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Showing 8001 - 8050Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for...
Supplemental New Drug Application Submitted for Ibrutinib in CLL
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
Belinostat Moves Forward in Trials for Two Aggressive Cancers
In February, the U.S. Food and Drug Administration (FDA) granted belinostat (Beleodaq), a targeted histone deacetylase (HDAC) inhibitor, priority review status based on a pivotal phase II trial in peripheral T-cell lymphoma. Just 1 month later, researchers at the National Cancer Institute (NCI) in...
Expert Point of View: Edith Perez, MD
Commenting on the I-SPY 2 neratinib results presented at the 2014 American Association for Cancer Research Annual Meeting, Edith Perez, MD, Deputy Director at Large, Mayo Clinic Comprehensive Cancer Center, Jacksonville, Florida, said that results were consistent with other data. “Testing for HER2...
I-SPY 2 Trial ‘Graduates’ Neratinib to Phase III Study in HER2-Positive, Hormone Receptor–Negative Breast Cancer
In the targeted-therapy era, it is important to identify subsets of patients who can benefit from novel agents and combinations as quickly as possible. The I-SPY 2 trial is designed to expedite this goal and to change the way that targeted agents are studied and approved. This innovative adaptive...
Blood Test Can Identify Prostate Cancer Patients Who Are Not Likely to Respond to Enzalutamide
A simple blood test may be able to identify men with castration-resistant prostate cancer who will not respond to enzalutamide (Xtandi). The presence of the splice variant androgen receptor (AR) V7 in circulating tumor cells identified men who were unlikely to respond to enzalutamide and whose...
ASCO Releases Guideline on Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers
ASCO has released a clinical practice guideline on prevention and treatment of chemotherapy-induced peripheral neuropathy in adult cancer patients, published in the Journal of Clinical Oncology.1 The guidelines resulted from the efforts of an expert panel, with representation from the fields of...
Recipients of the David A. Karnofsky Memorial Award and Lecture
2014: H.M. (Bob) Pinedo, MD, PhD 2013: Martine J. Piccart, MD, PhD 2012: Kanti R. Rai, MD 2011: Kenneth Anderson, MD 2010: Daniel D. Von Hoff, MD, FACP 2009: Clara D. Bloomfield, MD 2008: V. Craig Jordan, OBE, PhD, DSc 2007: Robert A. Kyle, MD, MACP 2006: Dennis J. Slamon, MD, PhD 2005: Charles L....
A Proposal for Patient-Selected Controlled Trials: Good Science and Good Medicine
The Clinical Trials and Translational Research Advisory Committee (CTAC) of the National Cancer Institute (NCI) met for the 22nd time on March 12, 2014, in their ongoing effort to improve efficiency and effectiveness of cancer clinical trials. A significant portion of the meeting addressed lagging...
FDA Approves Panitumumab Plus FOLFOX for Wild-Type KRAS Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has approved panitumumab (Vectibix) for use in combination with FOLFOX (fluorouracil, leucovorin, oxaliplatin) as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer. This approval converts the accelerated...
Should Breast Cancer Patients With One to Three Positive Nodes Routinely Receive Postmastectomy Radiation?
The Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) continues to provide valuable clinically relevant and practice-influencing information garnered from individual patient-level data from numerous randomized trials in breast cancer. The large numbers of patients and long-term follow-up...
Looking Ahead in Treating Chronic Lymphocytic Leukemia
It’s the dawn of a new era in the treatment of chronic lymphocytic leukemia (CLL), largely due to the development of agents targeting the BCR signaling pathway, according to John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, Columbus. At the 19th Annual Conference of the...
Surveillance After Colon Cancer Surgery: Too Much of a Good Thing?
Finding salvageable colon cancer recurrence is akin to finding a needle in a haystack, rendering routine patient surveillance of little value. But finding that needle offers an opportunity for treating recurrent disease early, which makes surveillance worthwhile. These were the opposing views...
Phase III Study of Talimogene Laherparepvec in Patients With Metastatic Melanoma: Overall Survival Analysis Reported
Amgen recently announced top-line results from the primary overall survival analysis of a phase III trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec (also known as T-VEC) for the treatment of unresected stage IIIB, IIIC, or IV melanoma compared to treatment...
Cryoablation of Breast Tumors Shows Promise in Patients With Early-Stage Disease
Cryoablation of breast tumors, which destroys lesions by exposing them to extremely low temperatures, shows promise as an alternative to surgery in carefully selected women with early-stage disease, according to a study presented at the American Society of Breast Surgeons Annual Meeting in Las...
Delaying Androgen Deprivation Therapy May Not Compromise Survival in Men With Prostate Cancer and PSA-Only Relapse
In men with prostate cancer and a prostate-specific antigen (PSA)-only recurrence after curative surgery or radiation, delaying androgen deprivation therapy for at least 2 years or until clinical progression (ie, new symptoms, metastasis by imaging techniques or short PSA doubling time) did not...
Expert Point of View: Peter P. Yu, MD
Commenting on the study by Jänne et al, ASCO President Peter P. Yu, MD, said that the issue of drug resistance is important to understand for all cancers, but it is difficult to overcome resistance. “This clinical trial has important implications not only for NSCLC patients but for all patients...
