Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study)
Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, dose-limiting adverse effect of commonly used chemotherapeutic agents. The purpose of this exploratory study was to evaluate the efficacy and safety of mirogabalin in patients with moderate to severe CIPN during chem...
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BMC
2023-11-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-11560-4 |
| _version_ | 1797559019858034688 |
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| author | Sonoko Misawa Tadamichi Denda Sho Kodama Takuji Suzuki Yoichi Naito Takahiro Kogawa Mamoru Takada Tomoki Suichi Kazuhito Shiosakai Satoshi Kuwabara on behalf of the MiroCIP study group |
| author_facet | Sonoko Misawa Tadamichi Denda Sho Kodama Takuji Suzuki Yoichi Naito Takahiro Kogawa Mamoru Takada Tomoki Suichi Kazuhito Shiosakai Satoshi Kuwabara on behalf of the MiroCIP study group |
| author_sort | Sonoko Misawa |
| collection | DOAJ |
| description | Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, dose-limiting adverse effect of commonly used chemotherapeutic agents. The purpose of this exploratory study was to evaluate the efficacy and safety of mirogabalin in patients with moderate to severe CIPN during chemotherapy and the effects of 12 weeks’ intervention on chemotherapy completion and CIPN severity. Methods Patients experiencing moderate to severe CIPN while undergoing oxaliplatin- or taxane-containing chemotherapy for colorectal, gastric, non-small-cell lung, or breast cancer received mirogabalin at between 5 and 15 mg twice daily. The primary endpoint was change in numeric rating scale (NRS) score for pain from baseline to week 12. Secondary endpoints included NRS scores for tingling and sleep, completion of chemotherapy, severity of CIPN, and quality of life (QOL) scores. The safety endpoint was incidence of adverse events. Results Of 58 patients who consented to participation, 52 were eligible and constituted the full analysis set and safety analysis set. From baseline to week 12 (last observation carried forward [LOCF]), NRS score decreased by 30.9%: mean change (95% confidence interval [CI]), − 1.7 (− 2.4 to − 1.0) (p < 0.001). Patients with baseline NRS of ≥ 6 experienced a 44.0% reduction in score from baseline to week 12 (LOCF): mean change (95% CI), − 3.3 (− 5.0 to − 1.5) (p = 0.002). Chemotherapy was discontinued in 18 (34.6%) patients; CIPN led to discontinuation in only 2 (3.8%). There was no notable worsening of CIPN severity in terms of Common Terminology Criteria for Adverse Events grade or Modified Total Neuropathy Score-reduced, although use of pain medications during chemotherapy might cause worsening of CIPN due to underestimation of subjective symptoms. QOL score based on the EuroQol five-dimensional descriptive system did not worsen during the 12 weeks. Thirty-one percent of patients experienced adverse drug reactions, and the most common event was somnolence (13.5%). Serious adverse events and death occurred in 3 patients and 1 patient, respectively; however, they were unrelated to mirogabalin treatment. Conclusions Intervention with mirogabalin during chemotherapy may be effective and safe for cancer patients with moderate to severe CIPN. It can contribute to completion of chemotherapy without worsening of CIPN. Trial registration Japan Registry of Clinical Trials (jRCTs031210101, registered 20/5/2021). |
| first_indexed | 2024-03-10T17:39:40Z |
| format | Article |
| id | doaj.art-5c5d7bed96f94e5a8e4f6cacca56729a |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-10T17:39:40Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj.art-5c5d7bed96f94e5a8e4f6cacca56729a2023-11-20T09:43:29ZengBMCBMC Cancer1471-24072023-11-0123111110.1186/s12885-023-11560-4Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study)Sonoko Misawa0Tadamichi Denda1Sho Kodama2Takuji Suzuki3Yoichi Naito4Takahiro Kogawa5Mamoru Takada6Tomoki Suichi7Kazuhito Shiosakai8Satoshi Kuwabara9on behalf of the MiroCIP study groupDepartment of Neurology, Graduate School of Medicine, Chiba UniversityDivision of Gastroenterology, Chiba Cancer CenterPrimary Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., LtdDepartment of