PEG-INTERFERON ΑLPHA 2B CAN IMPROVE MOLECULAR RECURRENCES IN THE TREATMENT-FREE REMISSION; A PILOT STUDY WITH 18-MONTH FOLLOW-UP
Author(s): ,
Manuel Ayala
Affiliations:
Hematology & BMT Unit, Specialties Hospital, Nacional Medical Center "La Raza",Mexican Institute for Social Security,México,Mexico
,
Dafne Moreno-Lorenzana
Affiliations:
Oncology Research Unit, Oncology Hospital, National Medical Center,Mexican Institute for Social Security,México,Mexico
,
Emilio J Cordova
Affiliations:
Immunogenomics and Metabolics Disease Laboratory,Instituto Nacional de Medicina Genómica, SS ,México,Mexico
,
Xochitl Aquino
Affiliations:
Grupo Consulmed,México,Mexico
Antonieta Chavez-Gonzalez
Affiliations:
Oncology Research Unit, Oncology Hospital, National Medical Center,Mexican Institute for Social Security,México,Mexico
EHA Library. Ayala M. Jun 16, 2018; 215440; PS1126
Prof. Dr. Manuel Ayala
Prof. Dr. Manuel Ayala
Contributions
Abstract

Abstract: PS1126

Type: Poster Presentation

Presentation during EHA23: On Saturday, June 16, 2018 from 17:30 - 19:00

Location: Poster area

Background

In 2010, Mahon et al reported the results of the STIM study in 100 patients with stable undetectable molecular response (uMR) for at least 2 years. Finding 6 months of relapses in 58% and year in 61% of patients, most of the losses of the uMR occur in the first 6 months of the suspension of the TKI. An update of the results at 65 months, found no relapse after 2 years of suspension.

Aims

Decrease molecular recurrence (MolRel) rate in patients with CML-CP in stable uRM with TKI suspension and maintenance for 6 months with P-IFNα2b.

Methods

A prospective, longitudinal, descriptive, single-cohort, open pilot study was conducted to evaluate the effectiveness of maintenance for 6 months with P-IFNα2b in reducing the rate of MolRel in patients with CML-CP in stable uRM. Treatment was initiated after elective discontinuation of TKI will receive 100 mg of P-IFNα2b subcutaneous weekly for 6 months. They will then suspend all treatment. MolRel surveillance will be initiated simultaneously with the TKI suspension, with peripheral blood simple taken for baseline quantitative q-PCR measurement and quarterly until 6 months of surveillance from the TKI suspension of or have molecular relapse. An analysis of lymphocyte subpopulations was performed by baseline flow cytometry and quarterly up to 6 months of suspended P-IFNα2b, as well as a blood analysis of basal and half-yearly microRNAs during the two years of suspension. In patients in whom molecular relapse is documented, TKI will be restarted at the dose prescribed prior to discontinuation of treatment.

Results

Thirty-one patients (16 male and 15 female) were included, with a median age at diagnosis of 44.5 years (25-77), the risks of Sokal to diagnosis were; high 20%, intermediate 23%, low 27%, N/A 30%. Twenty-four patients were suspended from imatinib, 6 of dasatinib, and one with nilotinib and the median time uRM was 49 (28-102). Twenty-seven patients completed 6 months of TKI discontinuation remaining at uRM 85%, the majority of MolRel occurred within 12 months of discontinuation; the molecular recurrence-free survival (MRFS) rate was 85%, 67% and 58% at 6, 12 and 24 months respectively. Patients who lost MMR (5/dasatinib and 8/imatinib) re-started the same TKI and all have now recovered MMR. The Adverse Events presented were grade 1-2 for myalgias 72% (17/55), headache 64% (30/34), hyperpigmentation 58% (41/17), asthenia 41% (17/24), adynamia 38%(14/24), arthralgias 35% (14/21), nausea 14/0%, alopecia 10/0%, fever 7/0%, diarrhea 3/0%, media time from TKI suspension is 19 (range 16-23) months.

Conclusion

Although these results are preliminary (since a sample of 50 patients is expected to be included), the trend suggests that P-IFNα2b may be useful as maintenance after TKI suspension to decrease the rate of molecular relapse at 6 months of the suspension of the TKI. It is expected to determine the involvement of the immunological behavior of lymphocyte subpopulations in the maintenance of uMR, using P-IFNα2b after TKI suspension, which will be reported later to complete the year of TKI suspension. To our knowledge this is the first prospective study in Latin America that reports this therapeutic strategy of TFR.

Session topic: 8. Chronic myeloid leukemia - Clinical

Keyword(s): Chronic myeloid leukemia, Interferon alpha, Therapy, Tyrosine kinase inhibitor

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