On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
On July 29, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2020 Medicare Physician Fee Schedule (MPFS) and other changes to Medicare Part B payment policies, including proposals related to the Quality Payment Program (QPP). At the same time, CMS released...
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...
Pregnancy after breast cancer appears to be safe in patients with germline BRCA mutations—and particularly among those with BRCA1 mutations—according to new research. Limited data are available on the safety of pregnancy and reproductive outcomes in patients with breast cancer and BRCA mutations,...
Cancer drugs currently account for 27% of all new drug approvals in the United States since 2010—an increase from the 4% share they occupied in the 1980s, a newly completed analysis summarized in the most recent issue of the Tufts CSDD Impact Report. From 1980 through 2018, the U.S. Food and Drug...
Olanzapine at a 5-mg dose, when combined with aprepitant, palonosetron, and dexamethasone, significantly reduced the risk of delayed nausea and vomiting in patients receiving cisplatin-based chemotherapy, according to new research. The study investigators believe this approach may be considered a...
As reported in The New England Journal of Medicine by Ian D. Davis, MBBS, PhD, FRACP, FAChPM, of Monash University and Eastern Health in Melbourne, and colleagues, the phase III ENZAMET trial has shown that the androgen receptor inhibitor enzalutamide improved progression-free and overall survival ...
As reported in The Lancet Oncology by Robert J. Motzer, MD, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown a maintained survival benefit for first-line nivolumab/ipilimumab vs sunitinib in patients with previously untreated intermediate- or poor-risk advanced...
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
In the Clinic provides overviews of novel hematology and 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 July 3, 2019, the oral nuclear export...
ON JUNE 27, 2019, the U.S. Food and Drug Administration (FDA) granted clearance of the DigniCap Delta scalp-cooling system to Dignitana, for use by health-care providers in the United States. The device is a fourth generation of the DigniCap scalp-cooling system. It is indicated to reduce the...
This week, the U.S. Food and Drug Administration (FDA) accepted new drug applications for enzalutamide in metastatic hormone-sensitive prostate cancer and zanubrutinib in relapsed or refractory mantle cell lymphoma, and granted both applications Priority Review. Priority Review for Enzalutamide in ...
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. The survival rates of adolescent and young adults with cancer have risen ...
Patients with metastatic colorectal cancer who engaged in moderate exercise while undergoing chemotherapy tended to have delayed progression of their disease and fewer severe side effects from treatment, according to the results of a new study published by Guercio et al in the Journal of Clinical...
In a single-institution study reported in the Journal of Clinical Oncology, Hamilton et al found that relapses of clinical stage I nonseminomatous germ cell tumors (NSGCT) during postorchiectomy active surveillance most frequently occurred in the retroperitoneum and were cured by single-modality...
In the French Sarcoma Group noncomparative phase II DESMOPAZ trial reported in The Lancet Oncology, Toulmonde et al found that the oral vascular endothelial growth factor (VEGF) receptor inhibitor pazopanib was active in adult patients with progressive desmoid tumors. As noted by the investigators, ...
In a phase I trial reported in The Lancet Oncology, Martine Bagot, MD, and colleagues found that IPH4102—a first-in-class monoclonal antibody targeting KIR3DL2—was safe and showed activity in patients with relapsed or refractory cutaneous T-cell lymphoma, particularly those with Sézary syndrome....
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien Hou, PharmD, DipIOM, LAc, explores the potential health benefits of...
In medical school, I learned a five-step model on how to deliver bad news to a patient. I still fall back on this method, time and again, in my primary care clinic; I have even used it when giving really tough feedback to a learner who is struggling in some aspect of performance. But I honestly...
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are four abstracts from different clinical trials evaluating newer treatments for Waldenström’s macroglobulinemia and T-cell lymphomas. Waldenström’s Macroglobulinemia ABSTRACT 7509: Outcomes with bendamustine plus ...
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
In a study reported in the Journal of Oncology Practice, Greenup et al found that cancer treatment costs influenced women’s decisions on breast cancer surgery. Researchers reported many women, even at the highest income levels, said that costs were higher than expected, and that most women...
In a phase I trial reported in the Journal of Clinical Oncology, Hont et al found that treatment of relapsed or refractory solid tumors with ex vivo expanded autologous multiantigen-associated specific cytotoxic T cells—or, tumor-associated antigen cytotoxic T cells—was safe and showed...
In a phase II study reported in The Lancet Oncology, Adkins et al found that the combination of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the EGFR inhibitor cetuximab showed activity in patients with either platinum- or cetuximab-resistant human papillomavirus...