Respirology, Graduate School of Medicine, Chiba UniversityDepartment of General Internal Medicine/Experimental Therapeutics/Medical Oncology, National Cancer Center Hospital EastDivision of Early Clinical Development for Cancer, Department of Advanced Medical Development, Cancer Institute Hospital of JFCRDepartment of General Surgery, Graduate School of Medicine, Chiba UniversityDepartment of Neurology, Graduate School of Medicine, Chiba UniversityData Intelligence Department, Global DX, Daiichi Sankyo Co., LtdDepartment of Neurology, Graduate School of Medicine, Chiba UniversityAbstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, dose-limiting adverse effect of commonly used chemotherapeutic agents. The purpose of this exploratory study was to evaluate the efficacy and safety of mirogabalin in patients with moderate to severe CIPN during chemotherapy and the effects of 12 weeks’ intervention on chemotherapy completion and CIPN severity. Methods Patients experiencing moderate to severe CIPN while undergoing oxaliplatin- or taxane-containing chemotherapy for colorectal, gastric, non-small-cell lung, or breast cancer received mirogabalin at between 5 and 15 mg twice daily. The primary endpoint was change in numeric rating scale (NRS) score for pain from baseline to week 12. Secondary endpoints included NRS scores for tingling and sleep, completion of chemotherapy, severity of CIPN, and quality of life (QOL) scores. The safety endpoint was incidence of adverse events. Results Of 58 patients who consented to participation, 52 were eligible and constituted the full analysis set and safety analysis set. From baseline to week 12 (last observation carried forward [LOCF]), NRS score decreased by 30.9%: mean change (95% confidence interval [CI]), − 1.7 (− 2.4 to − 1.0) (p < 0.001). Patients with baseline NRS of ≥ 6 experienced a 44.0% reduction in score from baseline to week 12 (LOCF): mean change (95% CI), − 3.3 (− 5.0 to − 1.5) (p = 0.002). Chemotherapy was discontinued in 18 (34.6%) patients; CIPN led to discontinuation in only 2 (3.8%). There was no notable worsening of CIPN severity in terms of Common Terminology Criteria for Adverse Events grade or Modified Total Neuropathy Score-reduced, although use of pain medications during chemotherapy might cause worsening of CIPN due to underestimation of subjective symptoms. QOL score based on the EuroQol five-dimensional descriptive system did not worsen during the 12 weeks. Thirty-one percent of patients experienced adverse drug reactions, and the most common event was somnolence (13.5%). Serious adverse events and death occurred in 3 patients and 1 patient, respectively; however, they were unrelated to mirogabalin treatment. Conclusions Intervention with mirogabalin during chemotherapy may be effective and safe for cancer patients with moderate to severe CIPN. It can contribute to completion of chemotherapy without worsening of CIPN. Trial registration Japan Registry of Clinical Trials (jRCTs031210101, registered 20/5/2021).https://doi.org/10.1186/s12885-023-11560-4AnalgesiaCancerChemotherapyChemotherapy-induced peripheral neuropathyMirogabalinNeurotoxicity |
| spellingShingle | Sonoko Misawa Tadamichi Denda Sho Kodama Takuji Suzuki Yoichi Naito Takahiro Kogawa Mamoru Takada Tomoki Suichi Kazuhito Shiosakai Satoshi Kuwabara on behalf of the MiroCIP study group Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) BMC Cancer Analgesia Cancer Chemotherapy Chemotherapy-induced peripheral neuropathy Mirogabalin Neurotoxicity |
| title | Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) |
| title_full | Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) |
| title_fullStr | Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) |
| title_full_unstemmed | Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) |
| title_short | Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study) |
| title_sort | efficacy and safety of mirogabalin for chemotherapy induced peripheral neuropathy a prospective single arm trial mirocip study |
| topic | Analgesia Cancer Chemotherapy Chemotherapy-induced peripheral neuropathy Mirogabalin Neurotoxicity |
| url | https://doi.org/10.1186/s12885-023-11560-4 |
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