Title: Larotinib in Patients with Advanced and Previously Treated Esophageal Squamous Cell
Carcinoma with Epidermal Growth Factor Receptor Overexpression or Amplification: An Open-
Label, Multicenter Phase 1b Study
Version: 0 Date: 19 Jul 2021
Reviewer's report:
Thank you for give me an opportunity for evaluating this prospective study. It seems this study
evaluated risk benefit of esophageal squamous cell carcinoma. We usually call this type of study
as phase 2 study, however authors described phase 1b. Is there any specific reason? Several
concerns are raised before publication.
Major
#1 Statistical procedure, its not clear what is primary endpoint of this study
#2 Why author choose non evaluable cases in this study? What is your purpose?
#3 What is dose-limiting toxicity of this drug?
#4 How about interstitial pneumonitis? Is that related with previous radiation?
#5 Patients characteristics is too simple. Previous surgery is important information.
#6 Why no response were obtained in 300mg larotinib? The explanation is not enough.
Title: Larotinib in Patients with Advanced and Previously Treated Esophageal Squamous Cell
Carcinoma with Epidermal Growth Factor Receptor Overexpression or Amplification: An Open-
Label, Multicenter Phase 1b Study
Version: 0 Date: 19 Jul 2021
Reviewer's report:
Thank you for give me an opportunity for evaluating this prospective study. It seems this study
evaluated risk benefit of esophageal squamous cell carcinoma. We usually call this type of study
as phase 2 study, however authors described phase 1b. Is there any specific reason? Several
concerns are raised before publication.
Major
#1 Statistical procedure, its not clear what is primary endpoint of this study
#2 Why author choose non evaluable cases in this study? What is your purpose?
#3 What is dose-limiting toxicity of this drug?
#4 How about interstitial pneumonitis? Is that related with previous radiation?
#5 Patients characteristics is too simple. Previous surgery is important information.
#6 Why no response were obtained in 300mg larotinib? The explanation is not enough.
Please review this paper.
user
Title: Larotinib in Patients with Advanced and Previously Treated Esophageal Squamous Cell
Carcinoma with Epidermal Growth Factor Receptor Overexpression or Amplification: An Open-
Label, Multicenter Phase 1b Study
Version: 0 Date: 19 Jul 2021
Reviewer's report:
Thank you for give me an opportunity for evaluating this prospective study. It seems this study
evaluated risk benefit of esophageal squamous cell carcinoma. We usually call this type of study
as phase 2 study, however authors described phase 1b. Is there any specific reason? Several
concerns are raised before publication.
Major
#1 Statistical procedure, its not clear what is primary endpoint of this study
#2 Why author choose non evaluable cases in this study? What is your purpose?
#3 What is dose-limiting toxicity of this drug?
#4 How about interstitial pneumonitis? Is that related with previous radiation?
#5 Patients characteristics is too simple. Previous surgery is important information.
#6 Why no response were obtained in 300mg larotinib? The explanation is not enough.
assistant