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Showing 4001 - 4050GeparSixto Study Finds Benefit for Neoadjuvant Carboplatin in Triple-negative Breast Cancer
In patients with triple-negative breast cancer, the addition of carboplatin significantly improved the rate of pathologic complete response after neoadjuvant chemotherapy in a study by the German Breast Group (GBG)/Gynecologic Oncology Working Group–Breast (AGO-B) reported at the 2013 ASCO Annual...
Maintenance Treatment Delays Progression in Metastatic Colorectal Cancer
For patients with unresectable metastatic colorectal cancer, maintenance treatment with capecitabine (Xeloda) and bevacizumab (Avastin) significantly delayed disease progression and improved overall survival in the phase III CAIRO3 study by the Dutch Colorectal Cancer Group. Miriam Koopman, MD,...
I'm Not the Person I Was Before Cancer
I’ve been the caretaker for my husband Will since he suffered three strokes in March 2011, followed by a diagnosis of leukemia a few months later. Now, our roles have reversed, and Will is taking care of me as I go through treatment for stage III follicular non-Hodgkin lymphoma (NHL). It’s been a...
Pemetrexed Maintenance in PARAMOUNT: Continuation Proves to Be a Strong Option for Advanced NSCLC, Although Not a Mandate
The PARAMOUNT trial1 represents an important landmark study of continuation maintenance therapy with pemetrexed (Alimta). While maintenance therapy gained a toehold in routine management of advanced non–small cell lung cancer (NSCLC) several years ago, the first trials that demonstrated a...
Olaparib Shows Robust Progression-Free Survival Benefit in Patients With BRCA Mutations
Maintenance therapy with olaparib extended progression-free survival and the time to disease progression after a second subsequent therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation, according to an updated analysis of Study 19 presented at the 2013 ASCO...
Pharmacyclics' Reply
We acknowledge the letters submitted to The ASCO Post from a patient advocate and a chronic lymphocytic leukemia (CLL) patient enrolled on the RESONATE study (PCYC-1112-CA). At Pharmacyclics, we are committed to adhering to high scientific and ethical standards as we strive to develop novel...
Clinical Trials, Crossover, and Clinical Equipoise: An Advocate's Perspective
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
Clinical Trials, Crossover, and Clinical Equipoise: A Patient's Perspective
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
Sitimagene Ceradenovec/IV Ganciclovir in Glioblastoma: Legitimizing the Gene Therapy Approach for Brain Tumors
The ASPECT study,1 a randomized, open-label, phase III trial examining adenovirus-mediated gene therapy with sitimagene ceradenovec followed by IV ganciclovir for patients with operable high-grade glioma, is an important achievement for both neuro-oncology and gene therapy. As vector engineering...
The BEATRICE Study: Where Does Targeting Breast Cancer Vasculature Stand in 2013?
Antiangiogenic strategies using the anti–vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab (Avastin) gained traction in breast cancer with the publication of the Eastern Cooperative Oncology Group (ECOG) 2100 trial in 2007. That study demonstrated a progression-free survival ...
Sorafenib Granted Priority Review for Differentiated Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals recently announced that the FDA has granted priority review designation to the supplemental new drug application of sorafenib (Nexavar) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer....
VeriStrat Assay Helps Select NSCLC Patients for Second-Line Therapy
VeriStrat, a serum-based protein assay, can help select which patients with non–small cell lung cancer (NSCLC) not known to have epidermal growth factor receptor (EGFR) mutations might benefit from an EGFR-targeted agent, according to a study presented at the ASCO Annual Meeting by Vanesa Gregorc, ...
Platinum Agents in Triple-Negative Breast Cancer: Encouraging New Data
For the treatment of triple-negative breast cancer, there is renewed interest in investigating the role of platinum chemotherapy, according to Melinda L. Telli, MD, Assistant Professor of Medicine at Stanford University, Palo Alto. At the Best of ASCO meeting in Los Angeles, Dr. Telli reviewed the...
Donatori di Musica Initiative Creates a Unique Environment for Oncology Patients
“Surely again, to heal men’s wounds by music’s spell.” —Euripides, Medea (480-406 BC) Commonly defined as organized sound, music has a unique power to stir human emotions, moods, and impressions. The salutary effect of music on the sick has been reported since antiquity. Aristotle and Plato wrote...
Cancer Does Not Discriminate
Looking back, my son Max’s fall as he was running after another little boy while playing baseball was such a blessing. Although he landed on his right arm, the fall didn’t seem severe enough to cause him to cry out in such excruciating pain. But after several hours of icing the bruise failed to...
Important Findings in Metastatic Colorectal Cancer Studies Address Treatment, Management Options
At the Best of ASCO Meeting in Los Angeles, Tony Reid, MD, PhD, Director of the Early Phase Clinical Research Program and Professor of Hematology/Oncology at the University of California, San Diego, reviewed important findings in metastatic colorectal cancer presented at the 2013 ASCO Annual...
