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Showing 7301 - 7350Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma
Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...
FDA Approves Brentuximab Vedotin in Two Lymphoma Indications
The antibody-drug conjugate brentuximab vedotin (Adcetris) was granted accelerated approval on August 19 for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin is the first new drug to be approved in Hodgkin lymphoma in more...
Yoga, Geriatric Assessment, and Nausea/Vomiting Addressed in Session on Supportive Care and Survivorship Issues
Marie E. Wood, MD, of the Familial Cancer Program at the University of Vermont, Burlington, addressed clinically relevant issues in supportive care and survivorship at the Best of ASCO® Annual Meeting ‘11 in Miami. Delayed Nausea and Vomiting Two studies addressed the problem of...
Improvements Highlighted in Treatment of Leukemias and Preleukemias
Certain preleukemic conditions and leukemia in high-risk patients have remained challenging to treat despite advances in hematology, according to Wendy Stock, MD, of the University of Chicago. But studies reported at the Best of ASCO® Annual Meeting ‘11 in Seattle show progress even in these ...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
Short-term Androgen Deprivation plus Radiotherapy Improves Outcomes in Intermediate-risk Prostate Cancer
The addition of short-term androgen-deprivation therapy to external-beam radiation therapy improved overall and disease-specific survival in men with nonbulky localized prostate cancer and prostate-specific antigen (PSA) levels up to 20 ng/mL, as reported recently in The New England Journal of...
New ASCO Focused Update Recommendation on Maintenance Treatment of Stage IV Non–Small Cell Lung Cancer
A focused update to the 2009 ASCO Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer reflects new evidence on maintenance therapy in patients with response or stable disease after four cycles of first-line cytotoxic chemotherapy.1 The 2009 update...
Can Bayesian Design Streamline Our Sluggish Clinical Trial System?
The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...
International Prostate Cancer Studies Report Inroads in Managing Bone Metastases
Treatment and prevention of bone metastases in patients with prostate cancer is coming of age, according to several studies presented at the European Multidisciplinary Cancer Congress (ECCO/ESMO/ESTRO). Among the most impressive studies reported was an international phase III trial of radium-223,...
Studies Validate Safety of Breast-conserving Surgery in Young Patients with Breast Cancer
Young age is not a reason, in itself, to recommend mastectomy for early breast cancer in women aged 40 and under, according to two studies presented at the 2011 Breast Cancer Symposium in San Francisco. While younger women have been pegged as having more aggressive disease, the results suggest that ...
SIDEBAR: Expert Q and A
D. Neil Hayes, MD, MPH, of the University of North Carolina, Chapel Hill, discusses the role of HPV status in head and neck cancer. Are you convinced human papillomavirus (HPV) positivity is associated with better prognosis? Dr. D. Neil Hayes: The HPV story influences almost everything we do in...
New Therapies and Prognostic Techniques Highlighted in Head and Neck Cancer
D. Neil Hayes, MD, MPH, of the University of North Carolina at Chapel Hill, described efforts to position the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux) in head and neck cancer treatment. Surprisingly negative results came from the phase III Radiation Therapy Oncology...
Novel Approaches and Agents Making Headway against Sarcoma
Novel approaches and agents reported at the ASCO 2011 Annual Meeting are improving outcomes in sarcoma, a heterogeneous disease with historically poor outcomes, according to William D. Tap, MD, Section Chief of Sarcoma Oncology at Memorial Sloan-Kettering Cancer Center in New York. Dr. Tap...
Adjuvant Treatment Still Standard in Melanoma, but New Drugs Prolong Life in Metastatic Setting
At the Best of ASCO® Miami meeting, Omid Hamid, MD, The Angeles Clinic and Research Institute (www.theangelesclinic.org), Los Angeles, California, reviewed abstracts that received a great deal of attention at this year’s Annual Meeting—the new treatments for metastatic melanoma. He also described...
Screening for Ovarian Cancer May Do More Harm Than Good, but New Therapies for the Disease Are Improving Outcomes
At the Best of ASCO Miami meeting, Daniela Matei, MD, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, described how new approaches are significantly prolonging remission in ovarian cancer. Ovarian Screening Provides No Benefit The Prostate, Lung, Colorectal, and Ovarian (PLCO) ...
