Transforming the oncology data paradigm by creating, capturing, and retrieving structured cancer data at the point of care: A Mayo Clinic pilot.

INTRODUCTION: Structured data capture requires defined languages such as minimal Common Oncology Data Elements (mCODE). This pilot assessed the feasibility of capturing 5 mCODE categories (stage, disease status, performance status (PS), intent of therapy and intent to change therapy). METHODS: A tool (SmartPhrase) using existing and custom structured data elements was Built to capture 4 data categories (disease status, PS, intent of therapy and intent to change therapy) typically documented as free-text within notes. Existing functionality for stage was supported by the Build. Participant survey data, presence of data (per encounter), and time in chart were collected prior to go-live and repeat timepoints. The anticipated outcome was capture of >50% sustained over time without undue burden. RESULTS: Pre-intervention (5-weeks before go-live), participants had 1390 encounters (1207 patients). The median percent capture across all participants was 32% for stage; no structured data was available for other categories pre-intervention. During a 6-month pilot with 14 participants across three sites, 4995 encounters (3071 patients) occurred. The median percent capture across all participants and all post-intervention months increased to 64% for stage and 81%-82% for the other data categories post-intervention. No increase in participant time in chart was noted. Participants reported that data were meaningful to capture. CONCLUSIONS: Structured data can be captured (1) in real-time, (2) sustained over time without (3) undue provider burden using note-based tools. Our system is expanding the pilot, with integration of these data into clinical decision support, practice dashboards and potential for clinical trial matching.

Characteristics, Treatment Patterns, and Clinical Outcomes After Heart Failure Hospitalizations During the COVID-19 Pandemic, March to October 2020.

OBJECTIVE: To compare clinical characteristics, treatment patterns, and 30-day all-cause readmission and mortality between patients hospitalized for heart failure (HF) before and during the coronavirus disease 2019 (COVID-19) pandemic. PATIENTS AND METHODS: The study was conducted at 16 hospitals across 3 geographically dispersed US states. The study included 6769 adults (mean age, 74 years; 56% [5033 of 8989] men) with cumulative 8989 HF hospitalizations: 2341 hospitalizations during the COVID-19 pandemic (March 1 through October 30, 2020) and 6648 in the pre-COVID-19 (October 1, 2018, through February 28, 2020) comparator group. We used Poisson regression, Kaplan-Meier estimates, multivariable logistic, and Cox regression analysis to determine whether prespecified study outcomes varied by time frames. RESULTS: The adjusted 30-day readmission rate decreased from 13.1% (872 of 6648) in the pre-COVID-19 period to 10.0% (234 of 2341) in the COVID-19 pandemic period (relative risk reduction, 23%; hazard ratio, 0.77; 95% CI, 0.66 to 0.89). Conversely, all-cause mortality increased from 9.7% (645 of 6648) in the pre-COVID-19 period to 11.3% (264 of 2341) in the COVID-19 pandemic period (relative risk increase, 16%; number of admissions needed for one additional death, 62.5; hazard ratio, 1.19; 95% CI, 1.02 to 1.39). Despite significant differences in rates of index hospitalization, readmission, and mortality across the study time frames, the disease severity, HF subtypes, and treatment patterns remained unchanged (P>0.05). CONCLUSION: The findings of this large tristate multicenter cohort study of HF hospitalizations suggest lower rates of index hospitalizations and 30-day readmissions but higher incidence of 30-day mortality with broadly similar use of HF medication, surgical interventions, and devices during the COVID-19 pandemic compared with the pre-COVID-19 time frame.

Surveillance mammography in older breast cancer survivors: Current practice patterns and patient perceptions.

INTRODUCTION: Although the benefits of surveillance mammography for older breast cancer survivors have not been quantified prospectively, it is unlikely that mammography provides substantial benefit (and possible that mammography is harmful) to women with limited life expectancy and a low risk for in-breast cancer events. MATERIALS AND METHODS: We identified 1268 women aged 77 and older with a history of Stage I-III breast cancer, who did not undergo bilateral mastectomy, were diagnosed with cancer at least three years prior to study entry, and who had consented to be surveyed as part of the Mayo Clinic Breast Disease Registry. We mailed them a one-time survey asking about their experiences with surveillance mammography. Women with metastatic disease were excluded. The primary endpoint was whether or not women reported at least one mammogram since breast cancer surgery. RESULTS: Eight hundred forty-six of 1268 (67%) returned the survey, 734 of whom were eligible for analysis. The median age at the time of survey was 82, and the median time since cancer diagnosis was 12 years. Ninety-three percent reported having had at least one mammogram since their initial breast cancer surgery. Seventy-nine percent reported that they had surveillance mammography annually over the prior three years, including 76% of the 491 aged 80+ and 64% of the 189 aged 85 + . DISCUSSION: Most older breast cancer survivors who have residual breast tissue are undergoing annual mammograms. Additional educational materials may be beneficial for patients and clinicians to better individualize plans for surveillance mammography in older breast cancer survivors.

