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Sarah Abou Alaiwi, MD, and Toni K. Choueiri, MD, on Checkpoint Inhibitors: Overall Survival and Polybromo-Associated Mutations
Toni K. Choueiri, MD, and Sarah Abou Alaiwi, MD, both of Dana-Farber Cancer Institute, discuss the association of polybromo-associated BAF-type mutations with overall survival in patients with different solid tumors treated with checkpoint inhibitors (Abstract 103).
FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
2019 ASCO: Nearly One-Quarter of Participants in the Pediatric MATCH Trial Have an Actionable Molecular Alteration
A study investigating the frequency of targetable molecular alterations in pediatric cancer among patients enrolled in the National Cancer Institute–Children’s Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) trial has found that about one-quarter of patients with...
AUA Releases New Clinical Guideline for Diagnosis and Treatment of Early-Stage Testicular Cancer
Recently, the American Urological Association (AUA) released a new clinical guideline on the diagnosis and treatment of early-stage testicular cancer. Testicular cancer is the most common cancer among men ages 20 to 40. Although it is a less common form of cancer, about 9,600 American men...
FDA Pipeline: Designations in Triple-Negative Breast Cancer, ctDNA Detection
This week, the U.S. Food and Drug Administration (FDA) granted a Fast Track designation to a treatment for CCR5-positive metastatic triple-negative breast cancer; granted Breakthrough Device designation to a test for the postsurgical detection and quantification of circulating tumor DNA (ctDNA);...
PRRT Shows Long-Term Effectiveness in Malignant Neuroendocrine Tumors
A 12-year retrospective clinical study of patients who received peptide receptor radionuclide therapy (PRRT) for malignant neuroendocrine tumors demonstrated the long-term effectiveness of this treatment, which also allows patients to maintain a high quality of life. The study was published by...
FDA Pipeline: Applications and Designations in Prostate Cancer, Leukemia, and HER2-Positive Cancers
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
SABR-COMET: Stereotactic Ablative Radiotherapy vs Standard Palliative Treatment in Oligometastatic Cancers
Results of the phase II SABR-COMET trial reported by Palma et al in The Lancet indicate that stereotactic ablative radiotherapy (SABR) was associated with improved survival vs standard palliative treatment in patients with oligometastatic cancers, although it was also associated with...
NRG1 Gene Fusions Detected at Low Incidence Across Multiple Tumor Types
A consortium of researchers have completed an analysis of a new gene fusion they believe is responsible for the development of a wide spectrum of cancer types. According to the investigators, their studies show that errant gene fusions in neuregulin-1, or NRG1, which are present in about...
AACR 2019: Phase I Trial Evaluates LOXO-195 in Patients With NTRK-Positive Solid Tumors
The investigational anticancer therapeutic LOXO-195, which targets a family of proteins called tropomyosin receptor kinases (TRKs), was safe, tolerable, and showed signs of clinical activity in patients who had solid tumors that harbored NTRK gene fusions and had become resistant to other...
Serum MicroRNA-371a-3p as a Biomarker for Testicular Germ Cell Tumors
In a study reported in the Journal of Clinical Oncology, Dieckmann et al found that serum levels of microRNA (miR)-371a-3p (M371 test) showed very high accuracy for detecting testicular germ cell tumors. Study Details In the prospective international study, serum samples from 616 patients with...
Subsequent Primary Neoplasms in Survivors of Adolescent and Young Adult Cancers
In a UK population-based cohort study (Teenage and Young Adult Cancer Survivor Study) reported in The Lancet Oncology, Bright et al found that subsequent primary neoplasms were most common in survivors of adolescent and young adult (AYA) breast, cervical, and testicular cancers, as well as Hodgkin...
Effect of Adjuvant Treatment for Early Testicular Cancer on Reproductive Potential
Men with early-stage testicular cancer can safely receive one course of adjuvant chemotherapy or radiotherapy without it having a long-term effect on their reproductive potential, according to a study published by Weibring et al in Annals of Oncology. Although it is known already that several...
2019 ASCO-SITC: Combined Targeting of TIM-3 and PD-L1 Immune Checkpoint Pathways in Advanced Relapsed or Refractory Solid Tumors
A phase Ia/Ib trial was launched in order to evaluate the safety of LY3321367, an anti–T-cell immunoglobulin domain and mucin domain–containing molecule-3 (TIM-3) antibody, administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in...
TAT 2019: Use of the Lung Immune Prognostic Index in Stratifying Outcomes in Patients Treated With Immune Checkpoint Inhibitors
The Lung Immune Prognostic Index (LIPI) calculated prior to the initiation of treatment may be used to stratify patients with diverse tumor types into groups that significantly associate with outcome following immune checkpoint inhibitor therapy, according to a retrospective study presented at the...
Neoplasm and Malignancy Risk in Nonproband Carriers of Pathogenic Germline Variants in DICER1
In a study reported in the Journal of Clinical Oncology, Stewart et al identified the risk of neoplasms and malignancies among nonproband carriers of pathogenic germline variants in DICER1. The nonproband carriers were the biologic relatives of probands enrolled in three cohorts of individuals...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Craig R. Nichols, MD, on Testicular Cancer Cases: Should They Be Discussed With High-Volume Centers?