SIDEBAR: Using Axitinib in Advanced Renal Cell Carcinoma
With a new tyrosine kinase inhibitor joining the armamentarium, the question is how to optimize targeted agents for advanced renal cell carcinoma. The AXIS trial demonstrated strong clinical activity for axitinib, which was superior to second-line sorafenib (Nexavar) and generally appears most...
Novel Management Strategies Assessed in Renal Cell and Prostate Cancers
At the Best of ASCO Miami meeting, William Oh, MD, of the Tisch Cancer Institute, Mount Sinai School of Medicine, New York, described new trends and remaining questions in the management of renal cell and prostate cancers. Axitinib vs Sorafenib in Second-line RCC Axitinib, a potent and selective...
Multiple Myeloma Research Spotlights Treatment Concerns and Advances
Myeloma data reported at this year’s ASCO meeting raise concern about the safety of a mainstay class of drugs in this disease, while also hinting at good efficacy of some novel drugs and approaches, according to William I. Bensinger, MD, of the Fred Hutchinson Cancer Research Center, Seattle....
SIDEBAR: Research Is Taking the Guesswork Out of Lymphoma Management
The selected studies answer some critical questions in lymphoma that hematologists face daily and that have been the source of intense debate in the field, according to Oliver Press, MD, PhD, of the Fred Hutchinson Cancer Research Center and the University of Washington, Seattle. “I think the...
Similar Outcomes Confirmed in Variety of Lymphoma Treatment Comparisons
Three abstracts reported at the Best of ASCO® meeting in Seattle provide guidance to hematologists when it comes to long-standing gray areas in lymphoma management, according to Oliver Press, MD, PhD, of the Fred Hutchinson Cancer Research Center and the University of Washington, Seattle....
Practice-changing Evidence in Treatment of Noncolorectal GI Cancers
Studies presented at the ASCO Annual Meeting in the field of noncolorectal gastrointestinal cancer both reaffirmed certain standards of care and introduced some practice-changing data, according to A. Craig Lockhart, MD, of Washington University in St. Louis. Perioperative Therapy for Gastric...
SIDEBAR: Risk-based Approach Needed for Stage II Colorectal Cancer
Management of stage II colorectal cancer remains a considerable gray area where an individualized risk-based approach and more molecular research are needed, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minnesota. “Stage II is a little bit more complicated than stage III,” he...
SIDEBAR: Will Aflibercept Break Dry Spell in New Agents for Colorectal Cancer?
Promising results were recently presented from VELOUR, a second-line phase III trial comparing FOLFIRI (leucovorin, fluorouracil, irinotecan) with vs without aflibercept, a fusion protein that binds placental growth factor, VEGFA, and VEGFB.1 “This is an important trial because it might lead to the ...
Standards of Care Confirmed in Latest Group of Colorectal Cancer Trials
Colorectal cancer studies reported at this year’s ASCO meeting offered little in the way of practice-changing information, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minnesota. But they did confirm existing standards of care, he noted at the Best of ASCO® meeting in Seattle....
Breast Cancer Studies Explore Wide Variety of Prevention and Treatment Strategies, Offering New Insights
At the Best of ASCO® meeting in Miami, Harold Burstein, MD, PhD, Dana-Farber Cancer Institute, Boston, and Carey K. Anders, MD, University of North Carolina at Chapel Hill, presented high-impact breast cancer abstracts that will enable clinicians to optimize their use of radiotherapy and biologics. ...
SIDEBAR: Searching for More Efficacious, Less Toxic Adjuvant Chemotherapy for NSCLC
Accumulating data are helping to better define the risk-benefit profile of various adjuvant chemotherapy regimens for non–small cell lung cancer (NSCLC) and the impact of adding biologic agents to the mix, according to H. Jack West, MD, of the Swedish Cancer Institute in Seattle. In the randomized ...
