title: Single-agent arsenic trioxide in the treatment of newly diagnosed acute promyelocytic leukemia: long-term follow-up data.
abstract: 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.
authors.affiliation: Department of Haematology, Christian Medical College and Hospital, Vellore 632004, India; vikram@cmcvellore.ac.in.
authors.forename: Vikram
authors.initials: V
authors.lastname: Mathews
authors.forename: Biju
authors.initials: B
authors.lastname: George
authors.forename: Ezhilarasi
authors.initials: E
authors.lastname: Chendamarai
authors.forename: Kavitha M
authors.initials: KM
authors.lastname: Lakshmi
authors.forename: Salamun
authors.initials: S
authors.lastname: Desire
authors.forename: Poonkuzhali
authors.initials: P
authors.lastname: Balasubramanian
authors.forename: Auro
authors.initials: A
authors.lastname: Viswabandya
authors.forename: Rajashekar
authors.initials: R
authors.lastname: Thirugnanam
authors.forename: Aby
authors.initials: A
authors.lastname: Abraham
authors.forename: Ramachandran Velayudhan
authors.initials: RV
authors.lastname: Shaji
authors.forename: Alok
authors.initials: A
authors.lastname: Srivastava
authors.forename: Mammen
authors.initials: M
authors.lastname: Chandy
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006197:Hair / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009262:Nails / Q000378:metabolism; D010087:Oxides / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012008:Recurrence; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001152:Arsenicals; D010087:Oxides; D000077237:Arsenic Trioxide