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Showing 201 - 250Phase III Study Explores Addition of Nintedanib to Docetaxel in Second-Line Treatment of Non–Small Cell Lung Cancer
In a phase III trial (LUME-Lung 1) reported in The Lancet Oncology, Reck et al assessed the addition of nintedanib to docetaxel in second-line treatment of non–small cell lung cancer (NSCLC).1 The combination significantly improved progression-free survival in all patients and improved overall...
Ceritinib Highly Active in Patients With ALK-Rearranged Advanced NSCLC
Non-small cell lung cancer (NSCLC) harboring ALK rearrangement is sensitive to the ALK inhibitor crizotinib (Xalkori), but resistance ultimately occurs. In a phase I study reported in The New England Journal of Medicine, Alice T. Shaw, MD, PhD, of Dana-Farber/Harvard Cancer Center, Boston, and...
Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma
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 July 23, 2014, idelalisib (Zydelig) was approved for use in...
First Approval of PD-1 Inhibitor: 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 September 4, 2014, pembrolizumab (Keytruda) was granted...
Fixed-Combination Netupitant/Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting
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 October 10, 2014, oral fixed-combination netupitant and...
Pazopanib Maintenance Improves Progression-Free Survival in Ovarian Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Andreas du Bois, MD, PhD, Professor of Gynecologic Oncology at Kliniken Essen-Mitte in Essen, Germany, and colleagues found that maintenance therapy with the vascular endothelial growth factor receptor (VEGFR) and platelet-derived...
Olaparib for BRCA-Mutated Previously Treated Advanced Ovarian Cancer
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 19, 2014, olaparib (Lynparza) was granted accelerated...
Microangiopathic Hemolytic Anemia and Thrombocytopenia
The ASCO Post is pleased to present Hematology Expert Review, an occasional feature that includes a case report detailing a particular hematologic condition followed by questions. Answers to each question with expert commentary can be found in the sidebar. In this installment, we present the case...
Gefitinib in EGFR-Mutant Metastatic NSCLC
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 July 13, 2015, gefitinib (Iressa) was approved for first-line ...
Pembrolizumab in Previously Treated PD-L1–Positive Metastatic NSCLC
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 October 2, 2015, the U.S. Food and Drug Administration granted...
Nivolumab in Combination With Ipilimumab in BRAF V600 Wild-Type 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 September 30, 2015, the U.S. Food and Drug Administration...
Nivolumab in Metastatic NSCLC After Platinum Therapy
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 October 9, 2015, the anti–programmed cell death protein 1...
Trabectedin in Unresectable or Metastatic Liposarcoma or Leiomyosarcoma
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 October 23, 2015, trabectedin (Yondelis) was approved for the...
Improved Progression-Free Survival With Trabectedin vs Dacarbazine After Chemotherapy Failure in Liposarcoma or Leiomyosarcoma
In a phase III trial reported in the Journal of Clinical Oncology, George D. Demetri, MD, of Harvard Medical School and Dana-Farber Cancer Institute, Boston, and colleagues found that treatment with trabectedin (Yondelis) significantly improved progression-free survival vs dacarbazine in patients...
Nivolumab as Single-Agent Treatment for BRAF V600 Wild-Type 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 November 24, 2015, nivolumab (Opdivo) was approved for use as...
Nivolumab in Advanced Renal Cell Carcinoma After Antiangiogenic Therapy
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 23, 2015, nivolumab (Opdivo) was approved for use in...
Reduced Relapse but No Quality-of-Life Benefit With ATRA/Arsenic Trioxide vs ATRA/Idarubicin in Acute Promyelocytic Leukemia
In a UK-based phase III trial (AML17) reported in The Lancet Oncology, Burnett et al found that a chemotherapy-free regimen of arsenic trioxide plus all-trans retinoic acid (ATRA) did not improve quality of life, the primary endpoint, vs ATRA plus idarubicin in patients with acute promyelocytic...
