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SIDEBAR: Oncology Drug Approvals in 2014

February 12, 2014: Ibrutinib (Imbruvica) receives accelerated approval for patients with chronic lymphocytic leukemia who have received at least one prior therapy.  January 10, 2014: Trametinib (Mekinist) and dabrafenib ­(Tafinlar) receive approval for use in combination in the treatment of...

leukemia

Omacetaxine Mepesuccinate Receives Full FDA Approval for CML

The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...

Expert Point of View: Anas Younes, MD

Anas Younes, MD, Chief of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center in New York, told The ASCO Post, “Of the 800 or so ALK-positive anaplastic large-cell lymphoma patients in the United States, 70% to 80% are cured by CHOP [cyclophosphamide, doxorubicin, vincristine,...

lymphoma

Crizotinib Proves Effective in ALK-Positive Lymphoma

Crizotinib (Xalkori) produced promising results in patients with ALK-positive lymphoma in two small studies presented at the 2013 American Society of Hematology (ASH) Annual Meeting. Crizotinib exerted potent antitumor activity in advanced ALK-positive lymphoma and achieved durable responses in...

leukemia

Gemtuzumab Ozogamicin Reduces Relapse, Improves Event-Free Survival in Pediatric AML

The monoclonal antibody gemtuzumab ozogamicin (Mylotarg) improved event-free survival and reduced the risk of relapse in children with acute myeloid leukemia (AML) in a study from the Children’s Oncology Group, presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition ...

leukemia

Idelalisib Plus Rituximab in Heavily Pretreated Relapsed CLL: ‘Dawn of a New Age’?

Idelalisib plus rituximab (Rituxan) improved progression-free survival, overall response rates, and overall survival compared with rituximab alone in heavily pretreated patients with relapsed chronic lymphocytic leukemia (CLL). Moreover, the combination provided effective, durable disease control...

Expert Point of View: Anas Younes, MD

This study provides proof of principle that different tumor types that express CD30 have a good chance of responding to anti-CD30 treatment. Brentuximab achieves good response rates of about 76% in mycosis fungoides and 85% in [anaplastic T-cell lymphoma]. In [mycosis fungoides] and cutaneous...

lymphoma

Promising Results Demonstrated for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma

Phase II results suggest that brentuximab vedotin (Adcetris) has encouraging activity in CD30-positive cutaneous T-cell lymphomas and lymphoproliferative disorders, including mycosis fungoides, the most common type of cutaneous T-cell lymphoma. High levels of responses were achieved in a 48-patient ...

breast cancer

Zoledronic Acid Fails to Benefit Women With Chemoresistant Breast Cancer

Zoledronic acid does not improve outcomes in patients with early breast cancer who do not have a full response to neoadjuvant anthracycline/taxane–based chemotherapy, according to results of the Neo-Adjuvant Trial Add-On (NATAN) study presented at the 2013 San Antonio Breast Cancer Symposium.1 A...

breast cancer

Adding Bevacizumab to Adjuvant Chemotherapy/Trastuzumab Fails to Improve Survival in HER2-Positive Breast Cancer

The addition of bevacizumab (Avastin) to adjuvant chemotherapy did not improve invasive disease-free survival or overall survival in patients with high-risk HER2-positive breast cancer in the large randomized phase III BETH trial. Although not specifically designed to answer this question, BETH...

breast cancer

Immune Modulation May Aid Some Breast Cancer Subtypes

There may be an immunogenic phenotype in breast cancer that could benefit from immune modulation as part of treatment, according to results from studies that correlated high levels of tumor-infiltrating lymphocytes with both pathologic complete responses and long-term outcomes. Studies presented at ...

leukemia

Novel Therapies May Help Wipe Out Residual Acute Lymphoblastic Leukemia

Minimal residual disease after induction and consolidation for the treatment of acute leukemia might be eradicated by novel therapies, thus obviating the need for stem cell transplantation. That is the prediction of Matthew J. Wieduwilt, MD, PhD, Assistant Clinical Professor of Medicine at the...

leukemia

Minimal Residual Disease Before and After Transplant: What Does It Mean?

In patients with acute leukemia, outcomes after hematopoietic stem cell transplantation are negatively impacted by the presence of minimal residual disease. However, transplant can prolong survival in patients with minimal residual disease after consolidation, according to two studies presented at...

Expert Point of View: Rebecca A. Miksad, MD, MPH

Rebecca A. Miksad, MD, MPH, Assistant Professor of Medicine at Harvard Medical School and Physician-Investigator at Beth Israel Deaconess Medical Center, Boston, who discussed the paper by Fine et al at the Gastrointestinal Cancers Symposium, said, “the study reports that a range of neuroendocrine...

neuroendocrine tumors

For Progressive Neuroendocrine Tumors, Clinical Benefit Is High With Capecitabine Plus Temozolomide

In an interim analysis of a phase II trial, 97% of patients with progressive metastatic neuroendocrine tumors achieved clinical benefit with the combination of capecitabine and temozolomide (CAPTEM). The results were reported at the 2014 Gastrointestinal Cancers Symposium by Robert L. Fine, MD,...

colorectal cancer
survivorship

Colorectal Cancer Survivors Face Challenges With Bowel Regulation

The fight against colorectal cancer leaves many survivors with battle wounds, according to studies that show a high incidence of assorted morbidities that can affect quality of life. Clinicians, in fact, may be unaware of the struggles with bowel function that occur during survivorship, researchers ...

colorectal cancer

Outcomes in Metastatic Colorectal Cancer: Studies Examine Relative Merits, Cost-Effectiveness

Targeted biologic agents have improved long-term outcomes in metastatic colorectal cancer, but debate continues as to their relative efficacy and proper sequencing. At the 2014 Gastrointestinal Cancers Symposium, a number of studies attempted to answer these questions by interrogating the clinical...

colorectal cancer

More Support for ‘All-RAS’ Testing in Metastatic Colorectal Cancer

Multiple studies reported at the 2014 Gastrointestinal Cancers Symposium add further support for widening the genetic analysis of colorectal cancer tumors. In fact, experts predict that more extensive genetic testing for RAS gene mutations (in KRAS and NRAS) beyond the routine analysis of KRAS exon ...

colorectal cancer

Aspirin Use Not Associated With Survival in PIK3CA-Mutant Colorectal Cancer

Contrary to emerging data from other studies, the regular use of aspirin was not associated with improved survival in patients with PIK3CA-mutant metastatic colorectal cancer in a study reported at the 2014 Gastrointestinal Cancers Symposium in San Francisco.1 Large Dataset “We did not validate...

colorectal cancer

Colorectal Cancer Screening: Quality Measures Should Focus on Patient Benefit Over Age Alone, Study Reports

Screening for colorectal cancer based on age alone may contribute to both underuse and overuse of colonoscopy, sigmoidoscopy, and fecal occult blood testing among older people, according to a study by investigators at the University of Michigan and the Veterans Affairs Center for Clinical...

Expert Point of View: Thomas W. Flaig, MD

This study has the potential to expand the number of patients who can benefit from organ-sparing therapy,” said Thomas W. Flaig, MD, Associate Professor in the Division of Medical Oncology at the University of Colorado Denver, commenting on the pooled analysis of RTOG 9906 and 0233 presented at the ...

bladder cancer

Fine-Tuning Bladder-Preservation Trimodality Therapy for Patients With Muscle-Invasive Bladder Cancer

Organ preservation is a hallmark of progress in the world of cancer management. For patients with muscle-invasive bladder cancer, the bladder-sparing approach is a well-established alternative to radical cystectomy. Patients undergo cystoscopic evaluation between the induction and consolidation...

kidney cancer
prostate cancer

Five Key Studies in Prostate Cancer and Renal Cell Carcinoma

The 10th Genitourinary Cancers Symposium, sponsored by ASCO, the American Society for Radiation Oncology, and the Society of Urologic Oncology, was held January 29–February 1, 2014, in San Francisco. The more than 630 abstracts presented addressed essential research in genitourinary malignancies,...

Expert Point of View: James Gulley, MD, PhD

“The key thing about this trial is that while the overall study was negative, subset analysis suggests that the patients who appear to benefit from ipilimumab have better prognostic factors, including no visceral disease, lower alkaline phosphatase, and elevated hemoglobin,” commented James...

health-care policy

The Evolution of U.S. Cooperative Group Trials: Publicly Funded Cancer Research at a Crossroads

Over the past 5 decades, National Cancer Institute (NCI) Clinical Trials Cooperative Groups have played an enormous role in the fight against cancer, tackling a broad social agenda, including cancer prevention, quality-of-life issues for patients with cancer, and comparison of benefits among...

lung cancer

I Refuse to Capitulate to Cancer

Early last year, just as I returned to my residency in neurologic surgery at Stanford University after completing 2 years of my postdoctoral fellowship in a laboratory developing optogenetic techniques, I started losing weight—dropping from 180 lb to 160 lb in just 6 months—and I was having fairly...

prostate cancer

State-of-the-Art Update on Prostate Cancer

The 2014 Genitourinary Cancers Symposium, held in San Francisco from January 29 to February 1, brought together more than 3,100 participants from around the world involved in the care of patients with genitourinary malignancies. The abstract presentations and plenary discussions offered the latest...

issues in oncology

Transition From Busy Oncologist to Retiree: Challenges and Opportunities

Oncology is a demanding field that requires special qualities to care for very sick patients, many of whom will die prematurely of their disease. Research indicates that years of facing life-and-death decisions in the clinic can be associated with oncology burnout syndrome, which effects physician...

leukemia

Adding Idelalisib to Rituximab Improved Survival in Patients With Relapsed CLL

Receiving rituximab (Rituxan) with idelalisib, rather than rituximab with placebo, “significantly improved progression-free survival, response rate, and overall survival” among patients with relapsed chronic lymphocytic leukemia (CLL) who were less able to undergo chemotherapy because of clinically ...

leukemia

Long-Term Benefit With Dasatinib After Imatinib Failure in Chronic-Phase Chronic Myeloid Leukemia

Patients with chronic myeloid leukemia (CML) in the chronic phase who are resistant or intolerant to imatinib (Gleevec) can experience long-term benefit with dasatinib (Sprycel), according to long-term results of a randomized phase III study. The CA180-034 study also found that early molecular and...

breast cancer

Breast Reconstruction Has Increased Over Time but Varies Widely by Region

Analysis of data from 20,560 women undergoing mastectomy for breast cancer found that breast reconstruction use “increased from 46% in 1998 to 63% in 2007 (P< .001), with increased use of implants and decreased use of autologous techniques over time (P < .001),” according to a report...

Expect Questions From Patients

Results from the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), showing that men with early-stage prostate cancer, particularly men under 65 years old, treated with radical prostatectomy had increased survival compared to those assigned to watchful waiting, has raised concerns among...

prostate cancer

Prostate Cancer Study Showing Increased Survival for Younger Men Undergoing Prostatectomy Not Expected to Increase Surgeries

Extended follow-up in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG4), reported recently in The New England Journal of Medicine,1 found that men with early-stage prostate cancer, particularly those under 65 years old, who were treated with radical prostatectomy had increased survival...

issues in oncology

Have You Heard?

“It’s not a matter of if a child will be seriously poisoned or killed. It’s a matter of when.” Lee Cantrell, PharmD, Director of the San Diego Division of the California Poison Control System and Professor of Clinical Pharmacy at the University of California, San Francisco, commenting on the...

MD Anderson Honors Two Champions for Women in Medicine and Research

Two champions of gender equality in medicine and research were recently honored by The University of Texas MD Anderson Cancer Center. Laurie Glimcher, MD, the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College and Provost for Medical Affairs of Cornell University since 2012, received...

survivorship

Ongoing Clinical Trials Actively Recruiting Adolescent and Young Adult Survivors of Childhood Cancer

ADOLESCENT AND YOUNG ADULT CHILDHOOD CANCER SURVIVORS Study Type: Randomized/interventional Study Title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer Study Sponsor and Collaborators: St. Jude Children’s Research Hospital Purpose: Five-year...

cns cancers

Mutation Predicts Benefit From Alkylating Chemotherapy in Oligodendroglial Tumors

Patients in the Radiation Therapy Oncology Group (RTOG) 9402 study with 1p/19q codeleted anaplastic oligodendroglial tumors had markedly prolonged overall survival after chemoradiotherapy (with procarbazine, lomustine, and vincristine) compared with radiation therapy alone. Some patients with...