Research Increasingly Points to the Role of Molecular Diversity in Metastatic Lung Cancer
Molecular diversity—its existence, extent, and implications for therapy—was a central theme of key metastatic lung cancer studies presented at this year’s ASCO meeting, according to D. Ross Camidge, MD, PhD, of the University of Colorado, Denver, who addressed major findings in advanced lung cancer ...
Panitumumab Is Not Beneficial in KRAS Mutations: No Exceptions
The need to restrict treatment with panitumumab (Vectibix) to metastatic colorectal cancer patients with wild-type (normal) KRAS tumors was upheld in a study presented at the 2011 European Multidisciplinary Cancer Congress (EMCC). The investigation found a consistent lack of benefit for the drug...
Time to Reconsider Treatment Paradigm for Elderly Patients with Advanced Non–Small Cell Lung Cancer?
Significantly longer median overall survival among elderly patients with advanced non–small cell lung cancer (NSCLC) receiving doublet chemotherapy rather than monotherapy yielded a 36% reduction in mortality risk in a phase III randomized trial. “We saw a survival benefit with doublet chemotherapy ...
Expert Point of View: European Perspective
Martine Piccart, MD, of the Institut Jules Bordet, Brussels, Belgium, and President-Elect of the European Society for Medical Oncology, was highly enthusiastic about the findings of the phase II T-DM1 study, but said, “We have to remember this is an open-label trial, and in a study like this,...
T-DM1: Antibody Drug Conjugate Outperforms Standard Anti‑HER2 Therapy in Metastatic HER2-positive Breast Cancer
The investigational antibody-drug conjugate T-DM1 improved progression-free survival over standard chemotherapy with docetaxel plus trastuzumab (Herceptin) when given as first-line treatment of HER2-positive metastatic breast cancer, according to an open-label phase II study reported at the 2011...
No Improvement in Survival with High-dose over Standard-dose Radiation for Stage III Non–Small Cell Lung Cancer
Surprisingly, less may be more when it comes to radiation therapy with concurrent chemotherapy for patients with stage III non–small cell lung cancer (NSCLC), according to an interim analysis of the randomized phase III Radiation Therapy Oncology Group (RTOG) 0617 trial presented at the 53rd Annual ...
NSCLC Studies: Bevacizumab/Pemetrexed Maintenance Improves Survival, KRAS Status Has No Impact on Outcomes with Sorafenib
Maintenance therapy with bevacizumab (Avastin) plus pemetrexed (Alimta) showed a modest improvement in progression-free survival vs bevacizumab alone in patients with advanced non–small cell lung cancer (NSCLC), according to the final analysis of the AVAPERL study. In a separate study, selecting...
Everolimus Overcomes Resistance to Hormonal Therapy in Advanced Breast Cancer
Adding everolimus (Afinitor) to exemestane in postmenopausal women with advanced breast cancer resistant to aromatase inhibitors significantly improved outcomes, according to the phase III BOLERO-2 trial reported at the 2011 European Multidisciplinary Cancer Congress, held September 23–27 in...
Alternative Treatment for Advanced Ovarian Cancer Reduces Neurotoxicity and Alopecia
A randomized phase III clinical trial found that carboplatin/pegylated liposomal doxorubicin (Doxil) was not superior in prolonging progression compared to the standard carboplatin/paclitaxel as first-line therapy of patients with advanced ovarian cancer. The carboplatin/liposomal doxorubicin...
Oxaliplatin Improved Overall Survival in Patients under 70
The addition of oxaliplatin to fluorouracil (5-FU) plus leucovorin improved overall survival in patients younger than 70 years old participating in the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-07 trial. Patients eligible for the trial had either stage II or III colon cancer and ...
Fighting to Get Back Control
I’ve had raging hormones since I was 18, when I was diagnosed with a benign pituitary adenoma. The tumor caused unpredictable menstrual cycles that remained constant throughout my life, even after it had been successfully treated. So 2 years ago, when I turned 40 and started having sudden bouts of...
Improved Survival with Concurrent Chemotherapy plus Radiotherapy for Patients with Stage III Non–Small Cell Lung Cancer
Five-year survival was statistically significantly higher for patients with stage III non–small cell lung cancer (NSCLC) who received concurrent rather than sequential cisplatin-based chemotherapy combined with thoracic radiotherapy, according to the phase III Radiation Therapy Oncology Group...
