The patient-centered medical home (PCMH) model of care has proved successful in overcoming some of the fragmentation of primary care. Dr Sprandio and his colleagues have now demonstrated the value of applying the principles of the medical home to cancer care, with particular implications for oncologists and for payers and unique reimbursement dilemmas. [ Read More ]
October 2011, Vol 2, No 6
Stockholm, Sweden—With recognition of common tumor mutations and a pipeline full of biologic agents that target them, personalized medicine should be all but a fait accompli. But one expert told attendees at the European Society for Medical Oncology’s 2011 European Multidisciplinary Cancer Congress, “We may be overpromising our patients.”[ Read More ]
Stockholm, Sweden—The cost of cancer therapies is a growing concern not only for patients but also for providers and payers. Addressing the cost burden for those involved in cancer care is becoming a priority that cannot be avoided with the growing role of targeted therapies in oncology.
Cost Nearly Doubles in Metastatic Breast Cancer
A study presented by Melissa Brammer, MD, Medical Director, Genentech, San Francisco, CA, shows that complications associated with treating cancer essentially double the cost of treating metastatic breast cancer.[ Read More ]
New York, NY—Maintenance therapy is now an option for the treatment of multiple myeloma in elderly patients and in patients who have undergone autologous stem-cell transplant (ASCT). [ Read More ]
The National Institute for Health and Clinical Excellence (NICE) has issued a report (Wonderling D, et al. Ann Intern Med. 2011;154:758-765) explaining the process and value of cost-effectiveness assessments and how these inform recommendations and decisions regarding clinical questions made by the UK National Clinical Guidelines Centre. The report dispels the following 3 myths regarding cost-effectiveness evaluations that further clarify the concept of value in medicine:[ Read More ]
Another report in the same issue of the Annals of Internal Medicine focuses on the relevance of 3 concepts that can help in understanding the value of clinical interventions for those involved in clinical decisions (Owens DK, et al. Ann Intern Med. 2011;154:174-180). The authors define value as “an assessment of the benefit of an intervention relative to expenditures.”[ Read More ]
Positron emission tomography (PET) is a promising approach for differentiating which patients with inoperable lung cancer will and will not benefit from additional treatment after standard chemotherapy/radiation therapy. Lead investigator Mitch Machtay, MD, Chairman of Radiation Oncology, Seidman Cancer Center, University Hospitals Case Western Medical Center, presented these results at the 2011 annual meeting of the American Society for Radiation Oncology (ASTRO), based on 251 patients with stage III lung cancer at 60 cancer centers around the country.[ Read More ]
The US Food and Drug Administration (FDA) is often criticized for delaying treatments for patients, especially those with terminal illnesses such as advanced cancer. However, a new drug-to-drug comparison (Roberts SH, et al. Health Aff [Millwood]. 2011;30:1375-1381) of the 35 new cancer drugs approved by the FDA and the European Medicines Agency (EMA) between 2003 and 2010 shows that:[ Read More ]
In a new study funded by the National Cancer Institute and the University of Michigan Clinical Research Center, inexpensive ginger supplements reduced markers of colon inflammation, indicating that ginger root may be beneficial in preventing colon cancer (Zick SM, et al. Cancer Prev Res [Phila]. 2011 Oct 11. Epub ahead of print). Colon inflammation is a precursor of colon cancer.[ Read More ]
On September 26, 2011, the FDA issued an approvable letter to Mela Sciences, the manufacturer of MelaFind, an investigational diagnostic device for early melanoma. This letter comes almost 1 year after the FDA rejected the device, requesting more clinical data. MelaFind is a noninvasive, multispectral computerized vision system that analyzes images of skin lesions. It is designed to differentiate nonulcerated, nonbleeding cutaneous malignant melanoma and high-grade lesions <2.2 cm from all other pigmented skin lesions. [ Read More ]
The US Food and Drug Administration (FDA) approved the targeted therapy vemurafenib tablets (Zelboraf, Hoffmann-La Roche) for the treatment of patients with unresectable or metastatic mela noma with the BRAF V600E gene mutation. The BRAF V600E mutation occurs in 40% to 60% of patients with melanoma.[ Read More ]
Along with vemurafenib the FDA concurrently approved the companion molecular diagnostic for this targeted therapy—the cobas 4800 BRAF V600 Mutation Test (Roche) for the diagnosis of BRAF V600E mutation in patients with melanoma. As a realtime polymerase chain-reaction test, it is 97.3% positive in detecting the mutation. (August 17, 2011)[ Read More ]
The FDA expedited the approval of brentuximab vedotin (Adcetris, Seattle Genetics) for the treatment of Hodgkin lymphoma, as well as for systemic anaplastic large-cell lymphoma (ALCL), a rare non-Hodgkin lymphoma that may manifest in several parts of the body, including the lymph nodes, skin, bones, soft tissue, lungs, and liver. Brentuximab is the first CD30-directed antibody-drug conjugate approved for systemic ALCL; it is also the first treatment ever approved for this rare disease.[ Read More ]
