https://scholars.lib.ntu.edu.tw/handle/123456789/538778
標題: | Randomized phase II trial of thalidomide alone versus thalidomide plus interferon alpha in patients with refractory multiple myeloma | 作者: | Chiou T.-J. Wang T.-H. Chao T.-Y. Lin S.-F. JIH-LUH TANG Chen T.-Y. Chang M.-C. Hsueh E.-J. Chen P.-M. |
關鍵字: | Adverse effect; Interferon-alpha; Paraprotein response; Refractory multiple myeloma; Thalidomide | 公開日期: | 2007 | 卷: | 25 | 期: | 3 | 起(迄)頁: | 140-147 | 來源出版物: | Cancer Investigation | 摘要: | The potential synergistic anti-myeloma effect for thalidomide combining with interferon alpha was not yet clear clinically. From March 2001 to January 2004, a total of 28 heavily pretreated multiple myleoma (MM) patients were enrolled in this open-labeled, randomized Phase II study. Patients with refractory MM were randomized to receive either thalidomide alone (200 mg/day up to the maximum dose 800 mg/day, arm B) or the combination of thalidomide and interferon alpha (3 MIU/m2 subcutaneous injection 3 times weekly, arm A). The objective of this study was to compare the safety and efficacy of thalidomide alone to combined regimen. The patients' characteristics were similar between the 2 arms. However, the average treatment duration was significantly longer in the arm B than the arm A (236 days versus 101 days, p = 0.029). Serum levels of paraprotein decline ? 25 percent were obtained in 6 of 12 patients (50.0 percent) treated with arm B and 3 of the 16 patients (18.8 percent) treated with arm A. The estimated time to event was 7.9 months (95 percent confidence interval [95%CI], 0.5-15.4) for arm B and 1.5 months (95%CI, 0.0-3.4) for arm A (log-rank test, p = 0.0193). The major adverse events in both arms consisted of neutropenia, anemia, thrombocytopenia, constipation, somnolence, and skin rash. Our study showed that thalidomide alone was effective and tolerated in patients with relapsed or refractory MM. The thalidomide combined with interferon alpha resulted in a lower frequency of paraprotein response, shorter treatment-duration and 25 percent of patients' refusing rate. It may be concluded that the combined regimen is not well tolerated in our patients and needed to be further evaluated in the future. Copyright ? Informa Healthcare. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-34347266571&doi=10.1080%2f07357900701208808&partnerID=40&md5=1a04306d4013e2e9f85f9304fc55f46a https://scholars.lib.ntu.edu.tw/handle/123456789/538778 |
ISSN: | 0735-7907 | DOI: | 10.1080/07357900701208808 | SDG/關鍵字: | alpha2b interferon; paraprotein; thado; thalidomide; unclassified drug; alpha2b interferon; antineoplastic agent; paraprotein; thalidomide; adult; aged; anemia; article; blurred vision; bradycardia; cancer combination chemotherapy; cancer relapse; clinical article; clinical trial; combination chemotherapy; confidence interval; constipation; controlled clinical trial; controlled study; dizziness; drug dose increase; drug dose reduction; drug efficacy; drug eruption; drug safety; drug tolerability; drug withdrawal; edema; fatigue; female; fever; flu like syndrome; fluid retention; human; infection; kidney dysfunction; leukopenia; log rank test; malaise; male; monotherapy; multicenter study; multiple myeloma; nausea and vomiting; neutropenia; open study; optimal drug dose; paresthesia; patient compliance; phase 2 clinical trial; priority journal; protein blood level; randomized controlled trial; side effect; somnolence; thrombocytopenia; treatment duration; treatment refusal; treatment response; weakness; blood; comparative study; drug administration; Kaplan Meier method; metabolism; middle aged; mortality; subcutaneous drug administration; Taiwan; time; treatment failure; treatment outcome; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Female; Humans; Injections, Subcutaneous; Interferon Alfa-2b; Kaplan-Meiers Estimate; Male; Middle Aged; Multiple Myeloma; Myeloma Proteins; Paraproteins; Taiwan; Thalidomide; Time Factors; Treatment Failure; Treatment Outcome; Treatment Refusal |
顯示於: | 醫學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。