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Purpose:. Tumor mutational burden (TMB) has emerged as a potential predictive biomarker for clinical response to ICI therapy, but whether TMB also predicts toxicity remains unknown. We investigated the relationship between TMB, objective response rate (ORR), overall survival (OS), and toxicity for ICI therapy across multiple cancer types. Experimental Design:. We searched MEDLINE, PubMed, and ASCO/ESMO/AACR meetings for clinical trials of anti-PD(L)1, CTLA-4, or combination in 29 cancer types. We assessed ICI administered, responses (complete or partial response), median OS, OS HR, and grade 3/4 toxicity. We conducted a systematic review, meta-analysis and meta-regression using tumor level TMB data from Foundation Medicine. Results:. One hundr.
Purpose:. Advances in prostate cancer lag behind other tumor types partly due to the paucity of models reflecting key milestones in prostate cancer progression. Therefore, we develop clinically relevant prostate cancer models. Experimental Design:. Since 1996, we have generated clinically annotated patient-derived xenografts (PDXs; the MDA PCa PDX series) linked to specific phenotypes reflecting all aspects of clinical prostate cancer. Results:. We studied two cell line–derived xenografts and the first 80 PDXs derived from 47 human prostate cancer donors. Of these, 47 PDXs derived from 22 donors are working models and can be expanded either as cell lines (MDA PCa 2a and 2b) or PDXs. The histopathologic, genomic, and molecular characteristics (
Purpose:. We examined cabazitaxel, a novel next-generation taxoid, in patients with metastatic gastric cancer in a multicenter phase II study. Patients and Methods:. Patients who have progressed on one or more prior therapies for locally advanced, unresectable, or metastatic disease were eligible, and prior taxane therapy was allowed.
The FDA has approved three androgen receptor inhibitors—enzalutamide, apalutamide, and darolutamide—for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). These approvals were all based on randomized, double blind, placebo-controlled trials demonstrating large improvements in metastasis-free survival (MFS) and internally consistent evidence of benefit seen across secondary endpoints. In this article, we summarize the FDA regulatory history of MFS and we describe the design, conduct, and results of the three pivotal trials supporting these important treatment options for patients with nmCRPC.
Purpose:. One of the challenges of adoptive T-cell therapy is the development of immune-mediated toxicities including cytokine release syndrome (CRS) and neurotoxicity (NT). We aimed to identify factors that place patients at high risk of severe toxicity or treatment-related death in a cohort of 75 patients with large B-cell lymphoma treated with a standard of care CD19 targeted CAR T-cell product (axicabtagene ciloleucel). Experimental Design:. Serum cytokine and catecholamine levels were measured prior to lymphodepleting chemotherapy, on the day of CAR T infusion and daily thereafter while patients remained hospitalized. Tumor biopsies were taken within 1 month prior to CAR T infusion for evaluation of gene expression. Results:. We identifie.
Purpose:. Clear cell renal cell carcinoma (ccRCC) is frequently associated with inactivation of the von Hippel–Lindau tumor suppressor, resulting in activation of HIF-1α and HIF-2α. The current paradigm, established using mechanistic cell-based studies, supports a tumor promoting role for HIF-2α, and a tumor suppressor role for HIF-1α. However, few studies have comprehensively examined the clinical relevance of this paradigm. Furthermore, the hypoxia-associated factor (HAF), which regulates the HIFs, has not been comprehensively evaluated in ccRCC. Experimental Design:. To assess the involvement of HAF/HIFs in ccRCC, we analyzed their relationship to tumor grade/stage/outcome using tissue from 380 patients, and validated these associations us.
The need for strict social distancing measures preventing visitors on inpatient oncology, ICU, and COVID units during the COVID-19 pandemic has had the unintended consequence of leading to significant psychological and spiritual distress for patients and families and "moral distress" for frontline health care teams tasked with supporting patients who are suffering or dying alone without the support of their loved ones.
The outbreak of coronavirus disease 19 (COVID-19), caused by the recently identified coronavirus named SARS-CoV-2, is leading patients to death (mortality: ~7%) because of cytokine storm. COVID-19 induces excessive secretion of proinflammatory cytokines and chemokines accompanied by the disruption of the bronchi and alveoli, which could ultimately develop into permanent lung impairments such as pulmonary fibrosis. To regulate the uncontrolled expression of proinflammatory cytokines/chemokines, improved cell-permeable nuclear import inhibitor (iCP-NI) has been developed by fusing sequence-optimized hydrophobic cell-penetrating peptide (CPP), namely advanced macromolecule transduction domain (aMTD) with nuclear localization signal (NLS) of st.
