2018
DOI: 10.1038/s41375-018-0233-7
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Tamibarotene maintenance improved relapse-free survival of acute promyelocytic leukemia: a final result of prospective, randomized, JALSG-APL204 study

Abstract: Between April 2004 and December 2010, we conducted a prospective randomized controlled study comparing tamibarotene with all-trans retinoic acid (ATRA) in the maintenance therapy of newly diagnosed acute promyelocytic leukemia (APL), and here report the final results of this study with a median follow-up of 7.3 years. Of 344 eligible patients who had received ATRA and chemotherapy, 319 (93%) achieved complete remission (CR). After completion of three courses of consolidation chemotherapy, 269 patients in molec… Show more

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Cited by 30 publications
(32 citation statements)
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“…A recent randomized study of the Japanese Adult Leukemia Study Group has demonstrated a significant benefit in relapse-free survival of tamibarotene over ATRA in maintenance therapy, especially in high-risk patients who obtained molecular remission with ATRA and chemotherapy. 47 Given the extreme rarity of relapse in low-risk patients who are PCR 2 after completion of consolidation, the panel concluded that there was no need for blood or marrow PCR monitoring after this time in these patients.…”
Section: Management After Consolidationmentioning
confidence: 99%
“…A recent randomized study of the Japanese Adult Leukemia Study Group has demonstrated a significant benefit in relapse-free survival of tamibarotene over ATRA in maintenance therapy, especially in high-risk patients who obtained molecular remission with ATRA and chemotherapy. 47 Given the extreme rarity of relapse in low-risk patients who are PCR 2 after completion of consolidation, the panel concluded that there was no need for blood or marrow PCR monitoring after this time in these patients.…”
Section: Management After Consolidationmentioning
confidence: 99%
“…A new synthetic retinoid Tamibarotene (Am80) with higher binding affinity to PML-RARA than ATRA has been under investigation. Tamibarotene is a potent inducer of differentiation in HL-60 and NB-4 cell lines in vitro; the synthetic retinoid has also shown a longer half-life when compared to ATRA [69]. Clinical studies have shown a modest effect in relapsed patients; however, statistical differences in efficacy seem to vanish at 5 years [69].…”
Section: Treatment Complications Of Aplmentioning
confidence: 99%
“…Among 269 APL with CR underwent maintenance random, four year relapse-free survival rate was 84% (ATRA) and 91% (Tamibarotene). In 52 high risk patients, this became significant (50% for ATRA, 87% for tamibarotene) 72 . In comparative analysis among those relapsed APL 74 , 80%(28/35) achieved CR and 22.86% CRm in tamibarotene-ATO versus 54.2% (19/35)CR with only 2.86-3.7% CRm in ATRA and ATO regimen 73 .…”
Section: Discussionmentioning
confidence: 99%