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Showing 1751 - 1800Adding Apalutamide to Abiraterone/Prednisone Extends Radiographic Progression-Free but Not Overall Survival
The phase III ACIS trial met its primary endpoint at 6 months showing that apalutamide plus abiraterone acetate/prednisone (AAP) extended radiographic progression-free survival vs abiraterone acetate/prednisone alone in patients with chemotherapy-naive metastatic castration-resistant prostate...
SWOG 1500: Cabozantinib Extends Progression-Free Survival vs Sunitinib in Metastatic Papillary Renal Cell Carcinoma
Cabozantinib achieved a statistically significant and clinically meaningful extension in progression-free survival compared with sunitinib in patients with metastatic papillary renal cell carcinoma, a relatively uncommon type of renal cell carcinoma, according to the randomized phase II SWOG 1500...
Comparing Radiotherapy Regimens for Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
A dose-intensified approach to salvage radiotherapy failed to show superiority to a conventional-dose strategy in patients with biochemically recurrent prostate cancer who had undergone radical prostatectomy, according to the phase III SAKK 09/10 trial presented at the 2021 Genitourinary Cancers...
LuPSMA Outperforms Cabazitaxel for Metastatic Castration-Resistant Prostate Cancer in Phase II Trial
Following disease progression on docetaxel, prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy reduced the risk of disease progression or death by 37% vs cabazitaxel in men with metastatic castration-resistant prostate cancer in the TheraP phase II trial reported at the 2021...
EV-301 and EV-201 Trials: Enfortumab Vedotin-ejfv Improves Survival in Metastatic Urothelial Cancer
Enfortumab vedotin-ejfv continues to move the needle forward as a validated treatment option for advanced urothelial carcinoma. At the 2021 Genitourinary Cancers Symposium, results from the phase III EV-301 study1 and EV-201 Cohort 22 provided support for the use of this agent in both patients...
No Benefit Found for Everolimus Plus Adjuvant Hormone Therapy in High-Risk Early-Stage Breast Cancer
Everolimus plus hormone therapy improves outcomes in the advanced disease setting but apparently not in the adjuvant setting, according to the results of the UNIRAD trial, presented as a part of the European Society for Medical Oncology (ESMO) Virtual Plenary program.1 “In the UNIRAD study, after...
Lenvatinib/Pembrolizumab Combination Improves Outcomes vs Sunitinib in Renal Cell Carcinoma
The combination of lenvatinib plus pembrolizumab was superior to sunitinib for progression-free and overall survival as well as other key endpoints in patients with advanced clear cell renal cell carcinoma (RCC), according to results of the phase III CLEAR trial presented at the 2021 Genitourinary ...
Nivolumab: First Adjuvant Immunotherapy to Show Survival Benefit in High-Risk Muscle-Invasive Urothelial Cancer
Adjuvant therapy with nivolumab, an anti–PD-1 immune checkpoint inhibitor, after radical surgery improved disease-free survival in high-risk muscle-invasive urothelial cancer regardless of PD-L1 status, according to the results of the CheckMate 274 randomized phase III trial presented at the 2021...
FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma
On March 22, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the...
Image-Guided Intensity-Modulated Radiotherapy in Patients With Cervical Cancer
Treatment with image-guided intensity-modulated radiotherapy (IG-IMRT) led to reduced late toxicities vs standard three-dimensional (3D) conformal radiotherapy in patients with cervical cancer, according to data presented by Supriya Chopra, MD, and colleagues during the Society of Gynecologic...
Niraparib Plus Bevacizumab Shows Clinical Benefit in Patients With Advanced Ovarian Cancer
The addition of niraparib maintenance to first-line platinum-based chemotherapy with bevacizumab demonstrated clinical benefit in patients with advanced ovarian cancer, according to data from the OVARIO study presented by Melissa M. Hardesty, MD, MPH, during the Society of Gynecologic Oncology...
