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Showing 101 - 150Addition of Panitumumab to Neoadjuvant Chemotherapy in Primary HER2-Negative Inflammatory Breast Cancer
In a single-center phase II study reported in JAMA Oncology, Matsuda et al found that adding the EGFR inhibitor panitumumab (Vectibix) to neoadjuvant chemotherapy produced high pathologic complete response (pCR) rates in patients with primary triple-negative inflammatory breast cancer. Study...
Molecular Minimal Residual Disease Detection Shows Further Promise in Acute Myeloid Leukemia
Extended next-generation sequencing genomic profiling in acute myeloid leukemia (AML) has revealed remarkable heterogeneity and molecular complexity of the disease and provided critical insights into the genetic mechanisms underpinning of preleukemic and leukemic pathogenesis.1,2 Despite...
Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 12, 2018, afatinib (Gilotrif) was approved...
How Will ctDNA Assays Aid in Managing Breast Cancer?
CIRCULATING TUMOR DNA (ctDNA) assays are now commercially available for use in lung cancer and melanoma, where they can identify the presence of specific mutations that drive treatment selection. In breast cancer, ctDNA remains more of a research tool, but this is poised to change. At the 2018...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA
On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations ...
Expert Point of View: Steven Vogl, MD and Eric P. Winer, MD, FASCO
Steven Vogl, MD, of Bronx, New York, commented that the results after pathologic complete response [pCR] in the I-SPY 2 study are “extraordinarily good,” and Eric P. Winer, MD, FASCO, Thompson Chair in Breast Cancer Research and Professor of Medicine, Harvard Medical School, Boston, said the...
Power of Pathologic Complete Response to Neoadjuvant Therapy Demonstrated in I-SPY 2 Trial
More evidence of the power of pathologic complete response (pCR) now comes from an update of the multicenter, adaptively randomized I-SPY 2 trial. In a study reported at the 2017 San Antonio Breast Cancer Symposium, pCR predicted for event-free and distant disease–free survival in high-risk...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR)...
Melanoma Mutations: What You Need to Know
CLINICIANS ARE now well acquainted with BRAF mutations in advanced melanoma, but there is more to genomics in this disease than identifying BRAF and prescribing a BRAF inhibitor. At the 2017 Debates and Didactics Conference, held at Sea Island, Georgia, Melinda L. Yushak, MD, MPH, of Emory...
Clinical Relevance of Minimal Residual Disease Monitoring Limited in Acute Myeloid Leukemia
Although a majority of major cancer centers may test for minimal residual disease (MRD), a recent survey conducted by researchers at Moffitt Cancer Center, Tampa, Florida, suggests most oncologists remain uncertain about what to do with the results. At the National Comprehensive Cancer Network®...
Overview of the Phase III MSLT-II Trial
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
No Improvement in Melanoma-Specific Survival With Completion Dissection vs Observation for Sentinel-Node Metastasis
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
Michèle Beau-Faller, MD, PhD, on NSCLC: Biomarker Findings From the French Cooperative Thoracic Intergroup
Michèle Beau-Faller, MD, PhD, of the Hôpital de Hautepierre & Institut Régional du Cancer, discusses study results on ultrasensitive detection of EGFR T790M mutation by droplet digital PCR in TKI naïve non–small cell lung cancer harboring EGFR mutation (Abstract 85PD).
Melanoma-Specific Survival With Completion Dissection vs Observation for Sentinel Node Metastasis
The phase III MSLT-II trial showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
FDA Oncology Drug Approvals Granted Between August 2016 and May 18, 2017
Pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, received regular approval from the U.S. Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing...
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed ...
FDA Grants Marketing Authorization for Ipsogen JAK2 RGQ PCR Kit to Detect JAK2 Genetic Mutations
The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH, to detect mutations affecting the Janus tyrosine kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating...
Study Finds No Evidence of Cytomegalovirus in Glioblastoma and Other High-Grade Gliomas
In a rigorous study of tumor tissue collected from 125 patients with aggressive brain cancers, researchers at Johns Hopkins said they have found no evidence of cytomegalovirus (CMV) infection and concluded that a link between the two diseases, as claimed by earlier reports, likely does not exist. A ...
Diamonds Are Forever, Tyrosine Kinase Inhibitors Are Not?
