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Showing 9551 - 9600Bevacizumab/Pemetrexed Maintenance Increases Progression-free Survival vs Bevacizumab Alone in Advanced Nonsquamous NSCLC
Maintenance therapy is associated with improved survival in non–small cell lung cancer (NSCLC), but few studies have compared active agents in this setting. In a phase III trial (AVAPERL trial) reported in Journal of Clinical Oncology by Fabrice Barlesi, MD, PhD, of Aix Marseille...
Significant Improvement in Overall Survival Seen with Pemetrexed Maintenance after Pemetrexed/Cisplatin Induction in Patients with Advanced NSCLC
In the phase III PARAMOUNT trial, pemetrexed (Alimta) continuation maintenance therapy significantly reduced the risk of disease progression by 38% compared with placebo after pemetrexed/cisplatin induction in patients with advanced nonsquamous non–small cell lung cancer (NSCLC). Final...
Obinutuzumab Shows Activity in Relapsed/Refractory Diffuse Large B-cell Lymphoma or Mantle Cell Lymphoma and Indolent Non-Hodgkin Lymphoma
Obinutuzumab is a type II, glycoengineered, humanized anti-CD20 monoclonal antibody. In the phase II GAUGUIN studies reported in Journal of Clinical Oncology by Franck Andre Morschhauser, MD, PhD of Centre Hospitalier Régional Universitaire de Lille and Gilles A. Salles, MD, PhD, of Hospices ...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21...
Addition of Aflibercept to Docetaxel/Prednisone Does Not Improve Overall Survival in Men with Metastatic Castration-resistant Prostate Cancer
In a phase III double-blind study (VENICE trial) reported in Lancet Oncology, Ian F. Tannock, DSc, of Princess Margaret Cancer Centre in Toronto, and colleagues evaluated the addition of the antiangiogenic agent aflibercept (Zaltrap) to standard docetaxel/prednisone therapy in patients with...
Addition of Panitumumab to Cisplatin/Fluorouracil Improves Progression-free Survival in Patients with Recurrent or Metastatic Head and Neck Cancer
Previous studies have shown that anti-EGFR monoclonal antibody treatment can improve clinical outcomes in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. In the open-label phase III SPECTRUM trial, Jan B. Vermorken, MD, of Antwerp University Hospital and...
Factors Influencing Delay in Breast Cancer Treatment Differ for African American and White Women
Different factors influence delay between diagnosis and first course of treatment for breast cancer for African American and white women, according to a recently published study in Cancer Epidemiology, Biomarkers & Prevention. The study used data from the Carolina Breast Cancer Study (CBCS)...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and...
Afatinib Prolongs Progression-free Survival Compared with Cisplatin plus Pemetrexed in EGFR-mutant Advanced Lung Adenocarcinoma
Afatinib is an oral selective ErbB family inhibitor that irreversibly blocks signaling from EGFR/ErbB1, HER2/ErbB2, and ErbB4 and has exhibited broad-spectrum activity against EGFR mutations in preclinical studies. A phase II study of afatinib in EGFR-mutation positive lung adenocarcinoma showed...
Five-year Survival Data from the Phase III CLASSIC Trial Show a 34% Reduction in Gastric Cancer Mortality
For patients with advanced gastric cancer, treatment with chemotherapy after surgery can reduce the risk of cancer-related death by 34% over 5 years compared to surgery alone, researchers reported at the 15th ESMO World Congress in Gastrointestinal Cancer (Abstract 007), held July 3 to 6 in...
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta)...
Intercalated Chemotherapy plus Erlotinib Improves Survival in Asian Patients with Advanced NSCLC and Known or Unknown EGFR Mutation Status
In a phase III trial (FASTACT-2) conducted in 28 centers in seven Asian countries, Yi-Long Wu, MD, of the Guangdong Academy of Medical Sciences and colleagues found that the intercalated combination of erlotinib (Tarceva) and chemotherapy improved progression-free survival vs chemotherapy alone as...
Oral Apixaban Lowers Rates of Major Bleeding in Patients with Acute Venous Thromboembolism
Single-agent apixaban (Eliquis) may simplify the treatment of patients with acute venous thromboembolism, according to a new study published online in The New England Journal of Medicine. In the phase III AMPLIFY trial, the oral factor Xa inhibitor anticoagulant was found to be as effective as ...
