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Showing 4551 - 4600ESMO 2014: Phase III Study Confirms Regorafenib’s Survival Benefit in Metastatic Colorectal Cancer
The phase III CONCUR trial of regorafenib (Stivarga) monotherapy in Asian patients with previously treated metastatic colorectal cancer confirmed the overall survival benefit seen in the previous CORRECT trial and in an exploratory analysis suggested the benefit is substantial in patients not...
ESMO 2014: BRAF/MEK Inhibitor Combinations Impressive in Melanoma Trials
For advanced/metastatic melanoma patients with BRAF mutations, two pathway inhibitors are much better than one, according to studies presented at the ESMO 2014 Congress that demonstrated improved progression-free and overall survival for regimens combining a BRAF inhibitor with an inhibitor of the...
ESMO 2014: Afatinib Improves Progression-Free Survival in Advanced Head and Neck Cancer
The tyrosine kinase inhibitor afatinib (Gilotrif) was significantly superior to methotrexate as second-line therapy in patients with advanced squamous cell carcinoma of the head and neck who progressed after platinum-based chemotherapy, according to results of the LUX-Head & Neck 1 trial. The...
ESMO 2014: CLEOPATRA Study Shows ‘Unprecedented’ Survival With Dual HER2 Blockade in Metastatic Breast Cancer
In the final overall survival analysis of the phase III CLEOPATRA trial, patients with HER2-positive metastatic breast cancer patients lived 15.7 months longer if they received pertuzumab (Perjeta) in addition to trastuzumab (Herceptin) and docetaxel, investigators reported at the ESMO 2014...
Second-Line Ramucirumab Plus Paclitaxel Improves Overall Survival in Patients With Advanced Gastric Cancer
The addition of the monoclonal antibody VEGFR-2 antagonist ramucirumab (Cyramza) to paclitaxel led to a statistically significant improvement in median overall survival in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma in a phase III trial, reported Wilke et al in ...
Male Pattern Baldness at Age 45 May Be Associated With Aggressive Prostate Cancer
In a prospective cohort study in the population of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, Zhou et al found that frontal plus moderate vertex baldness at age 45 is associated with increased risk of aggressive prostate cancer. The findings were reported in the...
ASTRO: Radiation Therapy Does Not Increase Risk of Lymphedema in Node-Negative Breast Cancer
A secondary analysis of the National Surgical Adjuvant Breast and Bowel Project B-32 trial indicates that radiation therapy does not increase the incidence of lymphedema in patients with node-negative breast cancer, according to research presented at the American Society for Radiation...
Phase II Trial Shows Overall Survival Benefit With VT-122 Plus Sorafenib in Advanced Hepatocellular Carcinoma
The investigational agent VT-122 appeared to benefit survival when combined with sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma, according to data presented at the 8th Annual International Liver Cancer Association Conference in Kyoto, Japan. Researchers reported an 11-month...
Breast-Conserving Therapy Shows Survival Benefit Over Mastectomy in Patients With Early-Stage Hormone Receptor–Positive Disease
When factoring in what is now known about breast cancer biology and heterogeneity, breast-conserving therapy may offer a greater survival benefit over mastectomy to women with early-stage, hormone receptor–positive disease, according to research from The University of Texas MD Anderson Cancer ...
High Concordance Between EGFR Mutations From Circulating-Free Tumor DNA and Tumor Tissue in NSCLC
Epidermal growth factor receptor (EGFR) mutations found in the circulating-free tumor DNA from the plasma of advanced non–small cell lung cancer (NSCLC) patients correlates well with the EGFR mutations from patient-matched tumor tissue DNA, according to new data reported by Douillard et...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
FDA Expands Approved Use of Ibrutinib for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who carry deletions of the short arm of chromosome 17, which are associated with poor responses to standard treatment for CLL. Ibrutinib...
FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women...