ALTTO Trial Finds Dual Anti-HER2 Therapy No Better Than Trastuzumab Alone
The highly anticipated results from the phase III ALTTO trial show no additional benefit for adding lapatinib (Tykerb) to trastuzumab (Herceptin) in the adjuvant treatment of HER2-positive breast cancer.1 The results were presented at the 2014 ASCO Annual Meeting’s Plenary Session by Martine J....
‘Unprecedented’ Survival Benefit in Prostate Cancer With Addition of Docetaxel to Hormone Therapy
Adding docetaxel to standard androgen ablation therapy (ie, testosterone suppression) extended survival by more than 1 year in men with newly diagnosed metastatic hormone-sensitive prostate cancer in the phase III E3805 trial, funded by the National Institutes of Health. As reported at the ASCO...
New Option for Preserving Fertility in Women Being Treated With Chemotherapy for Early-Stage Breast Cancer
One of the most reported studies emanating from the 2014 ASCO Annual Meeting involves the use of the luteinizing hormone–releasing hormone (LHRH) agonist goserelin (Zoladex) to reduce the risk of ovarian failure among women being treated with chemotherapy for early-stage breast cancer, and to...
Issues in the Management of the Axilla in Patients With Breast Cancer
For the past 40 years the story of breast cancer surgery in general, and for the past 20 years the management of the axilla in particular, has been one of increasing conservatism. To give our readers insight into the current and future direction of axillary management, The ASCO Post spoke with...
A New Era in the Management of Advanced HER2-Positive Breast Cancer
Approximately 20% of all breast cancers are human epidermal growth factor receptor 2 (HER2)-positive. Prior to the era of HER2-targeted therapy, HER2-positive breast cancer was characterized by a poor prognosis.1,2 The development of the first HER2-targeted therapy, trastuzumab (Herceptin), led to...
ASCO Clinical Practice Guideline: Systemic Therapy for Patients With Advanced HER2-Positive Breast Cancer
Approximately 15% of patients with breast cancer have tumors that overexpress the HER2 protein and these patients can benefit from HER2-targeted therapies. The American Society of Clinical Oncology recently released a clinical practice guideline on systemic therapy for patients with advanced...
FDA Approves Magnetic Resonance Contrast Agent for Evaluation of Breast Cancer
The U.S. Food and Drug Administration has approved a new indication for gadobutrol (Gadavist) injection for intravenous use with magnetic resonance imaging (MRI) of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two multicenter...
Expert Point of View: Gregory A. Masters, MD, FASCO
This combination shows good activity in the difficult-to-treat second-line setting of NSCLC,” said Gregory A. Masters, MD, FASCO, about the results of the REVEL study reported at the ASCO Annual Meeting. Dr. Masters, who is Attending Physician at the Helen F. Graham Cancer Center and Research...
Chemotherapy Plus Ramucirumab Provides Survival Advantage Over Chemotherapy Alone in Non–Small Cell Lung Cancer
Ramucirumab (Cyramza) added to docetaxel improved overall survival compared to chemotherapy alone in patients with stage IV non–small cell lung cancer (NSCLC) that has progressed on one prior therapy, according to results of a phase III trial presented at the 50th ASCO Annual Meeting.1 The...
Goserelin With Chemotherapy Prevents Early Menopause, Helps Preserve Fertility in Younger Women With Hormone Receptor–Negative Breast Cancer
The good news for younger women with hormone receptor–negative early breast cancer is that adding goserelin (Zoladex), a luteinizing hormone–releasing hormone (LHRH) agonist, to chemotherapy can prevent sudden menopause, better preserve ovarian function and fertility, and lead to successful...
Expert Point of View: Gregory A. Masters, MD, FASCO
At an ASCO press conference held during the Annual Meeting, moderator Gregory A. Masters, MD, FASCO, who is Attending Physician at the Helen F. Graham Cancer Center and Research Institute, Newark, Delaware, commented on the study presented by Liu et al. “This new combination demonstrates how...
Oral Two-Drug Regimen Appears Promising in Phase II Trial of Recurrent Platinum-Sensitive Ovarian Cancer
An all-oral combination of the investigational agents olaparib and cediranib nearly doubled progression-free survival in platinum-sensitive recurrent ovarian cancer in a National Cancer Institute (NCI)-sponsored randomized phase II trial reported at the 2014 ASCO Annual Meeting.1 The toxicity...
Expert Point of View: Nasser H. Hanna, MD
Formal discussant of the study by Park et al, Nasser H. Hanna, MD, Associate Professor of Medicine at the Indiana University Simon Cancer Center, Indianapolis, said that the trial confirms the difficulty of giving consolidation therapy, since less than two-thirds of patients were able to get the...
Pieces of the Puzzle in Treating Early Non–Small Cell Lung Cancer
Separate studies in early-stage non–small cell lung cancer (NSCLC) found that the addition of consolidation chemotherapy to concurrent chemoradiotherapy did not improve survival and that adjuvant erlotinib (Tarceva) did not improve survival. There was a suggestion of benefit for adjuvant erlotinib...
Ibrutinib 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 ...
