Much has been written about the oncology drug shortage crisis in the United States. In the spirit of being part of the solution to that problem, a group of oncologists has formed the Citizen’s Oncology Foundation (COF). The goal of the start-up not-for-profit association is two-pronged: to find...
Cisplatin-based adjuvant therapy is recommended for patients with resected stage II–IIIA non–small cell lung cancer (NSCLC). There have been no trials of adjuvant therapy in elderly patients with NSCLC, who constitute a large part of the NSCLC population. A number of analyses indicate that older...
In an editorial accompanying the recently reported UK phase III Bladder Cancer 2001 (BC2001) trial, Shipley and Zietman, from Massachusetts General Hospital and Harvard Medical School, point out that this trial shows that “the addition of a very tolerable regimen of chemotherapy to radiotherapy...
Radiotherapy is an alternative to surgery in muscle-invasive bladder cancer, particularly in less-fit patients. However, it is associated with high rates of incomplete response or recurrence, with salvage surgery often being required. Although synchronous chemoradiotherapy has improved local...
A recent press briefing moderated by Phil B. Fontanarosa, MD, MBA, Executive Editor, JAMA, presented new findings on comparative effectiveness research, and two of the studies discussed focused on cancer. Dr. Fontanarosa started by defining comparative effectiveness research, which gained...
Patients with advanced non–small cell lung cancer (NSCLC) should receive treatment with erlotinib (Tarceva) before receiving standard chemotherapy only if their tumor is known to harbor EGFR mutations, researchers reported at the 3rd European Lung Cancer Conference in Geneva, Switzerland.1 The...
Scientific advances have markedly improved prostate cancer survival, but this clinical success story is not without its share of controversy. From screening through treatment, a growing array of options offer an admixture of promise and confusion for clinicians and patients. Moreover, today’s...
It is said that time is perhaps the most treasured asset we have. If you are a practicing oncologist, everyone wants more and more of your time, and I’m not referring to patients. Rather, there is an increasing proliferation of folks who want to make sure we’re doing a good job, and they are...
New studies highlighting findings that will lead to improvements in the patient experience and identifying potential risks for development of cancers in the future were reported at a press briefing held during the 2012 ASCO Annual Meeting in Chicago. “In this era of sophisticated research advances, ...
One of the reasons large population-based studies are important is based on the “difference between efficacy—does a treatment work in a highly controlled setting of a phase III randomized clinical trial—and effectiveness—does a treatment work in general practice,” according to Benjamin D. Smith,...
Bayer HealthCare announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the oral multikinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer. The submission is based on the results of the pivotal, global phase III CORRECT...
Denosumab (Xgeva) significantly delayed time to first bone metastases among men with nonmetastatic castration-resistant prostate cancer enrolled in a phase III randomized, placebo-controlled trial. The time to first bone metastasis was 33.2 months among the 716 patients randomly assigned to receive ...
Sanofi and Regeneron Pharmaceuticals, Inc, recently announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent aflibercept (Zaltrap) concentrate for solution for infusion in combination with irinotecan/fluoropyrimidine–based...
According to a study published online in The New England Journal of Medicine (May 16, 2012), the FDA approved more new drugs in less time—about 15% faster—than the European Medicines Agency and Health Canada. The analysis compared drug review performance for the three agencies from 2001 to 2010....
This past May, a collaborative think tank of researchers was convened at The Ohio State University, Columbus, to share their expertise in a somewhat older treatment that is reemerging on many fronts: photodynamic therapy. Participants from the United States, Great Britain, and Japan took part in...
Plasma vascular endothelial growth factor A (VEGF-A) and tumor neuropilin-1 “are strong biomarker candidates for predicting clinical outcome in patients with advanced gastric cancer” after treatment with bevacizumab (Avastin). This was the conclusion of a mandatory biomarker program following up on ...
Since its founding in 2004, the Multiple Myeloma Research Consortium (MMRC) has grown from a handful of member institutions to 16 such academic centers and has launched 38 phase I and phase II clinical trials. Six of the drugs studied in those investigations are currently in phase III trials. And...