Impact of maintenance therapy post autologous stem cell transplantation for multiple myeloma in early and delayed transplant.

Based on phase 3 trials, maintenance therapy after autologous stem cell transplantation (ASCT) has become the standard of care in multiple myeloma (MM). We examined the trends in maintenance therapy in a large group of patients (2530) transplanted at a single institution over two decades. Majority (n = 1958; 77%) had an ASCT within 12 months of diagnosis (early ASCT). Maintenance was employed in 39% of the patients; 42% among early ASCT and 30.5% among delayed ASCT. Most common maintenance approach was an IMiD (61%), followed by a PI (31%), or a PI + IMiD (4%). Patients with high-risk FISH received PI-based maintenance more frequently. The PFS was superior with maintenance (36 vs. 22 months, p < 0.001); 37 vs. 25 months for early ASCT (p < 0.001) and 29 vs. 17 months for delayed ASCT (p = 0.0008). OS from ASCT was higher with maintenance for the whole cohort at 93 vs. 73 months (p < 0.001). OS from diagnosis was also better for the whole cohort with maintenance therapy, 112 vs. 93 months (p < 0.001). The improvement in PFS and OS was seen in high-risk and standard risk disease. The experience with maintenance therapy post ASCT for myeloma in a non-clinical trial setting confirms the findings from the phase 3 trials.

Post-Transplant Maintenance Treatment Options in Multiple Myeloma.

Maintenance therapy post autologous stem cell transplant (ASCT) is commonly employed in myeloma patients to prolong remission, as relapse invariably occurs after ASCT. After initial diagnosis and risk stratification, patients receive initial therapy with a combination of drugs, typically a proteasome inhibitor and an immunomodulatory imide drug (IMiD), and in those considered eligible, high-dose chemotherapy followed by autologous stem cell transplant. The aim of our study was to review the literature and consolidate evidence regarding different maintenance therapies post stem cell transplant in myeloma patients. We reviewed major databases including PubMed, Cochrane Library and Evidence-Based Medicine Reviews (EBMR), along with American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO) conference abstracts to include relevant literature. Ongoing clinical trials were also reviewed. Consolidation therapy is often employed to enhance the response to induction therapy and SCT and also to delay progression. Melphalan and thalidomide with or without steroids were initially used as maintenance therapy. More recently, lenalidomide-, bortezomib-, ixazomib-, or carfilzomib-based regimens have been employed as maintenance. Lenalidomide and bortezomib are the most commonly used drugs, with the latter being preferred in high-risk populations. Newer trials are utilizing tumor-specific antigen based vaccines along with adoptive T-cell therapies, and monoclonal antibodies as maintenance therapy. We conclude that maintenance therapy post SCT, with lenalidomide or bortezomib is the standard of care in myeloma patients. Patient tolerability, disease risk stratification and prior therapy received are major determinants of the choice of maintenance. Significant toxicity associated with maintenance therapies is a hindrance to long-term maintenance post stem cell transplant.

Male breast cancer in the United States: Treatment patterns and prognostic factors in the 21st century.

BACKGROUND: Male breast cancer (MBC) is a rare disease for which there is limited understanding of treatment patterns and prognostic factors. METHODS: Men with TNM stage I to stage III breast cancer diagnosed between 2004 and 2014 in the National Cancer Data Base were included. Trends in treatment modalities were described using the average annual percentage change (AAPC) and estimated using Joinpoint software for the analysis of trends. Kaplan-Meier curves and the multivariate Cox proportional hazards regression model were used to compare survival between subgroups and to identify prognostic factors. RESULTS: A total of 10,873 MBC cases were included, with a median age at diagnosis of 64 years. Breast-conserving surgery was performed in 24% of patients, and 70% of patients undergoing breast conservation received radiotherapy. Approximately 44% of patients received chemotherapy, and 62% of patients with estrogen receptor-positive disease received endocrine therapy. Oncotype DX was ordered in 35% of patients with lymph node-negative, estrogen receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative tumors. During the study period, there was a significant increase in the rates of total mastectomy, contralateral prophylactic mastectomy, radiotherapy after breast conservation, ordering of Oncotype DX, and the use of endocrine therapy (P < .05). On multivariate analysis, factors found to be associated with worse overall survival were older age, black race, higher Charlson Comorbidity Index, high tumor grade and stage of disease, and undergoing total mastectomy. Residing in a higher income area; having progesterone receptor-positive tumors; and receipt of chemotherapy, radiotherapy, and endocrine therapy were associated with better overall survival. CONCLUSIONS: Despite the lack of prospective randomized trials in patients with MBC, the results of the current study demonstrated that the treatment of this disease has evolved over the years. These findings further the understanding of the modern treatment and prognosis of MBC, and identify several areas for further research.

