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Showing 8251 - 8300Ibrutinib Surpasses Ofatumumab as Second-Line Treatment of Chronic Lymphocytic Leukemia
Ibrutinib (Imbruvica) significantly improved progression-free survival, overall survival, and response when compared with ofatumumab (Arzerra) as second-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the phase III RESONATE study. The study results were...
Expert Point of View: Cora N. Sternberg, MD, FACP
Despite the availability of hormonal therapy for the treatment of metastatic prostate cancer and the high response rates for these agents, most patients eventually experience progression to castration-resistant disease. “Multidisciplinary team approaches have contributed to the enormous progress...
Expert Point of View: Scott T. Tagawa, MD
Formal discussant Scott T. Tagawa, MD, Associate Professor of Clinical Medicine and Urology at Weill Cornell Medical College, New York, had the task of putting the three prostate cancer trials—PREVAIL, ELM-PC 4, and SWOG S0925—into context. “Since the approval of docetaxel, we have learned much...
Updated Information on Prostate Cancer Drugs: Enzalutamide, Orteronel, and Cixutumumab
Three separate studies of treatments for prostate cancer reported at the 2014 ASCO Annual Meeting in Chicago showed excellent, intermediate, and disappointing results. An update of the previously reported PREVAIL trial (see March 1 issue of The ASCO Post, page 1) was overwhelmingly positive for the ...
Combined With Chemotherapy, Cetuximab and Bevacizumab Found Comparable for First-Line Metastatic Colorectal Cancer Treatment
Call it a draw: Cetuximab (Erbitux), an EGFR inhibitor, and bevacizumab (Avastin), a VEGF inhibitor, confer comparable benefits as first-line treatment with chemotherapy for metastatic colorectal cancer, according to the phase III Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) ...
Exemestane/Ovarian Suppression Reduces Recurrence vs Tamoxifen/Ovarian Suppression in Premenopausal Breast Cancer
A joint analysis of two important phase III clinical trials—TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial)—showed that exemestane plus ovarian function suppression was superior to tamoxifen plus ovarian suppression in preventing recurrence in premenopausal...
Lung Cancer Mutation Consortium Finds Oncogenic Drivers in Majority of Metastatic Lung Adenocarcinomas
The Lung Cancer Mutation Consortium (LCMC) was formed to test adenocarcinomas of the lung for 10 oncogenic drivers in order to enable clinicians to select targeted treatments and enroll patients into suitable clinical trials. As recently reported in JAMA by Mark G. Kris, MD, William and Joy Ruane...
Panitumumab Plus FOLFOX for KRAS Wild-Type Metastatic Colorectal 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. Panitumumab (Vectibix) was recently approved by the U.S. Food and...
Ado-Trastuzumab Emtansine as a Late Treatment for HER2-Positive Metastatic Breast Cancer—Better and Less Toxic Than Physician’s Choice
TH3RESA is a randomized phase III open-label study, reported in The Lancet Oncology and summarized in this issue of The ASCO Post, which examined the activity of ado-trastuzumab emtansine (Kadcyla) in heavily pretreated HER2-positive metastatic breast cancer.1 Formerly known as T-DM1,...
Ado-Trastuzumab Emtansine Improves Progression-Free Survival vs Physician’s Choice in Advanced HER2-Positive Breast Cancer
There are few treatment options for breast cancer patients with progressive disease after two or more HER2-directed regimens for recurrent or metastatic disease. In the open-label phase III TH3RESA trial reported in The Lancet Oncology by Ian E. Krop, MD, PhD, of the Dana-Farber Cancer Institute,...
FDA Advisory Committee Votes Against Accelerated Approval for Olaparib in Ovarian Cancer
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have...
Expert Point of View: Jeffrey S. Weber, MD, PhD
Jeffrey S. Weber, MD, PhD, Director of the Donald A. Adam Comprehensive Melanoma Research Center at the Moffitt Cancer Center and Research Institute, Tampa, Florida, was very impressed by the response rate and survival outcomes. “Responses were outstanding. Eight of nine patients in cohort 2...
Concurrent Immunotherapy Pays Off in Advanced Melanoma
In advanced melanoma, two immune checkpoint inhibitors may be better than one, according to the promising outcomes of a study reported at the 2014 ASCO Annual Meeting. Concurrent treatment with the anti–CTLA-4 antibody ipilimumab (Yervoy) and nivolumab, an antibody targeting the programmed death...
Long-Term Follow-up of Phase I Nivolumab Trial
In the longest follow-up to date of any programmed death (PD)-1 receptor inhibitor in previously treated advanced melanoma, one-third of patients are demonstrating durable responses to the investigational agent nivolumab, and in some cases, these persist following discontinuation of the drug,...
Ipilimumab Reduces Recurrences as Adjuvant Treatment of Melanoma
Ipilimumab (Yervoy) has transformed the treatment of metastatic melanoma, producing long-term responses in about 20% of patients. A phase III study has now evaluated its impact in the adjuvant setting, and the results are a bit less striking. Primary Endpoint The European Organisation for Research...
Colorectal Cancer Survivors Prefer More Information on Late Effects of Treatment and Recurrence Risks
Survivors of nonmetastatic colorectal cancer, when surveyed about their needs and preferences for survivorship information, responded that they would prefer receiving more information about late effects of treatment, challenges to expect, general health maintenance, and risks of recurrence. Most of ...
Lung-MAP Trial Debuts—Other Personalized Studies Will Follow
Oncologists now have a means of bringing personalized medicine to advanced squamous cell carcinoma, and it involves a biomarker-driven clinical trial that maximizes the chance of successful treatment and new drug approvals. Lung-MAP (Lung Cancer Master Protocol) is a unique concept in which the...
Belinostat for Relapsed/Refractory Peripheral T-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. On July 3, 2014, belinostat (Beleodaq) was granted accelerated...
Progress in Differentiated Thyroid Cancer
Treatment of differentiated thyroid cancer has been slow to advance. Three decades lapsed between the description of the first differentiated thyroid cancer patient being cured by radioactive iodine in the 1940s1 and the report of the study that led to the approval of doxorubicin in the 1970s.2 The ...
Sorafenib Improves Progression-Free Survival in Progressive Radioactive Iodine–Refractory Differentiated Thyroid Cancer
Patients with radioactive iodine–refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis. In the double-blind phase III DECISION trial reported in The Lancet, Marcia S. Brose, MD, PhD, of Abramson Cancer Center of the University of Pennsylvania, and colleagues ...
Second-Line Regorafenib Improves Survival in Metastatic Colorectal Cancer
In the phase III double-blind, placebo-controlled CONCUR trial,1 previously treated patients with stage IV adenocarcinoma of the colon or rectum had increased overall survival, the primary endpoint, when treated with regorafenib (Stivarga). Regorafenib also improved progression-free survival, a...
Adding Novel Agent to Standard Therapy Improves Survival in Patients With Pancreatic Cancer After Prior Gemcitabine-Based Therapy
The addition of the novel agent MM-398 to standard treatment improved overall survival in patients with metastatic pancreatic cancer who have already received gemcitabine, according to a phase III trial reported at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.1 “Patients...
Expert Point of View: Jean-Yves Douillard, MD, PhD
Commenting on the RECOURSE data,1 ESMO spokesperson Jean-Yves Douillard, MD, PhD, Professor of Medical Oncology, Institut de Cancérologie de l’Ouest (ICO) René Gauducheau, Saint-Herblain, France, said, “The phase III trial of TAS-102 is a global study and confirms the results of the phase II study...
Phase III Trial Shows Improved Survival With TAS‑102 in Metastatic Colorectal Cancer Refractory to Standard Therapies
The new combination agent TAS-102 can improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers reported at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.1 “Around 50% of patients with...
Federally Funded Trials Praised—and Underfunded
All four studies presented at the 2014 ASCO Annual Meeting Plenary Session were at least partially funded by federal dollars, bringing long overdue attention to the value of federally supported cancer research. Perhaps because of this high visibility, ASCO leaders took to the soapbox to sound 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 the...
Impressive Delay in Thyroid Cancer Progression Achieved With Lenvatinib
The investigational tyrosine kinase inhibitor lenvatinib reduced disease progression by 79%, as compared to placebo, in patients with metastatic differentiated thyroid cancer that is refractory to radioactive iodine in the phase III SELECT trial. These findings were presented at the 2014 ASCO...
Benefit Confirmed for Adjuvant Oxaliplatin in Rectal Cancer
Patients with curatively resected rectal cancer are more likely to be disease-free at 3 years after treatment with an oxaliplatin-containing regimen than with fluorouracil (5-FU)/leucovorin, Korean investigators of the phase II multicenter ADORE trial reported at the ASCO Annual Meeting.1 Study...
Intralesional Injections Trigger Immune Responses in Melanoma
The emerging approach to treating metastatic melanoma is a full-throttle effort to stimulate an immune response. One of the components of this strategy could be intralesional injections, according to studies presented at the 2014 ASCO Annual Meeting. T-VEC Oncolytic Immunotherapy Talimogene...
Neoadjuvant Chemotherapy Less Invasive Option for Advanced Ovarian Cancer, but Jury Still Out
Neoadjuvant chemotherapy followed by interval debulking surgery may be a better strategy for the initial treatment of advanced ovarian cancer than the current standard of care, suggest results of a phase III trial. Neoadjuvant chemotherapy followed by interval debulking surgery led to fewer...
Expert Point of View: Philip McCarthy, MD
Melphalan, prednisone, and thalidomide (Thalomid), or MPT, was a widely accepted regimen in newly diagnosed multiple myeloma when the E1A06 trial was launched, noted Philip McCarthy, MD, Director of the Blood and Marrow Transplant Program at the Roswell Park Cancer Institute, Buffalo, New York....