Findings from a cohort of a phase II study reported by Stacchiotti et al in The Lancet Oncology indicated activity of the antiangiogenic agent pazopanib in advanced extraskeletal myxoid chondrosarcoma. As noted by the investigators, this rare sarcoma has low sensitivity to cytotoxic chemotherapy,...
In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...
In April 2019, a 3-year-old boy, Noah McAdams, missed the third round of chemotherapy for his acute lymphoblastic leukemia. His parents wanted instead to focus on alternative remedies of cannabidiol oil, alkaline water, mushroom tea, and herbal extracts. The sheriff was summoned; Noah’s parents...
A handful of investigational drugs in early-phase trials always create a buzz at ASCO Annual Meetings. Two that garnered attention this year, and could eventually change outcomes in the clinic, are the first-in-class KRAS inhibitor AMG 510 and the ROS1 inhibitor repotrectinib. Should late-phase...
Breast cancers that display heterogeneity of HER2 expression may represent a distinct subset of HER2-positive breast cancer that is associated with lower rates of pathologic complete response, according to a phase II study from Dana-Farber Cancer Institute. This trial evaluated HER2 heterogeneity...
IT WAS a chilly Chicago morning, and I was sitting at the lobby of my hotel when I saw a smiling gentleman cheerfully waving at me from his car. It was Lawrence H. Einhorn, MD, picking me up for our drive to Indiana. I was one of the recipients of the ASCO International Development and Education...
On June 27, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received...
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. The ASCO Post’s Integrative Oncology series is intended to facilitate the...
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,...
A study by Wei et al in the Journal of the American Academy of Dermatology has found that individuals with a first-degree relative with a history of melanoma are at an increased risk for melanomas and keratinocyte cancers such as squamous cell carcinoma and basal cell carcinoma. Methods...
In the phase II CLARITY trial reported in the Journal of Clinical Oncology, Hillmen et al found that the combination of ibrutinib and venetoclax resulted in high rates of minimal residual disease eradication in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In the...
Patients who experienced a disaster-level hurricance during radiotherapy for lung cancer had worse overall survival than those who completed treatment in normal circumstances, with longer disaster declarations associated with increasingly worse survival. These findings come from a...
Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...
In an analysis reported in The Lancet Oncology, Del Paggio and Tannock found that many phase III trials supporting U.S. Food and Drug Administration (FDA) approval of anticancer drugs have a low fragility index—a measure of how many people in a study would have had to have a different outcome ...
As reported in The Lancet Oncology, Hervé Tilly, MD, and colleagues found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in ...
In the phase III OPTIMISMM trial, reported by Paul G. Richardson, MD, and colleagues in The Lancet Oncology, researchers found that the addition of pomalidomide to bortezomib/dexamethasone improved progression-free survival in relapsed or refractory multiple myeloma previously treated with...
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Ting Bao, MD, DABMA, MS, and Jyothirmai Gubili, MS, explore the current...
I sit paralyzed at my desk. Everyone else has left the clinic. I can hear the sound of the broom in the hall as the after-hours cleaning begins. No phones ring, no patients hurry to appointments, no chatter lingers in the air. The silence is oppressive, the air is heavy, and the distance from my...
In a phase I trial reported in The Lancet Oncology, Bagot et al found that IPH4102—a first-in-class monoclonal antibody targeting KIR3DL2—was safe and showed activity in patients with relapsed or refractory cutaneous T-cell lymphoma, particularly those with Sézary syndrome....
A phase II study found that treatment with the antibody-drug conjugate enfortumab vedotin achieved responses in 44% of patients with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a checkpoint inhibitor. This is a noteworthy study because it...
Pazopanib significantly improved progression-free survival by 47% in patients with progressive carcinoid tumors, in a prospective randomized phase II trial presented at the 2019 ASCO Annual Meeting.1 “With these results, Alliance A021202 becomes the first randomized study to show that the vascular...
For patients with operable colon cancer, neoadjuvant chemotherapy resulted in numerous benefits in the FOxTROT trial but did not reach target significance for the primary endpoint. The study was presented at the 2019 ASCO Annual Meeting by Matthew T. Seymour, MD, of the University of Leeds School...
In the global phase III NALA trial, treatment of metastatic HER2-positive breast cancer with neratinib plus capecitabine significantly improved progression-free survival, delayed the time to intervention for central nervous system disease, and showed a trend toward improved overall survival vs...