The benefit from platinum-based adjuvant chemotherapy in non–small cell lung cancer (NSCLC) was demonstrated in four randomized trials (International Adjuvant Lung Cancer Trial [IALT], Canadian JBR.10 trial, Cancer and Leukemia Group B [CALGB] 9633 trial, and Adjuvant Navelbine International...
“I have me back,” is how breast cancer survivor Jeanette Daniel of Memphis described her life after being treated on a clinical trial at Vanderbilt-Ingram Cancer Center in Nashville. Being conducted by the Stand Up To Cancer P13K Dream Team, whose leader discovered the PI3K pathway, the trial...
Over 1,300 breast surgeons attended the 13th Annual Meeting of the American Society of Breast Surgeons, held May 2–6 in Phoenix. Presentations included investigations on recurrence after lumpectomy, gender differences in breast cancer, and the potential role of infrared thermography in diagnosing...
Three phase III, double-blind, multicenter, randomized studies showed that lenalidomide (Revlimid) maintenance therapy for patients with multiple myeloma significantly improved progression-free survival or time to progression, the primary endpoints of the studies published in The New England...
Commenting on the trial of combined BRAF and MEK inhibition in advanced melanoma, Michael K.K. Wong, MD, PhD, Professor of Medicine at Keck School of Medicine, University of Southern California, Los Angeles, called the findings “nothing short of extraordinary” and a potential “game changer.”...
In advanced melanoma, combination therapy with two investigational drugs—one targeting BRAF and the other the MEK pathway—achieved a median progression-free survival of 7.4 months, which rose to 10.8 months in patients who were optimally dosed, reported Jeffrey S. Weber, MD, PhD, Director of the...
Olanzapine (Zyprexa), an FDA-approved antipsychotic, effectively controlled chemotherapy-induced nausea and vomiting (CINV) in patients who failed to respond to guideline-recommended antiemetic therapy in a phase III trial presented at the ASCO Annual Meeting.1 “This is the first randomized trial...
Positive results continue to be reported for trastuzumab emtansine (T‑DM1), the antibody-drug conjugate linking trastuzumab (Herceptin) to a cytotoxic agent. Early results of the international phase III EMILIA study, presented at the 2012 ASCO Annual Meeting, showed a 35% reduction in risk of...
Since May 1, 2005, Karen H. Antman, MD, has served as Dean of Boston University School of Medicine and Provost of the Boston University Medical Campus, located in the historic South End of Boston. Her road to this esteemed institution was paved with prominent positions, such as former ASCO...
Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the FDA to extend the use of abiraterone acetate (Zytiga) administered with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or...
Obese patients present with more advanced and more aggressive forms of papillary thyroid cancer and should be screened for thyroid cancer with sonography, which is more sensitive in detecting thyroid cancer than physical examination alone, according to a study published online in the Archives of...
Over the past 2 decades, we have seen a substantial increase in the 5-year survival of patients with stage II and III colon cancer, marking an evolving oncologic success story. However, in the postoperative setting, the value of regular CT screening to monitor for recurrence has been greeted with...
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. “A simple blood test.” These were...
Onyx Pharmaceuticals recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11–0 (with 1 abstention) that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome...
The recently published book, Malignant: Medical Ethicists Confront Cancer, takes a personal look at the cancer experience from the perspective of seven medical ethicists who were also patients with cancer or cared for spouses with cancer.1 The book’s editor, Rebecca Dresser, JD, MS, who teaches law ...
“Our old friends are sometimes worth keeping, and that is certainly true for weekly paclitaxel,” said the invited discussant of CALGB 40502, Kathy Miller, MD, of Indiana University School of Medicine, Indianapolis, at the ASCO Annual Meeting. She noted that Dr. Rugo must “remain strict to the...
In the treatment of metastatic breast cancer, established older agents outperformed newer, more expensive drugs in two studies that made news at the 2012 ASCO Annual Meeting. Microtubule Inhibitors In the phase III open-label CALBG 40502/NCCTG N063H trial of 799 chemotherapy-naive patients with...
