LBA110 Background: There are limited data on COVID-19 in patients with cancer. We characterize the outcomes of patients with cancer and COVID-19 and identify potential prognostic factors. Methods: The COVID-19 and Cancer Consortium (CCC19) cohort study includes patients with active or prior hematologic or invasive solid malignancies reported across academic and community sites. Results: We included 1,018 cases accrued March-April 2020. Median age was 66 years (range, 18-90). Breast (20%) and prostate (16%) cancers were most prevalent; 43% of patients were on active anti-cancer treatment. At time of data analysis, 106 patients (10.4%) have died and 26% met the composite outcome of death, severe illness requiring hospitalization, and/or mechanical ventilation. In multivariable logistic regression analysis, independent factors associated with increased 30-day mortality were age, male sex, former smoking, ECOG performance status (2 versus 0/1: partially adjusted odds ratio (pAOR) 2.74, 95% CI 1.31-5.7; 3/4 versus 0/1: pAOR 5.34, 95% CI 2.44-11.69), active malignancy (stable/responding, pAOR 1.93, 95% CI 1.06-3.5; progressing, pAOR 3.79, 95% CI 1.78-8.08), and receipt of azithromycin and hydroxychloroquine. Tumor type, race/ethnicity, obesity, number of comorbidities, recent surgery, and type of active cancer therapy were not significant factors for mortality. Conclusions: All-cause 30-day mortality and severe illness in this cohort were significantly higher than previously reported for the general population and were associated with general risk factors as well as those unique to patients with cancer. Cancer type and treatment were not independently associated with increased 30-day mortality. Longer follow-up is needed to better understand the impact of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.

Hematopoietic cell transplantation (HCT) offers definitive management for a wide variety of malignant and nonmalignant diseases. Conditioning regimens and therapies used to prevent and treat GvHD are immune suppressive, often increasing the risk of developing fungal disease due to yeasts or molds. Antifungal prophylaxis may be useful in preventing morbidity and mortality during and after HCT. In this article, we review the epidemiology and current literature regarding strategies for prevention of invasive fungal disease (IFD) in the pre-engraftment and post-engraftment settings, and propose future direction for scientific discovery.

No abstract

2060 Background: The FDA has issued hundreds of cancer drug indications, with many new drugs, expanded indications, and biosimilars approved in recent years. While the gold standard for regulatory approval is the randomized controlled trial (RCT), RCT design including selection of control arms can differ considerably. We sought to investigate trends and patterns in RCT trial design used to support FDA approvals in oncology. Methods: We reviewed the available FDA package inserts of oncology drugs (N=258) for RCTs cited to support initial and expanded indication approvals as of January 2020; biosimilars were excluded. RCTs were linked to the HemOnc ontology, which contains trial-level metadata including publication year, endpoints, and trial design. Log-linear regression was performed to evaluate trends in approvals over time by endpoint. Study drugs were categorized as cytotoxic therapy, targeted therapy, or immunotherapy. RCTs were categorized by four designs: escalation (adding a drug or increasing the drug dose in an established regimen), in-class comparison (comparing two drugs in the same therapeutic class), out-of-class switch (comparing drugs in distinct therapeutic classes), and de-escalation (removing a drug or reducing the drug dose in an established regimen). Results: We identified 556 registration trials, 372 (67%) of which were RCTs. Approvals have been increasing exponentially over time (R2 0.9, p<0.001), both for RCTs reporting overall survival (OS) endpoints (R2 0.77, p<0.001), and non-OS endpoints (R2 0.67, p<0.001). Of the three most common trial designs (Table), in-class comparisons were least likely to report OS (28%; escalations 47%; out-of-class switches 43%, p=0.01 by Chi-squared). Class switches were common in immunotherapy trials compared to targeted or cytotoxic therapy. Conclusions: Despite growth in FDA approvals, a minority of registration trials report paradigmatic shifts in therapeutic approach (out-of-class switches), with the relative exception of immunotherapy trials. Escalation is the most common route to FDA approval, even though this design inevitably increases cost and toxicity. This suggests that new oncology drug approvals are not alone a useful metric of practice-changing innovation. [Table: see text]

Before the introduction of the BCR-ABL1 tyrosine kinase inhibitor (TKI) imatinib, chronic myeloid leukemia (CML) was the leading indication for allogeneic hematopoietic stem cell transplant (HSCT), and allogeneic HSCT remains the only treatment recognized as curative for CML. The success of imatinib and other TKIs (e.g., nilotinib, dasatinib) has made allogeneic HSCT a later-line therapy that is reserved only for advanced-phase, high-risk, or TKI-resistant patients with CML. Accumulating evidence from clinical trials investigating treatment-free remission suggests that TKIs may also provide an operational cure for some patients with CML. Herein, we discuss the concept of cure in CML and the current roles of both HSCT and TKIs in the treatment of CML.