File Download
  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study

TitleDaratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study
Authors
KeywordsDaratumumab
NK/T-cell lymphoma
CD38
Issue Date2021
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.jhoonline.org
Citation
Journal of Hematology & Oncology, 2021, v. 14 n. 1, p. article no. 25 How to Cite?
AbstractBackground: Natural killer/T-cell lymphoma (NKTCL) is a disease with limited treatment options and poor outcomes. Daratumumab monotherapy demonstrated clinical activity in a single-patient case report. We present data from the primary analysis of a phase 2 study of daratumumab monotherapy in relapsed or refractory (R/R) NKTCL. Methods: This phase 2 study with Simon’s two-stage design evaluated daratumumab in patients with histologically confirmed extranodal NKTCL, nasal type, per WHO classification that was refractory to or relapsed after ≥ 1 line of chemotherapy, who were not candidates for other treatment modalities. All patients received daratumumab 16 mg/kg intravenously once weekly for Cycles 1 and 2, every other week for Cycles 3 through 6, and every 4 weeks thereafter until progression or unacceptable toxicity; all cycles were 28 days. The primary end point was objective response rate (ORR) based on blinded independent central review per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin Lymphoma (Lugano classification). Results: In total, 32 Asian patients received daratumumab. The ORR was 25.0% (95% confidence interval [CI] 11.5–43.4); all 8 responders had a partial response; and the median duration of response was 55.0 days (95% CI 29–339). At 10.2 months of median follow-up, median progression-free survival (PFS) was 53.0 days (95% CI 43–106); the 4-month PFS rate was 13.0%. Median overall survival (OS) was 141.0 days (95% CI 94–438); the 6-month OS rate was 42.9%. Nineteen (59.4%) patients had grade 3/4 treatment-emergent adverse events (TEAEs); the most common was thrombocytopenia (25.0%; n = 8). TEAEs leading to death occurred in 4 patients (death, respiratory failure, septic shock, and pneumonia); all were unrelated to daratumumab. Conclusions: In patients with R/R NKTCL, daratumumab monotherapy was well tolerated with no new safety concerns and achieved an ORR of 25.0%. However, no patients achieved complete response, and duration of response was short. Trial registration ClinicalTrials.gov, NCT02927925. Registered 7 October 2016.
Persistent Identifierhttp://hdl.handle.net/10722/308303
ISSN
2023 Impact Factor: 29.5
2023 SCImago Journal Rankings: 7.522
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorHuang, H-
dc.contributor.authorZhu, J-
dc.contributor.authorYao, M-
dc.contributor.authorKim, TM-
dc.contributor.authorYoon, DH-
dc.contributor.authorCho, SG-
dc.contributor.authorEom, HS-
dc.contributor.authorLim, ST-
dc.contributor.authorYeh, SP-
dc.contributor.authorSong, Y-
dc.contributor.authorKwong, YL-
dc.contributor.authorKim, JS-
dc.contributor.authorJin, J-
dc.contributor.authorShi, Y-
dc.contributor.authorKim, H-
dc.contributor.authorQing, M-
dc.contributor.authorZhou, T-
dc.contributor.authorGao, G-
dc.contributor.authorDong, Z-
dc.contributor.authorQi, M-
dc.contributor.authorKim, WS-
dc.date.accessioned2021-11-12T13:45:22Z-
dc.date.available2021-11-12T13:45:22Z-
dc.date.issued2021-
dc.identifier.citationJournal of Hematology & Oncology, 2021, v. 14 n. 1, p. article no. 25-
dc.identifier.issn1756-8722-
dc.identifier.urihttp://hdl.handle.net/10722/308303-
dc.description.abstractBackground: Natural killer/T-cell lymphoma (NKTCL) is a disease with limited treatment options and poor outcomes. Daratumumab monotherapy demonstrated clinical activity in a single-patient case report. We present data from the primary analysis of a phase 2 study of daratumumab monotherapy in relapsed or refractory (R/R) NKTCL. Methods: This phase 2 study with Simon’s two-stage design evaluated daratumumab in patients with histologically confirmed extranodal NKTCL, nasal type, per WHO classification that was refractory to or relapsed after ≥ 1 line of chemotherapy, who were not candidates for other treatment modalities. All patients received daratumumab 16 mg/kg intravenously once weekly for Cycles 1 and 2, every other week for Cycles 3 through 6, and every 4 weeks thereafter until progression or unacceptable toxicity; all cycles were 28 days. The primary end point was objective response rate (ORR) based on blinded independent central review per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin Lymphoma (Lugano classification). Results: In total, 32 Asian patients received daratumumab. The ORR was 25.0% (95% confidence interval [CI] 11.5–43.4); all 8 responders had a partial response; and the median duration of response was 55.0 days (95% CI 29–339). At 10.2 months of median follow-up, median progression-free survival (PFS) was 53.0 days (95% CI 43–106); the 4-month PFS rate was 13.0%. Median overall survival (OS) was 141.0 days (95% CI 94–438); the 6-month OS rate was 42.9%. Nineteen (59.4%) patients had grade 3/4 treatment-emergent adverse events (TEAEs); the most common was thrombocytopenia (25.0%; n = 8). TEAEs leading to death occurred in 4 patients (death, respiratory failure, septic shock, and pneumonia); all were unrelated to daratumumab. Conclusions: In patients with R/R NKTCL, daratumumab monotherapy was well tolerated with no new safety concerns and achieved an ORR of 25.0%. However, no patients achieved complete response, and duration of response was short. Trial registration ClinicalTrials.gov, NCT02927925. Registered 7 October 2016.-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.jhoonline.org-
dc.relation.ispartofJournal of Hematology & Oncology-
dc.rightsJournal of Hematology & Oncology. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectDaratumumab-
dc.subjectNK/T-cell lymphoma-
dc.subjectCD38-
dc.titleDaratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study-
dc.typeArticle-
dc.identifier.emailKwong, YL: ylkwong@hkucc.hku.hk-
dc.identifier.authorityKwong, YL=rp00358-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s13045-020-01020-y-
dc.identifier.pmid33588922-
dc.identifier.pmcidPMC7885403-
dc.identifier.scopuseid_2-s2.0-85101436928-
dc.identifier.hkuros329965-
dc.identifier.volume14-
dc.identifier.issue1-
dc.identifier.spagearticle no. 25-
dc.identifier.epagearticle no. 25-
dc.identifier.isiWOS:000618196800001-
dc.publisher.placeUnited Kingdom-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats