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| |  Interleukin-2 Plus Sorafenib Combination Improves Disease Control Over Sorafenib Alone in Advanced Renal Cell Carcinoma: Presented at EMUC By Chris Berrie BARCELONA, Spain -- November 30, 2009 – The combination of interleukin-2 (IL-2) with sorafenib shows improved disease control over sorafenib alone for patients with advanced renal cell carcinoma (RCC), and is a safe and feasible treatment researchers stated at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). Principal investigator Giuseppe Procopio, MD, Fondazione IRCCS National Tumour Institute, Milan, Italy, presented a multicentre, randomised, prospective study here on November 28 on behalf of the Italian Trials in Medical Oncology Study group to demonstrate the activity and safety of the sorafenib plus IL-2 combination versus sorafenib alone. “The eligibility criteria of this study were the presence of measurable disease without brain metastases, all the histotypes, and all [Memorial Sloan-Kettering Cancer Center] risk groups,” explained Dr. Procopio. Patients were all previously untreated, and had an Eastern Cooperative Oncology Group performance status of 0 to 2. The 128 patients enrolled were randomised to either oral sorafenib alone (n = 63; 400 mg, twice daily, continuously) or in combination with IL-2 (n = 65). After enrolment of the first 40 patients, the initial IL-2 dosing of 4.5 MIU subcutaneously 5 times per week for 6 consecutive weeks every 8 weeks was reduced to 3 MIU subcutaneously 5 times per week for 2 consecutive weeks every 4 weeks. Treatment continued until either progressive disease or unacceptable toxicity. Patient characteristics and prognostic factors were well balanced across the treatment arms, and the primary endpoint of median progression-free survival demonstrated a benefit for the combination treatment over sorafenib alone -- 38 versus 30 weeks, respectively, although this did not reach statistical significance (P = .216). Similarly, combination treatment provided patient benefits for the secondary endpoint of response rate (all partial responses, 23% vs 10%) and for overall disease control (81% vs 74%). Tumour shrinkage was also favoured in the combination arm over sorafenib alone: 52% versus 34%. The most common adverse events were asthenia, hand-foot syndrome, hypertension, fever, diarrhoea, mucositis, and rash. “Usually the adverse events were low or moderate in severity,” noted Dr. Procopio, “and in the combination arm, there was improvement in terms of asthenia grade 3 and fever.” Finally, Dr. Procopio noted that his team is performing additional analyses of several subgroups within these data to identify any patient subgroups that might benefit better from the addition of IL-2 to standard sorafenib treatment. EMUC 2009 was jointly organised by the United European Gastroenterology Federation (UEGF) and the World Gastroenterology Organisation (WGO), together with the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG). Funding for this study was sponsored by Bayer Pharmaceuticals. [Presentation title: A Randomised, Prospective, Phase II Study With Sorafenib (So) and Interleukin-2 (IL-2) Versus So Alone as First-Line Treatment in Advanced Renal Cell Cancer (RCC): ROSORC Trial. Abstract P008]
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