On October 12, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its New Drug Application (NDA) for abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor. MONARCH 3 The NDA was based upon the positive interim...
On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer...
National Cancer Institute (NCI) researchers have found that for the most common high-risk type of human papillomavirus (HPV) to cause cervical cancer, an important viral gene may need to have a precise DNA sequence. The findings, published by Mirabello et al in Cell, contribute to a better...
In a systematic review and meta-analysis reported in JAMA Oncology, Barroso-Sousa et al evaluated the incidence of endocrine dysfunction in patients receiving currently approved immune checkpoint inhibitors for various advanced solid tumors. Patients who received combination therapy were found to...
As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...
Trastuzumab (Herceptin) therapy for breast cancers that express the HER2 protein does not increase the risk of complications at the surgical site in women who undergo immediate breast reconstruction after mastectomy, according to findings published by Shammas et al in the Journal of the American...
In a propensity score–matched analysis reported in JAMA Oncology, Mokdad et al found that adjuvant chemotherapy had a survival benefit vs observation after preoperative chemoradiotherapy and resection in patients with locally advanced gastroesophageal cancer. Study Details The study...
Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...
In a Japanese analysis reported in JAMA Oncology, Haratani et al found that development of immune-related adverse events was associated with improved survival among patients receiving nivolumab (Opdivo) for advanced or recurrent non–small cell lung cancer (NSCLC). Study Details The study...
Overweight and obesity are associated with increased risk of 13 types of cancer—and these cancers account for about 40% of all cancers diagnosed in the United States in 2014—according to the latest Vital Signs report by the Centers for Disease Control and Prevention (CDC). Overall, the...
Breast cancer during pregnancy is relatively uncommon; however, it poses a significant clinical challenge to the patient and her multidisciplinary care team. To shed light on this difficult issue, The ASCO Post spoke with Carey K. Anders, MD, a medical oncologist and researcher at the University...
DANA-FARBER CANCER INSTITUTE has announced the opening of the new Leonard P. Zakim Center for Integrative Therapies and Healthy Living. Increasing data have indicated that integrative therapies can help alleviate the side effects of cancer therapy. The Zakim Center, as it is commonly referred to,...
Breast cancer specialist Ann H. Partridge, MD, MPH, was born in Manhasset, Long Island, and grew up several miles east in Muttontown, New York. Since tiny Muttontown didn’t have its own school system, Dr. Partridge went to high school in nearby Locust Valley, a town on Long Island’s North Shore,...
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
PATIENTS WITH DNA mismatch repair–deficient (dMMR) metastatic colorectal cancer display a high level of microsatellite instability (MSI-H)1 and demonstrate poor chemosensitivity and shorter overall survival than patients with mismatch repair–proficient (pMMR) metastatic metastatic colorectal...
THE PHASE II CHECKMATE 142 TRIAL has shown that nivolumab (Opdivo) produces durable responses in previously treated recurrent or metastatic DNA mismatch repair–deficient (dMMR)/ microsatellite instability–high (MSI-H) colorectal cancer. These study findings were reported in The Lancet Oncology...
Studies show that only about one-third of patients with acute myeloid leukemia who have detectable amounts of cancer cells in their blood at the time of allogeneic hematopoietic cell transplantation will be alive 3 years later, compared with nearly three-quarters of those patients without minimal...
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...
IN WHAT APPEARS TO BE the largest blood-based biomarker study of a checkpoint inhibitor, an RNA transcript–based gene classifier was able to predict for melanoma patients’ response to tremelimumab. The study was recently published in the Journal for ImmunoTherapy of Cancer.1 “Our study, in many...
NADIA HARBECK, MD, PhD, of the Breast Center at the University of Munich, Germany, said the findings of LORELEI are among a growing list of indications that “the future is bright for endocrine-based therapy.” Although the results were hypothesis-generating and not yet practice-changing, she...
FORMAL DISCUSSANT of ARIEL3, Sandro Pignata, MD, of the IRCCS National Cancer Institute, “Fondazione G. Pascale,” Naples, Italy, said: “This is new evidence for maintenance therapy with rucaparib [Rubraca]. These results are extraordinary, particularly in the BRCA mutation patients, but also in...
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that...
INVITED DISCUSSANT Paul Baas, MD, PhD, of The Netherlands Cancer Institute, called the MAPS2 trial an “excellent example of how studies in mesothelioma should be run.” As Dr. Baas pointed out, both arms performed well as second- and third-line treatment, with median progression-free survival with ...
