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Showing 2651 - 2700FDA Approves Cabozantinib in Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of this oral tyrosine kinase inhibitor was based on the results of the phase III...
2019 GI Cancers Symposium: Nivolumab vs Nivolumab Plus Ipilimumab in Resectable Hepatocellular Carcinoma
Anti–programmed cell death protein 1 and anti–cytotoxic T-lymphocyte–associated protein 4 antibodies have shown activity in hepatocellular carcinoma. Based on these earlier findings, researchers sought to examine the safety, efficacy, and tolerability of perioperative treatment...
Novel Treatments in Newly Diagnosed Multiple Myeloma, Part 1
Here is an update on several different studies focusing on novel treatments for patients with newly diagnosed multiple myeloma presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Featured therapeutics include daratumumab plus lenalidomide and dexamethasone, ...
FDA Approves Cabozantinib for Previously Treated Hepatocellular Carcinoma
On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of cabozantinib was based on results from the phase III CELESTIAL trial....
Updated Survival Analysis of KEYNOTE-024: Pembrolizumab vs Platinum-Based Chemotherapy in Previously Untreated, Advanced NSCLC
As reported in the Journal of Clinical Oncology by Reck et al, an updated analysis of the phase III KEYNOTE-024 trial indicates continued overall survival benefit of first-line pembrolizumab vs platinum-based chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) with a...
Detection of Relapse in Children and Adolescents With Nongerminomatous Malignant Germ Cell Tumors
In a report from the Children’s Oncology Group published in the Journal of Clinical Oncology, Fonseca et al found that relapse in children and adolescents with nongerminomatous malignant germ cell tumors (MGCTs) was most frequently identified by tumor markers rather than imaging. Study...
FDA Expands Indication for Dasatinib to Pediatric Patients With Ph+ ALL in Combination With Chemotherapy
On January 2, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) in...
FDA Approves Tagraxofusp-ezrs for Blastic Plasmacytoid Dendritic Cell Neoplasm
On December 21, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. “Prior to [this] approval, there had been no...
Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas
THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in ...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Study Findings on Myeloproliferative Neoplasms Including Systemic Mastocytosis
HERE IS AN UPDATE on six different studies featured at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics focused on novel treatments for myelofibrosis, polycythemia vera and essential thrombocythemia, as well as systemic mastocytosis. Myelofibrosis ABSTRACT...
New Data Reported From International Studies of Lung Cancer Treatment
At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...
International Trials Present New Findings in Treatment of Breast Cancer
The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...
ESMO Immuno-Oncology 2018: OpACIN Trial: Neoadjuvant Ipilimumab Plus Nivolumab in Stage III Melanoma
Updated data of the OpACIN study, which studied combined ipilimumab (Yervoy) plus nivolumab (Opdivo) administered as neoadjuvant or adjuvant therapy in patients with high-risk stage III melanoma, demonstrated high response rates upon neoadjuvant therapy and promising long-term clinical outcome,...
ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy
Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...
Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...
Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL
In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...
Expert Point of View: Joseph C. Alvarnas, MD, and Henry Fung, MD
Commenting on the ibrutinib (Imbruvica)/chimeric antigen receptor (CAR) T-cell approach at a press conference, Joseph C. Alvarnas, MD, said: “Patients with CLL do not do as well on CAR T-cell therapy as those with B-cell acute lymphoblastic leukemia, and by combining ibrutinib with CAR T cells,...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
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 26, 2018, larotrectinib (Vitrakvi) was...
FDA Approves Olaparib for Maintenance Treatment of BRCA-Mutated, Advanced Ovarian Cancer
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer...
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...
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...
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 ...
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...
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...
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 ...
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 ...
No Benefit for Atezolizumab Plus Standard of Care for Maintenance in Colorectal Cancer Subset
ADDING ATEZOLIZUMAB (Tecentriq) to a fluoropyrimidine plus bevacizumab (Avastin) did not improve outcomes for patients with BRAF wild-type metastatic colorectal cancer enrolled in the umbrella MODUL trial.1 “Despite activity in other, immune-responsive tumor types, there was no improvement in...
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 ...
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...
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...
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 ...
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 ...
SABCS 2018: Oxybutynin for the Management of Hot Flashes in Women Unable to Receive Hormone Replacement Treatment
Treatment with oxybutynin helped reduce the frequency and intensity of hot flashes for women who could not take hormone replacement therapy, including breast cancer survivors, according to the results of a trial presented at the 2018 San Antonio Breast Cancer Symposium by Leon-Ferre et al (Abstract ...
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...
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...
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...
Artificial Intelligence–Based Smartphone App Decreases Pain and Reduces Inpatient Hospitalizations in Patients With Cancer
A smartphone application utilizing elements of artificial intelligence was associated with improved cancer pain outcomes and a significant reduction in pain-related hospital admissions, according to data presented at the 2018 Palliative and Supportive Care in Oncology Symposium.1 Results of the...
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...
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....
ASH 2018: ELIANA Trial: Tisagenlecleucel in Pediatric and Young Adult Patients With ALL
A single infusion of tisagenlecleucel (Kymriah) in pediatric and young adult patients with relapsed or treatment-resistant acute lymphocytic leukemia (ALL) continues to be highly effective in most patients, without the need for additional therapies. This latest analysis of the ELIANA trial results...
ASH 2018: Four vs Six Cycles of Chemotherapy in Diffuse Large B-Cell Lymphoma
A new study suggests that it may be safet to reduce the standard course of treatment for younger patients with low-risk diffuse large B-cell lymphoma (DLBCL) by two cycles of chemotherapy. The trial, which tracked patients for a median of more than 5 years and up to 11 years, showed 4 cycles of...
ASH 2018: Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa
The largest prospective trial of hydroxyurea for sickle cell anemia (SCA) has shown that this treatment—long the standard of care for treating SCA in developed countries—is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Tshilolo et al reported...
Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer
In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients...
