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Showing 7701 - 7750FDA Grants Priority Review to sBLA for Pembrolizumab in Recurrent or Advanced Gastric or GEJ Adenocarcinoma
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already...
Final Overall Survival Results of EMILIA Trial in Breast Cancer
As reported in The Lancet Oncology by Diéras et al, the final overall survival results of the phase III EMILIA trial show improved outcome with ado-trastuzumab emtansine (Kadcyla) vs capecitabine plus lapatinib (Tykerb) in previously treated HER2-positive advanced breast cancer. Approval of...
Two Faculty Members From Johns Hopkins Elected to National Academy of Sciences
Johns Hopkins University faculty members Stephen B. Baylin, MD, and Robert F. Siliciano, MD, PhD, have been elected to the National Academy of Sciences in recognition of their “distinguished and continuing achievements in original research.” They are among 84 new members and 21 foreign associates ...
New Immunotherapy Combinations Gain Ground in Advanced Melanoma, but Results Preliminary
Attention is focused among the cancer community on identifying the optimal immunotherapy combinations, with more than 800 ongoing trials of combination therapy. Two studies presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) reported promising preliminary...
The Ongoing Challenges of Lung Cancer Screening
Lung cancer persistently remains the leading cause of cancer death among men and women in the United States. Only about 15% of lung cancers are diagnosed at the localized stage, when clinical intervention could markedly improve patient outcomes. For decades, lung cancer specialists and advocacy...
Atezolizumab Improves Overall Survival in Small Subset of Patients With Triple‑Negative Breast Cancer
Triple-negative breast cancer is an aggressive disease with no approved targeted therapy, and it remains challenging to treat. Early data from a phase I study suggest that the PD-L1 inhibitor atezolizumab (Tecentriq) can extend the lives of a subset of women who respond to this checkpoint...
Expert Point of View: Filipa Lynce, MD
Formal discussant of the MONARCH 1 trial and the MONALEESA-2 biomarker analysis, Filipa Lynce, MD, of Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, noted that this is the first study to evaluate a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in patients with progressive...
Abemaciclib Active in Metastatic Breast Cancer
In the single-arm phase II MONARCH 1 trial, the investigational cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib achieved an objective response in about 20% of heavily pretreated patients with metastatic hormone receptor–positive, HER2-negative breast cancer and a disease control rate of...
Anticipate Sexual Dysfunction in Patients on Aromatase Inhibitors
For patients with breast cancer starting on aromatase inhibitors, sexual dysfunction is commonly reported. Early intervention may lessen its impact—but it’s not an easy fix, says a specialist in this area, Leslie R. Schover, PhD. Dr. Schover is Founder of Will2Love, an online sexual health program ...
Optimizing Treatment for Elderly Patients With Glioblastoma
In 2005, Stupp and colleagues published their landmark paper demonstrating in a randomized phase III trial that the addition of temozolomide to radiation increased overall survival in patients with newly diagnosed glioblastoma. Notably, patients over age 70 years were excluded from this study.1...
Short-Course Radiotherapy Plus Temozolomide Improves Survival in Older Patients With Glioblastoma
In a phase III trial reported in The New England Journal of Medicine, James R. Perry, MD, of Sunnybrook Health Sciences Centre, Toronto, and colleagues found that adding temozolomide to short-course radiotherapy improved overall survival in patients aged at least 65 years with newly diagnosed...
European Commission Approves Nivolumab for Head and Neck Squamous Cell Carcinoma Progressing After Platinum Therapy
On April 28, 2017, the European Commission approved nivolumab (Opdivo) as monotherapy for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in adults with disease progression on or after platinum-based therapy. Nivolumab is the first and only immuno-oncology treatment that has...
Managing Small Renal Masses: A Point-by-Point Consideration of ASCO’s Clinical Practice Guideline
As reviewed in this issue of The ASCO Post, a recent issue of the Journal of Clinical Oncology featured an ASCO Clinical Practice Guideline on the management of small renal masses reported by Finelli and colleagues.1 This comprehensive guideline is written by a group of well-regarded and...
