron emission tomography-computed tomography (PET-CT) may detect more asymptomatic distant metastases, but the evidence is based on uncontrolled studies.METHODS:For inclusion, patients had histological evidence of invasive ductal carcinoma of the breast and TNM stage III or IIb (T3N0, but not T2N1). Consenting patients from six regional cancer centers in Ontario were randomly assigned to 18F-labeled fluorodeoxyglucose PET-CT or conventional staging (bone scan, CT of the chest/abdomen and pelvis). The primary end point was upstaging to stage IV. A key secondary outcome was receiving curative intent combined modality therapy (ClinicalTrials.gov identifier: NCT02751710).RESULTS:Between December 2016 and April 2022, 184 patients were randomly assigned to whole-body PET-CT and 185 patients to conventional staging. Forty-three (23%) PET-CT patients were upstaged to stage IV compared with 21 (11%) conventional staged patients (absolute difference, 12.3% [95% CI, 3.9 to 19.9]; P = .002). Consequently, treatment was changed in 35 (81.3%) of 43 upstaged PET-CT patients and 20 (95.2%) of the 21 upstaged conventional patients. Subsequently, 149 (81%) patients in the PET-CT group received combined modality treatment versus 165 (89.2%) patients in the conventional staging group (absolute difference, 8.2% [95% CI, 0.1 to 15.4]; P = .03).CONCLUSION:In patients with LABC, PET-CT detected more distant metastases than conventional staging, and fewer PET-CT patients received combined modality therapy. Our randomized trial demonstrates the utility of the PET-CT staging strategy.

Appropriate adjuvant radiation therapy (RT) after breast cancer surgery is an important quality of care metric. Cancer treatment experience for immigrant women may differ due to challenges in navigating the health care system. This study compares the proportion of immigrant and Canadian born/long-term resident women receiving adjuvant RT and time to RT. A population-level retrospective cohort-study using linked provincial administrative databases was conducted including women >=18 years of age with Stage I-III breast cancer diagnosed between 2010-2016 in Ontario, Canada. Women were classified as immigrants using the federal database if they arrived in Canada in or after 1985, and as Canadian-born/long-term residents if they were born in Canada or arrived prior to 1985. Dependent variables (age, co-morbidity, socioeconomic factors, stage, and treatments) were collected. Data on proportion of women undergoing RT and time from surgery to RT was collected. Multivariable analysis was performed adjusting for dependent variables. Out of 54,090 patients, 46,930 (86.8%) were Canadian-born/long-term residents and 7,160 (13.2%) were immigrants. Immigrants were younger at diagnosis (54.3 vs. 63.0 years) and more often had Stage III disease (16.8% vs. 13.9%). Odds of receiving RT after breast conserving surgery (BCS) was 0.86 (95% CI 0.78-0.95), and 0.98 (95% CI 0.86-1.12) after mastectomy. Mean time from any surgery to RT was longer for immigrants (126.9 days vs. 117.1 days, p<0.001). Using a multivariable piecewise Cox regression model, excluding patients who received adjuvant chemotherapy before radiation, the hazard ratio for receipt of RT within 90 days for immigrants compared to Canadian long-term residents was 0.87 (95% CI; 0.83-0.92). Amongst immigrants, women from Latin America and the Caribbean had the longest wait times. There were no differences based on length of stay in Canada or immigration class. Our study demonstrates a lower proportion of immigrant women receiving RT after BCS compared to Canadian-born/long-term resident women in Ontario, and a longer wait time for adjuvant RT. Further research is needed to explore system, provider, and patient factors that may be driving this difference.

460 Background: Muscle invasive bladder cancer (MIBC) is an aggressive local disease where initial staging with conventional CT imaging is often suboptimal. To explore the role of PET-CT in both staging MIBC and assessing response to neoadjuvant chemotherapy (NAC), we conducted a prospective multicentre, randomized trial known as PETMUSE. We report here the first results from the neoadjuvant substudy which assessed interim PET-CT response after 2-3 cycles of NAC and how this correlated with disease free survival (DFS) and overall survival (OS). Methods: Patients with MIBC (T2a-4a, N0-3, M0) based on transurethral resection of their bladder tumor and CT staging were randomized 2:1 to PET-CT or no PET-CT. All PET-CT patients, receiving cisplatin-based NAC underwent a second PET-CT after 2 cycles of gemcitabine and cisplatin (GC) or 3 cycles of dose dense methotrexate, vinblastine, adriamycin, cisplatin (ddMVAC) to assess for interim response. Patients were scored (1-5) by 2 independent reviewers according to the extent of metabolic response on PET-CT. Disease-free survival (DFS) and overall survival (OS) were collected. Results: Between 2016 and 2021, 291 patients were enrolled on PETMUSE of which 46 participated in the neoadjuvant substudy. Median age was 68 (51-86); 36 (78%) were male; 26 were ECOG 0 (57%); 31 (68%) were T2, 13 (28%) were T3/T4; and 35 (76%) were node negative. In terms of NAC regimens: 22 (48%) received GC, 17 (37%) split dose GC, 6 (13%) ddMVAC, and 1 (2%) MVAC. On PET-CT, 23 (50%) had a complete metabolic response, 14 (30%) had a partial metabolic response, 5 (11%) had no change or mixed response and 4 (9%) had progressive disease or new lesion on PET scan. Metabolic response on PET-CT was a statistically significant prognostic factor for both DFS and OS (see Table). Conclusions: In MIBC patients receiving cisplatin-based NAC, metabolic response seen on interim PET-CT was correlated with DFS and OS. PET-CT warrants further study in this setting as a potential early indicator of response to NAC. Clinical trial information: NCT02462239 . [Table: see text][Table: see text]

