Tag: ASCO

ASCO 2014: Promising Results with Lenalidomide Plus Rituximab for Patients with Previously Untreated Follicular Lymphoma

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By Peter Martin, MD

On May 30, 2014, at the 50th annual meeting of the American Society of Clinical Oncology (ASCO) I had the pleasure of presenting updated, preliminary results from the multi-center, national cooperative group CALGB 50803 phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. This trial represents an important step as we move away from traditional cytotoxic chemotherapy towards a future with novel, better-tolerated regimens for treatment of patients with follicular lymphoma.

Patients in this trial received oral lenalidomide on days 1-21 of each 28-day cycle for a total of twelve cycles plus four weekly infusions of rituximab during cycle 1 followed by four additional infusions at the start of cycles 4, 6, 8, and 10. The primary objective was to measure the patient’s complete response rate. Overall, we found that the regimen was well tolerated, with very low rates of infection or other significant adverse events. Preliminary data from patients evaluable for complete response suggests that over 90% of patients responded, including roughly 70% complete responses. At two years, 89% of patients continued to respond. These efficacy data are consistent with what is typically seen with cytotoxic chemotherapy-based regimens and they support further evaluation of lenalidomide plus rituximab compared to chemotherapy in an ongoing phase III trial.

ASCO 2013: Ibrutinib Combined with R-CHOP Shows Positive Results in Patients with CD20-positive, B-cell non-Hodgkin Lymphoma

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By Jia Ruan, MD, PhD

Ibrutinib is a first-in-class oral Bruton’s tyrosine kinase inhibitor that has shown promise in treating a variety of relapsed and refractory B-cell malignancies. At the 2013 meeting of the American Society of Clinical Oncology in Chicago, Dr. Anas Younes of the MD Anderson Cancer Center presented results from a recent phase 1b trial combining ibrutinib with standard doses of R-CHOP in patients with previously untreated CD20 positive NHL (NCT01569750).

A total of seventeen patients were enrolled, including those with subtypes of diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. The recommended phase 2 dose of ibrutinib was established at 560 mg daily in combination with standard doses of R-CHOP given every 21 days.  The overall response rate of treatment was 100% with 7 complete and 3 partial responses in 10 evaluable patients. The most common adverse events were neutropenia (77%), thrombocytopenia (65%), vomiting (59%), anemia (53%), nausea (47%), fatigue (35%), headaches (29%), constipation (24%), diarrhea (24%), and dizziness (24%).

The study concluded that this novel combination of Ibrutinib and R-CHOP has an acceptable and expected safety profile.  An expansion cohort 560 mg ibrutinib is being opened to further explore the safety and efficacy of IR-CHOP in patients with newly diagnosed diffuse large B-cell lymphomas.

For a full listing of all current clinical trials underway in the Lymphoma Program, please click here.

ASCO 2013: Effectiveness of Entecavir and Lamivudine in Preventing Reactivation of Hepatitis B in HBsAg-Positive Patients with Untreated DLBCL

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By Peter Martin, MD

Patients with DLBCL and a history of hepatitis B are at increased risk from the reactivation of a viral infection following treatment with R-CHOP. Many guidelines recommend that patients at risk of hepatitis B reactivation receive anti-viral prophylaxis while receiving R-CHOP, but do not specify which drug should be used. At the recent annual meeting of the American Society of Clinical Oncology in Chicago, Dr. He Huang from Sun Yatsen University Cancer Center presented the results of a trial comparing two of the most commonly used drugs: entecavir and lamivudine.

Study subjects included patients receiving R-CHOP for previously untreated DLBCL and evidence of active infection (HBsAg-positive). Of the 121 HBsAg-positive patients, 61 were randomly assigned to entecavir and 60 to lamivudine. The primary endpoint was the incidence of HBV-related hepatitis; the secondary endpoint was chemotherapy disruption due to hepatitis.

The entecavir group had significantly lower rates of hepatitis, hepatitis B reactivation, and disruption of chemotherapy. The study concluded that for HBsAg-positive DLBCL patients receiving R-CHOP, entecavir was more effective in preventing hepatitis B reactivation, and should be considered the standard for primary preventive therapy in advanced stages of the disease.