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

Autor: Hilmi M; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France. hilmi.marc@gmail.com.; Biostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France. hilmi.marc@gmail.com., Naoun N; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France., Boilève A; Medical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Géraud A; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.; Biostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Bayle A; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.; Biostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Pagès A; Biostatistics and Epidemiology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Aupomerol M; Medical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Rouanne M; Urology Department, Hopital Foch, Université Paris-Saclay, Suresnes, France.; Department of Microbiology and Immunology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA., Madec FX; Urology Department, Hopital Foch, Université Paris-Saclay, Suresnes, France., Pommeret F; Medical Oncology Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Massard C; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France., Baldini C; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.; Laboratory for Immunomonitoring in Oncology (LIO), University Paris-Saclay, Gustave Roussy Cancer Campus, Villejuif, France., Scotté F; Interdisciplinary Patient Pathway Department, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Champiat S; Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris-Saclay, 94140, Villejuif, France.
Jazyk: angličtina
Zdroj: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [Support Care Cancer] 2022 Dec; Vol. 30 (12), pp. 9841-9849. Date of Electronic Publication: 2022 Oct 22.
DOI: 10.1007/s00520-022-07407-6
Abstrakt: 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.
(© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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