PMID- 20644086 OWN - NLM STAT- MEDLINE DCOM- 20100906 LR - 20181201 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 28 IP - 24 DP - 2010 Aug 20 TI - Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: long-term follow-up data. PG - 3866-71 LID - 10.1200/JCO.2010.28.5031 [doi] AB - PURPOSE We previously reported our results with a single-agent arsenic trioxide (ATO) -based regimen in newly diagnosed cases of acute promyelocytic leukemia (APL). The concern remained about the long-term outcome of this well-tolerated regimen. We report our long-term follow-up data on the same cohort. PATIENTS AND METHODS From January 1998 to December 2004, 72 patients with PML/RARalpha+ APL were enrolled. All patients were treated with a single-agent ATO regimen. Results Overall 62 (86.1%) achieved a hematologic remission (complete remission). After the initial report, an additional seven patients have relapsed for a total of 13 relapses. There were no additional toxicities to report on follow-up. At a median follow-up 60 months, the 5-year Kaplan-Meier estimate (+/- SE) of event-free survival, disease-free survival, and overall survival (OS) was 69% +/- 5.5%, 80% +/- 5.2%, and 74.2% +/- 5.2%, respectively. The OS in the good risk group as defined by us remains 100% over this period. CONCLUSION Single-agent ATO as used in this study in the management of newly diagnosed cases of APL is safe and is associated with durable responses. Results in the low-risk group are comparable to that reported with conventional therapy while additional interventions would probably be required in high-risk cases. FAU - Mathews, Vikram AU - Mathews V AD - Department of Haematology, Christian Medical College and Hospital, Vellore 632004, India; vikram@cmcvellore.ac.in. FAU - George, Biju AU - George B FAU - Chendamarai, Ezhilarasi AU - Chendamarai E FAU - Lakshmi, Kavitha M AU - Lakshmi KM FAU - Desire, Salamun AU - Desire S FAU - Balasubramanian, Poonkuzhali AU - Balasubramanian P FAU - Viswabandya, Auro AU - Viswabandya A FAU - Thirugnanam, Rajashekar AU - Thirugnanam R FAU - Abraham, Aby AU - Abraham A FAU - Shaji, Ramachandran Velayudhan AU - Shaji RV FAU - Srivastava, Alok AU - Srivastava A FAU - Chandy, Mammen AU - Chandy M LA - eng PT - Clinical Trial PT - Journal Article DEP - 20100719 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antineoplastic Agents) RN - 0 (Arsenicals) RN - 0 (Oxides) RN - S7V92P67HO (Arsenic Trioxide) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents/administration & dosage/pharmacokinetics/*therapeutic use MH - Arsenic Trioxide MH - Arsenicals/administration & dosage/pharmacokinetics/*therapeutic use MH - Disease-Free Survival MH - Female MH - Follow-Up Studies MH - Hair/metabolism MH - Humans MH - Infusions, Intravenous MH - Kaplan-Meier Estimate MH - Leukemia, Promyelocytic, Acute/*diagnosis/*drug therapy MH - Male MH - Middle Aged MH - Nails/metabolism MH - Oxides/administration & dosage/pharmacokinetics/*therapeutic use MH - Recurrence MH - Remission Induction MH - Time Factors MH - Treatment Outcome EDAT- 2010/07/21 06:00 MHDA- 2010/09/08 06:00 CRDT- 2010/07/21 06:00 PHST- 2010/07/21 06:00 [entrez] PHST- 2010/07/21 06:00 [pubmed] PHST- 2010/09/08 06:00 [medline] AID - JCO.2010.28.5031 [pii] AID - 10.1200/JCO.2010.28.5031 [doi] PST - ppublish SO - J Clin Oncol. 2010 Aug 20;28(24):3866-71. doi: 10.1200/JCO.2010.28.5031. Epub 2010 Jul 19.