1552O - Chemotherapy-induced peripheral neuropathy (CIPN) prevention trial evaluating the efficacy of hand-cooling and compression in patients undergoing taxan-based (neo-)adjuvant chemotherapy for primary breast cancer: First results of the prospective, randomized POLAR trial

Background

CIPN is a common, dose-limiting side effect of taxane-based chemotherapy. Currently there is no established strategy for prevention or treatment. Smaller studies suggest that cooling or compression could have a preventive effect. In this randomized trial we investigated the effectiveness of one-sided hand-cooling or compression for the prevention of CIPN.

Methods

122 breast cancer patients who received weekly (nab-)paclitaxel-based (neo-)adjuvant chemotherapy were 1:1 randomized to either cooling or compression of the dominant hand. No intervention was performed on the other hand. Cooling was performed with a frozen glove (Elasto-Gel; 84400APT Cedex, Akromed), compression was applied by two surgical gloves (one size smaller than tight-fitting size) 30 minutes before, during and 30 minutes after taxane therapy. The primary endpoint was efficacy to prevent grade ≥2 sensory polyneuropathy evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE). In a second hierarchical test, CIPN rates between both intervention groups were compared. CIPN was further assessed by the Total Neuropathy Score (TNSc), patient self-report questionnaires (EORTC-QLQ-CIPN20), MR-neurography (n=21) and nerve conduction studies. Additionally, we evaluated onycholysis, skin toxicity, quality of life, CIPN-associated dose-reductions, treatment discontinuations and potential risk factors.

Results

Cooling and compression were highly effective in preventing grade ≥2 CIPN (cooling: 25 vs. 46%; p-value=0.0008; compression: 23 vs. 39%; p-value=0.0016) with similar efficacy (no significant difference was found: p-value=0.7303). MR-neurography was highly sensitive for detecting CIPN showing increased T2 nerve-to-muscle signal ratio indicating edematous nerve changes. Updated results will be presented.

Conclusions

POLAR is the first trial to compare cooling and compression for preventing CIPN. Both interventions were highly effective and almost halved the risk of grade ≥2 CIPN. These findings could play an important role beyond gynecological oncology.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Intramural funding as part of the elevator pitch of the National Center for Tumor Diseases (NCT) Heidelberg.

Disclosure

L. Michel: Non-Financial Interests, Personal and Institutional, Advisory Board: German Breast Group (GBG); Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Eisai, AstraZeneca, Lilly, MSD; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Funding: Pfizer. K. Smetanay: Financial Interests, Personal, Invited Speaker: Celgene, Roche, AstraZeneca, MSD, Novartis, Lilly; Financial Interests, Personal, Advisory Board: MSD. C. Fremd: Financial Interests, Personal, Invited Speaker: Celgene, Pfizer, Novartis, Amgen, AstraZeneca, EISAI, Lilly; Financial Interests, Personal, Funding: Pfizer. D. Jäger: Financial Interests, Personal, Advisory Role: CureVac AG, Definiens, F. Hoffmann-La Roche Ltd, Genmab A-S, Life Science Inkubator GmbH, VAXIMM AG, OncoOne Research & Development Research GmbH, Oncolytics Biotech Inc, BMS Stiftung Immunonkologie; Financial Interests, Personal, Writing Engagements: Terrapinn, Touch Medical Media, BMS GmbH & Co KGaA; Financial Interests, Personal, Sponsor/Funding: Amgen Inc, Oryx GmbH, Roche Glycart AG, Parcel.com, BMS, IKTZ HD GmbH; Financial Interests, Personal, Advisory Board: CureVac, Definiens, Hoffmann-La Roche, Genmab A-S, Life Science Inkubator GmbH, Vaximm AG, Oncolytics Biotech Inc. F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, Tesaro, Pfizer, PharmaMar, Eisai, MSD, celgene , Lilly, Pierre-Fabre, Vaccibody, Seagen, Immunomedics, Janssen-Cilag, Myriad, Curevac; Financial Interests, Personal, Sponsor/Funding: Clovis, GenomicHealth. A. Schneeweiss: Financial Interests, Personal, Invited Speaker: Celgene, Roche, Abbvie, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly, GSK, Seagen, Gilead, Pierre Fabre, onkowissen.de; Financial Interests, Personal, Funding: Molecular Partner, Roche, Pfizer; Financial Interests, , Invited Speaker: Metaplan. All other authors have declared no conflicts of interest.