ONCOLOGY Vol 23 No 10 | Oncology

FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer

September 11, 2009

The US Food and Drug Administration has approved pemetrexed (Alimta), the first drug available for maintenance therapy of advanced or metastatic lung cancer. Pemetrexed disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication.

Accelerated Approval Granted for Bevacizumab in Glioblastoma

September 11, 2009

The US Food and Drug Administration (FDA) granted accelerated approval of bevacizumab (Avastin) for people with glioblastoma with progressive disease following prior therapy. The effectiveness of bevacizumab in this aggressive form of brain cancer is based on an improvement in objective response rate. Currently, no data are available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab in glioblastoma.

FDA Extends Review of Ofatumumab

September 11, 2009

The US Food and Drug Administration (FDA) has extended the action date for a biological licensing application (BLA) application for ofatumumab (Arzerra) by 3 months. The BLA was submitted on January 30, 2009 and was granted priority review by the FDA. Under priority review, the FDA sets the target date for a decision at 6 months, rather than the standard 10-month review. The 3-month extension allows the agency to review additional chemistry and manufacturing data submitted on June 5. The new action date for the BLA is October 31, 2009.

Degarelix for Advanced Prostate Cancer Gets Trade Name

September 11, 2009

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved the trade name Firmagon (degarelix for injection) for its prostate cancer treatment previously marketed under the generic name degarelix.

KRAS Safety Update Added to Panitumumab Prescribing Information

September 11, 2009

The US Food and Drug Administration (FDA) has approved revisions to the US prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including panitumumab (Vectibix). This decision follows the FDA’s December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed.

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs

September 11, 2009

The US Food and Drug Administration (FDA) recently published two rules that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

SGO White Paper Explores HPV Vaccine’s Impact on Cervical Cancer Prevention

September 11, 2009

The Society of Gynecologic Oncologists (SGO) has published the first in a series of four papers on a variety of cervical cancer issues and topics that were the focus of its Forum “The Future Strategies for Cervical Cancer Prevention: What Do We Need to Do Now to Prepare,” held last September in Chicago.

New Fertility Treatment Option Available for Cancer Patients

September 11, 2009

Cancer patients who want to start a family in the future now have a new option. Montefiore’s Institute for Reproductive Medicine & Health is the only site in the New York metropolitan area and one of approximately 25 sites across the country to offer a new treatment option to preserve fertility for female patients undergoing cancer treatment.

New Drug Application Filed for Pixantrone

September 11, 2009

Cell Therapeutics, Inc, announced that the US Food and Drug Administration (FDA) has accepted and has filed for review the company’s New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). As we went to press, a Prescription Drug User Fee Act (PDUFA) date was to be established by the FDA regarding the review of the pixantrone NDA by September 4, 2009.

Life Expectancy at All Time High, Death Rates Reach New Low, New Report Shows

September 11, 2009

US life expectancy reached nearly 78 years (77.9), and the age-adjusted death rate dropped to 760.3 deaths per 100,000 population, both records, according to the latest mortality statistics from the Centers for Disease Control and Prevention (CDC).

Radical Radiotherapy for Prostate Cancer Is the ‘Only Way To Go’

September 11, 2009

In 2008, approximately 186,000 American men were diagnosed with prostate cancer, resulting in about 28,600 deaths.[1] It is the most commonly diagnosed cancer, and second only to lung cancer as the leading cause of cancer death in men.

Optimal Therapy in Localized Prostate Cancer: An Unfolding Story

September 11, 2009

The optimal treatment for clinically localized prostate cancer is an ongoing subject of controversy.[1] As pointed out by Drs. Mirhadi and Sandler, no randomized trial has compared radical prostatectomy (RP) to radiation therapy (RT), and no study has definitively “proven” the superiority of one technique over the other. Therefore, we disagree with the author’s conclusion that RT “is the ‘only way to go’ when managing early-stage prostate cancer.”

Letrozole Superior to Tamoxifen After Breast Cancer Surgery, According to New Data

September 11, 2009

Newly published data in the August 20, 2009, issue of The New England Journal of Medicine affirm 5-year upfront use of letrozole (Femara) following surgery as an optimal treatment approach vs tamoxifen for postmenopausal women with early-stage breast cancer (hormone-receptor positive).

