To compare high dose cytrabine with intermediate dose in AML consolidation therapy in terms of toxicity profile and clinical efficacy

Abstract

Background: Acute myeloid leukemia is a term for hematopoietic neoplasm that is uniformly characterized by the presence of malignant clone of myeloid cells in the bone marrow with maturation arrest at the level of blast. Intermediate dose cytrabine may have slightly higher post-remission anti-leukemic efficacy compared to high dose cytrabine with less myelo-suppression for AML patients.

Objectives: To compare high dose cytrabine with intermediate dose in terms of clinical efficacy toxicity profile.

Study design: Observational, prospective type, case-control hospital-based study.

Participants: In our study a total of 137 patients participated including 69 cases and 68 controls.

Results: In our study 38 (55.10%) patients of group 1 are in remission.5 (7.20%) relapsed.26 (37.70%) cases died during follow up. In control group 23 (33.80%) patients are in remission.4 (5.90%) relapsed.41 (60.31%) patients died during the follow-up. Most patients presents with febrile neutropenia critical thrombocytopenia, GI symptoms (cases-49.90%, control-75.00%) . Most cases had fever in 2nd (23.20%) and 3rd (21.70%) week, whereas controls had fever in 1st (26.50%) and 2nd week (14.70%) . Controls required more platelet concentrates (41.20%) . Blood transfusion (33.80%) in addition to PRCs. Cases (29.00%) required PRCs. Chemotherapy related mortality was observed more in control group (60.30%) than in cases (37.70%) . Relapse were observed more in cases (7.20%) as compared to control (5.88%) .

Methods: The study was conducted on patients reporting to the department of clinical haematology at tertiary care institute of Sher-i-Kashmir Institute of Medical Sciences, Srinagar over a period of two years from august 2017 to march 2019. Written informed consent obtained from all patients. The sample included a maximum number of the cases of adult AML from both sexes. Controls were the cases who were on high dose cytrabine. All newly diagnosed patients of AML in the department of clinical haematology were included in the study. It was a time-bound study from august 2017 to march 2019.

Conclusion: In conclusion, the results of the present study demonstrated that high dose cytrabine monotherapy may be superior in terms of relapse rate and RFS compared to intermediate cytrabine combined with anthracyclines with a trend toward prolonged OS in the High dose cytrabine group. Intermediate dose cytrabine may have slightly higher post-remission anti-leukemic efficacy compared to high dose cytrabine with less myelo-suppression for AML patients. The strength of this study is that patients achieved CR by the same standard induction regimen, thereby minimizing the confounding effects of induction therapy. However, this study had a relatively small sample size and therefore requires validation through randomized controlled trials to confirm the present findings.