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Showing 26451 - 26500NDA 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...
FDA Issues New Safety Alert on Reumofan Plus and Reumofan Plus Premium
In August 21, the FDA issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain...
First Drug for Children with Rare Brain Tumor Approved
The FDA approved a new pediatric dosage form of everolimus (Afinitor Disperz) to treat the rare brain tumor called subependymal giant cell astrocytoma (SEGA). This is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended...
FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia
The FDA has approved bosutinib (Bosulif) to treat chronic myelogenous leukemia (CML). The drug is intended for patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive CML who are resistant to or who cannot tolerate other therapies, including imatinib (Gleevec). The...
Expert Point of View: Fritz H. Schröder, MD
I am happy to accept the invitation by The ASCO Post to comment on the recent, long-awaited publication of the PIVOT study (Wilt et al: N Engl J Med 367:203-213, 2012) and the accompanying editorial by Thompson and Tangen (N Engl J Med 367:270-271, 2012). The editorial both points out weaknesses of ...
Expert Point of View: Timothy Wilt, MD, MPH
PIVOT is the largest and longest randomized trial conducted in men with early-stage prostate cancer detected during the era of widespread PSA testing. The trial enrolled 731 men and followed them for up to 15 years after randomization. PIVOT results demonstrate that compared to observation, radical ...
No Survival Benefit of Radical Prostatectomy vs Observation for Localized Prostate Cancer Detected by PSA Testing
The relative benefits of surgery or observation in men with prostate cancer detected by prostate-specific antigen (PSA) testing have not been defined. Randomized trials comparing radical prostatectomy with observation were conducted before widespread use of PSA testing and an observational study...
Predictors and Treatment for Transformed Lymphoma: Current Paradigms
At the recent Pan Pacific Lymphoma Conference, held in Maui, Hawaii, Richard I. Fisher, MD, Chairman of the SWOG Lymphoma Committee and Vice-President for Strategic and Program Development at the University of Rochester Medical Center in New York, gave a presentation on the characteristics and...
Importance of Dermatologic Care for Patients with Cancer
I first became interested in treating skin issues associated with cancer about 10 years ago, during my dermatology residency training at the University of Chicago. Many of the agents under clinical development at the time, such as cetuximab (Erbitux) or sorafenib (Nexavar), were causing...
Expert Point of View: Dan L. Longo, MD
The term “abscopal” is from Greek roots that mean “away from the target.” Coined by R.H. Mole in 1953, it was used to label observed effects of radiation at a distance from the volume irradiated. Mounting evidence suggests an immunologic basis for the effect, but it should also be remembered that...
Contagious Cancer and an Unexplained Phenomenon Might Inspire Future Therapies
A deadly contagious cancer known as devil facial tumor disease is pushing the world’s largest carnivorous marsupial, the Tasmanian devil (Sarcophilius harrisii), to the brink of extinction. The loss of an interesting creature aside, the plight of the Tasmanian devil raises provocative questions...
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,...
Faculty Q&A Discussion: Anaplastic Large-cell Lymphoma
Dr. Armitage: For ALK-negative anaplastic large cell lymphoma, brentuximab vedotin is the best thing we have to deal with patients with recurrent disease, and who knows where it will end up in primary therapy. But if the patient is ALK-positive, there is a potential for crizotinib (Xalkori) to...
Management of a Patient with Systemic Anaplastic Large Cell Lymphoma following Failure of One or More Combination Regimens
Case Summary presented by Steven M. Horwitz, MD, Assistant Attending, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York. This is a case of a 49-year-old woman who developed an enlarged right axillary lymph node. The woman had noticed some discomfort under her right arm, which she...
Faculty Q&A Discussion: Brentuximab Vedotin
Dr. Armitage: It is no surprise that brentuximab vedotin is really an exciting agent, and it gives us a new opportunity in treating classical Hodgkin lymphoma. What if this person Dr. Engert just presented was at the same point with nodular lymphocyte-predominant lymphoma and no CD30 positivity....
Management of a Patient with Relapsed and Refractory Hodgkin Lymphoma
Case Summary presented by Andreas Engert, MD, Chairman, German Hodgkin Study Group, University Hospital of Cologne, Cologne, Germany This is a case report of a 23-year-old female patient who was diagnosed with Hodgkin lymphoma in January 2009. She received two cycles of ABVD (doxorubicin,...