Lanreotide Significantly Prolongs Progression-Free Survival in Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Although somatostatin analogs are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors, data on their antitumor effects are limited. In the phase III CLARINET trial reported in The New England Journal of Medicine, Caplin et al found that somatostatin...
FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer. The designation...
Study Compares Tamoxifen Gel Applied to the Breast With Oral Tamoxifen in Women With DCIS
A randomized, double-blind, placebo-controlled phase II trial comparing the antiproliferative effect of transdermal 4-hydroxytamoxifen gel (4-OHT), a potent antiestrogenic metabolite of tamoxifen, applied to the breast and oral tamoxifen in women with ductal carcinoma in situ (DCIS), has found the...
FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is...
Development of Orteronel for Prostate Cancer Voluntarily Discontinued by Takeda
Takeda Pharmaceutical Company Limited announced today that it has voluntarily decided to end the development program for orteronel (TAK-700), an investigational oral, nonsteroidal, selective inhibitor of 17,20-lyase, for prostate cancer. The decision follows the results of two phase III...
Study Reveals Long-Term Benefits With Prone Hypofractionated Radiation Therapy and a Concurrent Boost in Early-Stage Breast Cancer
Prone accelerated intensity-modulated radiation therapy with a concomitant boost produced excellent local tumor control and cosmesis while sparing normal tissues in women with early-stage breast cancer, according to the 5-year study results reported by Osa et al in the International Journal of...
Priming Pancreatic Cancer Cells With a Vaccine May Allow Them to Respond to Immunotherapy
Pancreatic ductal adenocarcinoma is considered a “nonimmunogenic” neoplasm and does not typically respond to immunotherapy, in part due to a complex tumor microenvironment that provides a formidable barrier to immune infiltration and function. A new study by Lutz et al has found that by ...
Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network
A unique public-private collaboration among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global...
ASCO 2014: Goserelin Helps Preserve Fertility Among Women Receiving Chemotherapy for Hormone Receptor–Negative Breast Cancer
Adding goserelin (Zoladex) to standard chemotherapy may be an effective method of preserving fertility among women with early-stage hormone receptor–negative breast cancer, according to findings from a federally funded phase III clinical trial. In the S0230/POEMS study, reported at the 2014...
ASCO 2014: Adjuvant Ipilimumab Significantly Improves Recurrence-Free Survival in Patients With High-Risk Stage III Melanoma
Adjuvant therapy with ipilimumab (Yervoy) for patients with high-risk stage III melanoma significantly improved recurrence-free survival, the primary endpoint of the phase III EORTC 18071/CA 184-029 study. Patients randomly assigned to receive ipilimumab had a 9-month absolute improvement in...
ASCO 2014: Cediranib Plus Olaparib Significantly Increases Progression-Free Survival in Women With Recurrent Ovarian Cancer
The combination of two investigational oral drugs, the PARP inhibitor olaparib and the antiangiogenic drug cediranib, significantly extended progression-free survival and increased the overall response rate compared to olaparib alone in a phase II study among women with recurrent,...
ASCO 2014: Lenvatinib Yields High Response Rates, Delays Progression in Patients With Radioiodine-Resistant Differentiated Thyroid Cancer
A phase III, multicenter, double-blind, placebo-controlled study found that the oral targeted drug lenvatinib is highly effective among patients with differentiated thyroid cancer resistant to standard radioiodine therapy. “The main result is an extraordinary improvement in progression-free...
ASCO 2014: Ceritinib Shows Rapid, Durable Response in ALK-Positive NSCLC
In a phase I study, ceritinib (Zykadia) was found to shrink tumors in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), regardless of whether patients had received previous treatment with an ALK inhibitor. The study was presented at the 2014 ASCO...
ASCO 2014: Adjuvant Exemestane With Ovarian Function Suppression Better at Preventing Breast Cancer Recurrence Than Tamoxifen
A joint analysis of two phase III trials demonstrated that the aromatase inhibitor exemestane more effectively prevents breast cancer recurrences than tamoxifen when either was given with ovarian function suppression to premenopausal women with hormone-sensitive cancers. Exemestane plus ovarian...
