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Background <p>Administration of high-dose methotrexate(HDMTX) requires strict intravenous hydration contributing to lengthy hospital stays. Transition to oral hydration regimen(OHR) after ensuring adequate methotrexate(MTX) clearance could decrease duration of hospitalization.</p> Purpose <p>The primary objective was to assess the feasibility of administration of OHR post HDMTX infusion in an in-hospital setting by evaluating the proportion of HDMTX courses completed on OHR.</p> Methods <p>This was a prospective, single-centre pilot study. Children with acute lymphoblastic leukemia/lymphoma aged 5-18years, treated on IciCLe-ALL-14 protocol were eligible. Following mandatory intravenous hydration phase and 24&#xa0;h MTX level &lt; 150micromol/L, children were started on OHR that included: (i) oral fluids, (ii) oral bicarbonate (650&#xa0;mg/m2/dose q6h, tablet strength 500&#xa0;mg) (iii) oral leucovorin(as per IciCLe-ALL-14 protocol, tablet strength 15&#xa0;mg). Oral fluid intake and urine output were documented by parents, adherence was monitored periodically by nurses. 42&#xa0;h MTX levels were measured. To ensure safety, children were changed to intravenous hydration if pre-defined clinical and laboratory withdrawal criteria were met.</p> Results <p>A total of 22 HDMTX courses of 13 participants were enrolled and 20 out of 22 (90.9%) HDMTX courses were completed on OHR. All, but two withdrawn courses, had a 42&#xa0;h methotrexate &lt; 1.0µmol/L. Withdrawals were due to inadequate urinary alkalinization with oral bicarbonate. Median oral hydration rate was 146.08ml/m<sup>2</sup>/h (Interquartile range, 60.01) against a minimum requirement of 125ml/m<sup>2</sup>/hr. No grade ¾ renal toxicity was observed. All courses with grade ½ vomiting achieved the required oral hydration rate and urine output. The median duration of oral hydration(OH<sub>d</sub>) was 25&#xa0;h (Interquartile range, 2) in the in-patient setting.</p> Conclusion <p>OHR post HDMTX infusion is feasible in an in-patient setting in pediatric population with acute lymphoblastic leukemia/lymphoma. Early identification of criteria warranting withdrawal from OHR and reinstitution of intravenous hydration helps in mitigating severe effects of toxicity. The length of hospitalisation of a HDMTX course could be cut short by a duration of 25&#xa0;h if implemented on outpatient basis. The study was approved by the Institute Ethics Committee of All India Institute of Medical Sciences, New Delhi (IECPG-542/23.09.2021, RT-23/25.11.2021, OT-06/07.06.2023) and registered under Clinical Trials Registry – India (CTRI/2022/02/040229 dated 11.02.2022).</p>

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Feasibility of an oral hydration regimen post high-dose methotrexate in children with acute leukemia: a pilot study

  • 期刊论文

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  • 发表日期：

    2026年2月9日

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  • Padma Sagarika Karri,
  • Ruksana Sidhique PR,
  • Jagdish Prasad Meena,
  • Rachna Seth,
  • Aditya Kumar Gupta

摘要

Background

Administration of high-dose methotrexate(HDMTX) requires strict intravenous hydration contributing to lengthy hospital stays. Transition to oral hydration regimen(OHR) after ensuring adequate methotrexate(MTX) clearance could decrease duration of hospitalization.

Purpose

The primary objective was to assess the feasibility of administration of OHR post HDMTX infusion in an in-hospital setting by evaluating the proportion of HDMTX courses completed on OHR.

Methods

This was a prospective, single-centre pilot study. Children with acute lymphoblastic leukemia/lymphoma aged 5-18years, treated on IciCLe-ALL-14 protocol were eligible. Following mandatory intravenous hydration phase and 24 h MTX level < 150micromol/L, children were started on OHR that included: (i) oral fluids, (ii) oral bicarbonate (650 mg/m2/dose q6h, tablet strength 500 mg) (iii) oral leucovorin(as per IciCLe-ALL-14 protocol, tablet strength 15 mg). Oral fluid intake and urine output were documented by parents, adherence was monitored periodically by nurses. 42 h MTX levels were measured. To ensure safety, children were changed to intravenous hydration if pre-defined clinical and laboratory withdrawal criteria were met.

Results

A total of 22 HDMTX courses of 13 participants were enrolled and 20 out of 22 (90.9%) HDMTX courses were completed on OHR. All, but two withdrawn courses, had a 42 h methotrexate < 1.0µmol/L. Withdrawals were due to inadequate urinary alkalinization with oral bicarbonate. Median oral hydration rate was 146.08ml/m2/h (Interquartile range, 60.01) against a minimum requirement of 125ml/m2/hr. No grade ¾ renal toxicity was observed. All courses with grade ½ vomiting achieved the required oral hydration rate and urine output. The median duration of oral hydration(OHd) was 25 h (Interquartile range, 2) in the in-patient setting.

Conclusion

OHR post HDMTX infusion is feasible in an in-patient setting in pediatric population with acute lymphoblastic leukemia/lymphoma. Early identification of criteria warranting withdrawal from OHR and reinstitution of intravenous hydration helps in mitigating severe effects of toxicity. The length of hospitalisation of a HDMTX course could be cut short by a duration of 25 h if implemented on outpatient basis. The study was approved by the Institute Ethics Committee of All India Institute of Medical Sciences, New Delhi (IECPG-542/23.09.2021, RT-23/25.11.2021, OT-06/07.06.2023) and registered under Clinical Trials Registry – India (CTRI/2022/02/040229 dated 11.02.2022).