Triple‑Modality Therapy Achieves Good Control in Inflammatory Breast Cancer
Contemporary triple-modality therapy achieves excellent locoregional tumor control of inflammatory breast cancer, with only 4 locoregional recurrences out of 114 patients treated at The University of Texas MD Anderson Cancer Center, Houston. The investigators described their approach at the...
Accrual of Older Patients to Breast Cancer Trials: A Critical Need
As the U.S. population ages,1 the number of older women with breast cancer will increase,2 as well as the number of patients with frailty and other comorbid medical conditions. These patients are at increased risk for toxicity and functional decline during their breast cancer treatment course....
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2017 Guidelines
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2017 Guidelines In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology®, covering 8 tumor types. Guidelines are now published for more than 60 tumor types and...
Suboptimal Genetic Testing and Counseling Among Women With Newly Diagnosed Breast Cancer
In a population-based study reported in a research letter in JAMA, Allison W. Kurian, MD, of Stanford University School of Medicine, and colleagues found that genetic testing and genetic counseling are suboptimal among women with newly diagnosed breast cancer.1 Study Details The study involved...
One in Five Cancers Diagnosed in the United States Is a Rare Cancer
About one in five cancer diagnoses in the United States is a rare cancer, according to new research from the American Cancer Society. The report, published by DeSantis et al in CA: A Cancer Journal for Clinicians, found rare cancers account for more than two in three cancers occurring in children...
Cholesterol-Lowering Medication Use and Breast Cancer Outcome
In a study reported in the Journal of Clinical Oncology, Signe Borgquist, MD, PhD, of Lund University, Sweden, and colleagues found that use of cholesterol-lowering medication during adjuvant endocrine therapy was associated with a reduced risk of breast cancer recurrence in hormone...
FDA OCE Launches Drug Information Soundcast in Clinical Oncology (DISCO)
The FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new podcast series from the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), covering new product approvals, emerging safety information for cancer treatments, and other current topics in cancer ...
ASCO CEO Reflects on His First Year in Office and What Is Ahead
June 27, 2017, marks the 1-year anniversary since Clifford A. Hudis, MD, FACP, FASCO, began his tenure as Chief Executive Officer of ASCO. With the launch of the national Cancer Moonshot and the changes in the White House and Congress, it has been a year of tremendous activity drawing on all of...
Expect Questions From Patients Who ‘Do Everything Right’ but Still Develop Cancer
A study reported in Science found that more than two-thirds of human cancers are caused by random mutations made during DNA replication.1 “The main message we would like to convey is that even for many patients who follow all of the guidelines from the advisory bodies—they don’t smoke, exercise...
Recognizing Major Role of Random Mutations in Causing Cancer Does Not Diminish Importance of Primary Prevention
Random mistakes made during DNA replication are responsible for about two-thirds of the mutations that cause human cancers, according to a study reported in Science.1 Recognizing the role of these replication errors “does not diminish the importance of primary prevention but emphasizes that not all ...
First Extensive Immune Profiling of Sarcomas Shows Possible Susceptibility to Immunotherapy
Sarcomas come in dozens of subtypes. Clinical trial results have been mixed when treating these diverse tumors with immunotherapy, a targeted therapeutic strategy that has success in other cancers. However, a study published by Pollack et al in the journal Cancer suggests how both existing and ...
RECIL 2017: New Response Evaluation Criteria in Lymphoma Clinical Trials
New criteria for evaluating response in lymphoma clinical trials—RECIL 2017—have been developed by an International Working Group with the aim of harmonizing criteria with the Response Evaluation Criteria in Solid Tumors (RECIST). The new criteria were reported by Younes et al in Annals ...
FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...
AUA 2017: Studies Examine Bladder Cancer Risk and Mortality in E-Cigarette and Traditional Smokers
Data presented at the 2017 Annual Scientific Meeting of the American Urological Association (AUA) showed harmful links between the use of e-cigarettes and bladder cancer risk, and associated the smoking of traditional cigarettes to a higher risk of mortality among patients with bladder cancer. Even ...
