内容紹介
Summary
Background: Nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1(PD-1), was approved for use in the treatment of patients with advanced gastric or gastroesophageal junction cancer who had been previously treated with >_2 chemotherapy regimens in Japan. Methods: We investigated the efficacy of nivolumab therapy in 15 consecutive patients with advanced gastric cancer between October 2017 and December 2018 in our facility. Results: In our study, the 6-month overall survival rate was 67.7%, and the median survival time(MST)was 6.3 months. Immune-related adverse events(irAEs)occurred in the following patients: 2 patients, interstitial pneumonia(13%); 1 patient, myocarditis(6.7%); 1 patient, hypothyroidism(6.7%); and 1 patient, liver dysfunction(6.7%). Of the patients with an absolute lymphocyte count(ALC)of <_2,000/μL at baseline, 33%(4/12)experienced irAEs, while of those with an ALC of >2,000/μL, 67% had irAEs. The 6-month overall survival rate was better in patients with an ALC >1,600/μL(100%, 4/4)than in those with an ALC of <_1,600/μL(35%, 4/11). The 6-month overall survival rate of the patients with a neutrophil-to-lymphocyte ratio(NLR)of <4 was 63%, which was better than the 33% rate in those with an NLR of >_4. Conclusions: Nivolumab therapy was a safe and feasible treatment option. The cutoff values of ALC of 2,000/μL for irAEs and of ALC of 1,600/μL and NLR of 4 for prognosis might be effective surrogate markers in nivolumab treatment.
要旨
2017年9月にPD-1に対するモノクローナル抗体であるニボルマブが,高度進行・再発胃癌患者の免疫チェックポイント阻害剤として保険承認された。今回,2017年10月～2018年12月までに当院でニボルマブを使用した胃癌患者15例の治療成績を解析した。① 全患者の6か月生存率67.7%,生存期間中央値(MST)は6.3か月と良好であった。② 免疫関連副作用(irAE)は,間質性肺炎2例(13%),心筋炎1例(6.7%),甲状腺機能障害1例(6.7%),肝不全1例(6.7%)であった。投与前リンパ球数絶対値≦2,000/μL群のirAE発症率33%(4/12)に対し,>2,000/μL群は67%(2/3)と高発現であった。③ 治療効果に関して,投与前リンパ球数>1,600/μL群の6か月生存は100%(4/4)で,≦1,600/μL群の35%(4/11)に比し良好であった。好中球/リンパ球数比(NLR)4未満群の6か月生存率は63%で,NLR 4以上群の33%に比し予後は良好であった。
目次
Background: Nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1(PD-1), was approved for use in the treatment of patients with advanced gastric or gastroesophageal junction cancer who had been previously treated with >_2 chemotherapy regimens in Japan. Methods: We investigated the efficacy of nivolumab therapy in 15 consecutive patients with advanced gastric cancer between October 2017 and December 2018 in our facility. Results: In our study, the 6-month overall survival rate was 67.7%, and the median survival time(MST)was 6.3 months. Immune-related adverse events(irAEs)occurred in the following patients: 2 patients, interstitial pneumonia(13%); 1 patient, myocarditis(6.7%); 1 patient, hypothyroidism(6.7%); and 1 patient, liver dysfunction(6.7%). Of the patients with an absolute lymphocyte count(ALC)of <_2,000/μL at baseline, 33%(4/12)experienced irAEs, while of those with an ALC of >2,000/μL, 67% had irAEs. The 6-month overall survival rate was better in patients with an ALC >1,600/μL(100%, 4/4)than in those with an ALC of <_1,600/μL(35%, 4/11). The 6-month overall survival rate of the patients with a neutrophil-to-lymphocyte ratio(NLR)of <4 was 63%, which was better than the 33% rate in those with an NLR of >_4. Conclusions: Nivolumab therapy was a safe and feasible treatment option. The cutoff values of ALC of 2,000/μL for irAEs and of ALC of 1,600/μL and NLR of 4 for prognosis might be effective surrogate markers in nivolumab treatment.
要旨
2017年9月にPD-1に対するモノクローナル抗体であるニボルマブが,高度進行・再発胃癌患者の免疫チェックポイント阻害剤として保険承認された。今回,2017年10月～2018年12月までに当院でニボルマブを使用した胃癌患者15例の治療成績を解析した。① 全患者の6か月生存率67.7%,生存期間中央値(MST)は6.3か月と良好であった。② 免疫関連副作用(irAE)は,間質性肺炎2例(13%),心筋炎1例(6.7%),甲状腺機能障害1例(6.7%),肝不全1例(6.7%)であった。投与前リンパ球数絶対値≦2,000/μL群のirAE発症率33%(4/12)に対し,>2,000/μL群は67%(2/3)と高発現であった。③ 治療効果に関して,投与前リンパ球数>1,600/μL群の6か月生存は100%(4/4)で,≦1,600/μL群の35%(4/11)に比し良好であった。好中球/リンパ球数比(NLR)4未満群の6か月生存率は63%で,NLR 4以上群の33%に比し予後は良好であった。