Craig R. Nichols, MD, of the Testicular Cancer Commons and the SWOG Group Chair's Office, discusses the superior outcomes obtained at high-volume centers, the impracticality of referring all patients to such centers, and the international efforts to develop virtual collaborations on salvage...
Stefanie C. Fischer, MD, on Nonseminoma: Outcomes After Adjuvant Bleomycin/Etoposide/Cisplatin
Stefanie C. Fischer, MD, of Manchester Cancer Research Centre and The Christie NHS Foundation Trust, discusses an international retrospective analysis of the rare clinical scenario of men relapsing after adjuvant treatment with bleomycin/etoposide/cisplatin for clinical stage I nonseminoma...
Inherited Variants in CHEK2 and Susceptibility to Testicular Germ Cell Tumors
In a study reported in JAMA Oncology, AlDubayan et al found that inherited pathogenetic variants in the checkpoint kinase 2 gene (CHEK2), among inherited pathogenetic DNA-repair gene (DRG) alterations, were associated with susceptibility to testicular germ cell tumors. The study involved screening ...
FDA Pipeline: Treatments for Tenosynovial Giant Cell Tumor and Pancreatic Cancer, Plus a Statement on Breast Implant–Associated Lymphoma
The U.S. Food and Drug Administration (FDA) recently granted the following designations and applications and also issued a statement: Priority Review for Pexidartinib in Tenosynovial Giant Cell Tumor The FDA has accepted a new drug application (NDA) and granted Priority Review for pexidartinib...
Impact of Stereotactic Ablative Radiotherapy on Survival for Patients With Advanced Cancers
The first report from a phase II, multicenter clinical trial has found that a newer, more aggressive form of radiation therapy—stereotactic ablative radiation—can extend long-term survival for some patients with stage IV cancers, while maintaining their quality of life. The study was...
ASCO Clinical Cancer Advances 2019 Names Advance of the Year: Progress in Treating Rare Cancers
Over the past year, major research advances provided new treatment options for patients with rare, difficult-to-treat cancers. In recognition of these achievements, ASCO named “Progress in Treating Rare Cancers” as the Advance of the Year. To continue the forward momentum, ASCO also...
Standard Site-Specific Therapy Based on Gene-Expression Profiling vs Empirical Chemotherapy for Cancer of Unknown Primary
In a Japanese phase II trial reported in the Journal of Clinical Oncology, Hayashi et al found that standard site-specific treatment based on gene-expression profiling was not associated with better outcomes vs empirical paclitaxel and carboplatin in patients with cancer of unknown primary site....
Overall Survival in Men and Women Receiving Immune Checkpoint Inhibitors for Advanced Cancers
In a systematic review and meta-analysis reported in JAMA Oncology, Wallis et al found no difference in overall survival benefit in women vs men receiving immune checkpoint inhibitor treatment for advanced solid tumors. The authors noted that a prior analysis had suggested men derived a greater...
2019 GI Cancers Symposium: Pembrolizumab in Pretreated, Advanced Neuroendocrine Tumors
Findings from the phase I KEYNOTE-028 trial, which studied pembrolizumab in a number of solid tumors, showed activity of the immunotherapy in some patients with heavily pretreated neuroendocrine tumors. Now, a phase II basket trial—KEYNOTE-158—is studying the efficacy and safety of...
Common Markers of Tumor Hypoxia Found Across Cancer Types
Unlike healthy tissues, tumors thrive in low-oxygen environments, often acquiring the ability to resist treatment and spread to other sites in the body. Despite being a well-known cause of therapy resistance and metastasis, the impact of hypoxia on tumor cells is poorly understood. Researchers have ...
FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...
Detection of Relapse in Children and Adolescents With Nongerminomatous Malignant Germ Cell Tumors
In a report from the Children’s Oncology Group published in the Journal of Clinical Oncology, Fonseca et al found that relapse in children and adolescents with nongerminomatous malignant germ cell tumors (MGCTs) was most frequently identified by tumor markers rather than imaging. Study...
Factors Influencing Response to Pembrolizumab in Various Advanced Cancers
In an analysis from the phase Ib KEYNOTE-028 trial reported in the Journal of Clinical Oncology, Ott et al found that response to pembrolizumab across different cancers was more likely in patients with higher tumor mutational burden, T-cell–inflamed gene-expression profile, and programmed...
Sorafenib in Progressive, Symptomatic, or Recurrent Desmoid Tumors
In a phase III trial reported in The New England Journal of Medicine, Gounder et al found that sorafenib improved progression-free survival vs placebo in patients with progressive, symptomatic, or recurrent desmoid tumors. As noted by the investigators, there is no current standard of care for...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
EORTC-NCI-AACR: Investigational Anti-HER2 Therapy in HER2-Expressing Solid Tumors
An antibody that binds simultaneously to two distinct regions of the HER2 receptor to block the growth of cancer cells has shown antitumor activity in a number of cancers, including those of the esophagus, stomach, and bowel. Updated results from a phase I clinical trial of the treatment, called...
FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
NCRI 2018: HiLo Trial: Rate of Thyroid Cancer Recurrence After Adjuvant Lower-Dose Radiation
Patients with thyroid cancer whose disease is at low risk of returning can be treated safely with a smaller amount of radiation following surgery, according to results from the HiLo trial presented by Wadsley et al at the 2018 National Cancer Research Institute (NCRI) Cancer Conference (Abstract...
Transcription Factors TP63 and SOX2 in Squamous Cell Carcinoma Progression
Squamous cell carcinomas (SCCs) are malignancies arising from squamous epithelium of various organs, such as esophagus, head and neck, lung, and skin. Previous studies demonstrated that two master transcription factors, TP63 and SOX2, effect genomic activation in SCCs. Now, researchers from...
Prevalence of Lynch Syndrome in Solid Tumors According to Microsatellite Instability Status
In a study reported in the Journal of Clinical Oncology, Latham et al found that microsatellite instability (MSI) and/or mismatch repair deficiency (MMR-D) is predictive of Lynch syndrome across a greater than heretofore recognized breadth of the solid tumor spectrum. As noted by the...
Incidental Germline Mutations in Patients With Advanced Solid Tumors Identified by Cell-Free Circulating Tumor DNA Testing
In a study reported in the Journal of Clinical Oncology, Slavin et al determined the prevalence of a set of germline cancer predisposition gene mutations incidentally identified by cell-free circulating tumor DNA (cfDNA) testing in patients with advanced solid tumors. Study Details The study...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for RET Fusion–Positive Thyroid Cancer
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have had disease progression following...
2018 ASTRO: Phase I Trial of SBRT for Oligometastatic Disease With Multiple Metastases
The phase I NRG Oncology clinical trial BR001 tested the hypothesis that stereotactic body radiotherapy (SBRT) could be used safely in patients with oligometastatic disease characterized by multiple metastases. Results from the trial indicate that using SBRT is safe as treatment for patients with 2 ...
Fluoropyrimidine DPYD Genotype–Guided Dosing in Patients With Cancer
In a Dutch study reported in The Lancet Oncology, Henricks et al found that DPYD genotype–guided dosing reduced the frequency of severe fluoropyrimidine toxicity in patients with cancer. Increased fluoropyrimidine toxicity is associated with reduced activity of the metabolic...
2018 ASTRO: SABR-COMET: Stereotactic Ablative Radiation Therapy for Oligometastatic Tumors
In the first randomized, phase II clinical trial of its kind, researchers have shown that an aggressive form of high-precision radiation therapy can increase survival in patients with oligometastatic tumors. These findings were presented by Palma et al in the plenary session at the 60th Annual ...
David Palma, MD, PhD, on Oligometastatic Tumors: Results From the SABR-COMET Trial
David Palma, MD, PhD, of the London Health Sciences Centre, discusses study findings on improvement in survival following stereotactic ablative radiation for oligometastatic tumors (Presentation 5 in PL 01).
Utility of FDG-PET for Residual Lesions After Chemotherapy for Metastatic Seminoma
In an analysis of International Global Germ Cell Cancer Group Registry data reported in the Journal of Clinical Oncology by Cathomas et al, fluorodeoxyglucose positron-emission tomography (FDG-PET) was found to have a low positive predictive value for vital tumor in residual lesions after...
Epacadostat Plus Anti–PD-1 Immunotherapy in Advanced Solid Tumors
As reported by Mitchell et al in the Journal of Clinical Oncology, the combination of the oral indoleamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor epacadostat and the anti–programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) showed activity in advanced solid tumors in the ...
Lalan S. Wilfong, MD, on Metastatic Solid Tumors: Limiting Low-Value Care
Lalan S. Wilfong, MD, of Texas Oncology, discusses reducing the use of a white blood cell growth factor treatment in advanced and incurable solid tumors for patients treated at a community oncology practice.
Bacterial Therapy Tolerable, Shows Early Activity in Patients With Advanced Solid Tumors
A phase I clinical trial investigating the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy had manageable toxicities and showed early clinical efficacy in patients with treatment-refractory solid tumor malignancies, according to data presented at the CRI-CIMT-EATI-AACR...
Cancer Vaccine Shows Clinical Benefit in Phase I Study of Patients With HER2-Positive Cancers
A preclinical study showing that a vaccination with a recombinant adenovirus expressing a truncated ErbB-2 antigen can cure advanced established murine breast cancer as well as extensive established metastatic lung cancer led to the launch of a small phase I study investigating a therapeutic cancer ...
Bleomycin-Related Toxicity and Operative Morbidity After Postchemotherapy Retroperitoneal Lymph Node Dissection in Germ Cell Tumors
In a retrospective single-institution analysis reported in the Journal of Clinical Oncology, Calaway et al found that the addition of bleomycin to etoposide/cisplatin did not appear to increase risk of pulmonary or postoperative morbidity after postchemotherapy retroperitoneal lymph node dissection ...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for Treatment of Lung and Thyroid Cancers
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) who require systemic therapy and have had...
