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    達拉非尼聯合曲美替尼治療III期黑色素瘤可長期生存獲益

    發布日期:2020年09月09日瀏覽量:文章來源:小柯機器人

    本期文章:《新英格蘭醫學雜志》:Online/在線發表

    瑞士蘇黎世大學醫院Reinhard Dummer團隊對達拉非尼聯合曲美替尼治療III期黑色素瘤進行了5年分析。2020年9月2日,該研究發表在《新英格蘭醫學雜志》上。

    在先前報道的3期臨床試驗的初步分析中,達拉非尼+曲美替尼輔助治療BRAF V600E或V600K突變的III期黑色素瘤切除患者12個月,無復發生存期比安慰劑更長。為了確認無復發生存獲益的穩定性,仍需長期數據。

    研究組招募了870例BRAF V600E或V600K突變的III期黑色素瘤切除患者,分別接受口服達拉非尼+曲美替尼或安慰劑治療,為期12個月。主要終點是無復發生存期。

    至少隨訪59個月后,第5年時,達拉非尼+曲美替尼組中仍存活且未復發的患者占52%,安慰劑組為36%;達拉非尼+曲美替尼組中仍存活且未發生遠端轉移的患者占65%,安慰劑組為54%。在隨訪期間,兩組間不良事件或嚴重不良事件的發生率無顯著差異。

    研究結果表明,達拉非尼+曲美替尼治療BRAF V600E或V600K突變的III期黑色素瘤患者,無復發或遠端轉移的生存期更長,且無明顯毒副作用。

    附:英文原文

    Author: Reinhard Dummer, M.D.,, Axel Hauschild, M.D.,, Mario Santinami, M.D.,, Victoria Atkinson, M.D.,, Mario Mandalà, M.D.,, John M. Kirkwood, M.D.,, Vanna Chiarion Sileni, M.D.,, James Larkin, M.D., Ph.D.,, Marta Nyakas, M.D.,, Caroline Dutriaux, M.D.,, Andrew Haydon, M.B., B.S., Ph.D.,, Caroline Robert, M.D., Ph.D.,, Laurent Mortier, M.D., Ph.D.,, Jacob Schachter, M.D.,, Thierry Lesimple, M.D.,, Ruth Plummer, M.D.,, Kohinoor Dasgupta, Ph.D.,, Eduard Gasal, M.D.,, Monique Tan, M.D.,, Georgina V. Long, M.B., B.S., Ph.D.,, and Dirk Schadendorf, M.D.

    Issue&Volume: 2020-09-02

    Abstract:

    Background

    In the previously reported primary analysis of this phase 3 trial, 12 months of adjuvant dabrafenib plus trametinib resulted in significantly longer relapse-free survival than placebo in patients with resected stage III melanoma with BRAF V600E or V600K mutations. To confirm the stability of the relapse-free survival benefit, longer-term data were needed.

    Methods

    We randomly assigned 870 patients who had resected stage III melanoma with BRAF V600E or V600K mutations to receive 12 months of oral dabrafenib (at a dose of 150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos. The primary end point was relapse-free survival. Here, we report 5-year results for relapse-free survival and survival without distant metastasis as the site of the first relapse. Overall survival was not analyzed, since the required number of events to trigger the final overall survival analysis had not been reached.

    Results

    The minimum duration of follow-up was 59 months (median patient follow-up, 60 months for dabrafenib plus trametinib and 58 months for placebo). At 5 years, the percentage of patients who were alive without relapse was 52% (95% confidence interval [CI], 48 to 58) with dabrafenib plus trametinib and 36% (95% CI, 32 to 41) with placebo (hazard ratio for relapse or death, 0.51; 95% CI, 0.42 to 0.61). The percentage of patients who were alive without distant metastasis was 65% (95% CI, 61 to 71) with dabrafenib plus trametinib and 54% (95% CI, 49 to 60) with placebo (hazard ratio for distant metastasis or death, 0.55; 95% CI, 0.44 to 0.70). No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.

    Conclusions

    In the 5-year follow-up of a phase 3 trial involving patients who had resected stage III melanoma with BRAF V600E or V600K mutations, 12 months of adjuvant therapy with dabrafenib plus trametinib resulted in a longer duration of survival without relapse or distant metastasis than placebo with no apparent long-term toxic effects.

    DOI: 10.1056/NEJMoa2005493

    Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2005493

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