Aggressive Systemic Mastocytosis in Association with Pure Red Cell Aplasia.

Aggressive systemic mastocytosis (ASM) is characterized by mast cell accumulation in systemic organs. Though ASM may be associated with other hematological disorders, the association with pure red cell aplasia (PRCA) is rare and has not been reported. Pure red cell aplasia (PRCA) is a syndrome, characterized by normochromic normocytic anemia, reticulocytopenia, and severe erythroid hypoplasia. The myeloid and megakaryocytic cell lines usually remain normal. Here, we report an unusual case of ASM, presenting in association with PRCA and the management challenges.

High-dose steroids as a therapeutic option in the management of spur cell haemolytic anaemia.

Spur cell haemolytic anaemia (SCA) is a form of anaemia that can be seen in patients with severely impaired liver function or advanced cirrhosis. It is associated with high mortality. The treatment options for SCA secondary to cirrhosis are limited. Our patient is a middle-aged man who developed SCA and was not a candidate for liver transplantation or splenectomy. High-dose steroids helped ameliorate haemolysis and improve anaemia and general condition of our patient.

Digital lesion leading to diagnosis of cholangiocarcinoma.

Cholangiocarcinomas (CCA) are uncommon malignancies that present late and have a poor prognosis. The patients may remain undiagnosed for many years because of non-specific presentation. CCA metastasises commonly to liver and adjacent lymph nodes. It can rarely metastasise to bone, lung, colon, pancreas, adrenal glands and spleen. Multiple treatment options are available including surgery, chemotherapy, radiotherapy and photodynamic therapy. The tumours have high rate of recurrence and most patients require palliative care. Our patient is a middle-aged man who presented with pain in right ring finger, workup of which revealed digital metastasis from underlying cholangiocarcinoma.

Occult myeloproliferative neoplasms: not so occult any more.

Non-cirrhotic, non-malignant portal vein thrombosis (PVT) is commonly secondary to inherited or acquired prothrombotic states. However, even after extensive workup, 25% of patients with PVT have no apparent prothrombotic aetiology identified (idiopathic PVT). Inherited conditions include factor V Leiden, PT mutation and protein C/S/AT deficiency. Acquired conditions include APS, PNH and BCR-ABL 1-negative myeloproliferative neoplasms (MPN). BCR-ABL-1 negative MPNs are the most frequent underlying prothrombotic risk factor for PVT (15%-30%). However, peripheral blood counts often remain within normal ranges in these patients with MPN because of portal hypertension sequel. Despite suggestive features of MPN in bone marrow, these patients lack adequate diagnostic criteria and are classified as occult MPN. The discovery of recurrent molecular abnormalities such as CALR gene exon 9 mutation presented a crucial advance in the diagnosis of occult MPNs. In our patient, the diagnosis of MPN was made on this basis, despite lack of peripheral evidence of MPN.

Perioperative ß-Blockers in Patients Undergoing Noncardiac Surgery-Scientific Misconduct and Clinical Guidelines.

BACKGROUND: ß-blocker use in perioperative period of noncardiac surgeries has been a topic of debate since many years. Earlier studies conducted in the 90s showed decreased cardiac adverse events and improved postoperative outcomes with ß-blocker use. Based on this, the ACCF and ESC published guidelines strongly supporting ß-blocker use. But contemporaneous studies conducted revealed conflicting evidence and have also proven some of the earlier studies to be fraudulent. Although ACCF guidelines have been updated to partially reflect the changes, ESC guidelines continue to support ß-blocker use. AREAS OF UNCERTAINTY: In light of the ACCF and ESC guidelines supporting ß-blocker use in perioperative period of noncardiac surgeries, our aim was to review the available literature and consolidate evidence in this regard. DATA SOURCES: PubMed search was conducted to include relevant studies between 1950 and 2015. RESULTS: We reviewed 24 eligible studies and few debates conducted in this regard. Based on our review, our findings were as follows: ß-blockers should be continued throughout perioperative period in patients who were on ß-blockers before surgery for other indications such as angina, hypertension, and symptomatic arrhythmias. Preoperative ß-blockers are indicated in patients undergoing high risk vascular surgery or those having high preoperative Cardiac Risk Index Score. In patients with intermediate-to-low cardiac risk, the proven benefit is not sufficient enough to suggest universal use. CONCLUSIONS: Based on our review, we conclude that the use of ß-blockers in perioperative period of noncardiac surgeries should be determined on an individual basis based on risk-benefit analysis. Guideline organizations should update their recommendations based on new evidence.