This issue of The ASCO Post discusses a recent trial reported by Strosberg et al in The New England Journal of Medicine that is the first phase III randomized international multicenter clinical trial evaluating lutetium Lu-177 dotatate as a peptide receptor radionuclide therapy in midgut...
In the treatment of metastatic estrogen receptor–positive breast cancer, a highly significant 45% reduction in progression was achieved with abemaciclib, combined with fulvestrant (Faslodex), in the global phase III MONARCH 2 trial, reported at the 2017 ASCO Annual Meeting by George W. Sledge, MD,...
The PARP INHIBITOR olaparib (Lynparza) improved progression-free survival in women with HER2-negative metastatic breast cancer that was either hormone receptor–positive or triple-negative in patients who had a germline BRCA mutation.1,2 These results of the international, randomized, open-label,...
The addition of abiraterone acetate (Zytiga) plus prednisolone/prednisone to standard androgen-deprivation therapy improves survival in men starting treatment for locally advanced or metastatic, hormone--naive prostate cancer, according to the results of two potentially practice-changing studies...
When patients with metastatic cancer used a Web-based tool to self-report symptoms proactively during treatment, they lived 5 months longer than did patients assigned to usual care. In addition, they had improved quality of life and fewer emergency room visits and hospitalizations compared with...
Three-year follow-up data from the phase III RAY study in patients with relapsed or refractory mantle cell lymphoma were presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. These results demonstrated that the subset of patients treated with ibrutinib...
An interim analysis of MAGNIFY, a phase IIIb, randomized, open-label, multicenter study of the R2 combination regimen (lenalidomide [Revlimid] plus rituximab [Rituxan]) in patients with relapsed or refractory marginal zone lymphoma, was presented at the International Conference on Malignant...
On June 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] Grades III or IV) for preoperative imaging, as an adjunct for the...
Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...
The U.S. Food and Drug Administration (FDA) has approved the use of daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a...
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 the phase III CA184-095trial reported in the Journal of Clinical Oncology, Tomasz M. Beer, MD, FACP, of the Knight Cancer Institute, Oregon Health and Science University, and colleagues found that ipilimumab (Yervoy) did not increase overall survival vs placebo in men with asymptomatic or...
Robert J. Cerfolio, MD, joined New York University (NYU) Langone on June 1 as Chief of Clinical Thoracic Surgery. He also will become the first Director of the Lung Cancer Center at NYU Langone’s Perlmutter Cancer Center. Dr. Cerfolio currently serves at the University of Alabama (UAB) Hospital in ...
Over the past 20 years, the Intergroupe Francophone du Myelome (IFM) and Dr. Michel Attal have pioneered the use of autologous hematopoietic cell transplantation (AHCT) for multiple myeloma in a series of randomized studies. Notable studies include comparisons of planned upfront AHCT vs...
On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia), a kinase inhibitor for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April...
One of the most active areas of research in breast cancer involves the targeting of the androgen receptor. Trials underway for androgen receptor antagonists and modulators, alone and in various combinations of available agents and novel therapies, are yielding encouraging early results. At the 2017 ...
Michael Berry, MD, a breast surgeon who is Director of the Margaret West Comprehensive Breast Center at The West Cancer Center, Memphis, told the The ASCO Post that these findings “echo what surgeons already know,” which is that lymphedema is a result of multiple insults to the axilla. But one...
In a study from the Mayo Clinic, Rochester, Minnesota, the risk of lymphedema in a population-based breast cancer cohort was related to multimodality therapy and not axillary surgery alone, investigators reported at the American Society of Breast Surgeons (ASBrS) Annual Meeting.1 “Most patients...
Phosphoinositide 3-kinase (PI3K) inhibitors represent a highly active class of drug for the treatment of chronic lymphocytic leukemia (CLL). Idelalisib (Zydelig), a PI3K-delta inhibitor and the first PI3K inhibitor to be approved by the U.S. Food and Drug Administration (FDA) for CLL, has...
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...