New Diagnostic Biomarker Test Shows Promise in Monitoring Ovarian Cancer

September 11, 2009

Ovarian malignancies are a leading cause of cancer death in women because they are usually detected in the late stages when the disease is incurable. Encouraging new research presented by Abbott at the American Association for Clinical Chemistry annual meeting,

Data Show Antitumor Activity With Sunitinib in Patients With Non–Small-Cell Lung Cancer and Irradiated Brain Metastases

September 11, 2009

Interim results from an open-label, phase II trial evaluating sunitinib malate (Sutent) showed progression free survival of 9.9 weeks in non–small-cell lung cancer (NSCLC) patients with irradiated brain metastases, which occur in more than one-quarter of all NSCLC patients. These data were presented at the 13th Annual World Conference of Lung Cancer, held July 31–­August 4, 2009, in San Francisco.

Study Links Virus to Some Cases of Common Skin Cancer

September 11, 2009

A virus discovered last year in a rare form of skin cancer has also been found in people with the second most common form of skin cancer among Americans, according to researchers at the Ohio State University Comprehensive Cancer Center–James Cancer Hospital and Solove Research Institute. Their findings were published online June 25, 2009, by the Journal of Investigative Dermatology.

Separated Cancer Patients Have Worse Survival Rates

September 11, 2009

Among unmarried cancer patients, those who are separated at the time of diagnosis do not live as long as widowed, divorced, and never married patients. That is the conclusion of a new study to be published in the November 1, 2009, issue of CANCER.

Risk of Pancreatic Cancer Linked to Variation in Gene That Determines Blood Type

September 11, 2009

Common variants of the gene that determines human blood type are associated with an increased risk of pancreatic cancer, according to a study by scientists at the National Cancer Institute (NCI) and colleagues from many universities and research institutions. The study, published online August 2, 2009, in Nature Genetics, is consistent with an observation first made more than 50 years ago.

Cervical Cancer Vaccine Proves Highly Effective in Recently Published Landmark Study

September 11, 2009

The final analysis of the largest efficacy trial of a cervical cancer vaccine was published July 25, 2009, in The Lancet. The study, involving 18,644 women, confirmed GlaxoSmithKline’s Cervarix is highly effective at protecting against the two most common cervical cancer–causing human papillomavirus (HPV) types, 16 and 18. The study also showed that the vaccine provides cross-protection against HPV types 31, 33, and 45, the three most common cancer-causing virus types beyond 16 and 18.

Racial Disparities in Breast Cancer Mortality Are Not Driven by Estrogen Receptor Status Alone

September 11, 2009

Black women who are diagnosed with breast cancer have a higher probability of dying from the disease than white women, regardless of their estrogen receptor status, according to research from the National Cancer Institute (NCI).

Radical Prostatectomy Reigns Supreme

September 14, 2009

Prostate cancer remains the most common solid organ malignancy diagnosed among men in the United States, with the American Cancer Society estimating that 1 in 6 men will be diagnosed with prostate cancer, and 1 in 35 will die of the disease.[1]

Localized Prostate Cancer: The Battle of Treatment Options Enters the Larger Arena

September 14, 2009

So here we go again with one more round in the battle of treatment options for localized prostate cancer. While more than 3 decades of such sparring has gotten us no closer to evidence-based conclusions, one might say that these matches do serve the purpose of bringing out the best and the worst of the therapeutic contenders.

Ginger

September 14, 2009

Native to Asia, ginger has many traditional uses. Current scientific evidence supports use of ginger for nausea and vomiting-clinical trials substantiate ginger’s effectiveness against nausea and vomiting associated with pregnancy, motion sickness, and postsurgery. A few studies of ginger for chemotherapy-induced nausea and vomiting yielded conflicting data, but a recent controlled trial demonstrates that ginger significantly reduces nausea and vomiting during the first day of chemotherapy.

Neoadjuvant Chemotherapy for Resectable Non–Small-Cell Lung Cancer

September 14, 2009

Lung cancer is the most common cancer diagnosed in men and women in the United States, and is the leading cause of cancer death.Over 160,000 individuals died as a result of lung cancer in 2008.[1] This number amounted to more than the number of deaths from colon, breast, and prostate cancers combined. The majority of lung cancer cases are non–small-cell lung cancer (NSCLC), and the poor outcomes are attributed to the high rate of metastases associated with this disease.

Preoperative Therapy for Early-Stage NSCLC: Opportunities and Challenges

September 14, 2009

The treatment of early-stage non–small-cell lung cancer (NSCLC) has undergone a paradigm shift recently with the addition of systemic therapy to local therapy. The use of cisplatin-based chemotherapy following surgery is now a standard approach for patients with stage II–IIIA disease.

Controversies in the Management of Localized Prostate Cancer: After the Rhetoric

September 11, 2009

For the September and October issues of ­ONCOLOGY, we have assembled a team of experts in the diagnosis and management of early-stage prostate cancer-ie, disease that has not clinically metastasized at first presentation, and which is theoretically curable-and have asked them to take a position on optimal patterns of care.