Lomustine, a nitrosourea-derivative alkylating agent, is an antineoplastic agent.100
Lomustine is used for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.100
Astrocytic and Oligodendroglial Tumors
Several randomized controlled trials have examined the efficacy of combination chemotherapy with procarbazine, lomustine, and vincristine (PCV) in patients with low-grade or anaplastic gliomas.117, 118, 119, 120, 121 The World Health Organization (WHO) classification of CNS tumors was updated in 2021; with this update, CNS tumors are now classified according to molecular characteristics rather than traditional histologic criteria.300 Of note, most practice-defining clinical trials used traditional histologic criteria as the basis for enrollment and cohort assessment, rather than contemporary molecular-based classifications; this makes the application of these trials to modern practice more challenging.300
The RTOG 9802 trial randomly assigned 251 adult patients with low-grade glioma (grade 2 astrocytoma, oligodendroglioma, or oligoastrocytoma) to receive radiation therapy alone or radiation therapy followed by 6 cycles of PCV.117 At a median follow-up of 11.9 years, median overall survival (OS) was prolonged with radiation therapy plus PCV (13.3 years versus 7.8 years with radiation therapy alone).118 Rates of progression-free survival (PFS) at 10 years were 51% in patients who received radiation therapy plus PCV and 21% in patients who received radiation therapy alone.118 In a post hoc analysis examining the results of RTOG 9802 by isocitrate dehydrogenase (IDH) mutation status, it was noted that receipt of PCV after radiation therapy was only associated with a survival benefit in patients with IDH-mutant disease; the addition of PCV to radiation therapy did not substantially increase survival among patients with IDH-wildtype disease.119
Two trials, the EORTC 26951 trial and the RTOG 9402 trial, examined the efficacy of adjuvant PCV in patients with anaplastic gliomas.120, 121 The EORTC 26951 trial compared radiation therapy alone to radiation therapy plus 6 cycles of adjuvant PCV in 368 adult patients with newly diagnosed anaplastic oligodendroglial tumors.120 At a median follow-up of 140 months, a benefit in median OS was observed with the addition of adjuvant PCV (42.3 months versus 30.6 months in patients treated with radiation therapy alone).120 Patients with 1p19q codeleted tumors appeared to derive a greater benefit from adjuvant PCV compared with patients who had 1p19q non-codeleted disease.120 The RTOG 9402 trial compared radiation therapy plus PCV to radiation therapy alone in 291 adults with anaplastic oligodendroglioma or anaplastic oligoastrocytoma.121 In the full trial population, median OS was not prolonged with PCV plus radiation therapy at a median follow-up of 11.3 years; the median OS was 4.6 years among patients treated with radiation therapy plus PCV and 4.7 years among patients treated with radiation therapy alone.121 However, median OS was substantially prolonged among patients with 1p19q codeletions who received radiation therapy plus PCV (14.7 years versus 7.3 years for patients with 1p19q codeletions who received radiation therapy alone).121
Combination therapy with thioguanine, procarbazine, lomustine, and vincristine (TPCV) has been used to treat previously untreated pediatric patients with low-grade gliomas.122 One randomized controlled trial (COG-A9952) compared TPCV to a regimen of carboplatin and vincristine in 274 patients <10 years of age with progressive or residual low-grade glioma after surgery; 5-year event-free survival rates were 52% with TPCV and 39% with the regimen of carboplatin and vincristine.122
Lomustine is used in combination regimens (e.g., lomustine, cisplatin and vincristine; lomustine, vincristine, and prednisone) as adjuvant therapy following surgical resection and radiation therapy for the treatment of pediatric medulloblastoma.111, 112, 123 One randomized controlled trial in patients 3-21 years of age with non-disseminated medulloblastoma compared an adjuvant chemotherapy regimen of lomustine, cisplatin, and vincristine to an adjuvant chemotherapy regimen of cyclophosphamide, cisplatin, and vincristine.123 Five-year event-free survival was similar between regimens (82 and 80% for the lomustine-containing regimen and the cyclophosphamide-containing regimen, respectively).123
