scholarly journals Multicenter randomized trial of arsenic trioxide and Realgar-Indigo naturalisformula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG-APL clinical study

2018 ◽  
Vol 93 (12) ◽  
pp. 1467-1473 ◽  
Author(s):  
Ming-Hua Yang ◽  
Wu-Qing Wan ◽  
Jie-Si Luo ◽  
Min-Cui Zheng ◽  
Ke Huang ◽  
...  
Keyword(s):  
Clinical Study ◽  
Randomized Trial ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Pediatric Patients ◽  
Promyelocytic Leukemia ◽  
Multicenter Randomized Trial

Oral arsenic trioxide for relapsed acute promyelocytic leukemia in pediatric patients

2011 ◽  
Vol 58 (4) ◽  
pp. 630-632 ◽  
Author(s):  
Wing Y. Au ◽  
Chi-Kong Li ◽  
Vincent Lee ◽  
Hui Leung Yuen ◽  
Jeffrey Yau ◽  
...  
Keyword(s):  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Pediatric Patients ◽  
Promyelocytic Leukemia

scholarly journals Arsenic trioxide is required in the treatment of newly diagnosed acute promyelocytic leukemia. Analysis of a randomized trial (APL 2006) by the French Belgian Swiss APL group

Haematologica ◽  
2018 ◽  
Vol 103 (12) ◽  
pp. 2033-2039 ◽  
Author(s):  
Lionel Adès ◽  
Xavier Thomas ◽  
Agnes Guerci Bresler ◽  
Emmanuel Raffoux ◽  
Olivier Spertini ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Promyelocytic Leukemia ◽  
Newly Diagnosed

scholarly journals Very Long Term Follow-up Data of Pediatric Acute Promyelocytic Leukemia Treated with Upfront Arsenic-Trioxide Based Regimens

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1400-1400 ◽  
Author(s):  
Fouzia N. ◽  
Anu Korula ◽  
Anup Joseph Devasia ◽  
Uday Prakash Kulkarni ◽  
Yasir Jeelani Samoon ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Retrospective Analysis ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Promyelocytic Leukemia ◽  
Long Term Follow Up

Abstract Combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) is currently considered the standard of care in the management of acute promyelocytic leukemia (APL). While APL is considered a highly curable malignancy there is recognition that the outcome in pediatric patients is inferior to that reported in young adults. There have been concerns raised in the past on the potential long term side effects of the use of ATO, especially in a pediatric population. There is limited long term follow up data on the use of ATO in the pediatric population. At our center we have been using ATO based regimens to treat pediatric and adult patients with APL since 1998 and hence we undertook this retrospective analysis to evaluate the long term clinical outcomes and toxicity profile in the pediatric cohort. Data on all consecutive pediatric patients (age ≤18yrs) diagnosed with APL and treated in the Department of Haematology, Christian Medical College, Vellore, from January, 1998 to December, 2017 were included in this retrospective analysis. Of the total 73 patients with age ≤ 18yrs diagnosed during this period, 5 refused treatment and were discharged against medical advice. Treatment in the remaining 68 patients consisted of single agent ATO until 2015 (n=57), as reported previously by us (Mathews et al. Blood 2016). From 2015 combination of ATO, ATRA ± an anthracycline in induction and consolidation was administered in a risk adjusted manner (n=11). The median age was 2 years (range: 2-18) with equal gender distribution (50% each). Sixty two (91.2%) achieved complete hematologic remission (CR), 5 (7.4%) early deaths occurred from intracranial hemorrhage (n=3), neutropenic sepsis (n=1) and pulmonary thrombo-embolism (n=1), one patient did not achieve CR at the end of induction. The median time to CR was 45 days (range: 25- 62). Other acute ATO-related toxicities were low grade, transient and not associated with any mortality (transaminitis = 12 [17.6%]; ATRA like syndrome = 6 [8.8%]). With a median follow-up of 71 months, the 5 year OS and EFS of pediatric cohort (n=68) was 78.9±5.2% and 61.8±6.4% respectively (Fig 1). Among the 62 patients in CR, 21 (33.9%) relapsed at a median of 18 months (range: 5-126) from the initial diagnosis; 16 bone marrow, 3 bone marrow+CNS and 2 molecular relapses; an additional 2 patients died in remission (one viral encephalitis and another data not available). Nineteen out of 21 (90.5%) patients who relapsed received ATO based re-induction while 2 refused treatment and were discharged at request. Out of the 19 treated patients, all attained second CR. CR was consolidated with an autologous SCT (n=10) or ATO based chemotherapy (n=9). The OS and EFS of the 19 relapsed patients was 72.9±10.4% and 68±10.8% respectively. On long term follow up of this pediatric cohort (median follow up 71 months; 18 (26.5%) > 10 years follow up and 37 (54.5%) > 5 years follow up) there were no long term renal, hepatic, metabolic complications or second malignancies noted. Our results indicate the high efficacy and long term safety of ATO based regimens in the treatment of children with APL. Even among the relapse pediatric APL patients treated with upfront ATO, salvage chemotherapy with ATO based regimen followed by autologous stem cell transplantation is associated with excellent long term survival and is not associated with any major long term complications. Disclosures No relevant conflicts of interest to declare.

scholarly journals Arsenic Trioxide Consolidation Allows Anthracycline Dose Reduction for Pediatric Patients With Acute Promyelocytic Leukemia: Report From the Children's Oncology Group Phase III Historically Controlled Trial AAML0631

2017 ◽  
Vol 35 (26) ◽  
pp. 3021-3029 ◽  
Author(s):  
Matthew A. Kutny ◽  
Todd A. Alonzo ◽  
Robert B. Gerbing ◽  
Yi-Cheng Wang ◽  
Susana C. Raimondi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
Promyelocytic Leukemia ◽  
Phase Iii ◽  
Oncology Group ◽  
Relapse Risk ◽  
Anthracycline Dose

Purpose The Children’s Oncology Group AAML0631 trial for newly diagnosed pediatric acute promyelocytic leukemia (APL) was a phase III historically controlled trial to determine the survival of patients receiving arsenic trioxide (ATO) consolidation and reduced doses of anthracyclines. Patients and Methods Patients age 2 to 21 years with de novo APL confirmed by PML-RARα polymerase chain reaction were stratified as standard risk (SR) or high risk (HR) on the basis of diagnostic WBC count. All patients received all-trans retinoic acid (ATRA) during induction, each consolidation course, and maintenance. All patients received two cycles of ATO therapy during consolidation 1, an additional two (SR) or three (HR) consolidation courses that included high-dose cytarabine and anthracycline, and maintenance therapy comprising ATRA, oral methotrexate, and mercaptopurine. Results One hundred one patients (66 SR and 35 HR) were evaluable for outcome. The 3-year overall survival was 94%, and event-free survival (EFS) was 91%. For SR and HR patients with APL, the overall survival was 98% versus 86% ( P = .003), and EFS was 95% versus 83% ( P = .03), respectively. The EFS for SR patients in AAML0631 was noninferior to that of patients in the AIDA 0493 historical control, which used a significantly higher anthracycline dose and did not include ATO consolidation. Relapse risk for patients in AAML0631 from end consolidation 1 (after ATO treatment) was only 4% at 3 years and did not differ significantly between SR and HR patients. Conclusion ATO consolidation cycles were well tolerated in pediatric patients with APL and allowed significant reduction in cumulative anthracycline doses while maintaining excellent survival and a low relapse risk for both SR and HR patients with APL.

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