1747P - Changes in global health status (GHS) in patients with advanced soft tissue sarcoma (STS) treated with first line palliative chemotherapy: Primary outcomes from the HOLISTIC study

Background

The HOLISTIC study assessed health-related quality of life (HRQoL) in advanced STS patients during first line palliative chemotherapy, focusing on change in GHS after 5 cycles (T5) of treatment.

Methods

This prospective study included patients in the Netherlands (NL, n=63) and in the United Kingdom (UK, n=72). Data on residence country, age, gender, relationship status, educational level, histological subtype, number of metastatic sites, hemoglobin, and ECOG performance status (PS) were collected. Questionnaires were filled out at baseline (T0) and at the beginning of each cycle. Change in EORTC-QLQ-C30 GHS scores was tested using a paired sample t-test. For patients who did not complete 5 cycles, the last score post baseline was carried forward. Univariate mixed-effect models with time as a fixed effect were created. Subsequently, interaction with time was included, and via backward selection a multivariate model was created.

Results

Median age of patients was 62 (27-79) years, 41% > 65 years; gender distribution was even. Most common STS subtypes were leiomyosarcoma (LMS, 30%), liposarcoma (LPS, 22%) and ‘other’ (30%). Doxorubicin-based chemotherapy was applied in 85% of patients. Questionnaire completion rates were 99% (T0), 69% (T1), 56% (T2), 50% (T3), 39% (T4) and 30% (T5). The mean GHS score was 68.2 at T0 and 61.4 at T5, indicating a mean difference of 10.5 points (p<0.01). In univariate analysis, predictors for worse GHS scores at T0 were UK residence (63.8 vs 70.8 [NL], p=0.02), >2 metastatic sites (60.9 vs 68.7 [≤2], p=0.04), PS 1 or 2 (65.4 vs 72.6 [PS 0], p=0.02), anemia (61.9 vs 70.3 [no anemia], p<0.01) and STS type ‘other’ (61.9 vs 70.9 [LMS], p=0.02)). This was confirmed by multivariate analysis, except for STS type ‘other’. GHS scores decreased faster in patients with PS 0 (-4.0 vs -0.3 [PS 1 or 2], p<0.01), no anemia (-4.0 vs -1.6 vs [anemia], p=0.04), LPS (-7.7 vs -4.0 [LMS], p=0.01) and STS type ‘other’ (-6.8 vs -4.0 [LMS], p=0.04).

Conclusions

First line palliative systemic treatment in advanced STS is associated with a significant decrease in GHS. These results may support informed decision making by advanced STS patients starting palliative chemotherapy.

Clinical trial identification

NCT03621332.

Editorial acknowledgement

Funding

The work was supported by The Royal Marsden NHS Foundation Trust together with The Institute of Cancer Research, which receives Biomedical Research Centre (BRC) funding through the National Institute for Health Research (NIHR). This work received financial support from Lilly (no grant number).

Disclosure

R.L. Jones: Financial Interests, Personal, Advisory Board, I worked as a consultant.: Adaptimmune, Athenex, Bayer, Boehringer Ingelheim, Blueprint, Clinigen, Eisai, Epizyme, Daiichi Sankyo, Deciphera, Immunedesign, Lilly, Springworks, Tracon, Upto Date, PharmaMar, Astex, Immunicum, Karma Oncology, Merck, Mundipharma, Synox; Financial Interests, Institutional, Research Grant, Research grant for a clinical trial.: MSD. A. Oosten: Financial Interests, Local PI: Cogent. J.J. De Haan: Financial Interests, Institutional, Local PI, Institutional Financial Support for clinical trials: Astellas, Boehringer Ingelheim, Cogent, Incyte, Inhibrx, Zentalis, Zymeworks. H. Gelderblom: Financial Interests, Institutional, Local PI: Deciphera, Cytovation; Financial Interests, Institutional, Coordinating PI: Boehringer Ingelheim, AmMax Bio, Debiopharm, Abbisko. N. Steeghs: Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim, Bristol Myers Squibb, Ellipses Pharma; Financial Interests, Personal, Advisory Board: GSK, Incyte; Financial Interests, Institutional, Local PI: Abbvie, Actuate Therapeutics, Amgen, Anaveon, Ascendis Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, CellCentric, Cogent Biosciences, Crescendo Biologics, Deciphera, Exelixis, Genentech, GSK, IDRx, Immunocore, Incyte, Janssen, Kling Biotherapeutics, Merck, Merck Sharp & Dohme, Merus, Molecular Partners, Novartis, Pfizer, Revolution Medicin, Roche, Sanofi, Sanofi, Seattle Genetics, Seattle Genetics, Taiho, Takeda; Financial Interests, Institutional, Research Grant: AstraZeneca, Blueprint Medicines, Deciphera, GSK, Lixte, Merck, Novartis, Pfizer, Roche, Zentalis. W.T.A. Van Der Graaf: Financial Interests, Institutional, Local PI, Clinical study: SpringWorks, Boehringer Ingelheim; Financial Interests, Institutional, Research Grant, IIS: Lilly; Financial Interests, Institutional, Local PI, Clinical Study: AYALA; Non-Financial Interests, Member of Board of Directors, President: EORTC; Non-Financial Interests, Member of Board of Directors: European Cancer Organisation; Non-Financial Interests, Member of Board of Directors, Chair: Dutch Sarcoma Group, Dutch AYA ‘Young and Cancer' Care Network. All other authors have declared no conflicts of interest.