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Showing 4801 - 4850Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer: Delaying Overt Metastatic Disease Is a Major Advance
Nonmetastatic (M0) castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to...
ARAMIS Trial: Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer
In a phase III ARAMIS trial reported in The New England Journal of Medicine, Karim Fizazi, MD, of the Institut Gustave Roussy, Universite Paris-Sud, Villejuif, France, and colleagues found that the androgen-receptor antagonist darolutamide significantly prolonged metastasis-free survival vs placebo ...
Access Program to Be Established for Patients After Olaratumab Is Withdrawn From the Global Market
ELI LILLY AND COMPANY recently announced that it has been working to facilitate the withdrawal of olaratumab from the market for the treatment of advanced soft-tissue sarcoma. Lilly’s actions to withdraw olaratumab from the market follow completion of the international phase III ANNOUNCE clinical...
Comparison of Combination Dosing Schedules of Neoadjuvant Ipilimumab/Nivolumab in Macroscopic Stage III Melanoma
In the phase II OpACIN-neo study reported in The Lancet Oncology, Rozeman et al identified a promising dosing schedule for neoadjuvant ipilimumab/nivolumab in macroscopic stage III melanoma. Study Design The trial included 86 evaluable patients with resectable stage III melanoma involving the...
ENGOT-OV16/NOVA: Niraparib Maintenance According to Complete or Partial Response to Platinum Chemotherapy for Recurrent Ovarian Cancer
In an analysis of the phase III ENGOT-OV16/NOVA trial in recurrent ovarian cancer reported in the Journal of Clinical Oncology, del Campo et al found that patients had clinical benefit from niraparib maintenance vs placebo irrespective of whether they had a partial response or complete response to...
PERSEPHONE: 4-Year Disease-Free Survival With 6 vs 12 Months of Adjuvant Trastuzumab for HER2-Positive Breast Cancer
The 4-year disease-free survival results of the UK phase III PERSEPHONE trial, reported by Earl et al in The Lancet, found that 6 months of adjuvant trastuzumab was noninferior to 12 months when given with chemotherapy in HER2-positive early breast cancer. Study Details The open-label trial...
EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
EHA 2019: CLL12 Trial Investigates Ibrutinib in Previously Untreated, Asymptomatic Early-Stage CLL
At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...
EHA 2019: BELLINI Trial Evaluates Addition of Venetoclax to Bortezomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma
The phase III BELLINI trial—reported by Kumar et al at the 24th Annual Congress of the European Hematology Association (EHA; Abstract LB2601) investigated the efficacy and safety of venetoclax/bortezomib/dexamethasone vs bortezomib/dexamethasone in patients with relapsed or refractory...
EHA 2019: CASSIOPEIA Trial Examines Addition of Daratumumab to Standard Treatment Before and After ASCT in Multiple Myeloma
In the phase III CASSIOPEIA trial, reported in The Lancet and presented at the 24th Annual Congress of the European Hematology Association (EHA; Abstract S145) by Moreau et al, daratumumab plus bortezomib/thalidomide/dexamethasone (D-VTd) given before and after autologous stem cell transplantation...
Neoadjuvant Dabrafenib/Trametinib in Stage IIIB/C, BRAF V600–Mutant Melanoma
In the single-center, phase II NeoCombi trial reported in The Lancet Oncology, Long et al found that neoadjuvant dabrafenib plus trametinib produced promising response rates in resectable, stage IIIB/C, BRAF V600–mutant melanoma. As noted by the investigators, adjuvant dabrafenib plus...
2019 ASCO: 3-Year Outcomes in the KRISTINE Trial on Neoadjuvant Trastuzumab Emtansine Plus Pertuzumab in HER2-Positive Breast Cancer
As reported at the 2019 ASCO Annual Meeting (Abstract 500) and in the Journal of Clinical Oncology by Hurvitz et al, 3-year outcomes in the phase III KRISTINE trial showed that neoadjuvant trastuzumab emtansine (T-DM1) plus pertuzumab was associated with increased risk of event-free survival events ...
