Ribociclib Receives FDA Breakthrough Therapy Designation in Premenopausal Women With Hormone Receptor–Positive, HER2-Negative Breast Cancer

On January 3, ribociclib (Kisqali) received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with...

Sequence of Postoperative Radiotherapy and Chemotherapy in Locally Advanced or Incompletely Resected NSCLC

In a study of National Cancer Database data reported in the Journal of Clinical Oncology, Francis et al found that receipt of adjuvant chemotherapy before vs concurrently with radiotherapy was associated with improved survival in patients with non–small cell lung cancer (NSCLC) found to have...

Association of Tumor-Infiltrating Lymphocytes With Prognosis in Breast Cancer Subtypes

In a study reported in The Lancet Oncology by Denkert et al, increased levels of tumor-infiltrating lymphocytes (TILs) in women receiving neoadjuvant chemotherapy were associated with improved prognosis in HER2-positive breast cancer and triple-negative breast cancer, but poorer outcome in luminal...

FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma

On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...

gynecologic cancer

Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer

In a phase II trial reported in JAMA Oncology, Richardson et al found that the addition of pazopanib to paclitaxel did not improve progression-free survival among women with persistent or recurrent ovarian cancer. Study Details In the double-blind study, 106 women from 26 U.S. study sites with...

breast cancer

Dual HER2 Inhibition Plus Aromatase Inhibitor in Metastatic Breast Cancer

The phase III ALTERNATIVE trial has shown progression-free survival benefit with the addition of lapatinib (Tykerb) to trastuzumab (Herceptin) and an aromatase inhibitor among postmenopausal women with HER2-positive, hormone receptor–positive metastatic breast cancer. These findings were...

kidney cancer

Activity of Hypoxia-Inducible Factor-2α Antagonist in Advanced Renal Cell Carcinoma

In a phase I trial reported in the Journal of Clinical Oncology, Courtney et al found that a first-in-class hypoxia-inducible factor-2α (HIF-2α) antagonist (PT2385) was active in patients with previously treated advanced clear cell renal cell carcinoma (RCC). Study Details In the...

skin cancer

FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma

On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...

kidney cancer

FDA Grants Breakthrough Therapy Designation to Combination of Avelumab and Axitinib in Advanced Renal Cell Carcinoma

On December 21, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab (Bavencio) in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma. “A combination approach with an immunotherapy, whose activity may ...

leukemia

Venetoclax in Chronic Lymphocytic Leukemia Progressing After Ibrutinib

An interim analysis of a phase II trial reported by Jones et al in The Lancet Oncology indicates that venetoclax (Venclexta) produces a response in a high proportion of patients with chronic lymphocytic leukemia progressing on or after ibrutinib (Imbruvica) treatment. Study Details The study...

pancreatic cancer

Addition of PEGPH20 to Nab-Paclitaxel/Gemcitabine in Pancreatic Ductal Adenocarcinoma

In a phase II study reported in the Journal of Clinical Oncology, Hingorani et al found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel (Abraxane)/gemcitabine improved progression-free survival in patients with previously untreated metastatic pancreatic ductal...

breast cancer

Long-Term Outcomes With Neoadjuvant vs Adjuvant Chemotherapy in Early Breast Cancer

A meta-analysis reported in The Lancet Oncology by the Early Breast Cancer Trialists’ Collaborative Group indicates that neoadjuvant chemotherapy is associated with a higher local recurrence risk vs the same chemotherapy given postoperatively after breast-conserving therapy. Study Details...

leukemia

FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response

On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...

breast cancer

FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

On December 22, the U.S. Food and Drug Administration (FDA) cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With [this] clearance, patients will have access to a treatment option that provides greater accuracy in delivering...

leukemia
lymphoma

ICER Releases Draft Evidence Report on CAR T-Cell Therapy for B-Cell Cancers

On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...

skin cancer

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...

breast cancer

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...

issues in oncology

Sexual Problems and Cancer: ASCO Clinical Practice Guideline Adaptation of CCO Guideline

As reported in the Journal of Clinical Oncology by Jeanne Carter, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues, ASCO has issued a clinical practice guideline adaptation of the Cancer Care Ontario (CCO) guideline on interventions to address sexual problems in people with cancer....

lymphoma

BTK Inhibitor in Relapsed or Refractory Mantle Cell Lymphoma

A phase II study (ACE-LY-004) reported in The Lancet by Wang et al showed durable responses with the Bruton tyrosine kinase inhibitor acalabrutinib (Calquence) in patients with relapsed or refractory mantle cell lymphoma. The study supported the recent approval of acalabrutinib in this setting....

kidney cancer

FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...

leukemia

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 ...

solid tumors
issues in oncology

California Trends in Cancer Survival by Health Insurance Status

A study using California Cancer Registry data showed that survival improvements in patients with cancer between 1997 and 2014 have largely been limited to those with private or Medicare insurance. These findings were reported in JAMA Oncology by Libby et al. Study Details The study involved...

colorectal cancer

Combination Agent in Asian Patients With Previously Treated Metastatic Colorectal Cancer

In the Asian phase III TERRA trial, trifluridine/tipiracil (Lonsurf) produced a significant improvement in overall survival vs placebo among patients with metastatic colorectal cancer refractory or intolerant of standard chemotherapies with or without exposure to biologic therapies. These findings...

lung cancer

FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC

On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...

Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term

Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five...

issues in oncology

FCC, NCI Working to Improve Rural Cancer Care via Broadband Access

The Federal Communications Commission’s Connect2Health Task Force (C2HFCC) has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas can improve...

prostate cancer

Study Finds Racial Disparities in Treatment of Clinically Significant Prostate Cancer

In a study reported in the Journal of Oncology Practice, Bickell et al found underuse of treatment for clinically significant prostate cancer was infrequent among white and black patients at two New York City hospitals, but black men accounted for nearly all such underuse of treatment. As noted by...

lymphoma

CAR T-Cell Therapy in Refractory B-Cell Lymphomas

As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...

gastroesophageal cancer
gastrointestinal cancer

Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma

The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...

health-care policy

AMA Urges Physicians to Take Steps to Avoid Medicare Payment Penalty

The American Medical Association (AMA) is reminding physicians that the Medicare reimbursement system has changed, and, if they have not done so already, they have until December 31, 2017, to take a few simple steps to avoid a Medicare payment penalty in 2019. The changes are part of the...

legislation

Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research

On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...

gynecologic cancer

FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...

solid tumors

Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers

At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...

issues in oncology

Does Warfarin Have Anticancer Potential in Persons Older Than Age 50?

A Norwegian population–based cohort study indicated that the use of warfarin was associated with a reduced risk of cancer overall and site-specific cancers among patients aged > 50 years. The findings were reported in JAMA Internal Medicine by Haaland et al. As noted by the investigators,...

solid tumors

Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors

Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...

kidney cancer

FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma

On December 13, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously...

lymphoma

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...

leukemia

ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL

At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...

lymphoma

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...

colorectal cancer

Primary Tumor Location and Outcomes in Stage III Colon Cancer According to RAS- and BRAF-Mutation Status

  In a study in the PETACC-8 trial population reported in JAMA Oncology, Taieb et al found that the risk of recurrence in patients with stage III colon cancer differed for the primary tumor location according to RAS- and BRAF-mutation status. Study Details A total of 2,559 patients were...

solid tumors

Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure

As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...

hematologic malignancies
symptom management

ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer

People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...

hematologic malignancies

ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura

In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...

hematologic malignancies
symptom management

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...

head and neck cancer

Number of Metastatic Lymph Nodes and Survival in Hypopharyngeal/Laryngeal Cancer

A study using National Cancer Database data has shown that the number of metastatic nodes is a primary independent factor associated with an increased mortality risk in patients with hypopharyngeal and laryngeal cancers. The study was reported in JAMA Oncology by Ho et al. Study Details The study ...

kidney cancer

Prognostic Factors in Stage III Favorable-Histology Wilms Tumor

An analysis from the Children’s Oncology Group Study AREN0532 reported in the Journal of Clinical Oncology by Fernandez et al showed that positive lymph nodes and loss of heterozygosity (LOH) at chromosome 1p or 16q are associated with poorer event-free survival in patients with stage III...

breast cancer

Hormonal Contraception and Breast Cancer Risk

As reported in The New England Journal of Medicine by Mørch et al, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. Study Details The study assessed the association between the...

leukemia

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...

multiple myeloma

ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma

The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials

In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...

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