Lung Cancer Screening: Actionable Evidence
This recent paper in The New England Journal of Medicine outlines the details of the clinical outcomes with two incidence screens that were conducted as part of the National Lung Screening Trial (NLST).1 In the wake of the positive review of the U.S. Preventive Services Task Force (USPSTF) draft...
Cabozantinib in Medullary Thyroid Cancer: A Landscape-Shaping New Treatment
Medullary thyroid cancer is derived from parafollicular C cells in the thyroid gland. The disease is sporadic in about 75% of cases and hereditary in the remaining 25%.1 Oncogenic mutations in the gene for tyrosine kinase receptor rearranged during transfection (RET) are driver genetic alterations...
Cabozantinib Improves Disease-Free Survival in Progressive Medullary Thyroid Cancer
Cabozantinib (Cometriq) is an inhibitor of hepatocyte growth factor receptor (MET), vascular endothelial growth factor receptor 2 (VEGFR2), and rearranged during transfection (RET) tyrosine kinases. In a phase III trial reported in Journal of Clinical Oncology, Rossella Elisei, MD, of University of ...
'Master Protocol' Could Revolutionalize Trials in Lung Cancer, and Eventually Other Cancers
Cancer advocates and clinical trialists, for some time, have been proposing a radical change to the laborious drug development process—that industry, academia, funding sources, and other stakeholders actually pool their brain power and financial means and work together, not separately, to develop...
A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine
Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...
Panitumumab vs Cetuximab in Chemorefractory Colorectal Cancer: Survival Benefits Comparable
For the treatment of wild-type KRAS metastatic colorectal cancer in previously treated patients, a head-to-head comparison of the two antibodies—cetuximab (Erbitux) and panitumumab (Vectibix)—that target the epidermal growth factor receptor (EGFR) concluded that they convey similar overall survival ...
SIDEBAR: Highlighted Abstracts to Watch in San Antonio
S1-01. Piccart-Gebhart M, Holmes AP, de Azambuja E, et al: The association between event-free survival and pathological complete response to neoadjuvant lapatinib, trastuzumab or their combination in HER2-positive breast cancer. Survival follow-up analysis of the NeoALTTO study (BIG 1-06) S1-02....
Program Co-Directors Highlight Abstracts of Interest for the Upcoming 2013 San Antonio Breast Cancer Symposium
The Co-Directors of the 2013 CTRC-AACR San Antonio Breast Cancer Symposium, which will be held December 10–14, 2013, have highlighted what they consider to be the most important abstracts to be presented at the Symposium. In a telebriefing in advance of the December meeting, C. Kent Osborne, MD,...
Yoga to Manage Sleep Disruption in Cancer Survivors: A Low-Risk Intervention With High Potential for Benefit
Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for...
No Progression-Free Survival Difference for Cediranib or Cediranib/Lomustine vs Lomustine in Recurrent Glioblastoma
In a phase III study (REGAL trial) reported in the Journal of Clinical Oncology, Tracy T. Batchelor, MD, MPH, of the Massachusetts General Hospital Cancer Center, and colleagues compared oral monotherapy with the investigational pan–vascular endothelial growth factor (VEGF) receptor tyrosine kinase ...
Neoadjuvant Treatment of Early Breast Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
Brivanib Studied in First- and Second-Line Therapy for Advanced Hepatocellular Carcinoma
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
Pemetrexed Improves Progression-Free Survival vs Gefitinib in Second-Line Setting for EGFR Wild-Type Nonsquamous NSCLC
Both pemetrexed (Alimta) and gefitinib (Iressa) are standard second-line treatments for advanced nonsquamous non–small cell lung cancer (NSCLC) in East Asia. In a phase II trial (CTONG 0806) reported at the International Association for the Study of Lung Cancer’s 15th World Conference on Lung...
Impact of Deficient DNA Mismatch Repair on Disease-Free Survival in Stage III Colon Cancer
In an analysis reported in the Journal of Clinical Oncology, Frank A. Sinicrope, MD, of the Mayo Clinic and North Central Cancer Treatment Group (NCCTG), and colleagues investigated the association of deficient DNA mismatch repair with prognosis in patients with stage III colon cancer treated with...
Important News Briefs: New Data Reported in Breast, Renal Cell, Head and Neck, and Lung Cancer
The 2013 European Cancer Congress (ECC), held September 27 to October 1 in Amsterdam, was jointly sponsored by the European Society of Medical Oncology, the European Cancer Organization, and the European Society of Radiation Oncology. With the Congress theme being “Reinforcing Multidisciplinarity,” ...
Two Trials Explore the Evolving Role of Bevacizumab in Ovarian Cancer
The optimal use of bevacizumab (Avastin) in ovarian cancer appears to be in high-risk subgroups and in patients with platinum-resistant ovarian cancer, according to results of two phase III trials presented at the 2013 European Cancer Congress (ECC) in Amsterdam. AURELIA investigated the safety and ...