Improved Progression-Free Survival With Trabectedin vs Dacarbazine After Conventional Chemotherapy in Advanced Liposarcoma or Leiomyosarcoma
In a phase III trial reported in the Journal of Clinical Oncology, Demetri et al found that treatment with trabectedin significantly improved progression-free survival vs dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior conventional chemotherapy. Interim analysis of...
FDA Approves Gefitinib for EGFR-Mutated Metastatic Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved gefitinib (Iressa) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an...
ASCO Provisional Clinical Opinion Update: HBV Screening for Cancer Patients Before Cancer Therapy
As reported in the Journal of Clinical Oncology by Hwang et al, ASCO has released a provisional clinical opinion update on screening of cancer patients for hepatitis B virus (HBV) infection before cancer treatment to reduce the risk of HBV reactivation. The ASCO consensus panel providing the update ...
Nilotinib Inferior to Imatinib in First-Line Treatment of Unresectable or Metastatic GIST
In the phase III ENESTg1 trial reported in The Lancet Oncology, Blay et al found that nilotinib (Tasigna) was associated with poorer progression-free survival vs imatinib (Gleevec) as first-line treatment in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). Trial...
Addition of Nivolumab to Ipilimumab Improves Response Rate and Progression-Free Survival in Previously Untreated Advanced Melanoma
In a phase II study reported in The New England Journal of Medicine, Postow et al found that dual checkpoint inhibitor therapy with the anti–CTLA-4 antibody ipilimumab (Yervoy) and the anti–PD-1 monoclonal antibody nivolumab (Opdivo) produced greater response rates and prolonged...
FDA Grants Breakthrough Therapy Designation to Rucaparib in Advanced Ovarian Cancer With BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Clovis Oncology’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with...
Study Identifies New Pathway for Stalling BRCA-Mutated Tumor Growth in Mice and Human Cells
Inhibiting the action of a particular enzyme dramatically slows the growth of tumor cells tied to BRCA1 and BRCA2 genetic mutations that are closely tied to breast and ovarian cancers, according to researchers at New York University (NYU) Langone Medical Center. Senior investigator Agnel Sfeir,...
Final Survival Analysis in COU-AA-302 Shows Benefit of Adding Abiraterone to Prednisone in Chemotherapy-Naive Castration-Resistant Prostate Cancer
In the final analysis of overall survival in the COU-AA-302 trial, reported in The Lancet Oncology by Ryan et al, the addition of abiraterone acetate (Zytiga) to prednisone significantly prolonged survival in chemotherapy-naive patients with castration-resistant prostate cancer. Abiraterone had...
Researchers Identify Potential Treatment Targeting Proliferation Pathway in Some Aggressive Tumors
Researchers from the Massachusetts General Hospital (MGH) Cancer Center and Boston University School of Medicine (BUSM) have identified a potential treatment targeting a pathway by which several aggressive tumors maintain their ability to proliferate, according to a study by Flynn et al published...
ATRX Mutation Linked to Brain and Pancreatic Neuroendocrine Tumors May Be Biomarker for Rare Adrenal Tumors
A somatic mutation in the ATRX gene has recently been identified as a potential molecular marker for gliomas, neuroblastomas, and pancreatic neuroendocrine tumors. Now, researchers at the Perelman School of Medicine at the University of Pennsylvania have found that the same mutated gene may serve...
Phase II Study Shows Activity of Paclitaxel Added to Trastuzumab/Pertuzumab in HER2-Positive Metastatic Breast Cancer
In a phase II trial reported in Journal of Clinical Oncology, Dang et al found that the addition of weekly paclitaxel to trastuzumab (Herceptin)/pertuzumab (Perjeta) produced good activity in patients with HER2-positive metastatic breast cancer. Paclitaxel may be a less toxic alternative to...
No Overall Survival Difference for Linifanib vs Sorafenib in Advanced Hepatocellular Carcinoma
In a phase III trial reported in the Journal of Clinical Oncology, Cainap et al found that treatment with linifanib, an ATP-competitive inhibitor of VEGF and PDGF receptor tyrosine kinases, did not improve overall survival compared with sorafenib (Nexavar) treatment in patients with advanced...
