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Capecitabine plus temozolomide in patients with grade 3 unresectable or metastatic gastroenteropancreatic neuroendocrine neoplasms with Ki-67 index < 55%: single-arm phase II study

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Abstract
Background: Grade 3 neuroendocrine neoplasms (NENs) of gastroenteropancreatic (GEP) origin with Ki-67 indices <55% do not respond well to platinum-based chemotherapy. The combination of capecitabine and temozolomide (CAPTEM) has shown favorable responses in grade 1-2 NENs, but has rarely been studied in patients with grade 3 NENs.

Patients and methods: This open-label, single-arm phase II trial included patients with unresectable or metastatic grade 3 NENs of GEP origin with Ki-67 indices <55% enrolled between June 2017 and July 2020. Patients received oral capecitabine 750 mg/m(2) twice daily on days 1 to 14 and oral temozolomide 200 mg/m(2) once daily on days 10 to 14 every 4 weeks. Histologic findings were centrally reviewed after the completion of enrollment. The primary endpoint was overall response rate, and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events.

Results: Of the 30 patients included in the full analysis set, 1 (3.3%) achieved complete response, 8 (26.7%) had partial responses, and 14 (46.7%) had stable disease, making the overall response rate 30.0%. At a median follow-up of 19.2 months, the median PFS was 5.9 months and the median OS was not reached. Patients with well-differentiated NENs showed significantly better median PFS (9.3 months versus 3.5 months, P = 0.005) and median OS (not reached versus 6.2 months, P = 0.004) than patients with poorly differentiated tumors. Expression of O-6-methyl-guanine methyltransferase protein did not correlate with clinical outcomes. The most common grade 3-4 adverse events were thrombocytopenia (10%), anemia (6.7%), and nausea (6.7%).

Conclusions: CAPTEM was effective and well tolerated in patients with grade 3 GEP-NENs with Ki-67 indices <55%, with superior efficacy outcomes compared with the historical controls receiving platinum- based chemotherapy.
Author(s)
김규표김용일류백렬류진숙신진호유창훈정재호정혜현홍승모
Issued Date
2021
Type
Article
Keyword
capecitabineMGMTneuroendocrine tumorOriginaltemozolomide
DOI
10.1016/j.esmoop.2021.100119
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7967
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8099746&amp;context=PC&amp;vid=ULSAN&amp;lang=ko_KR&amp;search_scope=default_scope&amp;adaptor=primo_central_multiple_fe&amp;tab=default_tab&amp;query=any,contains,Capecitabine%20plus%20temozolomide%20in%20patients%20with%20grade%203%20unresectable%20or%20metastatic%20gastroenteropancreatic%20neuroendocrine%20neoplasms%20with%20Ki-67%20index%20%3C%2055%25:%20single-arm%20phase%20II%20study&amp;offset=0&amp;pcAvailability=true
Publisher
ESMO OPEN
Location
스위스
Language
영어
ISSN
2059-7029
Citation Volume
6
Citation Number
3
Citation Start Page
0
Citation End Page
0
Appears in Collections:
Medicine > Medicine
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