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Showing 2701 - 2750FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
DNA Vaccine Leads to Immune Responses in HPV-Related Head and Neck Cancer in Small Study
A therapeutic vaccine may boost antibodies and T cells, helping them infiltrate human papillomavirus (HPV)-related head and neck cancer tumors. Researchers from the Abramson Cancer Center of the University of Pennsylvania tested the immunotherapy in two groups of patients with advanced head and...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
ON NOVEMBER 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib (Nexavar). KEYNOTE-224 APPROVAL WAS based on KEYNOTE-224, a...
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
ON NOVEMBER 16, 2018, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic...
Duvelisib in Resistant Chronic Lymphocytic Leukemia: Expanding the Treatment Armamentarium
The phase III DUO trial, reported by Flinn et al and reviewed in this issue of The ASCO Post, has led to the U.S. Food and Drug Administration (FDA) approval of a novel B-cell receptor (BCR) kinase inhibitor, duvelisib (Copiktra), which targets phosphoinositide 3-kinase (PI3K)-δ/γ in patients...
Quality of Life With Postmastectomy Radiotherapy vs No Radiotherapy in Intermediate-Risk Breast Cancer
In a 2-year follow-up of the phase III SUPREMO trial reported in The Lancet Oncology, Galina Velikova, PhD, of the Leeds Cancer Centre, St. James’s University Hospital, United Kingdom, and colleagues found worse chest wall symptoms in women with intermediate-risk breast cancer who did vs did not...
Study Identifies Suitable Partner for Bevacizumab in Recurrent Ovarian Cancer
For patients with recurrent ovarian cancer who receive platinum-based retreatment, the more suitable partner for bevacizumab (Avastin) may be carboplatin plus pegylated liposomal doxorubicin, rather than carboplatin and gemcitabine, according to the results of a phase III ENGOT/GCIG Intergroup...
Neoadjuvant Therapy With Reduced-Dose Immunotherapy for Stage III Melanoma
In patients with stage III melanoma, a reduced-dose neoadjuvant immunotherapy combination was well tolerated and led to high pathologic response rates, in the phase II OpACIN-neo trial presented at the European Society for Medical Oncology (ESMO) 2018 Congress.1 “Neoadjuvant ipilimumab (Yervoy) at...
Expert Point of View: Daniel Heinrich, MD, and Silke Gillessen, MD
Formal discussant of the ERA 223 trial, Daniel Heinrich, MD, of Akershus University Hospital, Lørenskog, Norway, reminded listeners at the European Society for Medical Oncology (ESMO) 2018 Congress that radium-223 was developed in Norway. “When the ALSYMPCA results came out, we were celebrating....
Treatment With Radium-223 Plus Abiraterone Not Advisable in Metastatic Prostate Cancer
The combination of radium-223 plus AAP (abiraterone acetate [Zytiga] and prednisone) was not superior to placebo plus AAP in the phase III ERA 223 trial, which enrolled men with asymptomatic bone-predominant metastatic castration-resistant prostate cancer.1 Patients treated with the combination had ...
Immunotherapy and Tyrosine Kinase Inhibitor Combination in Advanced Renal Cell Carcinoma
In the JAVELIN Renal 101 phase III study, the combination of the immune checkpoint inhibitor avelumab (Bavencio), a programmed death ligand-1 (PD-L1) blocking antibody, plus the tyrosine kinase inhibitor axitinib (Inlyta) significantly improved progression-free survival in previously untreated...
Phase III Study Supports Use of Cisplatin Over Cetuximab in HPV-Positive Oropharyngeal Cancer
In the United States and European countries, many oncologists are using cetuximab (Erbitux)/radiotherapy instead of cisplatin/radiotherapy in the treatment of human papillomavirus (HPV)-positive oropharyngeal cancer, based on the belief that cetuximab is equally effective with less toxicity than...
Pembrolizumab Improves Survival in Advanced Head and Neck Cancer
An overall survival advantage has now been shown for first-line immunotherapy in recurrent or metastatic head and neck cancer, researchers reported at the European Society for Medical Oncology (ESMO) 2018 Congress.1 In the phase III KEYNOTE-048 trial, treatment with the anti–programmed cell death...
Adding Pelvic Node Radiation and Short-Term Hormone Therapy to Salvage Radiation Provides Significant Benefit in Prostate Cancer
For patients with prostate cancer who have persistent or rising prostate-specific antigen (PSA) levels after radical prostatectomy, the addition of short-term androgen-deprivation therapy and radiotherapy to the pelvic lymph nodes demonstrated increased rates of freedom from disease progression,...
Radiotherapy Reduces Risk of Recurrence by More Than 70% in Some Patients With Ductal Carcinoma in Situ
Radiation therapy after breast-conserving surgery reduced the already-low risk of recurrence by more than 70% in patients with defined “good-risk” breast cancer, according to a long-term clinical trial report presented at the 2018 Annual Meeting of the American Society for Radiation Oncology...
Lung Cancer Screening: Proven Effective but Still Fighting for Acceptance
In 2010, the long-awaited findings from the National Lung Screening Trial (NLST) revealed that participants who received low-dose helical computed tomography (CT) scans had a 15% to 20% lower risk of dying of lung cancer than participants who received standard chest x-rays. In response, the U.S....
FDA Expands Approved Use of Brentuximab Vedotin in Some Types of PTCL
Today, the U.S. Food and Drug Administration (FDA) expanded the approved use of brentuximab vedotin (Adcetris) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL)—adults with previously untreated systemic anaplastic large cell...
Durvalumab With or Without Tremelimumab in Recurrent or Metastatic HNSCC With Low/No PD-L1 Expression
In a randomized phase II trial reported in JAMA Oncology, Siu et al found that the combination of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) plus the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) inhibitor tremelimumab and durvalumab alone showed evidence ...
FDA Approves Pembrolizumab for Hepatocellular Carcinoma Previously Treated With a Kinase Inhibitor
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib. KEYNOTE-224 Approval was based on KEYNOTE-224, a single-arm,...
Atezolizumab Plus Chemotherapy Improves Outcomes in Small Cell Lung Cancer
ATEZOLIZUMAB (TECENTRIQ), an anti–program cell death ligand 1 (PD-L1) antibody, combined with carboplatin/ etoposide as first-line treatment for extensive-stage small-cell lung cancer (SCLC) improved overall and progression-free survival and may represent a new standard of care, according to...
Pembrolizumab Shows Antitumor Activity in Non–Muscle Invasive Bladder Cancer
THE ANTI–PROGRAMMED cell death protein 1 (anti–PD-1) checkpoint inhibitor pembrolizumab (Keytruda) was found to have antitumor activity in patients with high-risk non–muscle invasive bladder cancer who were nonresponsive to bacillus Calmette-Guérin (BCG), according to the preliminary results of the ...
Radiation to Primary Tumor Improves Survival in Subset of Men With Metastatic Prostate Cancer
MEN WITH newly diagnosed metastatic prostate cancer do not typically receive treatment to the primary tumor with radiation or surgery. A new analysis of the STAMPEDE trial found that radiation administered to the prostate can improve overall survival in men with newly diagnosed metastatic prostate...
Results Reported for Olaparib Maintenance in Ovarian Cancer
TWO-YEAR MAINTENANCE therapy with olaparib (Lynparza), a poly (ADP-ribose) polymerase inhibitor, achieved a significant improvement in progression-free survival in patients with newly diagnosed advanced ovarian cancer and a BRCA1 or BRCA2 mutation, according to results of the phase III SOLO-1...
Brigatinib Improves Outcomes Over Crizotinib in ALK-Positive Non–Small Cell Lung Cancer
THE FIRST-LINE USE of brigatinib (Alunbrig) was superior to standard-of-care crizotinib (Xalkori) in patients with advanced anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), according to the first report of the phase III ALTA-1L trial presented at the International...
Immunotherapy Improves Survival in a Subset of Patients With Metastatic Triple-Negative Breast Cancer
IMMUNOTHERAPY APPEARS to be the new upfront standard of care for patients with metastatic triple-negative breast cancer, based on a late-breaking presentation at the European Society for Medical Oncology (ESMO) 2018 Congress1 and simultaneously published in The New England Journal of Medicine.2 In ...
