PracticeUpdate: Haematology & Oncology

ASCO 2016 5

• The conclusion drawn is that pacritinib had no cumulative toxicity and offered durable response in patients with myelofibrosis. Lymphoma and chronic lymphocytic leukaemia Rituximab maintenance after induction with abbreviated FCR in previously untreated elderly (≥ 65 years) CLL patients: Results of the randomized CLL 2007 SA trial from the French FILO Group (NCT00645606). C Dartigeas, E Van Den Neste, H Maisonneuve, et al • Researchers randomised 409 patients aged ≥ 65 years with B-cell chronic lymphocytic leukaemia (CLL) who received induction with four cycles of FCR to receive rituximab or observation. Median progression-free survival was 59.3 months with rituximab versus 49 months with observation (P = 0.0011), and 3-year progression-free survival and overall survival was also greater with rituximab than observation (83% vs 64.2% and 92.6% vs 87.2%, respectively). Improvement in progression-free survival with rituximab was similar between patients with or without del11q and unmutated IGHV. Rates of haematological and infectious toxicity were significantly greater in patients taking rituximab than those on observation (6.9% vs 1.9% and 18.8% vs 10.1%, respectively). • Progression-free survival in elderly patients with CLL was improved with 2-year rituximab maintenance therapy, although rituximab was also associated with higher toxicity. Acalabrutinib, a second-generation bruton tyrosine kinase (Btk) inhibitor, in previously untreated chronic lymphocytic leukemia (CLL). JC Byrd, JA Jones, RR Furman, et al • In this ongoing phase 1/2 study, outcomes have been assessed through December 2015 in 74 patients with previously untreated chronic lymphocytic leukaemia (CLL) receiving monotherapy acalabrutinib, a Btk inhibitor. Of the original 74 patients, 72 have continued on acalabrutinib, with most common adverse events being grade 1/2 headache, diarrhoea, arthralgia, contusion, nausea, and increased weight. Approximately half of patients experienced treatment-related lymphocytosis, which resolved in all but 1 patient. Partial response and stable disease were observed in 86% and 4% of patients, respectively. • Acalabrutinib was well-tolerated and has been associated with high response rates in patients with previously untreated CLL. A phase 3 study has been initiated.

© ASCO/Matt Herp 2016

• At 3 months, CMR was associated with better overall and relapse-free survival than lesser molecular responses. Updated results from the phase II study of hyper-CVAD in combination with ofatumumab as frontline therapy for adults with CD20 positive (CD20+) acute lymphoblastic leukemia (ALL). GC Issa, HM Kantarjian, F Ravandi, et al • In this update from a phase 2 study, 53 adults with CD20-positive (CD20+) acute lymphoblastic leukaemia (ALL) received the combination of ofatumumab with hyper-CVAD. Of the 50 patients evaluable for response, 49 had complete remission following one cycle, with 48 of 52 patients becoming negative for minimal residual disease. A majority of patients had febrile neutropaenia during induction and consolidation (67% and 89%, respectively). CR duration and overall survival rates at 2 years were 74% and 83%, respectively. • The researchers concluded that ofatumum- ab with hyper-CVAD is effective and safe in patients with CD20+ Ph− ALL. Long-term survival of patients with therapy- related MDS (tMDS) compared with de novo MDS following allogeneic hematopoietic cell transplantation (alloHCT). AT Pham, IT Aldoss, SM Li, et al • In a retrospective study, the outcomes were compared between 264 patients who had either therapy-induced myelodysplastic

syndrome (tMDS) or de novo MDS who received allogeneic haematopoietic cell transplantation (alloHCT). Patients with tMDS were more likely to have poor-risk karyotype than patients with de novo MDS (63% vs 31%, respectively; P < 0.01), but researchers did not find differences in 5-year overall survival, non-relapse mor- tality, and relapse rates between the groups. In patients with tMDS, more recent era of alloHCT and younger age were associated with improved overall survival (P < 0.01). • The outcomes associated with alloHCT in patients with tMDS are similar to those in patients with de novo MDS. Pacritinib (PAC) vs best available therapy (BAT) in myelofibrosis (MF): 60 week follow-up of the phase III PERSIST-1 trial. RA Mesa, M Egyed, A Szoke, et al • In the phase 3 PERSIST-1 trial, researchers randomised 327 patients with myelofibrosis naive to JAK inhibitor therapy to receive pacritinib or best available therapy. Spleen volume stable (SVR) ≥ 35% was reached in 24% of patients receiving pacritinib at 60 weeks, and 84% of patients receiving best available therapy crossed over to pacritinib. After crossover, SCR ≥ 35% was reached in 19%. Diarrhoea associated with pacritinib therapy was highest in the first 8 weeks (51%). Anaemia, thrombocytopenia, and neutropenia were also common adverse events.

DECEMBER 2016