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Showing 8051 - 8100FDA Approves Pembrolizumab for Merkel Cell Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9...
Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?
High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...
First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL
First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...
Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD
Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...
KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer
In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...
MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
ESMO Immuno-Oncology 2018: MYSTIC: First-Line Durvalumab With or Without Tremelimumab in Metastatic NSCLC
First-line immunotherapy with durvalumab (Imfinzi) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late-breaking results from the MYSTIC trial presented by Rizvi et al at the European Society for Medical...
ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC
Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...
Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma
In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...
Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...
Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer
In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...
FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia
On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...
Regorafenib in Previously Treated Metastatic Osteosarcoma
In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...
Apixaban Thromboprophylaxis in Patients With Cancer
In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...
CIMRA Assay for Detection of Gene Variants in Lynch Syndrome
An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...
Addition of Veliparib to Cisplatin/Etoposide in Extensive-Stage SCLC
In the phase II ECOG-ACRIN 2511 trial reported in the Journal of Clinical Oncology, Owonikoko et al found that the addition of the poly (ADP ribose) polymerase (PARP) inhibitor veliparib to cisplatin/etoposide was associated with a modest but statistically significant improvement in...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE
Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by...
RSNA 2018: Mammography Screening Beyond Age 75
Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....
RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women
A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...
RSNA 2018: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers
Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01). “If the positive preliminary findings are maintained as the ...
SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). In the study, 100 patients with ...
Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas
In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...
Vitamin D Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...
2019 Medicare Physician Fee Schedule and Quality Payment Program Final Rule Released
AT THE BEGINNING of November, the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Medicare Physician Fee Schedule and Quality Payment Program (QPP) outlining reimbursement changes for 2019. CMS estimates that the overall impact will be a 1% reimbursement cut for...
Role of Genomic Profiling in Younger Patients With Cancer
Although overall cancer survival rates continue to improve among all age groups in the United States—there are currently an estimated 15.5 million cancer survivors, and that number is expected to increase to 20.3 million by 20261—survival rates for adolescents and young adults with cancer (AYAs)...
Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...
Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?
IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...
Encorafenib Plus Binimetinib vs Vemurafenib in Advanced BRAF-Mutant Melanoma
AS REPORTED in The Lancet Oncology by Reinhard Dummer, MD, of the University Hospital Zurich Skin Cancer Center, and colleagues, the phase III COLUMBUS trial has shown a significant improvement in overall survival with the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular 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 September 24, 2018, duvelisib (Copiktra) was granted...
Bladder Cancer: Strategies to Address Checkpoint Inhibitor Failure
CHECKPOINT INHIBITORS have rapidly become the standard of care as second-line treatment, and in some patients first-line treatment, of advanced bladder cancer. However, the majority of patients do not respond and eventually experience disease progression; these patients will need subsequent...
Shedding Light on Mechanisms of Resistance to Treatment of Metastatic Castration-Resistant Prostate Cancer
ONE OF the pressing issues in metastatic castration-resistant prostate cancer is the development of resistance to therapies directed at the androgen receptor (AR), such as enzalutamide (Xtandi) and abiraterone acetate (Zytiga). Research is ongoing to identify mechanisms of resistance in the hope of ...
Management of HER2-Positive Breast Cancer: Business as Usual?
MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...
Pembrolizumab Triplet Shows Activity in BRAF-Mutant Melanoma
AS FIRST-LINE treatment of advanced BRAF-mutant melanoma, pembrolizumab (Keytruda) added to dabrafenib (Tafinlar) and trametinib (Mekinist) produced a nonsignificant improvement in progression-free survival. It also increased the rate of grade 3 to 5 treatment-related adverse events in the phase II ...
Using Tumor‑Infiltrating Lymphocytes to Treat Metastatic Melanoma
STEVEN A. ROSENBERG, MD, PhD, Chief of Surgery at the National Cancer Institute (NCI), began his pioneering research in adoptive cell transfer using interleukin (IL)-2 in the mid-1970s. His IL-2 studies were among the clinical trials that led to the first U.S. Food and Drug Administration approval ...