Sir Donald Munger: “You have been on holiday, I understand. Relaxing, I hope?” James Bond: “Oh, hardly relaxing, but most satisfying.” (Diamonds Are Forever) As tyrosine kinase inhibitors became the mainstay of therapy for patients with chronic myeloid leukemia (CML), our assumption has been that...
Pathologic Complete Response Not Boosted by Addition of Estrogen Deprivation to Chemotherapy and Dual HER2 Blockade
The addition of estrogen deprivation to neoadjuvant chemotherapy and HER2 blockade did not enhance the achievement of pathologic complete responses in women with early-stage breast cancer, according to the results of the NRG Oncology/NSABP B-52 trial reported at the 2016 San Antonio Breast Cancer...
Study Indicates Safety of Stopping Imatinib in CML With Undetectable Minimal Residual Disease for at Least 2 Years
As reported in the Journal of Clinical Oncology by Etienne et al, long-term follow-up in the French Stop Imatinib (STIM1) study indicates imatinib can be safely stopped in patients with chronic myeloid leukemia (CML) with undetectable minimal residual disease sustained for at least 2 years. Study...
Liquid Biopsy–Based Test Appears Comparable to Standard Tissue Testing in Detecting BRAF V600 Mutations
Cell-free (cf) DNA from plasma offers a minimally invasive approach to obtain material for BRAF mutation analysis for diagnostics and response monitoring. A study by Janku et al investigating whether the detection of BRAF V600 mutations in plasma cfDNA from patients with advanced cancers using the...
Novel Strategies Emerging for Triple-Negative Breast Cancer
Compelling hypotheses are emerging about the mechanisms driving triple-negative breast cancer, and they are driving drug development in this area, according to Joyce O’Shaughnessy, MD, Celebrating Women Chair of Breast Cancer Research at Baylor Charles A. Sammons Cancer Center. She is also Medical...
Occult Metastasis on Immunohistochemistry May Affect Survival in Stage I NSCLC
Mature results of the Cancer and Leukemia Group B 9761/Alliance study, reported in the Journal of Clinical Oncology by Martin et al, indicate that occult metastases detected by immunohistochemistry in N2 lymph nodes may be associated with poorer overall survival after resection in clinical stage I...
New Biomarker Identifies Uveal Melanoma Patients at High Risk for Metastasis
Among uveal melanomas categorized as class 1, those with high levels of PRAME mRNA were more likely to metastasize than those with low levels of PRAME mRNA, suggesting that patients who have class 1 uveal melanoma with high levels of PRAME mRNA should be monitored more closely for metastatic...
New Assay Detects Persistent Disease in Leukemia Patients Thought to Be in Remission
The outcomes of chronic myeloid leukemia (CML) have dramatically improved as the result of tyrosine kinase inhibitor treatment. Use of a tyrosine kinase inhibitor regimen can lower the blood CML biomarker to levels imperceptible by current detection methods. For patients in “molecular...
Jerald P. Radich, MD, on Treatment Milestones in CML: Stay the Course or Change Therapy?
Jerald P. Radich, MD, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance discusses the evolution in treating and monitoring CML and whether monitoring at 3 and 6 months will ultimately prove useful.
Breast Cancer Studies Focus on Tailoring Therapy for Patient Subsets
As part of our ongoing coverage of the 2011 ASCO Annual Meeting, The ASCO Post has provided substantive reports on key breast cancer trials, but others deserve attention. Lapatinib/Capecitabine Controls Brain Metastases Results of the French phase II LANDSCAPE trial found lapatinib (Tykerb) plus...
Breast Cancer Studies Explore Wide Variety of Prevention and Treatment Strategies, Offering New Insights
At the Best of ASCO® meeting in Miami, Harold Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston, and Carey K. Anders, MD, University of North Carolina at Chapel Hill, presented high-impact breast cancer abstracts that will enable clinicians to optimize their use of radiotherapy and biologics. ...
Encouraging Results with Neoadjuvant Therapy for High-risk Prostate Cancer
Use of the CYP17 inhibitor abiraterone acetate (Zytiga) in combination with leuprolide and prednisone prior to radical prostatectomy achieved pathologic complete response or near complete response in one-third of men with high-risk, localized prostate cancer. Abiraterone is FDA-approved for...
FDA Approves Cetuximab plus FOLFIRI/Therascreen in Colorectal Cancer
The FDA has granted approval to cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation–negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. ...
Gene Profiling–guided Therapy May Improve Survival in Patients with Carcinoma of Unknown Primary
Molecular gene-expression profiling is an emerging technique to determine tissue of origin in patients with carcinoma of unknown primary, although the value of predictions from such profiling in improving treatment outcomes is unclear. In a prospective trial using tumor profiling results to direct...
New Indication for Cetuximab plus FOLFIRI to Treat EGFR-positive, Wild-type KRAS Metastatic Colorectal Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In July 2012, cetuximab (Erbitux) was approved for use...
Cytotoxic Chemotherapy for Breast Cancer: Are We Done Tweaking It?
While novel targeted agents may grab the headlines in the treatment of breast cancer, oncologists still debate the optimal delivery of conventional cytotoxic chemotherapy, still a vital component of treatment. At the Best of ASCO Boston meeting, Steven J. Isakoff, MD, PhD, of Massachusetts General...
2012-2013 Oncology Meetings
November 2012 AACR-NCI-EORTC Molecular Targets and Cancer TherapeuticsNovember 12-16 • San Francisco, California For more information: www.aacr.org Connective Tissue Oncology Society 17th Annual MeetingNovember 14-17 • Prague, Czech Republic For more information: www.ctos.org Controversies in the...
Beyond Molecular Monitoring: Cytogenetic Testing and Mutational Analysis in Chronic Myeloid Leukemia
Cytogenetic analysis remains an important component of patient monitoring until a complete cytogenetic response is achieved. In addition, the ability of conventional cytogenetics to identify additional chromosomal abnormalities not detected by fluorescence in situ hybridization is noteworthy. Jorge ...
Oncology Meetings
January 2013 3rd International Conference on Medical, Biological and Pharmaceutical SciencesJanuary 4-5 • Bali, Indonesia For more information: www.psrcentre.org Breast-Gynecological International Cancer CongressJanuary 17-18 • Cairo, Egypt For more information: www.bgicc.eg.net/ Highlights of ASH® ...
2012 In Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2012. Cabozantinib (Cometriq) for the treatment of progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine...
Oncology Meetings
January 2013 Breast-Gynecological International Cancer CongressJanuary 17-18 • Cairo, EgyptFor more information: www.bgicc.eg.net/ Highlights of ASH® San Diego, CA and Toronto, CanadaJanuary 18-19 • San Diego, CA and Toronto, Ontario, CanadaFor more information: www.hematology.org/meetings...
Never a Dull Moment: A Day in the Life of an Oncology Fellow
Oncology fellows represent the future of cancer care, bringing the best and brightest young doctors into a rigorous training environment that molds their future career paths. Due to an impending workforce shortage in cancer care, the public health-care demands placed on today’s oncology fellows...
Oncology Meetings
February Highlights of ASH® Miami, FL and San Francisco, CAFebruary 1-2 • Miami, Florida, and San Francisco, CaliforniaFor more information: www.hematology.org/meetings Optimizing Outcomes in Colorectal CancerFebruary 7 • Boston, MassachusettsFor more information: www.omedlive.com Interventional...
Common Deletion in APOBEC3 Genes Associated with Increased Risk of Breast Cancer
Genome-wide association studies have identified numerous genetic susceptibility loci for breast cancer, although these loci explain only a small proportion of heritability. Relatively few studies have assessed associations of breast cancer risk with copy number variation, another important source...
New Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitor Treatment
A new guideline for molecular testing to select lung cancer patients for treatment with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors has been jointly developed by the College of American Pathologists, International Association for the Study ...
Immunohistochemistry Effectively Detects ALK Rearrangement in Non-small Cell Lung Cancer Study
ALK rearrangement has been demonstrated to be a potent oncogenic driver and a promising therapeutic target in non-small cell lung cancer. It defines a distinct molecular subset of NSCLC, in particular adenocarcinoma that can benefit by the treatment of ALK-inhibitors. Development of robust and...
FDA Approves Afatinib for Late-stage Lung Cancer
On July 12, 2013, the FDA approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations...
Afatinib as First-line Treatment for Metastatic NSCLC with EGFR Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On July 12, 2013, afatinib (Gilotrif) was approved for...
Pathologic Complete Response as a Test Bed for Novel Therapies: Proceed—With Caution!
Pathologic complete response as assessed surgically after neoadjuvant treatment is being touted by some researchers as a stand-alone endpoint justifying early drug approval for breast cancer. They argue that it provides a more efficient means of testing the value of agents that might be useful in...