Faculty Q&A Discussion: Communicating with Patients
Dr. Armitage: As oncologists, we face many challenges. I think the most difficult is when you say to a patient with a disease everybody expects will be cured, and every patient expects to be cured, “It is not worth trying to do that. It is time to worry about keeping you as well as possible for as ...
Management of a Patient with Hodgkin Lymphoma following Failure of Autologous Stem Cell Transplant
Case Summaries presented by Joseph M. Connors, MD, Clinical Director, Centre for Lymphoid Cancer, British Columbia Cancer Agency, University of British Columbia, Vancouver, British Columbia, Canada When considering the management of a patient whose Hodgkin lymphoma has relapsed despite high dose...
SIDEBAR: Melanoma Treatment Options Exploding, but Old Standbys Should Remain
New drugs are rapidly changing the treatment paradigm for stage IV melanoma, but there is still validity to some of the old standbys, according to Michael Sabel, MD, of the University of Michigan, Ann Arbor, who described the shifting landscape of melanoma treatment at the Best of ASCO Boston...
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...
SIDEBAR: A Closer Look at Radium-223
William Oh, MD, of Mount Sinai School of Medicine, New York, posed some questions about the first-in-class alpha emitter radium-223 chloride. “Is this an anticancer drug or a bone-targeted drug?” he said. “With abiraterone acetate (Zytiga) and enzalutamide (Xtandi), we see declines in PSA—an...
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]...
SIDEBAR: Progression-free Survival Curve for Regorafenib Hints at Subgroup Effect
In all likelihood, only a subset of patients given regorafenib derive benefit, as suggested by the progression-free survival curve seen in the CORRECT trial, according to Dr. Overman. “This is a very interesting curve. The medians don’t really capture the difference.… If you look more at the area...
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...
Encouraging Data Presented for Monoclonal Antibodies and Novel Oral Agent in Lymphocytic Leukemias
Novel agents may transform the outcomes of lymphocytic leukemias. In acute lymphocytic leukemia (ALL), encouraging data were presented for two monoclonal antibodies, and in chronic lymphocytic leukemia (CLL), a completely novel class of agents produced surprisingly robust results, said Attaya...
SIDEBAR: Maximizing Tyrosine Kinase Inhibitor Therapy in CML
Second-generation tyrosine kinase inhibitors as initial therapy in chronic myeloid leukemia (CML) continue to prove their worth by demonstrating protection against disease progression and by producing increasingly “higher quality” remissions, said Attaya Suvannasankha, MD, of Indiana University...
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...
Will Carfilzomib Add Value to Multiple Myeloma Treatment?
Carfilzomib (Kyprolis), the next-generation proteasome inhibitor recently approved by the FDA for relapsed/refractory multiple myeloma, showed strong activity in the front-line setting when paired with lenalidomide (Revlimid) and low-dose dexamethasone (CRd).1 The study evaluated stringent complete ...
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....
SIDEBAR: Is Watch and Wait the Best Strategy for Indolent NHL in the Rituximab Era?
Data from the RESORT and its planned subanalysis can guide oncologists in optimizing treatment for indolent non-Hodgkin lymphoma (NHL) with low–tumor burden advanced-stage disease, according to Michael E. Williams, MD, of the University of Virginia Cancer Center in Charlottesville. The phase III...
Which Rituximab-based Regimen Works Best in Non-Hodgkin Lymphoma?
The treatment of non-Hodgkin lymphoma (NHL) patients has been recently informed by several important studies, which were discussed at the Best of ASCO Boston meeting by Michael E. Williams, MD, of the University of Virginia Cancer Center in Charlottesville. Bendamustine Outperforms R-CHOP in NHL...
SIDEBAR: A Tough Call: The T1a HER2-positive Tumor
The optimal adjuvant management of T1a HER2-positive breast cancers is uncertain and requires an individualized approach, according to Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center....
SIDEBAR: Browsing the Anti-HER2 Options
“Where do current findings leave us in terms of anti-HER2 therapy options?” asked Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Center, Boston, who moderated the Best of ASCO Boston meeting. New drugs are joining trastuzumab (Herceptin) and lapatinib (Tykerb), and there will be some juggling...
SIDEBAR: Does Lapatinib Prevent CNS Metastases in HER2-positive Breast Cancer?
Lapatinib has shown some efficacy against existing brain metastases in patients with HER2-positive breast cancer but not in preventing them in the first place, according to Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller...
