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Showing 5401 - 5450SELECT 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 ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
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...
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...
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...
Expert Point of View: Rebecca Dent, MD, and Suzette Delaloge, MD, MSc
FORMAL DISCUSSANT of the ACE trial, Rebecca Dent, MD, of the National Cancer Center in Singapore, commented that the phase II ENCORE 301 study provided proof of concept that a histone deacetylase (HDAC) inhibitor can reprogram epigenetic changes.1 In that randomized, double-blind,...
HDAC Inhibitor May Overcome Endocrine Resistance in Advanced Breast Cancer
EPIGENETIC CHANGES are associated with the development of cancer, and epigenetic therapy is an attractive strategy for targeting the tumor microenvironment. One approach targeted to epigenetic changes is using histone deacetylase (HDAC) inhibition, which has antitumorigenic effects including growth ...
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 ...
Expert Point of View: Joaquin Mateo, MD, PhD
FORMAL DISCUSSANT Joaquin Mateo, MD, PhD, of the Prostate Cancer Translational Research Group, Vall d’Hebron Institute of Oncology, Barcelona, said that the TRITON2 findings were encouraging, although still preliminary. “We should interpret these results with caution, because this interim analysis ...
Progress Made in Identifying Gene-Signature Biomarkers in Renal Cell Carcinoma
A NEW ANALYSIS of the phase III IMmotion151 trial identified gene signatures in renal cell carcinoma that correlate with improved progression-free survival in patients treated with atezolizumab (Tecentriq) plus bevacizumab (Avastin) vs sunitinib (Sutent). These findings were presented at the...
Hippocampus-Sparing Whole-Brain Radiotherapy and Neurocognitive Function in Patients With Brain Metastases
ANALYSIS OF a phase III trial has confirmed that conformal avoidance of the hippocampal dentate gyrus using intensity-modulated radiotherapy during whole-brain radiotherapy for brain metastases preserves neurocognitive function and improves patient-reported symptom burden while achieving similar...
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...
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...
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 ...
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 ...
Dejan Juric, MD, on Advanced Breast Cancer: Results From the SOLAR-1 Trial
Dejan Juric, MD, of Massachusetts General Hospital, discusses phase III study findings on liquid biopsy–based assessment of PIK3CA mutational status and the combination of the selective PI3K-alpha inhibitor alpelisib plus fulvestrant in the treatment of advanced breast cancer (Abstract GS3-08).
SABCS 2018: SOLAR-1: Liquid Biopsies in Predicting Benefit of Alpelisib in PIK3CA-Mutant Breast Cancer
Liquid biopsy–based assessment of PIK3CA mutational status served as a better indicator of progression-free survival compared with analysis of tissue biopsy in patients with breast cancer enrolled in the phase III SOLAR-1 clinical trial, according to data presented by Juric et al at the 2018...
SABCS 2018: TAILORx Results Show Association Between Clinical Outcomes in Breast Cancer and Race
An analysis of the association between clinical outcomes and race in participants enrolled in the TAILORx trial found that even with equivalent treatments among women with hormone receptor–positive, HER2-negative breast cancer, black women had worse clinical outcomes than white women, despite ...
SABCS 2018: Surgical Choice May Impact Long-Term Quality of Life in Young Adults With Breast Cancer
A study by Dominici et al investigated the long-term quality of life outcomes in young breast cancer survivors across three surgical strategies: breast-conserving surgery, unilateral mastectomy, and bilateral mastectomy. The researchers found that patients who underwent mastectomy had lower breast...
François-Clément Bidard, MD, PhD, on Metastatic Breast Cancer: Using Circulating Tumor Cells to Direct Treatment
François-Clément Bidard, MD, PhD, of the Institut Curie and the University of Versailles, discusses phase III study findings on the clinical utility of circulating tumor cell count as a tool to choose between first-line hormone therapy and chemotherapy for estrogen receptor–positive, HER2-negative...
