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Showing 7701 - 7750Regorafenib in Metastatic Colorectal Cancer
Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose...
Prognostic Value of Integrated Cytogenetic and Mutational Risk Classification in Acute Myeloid Leukemia
Jay P. Patel, BS, and colleagues from Memorial Sloan-Kettering Cancer Center in New York recently performed mutational analysis of 18 genes in a subgroup of newly diagnosed acute myeloid leukemia (AML) patients who had been randomized to receive cytarabine plus high-dose or standard-dose...
Updated Findings Further Define Role of Tyrosine Kinase Inhibitors in CML
With three available tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia (CML), attention has turned from the ability to achieve a sustained response to the possibility of “curing” patients. Updates of pivotal trials presented at ASCO may help define the role of the tyrosine...
Richard Goldberg, MD, Gives First Moertel Lecture
Richard Goldberg, MD, Physician-in-Chief of The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, presented the first Charles G. Moertel Lecture of the Alliance for Clinical Trials in Oncology during the plenary session of the group’s recent...
Increased Adjuvant Therapy Use and Improved Survival in Dutch Elderly Patients with Stage III Colon Cancer: A Direct Correlation?
A survival benefit of adjuvant chemotherapy has been reported for select elderly patients with stage III colon cancer, but many elderly patients are not candidates for or are not given adjuvant therapy due to comorbidities and fear of toxicity. In a recent Annals of Oncology article, van...
SIDEBAR: Other Colorectal Cancer News from ASCO
Additional noteworthy gastrointestinal cancer studies presented during oral abstract sessions at the 2012 ASCO Annual Meeting included the following trials in metastatic colorectal cancer. Perifosine/Capecitabine Fails in Phase III Trial Adding perifosine, an oral alkylphospholipid inhibitor that...
Expert Point of View: Axel Grothey, MD
Over the past 10 years, agents targeting the VEGF system, such as bevacizumab, have become standard components of anticancer therapy in various malignancies. Recently, it has become increasingly evident that prolonged duration of anti-VEGF therapy is needed to optimize the therapeutic effect of...
Bevacizumab beyond Progression Prolongs Survival in Metastatic Colorectal Cancer
In a study highlighted at a press briefing during the 2012 ASCO Annual Meeting, German investigators reported that prolonging treatment with bevacizumab (Avastin) beyond disease progression extends overall survival in patients with metastatic colorectal cancer.1 Patients received bevacizumab plus...
ASCO Studies Point to Risks Associated with Treating Childhood Cancers
Risks associated with being a young cancer survivor were emphasized by two studies highlighted in press briefings at the 2012 ASCO Annual Meeting. Investigators from the Children’s Oncology Group (COG) reported that adolescents and young adults treated for high-risk B-precursor acute lymphoblastic ...
First-line Afatinib Superior to Standard Chemotherapy in Advanced EGFR-mutated Non–Small Cell Lung Cancer
First-line therapy with the investigational oral agent afatinib improved progression-free survival compared with standard chemotherapy (pemetrexed (Alimta)/cisplatin) in patients with advanced non–small cell lung cancer (NSCLC) harboring an EGFR mutation. Afatinib improved progression-free survival ...
Landscape for Treatment of Metastatic Melanoma Is Expanding
Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...
Second-line Treatments Tested in Patients with Non-Small Cell Lung Cancer
Results of two late-breaking phase III trials presented at 2012 ASCO Annual Meeting add to the evolving understanding of how best to treat non–small cell lung cancer (NSCLC). The TAILOR trial suggested the benefit of chemotherapy over EGFR-targeted therapy as second-line treatment of patients with...
Most Hospitals Do Not Meet Benchmark for Examining Lymph Nodes following Esophagectomy
“Fewer than one-third of patients and fewer than 1 in 10 hospitals met the benchmark of examining at least 15 lymph nodes” following esophagectomy for patients with esophageal cancer, according to a retrospective observational study reported in the Archives of Surgery. That benchmark was set by the ...
