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  • American Society of Clinical Oncology (ASCO)  (3)
  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 122-122
    Abstract: 122 Background: Enzalutamide and abiraterone plus prednisolone demonstrated improvement of survival for castration-resistant prostate cancer (CRPC). However, it remains quite unclear which agent is better in terms of efficacy and safety for Asian patients. Methods: An investigator-initiated, multicenter, randomized controlled trial was conducted in Japan. CRPC patients before chemotherapy were randomly assigned to the enzalutamide or the abiraterone plus prednisolone arm (1:1). The primary endpoint is time to prostate-specific antigen (PSA) progression and secondary endpoints include PSA response rate (≥50% decline from baseline), overall survival, radiographic progression-free survival, and safety assessment. Results: Between February 20, 2015 and July 30, 2019, 203 patients were enrolled. After randomization, 92 in the enzalutamide and 92 in the abiraterone plus prednisolone arm were treated and analyzed. Time to PSA progression was not significantly different between arms (median 21.2 and 11.9 months in the enzalutamide and the abiraterone plus prednisolone arm, respectively; hazard ration 0.81, 95% CI 0.51-1.27, p = 0.1732). There was a significant difference in PSA response rate between arms (72% and 57% in the enzalutamide and the abiraterone plus prednisolone arm, respectively, p = 0.0425). There were no significant differences in overall and radiographic progression-free survival between arms (median 32.9 and 35.5months in the enzalutamide and the abiraterone plus prednisolone arm, respectively; hazard ration 1.17, 95% CI 0.72-1.88, p = 0.5290 and median 17.6 and 14.0 months in the enzalutamide and the abiraterone plus prednisolone arm, respectively; hazard ration 0.92, 95% CI 0.63-1.34, p = 0.6532). Grade ≥3 of adverse events were observed in 11% and 21% in the enzalutamide and the abiraterone plus prednisolone arm, respectively ( p = 0.1044). Conclusions: Enzalutamide did not show any survival benefits compared with abiraterone plus prednisolone but showed better PSA response rate with no significant differences of severe adverse event rate for Japanese CRPC patients. Our data suggest that antecedent use of enzalutamide to abiraterone plus prednisolone have potentially clinical benefits in Asian CRPC populations. Clinical trial information: UMIN000015529.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 10073-10073
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 10073-10073
    Abstract: 10073 Background: In recent times,minimally invasive surgery, such as endoscopic surgery, has gained a lot of popularity.The navigation system was introduced to orthopedic surgery in the 1990s. These days, computed tomography (CT)-based navigation systems are commonly used in spine and joint replacement surgery because of their precision. The aim of our study was to evaluate the accuracy and efficacy of navigation-assisted excision of bone and soft tissue tumors. Methods: From January 2006 to December 2009, we performed navigation-assisted surgery in 16 patients (11 men and 5 women; mean age, 39 years; range, 13-70 years). We diagnosed 9 benign bone tumors and 7 malignant bone and soft tissue tumors. In 2 patients, the malignant soft tissue tumors infiltrated the adjacent bones. We performed excisional biopsies for the benign tumors and en bloc excisions for the malignant tumors. In all the cases, the point registration method was used with 10 skin markers that were placed around the tumor. Each excisional difference between the preoperative and postoperative plans was evaluated histologically or by postoperative CT. Results: The mean preoperative registration matching time was 12.8 min (range, 8-25 min). The total mean preparation time was 24 min (range, 16-35 min). The mean accuracy of this system, which was determined using the skin markers, was 0.93 mm (range, 0.6-1.5 mm). All biopsied and excised specimens were evaluated by pathologic examination and postoperative CT imaging. The mean difference between the planned margin and postoperative CT or the excised histological specimen was 0 to 4 mm. The mean follow-up period was 53.2 months (range, 10-70 months). There were no local recurrences, except for a case of chordoma that required excision of skip metastases and a case of extraskeletal osteosarcoma, in which the patient died from the disease. Conclusions: We report our experience with navigation-assisted surgery for bone and soft tissue tumors performed using skin markers. Navigation-assisted surgery was indicated in the case of sufficiently reliable, accurate, and minimally invasive resections.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 11568-11568
    Abstract: 11568 Background:A tenosynovial giant cell tumor (TGCT) is a locally aggressive benign neoplasm arising from intra- or extra-articular tissue, and categorized localized (L-TGCT) or diffuse-type (D-TGCT). D-TGCT most commonly develops in the knee or ankle. We revealed that zaltoprofen, a nonsteroidal anti-inflammatory drug possessing the ability to activate peroxisome proliferator-activated receptor gamma (PPARγ), can inhibit the proliferation of TGCT stromal cells via PPARγ. PPARγ is a ligand-activated transcription factor that belongs to the nuclear hormone receptor superfamily. Therefore, we conducted a randomized trial to evaluate whether zaltoprofen was effective for patients with TGCT. Methods:This study was a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the safety and efficacy of zaltoprofen for patients with L-TGCT or D-TGCT. For the treatment group, zaltoprofen 480 mg/day was administered for 48 weeks. The primary outcome was the progression-free rate (PFR) at week 48 after treatment administration. Disease progression was defined as follows requiring surgical interventions: 1) repetitive joint swelling due to hemorrhage; 2) limited range of joint motion; 3) invasion of adjacent cartilage or bone; 4) severe joint space narrowing; or 5) increase in tumor size (target lesion). This study was registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN000025901). Results:We allocated forty-one patients to zaltoprofen (n = 21; Z) or placebo (n = 20; P) groups. The mean age was 44 years (range, 26 to 66) in the group Z and 47 years (range, 24 to 69) in the group P. TGCTs located at a knee in 26 patients and at an ankle in 15 patients. The primary outcome of PFR for the group Z was not higher than that for the group P at week 48 (84.0% vs. 90.0%; p = 0.619). The objective tumor response was graded as partial response (PR) in 1 patient, stable disease (SD) in 19, and progressive disease (PD) in 1 for the group Z, and SD in 17 and PD in 3 for the group P. The mean musculoskeletal tumor society scoring system for group Z was significantly improved from baseline to week 48 (83.8% vs. 93.0%, p = 0.02), whereas that for the group P was not significantly improved (82.2% vs. 86.8%; p = 0.167). During the study period, one severe adverse event was observed (grade 3 hypertension) in the group Z. Conclusions:To our knowledge, this was the first study to evaluate the efficacy of zaltoprofen in patients with TGCT. The TGCT patients in zaltoprofen group did not have higher PER compared with those in the placebo group at week 48. Zaltoprofen appeared to improve the limb-function. Both groups presented with a stable disease course for 48 weeks, therefore, the long-term clinical course of TGCT should be clarified. Further analysis with long-term administration of zaltoprofen is considered for the future study. Clinical trial information: UMIN000025901.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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