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Given that radium-223 is a radiopharmaceutical that induces DNA damage, and olaparib is a PARP inhibitor that interferes with DNA repair mechanisms, we hypothesized their synergy in metastatic castration-resistant prostate cancer (mCRPC). We sought to demonstrate the safety and efficacy of olaparib + radium-223. We conducted a multicenter phase I 3+3 dose escalation study of olaparib with fixed dose radium-223 in patients with mCRPC with bone metastases. The primary objective was to establish the RP2D of olaparib, with secondary objectives of safety, PSA response, alkaline phosphatase response, radiographic progression-free survival (rPFS), overall survival, and efficacy by homologous recombination repair (HRR) gene status. Twelve patients were enrolled; all patients received a prior androgen receptor signaling inhibitor (ARSI; 100%) and 3 patients (25%) prior docetaxel. Dose-limiting toxicities (DLT) included cytopenias, fatigue, and nausea. No DLTs were seen in the observation period however delayed toxicities guided the RP2D. The RP2D of olaparib was 200 mg orally twice daily with radium-223. The most common treatment-related adverse events were fatigue (92%) and anemia (58%). The rPFS at 6 months was 58% (95% confidence interval, 27%-80%). Nine patients were evaluable for HRR gene status; 1 had a BRCA2 alteration (rPFS 11.8 months) and 1 had a CDK12 alteration (rPFS 3.1 months). Olaparib can be safely combined with radium-223 at the RP2D 200 mg orally twice daily with fixed dose radium-223. Early clinical benefit was observed and will be investigated in a phase II study.

BackgroundPatients with sarcoma often require individualized treatment strategies and are likely to receive aggressive immunosuppressive therapies, which may place them at higher risk for severe COVID-19. We aimed to describe demographics, risk factors, and outcomes for patients with sarcoma and COVID-19.MethodsWe performed a retrospective cohort study of patients with sarcoma and COVID-19 reported to the COVID-19 and Cancer Consortium (CCC19) registry (NCT04354701) from 17 March 2020 to 30 September 2021. Demographics, sarcoma histologic type, treatments, and COVID-19 outcomes were analyzed.Resultsof 281 patients, 49% (n = 139) were hospitalized, 33% (n = 93) received supplemental oxygen, 11% (n = 31) were admitted to the ICU, and 6% (n = 16) received mechanical ventilation. A total of 23 (8%) died within 30 days of COVID-19 diagnosis and 44 (16%) died overall at the time of analysis. When evaluated by sarcoma subtype, patients with bone sarcoma and COVID-19 had a higher mortality rate than patients from a matched SEER cohort (13.5% vs 4.4%). Older age, poor performance status, recent systemic anti-cancer therapy, and lung metastases all contributed to higher COVID-19 severity.ConclusionsPatients with sarcoma have high rates of severe COVID-19 and those with bone sarcoma may have the greatest risk of death.

When the COVID-19 pandemic began, formal frameworks to collect data about affected patients were lacking. The COVID-19 and Cancer Consortium (CCC19) was formed to collect granular data on patients with cancer and COVID-19 at scale and as rapidly as possible. CCC19 has grown from five initial institutions to 125 institutions with >400 collaborators. More than 5,000 cases with complete baseline data have been accrued. Future directions include increased electronic health record integration for direct data ingestion, expansion to additional domestic and international sites, more intentional patient involvement, and granular analyses of still-unanswered questions related to cancer subtypes and treatments.

BackgroundData on patients with COVID-19 who have cancer are lacking. Here we characterise the outcomes of a cohort of patients with cancer and COVID-19 and identify potential prognostic factors for mortality and severe illness.MethodsIn this cohort study, we collected de-identified data on patients with active or previous malignancy, aged 18 years and older, with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from the USA, Canada, and Spain from the COVID-19 and Cancer Consortium (CCC19) database for whom baseline data were added between March 17 and April 16, 2020. We collected data on baseline clinical conditions, medications, cancer diagnosis and treatment, and COVID-19 disease course. The primary endpoint was all-cause mortality within 30 days of diagnosis of COVID-19. We assessed the association between the outcome and potential prognostic variables using logistic regression analyses, partially adjusted for age, sex, smoking status, and obesity. This study is registered with ClinicalTrials.gov, NCT04354701, and is ongoing.FindingsOf 1035 records entered into the CCC19 database during the study period, 928 patients met inclusion criteria for our analysis. Median age was 66 years (IQR 57-76), 279 (30%) were aged 75 years or older, and 468 (50%) patients were male. The most prevalent malignancies were breast (191 [21%]) and prostate (152 [16%]). 366 (39%) patients were on active anticancer treatment, and 396 (43%) had active (measurable) cancer. At analysis (May 7, 2020), 121 (13%) patients had died. In logistic regression analysis, independent factors associated with increased 30-day mortality, after partial adjustment, were: increased age (per 10 years; partially adjusted odds ratio 1·84, 95% CI 1·53-2·21), male sex (1·63, 1·07-2·48), smoking status (former smoker vs never smoked: 1·60, 1·03-2·47), number of comorbidities (two vs none: 4·50, 1·33-15·28), Eastern Cooperative Oncology Group performance status of 2 or higher (status of 2 vs 0 or 1: 3·89, 2·11-7·18), active cancer (progressing vs remission: 5·20, 2·77-9·77), and receipt of azithromycin plus hydroxychloroquine (vs treatment with neither: 2·93, 1·79-4·79; confounding by indication cannot be excluded). Compared with residence in the US-Northeast, residence in Canada (0·24, 0·07-0·84) or the US-Midwest (0·50, 0·28-0·90) were associated with decreased 30-day all-cause mortality. Race and ethnicity, obesity status, cancer type, type of anticancer therapy, and recent surgery were not associated with mortality.InterpretationAmong patients with cancer and COVID-19, 30-day all-cause mortality was high and associated with general risk factors and risk factors unique to patients with cancer. Longer follow-up is needed to better understand the effect of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.FundingAmerican Cancer Society, National Institutes of Health, and Hope Foundation for Cancer Research.

Background Even though cytoreductive nephrectomy (CN) was once the standard of care for patients with advanced renal cell carcinoma (RCC), its role in treatment has not been well analyzed or defined in the era of immunotherapy (IO). Materials and Methods This study analyzed pathological outcomes in patients with advanced or metastatic RCC who received IO prior to CN. This was a multi-institutional, retrospective study of patients with advanced or metastatic RCC. Patients were required to receive IO monotherapy or combination therapy prior to radical or partial CN. The primary endpoint assessed surgical pathologic outcomes, including American Joint Committee on Cancer (AJCC) staging and frequency of downstaging, at the time of surgery. Pathologic outcomes were correlated to clinical variables using a Wald-chi squared test from Cox regression in a multi-variable analysis. Secondary outcomes included objective response rate (ORR) defined by response evaluation criteria in solid tumors (RECIST) version 1.1 and progression-free survival (PFS), which were estimated using the Kaplan-Meier method with reported 95% CIs. Results Fifty-two patients from 9 sites were included. Most patients were male (65%), 81% had clear cell histology, 11% had sarcomatoid differentiation. Overall, 44% of patients experienced pathologic downstaging, and 13% had a complete pathologic response. The ORR immediately prior to nephrectomy was stable disease in 29% of patients, partial response in 63%, progressive disease in 4%, and 4% unknown. Median follow-up for the entire cohort was 25.3 months and median PFS was 3.5 years (95% CI, 2.1-4.9). Conclusions IO-based interventions prior to CN in patients with advanced or metastatic RCC demonstrates efficacy, with a small fraction of patients showing a complete response. Additional prospective studies are warranted to investigate the role of CN in the modern IO-era. [ABSTRACT FROM AUTHOR]

PURPOSE: Initiating antineoplastic therapy can be distressful and affect patient retention of treatment-related side effects and safety protocols. Return visits can range from 8 to 28 days after treatment, during which patients may develop treatment-related questions and toxicities. This study's objective is to evaluate how implementing a follow-up phone call 24-48 hours after initial antineoplastic infusion, compared with standard pretreatment education, affects patient satisfaction and education retention. METHODS: We conducted a single-center pilot study where patients who were literate, English-speaking, with genitourinary malignancies, initiating intravenous chemotherapy or immunotherapy were eligible. The primary end point was patient knowledge retention. Secondary end points included patient satisfaction. The Leuven's Questionnaire Patient Knowledge Tool, a validated, standardized tool, was used to evaluate patient knowledge retention, with a higher score indicating more retention. Telephone follow-up was initiated 24-48 hours after initial infusion, where Leuven's Questionnaire was used to assess patient knowledge. A nurse then reinforced treatment-related education, reviewed notification parameters, and coordinated appropriate follow-up. One week later, participants were sent a follow-up Leuven's Questionnaire and standardized patient satisfaction assessment. RESULTS: Thirty-one patients with renal cell carcinoma, prostate, bladder, germ cell/testicular, or adrenal cancers were included in the study. Mean preintervention Leuven's Questionnaire score was 5.3 and mean postintervention score was 8.1 on a 1-10 scale (P <.0001). Ninety-seven percent of patients reported improved satisfaction postintervention. CONCLUSION: Proactive telephonic follow-up for oncology patients improves education retention, patient satisfaction, and has potential to improve patient safety and quality of care. Telephonic follow-up for oncology patients postinfusion improves satisfaction and quality of care. [ABSTRACT FROM AUTHOR]

