1878P - Efficacy of surgical gloves (SG) as compression therapy to prevent oxaliplatin-induced peripheral neuropathy (PN): The ELEGANT trial

Background

PN is a critical factor resulting in premature treatment discontinuation. No satisfactory prophylactic therapy exists. Encouraging results using SG to prevent paclitaxel-induced PN have been published. We investigated efficacy of SG to prevent oxaliplatin (Ox)-induced PN.

Methods

This prospective comparative, auto-controlled study included >18y patients (pts) with digestive cancer receiving Ox treatment Q2W (8 cycles). During each cycle, pts wore SG on the dominant hand. SG were used in pair, one on top of the other: the first one of 1/2 size smaller, the second 1 size smaller. Primary objective was to evaluate SG efficacy, reported as rate of pts with grade >= 2 PN in each hand. Secondary objectives included pts satisfaction, comfort, pain and ease when putting on the gloves assessed at the end of Ox treatment using 10-point numeric scale. Neuropathic Pain Symptom Inventory (NPSI) questionnaire and NP duration was also collected before each cycle, at Ox discontinuation, and 1 year after discontinuation. A total of 67 evaluable pts was required to identify a 20% difference in grade >= 2 PN rate with 2-sided paired χ² test (α: 5%; β:10%).

Results

Between October 2019 and June 2022, 81 pts were included. 64% were male and median age was 66 years [37-87). Tumor was mainly located on colon (47%), pancreas (25%) or rectum (7%). 58% of pts had metastatic disease at inclusion. The median Ox dose received/cycle was 74 [38-133] mg/m² for a median of 7 [1-12] cycles. 21 pts (26%) required at least one PN-related dose modification. 51 pts (63%) reported at least one grade >= 2 PN, including 17 pts (21%) with PN only located to hand without SG (McNemar: pvalue=0.0007). Pain and sensitivity troubles are also reduced in SG hand in 10% and 17% of patients, respectively (p=0.0391 and p=0.0010). At the end of treatment by Ox, mean satisfaction, comfort and ease when putting SG were 6/10. Mean pain when wearing SG was 1.7.

Conclusions

Compression therapy with SG is effective to reduce grade >= 2 oxaliplatin-induced PN and met patient satisfaction. This method of PN prevention is easy to implement. These results contribute to better prevent PN and to improve patient quality of life during and after chemotherapy.

Clinical trial identification

NCT03872908 N°ID-RCB: 2018-A02842-53.

Editorial acknowledgement

Legal entity responsible for the study

Centre Leon Bérard.

Funding

GIRCI AURA (Groupement Inter-régional de Recherche Clinique et d’Innovation) + AFIC (Association Françaises des Infirmier(e)s de Cancérologie).

Disclosure

C. Coutzac: Financial Interests, Personal, Advisory Board: BMS, Servier, Pierre Fabre, Merck Serono; Financial Interests, Institutional, Advisory Board: BMS, Amgen; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, MSD; Financial Interests, Institutional, Coordinating PI: ImCore Roche Genentech. C. de la Fouchardiere: Financial Interests, Personal, Advisory Board: Merck, Roche, Lilly, Bayer, Amgen, MSD, Servier, Pierre Fabre Oncologie, Bristol Myers Squibb, Incyte, Daiichi Sankyo, Astellas; Financial Interests, Personal, Invited Speaker: Ipsen, Eisai, Servier, MSD, Daichi Sankyo; Financial Interests, Institutional, Coordinating PI: Pierre Fabre Oncologie, Servier; Non-Financial Interests, Principal Investigator: Amgen, Daichi Sankyo, MSD. All other authors have declared no conflicts of interest.