Demonstrated efficacy
In clinical studies, TRISENOX
® (arsenic trioxide) injection has shown both high rates of remission
(complete and molecular) and high rates of survival for patients with relapsed or refractory acute
promyelocytic leukemia (APL).
Remission
TRISENOX delivers high rates of complete remission and molecular remission in relapsed or
refractory APL.
1-3
*Complete remission, as defined in the
Prescribing Information: Absence of visible
leukemic cells in bone marrow and peripheral recovery of platelets and white blood cells
with a confirmatory bone marrow ≥ 30 days later.
1
† ATRA = all-
trans retinoic acid
‡ In patients who met the criteria for complete remission, molecular remission monitored
by reverse transcription-polymerase chain reaction to detect PML/RAR-alpha transcripts.
1
Published remission data shown below have been adjusted based on the revised definition of
remission.4§
The U.S. multicenter trial was an open-label, single-arm, non-comparative trial in 40
patients with APL who had either relapsed from, or did not respond to, induction chemotherapy
using anthracycline and at least one course of ATRA or 9-
cis retinoic acid. Patients could
receive up to 60 doses of TRISENOX 0.15 mg/kg/day. Twenty-four patients were female; 35
were ≥ 18 years of age; 21 patients had 1 relapse; and 19 patients had > 1 relapse.
§ The definition was revised by the International Working Group of investigators in Madrid,
Spain, 2001. The definition given in the
Prescribing Information, which requires a
confirmatory bone marrow rate, is no longer current.
4
The single-institution pilot study was an open-label, non-comparative study in 12
patients with relapsed APL after extensive ATRA and cytotoxic treatment.
TRISENOX induces a high rate of molecular remission.
2
- Inducing molecular remission is a major treatment goal in APL, thought to be a target for achieving long-term survival5,6
- TRISENOX induces molecular remission in the majority of patients in relapse, so chemotherapy is not required5
Survival
Over half the patients in the U.S. multicenter trial were alive at the 18-month follow-up,
irrespective of the number of prior therapies and/or relapses.
2
Survival estimates for relapsed or refractory APL patients treated with TRISENOX:
2
Adapted from Soignet SL, et al. United States multicenter study of arsenic trioxide
in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001;19:3852-3860. Reprinted with
permission from the American Society of Clinical Oncology.
>> Click here to find out if TRISENOX may be
right for your APL patient.
Serious adverse events, grade 3 or 4, were common. Those events attributable to TRISENOX in the
Phase 2 study of 40 patients with refractory or relapsed APL included APL differentiation syndrome
(n = 3), hyperleukocytosis (n = 3), QTc interval prolongation (n = 16), atrial dysrhythmias (n = 2),
hyperglycemia
(n = 2), and torsades de pointes (n = 1).
In clinical trials, most patients taking TRISENOX experienced some drug-related toxicity, most
commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue,
edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. These adverse
effects have not been observed to be permanent or irreversible, nor do they usually require
interruption of therapy.
1. TRISENOX Prescribing Information. Frazer, Pa: Cephalon, Inc.;2005.
2. Soignet SL, Frankel SR, Douer D, et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001;19:3852-3860.
3. Soignet SL, Maslak P, Wang Z-G, et al. Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med. 1998;339:1341-1348.
4. Cheson BD, Bennett JM, Kopecky KJ, et al. Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol. 2003;21;4642-4649.
5. Douer D, Tallman MS. Arsenic trioxide: new clinical experience with an old medication in hematologic malignancies. J Clin Oncol. 2005;23:2396-2410.
6. Ito Y, Miyamura K. Clinical significance of minimal residual disease in leukemia detected by polymerase chain reaction: is molecular remission a milestone for achieving a cure? Leuk Lymphoma. 1994;16:57-64.