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Showing 23551 - 23600Smarter Trial Design Saves Money and Produces Better Drugs
The process of identifying a promising molecule and moving it from the laboratory through the highly complex series of clinical trials necessary to garner U.S. Food and Drug Administration (FDA) approval is a costly scientific gauntlet during which many new agents fail. New trial design,...
Gardasil 9 Adds Protection Against Cancer Caused by Additional Human Papillomavirus Types
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. On December 10, 2014, Gardasil 9 (human papillomavirus 9-valent...
Panelists Lambast, Explore the High Cost of Cancer Drugs
At the 2014 American Society of Hematology Annual Meeting, a symposium on the high cost of cancer drugs proved provocative and a bit testy as panelists presented their various points of view. ‘Medical Darwinian System’ Already known for his outspoken views on the topic is Hagop M. Kantarjian, MD,...
Will Checkpoint Inhibitors Be Winners in Hematologic Cancers, Too?
A “Featured Topic” session during the 56th American Society of Hematology (ASH) Annual Meeting and Exposition drew a standing-room-only crowd to hear two experts weigh in on checkpoint blockade in hematologic malignancies. While new to hematology, these drugs—the cytotoxic T-lymphocyte–associated...
Cleveland Clinic Piloting ‘Adaptive Therapy’ Approach in Multiple Myeloma
For newly diagnosed multiple myeloma patients, Cleveland Clinic specialists believe two drugs may suffice for most patients, bucking the trend toward using triplets for all patients and reserving them for patients with insufficient response to two. They described a pilot study of their “carepath”...
Victory for Pediatric Regimens in Adolescents and Young Adults With ALL
Long in the works, early results of the U.S. Intergroup C10403 trial clearly showed that treating acute lymphoblastic leukemia (ALL) in adolescents and young adults using a pediatric-inspired regimen improves event-free survival and overall survival and should be the backbone for future studies in...
Blinatumomab Achieves Complete Molecular Responses in Majority of B-Cell Leukemia Patients
Results from the international phase II BLAST study show that one cycle of blinatumomab (Blincyto) immunotherapy achieved complete minimal residual disease response in 78% of patients with acute lymphoblastic leukemia.1 Complete minimal residual disease response was achieved in 80% of patients...
Venetoclax Gaining Ground in Two Types of Leukemia
Venetoclax, formerly known as ABT-199, is moving forward into phase III development in acute myelogenous leukemia (AML) and chronic lymphocytic leukemia (CLL), based on encouraging data from separate phase Ib and II trials presented at the 56th Annual Meeting and Exposition of the American Society...
Breast Health Global Initiative Tackles Third-World Health Care
Benjamin O. Anderson, MD, is the Director of the Breast Health Global Initiative (BHGI) and surgical oncologist and Director of the Breast Health Clinic at the University of Washington in Seattle. The ASCO Post recently spoke with Dr. Anderson about the conceptual framework of the...
FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer
The recent U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. The BRCA...
Physical Activity Improves Survival for Men With Localized Prostate Cancer
Among a large group of men with localized prostate cancer, those who engaged in higher levels of physical activity had lower rates of overall mortality and lower rates of prostate cancer-specific mortality, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.1 “Our...
Complexities of Targeting HER2 in Estrogen Receptor–Positive Breast Cancers
The interactions between the estrogen receptor (ER) and HER2 pathways in breast cancers are clearly complex and remain incompletely understood. Historically, cancers that express both ER and HER2 were thought to be intrinsically resistant to endocrine therapy, likely due to HER2 being the dominant...
No Benefit of Adding Lapatinib to Fulvestrant in Hormone Receptor–Positive Advanced Breast Cancer
In a phase III trial (Cancer and Leukemia Group B [CALGB] 40302/Alliance) reported in the Journal of Clinical Oncology, Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues found that the addition of the dual EGFR-HER2 inhibitor lapatinib (Tykerb) to endocrine...
Daniel F. Hayes, MD, FASCO, Elected ASCO President for 2016–2017 Term
Daniel F. Hayes, MD, FASCO, has been elected President of the American Society of Clinical Oncology (ASCO) for the term beginning in June 2016. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2015. “I’m honored to be elected incoming president of ASCO, which ...
Crizotinib in ROS1-Positive NSCLC: A Next Step Forward
Advances in the molecular characterization of non–small cell lung cancer (NSCLC) have led to the identification of molecularly defined distinct subsets of patients who derive benefit from targeted therapies. Currently, two such groups of agents have moved widely into clinical practice: epidermal...
Coupling Head and Neck Cancer Screening and Lung Cancer Scans Could Improve Early Detection, Survival
Adding head and neck cancer screenings to recommended lung cancer screenings would likely improve early detection and survival, according to a multidisciplinary team led by scientists affiliated with the University of Pittsburgh Cancer Institute (UPCI), a partner with the University of Pittsburgh...
Lanreotide in Gastroenteropancreatic Neuroendocrine Tumors
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. On December 16, 2014, lanreotide (Somatuline depot injection) was ...