QuANTUM-R: Quizartinib vs Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD–Positive AML
In the phase III QuANTUM-R trial reported in The Lancet Oncology, Cortes et al found that the FLT3 inhibitor quizartinib produced a modest but significant improvement in overall survival vs salvage chemotherapy in relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute...
MAIA Trial: Addition of Daratumumab to Lenalidomide/Dexamethasone in Untreated Myeloma Ineligible for ASCT
In the phase III MAIA trial reported in The New England Journal of Medicine, Facon et al found that the addition of daratumumab to lenalidomide/dexamethasone significantly improved progression-free survival in previously untreated multiple myeloma ineligible for autologous stem cell transplantation ...
FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
2019 ASCO: Paclitaxel/Carboplatin vs Paclitaxel/Ifosfamide in Carcinosarcoma of the Uterus or Ovary
Results from the phase III NRG Oncology clinical trial GOG 0261 comparing paclitaxel plus carboplatin to paclitaxel plus ifosfamide in women with stage I–IV recurrent carcinosarcoma of the uterus or ovary found that treatment with paclitaxel/carboplatin was not inferior to...
2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma
New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival...
2019 ASCO: Addition of Veliparib to Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Results from an experimental arm of the phase II NRG-GI002 trial using veliparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, as part of total neoadjuvant therapy (induction chemotherapy followed by chemoradiotherapy and surgery) in patients with locally advanced rectal adenocarcinoma were...
Leonard J. Appleman, MD, PhD, on Metastatic Renal Cell Carcinoma: Pazopanib vs Placebo After Metastasectomy
Leonard J. Appleman, MD, PhD, of UPMC Hillman Cancer Center, discusses phase III trial findings that showed a trend toward worse survival with pazopanib in patients with metastatic kidney cancer who exhibited no evidence of disease following metastasectomy (Abstract 4502).
Sara A. Hurvitz, MD, on HER2-Positive Breast Cancer: KRISTINE Trial on Neoadjuvant Trastuzumab, Pertuzumab, and Chemotherapy
Sara A. Hurvitz, MD, of the David Geffen School of Medicine, University of California Los Angeles, discusses 3-year outcomes from the first phase III study to test a non-conventional regimen for the neoadjuvant and adjuvant treatment of HER2-positive breast cancer (Abstract 500).
Matthew A. Powell, MD, and Don S. Dizon, MD, on Uterine or Ovarian Cancer: Paclitaxel Plus Carboplatin vs Ifosfamide in Chemotherapy-Naive Patients
Don S. Dizon, MD, of the Lifespan Cancer Institute, and Matthew A. Powell, MD, of Washington University School of Medicine, discuss phase III findings on paclitaxel plus carboplatin vs paclitaxel plus ifosfamide in chemotherapy-naive patients with stages I to IV, persistent or recurrent...
2019 ASCO: TOPARP-B Finds Olaparib Shows Efficacy in Men With BRCA-Mutant Prostate Cancer
The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib may benefit some men with prostate cancer, according to findings from the phase II TOPARP-B trial presented by Mateo et al at the 2019 ASCO Annual Meeting (Abstract 5005). Olaparib previously showed activity against metastatic...
2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
2019 ASCO: Subgroups of Patients With Low-Grade Glioma May Benefit From PCV Chemotherapy Plus Radiotherapy
A recent, updated predictive analysis of the three World Health Organization (WHO)-defined molecular subgroups based on IDH mutation status and 1p/19q codeletion status represented in the high-risk treatment arms of a phase III trial found that both IDH-mutant subgroups may derive benefit ...
Cancer-Specific and Other-Cause Mortality Among Black Men With Prostate Cancer
In a study reported in JAMA Oncology, Dess et al found that after adjustment for nonbiologic differences, black men with nonmetastatic prostate cancer did not appear to have higher rates of prostate cancer–specific mortality vs white men. Black patients had higher rates of other-cause...
Addition of Bevacizumab to Erlotinib Improves Progression-Free Survival in EGFR-Mutated, Nonsquamous NSCLC
In an interim analysis of the phase III NEJ026 trial reported in The Lancet Oncology, Makoto Maemondo, MD, and colleagues found that the addition of bevacizumab to erlotinib improved progression-free survival in patients with EGFR-positive, nonsquamous non–small cell lung cancer (NSCLC). In the...
