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breast cancer
solid tumors

FDA Clears Expanded Indication of Scalp-Cooling System

Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as...

solid tumors

2018 ASCO: Pexidartinib in Tenosynovial Giant Cell Tumor

The phase III ENLIVEN study showed a statistically significant 39% overall response rate at week 25 based on central review of magnetic resonance imaging (MRI) scans using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (the primary endpoint) for patients treated with oral...

solid tumors

Apostolia-Maria Tsimberidou, MD, PhD, on Precision Medicine: Results From the IMPACT Study

Apostolia-Maria Tsimberidou, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses findings on clinical outcomes, including long-term survival, according to the pathway targeted and treatment period (Abstract LBA2553).

colorectal cancer
solid tumors
gynecologic cancers

2018 ASCO: Genomic Study Finds Lynch Syndrome Is Common Among Patients With MSI-High Tumors

A genomic study of more than 15,000 tumor samples showed that people who have tumors with high microsatellite instability (MSI-H)—a genomic marker associated with a large number of genetic mutations in the tumor—are more likely to have Lynch syndrome, a hereditary condition that...

solid tumors

2018 ASCO: IMPACT Trial Matches Treatment to Genetic Changes in the Tumor to Improve Survival Across Multiple Cancer Types

Researchers conducted a retrospective analysis of consecutive, prospectively molecularly profiled patients with advanced cancer who participated in a large, personalized medicine trial. They found that using molecular tests of tumors to select targeted therapy resulted in slower cancer growth and...

solid tumors

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) and granted Priority Review for larotrectinib in the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. ...

solid tumors

FDA Grants Fast Track Designation to Debio 1347 for Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration

Debiopharm International SA (Debiopharm) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Debio 1347, an inhibitor of fibroblast growth factor receptors 1, 2, and 3 (FGFR1–3), for the treatment of patients with unresectable or...

solid tumors

FDA Approves Dabrafenib/Trametinib Combination for BRAF-Positive Anaplastic Thyroid Cancer

Today, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of unresectable, metastatic, BRAF V600E mutation–positive anaplastic thyroid cancer. Anaplastic thyroid cancer accounts for about 1% to 2% of all...

solid tumors

FDA Grants Orphan Drug Designation to BN-Brachyury for the Treatment of Chordoma

On May 2, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the cancer vaccine BN-Brachyury for the treatment of chordoma. Chordoma is a rare type of cancer that develops along the spine, with presentation occurring at one of three main sites: sacrum, mobile spine, or...

solid tumors
hematologic malignancies

Update Regarding Tazemetostat Clinical Program

On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...

solid tumors

Morbidity in Testicular Cancer Survivors Treated With Standard Cisplatin-Based Chemotherapy

In a study reported in the Journal of Clinical Oncology, Kerns et al found that approximately 20% of testicular cancer survivors treated with cisplatin-based regimens had high cumulative burden of morbidity (CBM) scores and identified factors associated with risk for increased morbidity. Study...

solid tumors
issues in oncology

Postmarketing Label Modifications for Cancer Drugs Approved Without Supporting Randomized Controlled Trials

In a study reported in the Journal of Clinical Oncology, Shepshelovich et al found that cancer drugs approved by the U.S. Food and Drug Administration (FDA) for treatment of solid tumors without supporting randomized controlled trials were more likely to have postapproval safety-associated label...

solid tumors
immunotherapy

AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors

Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...

solid tumors
lung cancer

AACR 2018: Selective Inhibitor Shows Early Promise in Patients With RET-Altered Cancers

BLU-667, a next-generation inhibitor that selectively targets the oncogenic receptor tyrosine kinase RET, was well tolerated and had broad clinical benefit in patients with advanced cancer that had progressed on previous therapies, including multikinase inhibitor therapy. Proof-of-concept data from ...

solid tumors

Larotrectinib in Pediatric Solid Tumors With TRK Gene Fusions

As reported in The Lancet Oncology by Laetsch et al, phase I results from an ongoing phase I/II trial have shown activity of the TRK kinase inhibitor larotrectinib in pediatric patients with solid tumors harboring TRK fusions. Study Details In the study, 24 patients in a dose-escalation cohort...

solid tumors

Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available

On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...

solid tumors

SSO 2018: Is Low-Volume Disease in the Sentinel Node After Neoadjuvant Chemotherapy an Indication for Axillary Dissection?

