AYAs With Acute Lymphoblastic Leukemia (ALL):

Challenges and Treatment Guidelines

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ALL in adolescents and young adults (AYAs) and adults1

ALL is not just a childhood cancer; 46% of new ALL cases occur in adults.

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17 years

: Median age at diagnosis

of new ALL cases occur in people aged ≥20 years

of patients in this age group lose their fight against ALL

Challenges unique to AYA patients

ALL affects the AYA population, defined as those aged between 15 and 39 years, differently and with different outcomes than in children.2-4

A prognosis that varies by age and genetics

Pediatric

High hyperdiploidy and ETV6-RUNX1 are more prevalent in the pediatric population and are associated with favorable outcomes5,6

91%

5-year relative survival for children7

AYA

Aged 15 to 39 years

Ph+ ALL is more prevalent in the AYA population and is associated with poor prognosis5,6

60%

5-year relative survival for AYAs7

Abbreviation: Ph, Philadelphia chromosome.

Considerations in AYA patients

When it comes to treatment, AYA patients present with a range of age-related and age-specific issues that include8

  • Long-term side effects
  • Logistical issues such as transportation to clinic appointments, maintaining school and work obligations, and childcare

Of significant importance for this age group is the preservation of fertility.9,10

The impact of cancer treatment on fertility is related to the age of the patient at the time of diagnosis and treatment, and is dependent on the type, duration, and dose intensity of treatment.11,12

All NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) preferred regimens for frontline therapy for AYA patients with Ph-negative ALL contain pegaspargase (ONCASPAR).2

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ONCASPAR-containing regimens are the first line of defense for AYA patients with ALL13

NCCN Guidelines® Recommend Regimens That Include Pegaspargase (ONCASPAR®) for the Treatment of Ph-Negative B-Cell and T-Cell ALL in AYA and Adult Patients2,a

a The ALL Panel considers AYAs to be between the ages of 15 and 39 years. However, this age range is not a firm reference point because some of the recommended regimens have not been comprehensively tested across all ages.

bPegaspargase may be substituted with calaspargase pegol-mknl, an asparagine-specific enzyme, in patients aged ≤21 years for more sustained asparaginase activity.

cPediatric-inspired regimen.

dBlinatumomab can be considered for consolidation in MRD negative/unavailable if induced with inotuzumab ozogamicin + mini-hyperCVD, or in patients for whom multi-agent chemotherapy is contraindicated, and for consolidation in persistent/rising MRD.

eFor patients receiving 6-MP, consider testing for TPMT gene polymorphisms, particularly in patients who develop severe neutropenia after starting 6-MP. Testing for both TPMT and NUDT15 variant status should be considered, especially for patients of East Asian origin.

eDose modifications for antimetabolites in maintenance should be consistent with the chosen treatment regimen. It may be necessary to reduce dose/eliminate antimetabolite in the setting of myelosuppression and/or hepatotoxicity.

Abbreviations: 6-MP, mercaptopurine; CALGB, Cancer and Leukemia Group B; CCG, Children’s Cancer Group; COG, Children’s Oncology Group; CVAD, cyclophosphamide, vincristine, doxorubicin, and dexamethasone; DFCI, Dana-Farber Cancer Insitute; ECOG, Eastern Cooperative Oncology Group; GRAALL, Group for Research on Adult Acute Lymphoblastic Leukemia; MRC, Medical Research Council; MRD, minimal residual disease; NCCN, National Comprehensive Cancer Network®; PETHEMA, Programa de Estudio y Tratamiento de las Hemopatías Malignas; USC/MSKCC, University of Southern California/Memorial Sloan Kettering Cancer Center.

ONCASPAR FAQs

Get answers to frequently asked questions about ONCASPAR.

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION Section

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

WARNINGS and PRECAUTIONS 

Anaphylaxis and Serious Hypersensitivity Reactions: Anaphylaxis and serious hypersensitivity reactions can occur. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to (E.) coli derived L-asparaginase formulations. Premedicate patients 30-60 minutes prior to administration of ONCASPAR. Observe patients for 1 hour after administration in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Discontinue ONCASPAR in patients with serious hypersensitivity reactions.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, can occur. Discontinue ONCASPAR in patients with serious thrombotic events.

Pancreatitis: Pancreatitis can occur. Fatal outcomes have been reported. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR. 

Glucose Intolerance: Glucose intolerance can occur and, in some cases, be irreversible. Monitor serum glucose. 

Hemorrhage: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia can occur. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy. Discontinue ONCASPAR for severe or life-threatening hemorrhage. 

Hepatotoxicity: Hepatotoxicity and abnormal liver function can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment through at least 6 weeks after the last dose. In the event of serious liver toxicity, discontinue ONCASPAR and provide supportive care.

ADVERSE REACTIONS

The most common grade 3 and 4 adverse reactions with ONCASPAR (>5%) included hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. 

INDICATIONS AND USAGE

ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:

  • First-line acute lymphoblastic leukemia (ALL)
  • ALL and hypersensitivity to native forms of L-asparaginase
Please see Full Prescribing Information.