Survival Benefits of Front-Line Treatment With Nivolumab for Advanced Melanoma Confirmed, Yet Questions Remain
As reported in this issue of The ASCO Post, Robert and colleagues recently published a phase III study comparing the anti–programmed death 1 (PD-1) antibody nivolumab with the standard melanoma chemotherapy dacarbazine in the front-line treatment of patients with advanced BRAF wild-type melanoma.1...
Nivolumab Improves Outcomes vs Dacarbazine in Previously Untreated Advanced Melanoma Without a BRAF Mutation
In a phase III trial reported in The New England Journal of Medicine, Robert and colleagues found that the programmed cell death protein-1 (PD-1) immune-checkpoint–inhibitor antibody nivolumab (Opdivo) significantly increased overall survival, progression-free survival, and objective response rate...
Expert Point of View: Lajos Pusztai, MD
Commenting on the GeparSepto study presented at the San Antonio Breast Cancer Symposium, Lajos Pusztai, MD, Yale University School of Medicine, New Haven, Connecticut, said, “This study, along with a smaller SWOG study, establishes nab-paclitaxel as a legitimate treatment option for triple-negative ...
Nab-Paclitaxel Boosts Pathologic Complete Response in High-Risk Breast Cancer
Nab-paclitaxel (Abraxane) achieved superior results compared with conventional solvent-based paclitaxel in patients with early-stage high-risk breast cancer in the large phase III GeparSepto trial from the German Breast Group (GBG).1 The study, presented at the 2014 San Antonio Breast Cancer...
Oncotype DX Ductal Carcinoma in Situ Score Reliably Predicts Tumor Recurrence
Ductal carcinoma in situ, which accounts for 30% of all newly diagnosed breast cancers, does not always evolve into a lesion with metastatic potential. Only a proportion of these cases will progress to invasive breast cancer, but up until recently, it has not been possible to identify reliably...
No Benefit for Adjuvant Capecitabine Monotherapy in Elderly Patients With Early-Stage Breast Cancer
Adjuvant therapy with capecitabine plus ibandronate failed to improve outcomes vs ibandronate alone in elderly patients with moderate-to-high-risk early-stage breast cancer in the ICE study—the largest study to date conducted in elderly women with breast cancer.1 “Capecitabine is frequently used in ...
Low-Fat Diet Reduces Mortality in Breast Cancer Subset
The final survival analysis of the landmark Women’s Intervention Nutrition Study (WINS) confirmed that a low-fat diet can reduce the risk of dying for a subset of breast cancer patients.1 At the San Antonio Breast Cancer Symposium, Rowan T. Chlebowski, MD, PhD, of the Los Angeles Biomedical...
Highlights From the 2015 Gastrointestinal Cancers Symposium
The 2015 Gastrointestinal Cancers Symposium was held January 15 to 17. Direct your patients to www.cancer.net/blog to read the latest research on the treatment of colorectal cancer, including what it means for patient care. On the Cancer.Net blog, your patients can also listen to a podcast...
Latest ASCO-SEP® Edition Includes 20-Point Maintenance of Certification Course
The 4th edition of ASCO-SEP®, ASCO’s self-evaluation program, was released in October and not only includes 21 chapters of up-to-date information on all major cancer types, cancer prevention and more, but now also includes a Maintenance of Certification (MOC) Course in addition to its traditional...
Cancer.Net Launches PRE-ACT Patient Clinical Trial Education Program
Clinical trials are the key to driving advances in the prevention, diagnosis, and treatment of cancer, yet, it is estimated that only about 5% of patients with cancer participate in clinical trials. That is why Cancer.Net, ASCO’s patient-facing educational website, has teamed up with Neal Meropol,...
Top 10 Myths About FDA’s Office of Hematology and Oncology Products
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...
Rare-Cancer Expert Richard Carvajal, MD, Appointed Director of Experimental Therapeutics
Richard D. Carvajal, MD, has been named Director of the Experimental Therapeutics/Phase I program and melanoma service in medical oncology at New York-Presbyterian/Columbia University Medical Center effective November 1, 2014. Dr. Carvajal, a medical oncologist, has extensive clinical expertise in...
Anti–PD-1 Antibody Nivolumab in Previously Treated Unresectable or Metastatic Melanoma
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. On December 22, 2014, the anti–PD-1 (programmed cell death...
FDA Drug Approvals 2014
Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma. Approved December 22, 2014. Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014....
Treatment Paradigm in Advanced Melanoma Poised for Change… Again
In the treatment of advanced/metastatic melanoma, recent debate has focused on the choice of initial therapy: ipilimumab (Yervoy) or, for patients with BRAF-mutant cancer, a BRAF/MEK inhibitor. This issue is now taking a back seat to the emerging conversation about the positioning of antibodies...
Colorectal Cancer 2015
Despite advances in detection and treatment, colorectal cancer remains the third deadliest cancer among men and women in the United States. To get a better understanding of the current state of this disease and what lies ahead, The ASCO Post recently spoke with colorectal cancer expert John L....
