The US Food and Drug Administration (FDA) has granted accelerated approval for pralatrexate injection (Folotyn) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), which comprises a biologically diverse group of aggressive blood cancers.
The US Food and Drug Administration (FDA) recently cleared the OVA1 Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiologic test results fail to indicate malignancy.
Hologic, Inc, recently announced the US Food and Drug Administration (FDA) cleared the Company’s 510K application for the MammoSite ML radiation therapy system. With its multilumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.
Breast cancer is the most common newly diagnosed malignancy among American women. In 2008, an estimated 182,460 new cases of invasive breast cancer, and an additional 67,770 cases of in situ cancer were diagnosed. Approximately 40,480 women will die from breast cancer each year.
Chadha et al are to be commended for their excellent review of repeat breast-conservation therapy after isolated in-breast local failures. We will briefly review several important points already made by the study authors.
Breast-conservation therapy (BCT) is a well-characterized treatment for early-stage breast cancer that has been studied for decades. The risk of local recurrence following BCT for invasive breast cancer ranges from 8.8% to 14.3% at 20 years.
Repeat lumpectomy and retreatment radiotherapy following ipsilateral breast tumor recurrence (IBTR) by either external-beam irradiation or brachytherapy in lieu of salvage mastectomy is an area of significant recent clinical interest. Multiple authors have reported their results, with encouraging numbers of patients avoiding mastectomy.[1‑4]
The comparison of brachytherapy and surgery may be done on several levels. This review focuses the comparison on toxicity, the “soft” endpoints of biochemical relapse-free survival and clinical relapse-free survival, and the “hard” endpoint of prostate cancer–specific mortality.
Standard treatment options for prostate cancer patients include surveillance, surgery, external-beam radiotherapy, brachytherapy, the combination of external-beam and brachytherapy, and the combination of radiotheraputic modalities with hormonal therapy, for appropriately chosen patients.
In this review, we summarize contemporary data pertaining to active surveillance, a safe and appropriate strategy for select patients with low-risk cancer characteristics who undergo monitoring at regular intervals.
Active surveillance is becoming a very reasonable and appropriate “treatment” strategy for men with low-risk localized prostate cancer, as Large and Eggener eloquently describe in this review article. It is important to recognize that active surveillance is not what was once referred to as “watchful waiting,” which I believe many patients interpret as “watching and waiting to die.
Sorafenib Plus Chemotherapy Significantly Prolongs Progression-Free Survival in Advanced Breast Cancer
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc, announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled phase II trial showing that sorafenib (Nexavar) tablets in combination with the oral chemotherapeutic agent, capecitabine (Xeloda), significantly extended progression-free survival in patients with advanced breast cancer.
Removal of the primary breast tumor in women whose cancer has already metastasized can have a significant effect on their survival, Dutch researchers have found. Dr. Jetske Ruiterkamp, a surgical resident from the Jeroen Bosch Hospital, Den Bosch, The Netherlands, working under the supervision of Dr. Miranda Ernst, told Europe’s largest cancer congress, ECCO 15/ESMO 34, in Berlin that her research meant that women who were diagnosed at a late stage of the disease could expect to survive longer.
Pfizer Inc announced new, longer-term data from the Intergroup Exemestane Study (IES) showing that women who switched to exemestane (Aromasin) after taking tamoxifen for 2 to 3 years experienced a significant reduction (18%) in the risk of disease-free survival (DFS) events (hazard ratio [HR] = 0.82; 95% confidence interval [CI] = 0.73–0.92; P = .0009), compared to women who continued on tamoxifen for a full 5 years of treatment.
Data from the Austrian Breast and Colorectal Cancer Study Group (ABCSG)-24 study presented at the joint 15th ECCO and 34th ESMO congress in Berlin, show that adding capecitabine (Xeloda) to anthracycline- and taxane-containing regimens prior to surgery completely eradicated the tumor in 24% of women with HER2-positive or HER2-negative early breast cancer. This is an impressive finding since the proportion of women achieving total tumor eradication with standard chemotherapy for HER2-positive or HER2-negative early breast cancer is less than 20% (range = 6%–18%).
Despite the widespread perception that dietary supplements are safe, few products have been subjected to rigorous research. The potential risks of dietary supplement use are not known. A powdered blend of fruits, vegetables, and grains, Juice Plus is aggressively promoted to cancer patients based on claims of antioxidant effects. Current research evidence indicates that the potential risks of antioxidants outweigh the benefits in the context of cancer treatment. Patients should discuss antioxidant supplementation with their physicians.
The Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration voted unanimously in support of the approval of GlaxoSmithKline’s pazopanib (Votrient), an investigational oral agent. Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma.