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Quality of life in patients with liver metastases from colorectal cancer treated with first-line selective internal radiotherapy (SIRT): Results from the FOXFIRE prospective randomized studies

2017; Elsevier BV; Volume: 28; Linguagem: Inglês

10.1093/annonc/mdx393.117

1569-8041

Alastair Gray, Jane Wolstenholme, Francesco Fusco, Ian Chau, Luise Dunham, Sharon Love, Anne C. Roberts, Joanna Moschandreas, Pradeep S. Virdee, Valerie Lewington, G. Wilson, Paul Tait, Nasir Khan, David Berry, Andrew Wotherspoon, B. Paul Morgan, Harpreet Wasan, Guy van Hazel, Peter Gibbs, Ricky A. Sharma,

Advanced Radiotherapy Techniques

Background: Quality of life (QoL) in patients with colorectal cancer and liver metastases treated with selective internal radiotherapy (SIRT) using Yttrium-90 resin microspheres combined with FOLFOX (standard chemotherapy) has not been compared to FOLFOX alone. We report QoL results from a prospectively pooled analysis of 3 multicentre randomized trials: FOXFIRE, FOXFIRE-Global and SIRFLOX. Methods: Patients were randomized to FOLFOX or FOLFOX+SIRT in 14 countries. Second-line therapy was permitted upon disease progression. EORTC QLQ-C30 and EuroQoL EQ-5D (3 level) questionnaires were given to all patients at baseline, 2-3, 6 and 12 months from starting treatment and yearly thereafter, and at disease progression. We compared QoL scores between arms at each timepoint, calculating mean differences adjusted for baseline scores, using a 5% significance level. No missing data imputation was performed. Results: 1103 patients were randomised overall. Questionnaire response rates ranged from 92% (1010/1103) at baseline to 33% (163/493) at 24 months. Patients randomised to SIRT showed significantly (p < 0.05) worse scores on 3 of 6 QLQ-C30 functioning scales and 3 of 9 symptom scales (fatigue, nausea and vomiting, appetite loss) at 4-8 weeks after treatment (2-3 months from baseline). SIRT patients had significantly better functioning scores on 3 of 6 scales at disease progression, and significantly less dyspnoea or constipation. Almost no other QLQ-C30 scales showed significant differences at 6, 12 or 24 months. The EQ-5D showed a statistically significant decrement of 0.02 in patients in the SIRT group 2-3 months from baseline, but no differences at other timepoints. Conclusions: This analysis has shown that QoL is slightly impaired in functioning and symptom domains 4-8 weeks after treatment with SIRT+FOLFOX compared with FOLFOX alone, but slightly better when measured at disease progression. These differences were consistent between the QLQ-C30 and EQ-5D instruments. The differences detected were not large enough to be considered clinically significant. Clinical trial identification: FOXFIRE ISRCTN83867919; SIRFLOX NCT00724503; FOXFIRE-Global NCT01721954 Legal entity responsible for the study: University of Oxford Funding: Bobby Moore Fund of Cancer Research UK; Sirtex Medical Ltd Disclosure: I. Chau: Advisory Board: Sanofi Oncology, Eli Lilly, Bristol-Myers Squibb, MSD, Bayer, Roche, Five Prime Therapeutics. Research funding: Janssen-Cilag, Sanofi Oncology, Merck Serono, Novartis. Honorarium: Taiho, Pfizer, Amgen, Eli Lilly, Gilead Science. S. Love: Grants from: Cancer Research UK, Sirtex Medical and non-financial support from Sirtex Medical. J. Moschandreas: Grants from Cancer Research UK, Sirtex Medical and non-financial support from Sirtex Medical. P. Virdee: Grants from Cancer Research UK, Sirtex Medical and non-financial support from Sirtex Medical. P. Tait: Medical advisor and medical proctor for Sirtex medical. H. Wasan: Grants, personal fees, non-financial support and other uncompensated work from Sirtex Medical. G. Van Hazel: Compensation for participation in advisory committees from Sirtex. P. Gibbs: Personal fees from Sirtex. R. Sharma: Research funding, honoraria and consultancy fees from Sirtex Medical. All other authors have declared no conflicts of interest.