The new prognostic score for unresectable or recurrent gastric cancer treated with nivolumab: A multi‐institutional cohort study

Sato, Shigeo; Oshima, Yoshiteru; Mu, Yu; Seto, Yasuyuki; Yamashita, Hiroharu; Hayano, Koichi; Kano, Masayuki; Ono, Hideki; Mitsumori, Norio; Fujisaki, Muneharu; Kunisaki, Chikara; Akiyama, Hirotoshi; Endo, Itaru; Ichikawa, Yasushi; Urakami, Hidejiro; Kubo, Hirokazu; Nagaoka, Sakae; Shimada, Hideaki

doi:10.1002/ags3.12489

Cited by 20 publications

(20 citation statements)

References 24 publications

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“…More than half of the studies were reported from the Far East (n = 15) (Ichiki et al, 2019;Jiang et al, 2020;Kitadai et al, 2020;Takada et al, 2020;Ke et al, 2021;Morimoto et al, 2021;Ng et al, 2021;Pu et al, 2021;Sato et al, 2021;Tokuyama et al, 2021;Chen et al, 2022;Kim et al, 2022;Li et al, 2022;Wu et al, 2022;Zhang et al, 2022), followed by Europe (n = 12) (Dercle et al, 2016;Bigot et al, 2017;Mezquita et al, 2018;Svaton et al, 2018;Cantini et al, 2020;Awada et al, 2021;Onn et al, 2021;Ruiz-Bañobre et al, 2021;Stares et al, 2021;Assié et al, 2022;Schneider et al, 2022;Stares et al, 2022). A 3.5 gr/dL albumin cut-off was most frequently used in the included studies (n = 20) (Dercle et al, 2016;Bigot et al, 2017;Mezquita et al, 2018;Formica et al, 2020;Jiang et al, 2020;Kitadai et al, 2020;Lee et al, 2020;Takada et al, 2020;Awada et al, 2021;Brown et al, 2021;Khaki et al, 2021;Morimoto et al, 2021;Ng et al, 2021;Onn et al, 2021;…”

Section: Study Characteristicsmentioning

confidence: 99%

The association between albumin levels and survival in patients treated with immune checkpoint inhibitors: A systematic review and meta-analysis

Güven

Şahin

Erul

et al. 2022

Front. Mol. Biosci.

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Background: The albumin levels may potentially be used as a prognostic biomarker in patients with cancertreated with immune checkpoint inhibitors (ICIs) due to its close relationship with nutritional and inflammatory status. However, the available data is limited with heterogeneous patient cohorts, sample sizes and variable cut-offs. Therefore, we conducted a systematic review and meta-analysis to evaluate the association between survival outcomes and albumin levels in patients treated with ICIs.Methods: We conducted a systematic review using the PubMed, Web of Science, and Embase databases to filter the published studies up to 1 June 2022. The meta-analyses were performed with the generic inverse-variance method with a random-effects model due to the high degree of heterogeneity. The primary outcome measure was hazard ratio (HR) with 95% confidence intervals (CI). The study protocol was registered with the PROSPERO registry (Registration Number: CRD42022337746).Results: Thirty-six studies encompassing 8406 cancer patients with advanced disease were included in the meta-analyses. Almost half of the studies were conducted in NSCLC cohorts (n = 15), and 3.5 gr/dL was the most frequently used albumin cut-off in the included studies (n = 20). Patients with lower albumin levels had a significantly increased risk of death (HR: 1.65, 95% CI: 1.52–1.80, p < 0.0001) than patients with higher albumin levels. Subgroup analyses for study location, sample size, tumor type and albumin cut-off were demonstrated consistent results. Furthermore, in the subgroup analysis of eight studies using albumin levels as a continuous prognostic factor, every 1 gr/dL decrease in albumin levels was associated with significantly increased risk of death by a factor of 10% (HR: 1.10, 95% CI: 1.05–1.16, p = 0.0002). Similar to analyses with overall survival, the patients with lower albumin levels had an increased risk of progression or death compared to patients with higher albumin levels (HR: 1.76, 95% CI: 1.40–2.21, p < 0.001).Conclusion: The available evidence demonstrates that albumin levels may be a prognostic biomarker in advanced cancer patients treated with ICIs. Further research is needed to delineate the role of albumin levels in patients treated with ICIs in the adjuvant setting, as well as the possible benefit of therapeutic approaches to improve hypoalbuminemia.

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Section: Study Characteristicsmentioning

confidence: 99%

The association between albumin levels and survival in patients treated with immune checkpoint inhibitors: A systematic review and meta-analysis

Güven

Şahin

Erul

et al. 2022

Front. Mol. Biosci.

