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Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study

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Abstract

Purpose

Patients enrolled in oncology phase 1 trials (ph1) usually have advanced heavily pre-treated cancers with few therapeutic options. Quality of life (QoL) is one of the key cancer-treatment outcome measures, especially in ph1, and sexuality is an important part of Qol but rarely explored. This prospective study aims to assess supportive care needs, QoL and sexuality in ph1.

Methods

Between September 2020 and June 2021, we prospectively recruited patients enrolled in ph1 at Gustave Roussy in France. Supportive care needs, QoL (EORTC QLQ-C30) and sexuality (female sexual function index for women, male sexual health questionnaire [MSHQ] for men) were assessed at baseline, one, three and 5 months. We performed multivariate analyses to identify associations between clinical characteristics, QoL and quality of sexual life over time.

Results

At baseline, we analyzed 187 patients (45% women (n = 84) and 55% men (n = 103)). Patients expressed the need for consultations in pain management, nutrition, psychology and sexology in 28%, 26%, 19% and 9%, respectively. Lower global QoL was independently associated with Royal Marsden Hospital score (p = 0.012), urogenital location tumor (p = 0.021), elevated CRP levels (p = 0.014) and pain intensity (p = 0.005). Ninety-two percent of women had sexual dysfunction. In men, a lower MSHQ score was independently associated with urogenital location tumor (p = 0.021), ECOG Performance Status (p = 0.006), comorbidity at risk (p = 0.024) and pain intensity (p = 0.004).

Conclusions

There are significant needs for supportive care in ph1, especially in some subgroups of patients. New models of care should be developed to improve early phase pathways.

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Data availability

Data and study materials will not be made available to other researchers. Data and study material support the published claims and comply with field standards.

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Author information

Authors and Affiliations

  1. Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France

    Marc Hilmi, Natacha Naoun, Arthur Géraud, Arnaud Bayle, Christophe Massard, Capucine Baldini & Stéphane Champiat

  2. Biostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France

    Marc Hilmi, Arthur Géraud, Arnaud Bayle & Arnaud Pagès

  3. Medical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France

    Alice Boilève, Marion Aupomerol & Fanny Pommeret

  4. Urology Department, Hopital Foch, Université Paris-Saclay, Suresnes, France

    Matthieu Rouanne & François-Xavier Madec

  5. Department of Microbiology and Immunology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA

    Matthieu Rouanne

  6. Laboratory for Immunomonitoring in Oncology (LIO), University Paris-Saclay, Gustave Roussy Cancer Campus, Villejuif, France

    Capucine Baldini

  7. Interdisciplinary Patient Pathway Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France

    Florian Scotté

Authors
  1. Marc Hilmi
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  2. Natacha Naoun
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  3. Alice Boilève
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  4. Arthur Géraud
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  5. Arnaud Bayle
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  6. Arnaud Pagès
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  7. Marion Aupomerol
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  8. Matthieu Rouanne
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  9. François-Xavier Madec
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  10. Fanny Pommeret
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  11. Christophe Massard
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  12. Capucine Baldini
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  13. Florian Scotté
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  14. Stéphane Champiat
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Contributions

Conceptualization: M.H., N.N., M.R., S.C., A.G., A.P., A.B., M.A., F-X.M., F.P., S.C., F.S.

Data curation: M.H., N.N.;

Formal analysis: M.H., A.P.;

Funding acquisition: S.C., C.M., C.B.;

Investigation: M.H., N.N., A.G., S.C.;

Methodology: M.H., A.P.;

Project administration: M.H., S.C., C.M.;

Resources: S.C.;

Software: M.H., A.P.;

Supervision: C.B, S.C., F.S., C.M.;

Validation: A.B., M.A., C.M., C.B., F.S., S.C.;

Visualization: M.H., A.P.;

Roles/Writing—original draft: M.H., A.B., N.N.

Writing—review & editing: M.H., N.N., M.R., S.C., A.G., A.P., A.B., M.A., F-X.M., F.P., S.C., F.S.

Corresponding author

Correspondence to Marc Hilmi.

Ethics declarations

Ethics approval and consent to participate

The study was reviewed and approved by the Paris Saclay University Hospital Ethics Committee (registration No. 2022.150). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. A written informed consent was obtained from each patient.

Conflict of interest

As part of the Drug Development Department (DITEP), M.H., N.N., A.G., A.B., S.C., C.B. and C.M. declare the following financial interests/personal relationships which may be considered as potential competing interests:

Principal/sub-Investigator of Clinical Trials for Abbvie, Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Astex Pharmaceuticals, Astra Zeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, BicycleTx Ltd, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Celgene Corporation, Chugai Pharmaceutical Co, Clovis Oncology, Cullinan-Apollo, Curevac, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Faron Pharmaceuticals Ltd, Forma Tharapeutics, Gamamabs, Genentech, Glaxosmithkline, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Iteos Belgium SA, Janssen Cilag, Janssen Research Foundation, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Ose Pharma, Pfizer, Pharma Mar, Pierre Fabre, Medicament, Roche, Sanofi Aventis, Seattle Genetics, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Turning Point Therapeutics, Xencor.

Research Grants from Astrazeneca, BMS, Boehringer Ingelheim, GSK, INCA, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi.

Non-financial support (drug supplied) from Astrazeneca, Bayer, BMS, Boeringher Ingelheim, GSK, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche.

Other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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Hilmi, M., Naoun, N., Boilève, A. et al. Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study. Support Care Cancer 30, 9841–9849 (2022). https://doi.org/10.1007/s00520-022-07407-6

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  • DOI: https://doi.org/10.1007/s00520-022-07407-6

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