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,...
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...
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”...
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...
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...
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 ...
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...
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 ...
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 ...
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 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...
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...
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...
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 ...
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...
The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to Keith Stewart, MB, ChB, Professor of Medicine at the Mayo Clinic in Scottsdale, Arizona, who...
“People with a high genetic propensity to obesity have higher risks of esophageal metaplasia and neoplasia than people with a low genetic propensity,” according to analyses of data from the Barrett’s and Esophageal Adenocarcinoma Genetic Susceptibility Study. “These analyses provide the strongest...
Patients with unresectable stage III or IV melanoma treated with ipilimumab (Yervoy) plus sargramostim (Leukine) had longer overall survival and less toxicity than did those treated with ipilimumab alone, according to a phase II randomized clinical trial conducted by the Eastern Cooperative...
Resistance to castrating therapy and androgen deprivation therapy in prostate cancer is due in part to adaptive upregulation of androgen receptor levels by castration-resistant prostate cancer cells in the setting of prolonged exposure to a low-testosterone environment. In a study reported in...
The novelty of our approach is that we are going to be using multiple modalities” to study the effects of chemotherapy and hormonal therapy on the brain, looking for structural changes within the brain and how these changes might affect psychomotor function, particularly upper-extremity movements...
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...
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...
The Conquer Cancer Foundation of ASCO has announced the five recipients of the 2015 International Innovation Grant. This grant supports novel and innovative projects that may improve diagnosis, prevention, and treatment of cancer in low- and middle-income countries. For 2015, the 1-year grants of...
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...
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...
Inotuzumab ozogamicin combined with a low-intensity chemotherapy called mini-hyper-CVD achieved highly encouraging results in older patients with acute lymphoblastic leukemia (ALL) in a phase II study reported at the 56th Annual Meeting of the American Society of Hematology.1 After the...
An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
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)...
It is not enough for Mary-Claire King, PhD, to have identified the germline BRCA1 mutation associated with hereditary breast and ovarian cancers. Her clinically applicable discovery is one of the world’s greatest in genetics and one for which she has been highly lauded. But not one to rest on her...
The androgen receptor inhibitor enzalutamide (Xtandi) showed encouraging activity as a single agent in advanced triple-negative breast cancer patients expressing the androgen receptor, according to an international study presented at the 2014 San Antonio Breast Cancer Symposium.1 Enzalutamide...
A less intensive regimen of nab-paclitaxel (Abraxane) plus gemcitabine appears to be as efficacious as the standard regimen in first-line treatment for metastatic pancreatic cancer, but less toxic and far less expensive, according to a study that earned a Merit Award at the 2015 Gastrointestinal...
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...
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 ASCO Post is pleased to introduce “Hematology Expert Review,” a new feature including a case report detailing a particular hematologic condition followed by questions. Answers to each question appear with expert commentary. In this first installment, we present two cases of older men with...
Two years ago, the Accreditation Council for Graduate Medical Education (ACGME), the nonprofit organization that evaluates and accredits more than 9,000 medical residency programs in the United States, began phasing in implementation of its Next Accreditation System for graduate medical education,...
In a recent issue of the Journal of Clinical Oncology,1 and as reviewed in this issue of The ASCO Post, an ASCO expert endorsement panel reviewed and endorsed, with minor qualifications, the European Society for Medical Oncology (ESMO) clinical practice guidelines for management of familial/genetic ...
Approximately 5% to 6% of cases of colorectal cancer are associated with germline mutations conferring an inherited predisposition for disease. As reported by Stoffel and colleagues in the Journal of Clinical Oncology,1 ASCO has endorsed, with qualifying statements, the European Society for Medical ...
Male breast cancer represents less than 1% of all breast cancers, which partially explains why so little is known about the disease. Two presentations at the 2014 San Antonio Breast Cancer Symposium focused on the characteristics of male breast cancer drawn from a large international registry and...
The ASCO Post announces a new department on geriatric oncology to be published on an occasional basis. Geriatrics for the Oncologist is guest edited by Stuart Lichtman, MD, and developed in collaboration with the International Society of Geriatric Oncology (SIOG). Visit SIOG.org for more on...
In a study that reflected clinical practice, treatment of diffuse large B-cell lymphoma based on the results of interim positron-emission tomography (PET) was feasible; however, switching PET-positive patients to an alternative treatment still resulted in inferior treatment outcomes, and the...
Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...
Limited-stage nonbulky diffuse large B-cell lymphoma (DLBCL) carries an excellent prognosis, and radiotherapy provides no value in patients who obtain a complete response, according to the phase III 02-03 trial from the Lysa/Goelams group, presented at the 56th American Society of Hematology (ASH)...
Although the data are preliminary, single-agent AG-221 therapy targeted to the IDH2 (isocitrate dehydrogenase 2) mutation holds great promise as a nonchemotherapy approach to the treatment of advanced hematologic malignancies, including relapsed/refractory acute myelogenous leukemia (AML) and...
Commenting on this study, David Steensma, MD, of Dana-Farber Cancer Institute and Harvard Medical School in Boston, said that longer follow-up is needed, especially in light of the lack of overall survival benefit, which may have been due to salvage therapy. “Sorafenib clearly has activity in...
Investigators from Moffitt Cancer Center in Tampa, Florida, have reported an approach to pancreatic cancer that downstages some locally advanced patients to borderline resectable status and achieves a negative surgical margin rate exceeding 96%. The study earned a Merit Award at the 2015...
Commenting on the RAISE study at a press briefing held during the 2015 Gastrointestinal Cancers Symposium, moderator Smitha S. Krishnamurthi, MD, Associate Professor of Medicine at Case Western Reserve University School of Medicine, Cleveland, acknowledged that improvements of 1 to 2 months in...