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Showing 5551 - 5600Phase III Trial Shows No Benefit of Afatinib vs Trastuzumab Plus Vinorelbine in HER2-Positive Metastatic Breast Cancer
In the phase III LUX-Breast 1 trial reported in The Lancet Oncology, Harbeck et al found no benefit of afatinib (Gilotrif)/vinorelbine vs trastuzumab (Herceptin)/vinorelbine after previous trastuzumab treatment in patients with HER2-positive metastatic breast cancer. Broader inhibition of ErbB...
Single-Center Trial Indicates No Benefit of Hepatic Artery Chemoembolization vs Embolization in Hepatocellular Carcinoma
In a phase II study reported in the Journal of Clinical Oncology, Brown et al found no apparent benefit of hepatic artery chemoembolization using doxorubicin-eluting microspheres vs embolization with microspheres alone in patients with hepatocellular carcinoma. Study Details In the trial, 101...
Improved Melanoma-Specific Survival Reported With Wider Excision Margin in High-Risk Primary Melanoma
Wider excision margins in high-risk primary cutaneous melanoma were associated with improved melanoma-specific survival, according to long-term follow-up in a UK-led trial reported by Hayes et al in The Lancet Oncology. No significant improvement in overall survival was observed. The initial report ...
UK Trial Shows No Survival Benefit of Low–Molecular-Weight Heparin in Patients With Lung Cancer
In the UK phase III FRAGMATIC trial reported in the Journal of Clinical Oncology, Macbeth et al found no survival benefit of adding low–molecular-weight heparin to standard treatment in patients with lung cancer. Previous evidence suggested that low–molecular-weight heparin might...
ASCO Endorses Cancer Care Ontario Guideline on Active Surveillance for Management of Localized Prostate Cancer
As reported by Ronald C. Chen, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in the Journal of Clinical Oncology, ASCO has endorsed, with qualifications, the 2015 Cancer Care Ontario (CCO) guideline on active surveillance for management of localized prostate cancer....
Minimal Residual Disease Identified by NPM1 Mutation May Be Prognostic Marker for Poorer Outcome in Standard-Risk AML
In a study reported in The New England Journal of Medicine, Ivey et al found that a leukemia-specific marker consisting of a mutation in the gene encoding nucleophosmin (NPM1) can be used to identify minimal residual disease in peripheral blood in standard-risk acute myeloid leukemia (AML), with...
ASCO Clinical Practice Guideline Update on Ovarian Suppression/Adjuvant Endocrine Therapy in Hormone Receptor–Positive Breast Cancer
As reported in the Journal of Clinical Oncology by Burstein et al, ASCO has released a clinical practice guideline update on ovarian suppression as part of the extant guideline on adjuvant endocrine therapy in hormone receptor–positive breast cancer. The update is based on an update panel...
No Survival Benefit of Pemetrexed/Cisplatin Chemoradiation vs Standard Treatment in Nonresectable Stage III NSCLC
As reported by Senan et al in the Journal of Clinical Oncology, the phase III PROCLAIM trial showed no significant improvement in overall survival for chemoradiation with pemetrexed (Alimta)/cisplatin vs etoposide/cisplatin followed by consolidation pemetrexed vs a platinum-based doublet in...
Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status
On January 23, 2016, the indication for nivolumab (Opdivo) plus ipilimumab (Yervoy) in unresectable or metastatic melanoma was expanded through accelerated approval to include patients regardless of BRAF V600 mutation status.1 The combination was previously approved for treatment of patients with...
Rolapitant Reduces Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately and Highly Emetogenic Chemotherapy
In three phase III studies reported in The Lancet Oncology, the addition of the neurokinin-1 (NK-1) receptor antagonist rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in the prevention of chemotherapy-induced nausea and ...
Ofatumumab for Extended Treatment of Patients With Recurrent or Progressive Chronic Lymphocytic Leukemia
On January 19, 2016, ofatumumab (Arzerra) was approved for extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).1,2 Ofatumumab was previously approved for treatment of untreated patients...
Antithymocyte Globulin Reduces Need for Immunosuppressants After Hematopoietic Cell Transplantation From Unrelated Donors
In a phase III trial reported in The Lancet Oncology, Walker et al found that treatment with antithymocyte globulin reduced the need for immunosuppressive therapy in patients with hematologic malignancies receiving hematopoietic cell transplantation from unrelated donors. Study Details In this...