Improved Overall Survival in Metastatic Melanoma With First-Line Dabrafenib Plus Trametinib
In a phase III study reported in The New England Journal of Medicine, Robert et al found that the combination of the BRAF inhibitor dabrafenib (Tafinlar) plus the MEK inhibitor trametinib (Mekinist) significantly improved overall survival compared with the BRAF inhibitor vemurafenib (Zelboraf) in...
Briefer Biochemotherapy Yields Better Relapse-Free Survival but Greater Toxicity vs 1-Year High-Dose Interferon in High-Risk Melanoma
In a phase III trial (Southwest Oncology Group Intergroup S0008) reported in the Journal of Clinical Oncology, Flaherty et al found that a shorter course of biochemotherapy consisting of cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b produced better relapse-free...
No Benefit of Adding Lapatinib to Fulvestrant in Hormone Receptor–Positive Advanced Breast Cancer
In the phase III Cancer and Leukemia Group B (CALGB) 40302/Alliance trial reported in the Journal of Clinical Oncology, Burstein et al found that the addition of the dual EGFR-HER2 inhibitor lapatinib (Tykerb) to endocrine therapy with fulvestrant (Faslodex) did not improve progression-free...
High Rate of Hepatitis B Reactivation in Chinese Patients Receiving Rituximab for Lymphoma
In a prospective Chinese study reported in the Journal of Clinical Oncology, Seto et al found a 2-year rate of hepatitis B virus (HBV) reactivation of 41.5% in hepatitis B surface antigen (HBsAg)-negative and anti–hepatitis B core antigen antibody (anti-HBc)–positive patients receiving...
FDA Grants Breakthrough Therapy Designation to AP26113 for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Ariad Pharmaceutical’s investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who are resistant to crizotinib...
Promising Phase Ib Findings With Combined BRAF and MEK Inhibition With Vemurafenib and Cobimetinib in Advanced BRAF V600–Mutant Melanoma
In a phase Ib study reported in The Lancet Oncology, Ribas et al found that the combination of the BRAF inhibitor vemurafenib (Zelboraf) and the MEK inhibitor cobimetinib was safe and active in the treatment of advanced BRAF V600–mutant melanoma. Preclinical studies have shown that the...
Integrated Safety Analysis Shows Favorable Safety Profile of Single-Agent Trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer
The antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla) is currently indicated in the United States for treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab (Herceptin) and a taxane and who have either received prior therapy for metastatic...
Phase II Trial Shows Improved Progression-Free Survival but Greater Toxicity With Selumetinib vs Chemotherapy in Metastatic Uveal Melanoma
Oncogenic mutations in GNAQ and GNA11, resulting in MAPK pathway activation, are observed in > 80% of uveal melanomas. In a phase II trial reported in JAMA, Carvajal et al found that treatment with the MEK1/MEK2 inhibitor selumetinib significantly prolonged progression-free survival vs...
Ado-Trastuzumab Emtansine Plus Pertuzumab Shows Activity and No Unexpected Toxicity in HER2-Positive Locally Advanced or Metastatic Breast Cancer
In a phase IIa trial reported in the Journal of Clinical Oncology, Miller et al assessed combined HER2-targeted therapy with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla) and pertuzumab (Perjeta) in women with HER2-positive locally advanced or metastatic breast cancer. Pertuzumab...
Ceritinib Highly Active in Patients With ALK-Rearranged Advanced NSCLC, Including Those With Prior Crizotinib Treatment
Non–small cell lung cancer (NSCLC) harboring ALK rearrangement is sensitive to the ALK inhibitor crizotinib (Xalkori), but resistance ultimately occurs. In a phase I study reported in The New England Journal of Medicine, Shaw et al found that the more-potent ALK inhibitor ceritinib was...
PARP Inhibitor Veliparib Might Benefit Women With Resistant Gynecologic Cancers and BRCA Mutation
Preliminary research suggests that a targeted oral agent may improve outcomes while minimizing side effects in women with gynecologic cancers who carry a BRCA mutation and whose disease is not responding to other therapies. According to a phase II study presented at the Society of Gynecologic...