In this opinion piece, we respond to comments about the LUMINA trial by Meattini and colleagues in the Journal. LUMINA was a prospective cohort study which evaluated the omission of radiotherapy after breast conserving surgery (BCS) in patients treated with endocrine therapy with low risk clinico-pathologic features and luminal A breast cancer. We address their areas of concern including the single cohort design that required careful patient selection, the relatively short follow-up period of 5 years, and the limited follow-up on younger patients. The Ki67 biomarker was key to defining the luminal A phenotype. We clarify the evidence supporting the Ki67 criteria used. The compliance with endocrine therapy was high and similar to other contemporary trials. Based on the results of LUMINA, and mounting evidence from other trials, we feel comfortable offering our patients the option of no radiotherapy after BCS if they fit the trial eligibility criteria from LUMINA and have decided to receive adjuvant endocrine therapy. We concur that a patient -centered approach to treatment decision making should be used to make patients aware of all available information including the results of the LUMINA trial when deciding on post -operative breast radiotherapy.

e17050 Background: Some phase I/II trials showed that combining high dose IV vitamin C with chemotherapies decreased toxicities and improved QoL in advanced cancers, while others failed to show benefits. While grade ¾ AEs are not typically a co-primary endpoint, they are a measure of cumulative toxicity. We investigated whether high-dose IV vitamin C could improve prostate-specific antigen (PSA) response rate and mitigate docetaxel toxicities in patients with metastatic castrate-resistant prostate cancer (mCRPC) receiving docetaxel. Methods: Patients were randomized (2:1) to receive docetaxel (75mg/m2 IV every 3 weeks) plus IV vitamin C (1g/kg) or placebo twice a week. The primary endpoints were PSA50 response by24 weeks and adverse events (AEs) of fatigue, nausea, bone pain, and anorexia. Secondary endpoints included overall survival (OS) and QoL measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Results: 50 patients were randomized, 47 received therapy (treatment N = 32, control N = 15), 3 untreated (withdrawal, elevated creatine, low hemoglobin). The median age was 74 years (range 45-85) and ECOG 1. The median PSA was 108.3 ng/mL (range: 0.3, 2102.3). The median number of chemotherapy cycles was 6 (IQR 3-8). The study was suspended after the pre-specified interim analysis for primary endpoints showed futility. The PSA50 response was 41% for treatment and 33% for control (P = 0.44). Grade 1-2 and grade 3-4 prespecified AEs occurred in 69% and 6% of treatment group patients versus 60% and 0% of control group patients (one-sided Cochran Armitage test, P =0.90). Diarrhea (72% vs 19%) and anemia (47% vs 25%) and neutropenia (22% vs 19%) are more frequent in the Vit C group. Compared with the control group, treatment group patients showed a trend towards shorter median OS. FACT-P was not significantly different at any timepoints. Conclusions: Initial concurrent high-dose IV vitamin C with docetaxel did not improve PSA response, toxicity, or clinical outcomes. MCRPC patients receiving docetaxel should be advised against seeking concurrent high-dose IV vitamin C. Clinical trial information: NCT02516670 .

