Nilotinib improved imatinib-related adverse events in CML

Patients with chronic phase chronic myeloid leukemia who experienced treatment-related adverse events with imatinib demonstrated improved quality of life after they switched to treatment with nilotinib, according to updated study results presented at the 2014 Oncology Nursing Society Annual Congress.

The ENRICH study included 37 patients, all of whom previously received 400 mg daily imatinib (Gleevec, Novartis) for 3 months. All patients enrolled had experienced grade 1 to grade 2 persistent non-hematologic adverse events, for a total of 154 imatinib-related events.

Once on the ENRICH study, patients received 300 mg nilotinib (Tasigna, Novartis) twice daily for 3 months. Results showed 103 of the imatinib-related adverse events improved during this time, including 92 that resolved and 11 that improved from grade 2 to grade 1. Forty-seven adverse events remained unchanged, and four worsened.

Fifteen patients demonstrated a combined 34 grade 3 adverse events while on nilotinib treatment. Nilotinib-related adverse events included bronchitis, pruritus, rash, arthralgia, dehydration, hypokalemia, hypophosphatemia, pleural effusion, lipase, bilirubin and blood glucose increases.

Thirteen patients received nilotinib dose reductions due to adverse events, eight of whom re-escalated after improvement. Eight patients discontinued nilotinib treatment, six of which were due to adverse events.

Thirty-two patients had had a major molecular response — defined as at least a 3-log reduction of BCR-ABL — during treatment with imatinib.

During treatment with nilotinib, 16 patients achieved a major molecular response, 16 achieved a 4-log reduction in BCR-ABL, and 13 achieved a 4.5-log reduction in BCR-ABL.

Most patients reported improved quality of life with nilotinib within 24 hours (62%) or 7 days (53%).

Using the MD Anderson Symptom Inventory for CML, researchers observed a mean 1.21 reduction for symptom severity (n=34) and 1.55 reduction for symptom interference (n=33).

“Results from ENRICH showed that CML-chronic phase patients switching to nilotinib experienced improvement in imatinib-related adverse events and quality of life, with maintenance or improvement in molecular response,” the researchers concluded.

For more information:

Hopmann C. Poster #135. Presented at: Oncology Nursing Society Annual Congress; May 1-4, 2014; Anaheim, Calif.

Disclosure: The study was funded by Novartis.