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A Prospective Study to Evaluate the Effect of Therapeutic Drug Monitoring-Based Posaconazole Prophylaxis on Invasive Fungal Infection Rate During Acute Myeloid Leukemia Induction Therapy

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Abstract

Invasive fungal infections (IFIs) are a significant cause of morbidity and mortality in de-novo acute myeloid leukemia patients receiving induction chemotherapy. Despite using posaconazole, a broad-spectrum antifungal, for IFI prophylaxis, the breakthrough IFI rate is high in the real-world setting. One of the reasons could be frequent suboptimal plasma posaconazole levels. In the present study, we evaluated if therapeutic drug monitoring (TDM) guided posaconazole prophylaxis can reduce the IFI rates in comparison to a historical cohort. We enrolled 90 patients, > / = 16 years of age, without baseline IFIs, planned for remission induction therapy. All patients were started on posaconazole suspension 200 mg TDS and the dose was increased in a stepwise manner if trough levels were found to be suboptimal (< 350 ng/ml for day 2 or < 700 ng/ml subsequently). The TDM based approach resulted in a significant decline in breakthrough IFI rates (18% versus 52%, P < 0.0001) A total of 69 patients (78%) required dose escalation. Thirty-one patients required change in antifungals due to either suboptimal levels, persistent fever, diarrhoea or vomiting. We could not demonstrate an exposure–response relationship but the difference in IFI rates in patients with a median posaconazole level > / = 700 ng/ml (0%) and < 700 ng/ml (21.6%) was clinically meaningful. Posaconazole levels were found to be significantly lower in patients on antacids and prokinetics. The incidence of posaconazole-related grade 3 toxicity was low (2.3%). Thus TDM-based dosing of posaconazole helps reduce breakthrough IFI rate and should be a part of posaconazole prophylaxis.

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Data Availability

Trial data will be made available on request by writing an e-mail to the corresponding author for the purpose of systematic reviews and meta-analyses. The data will be shared after institutional ethics committee (IEC) approval of the proposal and regulatory clearances (Department of Atomic Energy).

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Acknowledgements

The authors acknowledge the AsiaPacific Clinical Oncology Research Development (ACORD) protocol development workshop, September, 2016, for valuable guidance in drafting the trial protocol. The authors acknowledge the contribution of Tulika Prasad, Madasamy Konar and Neha Sharma in capturing and maintaining the trial data, the resident doctors of the department of medical oncology in Tata Memorial Hospital (where the study was conducted) who attended to the trial patients during induction and helped in the proper implementation of the trial protocol and the nursing staff who helped in the timely collection of blood samples for posaconazole estimation and supervised the dosing of posaconazole as per the trial protocol. The authors also acknowledge the Tata Memorial Centre (TMC) research administrative council for providing funding for the study.

Funding

The study received funds from Tata Memorial Centre (TMC) research administrative council.

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  1. Mounika Boppana

    Present address: Department of Medical Oncology, Krishna Institute of Medical Sciences, Minister Road, Secunderabad, Telangana, 500003, India

Authors and Affiliations

  1. Department of Medical Oncology, Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Mounika Boppana, Alok Shetty & Thomas Eipe

  2. Adult Hematolymphoid Unit, Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Manju Sengar, Hasmukh Jain, Bhausaheb Bagal, Jayashree Thorat & Lingaraj Nayak

  3. Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Murari Gurjar, Madhavi Ambotkar & Vikram Gota

  4. Adult Hematolymphoid Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Anant Gokarn

  5. Department of Radiodiagnosis, Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Nitin Shetty & Akshay Baheti

  6. Clinical Research Secretariat, Tata Memorial Centre, Affiliated to Homi Bhabha National Institute, E Borges Road, Mumbai, Maharashtra, 400 012, India

    Smruti Mokal & Sadhana Kannan

  7. Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National University, Earnest Borges Road, Parel, Mumbai, 400012, India

    Manju Sengar

  8. Department of Medical Oncology, Asian Institute of Gastroenterology (AIG) Hospitals, Mindspace Road, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana, 500032, India

    Avinash Bonda

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Contributions

MS, HJ and MB designed and implemented the trial protocol. MB, JT, AB, LN, AG, BB, HJ and MS contributed in the acquisition of the data and the documentation process. MG, MA and VG contributed in estimation of the plasma posaconazole levels. NS and AB critically reviewed all the baseline and subsequent CT scans of the patients to diagnose or rule out IFI. MB, MS, HJ verified all the data. MB, MS, HJ, VG, SM and SK planned and conducted the data analysis. MB, MS, HJ, TE and VG drafted the manuscript. HJ, MS, AS, TE and VG contributed in critical revision of the manuscript. All authors reviewed the manuscript and approved the final version for publication.

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Correspondence to Manju Sengar.

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The authors have declared no conflicts of interest.

Ethical Approval

All authors declare that they approve the final version of the manuscript. In addition, the authors have declared no conflicts of interest. The study was approved by the institutional ethics committee and was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. The study was registered in the Clinical Trials Registry – India (CTRI) (CTRI/2017/06/008810).

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Patients were enrolled after obtaining a written informed consent. For patients aged 14–17 years assent and guardian consent were taken.

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Boppana, M., Sengar, M., Jain, H. et al. A Prospective Study to Evaluate the Effect of Therapeutic Drug Monitoring-Based Posaconazole Prophylaxis on Invasive Fungal Infection Rate During Acute Myeloid Leukemia Induction Therapy. Indian J Hematol Blood Transfus 40, 204–212 (2024). https://doi.org/10.1007/s12288-023-01709-3

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