BACKGROUND:Adjuvant radiotherapy is prescribed after breast-conserving surgery to reduce the risk of local recurrence. However, radiotherapy is inconvenient, costly, and associated with both short-term and long-term side effects. Clinicopathologic factors alone are of limited use in the identification of women at low risk for local recurrence in whom radiotherapy can be omitted. Molecularly defined intrinsic subtypes of breast cancer can provide additional prognostic information. METHODS:We performed a prospective cohort study involving women who were at least 55 years of age, had undergone breast-conserving surgery for T1N0 (tumor size <2 cm and node negative), grade 1 or 2, luminal A-subtype breast cancer (defined as estrogen receptor positivity of ≥1%, progesterone receptor positivity of >20%, negative human epidermal growth factor receptor 2, and Ki67 index of ≤13.25%), and had received adjuvant endocrine therapy. Patients who met the clinical eligibility criteria were registered, and Ki67 immunohistochemical analysis was performed centrally. Patients with a Ki67 index of 13.25% or less were enrolled and did not receive radiotherapy. The primary outcome was local recurrence in the ipsilateral breast. In consultation with radiation oncologists and patients with breast cancer, we determined that if the upper boundary of the two-sided 90% confidence interval for the cumulative incidence at 5 years was less than 5%, this would represent an acceptable risk of local recurrence at 5 years. RESULTS:Of 740 registered patients, 500 eligible patients were enrolled. At 5 years after enrollment, recurrence was reported in 2.3% of the patients (90% confidence interval [CI], 1.3 to 3.8; 95% CI, 1.2 to 4.1), a result that met the prespecified boundary. Breast cancer occurred in the contralateral breast in 1.9% of the patients (90% CI, 1.1 to 3.2), and recurrence of any type was observed in 2.7% (90% CI, 1.6 to 4.1). CONCLUSIONS:Among women who were at least 55 years of age and had T1N0, grade 1 or 2, luminal A breast cancer that were treated with breast-conserving surgery and endocrine therapy alone, the incidence of local recurrence at 5 years was low with the omission of radiotherapy. (Funded by the Canadian Cancer Society and the Canadian Breast Cancer Foundation; LUMINA ClinicalTrials.gov number, NCT01791829.).

Survival analysis showing the primary endpoint of disease-free survival for patients receiving tamoxifen (red lines) vs. placebo (black lines) in the MA.12 translational study cohort.

Postoperative radiation therapy has been a mainstay of treatment for early breast cancer for many years. The efficacy of chest wall radiation therapy after mastectomy and whole breast irradiation after breast conserving surgery was established through randomised controlled trials. 1 Early Breast Cancer Trialists' Collaborative GroupEffects of radiotherapy and surgery in early breast cancer. An overview of the randomized trials. N Engl J Med. 1995; 333: 1444-1455 Crossref PubMed Scopus (1054) Google Scholar , 2 Clarke M Collins R Darby S et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005; 366: 2087-2106 Summary Full Text Full Text PDF PubMed Scopus (4223) Google Scholar , 3 Darby S McGale P Correa C et al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10 801 women in 17 randomised trials. Lancet. 2011; 378: 1707-1716 Summary Full Text Full Text PDF PubMed Scopus (2799) Google Scholar In some of these trials, regional nodes were irradiated, but it is unclear how much of the effect of the radiation therapy occurred because of regional nodal irradiation. Radiotherapy to regional nodes in early breast cancer: an individual patient data meta-analysis of 14 324 women in 16 trialsRegional node radiotherapy significantly reduced breast cancer mortality and all-cause mortality in trials done after the 1980s, but not in older trials. These contrasting findings could reflect radiotherapy improvements since the 1980s. Full-Text PDF Open Access

To the Editor: The results of the LUMINA trial by Whelan et al. (Aug. 17 issue)(1) add substantially to our understanding regarding which postmenopausal patients with early-stage breast cancer can safely avoid radiation therapy after lumpectomy. However, few studies have shown how age at diagnosis affects this risk. The risk of local recurrence was similar among patients defined according to age groups of 50 to 60 years of age, 60 to 70 years of age, and older than 70 years of age in a study from London(2) and 60 to 69 years of age and 70 years of age or . . .

In MIBC standard staging with CT imaging is critical for making treatment decisions about neoadjuvant chemotherapy (NAC), and local treatment with either radical cystectomy (RC) or chemoradiation. However, CT imaging can often underestimate disease extent. The aim of this randomized study was to determine if adding 18F-FDG PET/CT (PET) to baseline CT, changes treatment received. Newly diagnosed MIBC pts (T2a-T4, N0-3, M0) without metastases on baseline CT, and predominant urothelial histology, were allocated 2:1 to PET or no further imaging. Enrollment occurred 05/16-11/21 at 6 Ontario centers. At the time of analysis, median duration of follow-up was 2 years. Primary outcome was proportion of pts not receiving expected treatment and secondary outcomes were disease-free survival (DFS) and overall survival (OS). Of 292 pts, 194 were randomized to PET and 98 to no PET. In the PET and no PET arms respectively: median age was 70 (43-93) and 68 (42-89); T2: 77% and 77%; node negative 88% and 87%; planned RC 66% and 69%; and planned NAC 70% and 64%. On PET, primary bladder tumor was seen in 86 (47%) pts, positive pelvic lymph nodes in 37 (20%), distant nodes in 32 (18%) and distant metastases in 13 (7%). By ITT analysis, 166 (86%) PET pts received expected treatment, 21 (11%) did not and 7 (4%) withdrew/died prior to treatment. In the no PET arm, 90 (92%) received expected treatment, 4 (4%) did not, and 4 (4%) withdrew/died prior to treatment. More PET pts were deemed palliative 18 (9.3%) vs 3 (3.1%). Notably >60% in both arms received NAC. PET pts were more likely to have a change in treatment, odds ratio 2.89 (95% CI 0.96-8.74, p=0.06) compared to CT alone. No statistically significant difference was observed between arms for DFS (HR=0.78, 95% CI 0.55-1.12) or OS (HR=1.02, 95% CI 0.66-1.56). In this large randomized study, there was a trend towards a change in management in pts having a PET, but this did not reach statistical significance. This trial provides new insights into the clinical utility of PET-CT in MIBC.

