Academic Journal
Randomized placebo-controlled double-blind phase II study of zaltoprofen for patients with diffuse-type and unresectable localized tenosynovial giant cell tumors: The REALIZE study
| العنوان: | Randomized placebo-controlled double-blind phase II study of zaltoprofen for patients with diffuse-type and unresectable localized tenosynovial giant cell tumors: The REALIZE study |
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| المؤلفون: | Takeuchi, Akihiko, Endo, Makoto, Kawai, Akira, Nishida, Yoshihiro, Terauchi, Ryu, Matsumine, Akihiko, Aiba, Hisaki, Nakamura, Tomoki, Tandai, Susumu, Ozaki, Toshifumi, Hoshi, Manabu, Kayano, Daiki, Okuda, Miho, Yamamoto, Norio, Hayashi, Katsuhiro, Miwa, Shinji, Igarashi, Kentaro, Yoshimura, Kenichi, Nomura, Akihiro, Murayama, Toshinori, Tsuchiya, Hiroyuki |
| المساهمون: | Center for Clinical Trials, Japan Medical Association, Japan Agency for Medical Research and Development |
| المصدر: | Frontiers in Oncology ; volume 12 ; ISSN 2234-943X |
| بيانات النشر: | Frontiers Media SA |
| سنة النشر: | 2022 |
| المجموعة: | Frontiers (Publisher - via CrossRef) |
| الوصف: | Background A tenosynovial giant cell tumor (TGCT) is a locally aggressive benign neoplasm arising from intra- or extra-articular tissue, categorized as localized (L-TGCT, solitary lesion) and diffuse (D-TGCT, multiple lesions) TGCT. Surgical excision is the mainstay of the treatment, and a high local recurrence rate of approximately 50% has been reported. We focused on zaltoprofen, a nonsteroidal anti-inflammatory drug that can activate peroxisome proliferator-activated receptor gamma (PPARγ) and inhibit the proliferation of TGCT stromal cells. Therefore, we conducted a randomized trial to evaluate the safety and effectiveness of zaltoprofen in patients with D-TGCTs or unresectable L-TGCTs. Methods This randomized, placebo-controlled, double-blind, multicenter trial evaluated the safety and efficacy of zaltoprofen. In the treatment group, zaltoprofen (480 mg/day) was administered for 48 weeks; the placebo group received similar dosages without zaltoprofen. The primary outcome was progression-free rate (PFR) 48 weeks after treatment administration. Disease progression was defined as the following conditions requiring surgical intervention: 1) repetitive joint swelling due to hemorrhage, 2) joint range of motion limitation, 3) invasion of the adjacent cartilage or bone, 4) severe joint space narrowing, and 5) increased tumor size (target lesion). Results Forty-one patients were allocated to the zaltoprofen (n=21) or placebo (n=20) groups. The PFR was not significant between the zaltoprofen group and the placebo group at 48 weeks (84.0% and 90.0%, respectively; p=0.619). The mean Japanese Orthopedic Association knee score significantly improved from baseline to week 48 in the zaltoprofen group (85.38 versus 93.75, p=0.027). There was a significant difference between the values at 48 weeks of placebo and zaltoprofen group (p=0.014). One severe adverse event (grade 3 hypertension) was observed in the zaltoprofen group. Discussion This is the first study to evaluate the efficacy and safety of zaltoprofen in patients ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| DOI: | 10.3389/fonc.2022.900010 |
| DOI: | 10.3389/fonc.2022.900010/full |
| الاتاحة: | http://dx.doi.org/10.3389/fonc.2022.900010 https://www.frontiersin.org/articles/10.3389/fonc.2022.900010/full |
| Rights: | https://creativecommons.org/licenses/by/4.0/ |
| رقم الانضمام: | edsbas.E35EEC6B |
| قاعدة البيانات: | BASE |
| DOI: | 10.3389/fonc.2022.900010 |
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