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solid tumors
immunotherapy

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...

solid tumors

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...

breast cancer
solid tumors
leukemia
lung cancer
lymphoma
multiple myeloma
issues in oncology
immunotherapy

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...

solid tumors

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...

solid tumors

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...

solid tumors

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...

solid tumors

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...

solid tumors

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...

solid tumors

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...

solid tumors

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...

solid tumors
issues in oncology

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 ...

solid tumors
issues in oncology

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...

solid tumors

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 ...

solid tumors

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).

solid tumors

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...

solid tumors
immunotherapy

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 ...

issues in oncology
solid tumors

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.

solid tumors
immunotherapy

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...

solid tumors
immunotherapy

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 ...

solid tumors

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 ...

solid tumors
lung cancer

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...

solid tumors
hematologic malignancies

FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...

solid tumors

BRAF V600E and Disease-Specific Mortality in Men With Papillary Thyroid Cancer

In a large-scale retrospective analysis reported in the Journal of Clinical Oncology, Wang et al found that male sex is a predictor of poorer disease-specific survival in BRAF V600E papillary thyroid cancer. The study involved 2,638 patients (male = 623, female = 2,015) from 11 centers in 6...

solid tumors
hematologic malignancies

Monthly High-Dose Vitamin D and Cancer Risk

In a study reported in JAMA Oncology, Scragg et al found that monthly high-dose vitamin D supplementation, without calcium, was not associated with a reduced risk of developing cancer. Study Details The current analysis is a post hoc analysis of the Vitamin D Assessment (ViDA) study, which...

solid tumors

FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors

On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...

solid tumors

Risk of Cancer After Treatment of Testicular Germ Cell Cancer

In a Dutch study reported in the Journal of Clinical Oncology, Groot et al found that the risk of subsequent malignant neoplasms was increased in the long-term follow up of patients receiving cisplatin or radiotherapy for testicular germ cell cancer. Risk vs General Population The study involved...

solid tumors

PDL1 Amplification in Solid Tumors

In a study reported in JAMA Oncology, Goodman et al found amplification of PDL1 genes in 0.7% of solid tumors, including more than 100 tumor types. Response to checkpoint inhibition was high in a small group of patients with PDL1 amplification. Prevalence of PDL1 Amplification The study included...

solid tumors
immunotherapy

Pembrolizumab in Platinum-Refractory or Relapsed Thymic Epithelial Tumors

In a Korean single-center phase II study reported in the Journal of Clinical Oncology, Cho et al found that pembrolizumab (Keytruda) was active in advanced thymic epithelial tumors progressing after platinum-based chemotherapy. Study Details The study included 26 patients with thymic carcinoma...

solid tumors
supportive care

Prognostic Model for Malignant Pleural Effusion

As reported in The Lancet Oncology, Psallidas et al developed a model that is predictive of 3-month survival in patients with malignant pleural effusion. Study Details The PROMISE study involved an analysis of 5 independent data sets from randomized trials to discover, validate, and prospectively ...

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...

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