710MO - Induction chemotherapy followed by chemoradiation in locally advanced cervical cancer: Quality of life outcomes of the GCIG INTERLACE trial

Background

Induction chemotherapy (IC) added to chemoradiation (CRT) in locally advanced cervical cancer (LACC) improves absolute 5 year progression free and overall survival by 9% and 8% respectively. 99% of patients experience adverse events (AEs) with IC/CRT vs 95% CRT alone, 59% vs 48% experience G3/4 AEs.

Methods

500 women with squamous/adeno/adenosquamous carcinoma FIGO 2008 stage IB1 node positive, IB2, II, IIIB and IVA were randomised to CRT alone or IC (6 weeks carboplatin AUC2 paclitaxel 80mg/m²) followed by CRT. QoL questionnaires (EORTC QLQ-C30 v3, QLQ-CX24) were completed at baseline (BL), D1 week 4 IC, D1 CRT, D1 week 3 CRT, 4 weeks post CRT and all follow ups (3 monthly for 2 years then 6 monthly to 5 years). Mixed modelling for repeated measures was used to compare the groups during trial treatment to 2 years follow up (adjusting for BL).

Results

QoL (global health status, physical and social functioning) became slightly worse during the IC treatment period. The symptom experience scale was slightly better during IC. These differences were small and not clinically relevant. With IC/CRT, emotional functioning increased from BL to week 4 IC. Peripheral neuropathy during IC/CRT became slightly worse with IC/CRT, again not clinically relevant. With IC/CRT, fatigue and nausea/vomiting became worse from BL to week 4 IC whilst pain and diarrhoea became better, consistent with reported AEs. However, over the whole period, the mean differences for these symptoms between the treatment groups was small and not clinically relevant. In all cases, mean score differences during trial treatment until 2 years post CRT showed only small differences (

Conclusions

IC added to CRT does not impact QoL in any clinically meaningful way, either during IC, during CRT or later. Considered alongside the survival advantage this further supports adding IC as standard of care in LACC.

Clinical trial identification

NCT01566240.

Editorial acknowledgement

Legal entity responsible for the study

University College London UK.

Funding

Cancer Research UK: C37815/A12832, C444/A25349, CTUQQR-Dec22/100009.

Disclosure

G. Eminowicz: Financial Interests, Personal, Advisory Board: GSK, Eisai; Financial Interests, Personal, Advisory Role: MSD, Eisai. J.A. Ledermann: Financial Interests, Personal, Advisory Board, Advisory Board and Speaker Fees: AstraZeneca, Clovis Oncology, GSK; Financial Interests, Personal, Advisory Board: Artios Pharma, Eisai, Merck/MSD, VBL Therapeutics, Bristol Myers Squibb, Nuvation, Ellipses, ImmunoGen, Miltenyi, Novocure, Immagene; Financial Interests, Personal, Invited Speaker, Speaker Fees: Neopharm; Financial Interests, Personal, Other, Independent Data Monitoring Committee: Mersana; Financial Interests, Personal, Other, IDMC: Sutro Bio, Mersana; Financial Interests, Institutional, Research Grant, Clinical Research University: AstraZeneca, MSD/Merck; Non-Financial Interests, Leadership Role, Vice President ( 2019-2021): European Society of Gynaecological Oncology; Non-Financial Interests, Officer, Chair Gynaecological Clinical Practice Guidelines: ESMO; Other, Associate Editor: Therapeutic Advances in Medical Oncology: Sage Publishing. M. McCormack: Financial Interests, Personal, Advisory Board: GSK, Eisai, AstraZeneca; Financial Interests, Personal and Institutional, Funding: Roche; Financial Interests, Personal, Sponsor/Funding, Meeting expenses: Medscape, Daiicho Sankyo; Financial Interests, Institutional, Funding: GSK, MSD. All other authors have declared no conflicts of interest.