Using a priority review, the FDA approved oral crizotinib (Xalkori, Pfizer) for the treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC) in patients with the anaplastic lymphoma kinase (ALK) genetic mutation, as detected by the companion test concurrently approved by the FDA. Approximately 3% to 5% of patients with NSCLC are ALK-positive.[ Read More ]
Stockholm, Sweden—An investigational alpha-pharmaceutical not only prevented skeletal-related events (SREs) in patients with prostate cancer with bone metastases in a phase 3 study presented at the 2011 European Multidisciplinary Cancer Congress, but it also improved overall survival. [ Read More ]
Stockholm, Sweden—Two expensive drugs may be better than 1 for maintenance treatment of advanced non– small-cell lung cancer (NSCLC), according to a study at the 2011 European Multidisciplinary Cancer Congress. Adding pemetrexed (Alimta) to bevacizumab (Avastin) maintenance therapy reduced the risk of disease progression in the phase 3 AVAPERL trial.[ Read More ]
Stockholm, Sweden—The indefinite use of bevacizumab (Avastin) in patients with re lapsed ovarian cancer got another boost at the 2011 European Multi disciplinary Cancer Congress, with a subanalysis of the phase 3 OCEANS trial showing consistent benefit across subgroups. The main finding of OCEANS, which was reported earlier at the 2011 American Society of Clinical Oncolo - gy annual meeting, was that the addition of bevacizumab to carboplatin (Paraplatin)/gemcitabine (Gemzar) in patients with advanced ovarian cancer reduced the risk of disease progress - ion by 52%.[ Read More ]
Stockholm, Sweden—In patients with advanced non–small-cell lung cancer (NSCLC) and anaplastic lymphoma kinase (ALK) gene rearrangements, treatment with crizotinib (Xalkori) provided clinically meaningful antitumor activity, producing responses in 51% of patients, in the multicenter phase 2 PROFILE 1005 study reported at the 2011 European Multidisciplinary Can cer Congress.[ Read More ]
Stockholm, Sweden—The use of everolimus (Afinitor) together with the aromatase inhibitor exemestane (Aromasin) more than halved the risk for disease progression in patients with advanced breast cancer, adding an average of 4 disease-free months, investigators reported at the 2011 European Society for Medical Oncology European Multidisciplinary Cancer Congress. [ Read More ]
Stockholm, Sweden—Trastuzumab emtansine (T-DM1), a novel monoclonal antibody–guided therapy for HER2- positive metastatic breast cancer, achieved almost a 40% reduction in the risk of disease progression compared with standard treatment with trastuzumab (Herceptin) and docetaxel (Taxotere), investigators reported at the 2011 European Multidisciplinary Cancer Congress.[ Read More ]
The New Era of Personalized Medicine in Oncology: Novel Biomarkers Ushering in New Approaches to Cancer Therapy
It is next to impossible for a day to go by without thinking about the contributions of personalized medicine to the care of patients living with cancer. [ Read More ]
New York, NY—Evidence suggests that maintenance therapy, as well as initiation of therapy for newly diagnosed follicular lymphoma, can be delayed in asymptomatic patients with low tumor burden, according to Andrew Zelenetz, MD, Chief of Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, NY.[ Read More ]
The FDA also approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott) as a companion diagnostic test for the diagnosis of the ALK gene in patients with NSCLC to identify appropriate candidates for crizotinib therapy. The test uses fluorescence in situ hybridization to detect those rearrangements on the 2p23 chromosome. (August 26, 2011)[ Read More ]
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended accelerated approval of the iron chelator deferiprone (Ferriprox, ApoPharma) for patients with transfusional iron overload that is inadequately treated with deferoxamine (Desferal), the standard chelation therapy for patients with diseases such as thalassemia or sickle-cell disease, who must undergo multiple blood transfusions to survive.[ Read More ]
The FDA approved 2 new indications for denosumab (Prolia, Amgen) for treating patients at high risk for therapy-induced bone fracture. The first indication is for increasing bone mineral density (BMD) in men receiving an dro gen-deprivation therapy for nonmetastatic prostate cancer; the second is for increasing BMD in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
The approval was based on 2 international randomized, placebo-controlled trials, one involving 1468 men with prostate cancer, the other including 252 women with breast cancer.[ Read More ]
New York, NY—Several advances have been made in the diagnosis and treatment of chronic lymphocytic leukemia (CLL), according to Susan O’Brien, MD, Chief, Acute Leukemia Section at M.D. Anderson Cancer Center, Houston. Treatment selection can now be guided by fluorescence in situ hybridization (FISH) testing for genetic abnormalities, and 2 new treatments in early-stage development hold promise for patients with a poor prognostic cytogenetic profile.[ Read More ]
