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issues in oncology
health-care policy

Developing 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...

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...

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...

Susan G. Komen for the Cure® Announces 2011 Brinker Award Winners for Scientific Distinction

Armando Giuliano, MD, and Carlos Arteaga, MD, are being honored as this year’s winners of the Susan G. Komen for the Cure® Brinker Awards for Scientific Distinction in basic science and clinical research. The awards will be presented on December 7 at the 34th Annual San Antonio Breast Cancer...

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 ...

issues in oncology

Cancer Information on Wikipedia as Accurate as on PDQ but Harder to Understand

A comparison of cancer information on Wikipedia and the patient version of information on the NCI’s Physician Data Query (PDQ) “found that although Wikipedia had similar accuracy and depth to the PDQ, the written style was more complex and thus might be less understandable to patients.” According...

colorectal cancer

Hepatic Resection Remains Preferred Strategy for Colorectal Liver Metastases

Hepatic resection was shown to be superior to radiofrequency ablation (RFA) for the treatment of colorectal liver metastases, according to a model used to stimulate a randomized controlled trial. Researchers from the Hepatobiliary and Pancreatic Surgery Program at the Providence Portland Medical...

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...

gynecologic cancers
geriatric oncology

Elderly Patients with Ovarian Cancer Least Likely to Receive Chemotherapy

An analysis of data for 4,617 women aged 65 years or older diagnosed with epithelial ovarian cancer found that those in the oldest age group, 80 and up, were least likely to receive any chemotherapy. While 53% of patients 80 and older received no chemotherapy, the rate was less than half (22%) for...

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...

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...

FDA Announces Changes in Drug Center’s Oncology Office

The FDA recently announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and...

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 ...

Newly Elected ASTRO Officers Installed at Annual Meeting

Recently elected officers for the American Society for Radiation Oncology (ASTRO) began their terms at ASTRO’s 53rd Annual Meeting in Miami Beach, which was held October 2-6, 2011. The new Board of Directors members are: President-elect: Colleen A. Lawton, MD, FASTRO, Medical College of Wisconsin, ...

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...

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...

prostate cancer

FDA Approves Denosumab to Increase Bone Mass in Patients with Cancer

Denosumab (Prolia) recently received FDA approval as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer.  Pivotal Trials The approvals were based...

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 ...

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: 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 ...

Special Supplement: Reports from Best of ASCO® Annual Meeting '11

The ASCO Post is pleased to present this special supplement with a focused review of more than 50 key abstracts from the Annual Meeting of the American Society of Clinical Oncology (ASCO), as presented and discussed at the Best of ASCO ’11 meetings (July 29-30, 2011, Miami, Florida, and August 5-6, ...

breast cancer

BRCA Mutation Has Little Effect on Outcome with Neoadjuvant Therapy

A retrospective analysis to determine the efficacy of neoadjuvant systemic therapy for breast cancer patients with and without BRCA mutations found the overall prognosis was similar in both groups of patients. “No significant differences were noted in survival outcomes with respect to BRCA status...

prostate cancer

Physicians Can Help Patients Set Realistic Expectations for Sexual Functioning after Treatment for Prostate Cancer

Models that can be personalized to predict erectile function of individual patients following treatment for early-stage prostate cancer have been developed and validated in a study involving a total of 2,940 men, and are ready for use in clinical practice, according to Martin G. Sanda, MD, the...

issues in oncology

Bevacizumab Labeling Revised to Include New Risks

The FDA recently announced changes made to the bevacizumab (Avastin) package insert regarding new safety concerns. These changes include the following: A new Warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and...

issues in oncology

Gel for Blood Vessel Surgery Approved

The FDA has approved LeGoo (PluroMed Inc, Woburn, Mass), a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops. LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels....

leukemia

FDA Issues Safety Announcement on Dasatinib

The FDA is warning the public that the leukemia drug dasatinib (Sprycel) may increase the risk of pulmonary arterial hypertension (PAH). Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label. In reported cases, patients developed PAH after...

Expert Point of View: Panitumumab Is Not Beneficial in KRAS Mutations: No Exceptions

Axel Grothey, MD, of the Mayo Clinic, Rochester, Minnesota, found the findings presented by Marc Peeters, MD, PhD,1 at the 2011 European Multidisciplinary Cancer Congress to be of great interest, from both clinical and research perspectives. “We have two discrepant analyses now for G13D. When we...

cost of care

New Technologies Are Driving Up Costs: Are They Worth the Price?

Expensive new cancer therapies and technologies are alluring for both physicians and their patients. Prostate cancer, because of the sheer volume of cases and the variability of treatment options, serves as a dynamic disease model in the ongoing debate over how to curb spending and maintain...

GI Symposium Helps Oncologists Stay Abreast of Fast-moving Research

Gastrointestinal cancers are a key therapeutic area in research, and science is moving forward in that arena at a fast clip. But how are those who focus on gastrointestinal malignancies in the clinic supposed to stay on top of it all? One great way is to attend the annual Gastrointestinal Cancers...

issues in oncology
cost of care

A Conversation with Richard J. Gilbertson, MD, PhD

St. Jude Children’s Research Hospital, Memphis, the country’s first and only NCI-designated Comprehensive Cancer Center devoted solely to children, recently appointed internationally regarded pediatric brain tumor researcher, Richard J. Gilbertson, MD, PhD, as its new Cancer Center Director. In a...

breast cancer

FDA Commissioner Announces Decision on Bevacizumab

On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will still remain on the market as an...

head and neck cancer

Rates of Surgery and Survival Increasing for Early-stage Cancers

Surgery is increasingly being used to treat patients with early-stage laryngeal cancer in the United States, and chemotherapy in combination with radiation therapy is being used increasingly to treat patients in an advanced stage of the disease, according to a report in the October issue of...

gynecologic cancers

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...

breast cancer

Fewer False-positives, Small Increased Risk of Late Diagnosis with Biennial Mammography

Screening mammography every other year reduced false-positive recalls by about one-third compared to annual screening, but was associated with a small increase in the probability of late-stage cancer diagnosis, according to a study funded by the NCI and published in Annals of Internal Medicine. To...

breast cancer

Low-level Expression of ESR1 Tied to Tamoxifen Resistance

Data from a retrospective analysis of two pivotal breast cancer studies suggest that the low-level expression of the estrogen receptor (ER) gene ESR1 “is a determinant of tamoxifen resistance in ER-positive breast cancer,” reported researchers in the Journal of Clinical Oncology. “We performed...

colorectal cancer

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 ...

colorectal cancer

Should Age at Initial Screening Colonoscopy Be Younger for Men?

A study to investigate the most appropriate age for initial screening colonoscopy to improve detection of adenomas, advanced adenomas, and colorectal cancer, and lower colorectal cancer mortality found that the most appropriate age might be different for men and women. “In our study, analysis of...

colorectal cancer

MRI Helps Predict Survival Outcomes in Patients with Rectal Cancer

Magnetic resonance imaging (MRI) can be used after neoadjuvant therapy for rectal cancer to predict survival outcomes for good and poor responders and offer patients additional treatment options before definitive surgery, according to a study conducted at 11 specialist colorectal cancer units in...

breast cancer

Adjuvant Trastuzumab in Nonanthracycline Regimen Studied

One of four large, randomized trials to evaluate adjuvant trastuzumab (Herceptin) in early-stage HER2-positive breast cancer—and the only study to include a nonanthracycline chemotherapy regimen—found that regimen had similar efficacy to anthracycline-containing regimens, but with lower rates of...

breast cancer

Challenging Perceptions about Treatment Options for Younger Women with Early-stage Breast Cancer

In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. “There is a perception out there...

cost of care
issues in oncology

A Conversation with Craig B. Thompson, MD

In November 2010, Craig B. Thompson, MD, was named President and CEO of Memorial Sloan-Kettering Cancer Center (MSK) in New York, succeeding Harold Varmus, MD, who is now Director of the NCI. A cancer clinician and researcher, before coming to Memorial Sloan-Kettering Dr. Thompson was Director of...

Expert Point of View: Lessening Patients’ Suffering at the End of Life

In her interview with The ASCO Post, Judith Redwing Keyssar, RN, sheds light on easing the suffering of patients facing the end of life. Although what she says is appropriate for patients who are clearly dying, I would emphasize that palliative care is also pertinent to patients who are not...

palliative care

A Conversation with Judith Redwing Keyssar, RN

The number of patients seeking hospice and palliative care has grown significantly since 1974, when the NCI funded the first hospice facility in Branford, Connecticut. Nevertheless, according to the National Center for Health Statistics, 85% of Americans still die in hospitals or nursing homes....

head and neck cancer

FDA Approves Cetuximab to Treat Metastatic Head and Neck Cancer

On November 7, the FDA approved cetuximab (Erbitux) in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck. The approval was based primarily on...

geriatric oncology

Geriatric Oncology, a Much Needed Discipline for Future Cancer Care

The U.S. health-care system, with its rapidly aging population, faces a multitude of difficult clinical and financial challenges in caring for its burgeoning population of older patients with cancer. Moreover, age-related social and medical issues among older patients need to be addressed by a...

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