Actively Recruiting Clinical Trials Focused on Novel Drug Combinations for Gallbladder and Biliary Tract Cancers
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on novel drug regimens in gallbladder and biliary tract cancers. These trials are attempting to determine the best dosages, side-effect profiles, and effectiveness of new...
Major Settlement Raises Questions About Evidence-Based Value in Cancer Care
An Oklahoma jury recently awarded $25.5 million to the widower of a 53-year-old woman diagnosed with stage IV nasopharyngeal cancer who was denied coverage for proton therapy by her health insurer, Aetna. The patient’s family subsequently raised $92,000 to cover her proton therapy at The University ...
Selected Abstracts From the 2019 ASCO Annual Meeting
To complement The ASCO Post’s comprehensive coverage of the 2019 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for plasma cell dyscrasias, particularly multiple myeloma. For full details of these study abstracts, visit ...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Early in 2019, ibrutinib was approved for...
Survey Finds Prophylactic Cranial Irradiation Use in Decline for Extensive-Stage Small Cell Lung Cancer
Delivery of prophylactic cranial irradiation to patients with extensive-stage small cell lung cancer (SCLC) has declined significantly since the publication of a study by Takahashi et al, according to a recent survey of academic radiation oncologists.1 Data presented at the 2019 Multidisciplinary...
Head and Neck Cancer Immunotherapy in Locally Advanced Disease: Clinical Trial Updates
Programmed cell death protein 1 (PD-1) inhibitors are approved for the second-line treatment of head and neck cancer and likely will be soon in the first-line treatment of locally advanced disease. According to Robert L. Ferris, MD, PhD, developments in immunotherapy for this population should be...
Pembrolizumab Improves Survival vs Chemotherapy in Previously Untreated Advanced NSCLC With PD-L1 Expression ≥ 1%
As reported in The Lancet by Tony S.K. Mok, MD, of Chinese University of Hong Kong, and colleagues, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung ...
KEYNOTE-001 Shows Long-Term Survival Benefit With Pembrolizumab in Advanced NSCLC
Before the introduction of immunotherapy with checkpoint inhibitors, the 5-year life expectancy for patients with advanced non–small cell lung cancer (NSCLC) was 5.5%. This dismal outlook has changed. Treatment with the immune checkpoint inhibitor pembrolizumab dramatically improved overall...
MONALEESA-7 Shows Overall Survival Benefit for Ribociclib/Endocrine Therapy
The first statistically significant overall survival benefit has been shown for a cyclin-dependent kinase (CDK) 4/6 inhibitor plus endocrine therapy as first-line treatment of advanced breast cancer. The results are from the phase III MONALEESA-7 trial, which evaluated ribociclib plus endocrine...
Activity of Selumetinib in Pediatric Pilocytic Astrocytoma and Low-Grade Glioma
In a phase II trial reported in The Lancet Oncology, Fangusaro et al found that the MEK1/2 inhibitor selumetinib was active in pediatric patients with recurrent, refractory, or progressive pilocytic astrocytoma with common BRAF aberrations and neurofibromatosis type 1...
Adam Brufsky, MD, PhD, on HER2-Positive Metastatic Breast Cancer: NALA Trial on Neratinib vs Lapatinib Plus Capecitabine
Adam Brufsky, MD, PhD, of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center, discusses phase III study findings on neratinib plus capecitabine vs lapatinib plus capecitabine in patients previously treated for HER2-positive metastatic breast cancer...
Ahmad A. Tarhini, MD, PhD, on High-Risk Melanoma: Adjuvant Ipilimumab vs High-Dose Interferon-α2b
Ahmad A. Tarhini, MD, PhD, of Emory University and Winship Cancer Institute, discusses phase III findings from the U.S. Intergroup E1609 trial, which showed survival benefits for patients with resected high-risk melanoma—for the first time in the history of melanoma adjuvant therapy (Abstract...
