Pharmacy & Therapeutics - November 2008 - (Page 667)

MEETING HIGHLIGHTS European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Walter Alexander European Society for Medical Oncology Identifying Benefited Subgroups and Promising Agents gene, however, progression-free survival was nearly doubled in the cetuximab/BSC group at 3.8 months, compared with 1.8 months in the BSC-alone group (P < 0.0001). For the primary endpoint of overall survival, again among patients with mutated K-ras genes, findings were similar: 4.5 months for cetuximab plus BSC and 4.6 months for BSC alone (P = 0.89). For wild-type K-ras, there was a significant advantage in survival when cetuximab was added, as follows: cetuximab plus BSC, 9.5 months; BSC alone, 4.8 months (P < 0.0001). Dr. Karapetis concluded: “K-ras is a marker that predicts who will benefit from cetuximab, and cetuximab does provide survival advantage, but only if the tumor has the wild-type K-ras.” For some of the 11,651 physicians and exhibitors attending the 33rd European Society for Medical Oncology (ESMO) Congress in Stockholm, Sweden, during September 2008, the paucity of positive blockbuster clinical trials was balanced by early-stage trials of therapies with exceptional promise and by identification of subgroups that derive particular benefit from treatment. Cetuximab (Erbitux) for Colorectal Cancer • Christos Karapetis, MD, Flinders University, Adelaide, Australia The presence of K-ras mutations provides a strong argument against the use of cetuximab (Erbitux, Bristol-Myers Squibb) in pretreated metastatic colorectal cancer, according to results of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG CO.17), presented as a late-breaking clinical trial by Dr. Karapetis. The K-ras gene plays an important role in cell-growth regulation and oncogenesis. Although anti– epidermal growth factor receptor (EGFR) therapies such as cetuximab block receptor activation, mutated K-ras genes remain “turned on” regardless of receptor inhibition, Dr. Karapetis said, suggesting a potential negative predictive value. Dr. Karapetis and colleagues looked at samples from 394 patients enrolled in the cetuximab phase 3 Eastern Cooperative Oncology Group (ECOG 0-2) trial who had been randomly assigned to receive, in a 1:1 ratio, intravenous (IV) cetuximab (400 mg/m2 in week 1, then 250 mg/m2 IV weekly) plus best supportive care (BSC) or BSC alone. Treatment was continued until disease progression or until unacceptable toxicity occurred. The primary endpoint was overall survival. For the secondary endpoint of progression-free survival, analysis showed identical median progression-free survival of 1.8 months for the two treatment groups among those with mutated K-ras genes. Among patients with the wild-type K-ras Mr. Alexander is a freelance medical writer living in New York City. Pazopanib in Non–Small-Cell Lung Cancer • Nasser Altorki, MD, Professor, Cardiothoracic Surgery, and Director, Division of Thoracic Surgery, New York Presbyterian–Weill Cornell Medical Center, New York, N.Y. • Jose Baselga, MD, Chief, Medical Oncology Service, Vall d’Hebron University Hospital and Céntro Medico Teknon, Barcelona, Spain A small early-phase trial of an investigative agent, pazopanib (GlaxoSmithKline), was selected for inclusion in the opening ESMO press conference because of the drug’s impressive single-agent activity with short-term treatment in early stage non–small-cell lung cancer (NSCLC). Pazopanib is an oral angiogenesis inhibitor and targets vascular EGFR (VEGFR), platelet-derived growth factor receptor (PDGFR), and c-kit. The study, stated lead investigator Dr. Altorki, enrolled 35 subjects with stage 1A-1B (33 patients, 94%) or stage 2A-2B NSCLC (two patients, 6%). The patients had received no cytotoxic, anti-angiogenic, or investigative therapy in the previous six months. The primary objective was to evaluate reductions in tumor volume after pazopanib treatment, as measured by high-resolution computed tomography. Each subject received pazopanib 800 mg preoperatively once daily for two to six weeks, followed by CT scanning and blood plasma evaluation. Surgical resection and biopsy followed. Reporting on the primary endpoint, Dr. Altorki said that after a median of 16 days of treatment, 30 patients (85.7%) Vol. 33 No. 11 • November 2008 • P&T® 667

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Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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