In:
Cancer Science, Wiley, Vol. 110, No. 6 ( 2019-06), p. 1995-2003
Abstract:
The immune checkpoint inhibitor nivolumab inhibits the programmed death 1 receptor and suppresses the immune resistance of cancer cells. This is a long‐term follow up of a single‐arm, open‐label, multicenter, phase II study of nivolumab in untreated Japanese patients with stage III / IV or recurrent melanoma. In addition, a post–hoc subgroup analysis stratified by melanoma types was performed. Nivolumab was administered intravenously at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the overall response rate ( ORR ), and secondary endpoints included overall survival ( OS ), progression‐free survival ( PFS ), best overall response, the disease control rate and change in tumor diameter. Safety was assessed by recording treatment‐related adverse events ( TRAE ), including select immune‐related adverse events. Of the 24 patients initially included in the primary phase II study, 10 survived for over 3 years (41.7%). The ORR was 34.8% (90% confidence interval [ CI ]: 20.8, 51.9) for all patients. When analyzing by melanoma type, the ORR was 66.7% (90% CI : 34.7, 88.3) for superficial spreading, 33.3% (90% CI : 11.7, 65.3) for mucosal, and 28.6% (90% CI : 10.0, 59.1) for acral lentiginous tumors. The median OS was 32.9 months, the 3‐year OS rate was 43.5%, and the 3‐year PFS rate was 17.2%. A long‐term response was observed in all the tumor types. The most common TRAE included skin toxicity (45.8%) and endocrine disorders (29.2%). This study demonstrated the long‐term efficacy and tolerability of nivolumab in patients with advanced or recurrent melanoma, irrespective of melanoma type.
Type of Medium:
Online Resource
ISSN:
1347-9032
,
1349-7006
DOI:
10.1111/cas.2019.110.issue-6
Language:
English
Publisher:
Wiley
Publication Date:
2019
detail.hit.zdb_id:
2115647-5
detail.hit.zdb_id:
2111204-6
