Title: Efficacy and Safety of Nivolumab in Advanced Gastric and Gastroesophageal Junction
Cancer: A Meta-Analysis of Randomized Controlled Trials
Version: 1 Date: 29 Aug 2024
Reviewer's report:
This manuscript is reporting a meta-analysis of the latest studies testing Nivolumab in advanced
gastric cancer.
This study is gathering trials with Nivolumab monotherapy and Nivolumab combined with
chemotherapy which are different settings, leading to subgroup analyses. These phase III trials
which led to approval and answered the question about the interest of Nivolumab in advanced
gastric cancer. The main interest of the study is to make a focus on Nivolumab monotherapy.
The study is rigorously conducted, and the results are well-presented.
One main limit is that this study includes both Janjigian 2024 and Janjigian 2021. Janjigian 2024,
JCO is the survival update with longer follow-up from Checkmate 649 reported in Janjigian
2021, meaning that those patients are included twice in the present study. Running the analyses
including only Janjigian 2024 and discarding Janjigian 2021 would seem more accurate.
In the Discussion section:
The main result is the strong result of Nivolumab monotherapy as compared with placebo, which,
despite several positive trials,  is not approved in all countries. The applicability of this result
should be further discussed.
Prescription of Nivolumab is linked to biomarkers such as PDL1 expression in Europe. This
should be discussed.
As getting more averse events under treatment than under placebo is an expected results, this
part could be reduced.  Expanding on Nivolumab combined with chemotherapy bringing the
same rates of AEs but more grade III AEs and with a different toxicity profile would bring some
interest.
Title: Efficacy and Safety of Nivolumab in Advanced Gastric and Gastroesophageal Junction
Cancer: A Meta-Analysis of Randomized Controlled Trials
Version: 1 Date: 29 Aug 2024
Reviewer's report:
This manuscript is reporting a meta-analysis of the latest studies testing Nivolumab in advanced
gastric cancer.
This study is gathering trials with Nivolumab monotherapy and Nivolumab combined with
chemotherapy which are different settings, leading to subgroup analyses. These phase III trials
which led to approval and answered the question about the interest of Nivolumab in advanced
gastric cancer. The main interest of the study is to make a focus on Nivolumab monotherapy.
The study is rigorously conducted, and the results are well-presented.
One main limit is that this study includes both Janjigian 2024 and Janjigian 2021. Janjigian 2024,
JCO is the survival update with longer follow-up from Checkmate 649 reported in Janjigian
2021, meaning that those patients are included twice in the present study. Running the analyses
including only Janjigian 2024 and discarding Janjigian 2021 would seem more accurate.
In the Discussion section:
The main result is the strong result of Nivolumab monotherapy as compared with placebo, which,
despite several positive trials,  is not approved in all countries. The applicability of this result
should be further discussed.
Prescription of Nivolumab is linked to biomarkers such as PDL1 expression in Europe. This
should be discussed.
As getting more averse events under treatment than under placebo is an expected results, this
part could be reduced.  Expanding on Nivolumab combined with chemotherapy bringing the
same rates of AEs but more grade III AEs and with a different toxicity profile would bring some
interest.
Please review this paper.
user
Title: Efficacy and Safety of Nivolumab in Advanced Gastric and Gastroesophageal Junction
Cancer: A Meta-Analysis of Randomized Controlled Trials
Version: 1 Date: 29 Aug 2024
Reviewer's report:
This manuscript is reporting a meta-analysis of the latest studies testing Nivolumab in advanced
gastric cancer.
This study is gathering trials with Nivolumab monotherapy and Nivolumab combined with
chemotherapy which are different settings, leading to subgroup analyses. These phase III trials
which led to approval and answered the question about the interest of Nivolumab in advanced
gastric cancer. The main interest of the study is to make a focus on Nivolumab monotherapy.
The study is rigorously conducted, and the results are well-presented.
One main limit is that this study includes both Janjigian 2024 and Janjigian 2021. Janjigian 2024,
JCO is the survival update with longer follow-up from Checkmate 649 reported in Janjigian
2021, meaning that those patients are included twice in the present study. Running the analyses
including only Janjigian 2024 and discarding Janjigian 2021 would seem more accurate.
In the Discussion section:
The main result is the strong result of Nivolumab monotherapy as compared with placebo, which,
despite several positive trials,  is not approved in all countries. The applicability of this result
should be further discussed.
Prescription of Nivolumab is linked to biomarkers such as PDL1 expression in Europe. This
should be discussed.
As getting more averse events under treatment than under placebo is an expected results, this
part could be reduced.  Expanding on Nivolumab combined with chemotherapy bringing the
same rates of AEs but more grade III AEs and with a different toxicity profile would bring some
interest.
assistant