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PALLIA 10 score in phase I cancer studies
  1. Kaïssa Ouali,
  2. Christine Mateus,
  3. Arianne Laparra,
  4. Patricia Martin Romano,
  5. Anda Sampetrean,
  6. Perrine Vuagnat,
  7. Andrea Varga,
  8. Stephane Champiat,
  9. Loic Verlingue,
  10. Arthur Geraud,
  11. Aurélien Marabelle,
  12. Antoine Hollebecque,
  13. Anas Gazzah,
  14. Rastilav Bahleda,
  15. Sophie Postel Vinay,
  16. Jean-Marie Michot,
  17. Alice Bernard-Tessier,
  18. Arnaud Bayle,
  19. Vincent Ribrag,
  20. Jean-Charles Soria,
  21. Florian Scotte,
  22. Christophe Massard,
  23. Elena Pavliuc and
  24. Capucine Baldini
  1. Palliative Care Unit, Gustave Roussy Institute, Villejuif, France
  1. Correspondence to Dr Kaïssa Ouali, Gustave Roussy Institute, Villejuif 94805, France; kaissa.ouali{at}gustaveroussy.fr

Abstract

Objective Phase I clinical trials usually include patients with advanced disease who have failed standard therapies and should benefit from early palliative care. We try to assess whether PALLIA 10, a score developed in France to help identify patients who might benefit from a palliative care referral, could be used in a phase I department trial.

Methods We assessed PALLIA 10 score and other prognostic factors in patients enrolled in phase I trials at Gustave Roussy Cancer Center prospectively during two periods of time (cohort 1 (C1) and 2 (C2)). A double-blind assessment of the PALLIA 10 score was done in C2 by a palliative care specialist and a nurse.

Results From 1 July 2018 to 1 November 2018 (C1) and from 1 December 2020 to 16 April 2021 (C2), 86 patients were assessed in C1 and 302 in C2. Median PALLIA 10 was very low in both cohorts (median 1, range 1–5 in C1 and 1–8 in C2). On C1 and C2, 12% and 5% of patients had a dedicated palliative consultation. In C2, assessment of PALLIA 10 score was significantly different between palliative care physician (median 5, range 3–8), phase I physician (median 1, range 1–6) and phase I nurse (median 3, range 1–8) (p<0.001).

Conclusion Median PALLIA 10 score was low when assessed by the phase I physician, which suggests the need for a better tool and appropriate clinician’s education to implement early palliative care in clinical practice and trials.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

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Footnotes

  • Contributors All the authors contributed in reviewing the articles. KO is the author acting as guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.