Time to Therapy and Safety of Testicular Tissue Cryopreservation in Children Undergoing Chemotherapy or Hematopoietic Stem Cell Transplant
Paul Campbell, DO, Abbey Riazzi, PA, Elizabeth Spitznagel, NP, Marion Schulte, RN, Olivia Frias, RN, Kas Myers, MD, Michael Daugherty, MD, MHI, Brian Vanderbrink, MD, William DeFoor, MD, MPH, Eugene Minevich, MD, Pramod Reddy, MD, Tara Streich-Tilles, MD, Karen Burns, MD, Andrew Strine, MD, MPH.
Cincinnati Children's Hospital, Cincinnati, OH, USA.
Introduction: With the use of more effective multimodal therapies and hematopoietic stem cell transplant (HSCT), the majority of children diagnosed with malignancies, hematologic disease, and immunodeficiencies are now surviving into adulthood. Many of these therapies are gonadotoxic with the potential for negative long-term implications on fertility. As these children age into adulthood, infertility is a leading cause for decreased quality life, and has placed an increased emphasis on fertility preservation prior to the initiation of gonadotoxic therapies. Sperm cryopreservation is the standard of care for post-pubertal males; however, the options are limited for pre-pubertal males or those unable to provide a specimen. Testicular tissue cryopreservation (TTC) is an experimental method to harvest and cryopreserve testicular tissue with germ cells that may allow for future fertility in the latter population. Due to the concern for delaying the initiation of therapy, we sought to evaluate the feasibility and safety of TTC.
Methods: We conducted a retrospective cohort study for patients undergoing TTC between 2017-2023. Patients at significant risk for primary testicular failure based on established criteria for cyclophosphamide equivalent dosing or radiation were eligible for TTC. Patients were excluded if they received their oncology or hematology care elsewhere. Those proceeding with TTC were enrolled in an IRB approved research protocol. TTC was performed in the operating room with 75% of the tissue submitted for cryopreservation and 25% for research purposes. TTC was combined with other procedures when possible to minimize anesthesia exposures and expedite initiation of therapy. The primary outcome was the time to initiation of therapy following TTC, while the secondary outcome was complication rate.
Results: A total of 108 patients met inclusion criteria and underwent TTC with a median age of 5.4 (IQR 2.1-8.7) years. A total of 44 (41%) patients had a malignancy, while 64 (59%) patients underwent HSCT due to non-malignant disease. Of those with malignancy, 28 (64%) patients were exposed to chemotherapy prior to or during TTC. The median operative time was 34.0 (IQR 28.0-39.0) minutes. Germ cells were identified in 102 (94%) specimens and malignant involvement was identified in 1 (1%) patient. A total of 96 (89%) patients underwent a concomitant procedure with a median of 1 (IQR 1-2) procedures. The median time to initiation of therapy was 5 (IQR 1.8-7.0) days and 7 (IQR 6.0-13.25) days for malignancy and HSCT due to non-malignant disease, respectively. The overall 30-day complication rate was 16.7% (18/108) with neutropenic (6/18) and non-neutropenic (6/18) fevers the most common. Only 3 were directly attributed to TTC, including 1 with dermatitis from the topical antiseptic and 2 with hematomas managed non-operatively. No patients had a delay in definitive care due to concern for wound healing or complications.
Conclusion: To our knowledge, this is the largest study evaluating the time to initiation of therapy after TTC. TTC can be performed safely, efficiently, and in conjunction with other procedures without resulting in delays in care. TTC affords the opportunity for fertility preservation in children undergoing chemotherapy or HSCT who would otherwise have no options.
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