Frozen section evaluation of sentinel lymph nodes after neoadjuvant chemotherapy has a higher false-negative rate than in the primary surgical setting, particularly for small tumor deposits. However, it is unknown whether similar false positive rates occur after chemotherapy. Researchers led by...

solid tumors

EAU 2018: Study Finds a Quarter of Penile Cancer Patients Do Not Receive Recommended Treatment

A major international survey has found that around a quarter of patients with penile cancer are not receiving the recommended treatment, and that these patients had half the survival rate of those who were treated according to guidelines. The study, presented at the European Association of Urology...

solid tumors

Testicular Cancer Survivors and Adequate Screening for Long-Term Heart Disease

Testicular cancer is the most common cancer in young men. The majority of patients are cured of their disease, but a newly published study shows many remain at risk for later complications from chemotherapy or other treatments. The study, published by Zaid et al in JNCCN –Journal of the...

solid tumors

Treatment Trends for Lymph Node–Positive Penile Cancer

In a study of data from the National Cancer Database reported in JAMA Oncology, Joshi et al found that two-thirds of patients with node-positive nonmetastatic squamous cell carcinoma of the penis received lymph node dissection and approximately half received chemotherapy in recent years. ...

solid tumors

Poorer Socioeconomic Status May Predict Lower Survival in Patients With Anal Cancer

Patients with lower income have a significantly reduced chance of surviving anal cancer, according to a new study led by investigators at NYU Langone Health’s Perlmutter Cancer Center published by Lin et al in the journal Cancer. The study shows that both overall and...

solid tumors

Circulating Tumor DNA Analysis: ASCO and CAP Joint Review

As reported in the Journal of Clinical Oncology and the Archives of Pathology & Laboratory Medicine by Jason D. Merker, MD, PhD, of Stanford University School of Medicine, and colleagues, ASCO and the College of American Pathologists (CAP) have issued a joint review on the status of...

solid tumors
hematologic malignancies

AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells

Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...

solid tumors

TAT 2018: EXPRESS Study Explores the Genomic Landscape of Patients Achieving an 'Exceptional' Response to Targeted Therapy

The level of genomic alterations in genes associated with the oncogenesis of specific solid tumor types is being investigated in patients that have demonstrated an exceptional response to currently approved targeted therapies, researchers announced at the International Congress on Targeted...

solid tumors
lymphoma
immunotherapy

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...

solid tumors
immunotherapy

SBRT and Anti–PD-1 Treatment in Metastatic Solid Tumors

In a phase I study reported in the Journal of Clinical Oncology, Luke et al found that a strategy of multisite stereotactic body radiotherapy (SBRT) followed by pembrolizumab was feasible in patients with metastatic solid tumors. It was hypothesized that stimulation of immune responses by SBRT...

solid tumors

Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children

In a study reported in The New England Journal of Medicine, Drilon et al found that the oral tropomyosin receptor kinase (TRK) inhibitor larotrectinib produced a high response rate and enduring responses in patients with TRK fusion–positive cancers. These fusions have been found to lead to...

solid tumors

Study Shows Need for Early Supportive Care in Patients Diagnosed With Uveal Melanoma

In a study published by Williamson et al in JAMA Ophthalmology, University of California, Los Angeles, (UCLA) researchers found that nearly all patients diagnosed with uveal melanoma had a number of unmet psychological and health information needs, particularly during the first 3 months after their ...

solid tumors

Chromatin Organization Marker and Cancer-Specific Survival

In a study reported in The Lancet Oncology, Kleppe et al found that a novel marker for chromatin organization in tumor cell nuclei was associated with outcome in a variety of cancer types. Study Details In the study, machine learning algorithms analyzed chromatin organization in 461,000 images of ...

solid tumors

Jeffrey M. Holzbeierlein, MD, on Penile, Urethral, and Testicular Cancers: Abstract Roundup

Jeffrey M. Holzbeierlein, MD, of the University of Kansas Medical Center, summarizes key abstracts on long-term sexual function in germ cell tumor survivors, sentinel node biopsy in clinical stage I testicular cancer, the impact of Medicaid expansion on diagnosis and management of patients with...

solid tumors
immunotherapy

Pembrolizumab Active in Thymic Carcinoma

In a single-center phase II study reported in The Lancet Oncology, Giaccone et al found that pembrolizumab (Keytruda) produced durable responses in patients with recurrent thymic carcinoma. Study Details In the study, 40 evaluable patients with advanced disease progressing after at least one line ...

solid tumors

Multiple-Basket Study of Targeted Therapy for Advanced Solid Tumors

In a phase IIa multiple-basket study (MyPathway) reported in the Journal of Clinical Oncology, Hainsworth et al found that agents targeting specific molecular alterations produced responses in tumors outside of current labeling for the agents, with high response rates being observed in some tumor...

solid tumors
immunotherapy

Linda Mileshkin, MBBS, on Solid Tumors: Early Treatment Study Results

Linda Mileshkin, MBBS, of the Peter MacCallum Cancer Centre, discusses phase Ib trial findings on the anti–PD-1 monoclonal antibody BGB-A317 in combination with the PARP inhibitor BGB-290 in advanced solid tumors.

solid tumors
immunotherapy

Jeffrey M. Lemons, MD, on Solid Tumors: Safety Data on SBRT and Immunotherapy

Jeffrey M. Lemons, MD, of the University of Chicago, discusses early safety and efficacy findings from a small study on pembrolizumab and multiorgan-site ablative stereotactic body radiotherapy in patients with advanced solid tumors (Abstract 20).

solid tumors

Everolimus in Previously Treated Thymoma and Thymic Carcinoma

In an Italian phase II study reported in the Journal of Clinical Oncology, Zucali et al found that everolimus was active in cisplatin-pretreated thymoma and thymic carcinoma; however, a high rate of fatal pneumonitis was observed. Study Details In the study, 51 patients with advanced/recurrent...

solid tumors

Age-Associated Mortality Risk and BRAF V600E Status in Papillary Thyroid Cancer

In a study reported in the Journal of Clinical Oncology, Shen et al found evidence that BRAF V600E mutation status explains the long-recognized increased mortality risk associated with age at diagnosis in patients with papillary thyroid cancer. Study Details The study involved data from 2,638...

solid tumors
issues in oncology

California Trends in Cancer Survival by Health Insurance Status

A study using California Cancer Registry data showed that survival improvements in patients with cancer between 1997 and 2014 have largely been limited to those with private or Medicare insurance. These findings were reported in JAMA Oncology by Libby et al. Study Details The study involved...

solid tumors

Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers

At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...

solid tumors

Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors

Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...

solid tumors

Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure

As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...

solid tumors

FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers

On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The ...

solid tumors

FDA Authorizes MSK-IMPACT Tumor Profiling Assay

Today, the U.S. Food and Drug Administration (FDA) authorized Memorial Sloan Kettering Cancer Center’s MSK-IMPACT tumor profiling assay, an in vitro diagnostic test that can identify more biomarkers that may be found in various cancers than any test previously reviewed by the...

solid tumors

Combination Therapy for Advanced Lung and Thymus Carcinoids

A European phase II trial has shown activity of long-acting pasireotide, everolimus (Afinitor), or their combination in patients with advanced lung and thymus carcinoids. These study findings were reported by Ferolla et al in The Lancet Oncology. Study Details In the study, 124 patients from 36...

solid tumors

Characteristics of Recurrence in Stage I to III Midgut Neuroendocrine Tumors

In a study reported in the Journal of the National Cancer Institute, Cives et al found that postsurgical relapse occurred in 31% of patients with stage I to III midgut neuroendocrine tumors over long-term follow-up, with liver, mesentery, and pelvic lymph nodes being the main sites of relapse....

solid tumors

Factors Associated With Outcome in Pediatric Adrenocortical Tumors

In a St. Jude Adrenocortical Tumor Registry and Children’s Oncology Group study reported in the Journal of Clinical Oncology, Pinto et al found that a positive Ki67 labeling index was associated with a poorer outcome in children with adrenocortical tumors independent of germline TP53 mutation ...

solid tumors

AACR-NCI-EORTC: NCI-MATCH Reaches Central Patient-Screening Goal

The National Cancer Institute (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented by Chen et al at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer...

solid tumors

AACR-NCI-EORTC: Noninvasive Computational Imaging Approach May Help Predict Response to Immunotherapy

A computational imaging-based signature of immune-cell infiltration in and around a tumor could predict patients’ responses to treatment with anti–programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) immunotherapies, according to data from a study presented by Sun et...

solid tumors

AACR-NCI-EORTC: Tazemetostat as Treatment for Certain Pediatric Relapsed or Refractory Solid Tumors

Children with relapsed or refractory malignant rhabdoid tumors, epithelioid sarcomas, or poorly differentiated chordomas with a particular genetic defect tolerated treatment with the investigational drug tazemetostat well, and some had objective and durable responses, according to data from a phase ...

solid tumors

Potential Treatment of Chordoma With PI3K Inhibitors

Patients with chordoma—a rare bone cancer of the skull and spine—could be helped by existing treatments, suggest scientists from the Wellcome Trust Sanger Institute, University College London Cancer Institute, and the Royal National Orthopaedic Hospital NHS Trust. In the largest...

solid tumors

Incidence of Endocrine Dysfunction With Immune Checkpoint Inhibitors

In a systematic review and meta-analysis reported in JAMA Oncology, Barroso-Sousa et al evaluated the incidence of endocrine dysfunction in patients receiving currently approved immune checkpoint inhibitors for various advanced solid tumors. Patients who received combination therapy were found to...

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