Breaking News
December 18, 2018 - Artificial intelligence and the future of medicine
December 18, 2018 - Montana State doctoral student receives grant for her work to improve neuroscience tool
December 18, 2018 - Early postpartum initiation of opioids associated with persistent use
December 18, 2018 - Russian scientists identify molecular ‘switch’ that could be target for treatment of allergic asthma
December 18, 2018 - Surgeons make more mistakes in the operating room during stressful moments, shows study
December 18, 2018 - Immune cells explode themselves to inform about the danger of invading bacteria
December 18, 2018 - Malnutrition in children with Crohn’s disease linked with increased risk of surgical complications
December 18, 2018 - FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)
December 18, 2018 - The long and short of CDK12
December 18, 2018 - CMR Surgical partners with Nicholson Center to launch U.S.-based training program for Versius
December 18, 2018 - Findings reinforce guidelines for cautious use of antipsychotics in younger populations
December 18, 2018 - Study finds new strains of hepatitis C virus in sub-Saharan Africa
December 18, 2018 - New battery-free, implantable device aids weight loss
December 18, 2018 - Parental alcohol use disorder associated with offspring marital outcomes
December 18, 2018 - Novel Breast Imaging Technique Might Cut Unnecessary Biopsies
December 18, 2018 - What can a snowflake teach us about how cancer spreads in the body?
December 18, 2018 - Management of nausea and vomiting in pregnancy costs the NHS more than previously thought
December 18, 2018 - Green leafy vegetables may reduce risk of developing liver steatosis
December 18, 2018 - Veganism linked to nutrient deficiencies and malnutrition if not planned correctly
December 18, 2018 - Coming Soon: A Tiny Robot You Swallow to Help You Stay Healthy
December 18, 2018 - Modified malaria drug proven effective at inhibiting Ebola
December 18, 2018 - Study finds epigenetic differences in the brains of individuals with schizophrenia
December 18, 2018 - Fitness instructors’ motivational comments influence women’s body satisfaction
December 18, 2018 - Study focuses on modification of lipid nanoparticles for successful brain cell targeting
December 18, 2018 - New gut bacteria may be effective against obesity, metabolic and mental disorders
December 18, 2018 - New two-in-one powder aerosol to upgrade fight against deadly superbugs in lungs
December 18, 2018 - Biofilms feed with swirling flows
December 17, 2018 - Study identifies specific neurological changes related to traumatic brain injury
December 17, 2018 - New study confirms geographic bias in lung allocation for transplant
December 17, 2018 - Research focuses on optimization of solid lipid nanoparticle that encapsulates Vinorelbine bitartrate
December 17, 2018 - Carpal tunnel syndrome – Genetics Home Reference
December 17, 2018 - A novel insulin accelerant
December 17, 2018 - Tips for caring for patients with disabilities, from a mother and physician
December 17, 2018 - Menopause-related sexual, urinary problems tied to worse quality of life
December 17, 2018 - In-school nutrition programs among students limit increases in BMI, finds study
December 17, 2018 - Risk for Hospitalization for Heart Failure Greater With Diabetes
December 17, 2018 - Food assistance may help older adults adhere to diabetes meds
December 17, 2018 - Supporting a family’s goals during a difficult pregnancy
December 17, 2018 - Neurons with Good Housekeeping Are Protected from Alzheimer’s
December 17, 2018 - New approach to tumor analysis could improve prognosis for bowel cancer patients
December 17, 2018 - New ‘epigenetics-based’ cervical cancer test outperforms Pap smear and HPV tests
December 17, 2018 - Ten year follow-up after negative colonoscopy related to reduced risk of colorectal cancer
December 17, 2018 - CTF along with NTAP and Sage announce first-ever open data portal for neurofibromatosis
December 17, 2018 - Intimacy: The Elusive Fountain of Youth?
December 17, 2018 - Will saliva translate to a real diagnostic tool?
December 17, 2018 - DFG establishes nine new Research Units and one new Clinical Research Unit
December 17, 2018 - Assisted living’s breakneck growth leaves patient safety behind
December 17, 2018 - America’s teens report dramatic increase in their use of vaping devices in just one year
December 17, 2018 - Enlarged heart linked to a higher risk of dementia
December 17, 2018 - Prostate cancer detection using MRI now first-line investigation tool
December 17, 2018 - Loughborough academics part of new project investigating effectiveness of personalized breast cancer screening
December 17, 2018 - Adolescents who use cognitive reappraisal had better metabolic measures, shows study
December 17, 2018 - Probiotics may offer therapeutic benefits for biopolar patients
December 17, 2018 - Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
December 17, 2018 - Studies reveal role of red meat in gut bacteria, heart disease development
December 17, 2018 - Eisai enters into agreement with Eurofarma for its anti-obesity agent lorcaserin
December 17, 2018 - Researchers use brain connectome to reassess neuroimaging findings of Alzheimer’s disease
December 17, 2018 - “Miracle” baby survives Ebola in Congo and rapid a new Ebola detection device
December 17, 2018 - Mechanisms behind neonatal diabetes uncovered
December 17, 2018 - AHF urges the WHO to expedite approval process for vaccine effective against Ebola
December 17, 2018 - Study finds misuse of benzodiazepines to be highest among young adults
December 17, 2018 - TGen receives PayPal grant to underwrite costs of genetic tests for children with rare disorders
December 17, 2018 - New research highlights why HIV-infected patients suffer higher rates of cancer
December 17, 2018 - Antibiotic-resistant bacteria could soon be targeted with Alzheimer’s drug
December 17, 2018 - Rutgers scientists take an important step in making diseased hearts heal themselves
December 17, 2018 - Tailored Feedback at CRC Screen Improves Lifestyle Behaviors
December 17, 2018 - Loss of two genes drives a deadly form of colorectal cancer, reveals a potential treatment
December 17, 2018 - How the Mediterranean Diet Can Help Women’s Hearts
December 17, 2018 - Sustained connections associated with symptoms of autism
December 17, 2018 - Concussion rates among young football players were higher than previously reported
December 17, 2018 - Cresco Labs granted approval to operate marijuana dispensary in Ohio
December 17, 2018 - Study provides insight into health risks facing new mothers
December 17, 2018 - AMSBIO expands Wnt signaling pathway product range to aid research
December 16, 2018 - Surgical treatment unnecessary for many prostate cancer patients
December 16, 2018 - Excess weight responsible for cancers globally finds report
December 16, 2018 - Regular sex associated with greater enjoyment of life in seniors
December 16, 2018 - Social stigma contributes to poor mental health in the autistic community
December 16, 2018 - Multidisciplinary team successfully performs complex surgery on patient suffering from enlarged skull
December 16, 2018 - Experts analyze data that can guide antidepressant discontinuation
December 16, 2018 - Menlo Therapeutics’ Successful Phase 2 Clinical Trial of Serlopitant Demonstrates Reduction of Pruritus Associated with Psoriasis
Ibrutinib outperforms chemoimmunotherapy in older patients with chronic lymphocytic leukemia