Benefit of Niraparib Maintenance Therapy Extends Beyond First Disease Progression in Recurrent Ovarian Cancer
The PARP (poly [ADP-ribose] polymerase) inhibitor niraparib is safe for long-term use and effective as maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer, according to data presented by Ursula A. Matulonis, MD, at the Society of Gynecologic Oncology (SGO) 2021...
Phase III ARIEL4 Trial Confirms Benefit of Rucaparib in BRCA-Mutated Relapsed Ovarian Cancer
In patients with BRCA-mutated, advanced, relapsed ovarian cancer, treatment with the PARP (poly [ADP-ribose] polymerase) inhibitor rucaparib led to a significant improvement in progression-free survival compared with standard-of-care chemotherapy. These results from the international phase III...
Pembrolizumab/Lenvatinib May Improve Survival in Advanced Endometrial Cancer
In the first report from the pivotal phase III KEYNOTE-775/Study 309 trial, the combination of lenvatinib and pembrolizumab significantly improved multiple outcomes compared to standard single-agent chemotherapy in patients with advanced, metastatic, or recurrent endometrial cancer that had...
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved in the past 15 months alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and Drug ...
FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
On March 10, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. TIVO-3 Efficacy was evaluated in TIVO-3 (ClinicalTrials.gov...
Expert Point of View: Rina Hui, MBBS, PhD, and Melina Marmarelis, MD
“It has been a long time coming to see a positive randomized phase III study with a checkpoint inhibitor in relapsed mesothelioma,” said the study’s invited discussant, Rina Hui, MBBS, PhD, Clinical Professor of Medicine, Crown Princess Mary Cancer Centre, Westmead Hospital, University of Sydney,...
CONFIRM Trial Reports Improvement in Survival With Nivolumab in Relapsed Malignant Mesothelioma
For the first time, a treatment has been shown to improve overall survival in heavily pretreated patients with relapsed malignant mesothelioma. In the phase III CONFIRM trial, single-agent nivolumab led to a significant improvement in both overall and progression-free survival, according to...
Expert Point of View: Frank Keller, MD, and E. Anders Kolb, MD
Frank Keller, MD, a pediatric hematologist/oncologist with Children’s Healthcare of Atlanta–Egleston Hospital, and E. Anders Kolb, MD, Director of the Nemours Center for Cancer and Blood Disorders, Nemours Children’s Health System in Delaware, provided comments on the studies for The ASCO Post....
Studies Provide Guidance on the Use of Blinatumomab in Pediatric Acute Lymphoblastic Leukemia
Monotherapy with blinatumomab as consolidation therapy before allogeneic stem cell transplant appears to be the optimal treatment for children with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (ALL), according to an international phase III trial that compared this approach...
FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. ZUMA-5 Approval in follicular lymphoma was based on a...
Expert Point of View: John C. Krauss, MD
Invited discussant John C. Krauss, MD, Medical Oncology Director of the Multidisciplinary Colorectal Cancer Clinic, Rogel Cancer Center of the University of Michigan, Ann Arbor, said he was impressed by the “rapidity with which the NRG-GI002 trial accrued,” which was about 10 months.1 “Equally...
Study Reports Little Benefit to Adding Pembrolizumab to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
The addition of pembrolizumab to neoadjuvant chemotherapy and radiotherapy (ie, total neoadjuvant therapy) failed to improve a rectal cancer–specific surrogate for survival in patients with locally advanced disease in the phase II NRG-GI002 trial.1 As reported at the 2021 Gastrointestinal Cancers...
FDA Pipeline: Designations in Ovarian, Head/Neck, and Thyroid Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a novel immunotherapy for the treatment of ovarian cancer as well as Breakthrough Therapy designation to treatments for HRAS-mutant head and neck squamous cell carcinoma and previously treated thyroid cancer....
Long-Term Follow-up of Adjuvant Imatinib for Localized Gastrointestinal Stromal Tumors
Final analysis of a collaborative intergroup study confirmed the efficacy of adjuvant treatment with imatinib in patients with localized gastrointestinal stromal tumor (GIST) in terms of prolonged relapse-free survival. In the high-risk subgroup, there was a trend toward a better long-term imatinib ...
FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the...
CLEAR Trial: Is Lenvatinib Plus Pembrolizumab the Best First-Line Immunotherapy Doublet in Metastatic Renal Cell Carcinoma?
At the 2021 Genitourinary Cancers Symposium, Motzer et al presented the clinical results of the CLEAR trial, adding a novel regimen, lenvatinib plus pembrolizu-mab, to the growing armamentarium of first-line treatments for patients with metastatic clear cell renal cell carcinoma (RCC). The...
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is...
Updates From Selected Clinical Trials in Breast Cancer
Each year, following the San Antonio Breast Cancer Symposium (SABCS), The ASCO Post asks Jame Abraham, MD, FACP, to offer his picks of the most important and most clinically relevant research presented at this meeting. The following are summaries of studies that caught Dr. Abraham’s attention from ...
KEYNOTE-177: New Analysis Confirms Benefit of Pembrolizumab vs Chemotherapy in Microsatellite Instability–High Advanced Colorectal Cancer
In an updated analysis of the pivotal phase III KEYNOTE-177 trial in microsatellite instability–high (MSI-H) metastatic colorectal cancer, the benefit of first-line pembrolizumab continued beyond disease progression on the subsequent line of treatment, despite a high crossover to immunotherapy for...
SIMPLIFY Trials: JAK Inhibitor Yields Long-Term Survival Benefit and Transfusion Independence in Myelofibrosis
Treatment with the novel JAK inhibitor momelotinib led to long-term overall survival and sustained transfusion independence in patients with intermediate- or high-risk myelofibrosis, according to updates from the SIMPLIFY-1 and SIMPLIFY-2 trials presented at the 2020 American Society of Hematology...
Expert Point of View: Yun Fan, MD, and Deborah Doroshow, MD, PhD
Invited discussant of KEYNOTE-598,1Yun Fan, MD, Director of Thoracic Tumor Center at Zhejiang Cancer Hospital in Hangzhou, China, suggested that patients with non–small cell lung cancer (NSCLC) with low PD-L1 expression and those with high tumor mutational burden may, in fact, derive the most...
KEYNOTE-598: No Improvement With Addition of Ipilimumab to Pembrolizumab in NSCLC
In the phase III KEYNOTE-598 study, the addition of ipilimumab to pembrolizumab increased toxicity without boosting efficacy as first-line therapy for metastatic non–small cell lung cancer (NSCLC) in patients with high expression of PD-L1. The findings were presented at the International...
Novel Approaches in Chronic Lymphocytic Leukemia
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic approaches in chronic lymphocytic leukemia (CLL). For full...
Updated Findings Bolster the Use of Checkpoint Inhibitors in Treatment of Liver Cancer
Although optimal regimens are still being determined, checkpoint inhibition has clearly established itself in the treatment of hepatocellular carcinoma, as judged by the number of abstracts on the topic at the 2021 Gastrointestinal Cancers Symposium. The ASCO Post brings readers short summaries of ...
Addition of Lenalidomide to R-CHOP in Newly Diagnosed Patients With DLBCL
In a phase II signal-seeking trial (ECOG-ACRIN E1412) reported in the Journal of Clinical Oncology, Grzegorz S. Nowakowski, MD, and colleagues found that the addition of lenalidomide (R) to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R2CHOP) improved outcomes...
FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression
On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved...
NEOSTAR: Neoadjuvant Nivolumab or Nivolumab/Ipilimumab in Operable NSCLC
The randomized phase II NEOSTAR trial, which examined single-agent and combined neoadjuvant immune checkpoint inhibitor therapy in patients with stage I to III non–small cell lung cancer (NSCLC), found combination therapy produced a significant clinical benefit (as assessed by major pathologic...
