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health-care policy

A Conversation with Monica Morrow, MD, FACS

Over the past 15 years, practice guidelines have become an accepted tool to help physicians optimize patient care by offering informed assessment of the benefits and potential harms associated with various care options. However, a plethora of new guidelines have entered the market, many of which...

issues in oncology

We Can Conduct Clinical Trials of Protons

A great deal has been written about proton therapy, with a good deal of heat and only a modest amount of light. I would like to comment on an aspect of the proton vs photon controversy that I believe has not been adequately addressed: Should we run clinical trials that would allow us to prove that...

cost of care
palliative care
health-care policy

Palliative Care, Quality of Life, and Cost

More than half of our nation’s patients with cancer are Medicare beneficiaries, making the entitlement program ground zero in the heated debate on health-care spending. Total Medicare expenditures attributable to beneficiaries in their last year of life runs upward of 30%; this statistic serves as...

lymphoma

Important Benefit for Small Population Is a Major Milestone in Lymphoma

The approval of brentuximab vedotin (Adcetris) is a major milestone for the treatment of patients with relapsed Hodgkin lymphoma and anaplastic large cell lymphoma. It represents an excellent example of personalized cancer therapy. Patients are preselected based on a predictive biomarker that is...

lymphoma

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...

breast cancer
legislation

Giving Women a Fighting Chance When They Have Breast Cancer

I knew there was a chance I could get breast cancer, I just never thought it would really happen to me. I am one of 2.5 million breast cancer survivors living in our country today. Just weeks after getting a clean mammogram and my 41st birthday, I felt a lump in my breast. As a young and otherwise...

issues in oncology

LETTER TO THE EDITOR: ‘Unrealistic Optimism’ or Losing Sight of the Forest for the Trees?

The article: “Unrealistic Optimism Poses Ethical Challenges, May Affect Informed Consent Process” (The ASCO Post, September 1, 2011, page 35) seems to be delving into a subject with an intent that is unclear. I agree fully with Dr. Jimmie Holland that discrimination between “optimism” and...

breast cancer

LETTER TO THE EDITOR: Treating Cancer or Fear?

I read the article by Deb Stewart, “Acting on Fear” (The ASCO Post, August 15, 2011, page 1) with interest, disappointment, and empathy. “Acting on fear” in cancer treatment generally, and particularly in breast cancer, is not uncommon. Hence, I was most interested in the article’s major thrust, as ...

breast cancer

Replacing Epirubicin with Docetaxel for Three Cycles Improved Outcomes for Node-positive Breast Cancer

Substituting docetaxel for epirubicin in the final three cycles of chemotherapy resulted in improvement in disease-free and overall survival in a trial among postmenopausal women with node-positive early breast cancer. Following complete excision, women enrolled in the Docetaxel Epirubicin Adjuvant ...

breast cancer

Comparing Therapies for Managing Hot Flashes in Women with Breast Cancer

In a double-blind, placebo-controlled trial, two often-prescribed treatments recommended in clinical guidelines for the management of hot flashes were found to be effective in managing hot flashes in patients with breast cancer. Patient-reported hot flash scores showed that venlafaxine, a selective ...

breast cancer

Doxorubicin/Cyclophosphamide with Docetaxel Equally Effective in Combination or Sequentially

Five-year disease-free survival and overall survival rates were “indistinguishable” in patients with operable, node-positive, HER2-nonamplified breast cancer treated with the sequential or combination regimens of doxorubicin/cyclophosphamide (AC) and docetaxel (T). The Breast Cancer International...

SIDEBAR: ASCO’s Role Recognized

One point that Paul H. Sugarbaker, MD, and David P. Ryan, MD, agreed on was that ASCO has done a service to the oncology community by presenting their debate about cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. That debate, conducted at the 2011 ASCO Annual Meeting, sparked...

SIDEBAR: Expect Questions from Patients and Colleagues

Among the merits of good clinical studies, according to David P. Ryan, MD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, is being able to cite them when a physician sits down with a patient to explain the possible benefits and drawbacks of treatment. Dr. Ryan stressed, ...

colorectal cancer

‘Hot Chemotherapy’ Generates Heated Debate about Its Use with Cytoreductive Surgery to Manage Peritoneal Metastases

"Hot chemotherapy” has become the common term for hyperthermic intraperitoneal chemotherapy (HIPEC), which together with cytoreductive surgery is being used by some surgeons to treat patients with carcinomatosis from colorectal cancer. While HIPEC is not considered the most important component of...

SIDEBAR: Customary Prompt Pay

In the 2006 Physician Fee Schedule, the Centers for Medicare & Medicaid Services (CMS) interpreted the Medicare Modernization Act definition of average sales price to include “prompt pay” in its calculation. CMS maintains that since the statute includes the words “prompt pay discount,” it must...

health-care policy

Oncology Community Faces Complex Challenges in Evolving Policy Arena

As the political environment heats up in advance of the upcoming presidential campaign season, many issues crucial to the oncology community are being placed on the political chopping block as policymakers seek ways to reduce the mounting debt and soaring health-care spending. To help clarify some...

health-care policy

ASCO Issues Policy Statement to Reduce Cancer Care Disparities

Last August, ASCO issued the policy statement, “Opportunities in the Patient Protection and Affordable Care Act to Reduce Cancer Care Disparities” in the Journal of Clinical Oncology.1 The statement builds on ASCO’s policy on disparities in cancer care released in 2009. It calls on both the...

SIDEBAR: Who Should Manage Survivorship Care?

It has been suggested that after completing their treatment, cancer patients can be transitioned to primary care providers for continued “survivorship” care. But at the Best of ASCO meeting, speakers and audience members alike felt survivorship care is the domain of the treating oncologist. Few...

survivorship
supportive care
geriatric oncology

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...

leukemia

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 ...

skin cancer

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...

ASCO Study Shows Integrating Nonphysician Providers into Oncology Practices Is a Win for Patients and Providers

Is the expanded use of nonphysician providers (NPPs) a viable way to help ease the challenges oncology practices could feel if the number of oncologists entering the field does not keep pace with potential growth in the demand for their services? The ASCO Workforce Advisory Group thought the...

prostate cancer

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...

gynecologic cancers

New Biomarker Test Cleared to Evaluate Ovarian Cancer Likelihood

Fujirebio Diagnostics announced that it has received 510(k) clearance from the FDA to market the company’s HE4 Test in an algorithm called ROMA to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding...

lung cancer

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...

breast cancer

Expert Point of View: No Value for Axillary Dissection in Patients with Breast Cancer and Occult Nodal Metastases

Two breast cancer studies presented at the 2011 Breast Cancer Symposium—NSABP B‑32 and ACOSOG Z11—suggest that aggressive approaches to surgically remove occult metastases are not necessary. Armando E. Giuliano, MD, of Cedars-Sinai Medical Center, Los Angeles, and principal investigator of ACOSOG...

SIDEBAR: A Snapshot of I-SPY 2

With principal investigator Laura Esserman, MD, MBA, of the University of California, San Francisco, and co–principal investigator Donald Berry, PhD, of MD Anderson Cancer Center, I-SPY 2 will screen up to 12 different drugs in neoadjuvant therapy for breast cancer over the course of the trial. In...

health-care policy

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 ...

Expert Point of View: International Prostate Cancer Studies Report Inroads in Managing Bone Metastases

"Radium-223 chloride is an effective, well tolerated, and convenient treatment, and it has a survival benefit. These favorable characteristics may well promote its use in clinical practice,” said formal discussant of this abstract, Wim J.G. Oyen, MD, Radboud University Nijmegen Medical Center,...

health-care policy

Health-care Policy: A Three-act Play

The health of Americans, the economy, the debt crisis, and the action or inaction in Washington are all seriously interrelated. Decades ago, the bank robber Willie Sutton was asked why he robs banks. His famous answer, “Because that’s where the money is,” succinctly describes the approach that...

Expert Point of View: Studies Validate Safety of Breast-conserving Surgery in Young Patients with Breast Cancer

Rakesh Patel, MD, Medical Director of the Targeted Radiation Institute at Western Radiation Oncology, Pleasanton, California, was the invited discussant of the second study. He noted that in spite of well documented equivalent survival rates between the surgical approaches, mastectomy rates are...

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...

head and neck cancer

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...

SIDEBAR: Questions and Answers about Adjuvant Imatinib in GIST

"As clinicians, we really need to ask who should receive adjuvant [imatinib], and we have several ways to risk-stratify patients, including tumor characteristics (size, location, mitotic index), mutational analyses, and a recently published nomogram for patient-specific survival,” said William D....

sarcoma

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...

SIDEBAR: Can Society Afford Bevacizumab in Ovarian Cancer?

For bevacizumab (Avastin), as for all targeted agents, there is a critical need to identify likely responders as well as patients at risk for serious toxicities, agreed Daniela Matei, MD, of the Indiana University Melvin and Bren Simon Cancer Center, and session moderator Daniel F. Hayes, MD, of...

gynecologic cancers

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...

kidney cancer
prostate cancer

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...

SIDEBAR: A Cautious Approach to Maintenance Therapy

Hematologists should weigh the risks and benefits carefully when considering lenalidomide (Revlimid) or other maintenance therapy for their patients with myeloma, according to William I. Bensinger, MD, of the Fred Hutchinson Cancer Research Center, Seattle. Lenalidomide is associated with...

multiple myeloma

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...

lymphoma

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....

gastrointestinal cancer

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: 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 ...

SIDEBAR: Is G13D KRAS Mutational Status Ready for Prime Time?

Individual oncologists will have to decide for themselves whether the results from the pooled analysis of cetuximab trials regarding G13D KRAS mutational status are ready for clinical application, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minnesota. “We still need...

colorectal cancer

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....

SIDEBAR: Stay Tuned for More Information on Neuropathy-related Genes

According to Daniel F. Hayes, MD, of the University of Michigan, Ann Arbor, who moderated the Best of ASCO® Miami conference, taxane-induced neuropathy is a more complicated story than the study by Schneider and colleagues may suggest. “There are now three observations regarding inherited germline ...

breast cancer

Other Breast Cancer Studies of Note

At this year’s Best of ASCO® Miami meeting, Harold Burstein, MD, PhD, discussed several studies he found interesting and relevant to clinical practice. Genomic Assays One study examined two genomic assays for ER-positive breast cancer, Oncotype DX and PAM50, and found considerable overlap among the ...

SIDEBAR: Studies Sparked Questions to Breast Cancer Specialists

Based on the MAP.3 findings, should we be using exemestane to prevent breast cancer in high-risk patients? Dr. Harold Burstein: The risk of developing breast cancer was 2.5% in the placebo arm, vs 1% to 1.5% risk with exemestane. Also, the cancers that were avoided were probably ones with good...

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