Multiple Myeloma Studies Explore Roles of Panobinostat in Relapsed/Refractory Disease and Thalidomide Compared to Lenalidomide as Part of Initial Therapy
At the 2014 ASCO Annual Meeting, one phase III trial confirmed the promise of a novel agent in advanced multiple myeloma, while another cooperative group trial returned some rather surprising results in newly diagnosed myeloma patients. Panobinostat Doubles Response, Prolongs Remission The phase...
Considerable Extension of Survival Achieved With Conventional Treatment in Grade 2 Glioma
Long-term results from the Radiation Therapy Oncology Group (RTOG) 9802 study in high-risk grade 2 gliomas were presented at the 2014 ASCO Annual Meeting. The study’s mature analysis showed a 41% reduction in mortality at 5 years with combination radiation therapy followed by six cycles of PCV...
What Do Humans and Laboratory Rats Have in Common?
The requirements for sound evidence of a drug’s therapeutic benefit have translated laboratory experience to human testing. In the laboratory, experimental animals give their lives to lethal testing of drugs and scientific analysis. LD50, the terminology denoting an anticipated 50% death rate of...
Everolimus Did Not Improve Survival in Hepatocellular Cancer After Progression on Sorafenib
“Despite the strong scientific rationale and preclinical data, everolimus [Afinitor] plus best supportive care failed to improve survival over placebo plus best supportive care” among patients with advanced hepatocellular cancer that progressed during or after receiving sorafenib (Nexavar), or who...
High False-Positive Rate of Elevated CEA Seen in Patients With Resected Colorectal Cancer
A retrospective study finding a 49% false-positive of carcinoembryonic antigen (CEA) testing among patients with a history of resected colorectal cancer, “suggests that confirmation of an ongoing increase in CEA level should be universal practice before an extensive workup is initiated,” Anya...
Ongoing Clinical Trials Actively Recruiting Patients With Bladder Cancer
The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with bladder cancer. The list includes randomized and nonrandomized phase 0 to III studies as well as observational clinical trials evaluating new therapies, surgical techniques, and...
Cancer Survivor and Patient Advocate Michael S. Katz, MBA, Has Helped Alter the Standard of Care for Myeloma Survivors
Michael S. Katz, MBA, has lived longer than any of his doctors thought he would. A two-time cancer survivor, Mr. Katz was diagnosed, first with multiple myeloma in 1990 and then with colorectal cancer in 2008, and has spent the past 2 decades tirelessly advocating for patients with cancer. The...
Taking Charge of Your Care
The first sign I had that something might be wrong was an uncontrollable itch all over my body. Although I had never had anything like that before, the problem was easy to initially dismiss. I’m a respiratory therapist and visit patients in their homes daily, so I chalked up the itchiness to an...
Pioneering Medical Oncologist Remembers a Time Before the Subspecialty Was Created
While the first written record of cancer dates back to ancient Egypt, the history of modern oncology is fairly short, dating back only slightly more than half a century. Clinical trials in the early days of the National Cancer Institute (NCI) and the emerging cooperative groups were led by a...
Ibrutinib in Previously Treated CLL and CLL With 17p Deletion
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 28, 2014, the approved use of ibrutinib (Imbruvica) in...
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...
Michael Bookman, MD, Joins US Oncology Research as Medical Director of Gynecology Research Program
Michael Bookman, MD, of the University of Arizona Cancer Center will join Arizona Oncology, a practice in The US Oncology Network, and serve as Medical Director of the US Oncology Research Gynecology Research Program. In his new role, effective October 6, 2014, Dr. Bookman will use his extensive...
Circulating Tumor Cells in Metastatic Breast Cancer: Are We Afraid of the Truth?
All truths are easy to understand once they are discovered; the point is to discover them.” —Galileo Galilei There are several “truths” in breast oncology that have been discovered over the years, become widely understood, and changed the way we practice. Prospective randomized studies have...
Early Change in Chemotherapy Based on Elevated Circulating Tumor Cells Does Not Improve Outcome in Metastatic Breast Cancer
Elevated circulating tumor cells are associated with poor prognosis in metastatic breast cancer. In a phase III trial (Southwest Oncology Group [SWOG] S0500) reported in Journal of Clinical Oncology, Jeffrey B. Smerage, MD, PhD, Clinical Associate Professor in Medical Oncology at the University of...
FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell...
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 with ovarian...
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 of Priority...
Study Finds New Genetic Risk Markers in Pancreatic Cancer
A large DNA analysis of people with and without pancreatic cancer has identified several new genetic markers that signal increased risk of developing the disease, report scientists from Dana-Farber Cancer Institute and other institutions worldwide. The markers are variations in the inherited DNA...
PREVAIL Trial: Enzalutamide Before Chemotherapy Prolongs Survival in Metastatic Prostate Cancer
The androgen-receptor inhibitor enzalutamide (Xtandi) has been shown to prolong survival in men with metastatic castration-resistant prostate cancer with progressive disease after chemotherapy. In the phase III PREVAIL trial reported in The New England Journal of Medicine, Tomasz M. Beer, MD, of...