Astrocytic and Oligodendroglial Tumors
The American Society of Clinical Oncology (ASCO) has published a guideline on the treatment of diffuse astrocytic and oligodendroglial tumors in adults.300 Recommended therapy depends on the WHO tumor classification; the WHO classification system for CNS tumors was updated in 2021, and the ASCO guideline provides recommendations based on both the 2016 and 2021 WHO classifications.300 The 2021 classification system is primarily based on molecular characteristics of the tumor (i.e., IDH mutant versus wildtype, 1p19q codeleted versus non-codeleted).300 Tumors with wildtype IDH are classified as glioblastomas in the 2021 classification, while tumors with mutant IDH are classified as either oligodendrogliomas (if 1p19q codeleted) or astrocytomas (if 1p19q non-codeleted).300 In previous WHO classifications, IDH-wildtype tumors could be classified as diffuse astrocytoma (WHO grade 2), anaplastic astrocytoma (WHO grade 3), or glioblastoma (WHO grade 4).300
Patients with IDH-mutant, 1p19q codeleted, CNS WHO grade 2 oligodendroglioma should be offered radiation therapy in combination with procarbazine, lomustine, and vincristine (PCV); temozolomide is a reasonable alternative to PCV when toxicity is a concern.300 Initial therapy may be deferred until radiographic or symptomatic progression in some people with positive prognostic factors (e.g., complete resection and younger age) or concerns about toxicity.300 Patients with IDH-mutant, 1p19q codeleted, CNS WHO grade 3 oligodendroglioma (formerly known as anaplastic oligodendroglioma) should be offered radiation therapy in combination with PCV; temozolomide is a reasonable alternative to PCV when toxicity is a concern.300 Patients with IDH-mutant, 1p19q non-codeleted, CNS WHO grade 2 astrocytoma (formerly known as IDH-mutant diffuse astrocytoma) should be offered radiation therapy with adjuvant PCV or temozolomide; in some cases (e.g., patients with positive prognostic factors, patients with concerns about short-term or long-term toxicity), initial therapy may be deferred until radiographic or symptomatic progression.300 Patients with IDH-mutant, 1p19q non-codeleted, CNS WHO grade 3 astrocytoma (formerly known as IDH-mutant anaplastic astrocytoma) should be offered radiation therapy with adjuvant temozolomide.300 Patients with IDH-mutant, CNS WHO grade 4 astrocytoma (formerly known as IDH-mutant glioblastoma) may be treated like patients with IDH-mutant WHO grade 3 astrocytoma or like patients with IDH-wildtype, CNS WHO grade 4 glioblastoma (described in the following paragraph).300
Concurrent temozolomide and radiation therapy should be offered to people with newly diagnosed IDH-wildtype, CNS WHO grade 4 glioblastoma, and 6 months of adjuvant temozolomide should be offered to patients who receive concurrent temozolomide and radiation therapy.300 Patients with older age, poor performance status, or concerns about toxicity or prognosis may be considered for treatment with best supportive care alone, hypofractionated radiation therapy alone, or temozolomide alone.300 No recommendation for or against any therapeutic strategy could be made for the treatment of recurrent IDH-wildtype, CNS WHO grade 4 glioblastoma.300 Drugs that have been studied in this setting include temozolomide, lomustine, carmustine, and bevacizumab; ASCO recommends that patients with recurrent glioblastoma are referred for participation in a clinical trial when possible.300
Pediatric low-grade gliomas are initially managed with surgery when feasible; surgery may be followed by adjuvant therapy if tumor resection is incomplete.301 Options for adjuvant therapy in patients with incomplete tumor resection include observation, chemotherapy, radiation therapy, or targeted therapy (for certain types of tumors).301 Chemotherapy is recommended first-line over radiation therapy in most pediatric patients who require adjuvant therapy.301 The most commonly used chemotherapy regimens in patients with progressive tumors or symptomatic nonresectable low-grade gliomas are carboplatin with or without vincristine; vinblastine; or TPCV.301 Regimens that may be considered in patients with disease recurrence or progression at an unresectable site include carboplatin with or without vincristine; TPCV; vinblastine alone; temozolomide alone; temozolomide in combination with carboplatin and vincristine; irinotecan plus bevacizumab; or lenalidomide alone.301