IN PATIENTS with malignant pleural mesothelioma, combination immunotherapy with two checkpoint inhibitors in the second or third line of treatment extended survival to at least 15 months in the MAPS2 trial,1 sponsored by the Intergroupe Francophone de Cancérologie Thoracique (IFCT) and reported at ...
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
“IN 2008, I presented the IPASS results. FLAURA has beaten me to the ground. The results exceeded expectations, and FLAURA is undoubtedly a positive study,” stated formal discussant Professor Tony Mok, MD, FASCO, Chair of Department of Clinical Oncology, the Chinese University of Hong Kong. “It is ...
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
In a study reported in the Journal of Oncology Practice, Barbera et al found that a province-wide effort to improve symptom screening and management has increased the frequency of screening but has not improved opioid prescription rates in elderly cancer patients with severe pain. A previous study...
Palliative care professionals are invited to participate in a unique project sponsored by the National Cancer Institute. Collinge and Associates, Inc, is seeking interdisciplinary professionals to help develop and evaluate a new online continuing education (CE/CME) course on the use of integrative...
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
FORMAL DISCUSSANT, Manuela Schmidinger, MD, of the Medical University of Austria, Vienna, commented on the CheckMate 214 findings. “We have just seen a change in the paradigm in the treatment of metastatic renal cell cancer.” “More than a decade ago, VEGF [vascular endothelial growth factor]...
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
THE VALUE OF cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in advanced breast cancer became ever more certain with the announcement of interim data from MONARCH 3, which evaluated abemaciclib in combination with endocrine therapy as first-line therapy for hormone receptor–positive/HER2-negative...
EARLY IN our careers, few of us imagined that a vaccine could one day prevent cancer. Now, there is a vaccine that keeps the risks from human papillomavirus (HPV) at bay, and yet universal adoption of the HPV vaccine has been incomplete. As a result of misinformation about the vaccine—and its...
Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are...
On September 22, Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in Europe; available in the United States as Gazyva) in combination with chemotherapy, followed by obinutuzumab maintenance in patients achieving a response, as a new treatment for previously untreated ...
The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics, and...
On September 29, Roche announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of...
Currently, two medications have been approved by the U.S. Food and Drug Administration to reduce the risk of breast cancer: tamoxifen and raloxifene. Both medications, selective estrogen receptor modulators (SERMs), have been shown to reduce the risk for breast cancer by up to 50% in prevention...
Earlier this year, at the Alexandria Center for Life Science, former Vice President Joe Biden and Jill Biden, PhD, launched the Biden Cancer Initiative, their new venture to continue the fight to make progress in cancer prevention, detection, treatment, and care. The Biden Cancer Initiative will...
A higher-dose, shorter form of radiation is safe, effective, and no more damaging to the breast tissue or skin of breast cancer patients under age 50 than it is in older patients. This is the finding of a study led by researchers from Perlmutter Cancer Center at New York University (NYU)...
Investigators at the Sidney Kimmel Cancer Center at Jefferson uncovered potential new proteins that contribute to the development and progression of several types of lymphoma. Their findings were published by Adams et al in Clinical Cancer Research. The researchers focused their attention on...
On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III ...
Health-care systems use performance measures for cervical cancer screening based on guidelines from such organizations as the American College of Obstetricians and Gynecologists to monitor the appropriateness of cervical cancer screening. According to the performance measure in the Healthcare...
A higher-dose, shorter form of radiation is safe, effective, and no more damaging to the breast tissue or skin of women with breast cancer under age 50 than it is in older patients, according to findings led by researchers from Perlmutter Cancer Center at NYU Langone Health, and presented at the...
My father, who was a physician, taught me at an early age to pay attention to any changes in my body. His advice has stood me in good stead for more than 83 years and probably saved my life more than once. In 1984, just before I turned 50, something was bothering me about my right breast. I could...
The text and photograph on this page are excerpted from a four-volume series of books titled Oncology Tumors & Treatment: A Photographic History, by Stanley B. Burns, MD, FACS, and Elizabeth A. Burns. The photo below is from the volume titled “The Anesthesia Era: 1845–1875.” The photograph...
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as ...
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 May 9, 2017, avelumab (Bavencio) was granted...