Background: COVID‐19 can have a particularly detrimental effect on patients with cancer, but no studies to date have examined if the presence, or site, of metastatic cancer is related to COVID‐19 outcomes. Methods: Using the COVID‐19 and Cancer Consortium (CCC19) registry, the authors identified 10,065 patients with COVID‐19 and cancer (2325 with and 7740 without metastasis at the time of COVID‐19 diagnosis). The primary ordinal outcome was COVID‐19 severity: not hospitalized, hospitalized but did not receive supplemental O2, hospitalized and received supplemental O2, admitted to an intensive care unit, received mechanical ventilation, or died from any cause. The authors used ordinal logistic regression models to compare COVID‐19 severity by presence and specific site of metastatic cancer. They used logistic regression models to assess 30‐day all‐cause mortality. Results: Compared to patients without metastasis, patients with metastases have increased hospitalization rates (59% vs. 49%) and higher 30 day mortality (18% vs. 9%). Patients with metastasis to bone, lung, liver, lymph nodes, and brain have significantly higher COVID‐19 severity (adjusted odds ratios [ORs], 1.38, 1.59, 1.38, 1.00, and 2.21) compared to patients without metastases at those sites. Patients with metastasis to the lung have significantly higher odds of 30‐day mortality (adjusted OR, 1.53; 95% confidence interval, 1.17–2.00) when adjusting for COVID‐19 severity. Conclusions: Patients with metastatic cancer, especially with metastasis to the brain, are more likely to have severe outcomes after COVID‐19 whereas patients with metastasis to the lung, compared to patients with cancer metastasis to other sites, have the highest 30‐day mortality after COVID‐19. Patients with metastatic cancer have more severe outcomes than patients without metastasis, with those with metastasis to the brain having the highest odds of severe COVID‐19. When adjusting for initial COVID‐19 severity, patients with metastasis to the lung, compared to patients with metastasis sites other than the lung, have the highest odds of 30‐day mortality. [ABSTRACT FROM AUTHOR]

Most cancer patients will have significant symptoms at some point during their cancer journey. If these symptoms (pain, nausea, vomiting and so forth) aren't managed effectively or happen when their care team is not available, they may use Emergency Department services. Through the Outpatient Quality Reporting Program (OP-35), CMS now holds physicians and systems accountable for ED visits and hospitalizations by patients receiving chemotherapy. We established a Triage/Same Day Service to manage urgent patient issues, in collaboration with primary disease team and Emergency Services. The purpose of the project was to establish process for rapid assessment, intervention and evaluation of patients with urgent symptoms by Disease Team or the Triage APP and RN to: (a) decrease ED/inpatient admissions, (b) strengthen communication and improve utilization of the ED Observation Unit through oversight of referral process, (c) ensure early intervention to decrease severity of symptoms and length of stay in event of inpatient admission, and (d) increase patient and family wellbeing and experience. Interventions were to (a) establish multidisciplinary work group (physicians, APPs, RNs, Quality leadership), (b) determine target patient population through data and program review, (c) develop Operating Model: hours of operation, triage RN staffing and training, triage APP staffing and training, and EMR visit type, (d) develop standard workflows for incoming patient calls: Call Center and Administrative Assistant routing and Oncology RN Telephone Auto-Attendant with scripting to route calls to appropriate resource if RN unavailable, (e) develop patient care workflows: triage RN assessment of patient issue and EMR to align with disease team recommendations for management of issue, triage RN pages Physician to review issue and determine if team or Triage APP will see patient, and Triage RN dispositions and documents plan (patient scheduled and seen same day by disease team, patient scheduled and seen same day by Triage APP), (f) If patient seen by Triage APP, real-time collaboration with disease team for management of patient (patient able to return home with plan, patient scheduled for hydration/blood products in Infusion Center, patient referred to ED Observation Unit). Evaluation includes monthly discussion and metric review with multiple groups and metrics (Patient Satisfaction scores, Triage/Same Day Service calls/visits, ED and ED Observation visits by disease team, and Inpatient LOS). Feedback and metrics have been overwhelmingly positive for program--we look forward to sharing more at ONS Congress 2022. [ABSTRACT FROM AUTHOR]