Venous thromboembolism is a major risk for surgical patients during the perioperative period. Prevention of perioperative venous thromboembolism remains a critical component of surgical patient care. The risk for venous thromboembolism in surgical patients can be stratified by their risk factors and by the type of operation. Pharmacological prophylaxis for venous thromboembolism includes unfractionated heparin, low-molecular weight heparin, fondaparinux, warfarin, antiplatelet therapy, and direct thrombin inhibitors. Mechanical devices such as graduated compression stockings, intermittent pneumatic compressions, and venous foot pumps are also effective modalities for venous thromboembolism prophylaxis. The optimal preventive measure of venous thromboembolism should be based on the degree of risk for venous thromboembolism with the intensity of prophylaxis while balancing potential treatment benefits and risks in each individual patient. The epidemiology of venous thromboembolism, the methods for achieving venous thromboembolism prophylaxis, and the approach to institute venous thromboembolism prophylaxis in surgical patients undergoing various operative interventions are reviewed in this article.
BACKGROUNDThe purpose of the study was to determine, in a Phase I/II study, the efficacy and safety profile of thalidomide with interleukin‐2 (IL‐2) in patients with metastatic renal cell carcinoma (MRCC).METHODSFifteen patients (8 of whom were previously treated) enrolled in Phase I were treated with escalating doses of oral thalidomide (200–600 mg) and a fixed dose of IL‐2 (7 mIU/m2) by subcutaneous injection. A course was 6 weeks, with the exception of Course 1, which was 7 weeks. Thirty‐seven Phase II patients who had not received prior chemotherapy or immunotherapy for renal cell carcinoma (RCC) received an initial thalidomide dose of 200 mg at Week 0, which was escalated to 400 mg after 48 hours. Subcutaneous IL‐2 was administered at the same fixed daily dose used in Phase I.RESULTSFifty‐one of 52 Phase I/II patients were evaluable. Twenty‐seven patients (52%) experienced disease control, including 4 (8%) complete responses, 15 (29%) partial responses, and 8 (15%) cases of stable disease. Disease progression was observed in 24 patients (47%). Survival in the 2 phases ranged from 4 weeks to 45.2+ months. At the time of last follow‐up, 2 of 51 patients (4%) remained on maintenance thalidomide therapy and continue to be followed. Three of the 51 patients with CRs (6%) ceased thalidomide therapy at 23–25 months and have maintained their responses to date. One complete responder was lost to follow‐up. As of January 2005, 14 of 51 patients (27%) remained alive. Toxicities were mild to moderate, including Grade 1 to 2 somnolence, constipation, neuropathy, rash, flu‐like symptoms, fluid retention, hypotension, and hypothyroidism (according to version 2.0 of National Cancer Institute Common Toxicity Criteria). In addition, two patients experienced deep venous thrombosis.CONCLUSIONSThalidomide in combination with IL‐2 is tolerable and can produce durable, active responses in patients with MRCC. To evaluate the merits of thalidomide as a valuable agent against MRCC and to more fully determine the efficacy of thalidomide/IL‐2 combination therapy, the scrutiny of Phase III testing is required. Further development of thalidomide/IL‐2 combination therapy will be the focus of this group. Cancer 2006. © 2006 American Cancer Society.
Thalidomide plus IL-2 in combination with GM-CSF is tolerable and produces durable responses in patients with MRCC. GM-CSF, however, did not produce a response rate superior to that reported in previous studies of combination thalidomide/IL-2 therapy. Further development of the thalidomide plus IL-2 combination therapy will address patients who have received molecular-targeted agents, such as sunitinib and sorafenib, as first- or second-line therapy.
This study demonstrates antitumor activity of combination IFN-alpha/capecitabine/thalidomide in MRCC. The 20% PR rate was notable, as the patient population had advanced disease and inferior performance status. Treatment was generally well tolerated, and further research is warranted to explore the efficacy of this combination for treating MRCC.
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