Biosimilars in Cancer Treatment: What Should the Oncology Community Expect?
Alternative versions of biologic agents, ie, “biosimilars,” will presumably be getting the green light by the FDA, giving oncologists more choices for treatments that come at lower costs to patients and society. The FDA plans to issue its guidance on biosimilars by the end of this year, paving the...
Expert Point of View: Hypofractionated Radiotherapy Effectively Controls High-risk Prostate Cancer
The take-home message of the study findings from the Fox Chase trial reported at the 53rd ASTRO Annual Meeting plenary session supports the use of hypofractionated intensity-modulated radiotherapy as a more convenient and cost-effective alternative than conventional IMRT, according to formal...
Hypofractionated Radiotherapy Effectively Controls High-risk Prostate Cancer
The use of hypofractionated intensity-modulated radiotherapy (IMRT) appears to be a reasonable option for men with intermediate- to high-risk prostate cancer,1 reported Alan Pollack, MD, Chairman of Radiation Oncology at the University of Miami Miller School of Medicine in Miami and lead...
Predictive Biomarker for Bevacizumab: Are We Getting Closer?
The need to identify a biomarker to guide treatment with bevacizumab (Avastin) is abundantly clear, and studies presented at the 2011 European Multidisciplinary Cancer Congress suggest this goal may be in sight. “Finding predictive biomarkers is a challenge, but there are candidates,” said Eric Van ...
Preoperative Chemoradiotherapy May Extend Survival for Patients with Esophagogastric Junction Adenocarcinoma
Several American and European clinical trials have yielded mixed results on the survival advantage of preoperative chemoradiotherapy for patients with locally advanced esophagogastric junction adenonocarcinoma. However, a distinguished panel at the 2011 ASTRO Annual Meeting did agree that surgery...
Fewer Rectal Side Effects with IMRT than with 3D-CRT for Prostate Cancer
The use of intensity-modulated radiation therapy (IMRT) is associated with fewer acute and late toxic effects than is three-dimensional conformal radiation therapy (3D-CRT) in men with localized prostate cancer, according to preliminary analysis of the Radiation Therapy Oncology Group (RTOG) 0126...
NCCN Meeting Addresses Issues in Hematologic Malignancies
The National Comprehensive Cancer Network (NCCN) 6th Annual Congress on Hematologic Malignancies, held recently in New York, included reviews of the management of hematologic diseases as well as discussions of outstanding issues in the field. The following is a synopsis of some of the important...
Expert Point of View: Novel HDAC Inhibitor May Restore Estrogen Sensitivity in Breast Cancer
Joyce O’Shaughnessy, MD, of Baylor Sammons Cancer Center in Dallas, who moderated the symposium where the results were presented, called the use of entinostat in advanced estrogen receptor–positive breast cancer “very, very promising.” She added, “I agree that it’s time for a phase III trial of...
Novel HDAC Inhibitor May Restore Estrogen Sensitivity in Breast Cancer
The addition of the investigational histone deacetylase (HDAC) inhibitor entinostat significantly delayed breast cancer progression and showed a trend for a survival benefit in the phase II ENCORE 301 study. The study was conducted in women with advanced estrogen receptor–positive breast cancer...
Aflibercept Improves Overall Survival in Patients with Metastatic Colorectal Cancer
The novel fusion protein aflibercept added to standard chemotherapy led to an overall survival benefit in a global phase III trial of second-line metastatic colorectal cancer, reported at the 2011 European Multidisciplinary Cancer Congress in Stockholm.1 “Adding aflibercept to FOLFIRI [leucovorin,...
Significantly Longer Survival with Axitinib Compared to Sorafenib in Patients with Renal Cell Carcinoma
A phase III study comparing the vascular endothelial growth factor receptor (VEGFR) inhibitors axitinib and sorafenib (Nexavar) as second-line therapy in patients with metastatic renal cell carcinoma found that axitinib produced significantly longer progression-free survival. Published in The...