Final Analysis of SWOG POEMS: Goserelin and Chemotherapy in Breast Cancer
Final results of SWOG Cancer Research Network’s international Prevention of Early Menopause Study (POEMS) showed continued evidence that women who get injections of the hormone drug goserelin along with standard breast cancer chemotherapy are more likely to become pregnant, without developing ...
FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies,...
Acupuncture for Joint Symptoms Caused by Aromatase Inhibitors
Arthralgia is a common and debilitating adverse effect experienced by patients with breast cancer who are being treated with aromatase inhibitors, often resulting in poor adherence. And premature treatment discontinuation can negatively impact disease-free and overall breast cancer survival....
Nilotinib for Pediatric Patients With Philadelphia Chromosome–Positive CML in Chronic Phase
Earlier in 2018, nilotinib (Tasigna) was approved for the treatment of pediatric patients aged ≥ 1 year with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) or Philadelphia chromosome–positive CML-CP resistant or intolerant to prior tyrosine...
The Persephone Trial Reconsidered
The Persephone presentation by Helena Margaret Earl, MBBS, PhD, got a lot of publicity after a pre–ASCO Annual Meeting press release, suggesting that 6 months of adjuvant trastuzumab (Herceptin) is enough. The advice of experts has been that the evidence is inconclusive, but I have not heard a...
ESMO 2018: CTONG 1103 Finds Benefit With Neoadjuvant Erlotinib in Some EGFR-Mutated NSCLCs
Neoadjuvant erlotinib (Tarceva) benefits selected patients with epidermal growth factor receptor (EGFR)-mutated non–small cell lung cancer (NSCLC) who undergo complete resection of stage IIIA-N2 disease, according to a randomized study comparing erlotinib with gemcitabine plus cisplatin as...
Quality of Life With Postmastectomy Radiotherapy vs No Radiotherapy in Intermediate-Risk Breast Cancer
In a 2-year follow-up of the phase III SUPREMO trial reported in The Lancet Oncology, Velikova et al found worse chest wall symptoms in women with intermediate-risk breast cancer who did vs did not receive postmastectomy radiotherapy. No other differences in quality-of-life outcomes were found ...
FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) as first-line treatment of metastatic squamous non–small cell lung...
ESMO 2018: HOBOE-2: Zoledronic Acid in Premenopausal Hormone Receptor–Positive Early Breast Cancer
Adjuvant treatment with zoledronic acid, plus hormonal therapy with the aromatase inhibitor letrozole, significantly increases disease-free survival compared to tamoxifen in premenopausal women with hormone receptor–positive early breast cancer, according to results reported by Perrone et al...
2018 ASTRO: SPPORT Trial: ADT With or Without Pelvic Lymph Node Radiation in Prostate Cancer
The first report of a large international clinical trial shows that, for men who show signs of prostate cancer after surgical removal of their prostates, extending radiation therapy to the pelvic lymph nodes combined with adding short-term androgen-deprivation therapy (ADT) to standard treatment...
2018 ASTRO: SABR-COMET: Stereotactic Ablative Radiation Therapy for Oligometastatic Tumors
In the first randomized, phase II clinical trial of its kind, researchers have shown that an aggressive form of high-precision radiation therapy can increase survival in patients with oligometastatic tumors. These findings were presented by Palma et al in the plenary session at the 60th Annual ...
2018 ASTRO: Overall Survival With Local Consolidative Therapy in Oligometastatic NSCLC
Adding radiation therapy or surgery to systemic therapy for patients with stage IV lung cancer whose cancer has spread to a limited number of sites can significantly extend overall survival, according to new results from a multicenter, randomized, controlled phase II study. The findings were...
2018 ASTRO: Radiation After Breast-Conserving Surgery in 'Good-Risk' DCIS
A subset of patients with low-risk breast cancer is highly unlikely to see cancer return following breast conservation surgery, but can lower that risk even further with radiation therapy, finds a new long-term clinical trial report. These 12-year follow-up data from the only prospective,...