ASCO 2014: Addition of Chemotherapy to Radiotherapy Improves Survival in Low-Grade Glioma
In a long-term follow-up analysis of RTOG 9802, the addition of PCV (procarbazine [Matulane], lomustine [CeeNu], and vincristine) to radiotherapy prolonged both progression-free survival and overall survival in adult patients with low-grade glioma. The findings were reported at the 2014 ASCO Annual ...
ASCO 2014: Investigational Anti–PD-L1 Antibody Demonstrates Promising Activity in Certain Patients With Metastatic Bladder Cancer
In a phase I study, the investigational anti–programmed death-ligand 1 (PD-L1) monoclonal antibody MPDL3280A demonstrated promising overall response rates in patients with previously treated metastatic urothelial bladder cancer whose tumors were characterized as PD-L1–positive. The ...
ASCO 2014: Bortezomib Combination Significantly Improves Progression-Free Survival in Newly Diagnosed Mantle Cell Lymphoma
An international, randomized phase III study found that replacing vincristine with bortezomib (Velcade) in R-CHOP (rituximab [Rituxan] plus cyclophosphamide, doxorubicin, vincristine, and prednisone) significantly improved outcomes in newly diagnosed patients with mantle cell lymphoma who were...
Proactive Patient-Centered Program May Reduce the Risk of Lymphedema in Survivors of Breast Cancer
A patient-centered educational and behavioral program focusing on self-care strategies appears to be an effective way to reduce the risk of lymphedema in survivors of breast cancer, according to the results of a prospective study by Fu et al at New York University. These findings, reported in the...
Early Study Shows Improved Survival With Radioimmunotherapy/Gemcitabine Combination in Patients With Advanced Pancreatic Ductal Cancer
A randomized phase Ib study of a combination of low radiosensitizing doses of gemcitabine and fractionated doses of 90Y-clivatuzumab tetraxetan in patients with metastatic pancreatic ductal cancer who had received at least two prior systemic therapies, has found a significant survival advantage in...
Necitumumab Plus Chemotherapy Shows Overall Survival Benefit in Patients With Squamous NSCLC
In the large phase III SQUIRE trial of necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin in the first-line treatment of advanced squamous non–small cell lung cancer (NSCLC), patients with stage IV metastatic disease showed a statistically significant improvement in overall...
Novel Targeted Drug May Provide a New Treatment Option for Patients With Recurrent Pigmented Villonodular Synovitis
According to early results from a phase I study, a new targeted drug, PLX3397, appears remarkably active against a rare neoplastic joint disorder known as pigmented villonodular synovitis. The study evaluated patients whose disease had progressed despite all other available therapies. More than...
Hyperfractionated Radiation Therapy Improves Local-Regional Control Without Increasing Late Toxicity in Locally Advanced Head and Neck Cancer
Patients with locally advanced squamous cell carcinoma of the head and neck treated with hyperfractionated radiation therapy experienced improved local-regional control and, with patients censored at 5 years, improved overall survival with no increase in late toxicity, according to a study...
Axillary Radiotherapy Associated With Fewer Side Effects Than Lymph Node Dissection in AMAROS Analysis
Radiation therapy, an emerging treatment modality for breast cancer in the lymph nodes, is associated with significantly fewer postoperative complications than axillary lymph node dissection, according to a detailed analysis of morbidity from the AMAROS trial presented at a press briefing prior to...
Doxepin Rinse Reduces Radiotherapy-Associated Oral Mucositis Pain in Patients With Head and Neck Cancer
In a phase III double-blind crossover trial (North Central Cancer Treatment Group [NCCTG] N09C6, Alliance for Clinical Trials in Oncology cooperative group) reported in the Journal of Clinical Oncology, Leenstra et al found that oral doxepin hydrochloride rinse significantly reduced...