Ibrutinib outperforms chemoimmunotherapy in older patients with chronic lymphocytic leukemia

image_pdfDownload PDFimage_print
Credit: CC0 Public Domain

Results from an multi-institutional, phase 3 clinical trial show that older patients with chronic lymphocytic leukemia (CLL) have a significantly lower rate of disease progression if treated with the newer targeted drug, ibrutinib, rather than bendamustine plus rituximab—the regimen previously considered as one of the most effective therapies in this group of patients.

The study, which is the first head-to-head comparison between these treatments, also suggests adding the immune-based therapy rituximab to ibrutinib does not bring additional benefits beyond those seen with ibrutinib alone.

Study results were reported simultaneously at the American Society of Hematology (ASH) 2018 Annual meeting and in the New England Journal of Medicine on Dec. 1, 2018.

CLL is a cancer of the white blood cells that is most common in older adults. The U.S. Food and Drug Administration (FDA) approved ibrutinib as a first line treatment for CLL in 2016, around the time when the new trial enrolled its final patients. Previous studies showed ibrutinib was more effective than chlorambucil, another chemotherapy drug, but hadn’t compared ibrutinib to bendamustine plus rituximab, a more effective regimen.

“Our results establish that ibrutinib should be a standard of care for older patients with CLL—it is more effective than the best available chemoimmunotherapy regimen,” said lead study author Jennifer A. Woyach, MD, associate professor of medicine and hematologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “The findings also suggest that when designing trials for CLL in older patients, ibrutinib is the efficacy standard by which other drugs should be measured.”

The trial enrolled 547 older patients with previously untreated, symptomatic CLL between 2013-2016. Participants’ median age was 71, with a range of 65-89 years. One-third were randomly assigned to receive bendamustine plus rituximab, one-third received ibrutinib plus rituximab and one-third received ibrutinib alone. Researchers tracked patient outcomes for a median of 38 months, just over three years.

Rates of survival without any disease progression (the study’s primary endpoint) were significantly better in patients who received ibrutinib plus rituximab (88 percent at 2 years) and ibrutinib alone (87 percent at 2 years) compared with bendamustine plus rituximab (74 percent at 2 years). However, the study saw no difference in overall survival among the three groups at this time.

The addition of rituximab to ibrutinib did not appear to improve outcomes compared with receiving ibrutinib alone. Overall, patients responded well to all three treatment regimens, with an overall response rate of 81 percent in those receiving bendamustine plus rituximab, 93 percent in those receiving ibrutinib plus rituximab and 94 percent of those receiving ibrutinib alone. Although the rates of complete eradication of leukemia were higher with bendamustine plus rituximab, this difference did not translate to better survival or lower rates of recurrence.

“Differences in overall survival are difficult to achieve in frontline CLL studies because patients do very well with second line treatment, especially in this study where there is a crossover from BR to ibrutinib at progression. However, we did see significant toxicities in the ibrutinib arms, which warrant further study and caution in using this drug in all older patients.”

“This study provides definitive evidence that ibrutinib is the most effective treatment for older adults with CLL in terms of durable cancer control. It is exciting to have these data available to doctors and their patients. Despite this successful trial, we are continuing to work hard to optimize BTK inhibitor therapy and refine treatment for this patient population to find the optimal treatment that produces maximum cancer control and minimal side effects,” adds Woyach.

As seen in previous trials, ibrutinib was associated with some significant side effects. In particular, up to 17 percent of patients receiving ibrutinib developed atrial fibrillation, an abnormal heart rhythm that increases the risk of strokes and other cardiovascular problems.

Despite the fact that CLL is most common in older people, the trial is one of just a few that have involved patients over age 65. A vast majority of clinical trials for CLL are conducted in younger adults, for whom the standard of care is different than in older patients.

“The study highlights the importance of doing clinical trials for older patients, because the toxicities are likely to be different for older versus younger patients, even with the same drug,” said Woyach.

The researchers are planning a new study to evaluate the combination of ibrutinib with antibody therapy and with another novel agent.


Explore further:
Clinical trial results show new drug is better for CLL patients

More information:
Jennifer A. Woyach et al. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL, New England Journal of Medicine (2018). DOI: 10.1056/NEJMoa1812836

Journal reference:
New England Journal of Medicine

Provided by:
The Ohio State University

Tagged with:

About author

Related Articles