Monday, October 2, 2023
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A large number of trials expected to have an impact on clinical practice were reported. Among the highlights:
Once patients with CML achieve remission, can TKI therapy be stopped? Several smaller studies have suggested it is possible, and now results from the largest cohort to date, in the European Stop TKI (EURO-SKI) study, show that stopping TKI therapy is feasible and that about half of patients remain free from relapse after 2 years. A further analysis of patients who were taking imatinib suggests that stopping imatinib after 5.8 years is associated with a higher likelihood of molecular relapse-free survival. Current guidelines recommend that most patients who achieve remission with TKI therapy continue taking the drugs indefinitely, yet it is unclear whether continued therapy is necessary for all patients. The EURO-SKI data provide "evidence that may be implemented in guidelines in the near future," said lead author, François-Xavier Mahon, MD, PhD, from the Bergonie Cancer Center of the University of Bordeaux, France.
After years of excitement over clinical trial results with chimeric antigen receptor (CAR) T-cell therapy, two products are expected to hit the market in 2017. Novartis' product is CTL019, an anti-CD19 CAR T-cell therapy developed for relapsed and refractory ALL in children. Results from a global registration trial show an 82% complete remission rate. Kite's product, Kte-C19 (anti-CD19) CAR T-cell therapy is for patients with refractory diffuse large B-cell lymphoma. "This whole field has just exploded. It probably represents one of the most exciting therapeutic strategies to be tried in any form of leukemia, let alone ALL, in the last decade or so," commented Daniel DeAngelo MD, PhD, from Harvard Medical School and the Dana-Farber Cancer Institute in Boston, Massachusetts. Commenting on CAR T-cell therapy generally, ASH President Charles Abrams, MD, said that because of the serious adverse events, "this therapy is not for the fainthearted, but we can usually carry patients through."
Obinutuzumab (Gazyva/Gazyvaro, Genentech/Roche) may be a potential replacement for rituximab (Rituxan, Genentech/Roche) in some patients with follicular lymphoma, suggest interim data from the GALLIUM study. Patients with advanced-stage symptomatic follicular lymphoma currently receive rituximab-based chemoimmunotherapy induction followed by rituximab maintenance as standard treatment. As reported by Robert E. Marcus, MD, from King's College Hospital, London, United Kingdom, data from the GALLIUM study indicate patients on obinutuzumab-based induction followed by obinutuzumab maintenance had a 34% reduced risk for progression compared with rituximab-based induction followed by rituximab maintenance. However, overall survival did not differ, and there was concern over the higher mortality seen in the subgroup of patients who received induction therapy with these agents in addition to bendamustine.
Younger patients with mantle cell lymphoma who have undergone an autologous stem cell transplantation should be given rituximab maintenance therapy, say French researchers who have found a survival benefit with the regimen. The new survival data come from the final results of the LyMa study presented by Steven Le Gouill, MD, PhD, from Nantes University Hospital in France. The 240 patients who responded to the transplant were randomly assigned (1:1) to be followed by observation or to receive rituximab maintenance (375 mg/m2, one infusion every 2 months for 3 years). Rituximab maintenance cut the risk for progression by 60% and the risk for death by 50%. The 4-year progression-free survival rate was 82.2% with rituximab vs 64.6% with observation, and the 4-year overall survival rate was 88.7% with rituximab vs 81.4% with observation. Rituximab maintenance (one infusion every 2 months for 3 years) is a new standard of care for young patients with mantle cell lymphoma, the investigators conclude.
Patients with CLL at risk for early relapse benefit from maintenance therapy with lenalidomide (Revlimid, Celgene), according to an interim analysis from the CLL M1 study by the German CLL study group. Patients who received lenalidomide as maintenance therapy had a greater than 80% reduced risk for progression compared with patients who did not. "There was also a conversion of a number of patients to minimal residual disease negativity with lenalidomide maintenance," said presenter Anna Maria Fink, MD, from the University Hospital Cologne, Germany. "This is the first study to show the benefits of lenalidomide maintenance in this patient population," she said. "However, it is unclear if this will have an impact on treatment in the future," she added, given that several new targeted therapies have altered the treatment landscape. Still, lenalidomide maintenance may be an option for selected patients on an individual basis, Dr Fink said.
