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These are trying times at FDA. The agency has its hands full regulating pharmaceuticals produced in the United States: Now come the perils of globalization, which were dramatized by the recent heparin scandal. FDA contends that the adverse events and deaths associated with Baxter’s heparin products were caused by a contaminant deliberately introduced somewhere in China’s raw material supply. Chinese regulators quickly rebuffed FDA’s claim, asserting the problem was more likely caused by impurities introduced in the final US drug production process.

ORLANDO-In a phase III study, the investigational GnRH blocker degarelix (Ferring Pharmaceuticals) significantly reduced testosterone levels within 3 days in more than 96% of study patients, Laurence Klotz, MD, of the University of Toronto, reported at AUA 2008. The fast effect on testosterone levels was close to the immediate effect achieved with surgery, he said.

The authors have provided a concise review of stereotactic body radiosurgery (SBRS) in the treatment of mainly spinal/paraspinal metastases. This technique was primarily developed to treat spinal metastases in the reirradiation scenario given that treatment alternatives are limited for these patients and that-in the setting of advanced metastatic disease-surgical decompression is often not a suitable option.

The goal of palliative radiotherapy is to treat symptoms as rapidly and efficiently as possible, with the fewest side effects.[1] For many years, pain medication, radiotherapy, and surgery were the only tools available for the treatment of bone metastases. This has changed significantly over the past 15 years. New systemic agents, including bisphosphonates such as zoledronic acid (Reclast, Zometa), are available to prevent the development of new lesions, strengthen the bone, and improve symptoms. In addition, targeted treatments directed at achieving tumor ablation now include radiofrequency ablation and stereotactic body radiation therapy (SBRT).

SAN DIEGO-A new way of harnessing the body’s immune system to attack cancer cells has produced impressive preclinical and early clinical results, according to investigators interviewed at the 2008 American Association of Cancer Research annual meeting.

SAN DIEGO-Results were disappointing for an adjuvant immunotherapy approach to follicular non-Hodgkin’s lymphoma presented at the 2008 American Association for Cancer Research annual meeting (abstract LB-204).

CHICAGO-Baseline and second-round screening results from the Dutch-Belgian NELSON randomized CT lung screening trial show a low rate of positive tests: 2.6% on baseline screening and 1.8% on second-round screening. This could make low-dose CT screening “more acceptable to the public and suitable for mass screening programs,” said Rob J. van Klaveren, MD, PhD, of Erasmus Medical College, Rotterdam. Dr. van Klaveren reported the results at ASCO 2008 (abstract 1508).

CHICAGO-Median overall survival was 13 months among 52 patients who received radioactive microspheres (SIR-Spheres) for colorectal cancer liver metastases after chemotherapy failure. The phase II Italian SITILO study was reported at ASCO 2008 (abstract 4078).

I recently attended a healthcare conference titled “Leadership Summit on Evidence-Based Medicine” in Alexandria, Virginia. As you know, private industry, insurance companies, and the government are trying to develop an evidence-based medicine approach to help check the growth of healthcare expenditures.

Cancer patients should avoid the routine use of antioxidant supplements, such as vitamin A or beta-carotene, during radiation and chemotherapy because the supplements may reduce the anticancer benefits of therapy, Brian D. Lawenda, MD, of the Naval Medical Center San Diego, and colleagues concluded (J Natl Cancer Inst 100:773-783, 2008).

I am a urologist in southwest Florida. As I discussed with one of our radiation oncologists (we use 21st Century Oncology), there are no trials comparing proton and standard radiation, eg, IMRT. If such a trial were conducted, I suspect, at best, the cancer control rates would be equivalent, and the side effect profiles would also be similar. So what is all the fuss? 

In the fashion world, the word fabulous is tossed around like bolts of fabric at a blowout sale. In the cancer treatment world, fabulous is not a common interjection. And when fashion design student Hattie Saltonstall was confronted with the disease, she felt far from fabulous.

SAN DIEGO-More than 70% of advanced pancreatic patients derived some clinical benefit when treated with nanoparticle albumin-bound (nab) paclitaxel (Abraxane) and gemcitabine (Gemzar), in a phase I study reported at the 2008 American Association of Cancer Research meeting (abstract 4179).

SAN DIEGO-The body’s immune system can be directed to shrink tumors and prevent new ones in a variety of tumor types, according to investigators who described new cellular strategies and vaccines at the 2008 American Association for Cancer Research annual meeting.