Stereotactic Ablative Radiotherapy May Improve Outcomes in Some Patients With Oligometastatic Tumors
IN PATIENTS with a controlled primary tumor and up to 5 oligometastatic lesions, delivering stereotactic ablative radiotherapy was associated with a 13-month improvement in overall survival when compared with palliative standard-of-care treatments alone (41 months vs 28 months; P = .09).1...
Local Consolidative Therapy Associated With Survival Benefit for Some With Oligometastatic NSCLC
FOR A SUBSET of patients with stage IV lung cancer, aggressive treatment may improve overall survival, according to data presented at the 2018 Annual Meeting of the American Society for Radiation Oncology (ASTRO).1 The results of the phase II study showed that with long-term follow-up, local...
Expert Point of View: Laurie H. Sehn, MD
LAURIE H. SEHN, MD, Chair, Lymphoma Tumour Group, BC Cancer Agency, Vancouver, British Columbia, Canada, said these results are not unexpected and support de-escalation in selected patients. “The FLYER trial evaluates treatment with four cycles compared with six cycles of cyclophosphamide,...
De-escalation of Chemotherapy in Favorable-Risk Diffuse Large B-Cell Lymphoma
THE REGIMEN of four cycles of rituximab (Rituxan)/cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) plus two cycles of rituximab was noninferior to that of six cycles of R-CHOP in younger patients with favorable-risk diffuse large B-cell lymphoma (DLBCL), according to the results of...
Expert Point of View: Aung Naing, MD, FACP
AT THE 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting, Aung Naing, MD, FACP, of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, commented on studies evaluating novel drugs to be combined with programmed cell death ...
Beyond Checkpoint Inhibitors: Novel Immunotherapy Combinations With Antitumor Activity
THE 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting hosted a meeting of the minds of the world’s premier cancer immunologists. In addition to the cutting-edge laboratory science explored and presented at the meeting, numerous phase I clinical trials and a few phase II studies offered ...
Should Oncologists Recommend Cannabis?
A RECENT survey of 400 clinical oncologists found that 80% discuss the use of medical cannabis with their patients, and although nearly 50% recommend it, fewer than 30% consider themselves knowledgeable enough to make such recommendations.1 Oncologists are perhaps among the most evidence-demanding ...
Expert Point of View: Susan M. O’Brien, MD
THE STUDY’S discussant, Susan M. O’Brien, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, said the results of the Alliance North American Intergroup Study A041202—demonstrating that ibrutinib (Imbruvica) is more...
Ibrutinib vs Standard of Care in Front-Line Treatment of Older Patients With Chronic Lymphocytic Leukemia
IBRUTINIB (IMBRUVICA) as a front-line agent proved superior to standard-of-care chemoimmunotherapy for chronic lymphocytic leukemia (CLL) in older patients in A041202, an Alliance-led National Clinical Trials Network study.1 At a follow-up of 38 months, the median progression-free survival was not ...
FDA Approves Atezolizumab in Combination With Bevacizumab and Chemotherapy for First-Line Treatment of Metastatic, Nonsquamous NSCLC
On December 6, 2018, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or...
A Battle With Leukemia: Part Memoir, Part Oncology History
BOOKMARK Title: Cancer Crossings: A Brother, His Doctors, and the Quest for a Cure to Childhood LeukemiaAuthor: Tim WendelPublisher: ILR PressPublication date: April 2018Price: $24.95, hardcover, 256 pages Tim Wendel is a journalist and author of several noted books, mostly concerning sports. In...
SABCS 2018: Whole-Breast Irradiation vs Accelerated Partial-Breast Irradiation for Preventing Ipsilateral Breast Tumor Recurrence
Data from the NSABP B-39/RTOG 0413 trial indicated that ipsilateral breast tumor recurrence (IBTR) rates 10 years after treatment could not reject the hypothesis that accelerated partial-breast irradiation (PBI) after lumpectomy was inferior to whole-breast irradiation (WBI), according to a...
SABCS 2018: Low-Dose Tamoxifen in Reducing Recurrence and New Disease for Patients With Breast Intraepithelial Neoplasia
Treatment with a low dose of tamoxifen (5 mg/d), compared with placebo, decreased the risk of disease recurrence and new disease for women who had been treated with surgery following a diagnosis of breast intraepithelial neoplasia. Moreover, it did not cause more serious adverse events, according...
Denial’s Many Faces
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