Regorafenib Has ‘Notable Anticancer Activity’ after Patients Develop Resistance to Imatinib and Sunitinib
The orally administered investigational multikinase inhibitor regorafenib demonstrated “notable anticancer activity” in a phase II trial among patients with advanced gastrointestinal stromal tumor (GIST) who developed resistance to imatinib (Gleevec) and sunitinib (Sutent). Researchers reported in...
Adjuvant Chemotherapy May Improve Survival for Patients with Periampullary Disease
The European Study Group for Pancreatic Cancer (ESPAC)-3 periampullary cancer trial found that adjuvant chemotherapy following surgical resection of periampullary adenocarcinoma “was not associated with a significant survival benefit in the primary analysis; however, multivariate analysis adjusting ...
‘Strong Persistent Benefit’ from Radiochemotherapy after Curative Gastric Cancer Resection
An update, with more than a 10-year median follow-up, from Intergroup 0116 (INT-0116), a randomized phase III trial of postoperative chemotherapy in patients at moderate risk of locoregional failure following curative gastric cancer resection, “demonstrates strong persistent benefit from adjuvant...
Symposium Focuses on Policy Issues in Personalized Cancer Care
“What is the biggest barrier to progress in personalized medicine?” asked moderator Anna Barker, PhD, leading a panel discussion at a recent meeting convened by the Washington-based advocacy group, the Personalized Medicine Coalition, with the American Association for Cancer Research and Feinstein...
Data Liquidity Coalition Takes Shape
A coalition to promote and implement data sharing in cancer by facilitating data ‘liquidity,’ first proposed in February at an Institute of Medicine (IOM) workshop, is taking shape with the formation of a steering committee and action plans that include a demonstration project. For several years,...
Response Rate Is Significantly Improved with Nab- vs Solvent-based Paclitaxel plus Carboplatin in Advanced NSCLC
Final results of a phase III trial found nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) plus carboplatin as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) resulted in a significantly improved overall response rate vs conventional solvent-based paclitaxel...
Older Chemotherapy Studies in Breast Cancer Coming of Age
Results of several long-running chemotherapy trials were reported at the 2012 ASCO Annual Meeting breast cancer oral session, reported in brief here. NSABP B-38 The final analysis of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-38 trial showed that the addition of gemcitabine...
Antidepressant Drug Has ‘Clinically Meaningful’ Effect on Chemotherapy-induced Painful Neuropathy
The oral antidepressant duloxetine (Cymbalta) at 60 mg/d improved chemotherapy-induced painful neuropathy in a randomized, double-blind, placebo-controlled, phase III trial.1 Overall, 59% of patients treated with duloxetine experienced some pain relief, 33% reported at least a 30% decrease in pain, ...
Lapatinib Shows Value Similar to Trastuzumab in Neoadjuvant Regimens for Breast Cancer, but with Greater Toxicity
Lapatinib (Tykerb) proved valuable as a component of neoadjuvant chemotherapy for HER2-positive operable breast cancer in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-41 trial presented at the 2012 ASCO Annual Meeting by Andre Robidoux, MD, of the NSABP and the University of...
No Improvement in Overall Survival, Worse Toxicity with Motesanib Added to Chemotherapy in Non–Small Cell Lung Cancer
Two trials (E4599 and AVAiL) have suggested a benefit to adding the anti–vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab (Avastin) to chemotherapy in patients with advanced nonsquamous non–small cell lung cancer (NSCLC). Bevacizumab acts by binding directly to circulating...
Adding Bevacizumab to Chemotherapy Improves Progression-free Survival in Platinum-sensitive Recurrent Ovarian Cancer
The addition of bevacizumab (Avastin) to gemcitabine and carboplatin, followed by bevacizumab until disease progression, resulted in significantly improved progression-free survival compared to gemcitabine and carboplatin plus placebo among women with platinum-sensitive recurrent ovarian, primary...
Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...
Expert Point of View: Grant McArthur, MB, BS, PhD
Grant McArthur, MB, BS, PhD, Head of the Cancer Therapeutics Program at the Peter MacCallum Cancer Centre in Melbourne, Australia, congratulated the investigators on a rapidly accrued, well-conducted, and ethical study that encouraged crossover to the active arm. He noted that regorafenib is an...
Striking Activity Shown for Regorafenib in Advanced GIST
Regorafenib, an orally administered investigational tyrosine kinase inhibitor that has shown activity in chemorefractory metastatic colorectal cancer, markedly delayed disease progression in patients with treatment-refractory metastatic gastrointestinal stromal tumor (GIST) in the phase III GRID...
Molecularly Targeted Treatment of Thyroid Cancer Rapidly Evolving
Recent advances in understanding the pathogenesis and altered signaling pathways in thyroid cancer are improving treatment options for this malignancy, especially for the subset of patients with medullary thyroid cancer and those with differentiated thyroid cancer that has metastasized, according...
Supportive Care Research Runs the Gamut from Genetic Markers of Treatment Side Effects to Neuropathic Pain Therapies
Attendees from around the world gathered for the Multinational Association for Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium on Supportive Care in Cancer, held June 28–30 in New York. Below are highlights from the meeting, representing...
FDA Approves Colon-cleansing Drug for Prep Prior to Colonoscopy
The FDA has approved sodium picosulfate, magnesium oxide, and citric acid (Prepopik) to help cleanse the colon in adults preparing for colonoscopy, Ferring Pharmaceuticals announced. The new solution is a low-volume, dual-acting stimulant and osmotic laxative. The FDA approval is based on data from ...
Kidney Transplant Recipients Switching to Sirolimus Had Lower Risk of Secondary Squamous Cell Carcinomas
Kidney transplant recipients with at least one previous cutaneous squamous cell carcinoma decreased their risk of developing new cutaneous squamous cell carcinomas by switching from calcineurin inhibitors (cyclosporine or tacrolimus) to sirolimus (Rapamune) in a multicenter phase III study. New...
Carfilzomib: New Drug with Accelerated Approval for Multiple Myeloma
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 In July 2012, carfilzomib (Kyprolis) was granted...
Enzalutamide Significantly Prolonged Survival in Men with Castrate-resistant Metastatic Prostate Cancer
“Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy” in an international phase III, double-blind, placebo-controlled trial, investigators reported in The New England Journal of Medicine. Median overall survival, the...
Ziv-aflibercept with FOLFIRI in Metastatic Colorectal Cancer
In August 2012, the antiangiogenic agent ziv-aflibercept (Zaltrap) was approved for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer resistant to or progressing after an oxaliplatin-containing regimen.1,2 Approval was based on...
FDA Grants Priority Review to Supplemental New Drug Application for Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer
Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer ...
VEGF Pathway Biomarker for Outcome with Bevacizumab
No biomarkers are available to guide patient selection for treatment with the anti-VEGF monoclonal antibody bevacizumab (Avastin). Lambrechts and colleagues from VIB and KULeuven and University Hospital Gasthuisberg, Belgium, and F. Hoffmann-La Roche in Basel, Switzerland, have identified a locus...
Predictive Markers for Outcome with Pazopanib in Metastatic Renal Cell Cancer
Several targeted drugs are approved for treatment of metastatic renal cell cancer, but no validated biomarkers are available for prediction of clinical outcome of treatment with these agents. In a recent study, Tran and colleagues from The University of Texas MD Anderson Cancer Center in Houston,...
Dying Patients with Cancer Who Avoid Aggressive Care but Stay Connected with an Oncologist Have Better Quality of Life
Dying patients with cancer who avoided hospitalizations and life-prolonging measures, who worried less, prayed or meditated, were visited by a pastor, and maintained a therapeutic alliance with their oncologist had the highest quality of life at the end of life, according to a study recently...
EMILIA Study: T-DM1 Significantly Improves Overall Survival in HER2-positive Metastatic Breast Cancer
Updated results from the phase III EMILIA study showed that trastuzumab emtansine (T-DM1) significantly improved overall survival of people with HER2-positive metastatic breast cancer compared to the combination of lapatinib and capecitabine (Xeloda). The new data were reported in a press release...
NDA for Chemosaturation System to Treat Melanoma in the Liver
Delcath Systems, Inc, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for its chemosaturation system (CHEMOSAT) for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The system is designed to...
Biomarker-driven Adaptive Trial Design Proving Informative in Non–Small Cell Lung Cancer
Biomarker-driven adaptive trial design is an accelerated strategy for targeted drug development that is proving informative in non–small cell lung cancer (NSCLC), according to Roy S. Herbst, MD, PhD, Chief of Medical Oncology and Associate Director of Translational Research at Yale Cancer Center,...
Exciting New Agents Offer Further Treatment Options for Metastatic Melanoma
“This is a very exciting time in melanoma,” said Michael Sabel, MD, of the University of Michigan, Ann Arbor. “For years, we chugged along with few options for systemic therapy. Then in 2010 and 2011, we saw melanoma data presented at ASCO plenary sessions. At ASCO 2012, we expanded in these areas...
Another Tyrosine Kinase Inhibitor Joins the Lineup in Renal Cell Carcinoma
The novel tyrosine kinase inhibitor tivozanib was superior to sorafenib (Nexavar) for the treatment of advanced renal cell carcinoma in the phase III TIVO-1 trial.1 Tivozanib is a potent, selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, with a long half-life that is...
Novel Drugs Enhance—but Complicate—Prostate Cancer Treatment
Three emerging agents for castration-resistant prostate cancer are extending lives and defining their roles in the treatment scenario, according to William Oh, MD, of Mount Sinai School of Medicine, New York, who commented on new data at the Best of ASCO Boston meeting. “We are talking about...
SIDEBAR: How Should SWOG 9346 Be Interpreted?
The findings of Southwest Oncology Group (SWOG) 9346 sparked controversy at the ASCO Annual Meeting, and the interpretations were debated at an official postpresentation discussion. At the Best of ASCO Boston meeting, William K. Oh, MD, of Mount Sinai School of Medicine, New York—who also served as ...
Continuous Androgen Deprivation Remains Standard of Care in Newly Diagnosed Metastatic Prostate Cancer
Continuous androgen deprivation therapy remains the standard of care for newly diagnosed hormone-sensitive metastatic prostate cancer, according to the phase III Southwest Oncology Group (SWOG) 9346 intergroup trial presented at this year’s ASCO Plenary Session.1 Study Rationale The large...
SIDEBAR: Is Microsatellite Instability Status also Predictive in Stage II Disease?
“Microsatellite instability status is a validated prognostic marker in stage II colorectal cancer. It is the strongest prognostic marker we have in that group,” Dr. Overman commented. “The fact is that we should be getting this [test] consistently to help us make this discussion [of prognosis]...
Evidence Is Changing Colorectal Cancer Treatment Landscape
Key colorectal cancer studies presented at this year’s ASCO Annual Meeting are changing the treatment landscape in this disease, according to Michael Overman, MD, of The University of Texas MD Anderson Cancer Center, who reviewed the data at the Best of ASCO San Diego meeting. The mix included...
New Agents Are Achieving Deeper Responses in CML
As tyrosinse kinase inhibitors become increasingly effective in treating chronic myeloid leukemia (CML), major molecular responses (≥ 3-log reduction in BCR-ABL transcripts) are being achieved for a growing percentage of patients. “In the new era of tyrosinse kinase inhibitors, we are learning how...
ABVD and BEACOPP Yield Equivalent Survival in Hodgkin Lymphoma
In the EORTC 20012 randomized phase III trial comparing eight cycles of ABVD vs eight cycles of BEACOPP, Hodgkin lymphoma patients achieved equivalent overall survival with either regimen, but BEACOPP was more toxic.1 “Our approach, and that of most U.S. centers, is to use ABVD,” Michael E....