Andrew D. Seidman, MD, and Miguel Martín, MD, PhD, on Triple-Negative Breast Cancer: Results From the CIBOMA/GEICAM Trial
Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Miguel Martín, MD, PhD, of the Instituto de Investigacion Sanitaria Gregorio Marañón, discuss phase III study findings on adjuvant capecitabine after standard chemotherapy for people with early triple-negative breast cancer...
Andrew D. Seidman, MD, and Charles E. Geyer, MD, on HER2-Positive Breast Cancer: Results From the KATHERINE Trial
Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer Center, and Charles E. Geyer, MD, of Virginia Commonwealth University, discuss phase III study findings on ado-trastuzumab emtansine vs trastuzumab as adjuvant therapy in patients with early HER2-positive breast cancer with residual invasive ...
Shoichiro Ohtani, MD, PhD, on Extending Adjuvant Aromatase Inhibitor Therapy: Phase III Trial Results
Shoichiro Ohtani, MD, PhD, of Hiroshima City Hiroshima Citizens Hospital, discusses study findings on extending anastrozole to 10 years, which led to higher rates of disease-free survival and distant disease–free survival (Abstract GS3-04).
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...
SABCS 2018: AMAROS Trial: 10-Year Follow-up of Axillary Radiotherapy or Surgery in Early-Stage Breast Cancer
Patients with early-stage breast cancer who had cancer detected in a sentinel lymph node biopsy had comparable 10-year recurrence and survival rates following either axillary radiotherapy or axillary lymph node dissection, according to data from the randomized, phase III AMAROS clinical trial...
SABCS 2018: Circulating Tumor Cell Count May Help Choose First-Line Treatment for Metastatic Breast Cancer
A phase III study by Bidard et al investigated whether circulating tumor cells could help physicians choose between hormone therapy or chemotherapy as front-line therapy for patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer. The researchers concluded that the...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
Current Perspectives on the Treatment of Breast Cancer
“We are on the cusp of a new way to treat breast cancer,” Mary L. (Nora) Disis, MD, said in summarizing advances using immunology to treat breast cancer. Immune checkpoint inhibitors, adaptive T-cell therapies, and vaccines can enlist and rev up the immune system and be combined with chemotherapy...
SABCS 2018: Delayed Initiation of Adjuvant Chemotherapy Associated With Worse Outcomes in Patients With Triple-Negative Breast Cancer
A retrospective study evaluating the influence of time to chemotherapy on patients with triple-negative disease and its impact on survival outcome has found that patients who delayed adjuvant chemotherapy more than 30 days after surgery had a significantly higher risk for disease recurrence and...
Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for...
Lenvatinib in Unresectable Hepatocellular Carcinoma
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...
ASH 2018: Ibrutinib Plus Rituximab vs Standard Chemoimmunotherapy in Younger Patients With Treatment-Naive CLL
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
SABCS 2018: Does Adjuvant Capecitabine Improve Outcomes in Early-Stage Triple-Negative Breast Cancer?
Treating patients with early-stage triple-negative breast cancer with capecitabine after surgery and standard chemotherapy did not significantly improve disease-free or overall survival compared with observation, according to data from the randomized, phase III GEICAM/CIBOMA clinical trial...
SABCS 2018: KATHERINE Trial: Adjuvant Ado-Trastuzumab Emtansine vs Trastuzumab in Early-Stage HER2-Positive Breast Cancer
The phase III KATHERINE clinical trial compared the use of ado-trastuzumab emtansine (T-DM1; Kadcyla) vs trastuzumab (Herceptin) as adjuvant therapy in patients with HER2-positive early-stage breast cancer with residual invasive disease after receiving neoadjuvant chemotherapy and...
Tait D. Shanafelt, MD, on CLL: Results From a Trial of the ECOG-ACRIN Cancer Research Group
Tait D. Shanafelt, MD, of Stanford University, discusses phase III study findings on ibrutinib-based therapy vs standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in untreated younger patients with chronic lymphocytic leukemia (Abstract LBA4).
