Open AccessThe new prognostic score for unresectable or recurrent gastric cancer treated with nivolumab: A multi‐institutional cohort study
Author(s) -
Sato Sho,
Oshima Yoko,
Matsumoto Yu,
Seto Yasuyuki,
Yamashita Hiroharu,
Hayano Koichi,
Kano Masayuki,
Ono Hidetaka Andrew,
Mitsumori Norio,
Fujisaki Muneharu,
Kunisaki Chikara,
Akiyama Hirotoshi,
Endo Itaru,
Ichikawa Yasushi,
Urakami Hidejiro,
Kubo Hirokazu,
Nagaoka Sakae,
Shimada Hideaki
Publication year - 2021
Publication title -
annals of gastroenterological surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.308
H-Index - 15
ISSN - 2475-0328
DOI - 10.1002/ags3.12489
Subject(s) - hazard ratio , medicine , nivolumab , proportional hazards model , cancer , cohort , gastroenterology , retrospective cohort study , oncology , incidence (geometry) , immunotherapy , confidence interval , physics , optics
Background Real‐world outcomes of nivolumab treatment for gastric cancer and associated prognostic factors remain unclear; the present study aimed to evaluate both items. Methods A total of 278 consecutive patients treated with nivolumab for gastric cancer during 2017‐2019 were enrolled in this multi‐institutional retrospective cohort study. The impact of laboratory findings, immune‐related adverse events (irAEs), and clinicopathological factors on long‐term survival was evaluated using the Cox proportional hazards model. Results The response rate was 11.7% in patients with measurable lesions. The overall and progression‐free survival estimates were 6.77 and 2.53 months, respectively. The incidence of irAEs was 30.6% (6.8% for grade ≥3). There were no treatment‐related deaths. Multivariate analysis revealed that C‐reactive protein level of ≤0.5 mg/dL (hazard ratio = 0.476, P < .001), irAE occurrence (hazard ratio = 0.544, P < .001), albumin level of >3.5 g/dL (hazard ratio = 0.688, P = .045), performance status 0 (hazard ratio = 0.711, P = .028), lymphocyte count >1000/μL (hazard ratio = 0.686, P = .027), and differentiated histological type (hazard ratio = 0.740, P = .046) were independently associated with improved survival. The median survival of patients with four or more good prognostic factors was 18.3 months. Conclusion Nivolumab showed safety and survival benefits in patients with previously treated unresectable or recurrent gastric cancer. Low C‐reactive protein level, irAE occurrence, high albumin level, high lymphocyte count, and differentiated histological type may affect outcomes. The presence of four or more good prognostic factors may help identify likely long‐term survivors.