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Showing 3001 - 3050Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies
In the not-so-distant past, clinical trials were considered an option only for the young and fit. Enrolling older people “used to be thought unethical,” said Janet Woodcock, MD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), as she opened...
Disease Progression and Deterioration of Health-Related Quality of Life in Advanced Breast Cancer
IN PATIENTS WITH estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer, better quality of life may be prolonged by delaying the progression of the disease, according to an ongoing quality-of-life assessment from the PALOMA-2 study, presented by Nadia Harbeck, MD, PhD, of...
Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Extended Endocrine Therapy in Postmenopausal Women With Breast Cancer: 2 Years as Effective as 5 Years
An additional 5 years of aromatase inhibitor therapy after 5 years of adjuvant endocrine therapy failed to improve disease-free survival compared with an additional 2 years of aromatase inhibitor therapy in postmenopausal women with hormone receptor–positive breast cancer, according to the results ...
Ribociclib Doubles Progression-Free Survival in Premenopausal Breast Cancer
PREMENOPAUSAL WOMEN with hormone receptor–positive, HER2-negative advanced breast cancer benefited substantially from the addition of ribociclib (Kisqali) to first-line endocrine therapy plus medical ovarian suppression, according to results from the MONALEESA-7 study.1 At the 2017 San Antonio...
Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma
FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...
Daratumumab Improves Progression-Free Survival in Front-Line Myeloma Setting
FOR NEWLY DIAGNOSED multiple myeloma patients not eligible for transplant, the addition of the anti-CD38 monoclonal antibody daratumumab (Darzalex) to subcutaneous bortezomib (Velcade), melphalan, and prednisone (VMP) reduced the risk of disease progression or death by 50%, the phase III ALCYONE...
Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...
ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma
Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses
Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...
SABCS 2017: Phase III EMBRACA Trial Meets Primary Endpoint
Patients with advanced HER2-negative breast cancer with germline BRCA mutations had significantly prolonged progression-free survival when treated with the poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib, compared with those who received chemotherapy of physician’s choice, according...
SABCS 2017: SOLD Trial Data Support Current Standard 12-Month Adjuvant Trastuzumab for HER2-Positive Breast Cancer
Disease-free survival after 9 weeks of adjuvant trastuzumab (Herceptin) and standard chemotherapy was not comparable to disease-free survival after 12 months of adjuvant trastuzumab and standard chemotherapy for women with early-stage HER2-positive breast cancer, supporting the current...
Immunotherapy Has Indelibly Changed the Treatment Paradigm in Urothelial Carcinoma
Cisplatin-based combination chemotherapy is the preferred first-line therapy for metastatic urothelial cancer and the only treatment shown to improve survival in patients with previously untreated disease for many years. This chemotherapy also has proven to be beneficial in the neoadjuvant and...
First-Line Pembrolizumab in Cisplatin-Ineligible Advanced Urothelial Cancer
As reported in The Lancet Oncology by Arjun V. Balar, MD, of Perlmutter Cancer Center of New York York Langone Medical Center, and colleagues, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic...
Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia
On November 9, 2017, dasatinib (Sprycel) was granted regular approval for treatment of pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase.1,2 Supporting Efficacy Data Approval was based on findings among 97 pediatric patients with chronic-phase...
Vemurafenib in Erdheim-Chester Disease
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 November 6, 2017, vemurafenib (Zelboraf) was granted...
Shifting Landscape of Oncology Drug Development and Approvals
Future oncology drug development and approvals will be faster and more efficient as well as take the patient experience more into account, said Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA). The Center was established as part of...
Expert Point of View: Michael Boyer, MBBS, PhD
Formal discussant of this trial, Michael Boyer, MBBS, PhD, a medical oncologist at Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, Australia, was enthusiastic about these results, with the caveat that overall survival data are needed. “Unresectable stage III non–small cell lung...
Durvalumab Therapy Improves Outcomes in Patients With Unresectable Stage III NSCLC
The PACIFIC study showed that the addition of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) following chemoradiotherapy for patients with unresectable stage III non–small cell lung cancer (NSCLC) dramatically improved progression-free survival compared with placebo....
SABCS 2017: Acupuncture May Reduce Joint Pain Caused by Aromatase Inhibitor Treatment
Acupuncture significantly reduced joint pain for postmenopausal women with early-stage breast cancer receiving treatment with an aromatase inhibitor compared with both sham acupuncture and no treatment, according to data from the randomized, phase III SWOG S1200 trial presented by Hershman et al at ...
Evidence-Based Support for Triplet Therapies in Multiple Myeloma
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
SABCS 2017: MONALEESA-7: Ribociclib Improved Progression-Free Survival for Pre- and Perimenopausal Women With HR-Positive Advanced Breast Cancer
Adding the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) to standard endocrine therapy with temporary ovarian suppression significantly improved progression-free survival for pre- and perimenopausal women with advanced hormone receptor–positive (HR-positive), HER2-negative...
Targeted Therapies Highlighted at This Year’s ASH Annual Meeting
In a webcast press briefing prior to the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, journalists got a peek at some of the most anticipated abstracts. ASH President Kenneth C. Anderson, MD, Director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper...
FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma
On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab was previously granted provisional approval in this setting under the FDA's ...
