Cancer immunotherapy does not increase the risk of death by COVID-19 in melanoma patients

  1. Maria Gonzalez-Cao
  2. Monica Antonazas-Basa
  3. Teresa Puertolas
  4. Eva Munoz-Couselo
  5. Jose Luis Manzano
  6. Cristina Carrera
  7. Ivan Marquez-Rodas
  8. Pilar Lopez-Criado
  9. Juan Francisco Rodriguez-Moreno
  10. Almudena Garcia-Castano
  11. Juan Martin-Liberal
  12. Pedro Rodriguez-Jimenez
  13. Susana Puig
  14. Pablo Cerezuela
  15. Marta Feito-Rodriguez
  16. Belen Rubio-Viqueira
  17. Guillermo Crespo
  18. Pablo Luna-Fra
  19. Cristina Aguayo
  20. Pablo Ayala de Miguel
  21. Rosa Feltes
  22. Lara Valles
  23. Ana Drozdowskyj
  24. Ainara Soria
  25. Cayetana Maldonado
  26. Luis Fernandez-Morales
  27. Rafael Rosell
  28. Mariano Provencio
  29. Alfonso Berrocal

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Abstract

Background: Covid-19 pandemic by the new coronavirus SARS-Cov-2 has produced devastating effects on the health care system, affecting also cancer patient care. Data about COVID-19 infection in cancer patients are scarce, and they point out a higher risk of complications due to the viral infection in this population. Moreover, cancer treatments could increase viral complications, specially those treatments based on the use of immunotherapy with checkpoints antibodies. There are no clinical data about the safety of immune check point antibodies in cancer patients when they become infected by SARS-CoV-2. As checkpoint inhibitors, mainly anti PD-1 and anti CTLA-4 antibodies, are an effective treatment for most melanoma patients, avoiding their use during the pandemic could lead to a decrease in the chances of curing melanoma. Methods: In Spain we have started a national registry of melanoma patients infected by SARS-Cov-2 since April 1st, 2020. A retrospective analysis of patients included in the Spanish registery has been performed weekly since the activation of the study. Interim analysis shows unexpected findings about cancer treatment safety in SARS-Cov-2 infected melanoma patients, so a rapid communication to the scientific community is mandatory Results: Fifty patients have been included as of May 17th, 2020. Median age is 69 years (range 6 to 94 years), 27 (54%) patients are males and 36 (70%) patients have stage IV melanoma. Twenty-two (44%) patients were on active anticancer treatment with anti PD-1 antibodies, 16 (32%) patients were on treatment with BRAF plus MEK inhibitors and 12 (24%) patients were not on active cancer treatment. COVID-19 episode has been resolved in 43 cases, including 30 (70%) patients cured, four (9%) patients that have died due to melanoma progression, and nine (21%) patients that have died from COVID-19. Mortality rates from COVID-19 according to melanoma treatment type were 16%, 15% and 36% for patients on immunotherapy, targeted drugs, and for those that were not undergoing active cancer treatment, respectively. Conclusion: These preliminary findings show that the risk of death in those patients undergoing treatment with anti PD-1 antibodies does not exceed the global risk of death in this population. These results could be relevant in order to select melanoma therapy during the COVID-19 pandemic  

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    SciScore for 10.1101/2020.05.19.20106971: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: This study was approved on March 23rd, 2020 by the Ethics Committee of the Hospital Puerta del Hierro, Madrid (Exp. 6/2020).
    Consent: The requirement for patient informed consent was waived by the Ethics Commitee due to the emergency research circumstances.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04356508Not yet recruitingCOVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
    NCT04268537Not yet recruitingImmunoregulatory Therapy for 2019-nCoV
    NCT04335305RecruitingCheckpoint Blockade in COVID-19 Pandemic

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

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  2. Version published to 10.1101/2020.05.19.20106971v1 on medRxiv