AUA 2017: New Studies Demonstrate Impact of BRCA, DNA Repair Gene Mutations in Prostate Cancer
Data presented at the 2017 Annual Scientific Meeting of the American Urological Association (AUA) showed new findings related to the impact of certain genetic mutations on the risk and development of prostate cancer, in particular metastatic disease. Male BRCA Mutations An analysis by Mano et al...
Durvalumab With Olaparib or Cediranib in Women’s Cancers
As reported in the Journal of Clinical Oncology by Lee et al, a phase I study has shown activity of the combination of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab with either the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) or vascular endothelial growth...
ASCO 2017: Gefitinib Treatment Can Delay Recurrence of Intermediate-Stage Lung Cancer
The targeted therapy gefitinib (Iressa) appears more effective in preventing recurrence after lung cancer surgery than the standard of care, chemotherapy. In a phase III clinical trial, patients with epidermal growth factor receptor (EGFR)-positive, stage II to IIIA non–small cell lung cancer ...
ASCO 2017: Healthy Lifestyle After Colon Cancer Diagnosis Helps Extend Survival
A study of 992 patients with stage III colon cancer found that those who reported a healthy lifestyle during and following adjuvant treatment had a 42% lower chance of death and a trend for lower chance of cancer recurrence than those who had less healthy lifestyles. The study will be presented by...
ASCO 2017: Adjuvant Capecitabine May Extend Survival in Biliary Tract Cancer
A phase III randomized clinical trial in 447 patients with biliary tract cancers showed that treating the disease with capecitabine after surgery extends survival by a median of 15 months compared to surgery alone. The finding could provide the basis for a new standard of care in the disease. This ...
Surveillance and Colorectal Cancer Risk in Patients With Intermediate-Risk Adenomas
A UK retrospective study showed that colonoscopic surveillance was associated with a reduced risk of colorectal cancer among patients with removal of intermediate-risk adenomas. The study was reported in The Lancet Oncology by Atkin et al. Study Details The study involved routine lower...
Hypofractionated Radiotherapy vs Conventionally Fractionated Radiotherapy in Early-Stage Glottic Cancer
Radiotherapy alone is often used to treat early-stage glottic cancer. However, the optimal radiation treatment schedule remains unknown. Both hypofractionated radiotherapy and conventionally fractionated radiotherapy are recommended treatment options. In an attempt to compare differences in overall ...
Hypofractionated Postmastectomy Radiation in Breast Cancer
In a phase II trial, Khan et al found that hypofractionated postmastectomy radiotherapy, completed in 15 treatment days, was safe and effective in women with stage II to IIIa breast cancer. The study was reported in the Journal of Clinical Oncology. Study Details In the study, 67 women from 2...
Reduced-Intensity vs Standard Conditioning Followed by ASCT in Myelodysplastic Syndrome
In the phase III RICMAC trial, use of a dose-reduced vs a standard myeloablative conditioning regimen prior to allogeneic stem cell transplantation (ASCT) did not appear to reduce 2-year relapse-free or overall survival in patients with myelodysplastic syndrome. These findings were reported by...
FDA Approves Ribociclib/Letrozole Co‑Pack for Postmenopausal Patients With Advanced or Metastatic Breast Cancer
On May 8, the U.S. Food and Drug Administration (FDA) approved the copackaging of ribociclib (Kisqali) and letrozole (Femara) tablets for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal ...
Intermittent Vismodegib Regimens in Basal Cell Cancers
In a phase II trial reported in The Lancet Oncology, Brigitte Dréno, MD, of Nantes University, Nantes, France, and colleagues found that two long-term intermittent vismodegib (Erivedge) dosing regimens provided a similar reduction in the number of clinically significant basal cell carcinomas among...
