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issues in oncology

Novel Initiative to Address Oncology Drug Crisis

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...

lung cancer
geriatric oncology

Canadian Registry Study of Adjuvant Therapy for NSCLC Shows Increased Use in Elderly Patients and Improved Survival

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...

bladder cancer

Expert Point of View: Chemoradiation with Fluorouracil and Mitomycin Reduces Recurrence of Muscle-invasive Bladder Cancer

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...

bladder cancer

Chemoradiation with Fluorouracil and Mitomycin Reduces Recurrence of Muscle-invasive Bladder Cancer

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...

lung cancer
prostate cancer
issues in oncology

JAMA Highlights New Comparative Effectiveness Studies

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...

lung cancer

Biomarker Analysis of the TORCH Study: First-line Erlotinib Only in Patients with EGFR-positive Non–Small Cell Lung Cancer

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...

prostate cancer

Advances in Prostate Cancer Accompanied by Ongoing Debates

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...

issues in oncology
health-care policy

Maintenance of Certification in Medical Oncology

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...

breast cancer
issues in oncology
supportive care
palliative care

Studies Report Findings in Patient-centered Care

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, ...

SIDEBAR: Difference between Efficacy and Effectiveness

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,...

colorectal cancer

New Drug Application Submitted for Regorafenib for the Treatment of Metastatic Colorectal Cancer

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...

prostate cancer

Denosumab Delays Time to First Bone Metastasis in Men with Castration-resistant Prostate Cancer

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 ...

colorectal cancer

Aflibercept Granted Priority Review for Metastatic Colorectal Cancer

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...

FDA Approves Drugs Faster than Canadian and European Counterparts

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....

International Photodynamic Medicine Symposium: Shedding New Light on an Old Therapy

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...

gastrointestinal cancer

Strong Biomarker Candidates for Predicting Clinical Response to Bevacizumab

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 ...

SIDEBAR: Success of the Multiple Myeloma Research Consortium

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...

lung cancer

Study Validates Prognostic Role of Tumor Lymphocytic Infiltration in Resectable Non–Small Cell Lung Cancer

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...

issues in oncology
survivorship

Cancer Survivors Stand Up, Give Thanks, and Give Back

“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...

breast cancer

Epidemiology, Diagnosis, and Treatment of Breast Cancer Explored at the American Society of Breast Surgeons Meeting

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...

hematologic malignancies
multiple myeloma

Maintenance Lenalidomide Improves Progression-free Survival and Time to Progression in Patients with Multiple Myeloma

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...

Expert Point of View: Dual BRAF and MEK Inhibition Is Active in Advanced Melanoma

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.”...

skin cancer

Dual BRAF and MEK Inhibition Is Active in Advanced Melanoma

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...

supportive care
palliative care
symptom management

Antipsychotic Effectively Controls Chemotherapy-induced Breakthrough Nausea and Vomiting

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...

breast cancer

T-DM1 Proves More Effective, Less Toxic Than Standard Treatment for Metastatic Breast Cancer

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...

Reflections on the Evolution of Clinical Cancer Research and Turning Points in a Distinguished Career

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...

prostate cancer

Supplemental New Drug Application Submitted for Abiraterone

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...

thyroid cancer

Obese Patients at Higher Risk of Aggressive Thyroid Tumors

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...

colorectal cancer

To Scan or Not to Scan for Colon Cancer Recurrence?

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...

breast cancer

Too Soon to Know How Circulating Tumor Cells Might Be Used to Guide Treatment of 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. “A simple blood test.” These were...

multiple myeloma

Novel Agent Carfilzomib Receives Positive Vote from Oncologic Drugs Advisory Committee for Use in Multiple Myeloma

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...

issues in oncology

Medical Ethicists Reflect on Their Personal Cancer Experiences

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 ...

Expert Point of View: Kathy Miller, MD

“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...

breast cancer

Older Breast Cancer Drugs Prove Superior to Newer Ones

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...

Expert Point of View: Michael Seiden, MD

“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....

gynecologic cancers

Bevacizumab and Olaparib Boost Progression-free Survival in Ovarian Cancer

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)...

cns cancers

New Standard of Care for Anaplastic Oligodendroglial Tumors with 1p/19q Codeletions

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...

Expert Point of View: William K. Oh, MD

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...

prostate cancer

SIDEBAR: SWOG 9346 Conclusions Debated in Special Post-plenary Discussion

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,...

prostate cancer

Continuous Androgen Deprivation Therapy Continues to Be Standard of Care for Newly Diagnosed Metastatic Prostate Cancer

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...

hematologic malignancies
lymphoma

German Study Finds Bendamustine Improves Progression-free Survival in Patients with Non-Hodgkin Lymphoma

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,...

breast cancer
global cancer care

Breast Cancer and Noncommunicable Diseases: Where in the World Do We Start?

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...

colorectal cancer

Adjuvant Chemotherapy May Confer Survival Benefit in Patients Older than 75 with Stage III Disease

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...

SIDEBAR: Expect Questions from Your Patients

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...

skin cancer

MEK Inhibitor Reduces Progression of BRAF-mutated Melanoma and Might also Benefit Others

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...

solid tumors

Identification of Novel Mechanism for Suppression of Antitumor Immunity

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...

thyroid cancer

Cabozantinib Prolongs Progression-free Survival in Advanced Medullary Thyroid Cancer

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...

solid tumors
colorectal cancer

Single Nucleotide Polymorphisms Predict Severe Toxicity of Adjuvant Therapy in Colorectal Cancer

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...

Mitotane-containing Regimens Explored for a Rare Tumor

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...

SIDEBAR: SFA-sponsored Research

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 ...

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