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...
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....
The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) have announced a new partnership to optimize patient care and foster excellence in the practices of pathology and oncology through interprofessional education, advocacy, quality improvement,...
Janet Woodcock, MD, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, has been awarded the Institute for Safe Medication Practices Lifetime Achievement Award, which recognizes “an individual who has had a significant career history of making...
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...
The American Association for Cancer Research (AACR) and ASCO have outlined steps in a joint statement to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems without undermining their...
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....
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 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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
Patients with Philadelphia chromosome–positive ALL have traditionally done poorly with conventional chemotherapy, but outcomes are improving in the era of tyrosine kinase inhibitors. This study reports the safety and efficacy with a combination of a targeted approach and low-intensity...
The addition of the tyrosine kinase inhibitor nilotinib (Tasigna) to standard low-intensity chemotherapy improved outcomes in elderly patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) and may represent a new approach to this group of patients, who are ...
Several studies presented at the 2014 ASH Annual Meeting supported the use of brentuximab vedotin (Adcetris) in Hodgkin lymphoma. The Reed-Sternberg cells of classical Hodgkin lymphoma typically express CD30, which is targeted by brentuximab vedotin, an anti-CD30 monoclonal antibody conjugated by a ...
Results of the large International Breast Cancer Study Group (IBCSG)-coordinated SOFT trial present a convincing argument for the addition of ovarian function suppression to adjuvant hormonal therapy to reduce the risk of tumor recurrence in younger women with hormone receptor–positive early-stage...
Epithelioid hemangioendothelioma is a rare and devastating vascular sarcoma that affects between 100 and 200 people, mostly young adults, each year in the United States. The cancer may arise as a solitary lesion but more commonly presents with metastatic involvement, usually in the liver and lungs. ...
The concept of “chemobrain” is underrecognized, noted Serena Wong, MD, co-investigator of a clinical trial examining the effects of chemotherapy and hormonal therapy on the brain. Dr. Wong is a medical oncologist at Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine at...
In the fall of 2010, I developed a sore throat and tonsillitis while on a hike in North Carolina. Although it was not uncommon for me to have sore throats accompanied by some swelling on my tonsils, this time much of the inflammation and swelling were centered on just my left tonsil. After 7 days...
Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...
In an oncology health-care system that is increasingly changing its delivery and payment models, how do busy oncologists successfully bridge the transition from a volume- to value-based, patient-centric model? This, and other topics on value fueled a robust discussion at the Association of...
Nearly 5,000 scientific abstracts were presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exhibition in San Francisco. Along with our targeted coverage of the meeting’s key newsmakers, The ASCO Post provides you with these brief reports of other interesting...
Matthew J. Ellis, MB, BChir, PhD, Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine, Houston, commented on endocrine resistance and the potential of the four-gene panel for assessing resistance for The ASCO Post. Endocrine response and resistance is a research focus...
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. In December 12, 2014, ramucirumab (Cyramza) was approved for use in ...
ASCO has released a policy statement calling for greater access to and education about phase I clinical trials, the first-in-human studies of new agents designed to fight cancer. In “The Critical Role of Phase I Trials in Cancer Research and Treatment” ASCO policy statement, the Society stresses...
Radical cystectomy is the standard therapeutic option for patients with muscle-invasive bladder cancer. However, 5-year overall survival for high-risk patients with pT3, pT4, pN-negative, and pN-positive M0 bladder cancer after radical cystectomy is only about 50% and ranges from 32% in patients...
As reported in the Journal of the National Cancer Institute, Anirban P. Mitra, MD, PhD, of the University of Southern California, and colleagues identified a novel genome-based signature that improves prediction of postcystectomy recurrence in patients with high-risk bladder cancer.1 Use of the...
Treatment of advanced bladder cancer continues to prove challenging, and therapies that offer long-term survival remain elusive. The ASCO Post recently spoke with Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, President of the Levine Cancer Center, Charlotte, North Carolina, about the current state...
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 4, 2014, ruxolitinib (Jakafi) was approved for the...
Surgeons at the cutting edge are offering minimally invasive resection to patients with small gastrointestinal stromal tumors (GISTs) deemed to be low-risk, according to panelists at a session of the American College of Surgeons 2014 Clinical Congress in San Francisco. “We are seeing more small...
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously...
As more experience is gained with the use of genetically engineered chimeric antigen receptor (CAR) T cells in patients with leukemia, the data continue to be highly encouraging. Three different groups using slightly different modifications of CAR T cells reported positive experiences in treating...
Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...
Some patients with rectal cancer who achieve a complete response to neoadjuvant chemoradiation therapy can be monitored for tumor recurrence and may never need surgery, according to a retrospective review from patients at Memorial Sloan Kettering Cancer Center, New York, presented at the 2015...
I am writing in regard to the report and commentary in this issue on the RAISE Trial. To begin, a discussion of this phase III clinical trial presented at the 2015 Gastrointestinal Cancers Symposium (RAISE study) may not be the most appropriate forum to air legitimate views on finances and...
A special report in The New England Journal of Medicine concluded that atypical hyperplasia of the breast “confers an absolute risk of later breast cancer of 30% at 25 years of follow-up.1” This is higher than previously recognized, and the report’s authors urged “more intensive screening and...
Atypical hyperplasia of the breast has “special importance as a predictor of future breast cancer,” according to a special report in The New England Journal of Medicine.1 That special importance is based on the high incidence of atypical hyperplasia—found in around 10% of the 1 million breast...
In 1995, I was diagnosed with advanced colorectal cancer and given little chance to live. The dire diagnosis came years after being assured by several physicians that the problem I was having with rectal bleeding and anemia was nothing more than the result of an internal hemorrhoid. Busy raising...
Few issues in health-care debates are more contentious and polarizing than population screening for the early detection of cancer. After a decades-long battle, lung cancer screening advocates have just received what they have long sought: The Centers for Medicare & Medicaid Services (CMS) has...
Scientific name: 8-methyl-N-vanillyl-6-nonenamide Brand names: Zostrix cream 0.025% or 0.075%, Salonpas Gel-Patch Hot, Sinus Buster (homeopathic intranasal spray). The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence ...
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 3, 2014, blinatumomab (Blincyto) was granted...
The first poly ADP ribose polymerase (PARP) inhibitor was developed in the early 1990s. Since then, the activity of PARP inhibitors has been explored in a variety of settings, including and perhaps most enthusiastically in the treatment of cancer. The greater dependence of several cancers on PARP,...
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 January 29, 2015, the U.S. Food and Drug Administration (FDA)...
INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...