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Showing 8701 - 8750ASCO’s International Clinical Trials Workshop Educates Nascent Researchers on the Inner Workings of Clinical Trials
Pharmaceutical companies are increasingly conducting drug development research outside of the United States, Western Europe, and Japan. Attracted to the perceived lower costs, easier patient recruitment, and market potential, drug developers are now conducting more phase III clinical trials in...
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...
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...
Using the New Melanoma Drugs in the Clinic
With two effective new treatments for advanced melanoma, the question has become how to best use them and how to manage their toxicities. Vemurafenib (Zelboraf) and ipilimumab (Yervoy)1 have different pharmacokinetics, which lend themselves to different patient types. Omid Hamid, MD, of The...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
‘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...
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...
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...
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...
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...
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...
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...
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...
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,...
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...
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 ...
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...
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...
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...
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 ...
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. ...
Incremental Advances Demonstrated in Management of Locoregional Lung Cancer
Data presented at the ASCO Annual Meeting this year on the management of locoregional lung cancer present a mixed picture, with some advances and some disappointments, according to H. Jack West, MD, of the Swedish Cancer Institute in Seattle, who reviewed studies in this area at the Best of ASCO...
SIDEBAR: Molecular Heterogeneity Complicates Management of Resistance
The molecular heterogeneity of lung cancers will make it a challenge to manage resistance in this era of targeted therapy, according to D. Ross Camidge, MD, PhD, of the University of Colorado, Denver. A case in point: the anaplastic lymphoma kinase (ALK) story. Recently updated data for crizotinib ...
Fear of the Unknown: Cancer Treatment Can Be Scarier than the Disease Itself
Two years ago, I was feeling fine except for a nagging problem with severe constipation. I believed this was caused by some loperamide I had taken to quell the episodes of diarrhea I experienced following dinner at a local barbecue restaurant. When the symptoms persisted for a couple of months, I...
SIDEBAR: Expect and Encourage Questions from Your Patients
Patients and physicians need to be active coparticipants in discussions about prostate cancer treatment: “patients, by asking questions and making sure that doctors know their preferences—for example, how important sexual function or control of urination is to them—and clinicians, by inviting...
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...
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...
Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer
Indication Crizotinib (Xalkori) is an oral inhibitor of receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-Met), and recepteur d’origine nantais (RON). In August 2011, the FDA granted the drug accelerated approval for the treatment of...
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...
AACR Issues Landmark Report on Cancer Progress
At a recent press conference in Washington, DC, the American Association for Cancer Research (AACR) assembled luminaries from the cancer research and care communities to discuss the salient points of the association’s newly released progress report on the current and future state of cancer research ...
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 ...
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...
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...
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...
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 ...
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...
