Management Options with Obinutuzumab

TON September 2015 Vol 8 No 5

Treatment for chronic lymphocytic leukemia (CLL) has come a long way with the availability of new drugs that improve outcomes. As new treatments become available, there is a corresponding learning curve.

At the Oncology Nursing Society annual meeting, Laurie Farrell, NP, an advanced nurse practitioner in hematology/oncology at the Center for Cancer and Hematologic Disease, Voorhees, NJ, updated nurses and advanced nurse practitioners about issues related to use of obinutuzumab in patients with CLL.

Obinutuzumab is approved by the US Food and Drug Administration as first-line treatment for CLL in combination with chlorambucil. Obinutuzumab is an engineered humanized type 2 monoclonal antibody targeted to the CD20 surface antigen that is expressed on B cells.

Black box warnings include hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML). Hepatitis B reactivation puts patients at risk for hepatic failure. PML is a virus that penetrates the brain. Patients should be tested and monitored for signs of these life-threatening adverse events.

Two-thirds of patients develop infusion-related reactions (IRRs), typically with the first infusion. Nursing interventions and assessment can reduce these reactions, Farrell continued.

Other adverse events can include tumor lysis syndrome (an oncologic emergency), infections, neutropenia (even delayed neutropenia), and thrombocytopenia. In elderly patients, additional adverse events to watch for include diarrhea, anemia, and nasopharyngitis.

Managing Adverse Events

Antimicrobial prophylaxis is recommended for patients with neutropenia. Premedication with glucocorticoids (dexamethasone and methylprednisolone) is recommended to reduce IRRs.

“Give time for the premedications to work,” Farrell suggested. “Hang a steroid at 8:00 am. It finishes at 8:20 am and wait another hour before starting obinutuzumab.” Premedication with antihyperuricemics is recommended to protect against tumor lysis syndrome. Because obinutuzumab can cause hypotension, antihypertensive medications may be withheld during treatment.

Approximately two-thirds of patients experience a reaction to the first infusion. The majority of IRRs occur within 1 day of infusion, but can also occur with subsequent infusions. Educate patients about what to expect. Support is critical for patients with an IRR, she said.

Patients with grade 4 IRRs should be admitted to the intensive care unit and never treated with obinutuzumab again. For grade 3 reactions, stop the drug and use the rescue protocol to manage symptoms. Rechallenge, and if patients experience a second grade 3 reaction, discontinue treatment.

For grades 1 and 2 IRRs, reduce the infusion rate. If the reactions continue, stop the medication and you can retry the next day.

CLL Facts

Median age at diagnosis is 71 years, and many patients have comorbidities. Most cases of CLL are found at annual blood screenings, and many patients are asymptomatic. About three-quarters of patients have early-stage disease at diagnosis. Common symptoms include fatigue, fever, and night sweats. Diagnosis is made when there are at least 5000 clonal B cells per microliter; these cells are small mature lymphocytes.

Asymptomatic patients are typically monitored and not treated until there is sufficient disease activity, although they may be anxious that they are not receiving treatment. Eventually, all patients will need treatment, Farrell said.

The decision to treat is based on clinical stage and disease activity. International Workshop on Chronic Lymphocytic Leukaemia criteria are used to make this decision.

Approval of obinutuzumab was based on the randomized CLL-11 trial in patients with previously untreated CLL and coexisting medical conditions or reduced renal function. “These patients mirror real-life patients that we see in the clinic,” she said.

Patients were randomized to receive either rituximab + chlorambucil or obinutuzumab + chlorambucil. The obinutuzumab combination reduced the risk of relapse or death by 58%. Median progression-free survival was 25.7 months for obinutuzumab + chlorambucil versus 15 months for rituximab + chlorambucil.

“This study gave a high level of evidence in support of obinutuzumab, and the National Comprehensive Cancer Network (NCCN) Guidelines now recommend this drug as appropriate first-line therapy for patients without del(17p) aged 70 or younger with comorbidities,” Ferrell said.

Resources are available for patients at www.GAZYVA.com/patient. Patients with insurance coverage problems can consult GAZYVA Access Solutions.

Reference
Farrell L. Gazyva (obinutuzumab) for chronic lymphocytic leukemia. Presented at: Oncology Nursing Society 40th Annual Congress; April 22-26, 2015; Orlando, FL.

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