Final results of a phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.
Hodgkin lymphoma
disease progression
interstitial lung disease
nivolumab
survival
Journal
Japanese journal of clinical oncology
ISSN: 1465-3621
Titre abrégé: Jpn J Clin Oncol
Pays: England
ID NLM: 0313225
Informations de publication
Date de publication:
22 Oct 2020
22 Oct 2020
Historique:
received:
23
04
2020
accepted:
18
06
2020
pubmed:
11
8
2020
medline:
13
11
2020
entrez:
11
8
2020
Statut:
ppublish
Résumé
Many patients with classical Hodgkin lymphoma show increased programmed death-1 ligand expression in Reed-Sternberg cells. We report the final results of a phase II study of nivolumab, an anti-programmed death-1 monoclonal antibody, in Japanese patients with relapsed or refractory classical Hodgkin lymphoma. Japanese patients with previously treated classical Hodgkin lymphoma (aged ≥ 20 years) were administered nivolumab (3 mg/kg on Day 1 of 14-day cycles) until progressive disease, an unacceptable adverse event, or another clinically relevant reason. Treatment could continue beyond progressive disease at the investigator's discretion in selected patients. Seventeen patients (median age: 63.0 years) were enrolled. The median follow-up was 38.8 months. One patient with non-Hodgkin lymphoma was excluded from efficacy analyses. The centrally assessed overall response rate in 16 classical Hodgkin lymphoma patients was 87.5% (95% confidence interval = 61.7-98.4%) and the disease control rate was 93.8% (95% confidence interval = 69.8-99.8%). The median (95% confidence interval) duration of response and progression-free survival were 8.5 (2.4-12.6) and 11.7 (1.8-42.3) months, respectively. The 3-year overall survival rate was 80.4% (95% confidence interval = 50.6-93.2%). Nivolumab was continued beyond progressive disease in seven patients; six were alive at the data cut-off. Adverse drug reactions occurred in all 17 patients with grades 3-4 adverse drug reactions in eight patients and no grade 5 adverse drug reactions. Pulmonary toxicities occurred in five patients; four of these occurred ≥17 months after starting nivolumab. Nivolumab is effective and tolerable in Japanese relapsed or refractory classical Hodgkin lymphoma patients. Continued monitoring may be necessary to detect late-onset pulmonary toxicities. JapicCTI-142755 (Japan Pharmaceutical Information Center).
Sections du résumé
BACKGROUND
BACKGROUND
Many patients with classical Hodgkin lymphoma show increased programmed death-1 ligand expression in Reed-Sternberg cells. We report the final results of a phase II study of nivolumab, an anti-programmed death-1 monoclonal antibody, in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.
METHODS
METHODS
Japanese patients with previously treated classical Hodgkin lymphoma (aged ≥ 20 years) were administered nivolumab (3 mg/kg on Day 1 of 14-day cycles) until progressive disease, an unacceptable adverse event, or another clinically relevant reason. Treatment could continue beyond progressive disease at the investigator's discretion in selected patients.
RESULTS
RESULTS
Seventeen patients (median age: 63.0 years) were enrolled. The median follow-up was 38.8 months. One patient with non-Hodgkin lymphoma was excluded from efficacy analyses. The centrally assessed overall response rate in 16 classical Hodgkin lymphoma patients was 87.5% (95% confidence interval = 61.7-98.4%) and the disease control rate was 93.8% (95% confidence interval = 69.8-99.8%). The median (95% confidence interval) duration of response and progression-free survival were 8.5 (2.4-12.6) and 11.7 (1.8-42.3) months, respectively. The 3-year overall survival rate was 80.4% (95% confidence interval = 50.6-93.2%). Nivolumab was continued beyond progressive disease in seven patients; six were alive at the data cut-off. Adverse drug reactions occurred in all 17 patients with grades 3-4 adverse drug reactions in eight patients and no grade 5 adverse drug reactions. Pulmonary toxicities occurred in five patients; four of these occurred ≥17 months after starting nivolumab.
CONCLUSION
CONCLUSIONS
Nivolumab is effective and tolerable in Japanese relapsed or refractory classical Hodgkin lymphoma patients. Continued monitoring may be necessary to detect late-onset pulmonary toxicities.
CLINICAL TRIAL REGISTRATION
BACKGROUND
JapicCTI-142755 (Japan Pharmaceutical Information Center).
Identifiants
pubmed: 32776097
pii: 5885451
doi: 10.1093/jjco/hyaa117
pmc: PMC7579338
doi:
Substances chimiques
Nivolumab
31YO63LBSN
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1265-1273Informations de copyright
© The Author(s) 2020. Published by Oxford University Press.
Références
J Clin Oncol. 2018 May 10;36(14):1428-1439
pubmed: 29584546
Cancer Sci. 2017 May;108(5):1007-1012
pubmed: 28267244
J Clin Med. 2018 Oct 15;7(10):
pubmed: 30326612
Int J Hematol. 2016 Aug;104(2):236-44
pubmed: 27086350
N Engl J Med. 2018 Jan 25;378(4):331-344
pubmed: 29224502
Curr Oncol Rep. 2019 Mar 27;21(5):39
pubmed: 30919161
JAMA Oncol. 2017 Nov 1;3(11):1511-1519
pubmed: 28662232
Clin Cancer Res. 2017 Apr 1;23(7):1623-1626
pubmed: 27881581
Mayo Clin Proc. 2015 Nov;90(11):1574-83
pubmed: 26541251
J Clin Oncol. 2007 Feb 10;25(5):579-86
pubmed: 17242396
J Clin Oncol. 2017 Jul 1;35(19):2125-2132
pubmed: 28441111
Bone Marrow Transplant. 2016 Jun;51(6):850-2
pubmed: 26828905
Lancet Oncol. 2018 Feb;19(2):229-239
pubmed: 29361469
Blood. 2019 Oct 3;134(14):1144-1153
pubmed: 31409671
N Engl J Med. 2015 Jan 22;372(4):311-9
pubmed: 25482239
Cancer J. 2018 Sep/Oct;24(5):249-253
pubmed: 30247261
Cancer J. 2016 Jan-Feb;22(1):23-6
pubmed: 26841013
Int J Hematol. 2017 Mar;105(3):383-386
pubmed: 27696192
Lancet Oncol. 2016 Sep;17(9):1283-94
pubmed: 27451390
J Clin Oncol. 2018 Apr 1;36(10):942-950
pubmed: 29394125
J Clin Oncol. 2016 Aug 10;34(23):2690-7
pubmed: 27069084
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593