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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).
Br J Dermatol. 2012 Sep; 167(3):678-87.BJ

Abstract

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.

Authors+Show Affiliations

St John's Institute of Dermatology, King's College London, London, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22924950

Citation

Whittaker, S, 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)." The British Journal of Dermatology, vol. 167, no. 3, 2012, pp. 678-87.
Whittaker S, Ortiz P, Dummer R, 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;167(3):678-87.
Whittaker, S., Ortiz, P., Dummer, R., Ranki, A., Hasan, B., Meulemans, B., Gellrich, S., Knobler, R., Stadler, R., & Karrasch, M. (2012). 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). The British Journal of Dermatology, 167(3), 678-87. https://doi.org/10.1111/j.1365-2133.2012.11156.x
Whittaker S, 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;167(3):678-87. PubMed PMID: 22924950.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Whittaker,S, AU - Ortiz,P, AU - Dummer,R, AU - Ranki,A, AU - Hasan,B, AU - Meulemans,B, AU - Gellrich,S, AU - Knobler,R, AU - Stadler,R, AU - Karrasch,M, PY - 2012/8/29/entrez PY - 2012/8/29/pubmed PY - 2013/1/16/medline SP - 678 EP - 87 JF - The British journal of dermatology JO - Br J Dermatol VL - 167 IS - 3 N2 - 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. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/22924950/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__ L2 - https://doi.org/10.1111/j.1365-2133.2012.11156.x DB - PRIME DP - Unbound Medicine ER -