MARC details
| 000 -LEADER |
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| fixed length control field |
02932nam a22003737a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
240723s20232023 xxu||||| |||| 00| 0 eng d |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
PMC10723519 [pmc] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
38105958 |
| 245 ## - TITLE STATEMENT |
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| Title |
Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study. |
| 251 ## - Source |
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| Source |
MedRxiv : the Preprint Server for Health Sciences. 2023 Dec 04 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
medRxiv. 2023 Dec 04 |
| 253 ## - Journal Name |
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| Journal name |
medRxiv : the preprint server for health sciences |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2023 Dec 04 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2024 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
epublish |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Medline status |
PubMed-not-MEDLINE |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Chemotherapy 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 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Indexing |
Automated |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
Washington Cancer Institute |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Associate Dean for Research Development |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
MedStar Health |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Preprint |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Chitalia, Ami |
| Institution Code |
WCI |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Gallagher, Christopher |
| Institution Code |
WCI |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Schlam, Ilana |
| Institution Code |
WCI |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Swain, Sandra M |
| Institution Code |
MSH |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Tiwari, Shruti |
| 790 ## - Authors |
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| All authors |
Lynce 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 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1101/2023.12.04.23297559">https://dx.doi.org/10.1101/2023.12.04.23297559</a> |
| Public note |
https://dx.doi.org/10.1101/2023.12.04.23297559 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