Refining Current Treatments and Looking Ahead in HER2-positive Breast Cancer
In a study presented at the ASCO Plenary Session, trastuzumab emtansine (T-DM1), the antibody-drug conjugate linking trastuzumab (Herceptin) to a cytotoxic agent, improved progression-free survival by 3.2 months, representing a 35% reduction in risk of progression in the phase III EMILIA trial.1...
Cytotoxic Chemotherapy for Breast Cancer: Are We Done Tweaking It?
While novel targeted agents may grab the headlines in the treatment of breast cancer, oncologists still debate the optimal delivery of conventional cytotoxic chemotherapy, still a vital component of treatment. At the Best of ASCO Boston meeting, Steven J. Isakoff, MD, PhD, of Massachusetts General...
SIDEBAR: Should EGFR Tyrosine Kinase Inhibitors Be Continued Beyond Progression?
It is not yet clear if it is beneficial to continue first-line EGFR tyrosine kinase inhibitors in patients with EGFR-mutated lung cancer who experience progression and are started on chemotherapy, according to Dr. Horn. Two trials, one in Asia (looking at gefitinib [Iressa]) and one in North...
SIDEBAR: Molecular Testing Requires Planning at Time of Biopsy
The molecular analysis of lung cancer patients is becoming more and more complex,” and clinicians therefore need to consider any additional tissue requirements upfront, Dr. Horn commented. At Vanderbilt University, testing for EGFR, KRAS, and eight other mutations is done using the Lung SnaPshot...
New Therapies Capitalize on Lung Cancer’s Molecular Vulnerabilities
Research reported at this year’s ASCO Annual Meeting attests to the tremendous molecular diversity of non–small cell lung cancer (NSCLC) and the power of appropriately selected treatment, according to Leora Horn, MD, of Vanderbilt University Medical Center, who presented data on molecular findings...
Best of ASCO® Meetings Offer Data, Commentary, and Interaction with the Experts
Three Best of ASCO meetings were held over the summer in Chicago, Boston, and San Diego. The faculty distilled the most interesting and immediately applicable data from the 2012 ASCO Annual Meeting, provided personal perspectives, and interacted with attendees for an educational experience that was ...
On Mentoring: Looking Back with Gratitude and Paying It Forward
Upon graduation from medical school, doctors are given a gift that lasts a lifetime—the gift of respect. That respect needs to be re-earned every day, but it is accompanied by other rewards that come with caring for people: the ability to gain another’s trust, to reverse illness that alters the...
2012-2013 Oncology Meetings Calendar
October 2012 14th Biennial Meeting of the International Gynecologic Cancer SocietyOctober 13-16 • Vancouver, Canada For more information: www2.kenes.com/igcs2012/Pages/home.aspx 13th World Congress of the International Society for Diseases of the EsophagusOctober 15-17 • Venice, Italy For more...
LETTER TO THE EDITOR: Individualism in Clinical Decision-making
I found a statement by Dr. Peter Bach in the August 15, 2012, issue of The ASCO Post (in the article, “As Conflicting Guidelines Evolve, Experts Continue to Debate the Merits of Cancer Screening”) very troubling. To wit: There’s a cognitive dissonance between the practice of evidence-based medicine ...
Long-term Survivors of Hodgkin Lymphoma May Have Increased Risk of Neurocognitive Impairment
A “new finding” that long-term survivors of childhood Hodgkin lymphoma may be at risk for neurocognitive impairment and central nervous system (CNS) pathology arose from a study among 62 patients treated with either high-dose (≥ 30 Gy) thoracic radiation or lower-dose (< 30 Gy) thoracic...
Reduced Disease Progression in Patients with Continued Gemcitabine Maintenance or Erlotinib Switch Maintenance
A phase III study showed that progression-free survival was significantly prolonged with continuation maintenance with gemcitabine or switch maintenance with erlotinib (Tarceva) compared with observation in patients with advanced non–small cell lung cancer (NSCLC) who received first-line treatment...
Anthracycline/Trastuzumab Treatment Linked to Increased Risk of Heart Failure, Cardiomyopathy
A population-based, retrospective cohort study of 12,500 women diagnosed with incident, invasive breast cancer found that anthracycline and trastuzumab (Herceptin) were associated with increased risk of heart failure and/or cardiomyopathy. “Compared with women who received no chemotherapy, our...