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“…It is regularly assessed during the treatment of these patients; nevertheless, little is known about the impact of the nutritional status on the efficacy of immunotherapy. Moreover, only a few small studies have evaluated nutritional indexes in standard chemotherapy-treated mGOJ/GC patients, with these indexes being mostly based on inflammation parameters (i.e., CRP), all of them in pan-Asian cohorts (21)(22)(23)(24).…”

Section: Discussionmentioning

confidence: 99%

“…It combines the serum albumin, a proxy of nutritional status and a marker of stem-cell differentiation and apoptosis (25)(26)(27)(28), and the total lymphocyte count, that is known to be positively associated with response to chemotherapy and survival in mGOJ/GC (29,30). Hypoalbuminemia especially is commonly studied alone (21) or in combination with other lab values as neutrophil-to-lymphocyte ratio, CRP (31), serum lactate dehydrogenase (32) or total cholesterol level (33) as a negative predictor of treatment outcome in mGOJ/GC patients treated with anti-PD-1 agents. In our work, albumin level confirmed its prognostic value in univariate but not in multivariate analysis, while PNI retained significance value at P<0.05.…”

Section: Discussionmentioning

confidence: 99%

“…Several real-world data of the prognostic factors in mGOJ/GC patients treated with ICI have been published in the last years. Sato et al recently analyzed a large cohort of more than 200 Japanese heavily pretreated GC patients receiving Nivolumab ( 21 ). They found that C‐reactive protein (CRP) <0.5 mf/dL, immune‐related adverse events, albumin >3.5 g/dL, performance status 0, lymphocyte count >1,000/µL, and differentiated pathological type were independently associated with improved survival in multivariate analysis.…”

Section: Discussionmentioning

confidence: 99%

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Nutritional index for immune-checkpoint inhibitor in patients with metastatic gastro-esophageal junction/gastric cancer

Morelli¹,

Formica²,

Patrikidou

et al. 2022

J Gastrointest Oncol

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Background: Nutritional status is strongly associated to prognosis in mGOJ/GC patients. The aim of the present study was to develop an ICI-specific nutritional index (NI).Methods: Ten serum and anthropometric nutritional markers derived from blood tests or CT scans were analyzed at baseline in patients treated with second-line ICI and correlated with overall survival (OS). An ICI-specific NI (the NUTRIICI) was developed with its specificity assessed in an independent group of patients treated with standard second-line chemotherapy.Results: From June 2014 to December 2018, 57 mGOJ/GC patients (14 females, 43 males) with a median(m) age of 61 years (range 29-85) received ICI as second-line therapy (Pembrolizumab n=26, Nivolumab n=16, Avelumab n=15). Among the 10 analyzed variables, Onodera's prognostic NI (PNI) ≤33 and waist-to-hip (WHR) <1 were independent predictors of OS and used to build the NUTRIICI. Patients with both favorable factors (i.e., PNI >33 and WHR ≥1, comparator group) had a mOS of 18.0 vs. 6.7 months of patients with one unfavorable factor (either PNI ≤33 or WHR <1, Hazard Ratio, HR 3.06), vs. 1.3 months of patients with both unfavorable factors (HR 17.56), overall P<0.0001. In the independent group of patients treated with standard chemotherapy NUTRIICI was not associated with prognosis (P=0.57).Conclusions: NUTRIICI is the first ICI-specific NI for mOGJ/GC patients receiving second-line ICI. A validation in larger cohorts is strongly encouraged.

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“…Compared with other already established prognostic tools, the VIOLA score is favourable for several reasons. Major contributors to low feasibility in everyday practice of other scores are (i) the need for information that is not available at initial diagnosis, such as specific treatment information 22 , 23 , 26 , 27 ; (ii) the need for information that needs to be evaluated solely to calculate the score 28 , 29 , 30 ; (iii) complicated calculations to get appropriate score results. 31 Another important issue of existing scores is the fact that known key prognostic factors such as age and sex are often not included and, thus, represent major limitations.…”

Section: Discussionmentioning

confidence: 99%

Development of an alarm symptom-based risk prediction score for localized oesophagogastric adenocarcinoma (VIOLA score)

Puhr

Kuchling

et al. 2022

ESMO Open

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The new prognostic score for unresectable or recurrent gastric cancer treated with nivolumab: A multi‐institutional cohort study

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Cited by 20 publications

References 24 publications

The association between albumin levels and survival in patients treated with immune checkpoint inhibitors: A systematic review and meta-analysis

The association between albumin levels and survival in patients treated with immune checkpoint inhibitors: A systematic review and meta-analysis

Nutritional index for immune-checkpoint inhibitor in patients with metastatic gastro-esophageal junction/gastric cancer

Development of an alarm symptom-based risk prediction score for localized oesophagogastric adenocarcinoma (VIOLA score)

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