“We are approaching the 15th year of exploring molecularly targeted therapies in ovarian cancer,” said Michael Seiden, MD, of Fox Chase Cancer Center, Philadelphia, and formal discussant of the papers presented during an oral abstract session on gynecologic cancer at the 2012 ASCO Annual Meeting....
A trio of randomized, controlled trials of different molecularly targeted therapies showed variable results in ovarian cancer, as reported at the 2012 ASCO Annual Meeting in Chicago. The phase III AURELIA trial demonstrated that the addition of the vascular endothelial growth factor (VEGF)...
Adjuvant chemotherapy with PCV (procarbazine [Matulane], lomustine [CeeNU], and vincristine) following standard radiation therapy delayed disease progression and increased survival in patients with a relatively rare type of brain tumor called anaplastic oligodendroglioma. A subgroup analysis found...
Formal discussant of the SWOG 9346 trial, William K. Oh, MD, Tisch Cancer Institute at the Mount Sinai School of Medicine, New York, said that at least 23 phase II trials have suggested that intermittent androgen deprivation therapy was safe and effective and that this practice has been broadly...
Based on the controversial nature of the SWOG 9346 findings, presented at the 2012 Annual Meeting Plenary Session, ASCO intiated a pilot program at the meeting for a “town hall” type of discussion, where attendees could voice their concerns and questions, and where presenter Maha Hussain, MD,...
Based on a prespecified definition of survival comparability, intermittent androgen deprivation proved to be inferior to continuous androgen deprivation for men with newly diagnosed hormone-sensitive metastatic prostate cancer in the phase III SWOG 9346 intergroup trial. The data were presented at...
Updated results of the StiL NHL1 study, presented at the 2012 ASCO Annual Meeting Plenary Session, showed that bendamustine plus rituximab (Rituxan) more than doubled the median progression-free survival, compared with the standard R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin,...
As the world’s most common cancer among women, and the most likely reason around the globe that a woman will die of cancer, breast cancer affects countries at all economic levels. Despite the common misconception that breast cancer is primarily a problem of high-income countries, the majority of...
Because few people over 75 participate in clinical trials, it is unknown whether adjuvant chemotherapy could benefit this population. Faced with this gap in clinical trial evidence, researchers reviewed data from 5,489 patients ≥ 75 years with stage III colon cancer. The review suggests that...
Promising results announced at the recent ASCO Annual Meeting from studies with BRAF and MEK inhibitors have made headlines, but only one of these agents—the BRAF inhibitor vemurafenib (Zelboraf)—has been approved by the FDA. The others are still investigational. Patients interested in gaining...
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. The MEK inhibitor trametinib...
The efficacy of cancer immunotherapy has been limited, likely reflecting in large part the incomplete understanding of the complex interactions between tumors and the immune microenvironment. A study presented at the 2012 ASCO Annual Meeting helps clarify some of these interactions. Changes in...
Cabozantinib prolonged progression-free survival in patients with unresectable, locally advanced, or metastatic medullary thyroid cancer with documented disease progression in the phase III EXAM trial. Based on these results, Exelixis submitted a New Drug Application to the FDA in May 2012. The...
Oxaliplatin/fluoropyrimidine–based adjuvant therapy is of benefit in patients with resected stage II/III colon cancer, but the ability to predict risk of toxicity could improve care by permitting individualization of treatment. Ana Custodio, MD, and colleagues from GEMCAD (Grupo Español...
Response rates and progression-free survival rates were significantly better among patients with advanced adrenocortical carcinoma receiving mitotane (Lysodren) plus EDP (etoposide, doxorubicin, and cisplatin) than in patients receiving mitotane with streptozocin (Zanosar), according to results of...
The Sarcoma Foundation of America has sponsored the following research projects—each selected through a rigorous peer-review process—in collaboration with the Conquer Cancer Foundation: Evaluation of the Hedgehog Signaling Pathway in the Growth of Myogenic Sarcomas Targeting the Notch Signaling ...