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. 2024 Sep 6:14:1452099.
doi: 10.3389/fonc.2024.1452099. eCollection 2024.

Topical treatment of chemotherapy-induced peripheral neuropathy (CIPN) with high-concentration (179 mg) capsaicin patch in breast cancer patients - results of the QUCIP study

Michael Patrick Lux  1 , Lilit Flöther  2 , Catrin Frömter  3 , Brigitte Rack  4 , Kristina Veselinovic  4 , Myriam Heine  5 , Stefan Paepke  6 , Petra Krabisch  7 , Tamara Quandel  5 , Rainer Sabatowski  8
Affiliations

Topical treatment of chemotherapy-induced peripheral neuropathy (CIPN) with high-concentration (179 mg) capsaicin patch in breast cancer patients - results of the QUCIP study

Michael Patrick Lux et al. Front Oncol. .

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) following oral or intravenous chemotherapy often results in neuropathic pain, accompanied by symptoms such tingling, burning and hypersensitivity to stimuli, with a notable decline in quality of life (QoL). Effective therapies for CIPN are lacking, with a high demand for analgesics to address this issue. The QUCIP study aimed to assess the effectiveness of high concentration (179 mg) capsaicin patch (HCCP) in alleviating neuropathic pain and associated symptoms in breast cancer patients with confirmed CIPN.

Methods: QUCIP is a prospective, multi-center observational study spanning 36 weeks with up to three HCCP treatments. Initial treatment (visit V0) was followed by two telephone contacts (T1, T2) and subsequent face-to-face visits every 12 weeks or upon retreatment (visits V1-V3). 73 female patients with painful CIPN post neoadjuvant/adjuvant breast cancer therapy were enrolled. Primary endpoint was the reduction of neuropathic pain symptom score (painDETECT®). Secondary endpoints included improvements in CIPN-specific QoL (QLQ-CIPN20), reductions in pain intensity (numeric pain rating scale, NPRS), and achievement of ≥ 30% and ≥ 50% pain reduction.

Results: Median age was 61 years, with 52.0% of patients experiencing peripheral neuropathic pain for > 1 year (> 2 years: 34.2%). The painDETECT® score significantly decreased from baseline (19.71 ± 4.69) to 15.80 ± 6.20 after initial treatment (p < 0.0001) and continued to decrease at follow-up visits. The NPRS indicated significant pain intensity reduction at each time point, particularly pronounced in patients receiving three HCCP treatments. Clinically significant pain relief of ≥ 30% increased from 25.0% at week 4 (T2) to 36.2%, 43.5%, and 40.0% at weeks 12 (V1), 24 (V2), and 36 (V3), respectively. The percentage of patients achieving pain relief of ≥ 50% increased from 14.7% at T2 to 15.5%, 21.7% and 32.5% at V1, V2 and V3, respectively. Patients further reported a significant improvement in their CIPN-related QoL throughout the study. Adverse drug reactions (ADRs) mainly included application site reactions.

Conclusion: In this study, HCCP shows benefit in managing CIPN in real-world settings. The data demonstrate a sustained and progressive reduction in neuropathic pain and symptomatology, confirming the clinical benefit of repeated treatment observed in former clinical trials. HCCP treatment has also the potential to significantly improve the QoL associated with CIPN. The safety profile of HCCP was confirmed, supporting its use in clinical practice.

Keywords: CIPN; breast cancer; high-concentration capsaicin; non-interventional study; painful chemotherapy-induced peripheral neuropathy; peripheral neuropathic pain; quality of life; topical therapy.

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Conflict of interest statement

ML: Lilly, AstraZeneca, MSD, Novartis, Pfizer, Eisai, Exact Sciences, Daiichi-Sankyo, Grünenthal GmbH, Gilead, Pierre Fabre, PharmaMar, Roche; LF: Grünenthal GmbH, Kiowa Kirin; CF: AstraZeneca, Amgen, Aventis, Celgene, Eisai, Genomic Health, Grünenthal GmbH, GSK, Lilly, Novartis, Pfizer, pfm medical, Roche, Sanofi, Teva; MH: employee of Grünenthal GmbH; SP: B&D, 3MMM/KCI, Endomag Ltd Cambridge, Grünenthal GmbH, Invitrocue Europe GmbH, Neodynamics Schweden, Novus Scientific Schweden, pfm medical ag, Roche, Sysmex Deutschland, Triconmed; TQ: employee of Grünenthal GmbH; RS: Grünenthal GmbH. MH and TQ are employed by Grünenthal GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Grünenthal GmbH. The funder was involved in the initial study design and provided financial support for data collection, analysis, and manuscript preparation.

Figures

Figure 1
Figure 1
Flowchart of study participant disposition and data collection. Visit 3 was the end of the study. Therefore, only results from treatments between V0 and V2 were analysed. During this period, 30 patients received one treatment, 22 received two treatments and 21 patients underwent all three treatments. Frequency, seriousness, and severity of ADRs were recorded throughout the observational period.
Figure 2
Figure 2
Reduction in painDETECT® scores. (A, B) Mean change in painDETECT ® final score (scale 0–38) based on OC data (A) and on data from patients who received 3 consecutive HCCP treatments at V0, V1, and V2 (B). After three treatments patients achieved average final painDETECT® scores below 12, indicating a reduced likelihood of neuropathic pain. (C) Mean change in painDETECT ® total score based on the assessment of seven sensory symptoms (score 0–35, above pillars) as well as of individual symptoms (scale from 0-5). NP: neuropathic pain. SD: standard deviation. V: visit. a p ≤ 0.001, b p ≤ 0.01, c p ≤ 0.05 vs baseline (two-sided one-sample t-test). No separate median line is shown for V0 in (B) because the median coincides with the first quartile.
Figure 3
Figure 3
Course of peripheral neuropathic pain intensity and response rates. (A, B) Average daily pain intensity recorded by NPRS in the total cohort (OC) (A) and in patients who received three consecutive HCCP treatments at V0 to V2 (B). (C, D) Percentage of patients with pain reduction of ≥ 30% or 50% in the total cohort (OC) (C) and in patients who received three consecutive HCCP treatments at V0 to V2 (D). SD: standard deviation. T, telephone contact; V, visit. a p ≤ 0.001, b p ≤ 0.01, c p ≤ 0.05 vs baseline (two-sided one-sample t-test).
Figure 4
Figure 4
Reduction of CIPN-specific symptoms and improvement in QoL according to the QLQ-CIPN20 questionnaire. Mean change in QLQ-CIPN20 total score (A) and its sensory (B) and motor (C) subscales. Lower score corresponds to an improvement in QoL and a decrease in symptoms. Autonomous symptoms (not shown) remained mainly unchanged. SD, standard deviation; T, telephone contact; V, visit. a p ≤ 0.001, b p ≤ 0.01, c p ≤ 0.05 vs baseline (two-sided one-sample t-test).
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