Surgery (with total or near-total resection of the tumor when feasible) is standard therapy for pediatric patients with medulloblastoma; surgery is typically followed by adjuvant radiation (in patients >3 years of age) and/or adjuvant chemotherapy.302 Treatment selection will depend on the age of the patient and other patient-specific factors such as risk group (average versus high risk).302 Patients >3 years of age with average-risk disease typically receive chemotherapy along with radiation therapy as part of standard treatment.302 A variety of chemotherapy regimens have been used successfully in these patients, including the combination of cisplatin, lomustine, and vincristine and the combination of cisplatin, cyclophosphamide, and vincristine.302 In patients >3 years of age with high-risk disease, multimodal therapy has been shown to improve duration of disease control and overall disease-free survival.302 Chemotherapy drugs that have been used in patients with high-risk disease include cisplatin, lomustine, cyclophosphamide, etoposide, and vincristine.302
Although lomustine is labeled for use in combination with other agents for the treatment of Hodgkin's lymphoma in patients whose disease has progressed following initial chemotherapy,100 combination regimens containing other agents currently are preferred for this cancer.303
Dispensing and Administration Precautions
Lomustine is administered orally as a single dose, once each treatment cycle.100 The drug is commercially available in 3 strengths of capsules, enabling selection of the proper combination of capsules to supply the prescribed dose (rounded to the nearest 10 mg).100 Patients should be instructed regarding the differences in appearance of the capsules and advised that all the capsules dispensed are to be consumed in one dose.100 A minimum of 6 weeks must elapse between each dose of lomustine because of the risk of toxicities, including fatal toxicities.100
Store the capsules at 25°C; excursions permitted from 15-30°C.100 Avoid temperatures >40°C.100
Round doses to the nearest 10 mg.100
For primary or metastatic brain tumors following the appropriate surgical and/or radiotherapeutic procedures, the recommended dosage of lomustine in adults and pediatric patients is 130 mg/m2 administered as a single oral dose once every 6 weeks.100 Do not repeat the dose for at least 6 weeks.100 If lomustine is administered in conjunction with other myelosuppressive drugs, dosage should be reduced accordingly.100 Patients who have compromised bone marrow function (such as those who have received prior extensive radiation therapy or chemotherapy) should receive reduced doses of 100 mg/m2.100 Perform weekly blood counts and withhold each subsequent dose for >6 weeks as needed until leukocyte and platelet counts have returned to at least 4000/mm3 and 100,000/mm3, respectively.100 The manufacturer suggests that dosage subsequent to the initial dose may be adjusted based on hematologic response in accordance with the schedule in Table 1.100
In combination with other chemotherapy agents for secondary treatment of Hodgkin's lymphoma in patients with disease progression following initial chemotherapy, the usual adult and pediatric dosage of lomustine is 130 mg/m2 administered as a single oral dose once every 6 weeks.100 Do not repeat the dose for at least 6 weeks.100 When lomustine is administered in conjunction with other myelosuppressive drugs, dosage should be reduced accordingly.100 Patients who have compromised bone marrow function (such as those who have received prior extensive radiation therapy or chemotherapy) should receive reduced doses of 100 mg/m2.100 Perform weekly blood counts and withhold each subsequent dose for >6 weeks as needed until leukocyte and platelet counts have returned to at least 4000/mm3 and 100,000/mm3, respectively.100 The manufacturer suggests that dosage subsequent to the initial dose may be adjusted based on hematologic response in accordance with the schedule in Table 1.100
Dosage Modification for Toxicity
Perform weekly blood counts and withhold each subsequent dose of lomustine for >6 weeks as needed until leukocyte and platelet counts have returned to at least 4000/mm3 and 100,000/mm3, respectively.100 Modify each dose of lomustine according to the hematologic response of the prior dose in accordance with the schedule in Table 1.100
