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Showing 5001 - 5050ECHO-301/KEYNOTE-252: Addition of Epacadostat to Pembrolizumab in Unresectable or Metastatic Melanoma
As reported in The Lancet Oncology by Long et al, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma. Study Details In the...
Failure-Free Survival With Ultrahypofractionated vs Conventionally Fractionated Radiotherapy in Prostate Cancer
In the Scandinavian phase III HYPO-RT-PC trial reported in The Lancet, Widmark et al found that ultrahypofractionated radiotherapy was noninferior to conventionally fractionated radiotherapy in failure-free survival in patients with intermediate- to high- risk prostate cancer. Study Details In...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
15-ICML: ROBUST Trial Examines Efficacy of Lenalidomide/R-CHOP in Previously Untreated ABC-Type DLBCL
The ROBUST trial compared the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone) vs placebo/R-CHOP in previously untreated, prospectively selected, CD20-positive patients with activated B-cell–like (ABC)-type diffuse large B-cell...
15-ICML: Genotyping of ctDNA in Classical Hodgkin Lymphoma
An abstract presented by Camus et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 138) found that targeted genotyping of circulating tumor DNA (ctDNA) in classical Hodgkin lymphoma at diagnosis “may help to assess early treatment response in complement to...
Final Analysis of the PHARE Trial: 6 Months vs 12 Months of Adjuvant Trastuzumab in HER2-Positive Breast Cancer
In the French phase III PHARE trial reported in The Lancet, Pivot et al found that noninferiority of 6 months vs 12 months of adjuvant trastuzumab combined with standard chemotherapy could not be demonstrated for disease-free survival in HER2-positive early breast cancer. An earlier interim...
Does Adjuvant Chemoradiotherapy Extend Relapse-Free Survival in Stage III or IVA Endometrial Cancer?
In the phase III GOG 258 trial reported in The New England Journal of Medicine, Matei et al found that 6 months of adjuvant platinum-based chemotherapy plus radiation therapy did not improve relapse-free survival vs chemotherapy alone in stage III or IVA endometrial cancer. In the open-label...
Noninferiority Trial Establishes Chemoradiotherapy Regimen as ‘First Standard of Care for HPV-Positive Oral Cancer’
A noninferiority phase III trial, previously reported in The Lancet, has established the standard of care in human papillomavirus (HPV)-related oral cancer, according to Andy M. Trotti, MD, a radiation oncologist at Moffitt Cancer Center in Tampa, Florida. Data from the NRG Oncology RTOG 1016 trial ...
Synergistic Relationship Between Radiotherapy and Immunotherapy for Squamous Cell Carcinoma of the Head and Neck
Recent technologic improvements in radiotherapy now offer an unprecedented opportunity to enhance immune response, and going forward, may play a role in the definitive treatment of head and neck cancer, according to William Stokes, MD, Assistant Professor in the Department of Radiation Oncology at...
Immune Therapies Emerging in Disease-Specific Treatment of HPV-Positive Head and Neck Cancer
Patients with human papillomavirus (HPV)-related head and neck cancer stand to benefit greatly from immunotherapy, according to Nabil F. Saba, MD, FACP, Director, Head and Neck Medical Oncology Program, Winship Cancer Institute of Emory University, Atlanta. He added, immunotherapy will likely play...
Improved Survival Shown With First-Line Pembrolizumab in Advanced Head and Neck Cancer
In the final analysis of KEYNOTE-048, first-line pembrolizumab monotherapy led to a significant improvement in overall survival, vs standard chemotherapy with targeted therapy (EXTREME regimen), in patients with recurrent or metastatic head and neck squamous cell carcinoma expressing programmed...
Fixed-Duration Venetoclax Plus Obinutuzumab as First-Line Treatment in Older Patients With CLL Who Have Comorbidities
A fixed-duration regimen of venetoclax plus obinutuzumab demonstrated superior progression-free survival, complete response rates, and minimal residual disease (MRD) negativity compared with chlorambucil plus obinutuzumab as first-line therapy for older patients with chronic lymphocytic leukemia...
Apalutamide Improves Survival Outcomes in Castration-Sensitive Metastatic Prostate Cancer in TITAN Trial
Adding apalutamide to androgen-deprivation therapy (ADT) significantly improved survival in men with metastatic castration-sensitive (also termed hormone-sensitive) prostate cancer, according to the results of the phase III TITAN trial, which were presented at the 2019 ASCO Annual Meeting and...
KEYNOTE-062: Pembrolizumab Is a New First-Line Option in Gastric/Gastroesophageal Junction Cancer
KEYNOTE-062, a study of first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, found pembrolizumab to be noninferior to chemotherapy and perhaps better than chemotherapy in a subgroup of patients. The results were reported at the 2019 ASCO Annual Meeting ...
POLO Trial Shows Maintenance Olaparib Improves Progression-Free Survival in Metastatic Pancreatic Cancer
In patients with metastatic pancreatic cancer and germline mutations in BRCA1 or BRCA2, maintenance therapy with olaparib doubled the time to disease progression and the proportion of patients who were progression-free at 2 years, in the phase III POLO trial.1 “Maintenance olaparib provided a...
ENZAMET Trial Shows Enzalutamide Improves Overall Survival in Hormone-Sensitive Metastatic Prostate Cancer
Agents that improve survival in metastatic castration-resistant prostate cancer when added to background androgen-deprivation therapy (ADT) are showing success in treating metastatic prostate cancer earlier while it is still hormone-sensitive. These agents include docetaxel (chemotherapy) and...
Evidence Lacking That Denosumab Alters the Course of Breast Cancer
I am writing to provide personal context to my column on adjuvant denosumab or bisphosphonates for resected breast cancer, which appears on page 52 in this issue of The ASCO Post. I have been upset since 2013 that adjuvant zoledronate has been recommended for women with breast cancer onset after...
Darolutamide 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...