New York, NY—The era of personalized medicine is progressing. At the Fred Hutchinson Cancer Center, Seattle, WA, and at other centers, patients with intermediate-risk acute myeloid leukemia (AML) are now being tested for 3 molecular markers that predict prognosis. The goal is to use these markers for treatment selection and for monitoring response. [ Read More ]
The decision this month (October 2011) by the US Preventive Services Task Force (USPSTF) to recommend against a prostate-specific antigen (PSA)-based screening for prostate cancer in healthy men1 has caused quite a stir both in and outside of medical circles, reminding many people of the task force’s 2009 recommendation against routine breast cancer screenings for women under age 50 years. [ Read More ]
In September 2011, the American Association of Cancer Research (AACR) issued a new report, “AACR Cancer Progress Report 2011” (www.aacr.org/Uploads/Document Re pository/2011CPR/2011_AACR_CPR_ Text_web.pdf) on the current state of cancer research and the implications of recent cuts in funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI). These cuts in NIH and NCI funding are already adversely affecting the progress made in cancer research in the United States.[ Read More ]
In phase 1 and 2 clinical trials, olaparib, a small-molecule poly(ADPribose) polymerase (PARP) inhibitor, has demonstrated objective responses in women with breast or ovarian cancer and BRCA1 and BRCA2 mutations. Results of a new study show that olaparib may be a promising therapy for women with aggressive ovarian cancer (Gelmon KA, et al. Lancet Oncol. 2011;12:852-861).[ Read More ]
The BCR-ABL inhibitor nilotinib (Tasigna) was developed as a selective treatment for patients with chronic myeloid leukemia (CML) who are not responding appropriately to imatinib (Gleevec) therapy. Previous results from the Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd) study showed 12-month superior efficacy for nilotinib over imatinib in patients with newly diagnosed Philadelphia chromosome– positive (Ph+) CML in the chronic phase. [ Read More ]
San Francisco, CA—A novel histone deacetylase (HDAC) inhibitor, when added to the aromatase inhibitor exemestane (Aromasin), appears to restore sensitivity to the endocrine agent by significantly delaying recurrences and creating an increased survival trend.
The findings come from the Entinostat Combinations Overcoming Resistance (ENCORE 301) study presented at the 2011 Breast Cancer Symposium by Denise Yardley, MD, Sarah Cannon Research Institute and Tennessee Oncology, Nashville.[ Read More ]
San Francisco, CA—Several studies presented at the 2011 Breast Cancer Symposium shed light on the quality of breast cancer care received by women who are uninsured or receiving Medicaid.
In a study conducted at Rollins School of Public Health of Emory University, Atlanta, researchers investigated the quality of breast cancer treatment in patients enrolled under Medicaid and the Breast and Cervical Cancer Prevention and Treatment Act (BCCPTA) of 2000 in Georgia.[ Read More ]
San Francisco, CA—Accelerated partial breast irradiation using brachytherapy (APBIb) for breast cancer has been rapidly adopted in the United States, although its use varies by region, race, and ethnicity. Jona A. Hattangadi, MD, Harvard Radiation Oncology Program, Boston, reported the findings at the 2011 ASCO Breast Cancer Symposium, which was sponsored by 6 breast, oncology, and surgical societies.[ Read More ]
San Francisco, CA—The debate over the clinical significance of occult micrometastases in the lymph nodes of patients with breast cancer continues. [ Read More ]
San Francisco, CA—Whether women receive chemotherapy or surgery first as their initial treatment for breast cancer does not affect long-term localregional recurrence, according to a large case series from the University of Texas M.D. Anderson Cancer Center, Houston, that was presented at the 2011 Breast Cancer Symposium.[ Read More ]
The population of cancer survivors is rapidly growing. More than 12 million Americans are alive after a cancer diagnosis: most are living at least 5 years and 16% are alive 20 years after diagnosis.
This growing population of cancer survivors is at risk for many comorbidities, especially as they age. A study of 10,397 childhood cancer survivors showed that group is 8 times more likely to have a severe or life-threatening condition than their siblings (Oeffinger K, et al. N Engl J Med. 2006; 355:1572-1582).[ Read More ]
The concurrent use of chemotherapy and thoracic radiotherapy (TRT) confers a greater survival benefit in patients with stage III non–small-cell lung cancer (NSCLC) than a sequential use of these therapies, based on results from a phase 3 clinical study (Curran WJ, et al. J Natl Cancer Inst. 2011;103: 1452-1460).
This study compared standard therapy (ie, chemotherapy followed by radiation) with 2 regimens of concurrent chemoradiation in 610 patients with inoperable stage II or III NSCLC enrolled from 153 centers in the United States and Canada.[ Read More ]
On July 29, 2011, a 3-judge panel from the US Court of Appeals for the Federal Circuit invalidated some patents held by Myriad Genetics and the University of Utah Research Foundation for methods of analyzing individuals’ gene sequences for the presence of BRCA1 and BRCA2 mutations, but upheld other related patents in a reversal of a lower court ruling. The decision has left the door open to many questions.[ Read More ]