Nadir After Prior Dose - Leukocytes (cells/mm3) | Nadir After Prior Dose - Platelets (cells/mm3) | Percentage of Prior Dose to Be Given |
|---|---|---|
≥4000 | ≥100,000 | 100% |
3000-3999 | 75,000-99,999 | 100% |
2000-2999 | 25,000-74,999 | 70% |
<2000 | <25,000 | 50% |
The manufacturer makes no specific dosage recommendations in hepatic impairment.100
The manufacturer makes no specific dosage recommendations in renal impairment.100
The manufacturer makes no specific dosage recommendations in geriatric patients.100 No data are available from clinical studies of lomustine in patients ≥65 years of age to identify differences in response compared to younger adults.100 Other reported clinical experience has not identified differences in response to lomustine between geriatric patients and younger adults; however, dosage selection for a geriatric patient should be undertaken with caution, taking into account the greater frequency of reduced hepatic, renal, or cardiac function, and of concomitant diseases or drug therapies.100
Lomustine and its metabolites undergo substantial renal excretion and the risk of toxic reactions may be increased in patients with reduced renal function.100 Since geriatric patients are more likely to have reduced renal function, the dosage of lomustine should be carefully selected, and renal function monitored.100
A boxed warning is included in the prescribing information for lomustine concerning the risk of delayed, dose-related, and cumulative myelosuppression.100 The development of myelosuppression may contribute to bleeding and fatal infections.100 Delayed myelosuppression usually occurs 4-6 weeks after administration of lomustine and persists for 1-2 weeks.100 Thrombocytopenia generally is more severe than leukopenia.100 Cumulative myelosuppression with lomustine can manifest as cytopenias of greater severity and longer duration.100 The manufacturer recommends that blood counts be performed weekly during and for at least 6 weeks after discontinuance of lomustine therapy.100 Do not give lomustine more frequently than once every 6 weeks.100 Adjust the dosage of lomustine based on nadir blood counts from the previous dose.100
A boxed warning is included in the prescribing information for lomustine concerning the risk of fatal toxicity with overdosage of lomustine.100 The manufacturer recommends prescribing and dispensing only 1 dose of lomustine per treatment cycle, because dispensing or administering >1 dose per treatment cycle can lead to fatal toxicity.100 Dispense enough capsules at a time for 1 dose of lomustine.100 Both the prescriber and pharmacist should emphasize to the patient that the medication is dosed once every 6 weeks.100
Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis has occurred at 6 months or later following initiation of lomustine therapy in patients typically receiving cumulative doses of lomustine exceeding 1100 mg/m2.100 Patients with a forced vital capacity (FVC) or carbon monoxide diffusing capacity (DLCO) below 70% of the predicted value at baseline testing are particularly at risk for pulmonary toxicity associated with lomustine therapy.100
Pulmonary function tests should be conducted before initiation of therapy and at frequent intervals during treatment in patients receiving lomustine.100 Permanent discontinuation of lomustine is recommended in patients who develop pulmonary fibrosis.100
Secondary malignancies, including acute leukemia and myelodysplasia, have been reported following long-term therapy.100
Hepatic toxicity, manifested by increased serum concentrations of transaminase, alkaline phosphatase, and bilirubin, has been reported in patients receiving lomustine.100 Monitor liver function during therapy.100
Decreased kidney size and progressive renal failure have occurred in patients receiving lomustine.100 Monitor renal function during therapy.100
Fetal/Neonatal Morbidity and Mortality
Lomustine may cause fetal harm when administered to a pregnant woman.100 Lomustine has been shown to be embryotoxic and teratogenic in animal studies.100 Inform pregnant women of the potential fetal risk with lomustine.100
Verify pregnancy status before initiating lomustine.100 Advise females of reproductive potential to use effective contraception during lomustine therapy and for at least 2 weeks following the final dose.100