Increased Risk of Severe Neurocognitive Impairment in Adult Survivors of Pediatric CNS Tumors
As reported in the Journal of Clinical Oncology by Brinkman et al, a study in the St. Jude Lifetime Cohort showed that adult survivors of pediatric central nervous system (CNS) tumors are at increased risk of severe neurocognitive impairment. Study Details The study involved 224 survivors of CNS...
Eribulin Improves Overall Survival vs Dacarbazine in Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in The Lancet, Schöffski et al found that eribulin improved overall survival vs dacarbazine in patients with advanced or metastatic soft-tissue sarcoma who had received at least two prior systemic treatments for advanced disease. Outcome in the subgroup with...
Intense Tumor Lymphocytic Infiltration Prognostic of Better Outcome in Resectable NSCLC
Intense tumor lymphocytic infiltration was associated with improved outcomes in patients with resectable non–small cell lung cancer, according to a study reported in the Journal of Clinical Oncology by Brambilla et al. Study Details The LACE-Bio (Lung Adjuvant Cisplatin Evaluation...
High Conditional Survival for Patients With Metastatic Testicular Germ Cell Tumors Receiving First-Line Curative Therapy
Two-year conditional overall and disease-free survival were substantially increased in patients surviving and surviving without recurrence for 2 years after first-line curative therapy for metastatic testicular germ cell tumors, according to a study reported by Ko et al in the Journal of Clinical...
Dutch Study Shows Increased Risk of Second Cancer for Survivors of Hodgkin Lymphoma During Long-Term Follow-up
In a Dutch study reported in The New England Journal of Medicine, Schaapveld et al found that survivors of Hodgkin lymphoma treated between 1965 and 2000 were at a 4.6-fold greater risk of second cancer vs the general population during long-term follow-up. There was no significant difference in the ...
Study Finds Enzalutamide Increases Progression-Free Survival vs Bicalutamide in Metastatic Prostate Cancer
Use of the androgen receptor–inhibitor enzalutamide (Xtandi) more than doubled progression-free survival vs the nonsteroidal antiandrogen bicalutamide in patients with metastatic prostate cancer progressing on androgen-deprivation therapy, according to the randomized phase II TERRAIN trial...
ACS/ASCO Breast Cancer Survivorship Care Guideline
The American Cancer Society (ACS) and ASCO have issued a Breast Cancer Survivorship Care guideline, published jointly in the Journal of Clinical Oncology and CA: A Cancer Journal for Clinicians. The guideline recommendations were formulated by a multidisciplinary expert work group and are based on...
Reduction in Late Mortality in Childhood Cancer Survivors in the Childhood Cancer Survivor Study Cohort
In a study reported in The New England Journal of Medicine, Armstrong et al found that late mortality decreased over time among 5-year survivors of childhood cancer in the Childhood Cancer Survivor Study cohort. The reduction is consistent with efforts during recent decades to modify treatment with ...
Addition of TG4010 Vaccine to First-Line Chemotherapy Appears to Improve Progression-Free Survival in Advanced NSCLC
As reported in The Lancet Oncology by Quoix et al, the addition of immunotherapy with TG4010—the modified vaccinia Ankara expressing MUC1 and interleukin 2—to first-line chemotherapy improved progression-free survival in patients with advanced non–small cell lung cancer (NSCLC) in ...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 11, 2015, alectinib (Alecensa) was granted...
No Benefit of Adding Adjuvant and Maintenance Lapatinib to Chemoradiation in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck
In a phase III trial reported in the Journal of Clinical Oncology, Harrington et al found that the addition of concurrent adjuvant lapatinib (Tykerb) to chemoradiation therapy and the use of maintenance lapatinib did not improve disease-free or overall survival in high-risk patients with resected...
Similar Low Incidence of Bowel Symptoms With Hypofractionated vs Conventionally Fractionated Radiotherapy in Localized Prostate Cancer
As reported by Wilkins et al in The Lancet Oncology, 2-year patient-reported outcomes in a UK phase III trial (CHHiP) substudy have shown a similar low incidence of bowel problems among patients with intermediate-risk localized prostate cancer receiving hypofractionated vs conventionally...
Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 18, 2015, approval of the programmed cell death...
Increased Incidence of in Situ and Invasive Melanoma in Denmark
In a study reported in JAMA Dermatology,1 Neel Maria Helvind, MD, of the University Hospital Rigshospitalet, Copenhagen, Denmark, and colleagues analyzed the increases in melanoma incidence seen in Denmark between 1985 and 2012. Over that time, the incidence of malignant melanoma doubled to rates...
Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation in Older Patients With AML in First Remission
In a phase II study (CALGB 100103/Alliance/Blood and Marrow Transplant Clinical Trial Network 0502) reported in the Journal of Clinical Oncology,1 Steven M. Devine, MD, of The Ohio State University, Columbus, et al found that reduced-intensity conditioning allogeneic hematopoietic stem cell...
Transcription Factor CDX2 May Be Prognostic Biomarker in Stage II and III Colon Cancer
In a study reported in The New England Journal of Medicine, Dalerba et al found that absence of the transcription factor CDX2, although prognostic for poor outcome in stage II and III colon cancer vs cancers with CDX2 expression, identified a subgroup of high-risk patients who appeared to benefit...
Increased Survival and Toxicity With Docetaxel, No Apparent Benefit of Zoledronic Acid in Prostate Cancer
As reported in The Lancet by James et al, results of the STAMPEDE trial, which used a multiarm, multistage seamless phase II/III design, showed increased survival and toxicity with docetaxel and little benefit of zoledronic acid when added to first-line long-term hormone therapy in patients with...
Superior Long-Term Outcomes Linked to Axillary Pathologic Complete Response After Chemotherapy for Breast Cancer
In an analysis of experience at MD Anderson Cancer Center reported in JAMA Oncology, Mougalian et al found that 10-year overall and relapse-free survival rates in patients with stage II or III breast cancer and axillary metastases receiving primary systemic chemotherapy were higher in those with vs ...
UK Trial Shows Little Benefit of Pregabalin Combined With Palliative Radiotherapy for Cancer-Induced Bone Pain
In a UK study reported in the Journal of Clinical Oncology, Fallon et al found no improvement with pregabalin vs placebo combined with concurrent palliative radiotherapy in relieving cancer-induced bone pain. Study Details In the double-blind trial, 233 patients with bone metastases who were...
Comparing Recurrence Risk With Anastrozole vs Tamoxifen in Postmenopausal Women With Ductal Carcinoma in Situ
Two recently reported phase III trials compared adjuvant anastrozole vs tamoxifen in postmenopausal women with hormone receptor–positive ductal carcinoma in situ. As reported in The Lancet by Margolese et al,1 the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial, performed in...
Dose-Intensified vs Standard Salvage Radiation for Biochemically Recurrent Prostate Cancer After Prostatectomy
Initial results of a European phase III trial (SAKK 09/10), reported in the Journal of Clinical Oncology by Ghadjar et al of the Swiss Group for Clinical Cancer Research, showed little difference in acute toxicity with salvage radiotherapy of 70 vs 64 Gy in patients with biochemical recurrence of...
Dutch Trial Indicates 6-Year Surveillance Interval Is Sufficient for Many Individuals With Familial Colorectal Cancer
In a Dutch trial reported in the Journal of Clinical Oncology, Simone D. Hennink, MD, of Leiden University Medical Center in Leiden, the Netherlands, and colleagues found that a 6-year colonoscopic surveillance interval is sufficient for many individuals with familial colorectal cancer.1 However,...
Neoadjuvant HER2 Inhibitor Therapy and Effect of Molecular Heterogeneity on Response in HER2-Positive Breast Cancer
In the phase III CALGB 40601 trial, reported in the Journal of Clinical Oncology by Lisa A. Carey, MD, of University of North Carolina at Chapel Hill, and colleagues, pathologic complete response rate was not significantly increased by adding neoadjuvant trastuzumab (Herceptin) plus lapatinib...
High Rate of Local Control Reported With High-Dose Hypofractionated Proton Beam Therapy in Liver Cancers
High-dose hypofractionated proton beam therapy produced a high rate of local control in patients with localized unresectable hepatocellular carcinoma or intrahepatic cholangiocarcinoma, according to a phase II study reported in the Journal of Clinical Oncology by Hong et al. Study Details In the...
Higher Risk of Cancer Mortality in Solid-Organ Transplant Recipients
In a study reported in JAMA Oncology, Acuna et al found a nearly threefold increased risk of cancer mortality in solid-organ transplant recipients compared with the general population in Ontario, Canada. Study Details The population-based cohort study included data from 11,061 patients who...
Study Finds Association Between Androgen-Deprivation Therapy in Prostate Cancer and Risk of Alzheimer’s Disease
In a retrospective analysis reported in the Journal of Clinical Oncology, Nead et al found that use of androgen-deprivation therapy in the treatment of prostate cancer was associated with an increased risk of subsequent Alzheimer’s disease. Study Details In the study, a text-processing...
French Trial Shows Addition of First-Line Bevacizumab to Cisplatin/Pemetrexed Improves Survival in Malignant Pleural Mesothelioma
In the French phase III MAPS trial reported in The Lancet, Zalcman et al found that the addition of bevacizumab (Avastin) to standard cisplatin/pemetrexed (Alimta) treatment increased overall and progression-free survival in patients with newly diagnosed pleural mesothelioma. Vascular endothelial...
Material and Psychological Financial Hardship for U.S. Cancer Patients
In a population-based study reported in the Journal of Clinical Oncology, Yabroff et al found that cancer and its treatment were associated with material financial hardship for 29% and psychological financial hardship for 32% of patients aged 18 to 64 years in the United States. Financial hardship...
Increased Breast Cancer Risk Reported in Childhood Sarcoma and Leukemia Survivors With No History of Chest Radiotherapy
In an analysis of the Childhood Cancer Survivor Study reported in the Journal of Clinical Oncology, Henderson et al found that childhood survivors of sarcoma and leukemia with no history of chest radiotherapy were at an increased risk of breast cancer. Increased Risk The study included data from...
UK Study Finds No Association Between Self-Reported Unhappiness and Mortality Risk
As reported in The Lancet by Liu et al, a study in UK women that attempted to adjust for the effect of health and lifestyle factors found that self-reported unhappiness was not associated with an increased risk of mortality from cancer or other conditions. Study Details The study involved data...
Pilot Study Indicates Little Activity of Vemurafenib in Metastatic BRAF-Mutated Colorectal Cancer
In a phase II pilot study reported in the Journal of Clinical Oncology, Scott Kopetz, MD, PhD, of The University of Texas MD Anderson Cancer Center, and colleagues found little clinical activity of vemurafenib (Zelboraf) in patients with metastatic BRAF-mutated colorectal cancer.1 The BRAF V600E...
Phase III Trial Shows Improved Progression-Free Survival With Ibrutinib vs Temsirolimus in Relapsed/Refractory Mantle Cell Lymphoma
In aphase III trial reported in The Lancet and at the recent American Society of Hematology Annual Meeting and Exposition, Martin Dreyling, MD, of the European Mantle Cell Lymphoma Network, and colleagues found that ibrutinib (Imbruvica) was associated with improved progression-free survival vs...
Lenalidomide Plus Rituximab Highly Active in Initial Treatment of Mantle Cell Lymphoma
In a phase II trial reported in The New England Journal of Medicine by Jia Ruan, MD, PhD, and colleagues, first-line treatment with the immunomodulatory agent lenalidomide (Revlimid) and the anti-CD20 antibody rituximab (Rituxan) followed by maintenance lenalidomide and rituximab produced a high...
Two Inherited Genetic Variants Predict Event-Free and Overall Survival in Diffuse Large B-Cell Lymphoma Treated With Immunochemotherapy
In a genome-wide association study reported in Journal of Clinical Oncology, Hervé Ghesquieres, MD, PhD, of Centre Léon Bérard, Lyon, France, and colleagues identified two inherited genetic variants that were associated with poorer event-free and overall survival in patients with diffuse large...
Global and North American Phase II Studies Show Alectinib Is Highly Active in Crizotinib-Resistant/Refractory ALK-Rearranged NSCLC
In two phase II trials, reported in the Journal of Clinical Oncology and The Lancet Oncology, the ALK inhibitor alectinib (Alecensa), which is active against acquired crizotinib resistance mutations and exhibits high central nervous system (CNS) penetration, was associated with considerable...
Uridine Triacetate Granules for Fluorouracil or Capecitabine Overdose or Early Severe Toxicity
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 11, 2015, uridine triacetate (Vistogard) was approved...
Elotuzumab in Previously Treated Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 30, 2015, elotuzumab (Empliciti) was approved for...
Study Finds Alectinib Highly Active in ALK-Positive, Crizotinib-Resistant NSCLC
In a North American phase II trial reported in The Lancet Oncology, Shaw et al found that alectinib (Alecensa), which is active against acquired crizotinib (Xalkori) resistance mutations and exhibits high central nervous system (CNS) penetration, was associated with considerable activity in...