2018 ASTRO: FAST Trial Finds Long-Term Side Effects Similar for Once-Weekly and Conventional Breast Radiation Therapies
In a 10-year study of women who received radiation therapy to treat early-stage breast cancer, those receiving fewer, larger individual radiation doses experienced similarly low rates of late-onset side effects as those undergoing conventional radiation therapy. Findings from the...
ESMO 2018: Survival Results From STAMPEDE: Local Radiotherapy in Newly Diagnosed Metastatic Prostate Cancer With Low Disease Burden
Radiotherapy to the prostate improved overall survival in men newly diagnosed with metastatic prostate cancer who have a low metastatic disease burden, but not in those with higher burden of disease, according to results from a preplanned analysis of a large comparison study reported by Parker et...
ESMO 2018: JAVELIN Renal 101: Avelumab Plus Axitinib in Previously Untreated Renal Cell Carcinoma
A combination of the immune checkpoint blocker avelumab (Bavencio) plus the tyrosine kinase inhibitor axitinib (Inlyta) improved progression-free survival (PFS) in previously untreated patients with advanced renal cell carcinoma (RCC) in the phase III JAVELIN Renal 101 study, according to results...
ESMO 2018: SOLO-1: Olaparib Maintenance Extends Progression-Free Survival in BRCA1/2-Mutated Advanced Ovarian Cancer
Two-year maintenance therapy with olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, led to a substantial improvement in progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer and a BRCA1/2 mutation, results from the phase III SOLO-1 trial...
Cabozantinib in Advanced Hepatocellular Cancer: Call for Revision of Practice Standards
As reported in The New England Journal of Medicine by Ghassan K. Abou-Alfa, MD, and colleagues, and reviewed in this issue of The ASCO Post, the phase III CELESTIAL trial has demonstrated that cabozantinib (Cabometyx) improved the median overall survival to 10.2 months in comparison to 8 months...
Nivolumab Plus Ipilimumab in Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma
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 April 16, 2018, nivolumab (Opdivo) and ipilimumab...
ESMO 2018: SOLAR-1: Alpelisib in Patients With PIK3CA-Mutated HR-Positive, HER2-Negative Advanced Breast Cancer
Targeting a common mutation in patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with the alpha-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib improved progression-free survival, according to...
Current Treatment Landscape of Relapsed or Refractory Chronic Lymphocytic Leukemia
Novel agents such as ibrutinib (Imbruvica), idelalisib (Zydelig), and venetoclax (Venclexta) have transformed the treatment of chronic lymphocytic leukemia (CLL) and are increasingly used to treat the disease. The optimal sequencing of these agents is not clear in relapsed or refractory disease,...
Regardless of Taxane Used, Pembrolizumab Plus Chemotherapy Improves Survival in Squamous NSCLC
The addition of pembrolizumab (Keytruda) to a standard platinum doublet as first-line therapy improved overall and progression-free survival in patients with metastatic squamous non–small cell lung cancer (NSCLC), in the primary analysis of KEYNOTE-407.1,2 Furthermore, it did not seem to matter...
NELSON Trial: ‘Call to Action’ for Lung Cancer CT Screening of High-Risk Individuals
Results of the very large, randomized, population-based NELSON trial confirm the value of low-dose computed tomography (CT) screening in people at high risk for developing lung cancer. The protective value of screening was more pronounced in women than in men. These study findings were presented at ...
Expert Point of View: Everett Vokes, MD
“PACIFIC is a positive trial, with a 32% improvement in survival, and maintenance durvalumab is a new standard of care,” stated formal discussant Everett Vokes, MD, Chair of the Department of Medicine at the University of Chicago and a pioneer in the concurrent use of chemotherapy and radiotherapy ...
Durvalumab Improves Overall Survival in Unresectable Stage III NSCLC
Several lung cancer trials have shown prolonged progression-free survival with checkpoint inhibitor therapy. For the first time, the phase III PACIFIC trial has found an overall survival benefit for the selective programmed cell death ligand 1 (PD-L1) checkpoint inhibitor durvalumab (Imfinzi) vs...
