Promising Immune Treatment of Advanced Cutaneous Squamous Cell Carcinoma with Cemiplimab—Real-World Experience in the Global SARS-CoV-2 Pandemic

Round 1

Reviewer 1 Report

RE:    

Promising immune treatment of advanced cutaneous squamous cell carcinoma with cemiplimab – Real-World Experience in the 3 global SARS-CoV-2 pandemic by

Marta Pabianek et al

Remarks

1)   his work reports the successful therapy of cSCC with PD-1 AB and the impact of the SARS-Cov-2 pandemic in terms of delaying  of diagnosis and therapy; question: with the exception of Pat. 1+5, the title cannot be applied to the rest of the patients. The first patient was apart from that a classical case of neglect, 88 years old and living on his own

2)   The text is in principle well written with impressive cases, but as far as I can judge as a non-native English speaker, there are some wrong expressions like diametrically line 63 (I suppose it should be dramatic) ; so maybe the text should be checked

3)   Question: pat 1: how many cycles has the pat received after the complete response after 6 cycles ; this information should be given for all patients, i.e. whether the treatment is still ongoing, or for how long the therapy was continued after CR, 2 years ?

4)   Line 158 : ref of the guidelines

5)   Line 162 : please add that the response is also ongoing with respective literature e.g. ASCo meetings and

Rischin D, et al J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757. Or Migden MR, et al Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4.

6)   Please state whether the patients were immunocompromised

Author Response

Dear Editors and Reviewer,

We would like to thank the reviewer for all constructive comments regarding the manuscript.

Please find below answers to all comments. The changes are added to the manuscript with highlighted text and described below in response to the reviewers.

Reviewer 1

Remarks

• his work reports the successful therapy of cSCC with PD-1 AB and the impact of the SARS-Cov-2 pandemic in terms of delaying  of diagnosis and therapy;
  question: with the exception of Pat. 1+5, the title cannot be applied to the rest of the patients. The first patient was apart from that a classical case of neglect, 88 years old and living on his own

Answer: The title indicating the treatment for patients with advanced cSCC during SARS-Cov-2 pandemic is highlighting how the pandemic is affecting the diagnosis and patients’ delay in visiting the doctors. Due to the pandemic patients have been not visiting medical doctors on time.
However, if this is recommended by the reviewer, the title could be modified accordingly.

• The text is in principle well written with impressive cases, but as far as I can judge as a non-native English speaker, there are some wrong expressions like diametrically line 63 (I suppose it should be dramatic) ; so maybe the text should be checked

Answer: We would like to thank for that notification. The whole manuscript has been checked and corrected accordingly.

• Question: pat 1: how many cycles has the pat received after the complete response after 6 cycles ; this information should be given for all patients, i.e. whether the treatment is still ongoing, or for how long the therapy was continued after CR, 2 years ?

Answer: The treatment is still ongoing for all patients. The therapy is continued 14 months for patient 1 after CR; 10 months for patient 2 after CR; 10 months for patient 3 after PR; 13 months for patient 4 after PR. This information is added to the manuscript

• Line 158 : ref of the guidelines

Answer: Corrected. The reference to guidelines has been added.

5)   Line 162 : please add that the response is also ongoing with respective literature e.g. ASCo meetings and

Rischin D, et al J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757. Or Migden MR, et al Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4.

Answer: Corrected. The information has been added with the relevant reference.

6)   Please state whether the patients were immunocompromised

Answer: None of the patient was immunocompromised. This information is added to the manuscript. Lines: 43-44.

Reviewer 2 Report

Abstract Line 2 : correct the spelling error to " gold standard" or avoid the term please mention : standard curative treatment or standard of care

Manuscript:

line 74: Please phrase the sentence as "After 18 weeks complete response was noted " not Obtained. Thank you

Line 152: Please replace the word "pitiful" to words such as poor, dismal  or don't mention any adjectives, plainly state the facts.

Line 159: Please mention that FDA approval of Cemiplimab was based on response rates of 44%  not on PFS/OS survival data. 

Can you add 1-2 lines of alternate chemo or systemic therapy approved in advanced SCC and also recent approval of keytruda

Line 191 -194 : nice to have included the available retrospective real-world data which is more relevant to your manuscript, please summarize the data in detail listing the published manuscripts and make a table of response rates and PFS/OS data, it will give readers an idea to compare with a preliminary study of Midgen et al.

Broaden the scope of real-world data with all the available literature Dr. Midgen et al published recently a follow-up -

https://www.futuremedicine.com/doi/full/10.2217/fon-2019-0762?rfr_dat=cr_pub++0pubmed&url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org

Also, there is data from another single-center in USA.  https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.e21545

overall the range of ORR is b/w 40-60% and CR rates 15-20 %

Author Response

Dear Editors and Reviewer,

We would like to thank the reviewer for all constructive comments regarding the manuscript.

Please find below answers to all comments. The changes are added to the manuscript with highlighted text and described below in response to the reviewers.

Reviewer 2

Abstract Line 2 : correct the spelling error to " gold standard" or avoid the term please mention : standard curative treatment or standard of care

Answer: Thank you. Corrected.

Manuscript:

line 74: Please phrase the sentence as "After 18 weeks complete response was noted " not Obtained. Thank you

Answer: Corrected.

Line 152: Please replace the word "pitiful" to words such as poor, dismal  or don't mention any adjectives, plainly state the facts.

Answer: Corrected.

Line 159: Please mention that FDA approval of Cemiplimab was based on response rates of 44%  not on PFS/OS survival data. 

Answer: We would like to thank for that constructive comment. This information has been added to the manuscript. Please check the lines: 160-163 in the manuscript.

Can you add 1-2 lines of alternate chemo or systemic therapy approved in advanced SCC and also recent approval of Keytruda

Answer: We would like to thank for that comment. This information has been added to the manuscript. Please check the lines: 164-168 in the manuscript.

Line 191 -194 : nice to have included the available retrospective real-world data which is more relevant to your manuscript, please summarize the data in detail listing the published manuscripts and make a table of response rates and PFS/OS data, it will give readers an idea to compare with a preliminary study of Midgen et al.

Broaden the scope of real-world data with all the available literature Dr. Midgen et al published recently a follow-up -

https://www.futuremedicine.com/doi/full/10.2217/fon-2019-0762?rfr_dat=cr_pub++0pubmed&url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org

Also, there is data from another single-center in USA.  https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.e21545

overall the range of ORR is b/w 40-60% and CR rates 15-20 %

Answer: We would like to thank for that suggestion. The table 1 presents the summary from case report data and phase study in comparison to our study.