ELCC 2017: Prospective Study Shows Concordance of EGFR Mutation Detection Between ctDNA and Tumor Samples
Detection of EGFR mutations in circulating tumor (ct) DNA from plasma samples can be accomplished using the cobas platform, according to findings presented by Kumar et al at the 2017 European Lung Cancer Conference (ELCC) (Abstract 95PD). Assays of ctDNA offer a noninvasive method of finding EGFR...
Lenalidomide as Maintenance Therapy in Multiple Myeloma After Autologous Stem Cell Transplantation
On February 22, lenalidomide (Revlimid) was approved as maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplantation.1,2 The drug was previously approved to treat multiple myeloma (in combination with dexamethasone), anemia caused by...
Avelumab in Merkel Cell Carcinoma
On March 23, 2017, avelumab (Bavencio) was granted accelerated approval for treatment of patients aged ≥ 12 years with metastatic Merkel cell carcinoma. Avelumab is the first U.S. Food and Drug Administration–approved product to treat this disease.1,2 Supporting Efficacy Data Approval was based on ...
Expanding Role Seen for Minimal Residual Disease in Managing Multiple Myeloma
Minimal residual disease is a promising biomarker for guiding the management of multiple myeloma that is becoming increasingly important with the advent of more efficacious therapies, according to emerging data and expert opinion. “The story of minimal residual disease in multiple myeloma is like...
Blinatumomab ‘Takes a BiTE’ Out of Acute Lymphoblastic Leukemia
An investigational immunotherapy is improving outcomes in difficult-to-treat acute lymphoblastic leukemia (ALL) and showing promise in other cancers, as well. Blinatumomab (Blincyto), the first U.S. Food and Drug Administration (FDA)-approved bispecific T-cell engager (BiTE), has demonstrated...
ELCC 2017: Ensartinib Demonstrates CNS Activity in ALK-Positive NSCLC
Ensartinib demonstrated intracranial responses in patients with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, according to findings presented by Reckamp et al at the 2017 European Lung Cancer Conference (ELCC)...
Immune System Is Shaping the Future of Multiple Myeloma Treatment
From immunomodulatory agents and proteasome inhibitors to steroids, alkylators, and antibodies, recent years have witnessed an explosion of drug approvals for multiple myeloma. The challenge now, said Amrita Krishnan, MD, FACP, is figuring out how to incorporate them all, particularly in the...
Register Today for the ASCO Research Community Forum 2017 Annual Meeting
Registration is now open for the ASCO Research Community Forum 2017 Annual Meeting. Join fellow physician investigators and research staff from across the country for this unique meeting focused on sharing best practices for effectively conducting and managing clinical research and developing...
QOPI® Certification Program Certifies First Practice in Brazil
On April 5, ASCO announced that Instituto de Oncologia do Vale (IOV) was the first practice in Brazil to receive Quality Oncology Practice Initiative (QOPI®) certification through the QOPI Certification Program, LLC (QCP). IOV is the second international practice to achieve this milestone in...
ELCC 2017: Development and Validation of Lung Toxicity Prediction Models Aids Effective Use of Radiotherapy in NSCLC
Validation using patient data of an outcome prediction model for the development of dyspnea subsequent to radiotherapy revealed that the prognostic factors in the model did not adequately predict for delta toxicity endpoints, according to results reported by Defraene et al at the 2017 European Lung ...
Neoadjuvant Immunotherapy in High-Risk Melanoma: A New Approach
Melanoma is an immunogenic tumor, as it expresses various melanoma-specific antigens. However, it is both biologically and clinically heterogeneous. Biologically, it expresses different melanoma antigens and has diverse genetic profiles among different patients. Clinically, it varies in the amount ...
Karmanos Cancer Institute Now Offers Image-Fusion Technology to Detect Prostate Cancer
The Barbara Ann Karmanos Cancer Institute is using a sophisticated new way to diagnose and treat prostate cancer more effectively. Urology specialists at Karmanos have begun using the UroNav Fusion Biopsy System, which fuses three-dimensional MRI (magnetic resonance imaging) images of the prostate...