PI3K-Delta Inhibitor Idelalisib Produces High Response Rates in Relapsed Indolent Lymphoma
Phosphatidylinositol 3-kinase (PI3K)-delta mediates B-cell receptor signaling and microenvironment support signals that promote the growth and survival of malignant B lymphocytes. In a phase II study reported in The New England Journal of Medicine, Gopal et al found that the PI3K-delta inhibitor...
Adding Idelalisib to Rituximab Improves Progression-Free and Overall Survival in Patients With Difficult-to-Treat, Relapsed CLL
Use of standard chemotherapy is difficult in patients with relapsed chronic lymphocytic leukemia (CLL) who have significant coexisting medical conditions. In a phase III trial reported in The New England Journal of Medicine, Furman et al found that the combination of idelalisib, an oral inhibitor...
Addition of Nintedanib to Docetaxel Improves Progression-Free Survival as Second-Line Treatment in NSCLC
In a phase III trial (LUME-Lung 1) reported in The Lancet Oncology, Reck et al assessed the addition of nintedanib to docetaxel in second-line treatment of non–small cell lung cancer (NSCLC). The combination significantly improved progression-free survival in all patients and improved overall ...
Oral CMX001 100 mg Twice Weekly Reduces Cytomegalovirus Events in Patients Receiving Hematopoietic Cell Transplants
The anti-cytomegalovirus agent CMX001 is an oral lipid acyclic nucleoside phosphonate that is absorbed in the small intestine and transported throughout the body as a phospholipid. It is converted intracellularly to cidofovir diphosphate, but unlike cidofovir, is not a substrate of organic ion...
Tremelimumab Shows Some Activity in Chemotherapy-Resistant Advanced Malignant Mesothelioma, Phase II Study Finds
Tremelimumab is an anticytotoxic T-lymphocyte antigen 4 (CTLA4) monoclonal antibody, a class of inhibitor that has shown activity in multiple tumor types. Ipilimumab (Yervoy), another agent in this class, was found to significantly prolong overall survival in metastatic melanoma despite a...
Cabozantinib Improves Disease-Free Survival in Progressive Medullary Thyroid Cancer
Cabozantinib (Cometriq) is an inhibitor of hepatocyte growth factor receptor (MET), VEGFR2, and rearranged during transfection (RET) tyrosine kinases. In a phase III trial reported in Journal of Clinical Oncology, Rosella Elisei, MD, of the University of Pisa, and colleagues found that cabozantinib ...
Survival Trend With Palliative FOLFOX4 vs Doxorubicin in Asian Patients With Advanced Hepatocellular Carcinoma
In a study reported in Journal of Clinical Oncology, Shukui Qin, MD, of People’s Liberation Army Cancer Centre, Bayi Hospital, in Nanjing, and colleagues compared FOLFOX4 (infusional fluorouracil [5-FU], leucovorin, and oxaliplatin) with doxorubicin as palliative chemotherapy in patients with ...
First-Line Brivanib Not Noninferior to Sorafenib in Advanced Hepatocellular Carcinoma
The investigational drug brivanib is a dual inhibitor of VEGF and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. In a noninferiority trial (BRISK-FL) reported in Journal of Clinical Oncology, Philip J. Johnson, MD, of the Institute of Translational Medicine,...
Best of ASCO 2013: Promises and Challenges of Applying Molecular Profiling to Clinical Practice
A “new kind of pathology,” in which anatomy and histology are supplemented by molecular etiology, has been emerging over the past decade and promises better response rates among cancer patients as genomic alterations in cancer continue to be identified and treated with targeted...
Novel Selective ALK Inhibitor Demonstrates Good Activity in Advanced NSCLC
Crizotinib (Xalkori), a multitargeted receptor tyrosine kinase inhibitor, is the only agent currently available for treating ALK-rearranged non–small cell lung cancer (NSCLC). CH5424802 is a novel selective oral ALK inhibitor with activity in tumor cell lines harboring ALK alterations,...