Purpose:. Duration of first remission is important for the survival of patients with multiple myeloma. Experimental Design:. From the CoMMpass study (NCT01454297), 926 patients with newly diagnosed multiple myeloma, characterized by next-generation sequencing, were analyzed to evaluate those who experienced early progressive disease (PD; time to progression, TTP ≤18 months). Results:. After a median follow-up of 39 months, early PD was detected in 191/926 (20.6%) patients, 228/926 (24.6%) patients had late PD (TTP >18 months), while 507/926 (54.8%) did not have PD at the current follow-up.
Purpose:. Drug-induced interstitial lung disease (DILD) is a rare, but potentially fatal toxicity. Clinical and radiological features of DILD in the early experimental setting are poorly described. Patients and Methods:. A total of 2,499 consecutive patients with advanced cancer on phase I clinical trials were included. DILD was identified by a dedicated radiologist and investigators, categorized per internationally recognized radiological patterns, and graded per Common Terminology Criteria for Adverse Events (CTCAE) and the Royal Marsden Hospital (RMH) DILD score. Clinical and radiological features of DILD were analyzed. Results:. Sixty patients overall (2.4%) developed DILD. Median time to onset of DILD was 63 days (range, 14–336 days). A t.
Purpose:. Rhabdoid tumors are devastating pediatric cancers in need of improved therapies. We sought to identify small molecules that exhibit in vitro and in vivo efficacy against preclinical models of rhabdoid tumor. Experimental Design:. We screened eight rhabdoid tumor cell lines with 481 small molecules and compared their sensitivity with that of 879 other cancer cell lines. Genome-scale CRISPR–Cas9 inactivation screens in rhabdoid tumors were analyzed to confirm target vulnerabilities. Gene expression and CRISPR–Cas9 data were queried across cell lines and primary rhabdoid tumors to discover biomarkers of small-molecule sensitivity. Molecular correlates were validated by manipulating gene expression. Subcutaneous rhabdoid tumor xenograft.
Introduction: SARS-CoV2 (S-2) infection duration (S-2-D) and its impact on patients with cancer and mild to moderate COVID-19 undergoing cancer-directed therapy (CDT), especially in the underserved population, is not well described. We conducted a retrospective study to analyze S-2 positive (+) patients on CDT to describe the S-2-D and its impact on CDT. Methods: 299 patients with cancer were tested with nasopharyngeal (NP) S-2 PCR assay at Columbia University Medical Irving Center (CUIMC), a Minority-NCI Community Oncology site, of whom 77(26%) tested positive. We retrospectively analyzed 25 S-2 (+) patients with mild to moderate COVID-19 receiving CDT. NP PCR were repeated every one to two weeks until two successive negative (-) PCRs were.
Purpose:. Quantitative relationships between treatment-induced changes in tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS), are lacking. We present a population modeling framework identifying and quantifying such relationships, based on longitudinal data collected in patients with metastatic colorectal cancer (mCRC) to evaluate the value of tumor size and CTC counts as predictors of OS. Experimental Design:. A pharmacometric approach (i.e., population pharmacodynamic modeling) was used to characterize the changes in tumor size and CTC count and evaluate them as predictors of OS in 451 patients with mCRC treated with chemotherapy and targeted therapy in a prospectively randomized phase III study (CAI.
Purpose:. To determine the impact of basal-like and classical subtypes in advanced pancreatic ductal adenocarcinoma (PDAC) and to explore GATA6 expression as a surrogate biomarker. Experimental Design:. Within the COMPASS trial, patients proceeding to chemotherapy for advanced PDAC undergo tumor biopsy for RNA-sequencing (RNA-seq).
Purpose:. We evaluated the prognostic and predictive value of circulating tumor cells (CTCs) hormone receptor–positive (HR + ) metastatic breast cancer (MBC) patients randomized to letrozole alone or letrozole plus bevacizumab in the first-line setting (CALGB 40503). Experimental Design:. Blood samples were collected at pretreatment and three additional time points during therapy.
Introduction: Since December 2019, coronavirus disease 2019 (COVID-19) has spread to every country, taking on pandemic proportions in few months. Physicians were asked to redefine ordinary hospital organization, reprogramming clinically differentiable activities. Materials and Methods: During the COVID pandemic our Institution was supported by a call center (CC, named TOPS s.r.l.) to make a triage for cancer patients (pts) scheduled for follow-up in our outpatient clinics: C1 (dedicated to female tumors), C2 (for gastrointestinal, urogenital,and thoracic tumors) and D1 (for tumors in over 5 years’ follow-up). We report preliminary data referred to the period 7th April-24th May, 2020. The activity was divided into two phases (F): April (F1)
Background: We aimed to analyze the impact on treatment delivery in patients with lung cancer during the COVID-19 pandemic and to describe the patterns of treatment change. Methods: We accessed treatment records of all lung cancer patients treated from 02/20 to 06/20 at the oncology day hospital in our institution (HGUGM; Madrid, Spain).
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 w.

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