Trebananib Improves Progression-Free Survival in Recurrent Ovarian Cancer
Trebananib, an investigational antiangiogenesis inhibitor with a different mechanism of action than bevacizumab (Avastin), significantly improved progression-free survival in recurrent platinum-resistant and partially platinum-sensitive ovarian cancer in the phase III TRINOVA-1 trial. The addition...
Cediranib Achieves 'Groundbreaking' Results in Relapsed Ovarian Cancer
The investigational oral vascular endothelial growth factor (VEGF) inhibitor cediranib extended progression-free survival when given with platinum-based chemotherapy and improved overall survival when given as maintenance therapy in patients with recurrent ovarian cancer. Experts are hopeful that...
Strong Showing for Ado-Trastuzumab Emtansine in Advanced HER2-Positive Heavily Pretreated Breast Cancer
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab emtansine (Kadcyla), formerly known as T-DM1, extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including...
Novel EGFR Inhibitor Added to Radiotherapy Fails to Improve Outcomes in Head and Neck Cancer
The addition of zalutumumab, an investigational epidermal growth factor receptor (EGFR) inhibitor, to primary chemoradiotherapy did not increase locoregional control or improve survival at 3 years in patients with squamous cell carcinoma of the head and neck compared with chemoradiotherapy alone,...
Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia
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. Indication On November 1, 2013, obinutuzumab (Gazyva) was approved...
Has a New Standard of Care for Metastatic Pancreatic Cancer Been Established?
For a number of years following the approval of gemcitabine for advanced pancreatic cancer, one phase III clinical trial after the next failed to demonstrate a survival benefit of combination chemotherapy compared to gemcitabine alone. Even the one positive study from the mid-2000s—the PA.3 trial...
Cetuximab Confers Survival Benefit in All-RAS Wild-Type Colorectal Tumors
The FIRE-3 study compared the two epidermal growth factor receptor (EGFR) antibodies, on top of chemotherapy, in the first-line treatment of metastatic colorectal cancer. A preplanned analysis of KRAS wild-type patients without RAS mutations, ie, “all-RAS wild-type,” showed overall survival to be...
Time to Think Beyond KRAS in Metastatic Colorectal Cancer
Eric Van Cutsem, MD, PhD, Professor of Internal Medicine at the University of Leuven in Belgium, told attendees at the 2013 European Cancer Congress that in the management of metastatic colorectal cancer, it is time to expand KRAS testing to include more rare mutations. Until recently, KRAS status...
TP53 Status May Predict Benefit From Cetuximab in Locally Advanced Rectal Cancer
In a retrospective analysis of the randomized phase II EXPERT-C trial, TP53 emerged as a strong, independent predictive biomarker for the benefit of cetuximab (Eribitux) in MRI-defined high-risk, locally advanced rectal cancer, according to Francesco Sclafani, MD, of The Royal Marsden NHS...
In Operable Rectal Cancer, No Support Found for Adjuvant Chemotherapy
For patients with operable rectal cancer, there is no clear role for adjuvant chemotherapy, according to an analysis of the PROCTOR and SCRIPT trials from the Dutch Colorectal Cancer Group. The findings were presented by Anne J. Breugom, MD, of Leiden University Medical Center in the Netherlands,...
Metastatic Melanoma: Encouraging Data Keep Coming
Excitement continues to build in the metastatic melanoma arena, as novel agents keep upping the ante for efficacy. The following news from the 2013 European Cancer Congress has added to the buzz. New MEK Inhibitor In the phase IB BRIM7 study, cobimetinib, a novel MEK inhibitor, when combined with...
Response-Guided Neoadjuvant Therapy for Breast Cancer: A Promising Model Warranting Additional Investigation
GeparTrio was an innovative phase III trial conducted by the German Breast Group, enrolling over 2,000 women with early breast cancer who were candidates for neoadjuvant chemotherapy. Patients with evidence of early response, defined as reduction in clinical tumor size by 50% or more, following two ...
Dr. Weisenthal Replies
Dr. Mason states that I implied that Dr. Telli supports the routine application of chemosensitivity assays. I have no knowledge regarding Dr. Telli’s views on this subject, nor did I in any way attempt to represent her views, much less imply that she was supportive of anything relating to...
Ibrutinib in Previously Treated Mantle Cell 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. Indication On November 13, 2013, ibrutinib (Imbruvica) was granted...
National Cancer Policy Summit: Setting Priorities for the Next 3 Years
Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...
FDA Grants Regular Approval to Crizotinib for ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) has granted regular approval for crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The approval was based...
Adjuvant Trastuzumab Duration: When Is Enough, Enough?
The duration of adjuvant systemic chemotherapy for breast cancer has been a subject of investigation, scrutiny, and meta-analysis.1,2 With the appreciation that prolonged regimens of cytotoxic chemotherapy of, for example, 1 to 2 years in duration were not superior in reducing breast cancer...
Expert Point of View: Kenneth C. Anderson, MD
Commenting on the evidence for treating precursor myeloma in the study by Mateos et al,1 Kenneth C. Anderson, MD, Kraft Family Professor of Medicine at Harvard Medical School and Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber Cancer ...