At the 2017 ASCO Annual Meeting, results were presented from the phase II I-SPY 2 trial investigating pembrolizumab (Keytruda) in combination with standard therapy (paclitaxel followed by doxorubicin and cyclophosphamide) as a neoadjuvant treatment for patients with locally advanced triple-negative ...
On June 2, the European Commission (EC) approved nivolumab (Opdivo) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. This makes nivolumab the first immuno-oncology agent approved in the European Union ...
“The results of this trial are promising but need to be reproduced in the United States and other countries before clear recommendations can be made. There are adjuvant studies such as ALCHEMIST underway to test this strategy in U.S. patients,” said Trever Bivona, MD, PhD, Associate Professor of...
Adjuvant therapy with gefitinib (Iressa), an epidermal growth factor receptor (EGFR)-targeted agent, was more successful at preventing recurrence than standard-of-care chemotherapy, in a phase III study of patients with EGFR-positive non–small cell lung cancer (NSCLC).1 Gefitinib extended...
About 50% of all cancer survivors and 70% of young breast cancer survivors report a moderate to high fear of recurrence. The fear can be so distressing that it negatively affects medical follow-up behavior, mood, relationships, work, goal setting, and quality of life. Yet interventions to alleviate ...
On May 26, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (Zykadia) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April 2014,...
Eric Paul Winer, MD, was born in Boston in 1956, a year when gasoline was 22 cents a gallon and IBM released the world’s first computer with a hard drive. His grandfather on his mother’s side had hemophilia and died 5 years before Dr. Winer was born. Although there was a 50% chance that Dr. Winer...
Waun Ki Hong, MD, FACP, one of the nation’s leading experts in head and neck and lung cancers, was born in South Korea and grew up in a tiny village outside the nation’s capital of Seoul. Number six of seven siblings, Dr. Hong described his early life in the cozy village as blissful, until the...
Bisphosphonates were first synthesized more than a century ago, with their initial usage restricted to a range of industrial processes until their potential clinical relevance was appreciated in the late 1960s.1 Then, following development for the treatment of osteoporosis and Paget’s disease of...
In the phase III OPTIMIZE-2 trial reported in JAMA Oncology, Gabriel N. Hortobagyi, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that an every-12-week schedule of zoledronic acid was noninferior to an every-4-week schedule with regard to skeletal-related event...
On March 30, 2017, osimertinib (Tagrisso) was granted regular approval for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M–mutant non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test, who have progressed...
Adding hydroxychloroquine, an inhibitor of autophagy, to neoadjuvant chemotherapy for pancreatic cancer increases its efficacy and alters the tumor’s molecular profile in a way that may render the tumor more susceptible to immune checkpoint inhibitors, according to interim data from a phase II...
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 National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) has funded three studies in its first multi-industry collaborative research project, in which Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company are collaborating with NCCN to study combination...
Platinum-based combination chemotherapy became a mainstay of first-line treatment for metastatic urothelial cancer in the 1980s. With combination platinum-based regimens, 40% to 50% of patients achieve an objective response to treatment. However, aside from approximately 5% to 10% of patients who...
As reported in The Lancet Oncology by Padmanee Sharma, MD, PhD, of MD Anderson Cancer Center, and colleagues, the phase II CheckMate 275 trial has shown that nivolumab (Opdivo) produced durable responses in patients with metastatic urothelial cancer who had received at least one prior...
Commenting on the phase I study of atezolizumab (Tecentriq) presented at the 2017 American Association for Cancer Research Annual Meeting, Aditya Bardia, MD, MPH, Attending Physician at Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, said: “It is very encouraging to...
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 ...
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...
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...
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 ...
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...
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...
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...
There is no standard adjuvant therapy for patients with resectable biliary tract cancer, but that may be about to change based on results of the phase III BILCAP trial.1 Adjuvant capecitabine significantly improved overall survival in the BILCAP trial, and this is the first study to show a benefit...
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...
Many patients with cancer who receive vinca alkaloids such as vincristine have a treatment regimen including other chemotherapy drugs that are administered intrathecally. If vincristine is mistakenly administered into the spinal fluid, it is uniformly fatal, causing ascending paralysis, neurologic...
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
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 ...
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...