Molecular Pathologists vs the FDA: Proposed Regulation of Laboratory-Developed Tests Sparks Debate
The packed ballroom looked like a plenary session at any big medical research meeting. But on the dais were representatives of the Food and Drug Administration (FDA), the subject was the Agency’s proposed regulation of laboratory-developed tests, and the attendees who lined up to ask questions for...
Overdiagnosis May Be Overblown in Lung Cancer Screening
“Overdiagnosis has been overblown” in concerns voiced about lung cancer screening with low-dose computed tomography, Andrea B. McKee, MD, told participants at the opening session of the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. Dr. McKee is Chair of the Department of Radiation ...
Top 10 Lessons Learned So Far About Treating Lung Cancer With Immunotherapy
Immunotherapy agents “really work” in treating lung cancer, but they have unique toxicities, are challenging to combine with other therapies, and questions remain about dose and duration, Roy S. Herbst, MD, PhD, stated at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. “There are ...
More Than 1.5 Million Cancer Deaths Averted During 2 Decades of Dropping Mortality
The American Cancer Society’s annual cancer statistics report found that a 22% drop in cancer mortality over 2 decades led to the avoidance of more than 1.5 million cancer deaths that would have occurred if peak rates had persisted. And while cancer death rates have declined in every state, the...
‘Clinically Meaningful Improvements’ in Survival for Patients With NSCLC When Veliparib Is Added to Carboplatin and Paclitaxel
Adding veliparib to carboplatin and paclitaxel resulted in “clinically meaningful improvements” in progression-free survival and overall survival among patients with previously untreated metastatic or advanced non–small cell lung cancer (NSCLC), particularly those with squamous histology. The...
Significant Improvement in Progression-Free Survival Using Sunitinib as Switch Maintenance in Advanced NSCLC
Progression-free survival was significantly improved among patients with advanced non–small cell lung cancer (NSCLC) receiving sunitinib (Sutent) as switch maintenance compared to placebo, according to results of an Alliance phase III trial (Cancer and Leukemia Group B [CALGB] 3067). The effect of...
Contralateral Prophylactic Mastectomy: Know the Data When Discussing the Option With Patients
Oncologists need a better understanding of why women choose contralateral prophylactic mastectomies without indication, and they need data to counter their patients’ misperceptions about this treatment choice. “Many women who choose [contralateral prophylactic mastectomy] are not at increased risk...
Vitamin D Protects Against Colorectal Cancer by Boosting the Immune System
A study by investigators at Dana-Farber Cancer Institute has demonstrated that vitamin D can protect some people with colorectal cancer by heightening the immune system’s vigilance against tumor cells. The research, released earlier this month by the journal Gut, shows a link between vitamin D and...
Fulvestrant Surpasses Anastrozole in First-Line Treatment of Metastatic Breast Cancer
Fulvestrant (Faslodex) at a 500-mg dose was superior to anastrozole as first-line therapy for advanced hormone receptor–positive breast cancer in the phase II FIRST study.1 Overall survival and time to disease progression were significantly better with fulvestrant than with the current standard of...
Tamoxifen Prevention of Breast Cancer Extends More Than 16 Years
The benefits of tamoxifen as primary prevention of breast cancer are well established. The good news is that the benefits live on, with a protective effect that extends up to 22 years. At a median follow-up of 16 years, women treated with 5 years of tamoxifen enjoyed a 29% reduction in the risk of...
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three...
FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...
FDA Approves Nivolumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been...
BOLERO-1: Everolimus Plus Trastuzumab/Paclitaxel Misses the Mark in First‑Line HER2-Positive Advanced Breast Cancer
The addition of everolimus (Afinitor) to weekly trastuzumab (Herceptin) plus paclitaxel in the first-line metastatic breast cancer setting did not improve outcomes in the phase III BOLERO-1/TRIO-019 but did provide a “signal” in the hormone receptor–negative subset. The study was reported at the...
Expert Point of View: Mary L. Disis, MD
Study discussant Mary L. Disis, MD, Professor of Medicine and Associate Dean of Translational Science at the University of Washington, Seattle, commented that the response rate, approaching 20%, is “in the ballpark” of those observed in melanoma, lung cancer, and renal cancer. She pointed out that...
Pembrolizumab Holds Promise in Breast Cancer, Early Studies Suggest
Single-agent treatment with the immunotherapy drug pembrolizumab produced a “signal of activity” and led to some durable responses in patients with metastatic triple-negative breast cancer, Rita Nanda, MD, of the University of Chicago, reported at the 2014 San Antonio Breast Cancer Symposium.1...
Neoadjuvant Therapy in Triple-Negative Breast Cancer: Impact of Subtype
Among women with triple-negative breast cancer, overall, basal-like and non–basal-like tumors were equally likely to demonstrate a pathologic complete response to neoadjuvant chemotherapy, but they responded differently to the addition of carboplatin and bevacizumab (Avastin) to a standard...