Shaji K. Kumar, MD, on Newly Diagnosed Multiple Myeloma: Treatment Trial Results
Shaji K. Kumar, MD, of the Mayo Clinic, discusses phase III findings on daratumumab plus lenalidomide and dexamethasone vs lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who are ineligible for transplant (Abstract LBA2).
ASH 2018: MAIA Trial: Does Adding Daratumumab Improve Outcomes in Patients With Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplant?
Interim results from a large international phase III clinical trial show that adding the immunotherapy daratumumab (Darzalex) to standard therapy significantly extended progression-free survival (PFS) in newly diagnosed patients with multiple myeloma who were ineligible for a stem cell transplant....
Steven M. Horwitz, MD, on PTCL: Results From the ECHELON-2 Trial
Steven M. Horwitz, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III findings on brentuximab vedotin and CHP vs CHOP in the front-line treatment of patients with CD30-positive peripheral T-cell lymphomas (Abstract 997).
Anas Younes, MD, on DLBCL: Phase III Trial Results
Anas Younes, MD, of Memorial Sloan Kettering Cancer Center, discusses trial findings on ibrutinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in people with previously untreated non–germinal center B-cell–like diffuse large B-cell lymphoma (Abstract 784).
Mikkael A. Sekeres, MD, on MDS: Results From the Medalist Trial
Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses phase III study findings on luspatercept to treat anemia in patients with very low-, low-, or intermediate-risk myelodysplastic syndromes with ring sideroblasts who require red blood cell transfusions (Abstract 1).
John P. Leonard, MD, on NHL: Results From the AUGMENT Trial
John P. Leonard, MD, of Weill Cornell Medicine/Cornell University, discusses phase III findings on lenalidomide plus rituximab vs rituximab plus placebo for people with relapsed or refractory indolent non-Hodgkin lymphoma (Abstract 445).
ASH 2018: MEDALIST: Luspatercept in Patients With Myelodysplastic Syndrome Requiring Red Blood Cell Transfusion
In the phase III MEDALIST clinical trial, luspatercept significantly reduced the need for frequent blood transfusions in just over half (53%) of patients with myelodysplastic syndromes (MDS) who were anemic, required regular red blood cell transfusions, and showed abnormal iron overload in red...
Radiotherapy With Cisplatin or Cetuximab in Low-Risk, HPV-Positive Oropharyngeal Cancer
In the phase III De-ESCALaTE trial reported in The Lancet, Mehanna et al found no difference in severe toxicity with cisplatin vs cetuximab (Erbitux) plus radiotherapy in low-risk human papillomavirus (HPV)-positive oropharyngeal cancer. Cetuximab was associated with poorer recurrence and survival...
EORTC-NCI-AACR: Investigational Anti-HER2 Therapy in HER2-Expressing Solid Tumors
An antibody that binds simultaneously to two distinct regions of the HER2 receptor to block the growth of cancer cells has shown antitumor activity in a number of cancers, including those of the esophagus, stomach, and bowel. Updated results from a phase I clinical trial of the treatment, called...
Multigene Classifier Test for Thyroid Nodules With Indeterminate Cytology
In a study reported in JAMA Oncology, Steward et al found that the use of a multigene genomic classifier test (ThyroSeq v3) could reduce the need for diagnostic surgery in a substantial proportion of patients with thyroid nodules with indeterminate cytology. The blinded prospective cohort...
ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma
As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...
Addition of Interleukin-2 to Dinutuximab Beta in High-Risk Neuroblastoma
In an international phase III trial (HR-NBL1/SIOPEN) reported in The Lancet Oncology, Ladenstein et al found that the addition of interleukin (IL)-2 to dinutuximab beta did not improve event-free survival in children and young people with high-risk neuroblastoma. Study Details The current report...
Phase III Trial of Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early Cervical Cancer
In a phase III trial (Laparoscopic Approach to Cervical Cancer [LACC]) reported in The New England Journal of Medicine, Ramirez et al found that minimally invasive radical hysterectomy was associated with poorer disease-free and overall survival vs open abdominal radical hysterectomy in women with...
FDA Approves Venetoclax Combination for Adults With AML
On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...