Ruxolitinib Improves Outcomes in Steroid-Refractory or Steroid-Dependent Graft-vs-Host Disease
Ruxolitinib was superior to best available therapy in achieving efficacy as determined by best overall response and duration of response, with acceptable safety in adolescents and adults with steroid-dependent or steroid-refractory chronic graft-vs-host disease effects. These findings were shown in ...
Transplant May Improve Survival in Older Patients With High-Risk Myelodysplastic Syndrome
Stem cell transplants are not frequently offered to older patients with high-risk myelodysplastic syndromes (MDS). According to a study from the Blood and Marrow Transplant Clinical Trials Network (BMTCTN 1102), these patients may indeed achieve a survival benefit from stem cell transplant. As...
DREAMM-2 Analysis: Number of Prior Treatments No Hindrance to Efficacy of Belantamab Mafodotin-blmf
A post hoc analysis of the phase II DREAMM-2 trial showed single-agent belantamab mafodotin-blmf to be efficacious and tolerable in patients with relapsed or refractory multiple myeloma treated with at least three prior therapies, investigators reported at the 2020 American Society of Hematology...
Subcutaneous Daratumumab Meets Primary Endpoint in APOLLO Trial in Myeloma
The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...
Study Finds Asciminib Safer, More Effective Than Bosutinib in Chronic-Phase CML
Since the introduction of imatinib almost 18 years ago, similar next-generation tyrosine kinase inhibitors have been approved for chronic myeloid leukemia (CML), including dasatinib, nilotinib, bosutinib, and ponatinib. These drugs attack a similar target, making it more likely that resistance to...
Prevalence of Cisplatin-Related Hearing Loss in Pediatric, Adolescent, and Young Adult Patients
Cisplatin is one of the most effective chemotherapy agents, used in just under half of pediatric cancer cases. Permanent hearing loss is a common side effect of this medication, but previous studies have been too small and too varied to accurately characterize this risk. In a new study published by ...
LuPSMA vs Cabazitaxel for Metastatic Castration-Resistant Prostate Cancer: Phase II TheraP Trial
Following disease progression on docetaxel, prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy reduced the risk of disease progression or death by 37% vs cabazitaxel in men with metastatic castration-resistant prostate cancer in the phase II TheraP trial reported by Michael S....
Lenvatinib Combination Regimens vs Sunitinib in Renal Cell Carcinoma: Phase III CLEAR Trial
The combination of lenvatinib plus pembrolizumab showed superiority over sunitinib in terms of overall survival, progression-free survival, and objective response rate in patients with advanced clear cell renal cell carcinoma (RCC), according to results of the phase III CLEAR trial. The CLEAR study ...
Dose-Intensified Radiotherapy Not Superior to Conventional Regimen for Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
A dose-intensified approach to salvage radiotherapy failed to show superiority to a conventional dose strategy in patients with biochemically recurrent prostate cancer who had undergone radical prostatectomy, according to a study presented by Pirus Ghadjar, MD, and colleagues at the 2021...
Fecal Microbiota Transplants May Help Patients With Advanced Melanoma Respond to Immunotherapy
For patients with melanoma who do not respond to treatment with immunotherapy, adjusting the composition of microorganisms in the intestines through the use of fecal transplants may aid in overcoming resistance to therapy. These findings were published by Davar et al in Science. In the study, some...
Enfortumab Vedotin-ejfv Prolongs Survival in Patients With Metastatic Urothelial Carcinoma
Treatment with the antibody-drug conjugate enfortumab vedotin-ejfv has been found to significantly increase survival of patients with metastatic urothelial carcinoma, according to results from the phase III EV-301 clinical trial. These findings were presented by Thomas Powles, MD, PhD, and...
Update From ACIS Trial of Apalutamide Plus Abiraterone/Prednisone in Metastatic Prostate Cancer
The phase III ACIS trial met its primary endpoint at 6 months, showing that apalutamide plus abiraterone acetate/prednisone extended radiographic progression-free survival vs abiraterone acetate/prednisone alone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer. An ...
