000 03657na a2200229 4500
003 PC13321
005 20180417105945.0
008 130622s2012 xxx||||| |||| 00| 0 eng d
040 _cH120
041 _aeng
100 _aOrtiz Romero, Pablo Luis
_91223
_eDermatología Médico-Quirúrgica y Venereología
245 0 0 _aEfficacy 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).
_h[artículo]
260 _bBritish Journal of Dermatology,
_c2012
300 _a167(3):678-87.
500 _aFormato Vancouver: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B et al. 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). Br J Dermatol. 2012 Sep;167(3):678-87.
501 _aPMID: 22924950
504 _aContiene 35 referencias
520 _aBackground 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 (R)) 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.
710 _9145
_aServicio de Dermatología Médico-Quirúrgica y Venereología
856 _uhttp://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/1/pc13321.pdf
_ySolicitar documento
942 _n0
_2ddc
_cART
999 _c13321
_d13321