Advise males with female partners of reproductive potential to use condoms during treatment with lomustine and for 3.5 months following the final dose.100
There are no available studies to date using lomustine in pregnant women.100 Based on animal studies and its mechanism of action, lomustine may cause fetal harm when administered during pregnancy.100 Teratogenic and embryotoxic effects were observed when lomustine was administered to rats and rabbits, respectively, at dose levels approximately 2-4 times the recommended human dose (130 mg/m2) over 6 weeks based on body surface area.100
Verify pregnancy status before initiating lomustine.100 Inform pregnant women of the potential fetal risk with lomustine.100
It is not known if lomustine or its metabolites are present in human milk.100 The effects of the drug on the breast-fed child, and its effects on milk production are also not known.100
Because of the potential for serious adverse reactions in breast-fed infants from lomustine exposure through breastmilk, advise women to avoid breast-feeding during lomustine therapy and for 2 weeks following the final dose.100
Females and Males of Reproductive Potential
Based on animal data and its mechanism of action, lomustine can cause fetal harm.100
Advise females of reproductive potential to use effective contraception during lomustine therapy and for at least 2 weeks following the final dose.100 Advise males with female partners of reproductive potential to use condoms during treatment with lomustine and for 3.5 months following the final dose.100
Based on animal data and its mechanism of action, lomustine may adversely affect fertility in males and females of reproductive potential.100
The use of lomustine, including the dose in pediatric patients, has not been established based on adequate, well-controlled clinical trials.100
No data are available from clinical studies of lomustine in patients ≥65 years of age to identify differences in response compared to younger adults.100 Other reported clinical experience has not identified differences in response to lomustine between geriatric patients and younger adults; however, dosage selection for a geriatric patient should be undertaken with caution, taking into account the greater frequency of reduced hepatic, renal, or cardiac function, and of concomitant diseases or drug therapies.100
Since geriatric patients are more likely to have reduced renal function, the dosage of lomustine should be carefully selected, and renal function monitored.100
The impact of hepatic impairment on the pharmacokinetics of lomustine is not known.100
The impact of renal impairment on the pharmacokinetics of lomustine is not known.100
Because lomustine and its metabolites undergo substantial renal excretion, the risk of toxic reactions may be increased in patients with reduced renal function.100
Common adverse effects reported with lomustine include delayed myelosuppression, nausea, vomiting, stomatitis, and alopecia.100
Formal drug interaction studies have not been conducted with lomustine.100 The metabolic pathways involved in the elimination of lomustine have not been fully characterized.100
A nitrosourea, lomustine acts by alkylating both DNA and RNA.100 Lomustine may also be involved in the inhibition of several key enzymatic processes through carbamoylation of amino acids in proteins.100
Lomustine is known to cross the blood-brain barrier.100 The metabolic pathways involved in the elimination of lomustine have not been fully characterized.100 Following oral administration of radiolabeled lomustine at doses ranging from 30<100 mg/m2, about 50% of the radioactivity is excreted in the urine as metabolites within 24 hours.100 The elimination half-life of lomustine ranges from 16<48 hours.100 The effects of age, sex, race, renal impairment, and hepatic impairment on lomustine pharmacokinetics are not known.100
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 10 mg | Gleostine® | NextSource Biotechnology |
40 mg | Gleostine® | NextSource Biotechnology | ||
100 mg | Gleostine® | NextSource Biotechnology |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions November 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
100. NextSource Biotechnology. Gleostine® (lomustine) capsules prescribing information. Pompano Beach, FL; 2024 Jan.
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