2019 ASCO: Partial- vs Whole-Breast Irradiation in Early-Stage Breast Cancer
Partial-breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole-breast irradiation for many women with low-risk, early-stage breast cancer, according to new data from the NRG Oncology/NSABP B-39/RTOG 0413 trial. Results were presented by Ganz et al...
IMpower130: Addition of First-Line Atezolizumab to Chemotherapy in Metastatic Nonsquamous NSCLC
As reported in The Lancet Oncology by West et al, the phase III IMpower130 trial found that the addition of atezolizumab to carboplatin plus nab-paclitaxel significantly improved overall and progression-free survival in first-line treatment of stage IV nonsquamous non–small cell lung cancer...
Javier Sastre, MD, PhD, on Colorectal Cancer: Bevacizumab and FOLFOXIRI in Metastatic Disease
Javier Sastre, MD, PhD, of Hospital Clinico San Carlos, discusses phase III findings on the assessment of circulating tumor cells as a prognostic factor and FOLFOXIRI plus bevacizumab combination outcomes for patients with poor-prognosis colorectal cancer (Abstract 3507).
Sagar Lonial, MD, on Smoldering Multiple Myeloma: Delaying Disease Progression With an Immunomodulatory Agent
Sagar Lonial, MD, of Winship Cancer Institute of Emory University, discusses the potentially practice-changing phase III findings showing that lenalidomide substantially delayed progression of smoldering multiple myeloma to aggressive disease when compared with observation alone (Abstract 8001).
Angela Lamarca, MD, PhD, on Biliary Tract Cancers: Active Symptom Control With Oxaliplatin and Fluorouracil
Angela Lamarca, MD, PhD, of The Christie NHS Foundation Trust and the University of Manchester, discusses phase III findings from a multicenter study of active symptom control alone or active symptom control with oxaliplatin and fluorouracil for patients with locally advanced or metastatic biliary...
Richard T. Penson, MD, and Don S. Dizon, MD, on Ovarian Cancer: SOLO3 Trial on Olaparib vs Chemotherapy in Relapsed Disease
Don S. Dizon, MD, of the Lifespan Cancer Institute, and Richard T. Penson, MD, of Massachusetts General Hospital Cancer Center, discuss phase III study findings on the PARP inhibitor olaparib, which showed a significantly higher objective response rate vs nonplatinum chemotherapy for patients with...
Gilberto Lopes, MD, MBA, on the RELAY Trial in Metastatic NSCLC: Erlotinib and Ramucirumab in EGFR Mutant–Positive Disease
Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, offers commentary on phase III findings from the RELAY study, which showed that erlotinib plus ramucirumab led to superior progression-free survival in previously untreated patients with EGFR...
Kim N. Chi, MD, on Metastatic Castration-Sensitive Prostate Cancer: First Results From the TITAN Trial
Kim N. Chi, MD, of BC Cancer, discusses the first phase III findings from the TITAN study of apalutamide vs placebo in patients with metastatic castration-sensitive prostate cancer receiving androgen-deprivation therapy (Abstract 5006).
Michael J. Morris, MD, on Metastatic Prostate Cancer: Adding Abiraterone Acetate to Enzalutamide
Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center, discusses the phase III findings from the Alliance A031201 trial, which showed that adding abiraterone acetate to enzalutamide did not improve survival in men with metastatic castration-resistant prostate cancer (Abstract 5008).
Patricia A. Ganz, MD, on Breast Cancer: Whole- vs Partial-Breast Irradiation
Patricia A. Ganz, MD, of NRG Oncology and Jonsson Comprehensive Cancer Center at UCLA, discusses the NRG/NSABP phase III findings, which showed that partial-breast irradiation was more convenient and resulted in less fatigue but slightly poorer cosmesis at 36 months in patients who did not receive...
Paul G. Richardson, MD, on Relapsed or Refractory Multiple Myeloma: Adding Isatuximab to Pomalidomide and Low-Dose Dexamethasone
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses findings from the phase III ICARIA-MM trial showing that isatuximab, pomalidomide, and low-dose dexamethasone significantly improved progression-free survival and overall response vs pomalidomide and dexamethasone (Abstract 8004).
