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document
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 ) . 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 .
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Intervention_Pharmacological
bexarotene combined with
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Intervention_Physical
psoralen-ultraviolet A
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Intervention_Pharmacological
( PUVA )
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Intervention_Physical
PUVA treatment alone
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Intervention_Physical
Psoralen plus ultraviolet A ( PUVA )
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Intervention_Physical
PUVA alone
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Intervention_Pharmacological
PUVA and bexarotene
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Outcome_Other
Efficacy and safety
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Outcome_Physical
disease response
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Outcome_Physical
response rates
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Participant_Condition
Cutaneous Lymphoma
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Participant_Condition
mycosis fungoides