A Vivid Look Back, a Cogent Look Forward
Cancer memoirs come in a variety of literary styles and voices. Not surprisingly, the most poignant cancer memoirs are by those who are writing, in essence, their final words before departing this earth. The most widely read of that variety has been the beautifully written best seller When Breath...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer
MORE THAN A QUARTER of patients with recurrent high-grade glioma treated with the retroviral vector Toca 511 and the prodrug of the chemotherapy fluorouracil (5-FU), Toca FC, were alive more than 3 years after treatment, according to data from a subset of patients in a phase I clinical trial, Toca ...
Recent Study Findings in Hematologic Malignancies
HERE IS A BRIEF LOOK at the study findings and clinical implications of several recent and important clinical trials in neoplastic hematology. Attention is focused on clonal myeloid disorders, acute lymphoblastic leukemia, lymphoma, and plasma cell dyscrasias. Clonal Myeloid Disorders STUDY:...
New Interdisciplinary Lung Cancer Center at NYU Langone Health
The Perlmutter Cancer Center at New York University (NYU) Langone Health, a National Cancer Institute–designated center, has announced the creation of a new interdisciplinary center bringing together new and existing programs to study, diagnose, treat, and prevent the nation’s leading cancer: lung ...
Early Integrated Palliative Care Improves Patient Coping Strategies, Quality of Life, and Symptoms of Depression
A new study has shed light on how palliative care interventions may improve patient outcomes. According to data presented at the 2017 Palliative and Supportive Care in Oncology Symposium,1 patients with incurable cancer who received early integrated palliative care had an increased use of active...
Expert Point of View: Eric Van Cutsem, MD, PhD
Invited discussant Eric Van Cutsem, MD, PhD, of the University Hospitals Leuven in Belgium, put the JACOB trial findings in context of what is known for HER2-positive metastatic gastric/gastroesophageal junction cancer, where two targeted agents are approved: trastuzumab (Herceptin) in the first...
Update on NCI-MATCH Precision Medicine Trial
THE NATIONAL CANCER INSTITUTE (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented at the 2017 American Association for Cancer Research–NCI–European Organisation for Research...
Metastatic Gastric Cancer: Dual HER2-Targeting Study Does Not Meet Primary Endpoint
Dual HER2 targeting in metastatic gastric and gastroesophageal junction cancers did not significantly improve outcomes over trastuzumab (Herceptin) alone—both in combination with chemotherapy—according to the results of the phase III JACOB study reported at the 2017 European Society for Medical...
Clinical Trials Actively Recruiting Geriatric Oncology Patients
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on geriatric oncology. These studies highlight psychological interventions, managing cancer symptoms, the surgical process, fall prevention, and making treatment decisions; as well ...
Melanoma Mutations: What You Need to Know
CLINICIANS ARE now well acquainted with BRAF mutations in advanced melanoma, but there is more to genomics in this disease than identifying BRAF and prescribing a BRAF inhibitor. At the 2017 Debates and Didactics Conference, held at Sea Island, Georgia, Melinda L. Yushak, MD, MPH, of Emory...
This #GivingTuesday, Help Conquer Cancer
TUESDAY, NOVEMBER 28, marks the 6th consecutive year of #GivingTuesday, a global day of giving that celebrates philanthropy. Taking place on the heels of Black Friday and Cyber Monday, #GivingTuesday serves as a reminder that the holiday season is about giving back as well as giving gifts. Those...
Expert Point of View: Nadia Harbeck, MD, PhD
Invited discussant Nadia Harbeck, MD, PhD, Head of the Breast Center of the University of Munich (LMU), Germany, said the UNICANCER-NeoPAL trial points toward the future of endocrine therapy in early breast cancer—using cyclin-dependent kinase 4/6 (CDK4/6) inhibitors as a means of “enhancing” this ...
ESMO Asia 2017: AXEPT Trial: New Second-Line Therapy for Metastatic Colorectal Cancer Is Effective and Safe
A randomized trial in 650 patients has confirmed the safety and efficacy of a new second-line treatment for metastatic colorectal cancer, researchers reported at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract LBA3_PR). Oral fluorinated pyrimidines have been...
Pathologic Complete Response Rates Not Improved With Neoadjuvant Letrozole/Palbociclib
As neoadjuvant treatment of women with high-risk luminal breast cancer, the combination of letrozole and palbociclib (Ibrance) did not reduce the residual cancer burden or improve the rates of breast-conserving surgery, in the phase II UNICANCER- NeoPAL study presented at the 2017 European Society ...
Brigatinib in Crizotinib-Pretreated Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, brigatinib (Alunbrig) was granted accelerated approval for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).1,2 Supporting Efficacy...
Where Are We Now in Triple-Negative Breast Cancer?
The treatment of triple-negative breast cancer is rapidly evolving, as clinical trials continue to test chemotherapy agents and combinations and immunotherapy studies promise potentially “game-changing” interventions early in the course of disease, Joyce O’Shaughnessy, MD, reported at the 19th...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
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 October 18, 2017, the chimeric antigen receptor (CAR)...
New Options for the Management of Hodgkin Lymphoma
With the vast majority of patients cured with primary therapy, classical Hodgkin lymphoma is largely a success story. For the 10% to 20% of patients who either relapse or are refractory to front-line therapy, the disease can still be fatal. At the National Comprehensive Cancer Network® (NCCN®) 12th ...
FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
