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CLOFARABINE IN RELAPSED-REFRACTORY ACUTE MYELOGENOUS LEUKEMIA: A SINGLE CENTRE EXPERIENCE
Author(s):
Barbara Scappini
,
Barbara Scappini
Affiliations:
Haematology,AOU Careggi Florence,Florence,Italy;Haematology,University of Florence,Florence,Italy
Giacomo Gianfaldoni
,
Giacomo Gianfaldoni
Affiliations:
Haematology,AOU Careggi Florence,Florence,Italy
Marco Armenio
,
Marco Armenio
Affiliations:
Haematology,University of Florence,Florence,Italy
Francesco Mannelli
,
Francesco Mannelli
Affiliations:
Haematology,AOU Careggi Florence,Florence,Italy
Ilaria Cutini
,
Ilaria Cutini
Affiliations:
Haematology,AOU Careggi Florence,Florence,Italy
Matteo Piccini
,
Matteo Piccini
Affiliations:
Haematology,University of Florence,Florence,Italy
Caterina Biagiotti
,
Caterina Biagiotti
Affiliations:
Haematology,University of Florence,Florence,Italy
Rosa Fanci
,
Rosa Fanci
Affiliations:
Haematology,University of Florence,Florence,Italy
Massimo Di Gioia
,
Massimo Di Gioia
Affiliations:
Haematology,University of Florence,Florence,Italy
Alberto Bosi
Alberto Bosi
Affiliations:
Haematology,University of Florence,Florence,Italy
(Abstract release date: 05/18/17) EHA Library. Scappini B. 05/18/17; 182400; PB1686
Barbara Scappini
Barbara Scappini
Contributions
PDF Abstract
Abstract

Abstract: PB1686

Type: Publication Only

Background
Clofarabine has been shown to be effective in AML patients, mainly in combination with high dose cytarabine

Aims
On the basis of these reports, we tested clofarabine in association with high dose cytarabine in relapsed/refractory AML patients, selecting cases of primary refractory to at least two induction therapies, relapsed but refractory to a standard re-induction treatment, or very early relapsed.

Methods

Betweeen 2008 and 2016 we treated 67 patients with a regimen including clofarabine at 22,5 mg/m2 daily on days 1-5, followed after three hours by cytarabine at 1 gr/m2 daily on days 1-5.
Among the 67 patients, 24 were in first relapse, 29 in second or third relapse, 14 with resistant disease. The mean age was 54 years (range .36-77 years).

Results

20/67 patients achieved a complete remission (29,9%), 4/67 a partial response (6%), 38/67 had resistant disease (56,7%), 3/67 died of complications during the aplastic phase (4,4%).
The most frequent non haematologic adverse events were: transient liver toxicity (41% grade 1-2, 11% grade 3-4) skin rash (33%), vomiting (28%), diarrhea (15%)
Comparing with other salvage strategies, in this cohort of patients we did not observe a significant delay in bone marrow recovery (median time to ANC recovery 21 days).
Febrile neutropenia was observed in 58 cases (85%), with bacterial infections microbiologically documented in 20 patients (29%) and 2 cases (3%) of fungal infections.
The median overall survival of the whole cohort was 115 days, with a median event free survival of 111 days
Among the responding patients, 16 (24%). underwent allogeneic bone marrow transplantation; in these selected patients, median overall survival was 185 days.

Conclusion

These results suggest that the clofarabine-ARA-C regimen was able to induce a response in about one third of this particularly poor prognosis category of patients, with safety data consistent with previously reported salvage therapies. Nevertheless, long term results remain still and completely unsatisfactory. Further studies, with different combinations or in more selecting conditions, are warranted.

Session topic: 4. Acute myeloid leukemia - Clinical

Keyword(s): Therapy, Clofarabine, Acute Myeloid Leukemia

Abstract: PB1686

Type: Publication Only

Background
Clofarabine has been shown to be effective in AML patients, mainly in combination with high dose cytarabine

Aims
On the basis of these reports, we tested clofarabine in association with high dose cytarabine in relapsed/refractory AML patients, selecting cases of primary refractory to at least two induction therapies, relapsed but refractory to a standard re-induction treatment, or very early relapsed.

Methods

Betweeen 2008 and 2016 we treated 67 patients with a regimen including clofarabine at 22,5 mg/m2 daily on days 1-5, followed after three hours by cytarabine at 1 gr/m2 daily on days 1-5.
Among the 67 patients, 24 were in first relapse, 29 in second or third relapse, 14 with resistant disease. The mean age was 54 years (range .36-77 years).

Results

20/67 patients achieved a complete remission (29,9%), 4/67 a partial response (6%), 38/67 had resistant disease (56,7%), 3/67 died of complications during the aplastic phase (4,4%).
The most frequent non haematologic adverse events were: transient liver toxicity (41% grade 1-2, 11% grade 3-4) skin rash (33%), vomiting (28%), diarrhea (15%)
Comparing with other salvage strategies, in this cohort of patients we did not observe a significant delay in bone marrow recovery (median time to ANC recovery 21 days).
Febrile neutropenia was observed in 58 cases (85%), with bacterial infections microbiologically documented in 20 patients (29%) and 2 cases (3%) of fungal infections.
The median overall survival of the whole cohort was 115 days, with a median event free survival of 111 days
Among the responding patients, 16 (24%). underwent allogeneic bone marrow transplantation; in these selected patients, median overall survival was 185 days.

Conclusion

These results suggest that the clofarabine-ARA-C regimen was able to induce a response in about one third of this particularly poor prognosis category of patients, with safety data consistent with previously reported salvage therapies. Nevertheless, long term results remain still and completely unsatisfactory. Further studies, with different combinations or in more selecting conditions, are warranted.

Session topic: 4. Acute myeloid leukemia - Clinical

Keyword(s): Therapy, Clofarabine, Acute Myeloid Leukemia

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