التفاصيل البيبلوغرافية
| العنوان: |
A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy |
| المؤلفون: |
Kotaka, Masahito, Saito, Yoji, Kato, Takeshi, Satake, Hironaga, Makiyama, Akitaka, Tsuji, Yasushi, Shinozaki, Katsunori, Fujiwara, Toshiyoshi, Mizushima, Tsunekazu, Harihara, Yasushi, Nagata, Naoki, Kurihara, Naoto, Ando, Masahiko, Kusakawa, Genichi, Sakai, Takumi, Uchida, Yugo, Takamoto, Mikihiro, Kimoto, Saki, Hyodo, Ichinosuke |
| المصدر: |
Cancer Chemother Pharmacol |
| بيانات النشر: |
Springer Berlin Heidelberg |
| سنة النشر: |
2020 |
| مصطلحات موضوعية: |
Original Article, psy, art |
| الوصف: |
PURPOSE: The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN). METHODS: This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1–3); 1-day ART (ART-123: day 1, placebo: days 2–3); and 3-day ART (ART-123: days 1–3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators. RESULTS: Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI −.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: −23.5 [95% CI −48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: −18.5 [95% CI −44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred. CONCLUSION: ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00280-020-04135-8) contains supplementary material, which is available to authorized users. |
| نوع الوثيقة: |
text |
| اللغة: |
English |
| العلاقة: |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561567Test/ |
| الإتاحة: |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561567Test/ |
| حقوق: |
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| رقم الانضمام: |
edsbas.D32E0D70 |
| قاعدة البيانات: |
BASE |