Crizotinib Improves Progression-free Survival vs Pemetrexed or Docetaxel in Advanced ALK-positive NSCLC
In a phase III trial reported by Alice T. Shaw, MD, PhD, of Massachusetts General Hospital, and colleagues in The New England Journal of Medicine, crizotinib (Xalkori) improved progression-free survival compared with standard chemotherapy in previously treated patients with advanced...
Lugano 2013: PET-guided Radiation Therapy Improves Survival in Patients with Advanced Diffuse Large B-cell Lymphoma
Residual masses are often detected on post-therapy computed tomography (CT) scans in patients with diffuse large B-cell lymphoma, and the potential role of consolidative radiation therapy in such cases remains undefined. An analysis of the use of PET-guided radiation therapy presented by Laurie H....
Lugano 2013: Ibrutinib Highly Active in Patients with Chronic Lymphocytic Leukemia with 17p Deletion
The 17p deletion in chronic lymphocytic leukemia (CLL) is associated with worse outcome in patients receiving standard chemotherapy. The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib has shown durable antitumor activity in high-risk CLL. Adrian Wiestner, MD, PhD, of the National...
High Rate of Durable Remissions with BTK Inhibitor Ibrutinib in Patients with Relapsed Chronic Lymphocytic Leukemia
Durable remissions are uncommon with current treatments for relapsed chronic lymphocytic leukemia (CLL). Bruton’s tyrosine kinase (BTK) is an essential component of B-cell receptor signaling that mediates interactions with the tumor microenvironment and promotes survival and proliferation of...
First-line Carboplatin plus Pemetrexed Improves Survival vs Pemetrexed Alone in Patients with Advanced NSCLC and Poor Performance Status
A significant proportion of patients with advanced non–small cell lung cancer (NSCLC) have poor performance status, and optimal clinical management of these patients has not been established. In an attempt to help define optimal chemotherapy in such patients, Mauro Zukin, MD, of Instituto...
Imatinib Active in Melanomas with KIT Mutation but Not KIT Amplification Alone
Mutations and amplifications in the KIT oncogene have been identified in mucosal and acral melanomas and in melanomas arising on chronically sun-damaged skin. In a multicenter phase II study reported in the Journal of Clinical Oncology, F. Stephen Hodi, MD, of Dana-Farber Cancer Institute, and...
PHARE Trial Fails to Establish Noninferiority of 6 vs 12 Months of Adjuvant Trastuzumab in Early HER2-positive Breast Cancer
The phase III open-label PHARE trial, conducted in 156 centers in France, examined whether 6 months of adjuvant trastuzumab (Herceptin) was noninferior to 12 months of treatment in women with early HER2-positive breast cancer. As reported by Xavier Pivot, MD, of University Hospital Jean-Minjoz,...
Impact of Age on Efficacy of Newer Adjuvant Therapies in Patients with Stage II/III Colon Cancer
Available data suggest that patients with stage II/III colon cancer receive similar benefit from intravenous fluorouracil (5-FU) adjuvant therapy regardless of age. Combination regimens and oral fluoropyrimidine therapy are now standard treatments in this setting. Nadine J. McCleary, MD, MPH, and...
Acetyl-L-carnitine Ineffective for Taxane-related Peripheral Neuropathy
Various studies have suggested that acetyl-L-carnitine, a natural compound involved in neuronal protection, may be effective in preventing and treating sensory neuropathy. Dawn L. Hershman, MD, MS, of Columbia University Medical Center, and colleagues recently assessed whether daily...
NCI Will No Longer Accept R01 and P01 Applications for Phase III Clinical Trials of Medical Interventions and Cancer Imaging Modalities
The National Cancer Institute (NCI) has announced that it will no longer accept investigator-initiated R01 and P01 applications that propose phase III clinical trials for cancer-related medical interventions or cancer imaging modalities. The policy change takes effect starting with the due date of...
Trebananib plus Paclitaxel Significantly Delays Disease Progression in Patients with Recurrent Ovarian Cancer
In a phase III trial, treatment with the investigational agent trebananib plus paclitaxel resulted in a statistically significant improvement in progression-free survival in patients with recurrent ovarian cancer, according to Amgen. Trebananib is an investigational peptibody designed to inhibit...
Some Stage II/III HER2-positive Tumors May Be Treated with Targeted Therapy without Chemotherapy
Results from a multicenter phase II study of patients with locally advanced HER2-positive breast cancer who receive targeted therapy with trastuzumab (Herceptin) and lapatinib (Tykerb) “support the hypothesis that selected patients with HER2-positive tumors may not need...
