首页> 外文OA文献 >Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056)
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Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056)

机译:贝沙罗汀联合补骨脂素-紫外线A(PUVA)与单独PUVA治疗在IB-IIA真菌病真菌中的疗效和安全性:EORTC皮肤淋巴瘤专案小组III期随机临床试验的最终结果(NCT00056056)

摘要

Background  Psoralen plus ultraviolet A (PUVA) is the standard treatment for early stages of mycosis fungoides. There have been no adequate randomized controlled trials with sufficient power comparing this modality with other therapies. Objective  To assess disease response and to compare the response rates of patients treated with PUVA alone or PUVA and bexarotene. Methods  EORTC 21011 (NCT 00056056) was a randomized phase III study comparing combined bexarotene (Targretin(®) ) and PUVA vs. PUVA alone in patients with stage IB and IIA mycosis fungoides (MF). The primary endpoint was the overall response rate [complete clinical response (CCR) plus partial response (PR)]. Results  The study was prematurely closed due to low accrual after 93 of 145 required patients (65%) were randomized. Of the 93 randomized patients, 87 started treatment, 41 received PUVA and 46 received PUVA + bexarotene. Total UVA doses received were 107 J cm(-2) (range 1·4-489·9) in the PUVA arm vs. 101·7 J cm(-2) (0·2-529·9) in the combination arm. The safety profile was acceptable with few grade 3-4 toxicities observed in either arm. More drop-outs due to toxicity were observed in the combination arm compared with the PUVA-alone arm. The best overall response (CCR + PR) rate was 71% for PUVA alone and 77% for the combination arm (P = 0·57). The median duration of response was 9·7 months for PUVA vs. 5·8 months for the combination arm (P = 0·33). CCR was seen in 25 patients of whom 10 received PUVA alone (CCR 22%) and 15 received combination therapy (CCR 31%) (P = 0·45). CCR was sustained in 25% of patients regardless of therapy. There was a trend towards fewer PUVA sessions needed to achieve CCR in the combination arm (median 22) compared with the PUVA arm (median 27·5) (P = 0·11). Similarly, a trend towards lower UVA dose required to achieve CCR in the combination arm (median 55·8 J cm(-2) ) compared with the PUVA arm alone (median 117·5 J cm(-2) ) (P = 0·5) was observed. Conclusions  No significant difference in response rate or response duration was observed in this study. However, there was a trend towards fewer PUVA sessions and lower UVA dose required to achieve CCR in the combination arm (PUVA + bexarotene) but this did not achieve statistical significance due to insufficient power.
机译:背景补骨脂素加紫外线A(PUVA)是蕈样真菌病早期的标准治疗方法。尚无足够的随机对照试验具有足够的功效将该方法与其他疗法进行比较。目的评估疾病反应并比较单独使用PUVA或PUVA和贝沙罗汀治疗的患者的反应率。方法EORTC 21011(NCT 00056056)是一项随机III期研究,比较了IB期和IIA期真菌病真菌(MF)患者联合使用贝沙罗汀(Targretin®)和PUVA与单独PUVA的比较。主要终点为总体缓解率[完全临床缓解(CCR)加部分缓解(PR)]。结果由于145名需要治疗的患者中的93名(65%)被随机分组​​,该研究由于预料不足而提前结束。在93名随机分组的患者中,有87名开始接受治疗,41名接受了PUVA治疗,46名接受了PUVA +贝沙罗汀治疗。 PUVA组接受的总UVA剂量为107 J cm(-2)(范围1·4-489·9),组合组为101·7 J cm(-2)(0·2-529·9) 。安全性是可以接受的,在任一组中均观察到极少的3-4级毒性。与单独使用PUVA的手臂相比,在组合手臂中观察到了更多的由于毒性引起的退学。最佳的总反应率(CCR + PR)对于单独的PUVA为71%,对于组合臂为77%(P = 0·57)。 PUVA的中位反应持续时间为9·7月,而联合用药组的中位反应时间为5·8月(P = 0·33)。在25例患者中发现了CCR,其中10例单独接受PUVA(CCR 22%),15例接受联合疗法(CCR 31%)(P = 0·45)。无论采用何种治疗方法,25%的患者均能维持CCR。与PUVA组(中位数27·5)相比,组合组(中位数22)中实现CCR所需的PUVA疗程呈减少趋势(P = 0·11)。同样,与单独使用PUVA臂(中位数117·5 J cm(-2))相比,组合臂达到CCR所需的UVA剂量有降低的趋势(中位数117·5 J cm(-2))(P = 0 ·5)被观察到。结论:在这项研究中,观察到反应率或反应持续时间没有显着差异。然而,有一种趋势是在联合治疗组(PUVA +贝沙罗汀)中达到CCR所需的PUVA疗程减少,UVA剂量降低,但由于功率不足,因此没有统计学意义。

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