Background: Some population-based recruitment methods, such as registries and databases, have been used to increase enrolment in clinical trials by identifying eligible participants based on baseline characteristics; however; these methods have not been tested in surgical trials, in which accrual occurs before surgery. We evaluated the use of population-based electronic databases to identify patients who potentially could be accrued to the Simultaneous Resection of Colorectal Cancer with Synchronous Liver Metastases (RESECT) trial and compared it to the traditional methods used to accrue patients (e.g., multidisciplinary rounds, letters to community surgeons) for that same trial during the same period. Methods: An electronic database (ePath) was interrogated every 2 weeks for patients diagnosed with colorectal cancer from Feb. 1, 2017, to Mar. 30, 2019. A radiologic image database (OneView) was reviewed to identify those with liver metastases (level 1 screening). Reports were interrogated to identify potentially eligible patients for the RESECT trial (level 2 screening). A hepatobiliary surgeon reviewed radiology images to identify eligible patients for the trial (level 3 screening). The primary outcome was patient eligibility for the ongoing RESECT trial. Results: The population-based method identified 90 (11.2%) of 803 patients diagnosed with colorectal cancer over the study period. Among the 90 patients, level 2 screening identified 60 (67%) potentially eligible patients for the RESECT trial. Of the 90 patients, 18 (20%) were eligible after radiographic image review (level 3 screening). Traditional accrual methods identified 38 patients with liver metastases, 27 (71%) of whom were identified as potentially eligible on level 2 screening, and 14 (37%) of whom were deemed to be eligible on level 3 screening. Twenty-six patients were identified by both methods. Twelve patients were identified by population-based methods alone, and 8 patients by traditional methods alone. Six eligible patients were identified by both methods. Baseline characteristics were similar between the 2 groups. Conclusion: A population-based electronic database method of patient accrual was able to identify eligible participants for the RESECT trial. However, optimal accrual likely requires the use of traditional methods as well.

482 Background: Nutritional status is a major determinant of outcomes following surgery. Perioperative nutritional supplementation may improve postoperative outcomes, however, studies on the topic have led to controversial results. Methods: Single-centre, feasibility randomized trial among gastrointestinal cancer patients undergoing surgery, comparing perioperative nutritional supplements versus placebo. The supplements included: protein supplementation (preoperative day 30-6), “immunonutrition” (preoperative day 5-1 and postoperative day 1-5), and carbohydrate loading (surgery day). Primary outcome was enrollment fraction (i.e., enrolled/eligible patients). Secondary outcomes were patient compliance with study packages (target > 70% of total packages provided) and 90-day postoperative complication rate, including postoperative infectious complications. A priori, we considered protocol modifications to improve enrollment fraction and compliance. Results: From October 2018 to March 2020, 495 patients were screened, of which, 144 were eligible and 71 were enrolled (enrollment fraction: 49%, 95%CI, 41-57%). Patients did not enroll for various reasons including refusal without reason (n = 33) and too much burden (n = 25). Protocol modifications did not impact enrollment fraction or compliance. Modifications included decreasing the interval from enrollment to surgery from 4 weeks to 2 weeks, and decreasing the complexity and length of the baseline assessment. Median overall compliance was 80%, lower for intervention versus control arm (67% and 87%, respectively). Postoperative complication rates were similar between control (18/31 (58%, 95% CI: 41-74)) and intervention (22/34 (65%, 95%CI 48-79)) arms. There was a trend for lower postoperative infectious rates in the intervention arm (12/34 (35%, 95%CI 22-52)) compared to control (16/31 (52%, 95%CI 35-68)). Conclusions: A trial like this is feasible, with an enrollment fraction of 49% and an overall patient compliance with study packages of 80%. Pilot trial protocol modifications did not increase these proportions. Clinical trial information: NCT03445260.