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Phase I study of bortezomib in combination with irinotecan in patients with relapsed/refractory high‐risk neuroblastoma

dc.contributor.authorMody, Rajen
dc.contributor.authorZhao, Lili
dc.contributor.authorYanik, Gregory Anthony
dc.contributor.authorOpipari, Valerie
dc.date.accessioned2017-10-05T18:16:15Z
dc.date.available2019-01-07T18:34:35Zen
dc.date.issued2017-11
dc.identifier.citationMody, Rajen; Zhao, Lili; Yanik, Gregory Anthony; Opipari, Valerie (2017). "Phase I study of bortezomib in combination with irinotecan in patients with relapsed/refractory high‐risk neuroblastoma." Pediatric Blood & Cancer 64(11): n/a-n/a.
dc.identifier.issn1545-5009
dc.identifier.issn1545-5017
dc.identifier.urihttps://hdl.handle.net/2027.42/138203
dc.description.abstractPurposePrognosis for relapsed/refractory high‐risk neuroblastoma (HR‐NBL) remains poor. Bortezomib, a proteasome inhibitor, has shown preclinical activity against NBL as a single agent and in combination with cytotoxic chemotherapy including irinotecan.Patients and MethodsEighteen HR‐NBL patients with primary refractory (n = 8) or relapsed (n = 10) disease were enrolled in a Phase I study using modified Time To Event Continual Reassessment Method. Bortezomib (1.2 mg/m2/day) was administered on days 1, 4, 8, and 11 intravenously (IV) and irinotecan was given IV on days 1–5 (35, 40, or 45 mg/m2/day, on dose levels [DL] 1–3, respectively). The maximum tolerated dose (MTD), dose‐limiting toxicity (DLT), and response rate were examined.ResultsEighteen NBL patients were evaluable for toxicity; 17 were evaluable for response assessment. A total of 142 courses were delivered (mean 8.2, median 2, range 1–48), with two patients receiving more than 40 courses of therapy. Two DLTs were reported, including a grade 4 thrombocytopenia (DL2) and a grade 3 irritability (DL3). MTD was estimated as DL3. Two of 17 (12%) evaluable patients showed objective responses (ORs) lasting more than 40 courses, including 1 partial remission and 1 complete remission. Four patients (23%) had prolonged stable disease (SD) lasting six or more courses, with a total of 35% study patients demonstrating clinical benefit in the form of prolonged OR or SD.ConclusionThe combination of bortezomib and irinotecan was well tolerated by patients with relapsed/refractory NBL with favorable toxicity profile. It also showed modest but promising clinical activity and merits further testing in Phase II studies.
dc.publisherWiley Periodicals, Inc.
dc.subject.otherrelapsed/refractory high‐risk neuroblastoma
dc.subject.otherproteasome inhibitor
dc.subject.otheririnotecan
dc.titlePhase I study of bortezomib in combination with irinotecan in patients with relapsed/refractory high‐risk neuroblastoma
dc.typeArticleen_US
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelPediatrics
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/138203/1/pbc26563.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/138203/2/pbc26563_am.pdf
dc.identifier.doi10.1002/pbc.26563
dc.identifier.sourcePediatric Blood & Cancer
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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