ASCO 2013: Novel Heat Shock Protein Inhibitor Effective in Combination with Docetaxel as Second-line Therapy for Advanced Lung Cancer
A large randomized phase II study, GALAXY-1, found that a novel heat shock protein (Hsp) 90 inhibitor, ganetespib, when combined with docetaxel in second-line therapy, leads to longer overall survival compared to standard second-line docetaxel alone in patients with advanced lung adenocarcinoma...
ASCO 2013: Less Lymphedema with Axillary Radiotherapy than Node Dissection, but Comparable Disease Control
A European phase III clinical trial found that lymphedema was twice as common among women with sentinel lymph node–positive early breast cancer who had axillary lymph node dissection compared to those who had axillary radiotherapy. Overall and disease-free survival 5 years after treatment...
ASCO 2013: Weekly Paclitaxel Is Less Toxic but as Effective for Women with Higher-risk Early-stage Breast Cancer
Low-dose weekly administration of paclitaxel resulted in equal progression-free survival but reduced overall toxicity compared to every-2-week dose-dense administration for women with higher-risk early-stage breast cancer who have undergone surgery, according to a phase III randomized trial....
ASCO 2013: 10 Years of Tamoxifen Better Than 5 in Reducing Breast Cancer Recurrence and Death
Ten years of adjuvant treatment with tamoxifen reduces breast cancer recurrence and mortality among women treated for early-stage estrogen receptor (ER)–positive breast cancer, according to results of the British phase III aTTom study. These findings, presented at the 2013 ASCO Annual Meeting ...
ASCO 2013: Sorafenib Stalls Growth of Treatment-resistant Differentiated Thyroid Cancer
A randomized phase III study found that the targeted drug sorafenib (Nexavar) stalls disease progression by 5 months in patients with metastatic differentiated thyroid cancer that has progressed despite standard radioactive iodine therapy. If approved in this setting by the U.S. Food and Drug...
ASCO 2013: Adding Bevacizumab to Standard First-line Chemoradiation for Glioblastoma Does Not Improve Overall Survival
A randomized phase III study found no improvement in overall survival after the addition of bevacizumab (Avastin) to standard first-line chemoradiation for glioblastoma. Patients who received bevacizumab also experienced more side effects compared to those treated with chemoradiation alone. The...
ASCO 2013: Adding Bevacizumab to Chemotherapy Significantly Improves Response Rates and Survival in Women with Advanced Cervical Cancer
Adding bevacizumab (Avastin) to chemotherapy regimens with or without a platinum drug improved outcomes for women with metastatic or relapsed cervical cancer treated in a randomized phase III study. Presenting the results at the 2013 ASCO Annual Meeting (Abstract 3), lead author Krishnansu Sujata...
ASCO 2013: Cetuximab Offers Survival Advantage over Bevacizumab When Combined with FOLFIRI for First-line Treatment of Advanced Colorectal Cancer
First-line cetuximab (Erbitux) plus FOLFIRI chemotherapy (leucovorin, fluorouracil [5-FU], irinotecan) offered a roughly 4-month survival advantage over bevacizumab (Avastin) plus FOLFIRI for patients with KRAS wild-type metastatic colorectal cancer in the German phase III clinical trial FIRE-3. A ...
ASCO 2013: Nivolumab Produces Durable Responses in Patients with Stage IV Melanoma
Long-term follow-up results from an expanded phase I study indicate that nivolumab produced long-lasting responses in patients with stage IV melanoma. Overall, 33 out of 107 patients (31%) treated with five different doses of nivolumab experienced tumor shrinkage of at least 30% and responses were...
ASCO 2013: Everolimus Significantly Delays Tumor Growth in Women with HER2-positive Advanced Breast Cancer
The addition of everolimus (Afinitor), an mTOR inhibitor, to trastuzumab (Herceptin) and vinorelbine significantly extended progression-free survival in women with HER2-positive advanced breast cancer, compared to treatment with placebo plus trastuzumab and vinorelbine, in the phase III BOLERO-3...
ASCO 2013: Pazopanib Maintenance Therapy Delays Relapse of Advanced Ovarian Cancer
A phase III clinical trial has found that pazopanib (Votrient), an oral multikinase inhibitor, extends disease-free survival by an average of 5.6 months, compared to placebo, in women with advanced ovarian cancer who had initial successful treatment with surgery and chemotherapy. “Our...
Ofatumumab plus Chlorambucil Improves Progression-free Survival in Patients with Previously Untreated CLL
In a phase III study, patients with previously untreated chronic lymphocytic leukemia (CLL) achieved an improvement in progression-free survival when treated with ofatumumab (Arzerra) in combination with chlorambucil vs chlorambucil alone. The study evaluated safety and efficacy of ofatumumab plus ...
ASCO 2013: Standard-dose Radiation Is Superior to High-dose Radiation for Patients with Locally Advanced Stage III NSCLC Undergoing Chemotherapy
A phase III trial in patients with stage III non–small cell lung cancer (NSCLC) concluded that standard-dose radiotherapy (60 Gy) is safer and more effective than high-dose radiotherapy (74 Gy), extending survival by 9 months and causing fewer treatment-related deaths. While 60 Gy is already...
ASCO 2013: Anti–PD-L1 Drug Shows Promising Anticancer Effects in a Variety of Advanced Cancers
A phase I expansion study of the investigational drug MPDL3280A— an engineered PD-L1 targeted antibody—shows impressive tumor shrinkage rates in patients with several different cancers—including lung, melanoma, kidney, colorectal, and gastric cancers—that had progressed...
ASCO 2013: Phase I Trial Suggests Ipilimumab and PD-1 Drug Nivolumab May Be Better Together than Alone for Advanced Melanoma
Results from a phase I study show that combination therapy with ipilimumab (Yervoy) and the investigational antibody drug nivolumab led to lasting tumor shrinkage in approximately half of patients with aggressive, advanced melanoma. The results will be presented at the 2013 ASCO Annual Meeting in...
Study Identifies Possible New Treatment Target for Acute Leukemia
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with cytogenetically normal acute myeloid leukemia (AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital...
Emil ‘Tom’ Frei III, MD, Trailblazer in the Development of Combination Chemotherapy, Dies at 89
The pages of medical history are dog-eared with breakthroughs that have transformed medicine and saved lives. One of those dog-eared pages belongs to Emil Frei III, MD, known to his colleagues and friends as Tom. In the dawn of oncology, Dr. Frei, along with his associate, Emil Freireich, MD, did...
Pharmacyclics Completes Enrollment of Phase III Ibrutinib CLL Study and Phase II Ibrutinib MCL Study
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
Adding Cetuximab to Chemotherapy Enables Select Patients with Advanced Colorectal Cancer and Liver Metastasis to Undergo Surgery
New results from a clinical trial conducted in Shanghai, China, indicate that adding cetuximab (Erbitux) to standard chemotherapy enables some patients with otherwise inoperable liver metastases due to colorectal cancer have their metastases surgically removed. Such surgery can be curative, and is...
Novel Two-step Immunotherapy Showed Promise for Patients with Recurrent Ovarian Cancer
A novel two-step immunotherapy approach yielded clinically beneficial responses in patients with advanced ovarian cancer, including one patient who achieved complete remission, according to data from two phase I clinical trials presented at the AACR Annual Meeting 2013, held in Washington, DC,...
Biomarker Analysis Identified Women Most Likely to Benefit from T-DM1
For women with metastatic, HER2-positive breast cancer, the amount of HER2 on their tumor might determine how much they benefit from T-DMI—also now known as ado-trastuzumab emtansine (Kadcyla)—according to data from a subanalysis of the phase III clinical trial that led the FDA to...
New Imaging Agent Enables Better Cancer Detection, More Accurate Staging
Researchers at the University of California, San Diego School of Medicine have shown that a new imaging dye, designed and developed at UC San Diego Moores Cancer Center, is an effective agent in detecting and mapping cancers that have reached the lymph nodes. The radioactive dye technetium Tc-99m...
Amgen Announces Results of Phase III Talimogene Laherparepvec Trial in Late-stage Melanoma
Amgen has announced results from a phase III trial evaluating the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC, or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Talimogene...
IOM Gauges Progress in Goals for Improving the Cancer Clinical Trials System
The National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop in February to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. This was a follow-up meeting to...
Zora Brown, Prominent Cancer Research Advocate, Dies at 63
The American Association for Cancer Research (AACR) reported with sadness the loss of Zora Brown, a trustee for the AACR Foundation for the Prevention and Cure of Cancer, a breast and ovarian cancer survivor, and a pioneering advocate for cancer research and breast cancer awareness among...