GlaxoSmithKline (GSK) recently announced the submission of a new drug application to the US Food and Drug Administration for casopitant (Rezonic, Zunrisa), a novel, investigational NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) as an add-on therapy to the standard dual therapy of a 5-HT3 receptor antagonist, such as ondansetron (Zofran), and dexamethasone.

Researchers report that zoledronic acid (Zometa), a drug used to treat bone metastases and recently approved to treat osteoporosis, also lowers the risk of breast cancer recurrence in premenopausal patients with early-stage disease who have undergone surgery and are receiving ovarian suppression and hormone therapy. All women in this multicenter phase III trial had cancer that was estrogen-receptor– or progesterone-receptor–positive. The study was presented at the ASCO plenary session by lead author Michael Gant, md, professor of surgery at the Medical University of Vienna and the president of the Austrian Breast and Colorectal Cancer Study Group, or ABCSG (abstract LBA4).

Kanti R. Rai, MD, was born in the sun-drenched city of Jodhpur, India, during the waning years of British colonial rule. It was a beloved uncle who inspired his medical career-a free-spirited doctor who once took 8-year-old Kanti with him on house calls, riding atop a camel.

CHICAGO-The first clinical trial targeting stem cells in breast cancer is underway with the potential to revolutionize therapeutic targets, according to one of the pioneers in stem cell research. The stem cell hypothesis suggests that stem cells drive tumor invasion and metastases. “Cytotoxic chemotherapies have not been very effective for patients with advanced cancer,” Max Wicha, MD, told ONI. “I think the stem cell model is a potential explanation for why we haven’t done better in treating cancer.”

The truth about cancer pain hurts: Many oncology patients still suffer needlessly from unrelieved pain. This quandary is underscored by two disconcerting facts: We have the tools to alleviate upwards of 90% of cancer pain, and the problem was identified decades ago.

Screening ultrasound paired with mammography upped breast cancer detection in high-risk women with dense breasts, but the combination also caused a spike in the number of false positives, according to an update of the ACRIN 6666 trial. These results, along with other barriers, may render ultrasound less attractive than MRI in this patient population, commented a breast imaging expert.

SAN DIEGO-For women with ductal carcinoma in situ, it may be possible to deliver chemotherapy intraductally, thus providing a less toxic means of treatment, according to a feasibility study spearheaded by Susan Love, MD, of UCLA’s David Geffen School of Medicine. Dr. Love presented her research at the 2008 American Association for Cancer Research annual meeting (abstract LB-245).

Bone metastases are a common feature of many solid cancers, especially those originating from the prostate, breast, lung, kidney, melanoma, and other sites. Up to 80% of patients with these cancers will develop painful bony disease during the course of their disease.

GENEVA-Patients with NSCLC who received MAGE-A3 ASCI (antigen-specific cancer immunotherapeutic) had longer disease-free (HR 0.76) and overall survival (HR 0.81) than those who received placebo, although in this phase II study of 182 patients, the difference did not reach significance.

Preliminary results from two trials presented at the 44th Annual Meeting of ASCO in Chicago have consolidated the role of K-ras as a biomarker of nonresponse to cetuximab and panitumumab in metastatic colorectal cancer (mCRC). The phase III CRYSTAL and OPUS trials presented unplanned subgroup analyses of the correlation of K-ras status with response to therapy with first-line FOLFIRI or FOLFOX, respectively, with or without cetuximab in patients with mCRC. Both studies demonstrated a clear benefit with the addition of cetuximab in K-ras WT patients.

Boosting the intensity of ICE chemotherapy still can’t overcome the inherent chemoresistance of small-cell lung cancer, according to study results from the European Group for Blood and Marrow Transplantation.

In 2008, new CPT codes were published for smoking and tobacco use cessation. The codes can be found in the Preventive Medicine section under Evaluation and Management (E&M) services.

ROCKVILLE, Maryland-FDA has approved Progenics and Wyeth’s Relistor (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

With proton beam therapy centers proliferating in the United States, particularly for use in treating prostate cancer (see April 2008 ONI, page 1), the debate is heating up over the need for randomized clinical trials comparing proton beam therapy with conventional x-ray (photon) therapy in prostate and other cancers.

The recently opened Institute of Cancer “Octavio Frias de Oliveira,” in Brazil’s capital of São Paulo, is a state institution that will care for cancer patients from São Paulo as well as neighboring states, according to information provided by ONI Editorial Advisory Board member Paulo Hoff, MD, of The Medical School of the University of São Paulo.