000			02932nam a22003737a 4500
008			240723s20232023 xxu||||| |||| 00| 0 eng d
024			_aPMC10723519 [pmc]
040			_aOvid MEDLINE(R)
099			_a38105958
245			_aAdjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study.
251			_aMedRxiv : the Preprint Server for Health Sciences. 2023 Dec 04
252			_amedRxiv. 2023 Dec 04
253			_amedRxiv : the preprint server for health sciences
260			_c2023
260			_p2023 Dec 04
260			_fFY2024
265			_sepublish
265			_tPubMed-not-MEDLINE
520			_aChemotherapy and immune checkpoint inhibitors have a role in the post-neoadjuvant setting in patients with triple-negative breast cancer (TNBC). However, the effects of nivolumab, a checkpoint inhibitor, capecitabine, or the combination in changing peripheral immunoscore (PIS) remains unclear. This open-label randomized phase II OXEL study (NCT03487666) aimed to assess the immunologic effects of nivolumab, capecitabine, or the combination in terms of the change in PIS (primary endpoint). Secondary endpoints include the presence of ctDNA, toxicity, clinical outcomes at 2-years and association of ctDNA and PIS with clinical outcomes. Forty-five women with TNBC and residual invasive disease after standard neoadjuvant chemotherapy were randomized to nivolumab, capecitabine, or the combination. Here we show that a combination of nivolumab plus capecitabine leads to a greater increase in PIS from baseline to week 6 (91%) compared with nivolumab (47%) or capecitabine (53%) alone (log-rank p = 0.08), meeting the pre-specified primary endpoint. In addition, the presence of circulating tumor DNA (ctDNA) was associated with disease recurrence, with no new safety signals in the combination arm. Our results provide efficacy and safety data on this combination in TNBC and support further development of PIS and ctDNA analyses to identify patients at high risk of recurrence.
546			_aEnglish
650			_zAutomated
651			_aWashington Cancer Institute
656			_aAssociate Dean for Research Development
656			_aMedStar Health
657			_aPreprint
700			_aChitalia, Ami _bWCI
700			_aGallagher, Christopher _bWCI
700			_aSchlam, Ilana _bWCI
700			_aSwain, Sandra M _bMSH
700			_aTiwari, Shruti
790			_aLynce F, Mainor C, Donahue RN, Geng X, Jones G, Schlam I, Wang H, Toney NJ, Jochems C, Schlom J, Zeck J, Gallagher C, Nanda R, Graham D, Stringer-Reasor EM, Denduluri N, Collins J, Chitalia A, Tiwari S, Nunes R, Kaltman R, Khoury K, Gatti-Mays M, Tarantino P, Tolaney SM, Swain SM, Pohlmann P, Parsons HA, Isaacs C
856			_uhttps://dx.doi.org/10.1101/2023.12.04.23297559 _zhttps://dx.doi.org/10.1101/2023.12.04.23297559
942			_cART _dArticle
999			_c14247 _d14247