FDA Approves Siltuximab for Rare Castleman’s Disease
The U.S. Food and Drug Administration (FDA) today approved siltuximab (Sylvant injection) for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. Multicentric Castleman’s...
FDA Approves Ramucirumab for Stomach Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy....
European Phase II Study Indicates Activity of Enzalutamide in Hormone-Naive Prostate Cancer
As reported in The Lancet Oncology by Tombal et al, a single-arm phase II trial of the androgen receptor inhibitor enzalutamide (Xtandi) has shown that the agent is active in suppressing disease and well tolerated in men with hormone-naive prostate cancer. In this ongoing trial, 67 men with...
Chronic Inflammation in Benign Prostate Tissue Is Associated With Aggressive Prostate Cancer
An analysis of prostate tissue biopsies collected from participants in the placebo arm of the Prostate Cancer Prevention Trial (PCPT) has found that those whose benign prostate tissue had chronic inflammation had 1.78 times higher odds of having prostate cancer, and 2.24 times higher odds of having ...
FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. Trial...
Study Finds a Quarter of Men Drop Out of Prostate Cancer Monitoring, Casting Doubt on Safety of Active Surveillance
Noncompliance appears to be a major challenge for active surveillance, according to the results of long-term follow-up of patients with prostate cancer presented at the European Association of Urology 29th Annual Congress in Stockholm. Over a quarter of men dropped out of the active surveillance...
I-SPY 2 Results Identify Subset of Breast Cancer Patients Most Likely to Benefit From Neratinib
Findings from the I-SPY 2 randomized phase II clinical trial for women with newly diagnosed stage II breast cancer show that a neoadjuvant regimen containing the investigational drug neratinib, a pan-HER inhibitor, and standard chemotherapy is beneficial for patients with hormone...
Dose-Escalated Hypofractionated IMRT for Localized Prostate Cancer Has Similar Side Effects Compared to Conventional IMRT
Dose-escalated intensity-modulated radiotherapy with use of a moderate hypofractionation regimen (72 Gy in 2.4-Gy fractions) can safely treat patients with localized prostate cancer with limited grade 2 or 3 late toxicity, according to a study by Hoffman et al published in the International Journal ...
Findings of AURELIA Trial Support Consideration of Bevacizumab/Chemotherapy in Carefully Selected Patients With Platinum-Resistant Ovarian Cancer
The recently reported open-label phase III AURELIA trial showed that the addition of bevacizumab (Avastin) to chemotherapy resulted in significant improvements in progression-free survival, the primary study endpoint, and objective response rate in women with recurrent platinum-resistant ovarian...
Long-Term Benefit With Dasatinib After Imatinib Failure in Chronic-Phase CML
Patients with chronic myeloid leukemia (CML) in the chronic phase who are resistant or intolerant to imatinib (Gleevec) can experience long-term benefit with dasatinib (Sprycel), according to results of a randomized phase III study. The CA180-034 study also found that early molecular and...
Lymphedema Lingers Long After Sentinel Lymph Node Dissection for Early Breast Cancer
Patients with early-stage breast cancer who underwent sentinel lymph node dissection experienced lymphedema more frequently than clinically suspected and with increasing incidence over time, according to a presentation at the 2014 Society of Surgical Oncology (SSO) Cancer Symposium in Phoenix...
ASCO Issues Updated Recommendations for Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer
A review by ASCO’s Update Committee of new data from randomized clinical trials has led to a change in recommendations for the use of sentinel lymph node biopsy in patients with early-stage breast cancer. The updated guideline will enable more women with early-stage breast cancer to avoid the ...
Analysis of SWOG Trials Indicates No Survival Difference After 1 Year in Cancer Patients Treated In vs Out of Clinical Trials
In a study reported in the Journal of the National Cancer Institute, Unger et al evaluated whether cancer patients from SWOG clinical trials were similar to nontrial patients in baseline characteristics and survival. They found that, overall, trial participation in standard treatment arms did not...