lung cancer

Antioxidants Accelerate Lung Cancer Progression and Reduce Survival in Mice

Clinical trials of antioxidants in cancer have yielded inconsistent results. In a study reported in Science Translational Medicine, Sayin and colleagues evaluated the effects of the antioxidants N-acetylcysteine and vitamin E in mouse models of BRAF- and KRAS-induced lung cancer. N-acetylcysteine...

survivorship

Join the 21st Annual Cancer Survivors’ Celebration Walk &amp; 5K

Nearly 4,000 attendees, including more than 700 cancer survivors along with friends and family members, will gather in Chicago’s Grant Park for the Robert H. Lurie Comprehensive Cancer Center of Northwestern University’s Annual Cancer Survivors’ Celebration Walk & 5K Run. This year’s event will ...

supportive care

Two Behavioral Interventions Help Cancer Patients Struggling With Sleep Issues, Penn Medicine Study Finds

Patients with cancer who are struggling with sleep troubles, due in part to pain or side effects of treatment, can count on two behavioral interventions for relief—cognitive behavioral therapy for insomnia and mindfulness-based stress reduction—Penn Medicine researchers reported in a recent study...

health-care policy

The FDA’s Bad Ad Program

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The...

multiple myeloma

Unraveling the Molecular Complexity of Multiple Myeloma

In 2011, the Multiple Myeloma Research Foundation (MMRF) announced the launch of CoMMpass (Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile), a clinical study at the heart of its Personalized Medicine Initiative. CoMMpass will follow 1,000 newly diagnosed...

prostate cancer

Does ‘Specialist Bias’ Contribute to Overtreatment of Prostate Cancer?

Specialist bias, in which specialists recommend the therapy that they are capable of delivering, is thought to influence the treatment of patients with localized prostate cancer and to contribute to overtreatment of men with limited life expectancy,” Ayal A. Aizer, MD, MPH, and colleagues, from the ...

William Pao, MD, PhD, Joins Roche to Lead Oncology Research

Roche recently announced that William Pao, MD, PhD, Professor of Medicine and Head of the Hematology-Oncology Division at Vanderbilt University Medical Center, Nashville, will join Roche Pharma Research and Early Development (pRED) as Global Head of the Oncology Disease and Translational Area...

lung cancer

Decision Time for Lung Cancer Screening in High‑Risk Populations

For decades, dedicated members of the oncology community have fought to increase the nation’s focus on lung cancer prevention and treatment. Although smoking cessation initiatives have reduced cigarette consumption, lung cancer 5-year survival has remained stagnant at 15%, lagging far below most...

issues in oncology

‘How Am I Doing, Doc?’

The goal of effective adjuvant therapy is to increase overall survival. It has been suggested cynically that all we need to accomplish, actually, is to delay recurrence until after the time the patients die from another cause. However, patients want to hear from us that “it’s never coming back,”...

breast cancer

Study Shows Pathologic Complete Response to Neoadjuvant Therapy for Breast Cancer of Prognostic Value but Not for Use as Surrogate for Survival

Pathologic complete response to neoadjuvant therapy has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) working group to...

Hagop Kantarjian, MD, and Victor Fazio, MD, Named Recipients of 2014 Lifetime Achievement Awards Presented by Castle Connolly Medical Ltd

Hagop Kantarjian, MD, Professor and Chair of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, and Victor Fazio, MD, Chairman Emeritus, Digestive Disease Institute; Department of Colorectal Surgery, Cleveland Clinic, Rochester, were honored recently with the “Lifetime...

Association of Community Cancer Centers Honors Researcher and Community Oncologist With National Award

In recognition of his dedication to cancer research and education, and for promoting the goals of cancer prevention, early detection, and quality cancer treatment, John Powderly II, MD, Certified Physician Investigator, President and Founder of Carolina BioOncology Institute, Huntersville, North...

Awards Presented at Annual Meeting of Society of Interventional Radiology

The Journal of Vascular and Interventional Radiology, the Society of Interventional Radiology’s (SIR) peer-reviewed scientific journal, together with SIR Foundation, recently presented a number of awards at SIR’s 39th Annual Scientific Meeting in San Diego. Clinical Research Eliseo Vano, PhD, an...

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