For patients with CD30-expressing cutaneous T-cell lymphoma (CTCL), treatment with the CD30-targeting antibody brentuximab vedotin (Adcetris, Seattle Genetics) was superior to physician's choice of therapy (methotrexate or bexarotene) in the phase 3 head-to-head-comparator ALCANZA study, the first reported randomized phase 3 trial testing a new systemic agent against standard-of-care therapy in CTCL. Youn Kim, MD, from Stanford University School of Medicine, California, reported that the clinical outcomes with brentuximab vedotin were "far superior," with highly significant improvements in both overall response rates (56% vs 13%) and median progression-free survival (16.7 vs 3.5 months). Safety data were consistent with the established tolerability profile for brentuximab vedotin. "These compelling results have potential practice-changing implications," Dr Kim said.
The dramatic increase in venous thromboembolism (VTE) seen in children's hospitals in the United States may be associated not just with the use of central venous catheters (CVCs) but also where they are placed. Preliminary results from an analysis of 1096 children show that the incidence of CVC-associated VTE was 5.7% across all the children, but 85% of the events were in children with peripherally inserted central catheters (PICCs). "We are putting a lot more central lines in children, and most of them are receiving PICCs. The results of our study are cause to pause," said presenter Julie Jaffray, MD, from the Children's Hospital of Los Angeles in California. The new finding comes from the CIRCLE (Clot Incidence Rates in Central Lines) study. "We know children with cancer or who are in the pediatric intensive care unit will need a central line placed. But these lines aren't perfect," Dr Jaffray said. "The important question is: are we choosing the right line for them or are we just putting in the line that's easier to place?"
A multidisciplinary approach dramatically cut mortality in pregnant women with SCD, after being in place for only 13 months. The Korle-Bu Teaching Hospital, a national referral center in Accra, Ghana, treats about 250 pregnant women with SCD every year; up to 12% die during pregnancy and after childbirth. But after the intervention, there was an 89% decline in maternal deaths (9.5% vs 1.1%), along with a 62% reduction in perinatal mortality (60.8% vs 23% per 1000 total births). "There was also a 12.9% decrease in cesarean deliveries after the intervention," reported Eugenia Vicky Naa Kwarley Asare, MBChB, BSc, from the Ghana Institute of Clinical Genetics, Korle-Bu, and the Korle-Bu Teaching Hospital in Accra, Ghana. The multidisciplinary obstetric team dedicated to SCD includes an obstetrician, hematologist, pulmonologist, and nurse. Dr Asare said the next step is to implement a similar program at three major health centers in Accra.
A first-in-class drug has demonstrated efficacy in reducing sickle-cell–related pain crises, a substantial cause of morbidity in SCD. The novel agent is a humanized antibody against P-selectin, crizanlizumab (SelG1, developed by Selexys Pharmaceuticals, which has been acquired by Novartis). Results of the phase 3 SUSTAIN trial show crizanlizumab reduced the frequency of pain crises by nearly half compared with placebo. In addition, median times to first and second crises with high-dose crizanlizumab were 2 to 3 times as long compared with placebo, reported lead author Kenneth I. Ataga, MBBS, from the University of North Carolina at Chapel Hill. The new findings suggest SCD patients may soon have another option to treat these episodes. Currently, only one treatment is available, hydroxyurea, which was approved about 15 years ago by the US Food and Drug Administration.
Although a commercial product is still about 10 years away from market, there was a buzz here about artificial blood cells that could be used for trauma patients. The lead indication is use in the battlefield, where a paramedic would mix a bag of red powder with a bag of sterile water to make artificial blood that could be immediately given to any individual, without the need to check blood type. It could make a difference between life and death. It is estimated that 25% of in-field deaths of US military personnel are preventable, and hemorrhagic shock is the cause of death in 90% of these cases, where individuals die not from damage to major organs but because they basically bleed to death before they can be brought to a hospital, said Allan Doctor, MD, from Washington University in St Louis, Missouri. Another potential use is for trauma victims, again to prevent death from blood loss. The product could be carried by ambulances and rescue helicopters, and it could sit on the shelf for years, without the need for refrigeration, until it is needed, unlike donated blood, which requires special storage conditions, ages, and can eventually no longer be used.
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