Long-term outcomes in patients with advanced melanoma who had initial stable disease with pembrolizumab in KEYNOTE-001 and KEYNOTE-006.
Long-term outcomes in patients with advanced melanoma who had initial stable disease with pembrolizumab in KEYNOTE-001 and KEYNOTE-006.
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DOI：
10.1016/j.ejca.2021.08.013
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发表时间：
2021-11
影响因子：
8.4
通讯作者：
Ribas, Antoni
中科院分区：
文献类型：
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作者：
Hamid, Omid;Robert, Caroline;Daud, Adil;Carlino, Matteo S.;Mitchell, Tara C.;Hersey, Peter;Schachter, Jacob;V. Long, Georgina;Hodi, F. Stephen;Wolchok, Jedd D.;Arance, Ana;Grob, Jean Jacques;Joshua, Anthony M.;Weber, Jeffrey S.;Mortier, Laurent;Jensen, Erin;Diede, Scott J.;Moreno, Blanca Homet;Ribas, Antoni
使用培溴利珠单抗的黑色素瘤和早期稳定型疾病(SD)患者预后不明朗。我们介绍了早期SD、部分缓解(PR)或完全缓解(CR)患者使用培溴利珠单抗后的长期结果分析。在Keynote-001和Keynote-006研究中接受培布罗利珠单抗治疗，并在12周或24周接受SD、PR或CR的患者包括在内。在12周分析的294例患者中，12周时有107例(36.4%)出现SD值，其中7例(6.5%)总体疗效最好，43例(40.2%)有PR值，57例(53.3%)有SD值。12周时CR、PR和SD患者的48个月总生存率(OS)分别为95.2%、73.0%和47.7%。在12周时，SD患者的48个月OS率为72.1%，随后发生反应的患者为72.1%；在12周时，PR患者的48个月OS率为75.0%，随后无反应或进展。在12周、24周前进展的SD患者中，36个月和48个月的OS率分别为11.6%和11.6%。在早期(12周)SD患者中，有相当比例(46.7%)的患者获得了后续的PR或CR。12周后出现SD和随后的CR/PR的患者的存活率与维持PR的患者相似。相反，12周及以后进展的SD患者的生存结果较差。这些发现可能指导早期达到SD的患者的治疗决定。ClinicalTrials.gov：NCT01295827(主题-001)；NCT01866319(主题-006)。
Patients with melanoma and early stable disease (SD) with pembrolizumab have unclear prognosis. We present post hoc analyses of long-term outcomes for patients with early SD, partial response (PR) or complete response (CR) with pembrolizumab. Patients who received pembrolizumab in the KEYNOTE-001 and KEYNOTE-006 studies and had SD, PR or CR at weeks 12 or 24 were included. Of 294 patients in the week 12 analysis, 107 (36.4%) had SD at week 12, of whom 7 (6.5%) had a best overall response of CR, 43 (40.2%) had PR and 57 (53.3%) had SD. Forty-eighte–month overall survival (OS) rates were 95.2%, 73.0% and 47.7%, respectively, for patients with CR, PR and SD at week 12. Similar results were observed in the 241 patients in the week 24 analysis. Forty-eight–month OS rates were 72.1% for patients with SD at week 12 followed by subsequent response and 75.0% for patients with PR at week 12 followed by no change in response or progression. Thirty-six–month and 48-month OS rates were 11.6% and not reached, respectively, for patients with SD at week 12 followed by progression before week 24. A substantial proportion of patients (46.7%) with early (week 12) SD with pembrolizumab achieved subsequent PR or CR. Patients with SD at week 12 and subsequent CR/PR had similar survival to those who maintained PR. In contrast, patients with SD at week 12 and subsequent progression had poor survival outcomes. These findings may guide treatment decisions for patients achieving early SD. Clinicaltrials.gov: NCT01295827 (KEYNOTE-001); NCT01866319 (KEYNOTE-006).
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影响因子：
50.5
作者：
Michielin, O.;van Akkooi, A. C. J.;Keilholz, U.
通讯作者：
Keilholz, U.
影响因子：
158.5
作者：
Robert, Caroline;Schachter, Jacob;Ribas, Antoni
通讯作者：
Ribas, Antoni
影响因子：
50.5
作者：
Lee, J. H.;Long, G. V.;Rizos, H.
通讯作者：
Rizos, H.
影响因子：
8.4
作者：
Garbe, Claus;Amaral, Teresa;Eggermont, Alexander M. M.
通讯作者：
Eggermont, Alexander M. M.
DOI：
10.1007/164_2017_17
发表时间：
2018-01-01
期刊：
MECHANISMS OF DRUG RESISTANCE IN CANCER THERAPY
影响因子：
--
作者：
Winder, Matthew;Viros, Amaya
通讯作者：
Viros, Amaya