{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T19:04:09Z","timestamp":1761764649125},"reference-count":37,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2006,2,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To investigate escalating doses of thalidomide compared with medroxyprogesterone in patients with metastatic renal cell carcinoma (RCC), who had either progressed after first-line immunotherapy or who were not suitable for immunotherapy. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Thalidomide was started at 100 mg\/d orally (PO) and escalated by 100 mg\/d every 2 weeks to the maximum dose of 400 mg\/d. Medroxyprogesterone was given at a fixed dose of 300 mg PO daily. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Sixty patients were entered (thalidomide:medroxyprogesterone = 29:31; median age, 59 [thalidomide], 60 [medroxyprogesterone]; No. of patients assessable for response, 22 [thalidomide], 26 [medroxyprogesterone]). In the thalidomide arm, there was no objective response seen. The best response was SD in three patients lasting 5+, 6+, and 12 months, respectively. All patients in the medroxyprogesterone arm progressed. There was no difference in overall survival between the two arms; median survival in the thalidomide arm was 8.2 months compared with 4.8 months in the medroxyprogesterone arm (P = .62). Hazard ratio was 0.88 (95% CI, 0.67 to 1.94). Median duration of treatment was 73 days (range, 14 to 364 days) in the thalidomide arm, and 84 days (range, 7 to 175 days) in the medroxyprogesterone arm. The high incidence of toxicity in the thalidomide arm, mainly somnolence, constipation, fatigue and paraesthesia, meant that only 30.8% of patients were able to tolerate the maximum dose of 400 mg\/d of treatment. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Thalidomide is not superior to medroxyprogesterone acetate in patients with metastatic RCC. Its risk\/benefit ratio does not favor its use in this patient population. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2005.03.7309","type":"journal-article","created":{"date-parts":[[2006,2,16]],"date-time":"2006-02-16T23:47:57Z","timestamp":1140133677000},"page":"898-903","source":"Crossref","is-referenced-by-count":16,"title":["Randomized Phase II Study Comparing Thalidomide With Medroxyprogesterone Acetate in Patients With Metastatic Renal Cell Carcinoma"],"prefix":"10.1200","volume":"24","author":[{"given":"Chooi P.","family":"Lee","sequence":"first","affiliation":[{"name":"From the Department of Medicine, Royal Marsden Hospital, and Department of Clinical Neurophysiology, Chelsea and Westminster Hospital, London; St James's University Hospital, Leeds; and Yorkshire Cancer Research Academic Unit of Oncology, Weston Park Hospital, Sheffield, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poulam M.","family":"Patel","sequence":"additional","affiliation":[{"name":"From the Department of Medicine, Royal Marsden Hospital, and Department of Clinical Neurophysiology, Chelsea and Westminster Hospital, London; 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