Breaking News
March 24, 2019 - Hidden differences between pathology of CTE and Alzheimer’s disease discovered
March 24, 2019 - Knowing causative genes of osteoporosis may open door to more effective treatments
March 24, 2019 - Toilet-seat based cardiovascular monitoring system getting ready to begin commercialization
March 24, 2019 - New model for intensive care identifies factors that send ill patients to ICU
March 24, 2019 - Recommendations Issued for HSCT in Multiple Myeloma
March 24, 2019 - Deep brain stimulation provides sustained relief for severe depression
March 24, 2019 - “Statistical significance” may soon be a thing of past?
March 24, 2019 - Researchers track effects of epigenetic marks carried by sperm chromosomes
March 24, 2019 - AHA News: Family Adopts Three Children With Three Different Heart Conditions
March 24, 2019 - Research into opioid painkillers could provide clues for safer drug development
March 23, 2019 - Lung cancer survivor recounts her lifetime struggles
March 23, 2019 - Radial and femoral approach for PCI achieve similar results in terms of survival
March 23, 2019 - Study sheds light on the optimal timing of coronary angiography in NSTEMI patients
March 23, 2019 - Excess hormones could cause a condition that can lead to blindness in women, study finds
March 23, 2019 - Dramatic shifts in first-time opioid prescriptions bring hope, concern
March 23, 2019 - Antidepressant drugs may not work when neurons are out of shape
March 23, 2019 - TTUHSC El Paso to establish endowed chair in neurology through a major grant
March 23, 2019 - New device approved by FDA for treating patients with moderate-to-severe heart failure
March 23, 2019 - People with peripheral artery disease have lower Omega-3 Index, shows research
March 23, 2019 - Trigger warnings have minimal impact on how people respond to content, shows research
March 23, 2019 - Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies
March 23, 2019 - Selfish genetic elements amplify inflammation and age-related diseases
March 23, 2019 - Study provides new understanding of how the brain recovers from damage caused by stroke
March 23, 2019 - CRISPR/Cas libraries could revolutionize drug discovery
March 23, 2019 - Allergic reaction during pregnancy may alter sexual-development in offspring’s brain
March 23, 2019 - Seeing through a robot’s eyes helps those with profound motor impairments
March 23, 2019 - Recent research shows that ease of breastfeeding after C-section differs culturally
March 23, 2019 - Newly discovered parameters offer more control over efficient release of drugs
March 23, 2019 - ‘De-tabooing’ of abortion- Women would like more support from health care community
March 23, 2019 - Anti-TB drugs can increase susceptibility to Mtb reinfection
March 23, 2019 - New survey indicates need of attention to neglected tropical diseases
March 23, 2019 - Innovative in vitro method to develop easy-to-swallow medicine for children and older people
March 23, 2019 - Sugary drinks could raise risk of early deaths finds study
March 23, 2019 - Lian wins ENGINE grant for stem-cell-based therapy to treat Type 1 diabetes
March 23, 2019 - Overall, Physicians Are Happy and Enjoy Their Lives
March 23, 2019 - Researchers discover how blood vessels protect the brain during inflammation
March 23, 2019 - CDC study shows modest improvement in optimal hospital breastfeeding policy
March 23, 2019 - Family-based prevention program to reduce alcohol use among older teens
March 23, 2019 - Remote monitoring of implanted defibrillators in heart failure patients prevents hospitalizations
March 23, 2019 - Appropriate doffing of personal protective equipment may reduce healthcare worker contamination
March 23, 2019 - Window screens can suppress mosquito populations, reduce malaria in Tanzania
March 23, 2019 - Researchers discover new biomarker for postoperative liver dysfunction
March 23, 2019 - Pregnancy history may be linked to cognitive function in older women, finds study
March 23, 2019 - Study shows ticagrelor is equally safe and effective as clopidogrel after heart attack
March 23, 2019 - FDA Approves First Drug for Postpartum Depression, Zulresso (brexanolone)
March 23, 2019 - New guidelines outline new treatment management for psoriasis
March 23, 2019 - Thermally abused cooking oil may promote progression of breast cancer
March 23, 2019 - High-fructose corn syrup fuels growth of colon tumors in mice
March 23, 2019 - Partnership aims at establishing best practices to promote diversity in clinical trials
March 23, 2019 - New study examines presence of microbes in tap water from residences, office buildings
March 23, 2019 - Early life trauma may affect brain structure, contribute to major depressive disorder
March 23, 2019 - NIH starts clinical trial of drug to treat cravings associated with opioid use disorder
March 23, 2019 - Cervix bacteria, immune factors could be a warning signal of premature birth, reports new research
March 23, 2019 - Worst-ever emergency care performance figures underscore the need to focus on staffing
March 23, 2019 - The Current issue of “The view from here” is concerned with Cancer
March 23, 2019 - Mouse model validates how ‘good’ and ‘bad’ bacteria affect acne
March 23, 2019 - Individual amygdala neurons respond to touch, imagery and sounds
March 23, 2019 - Combination of two topical creams can prevent cancer
March 23, 2019 - Study suggests depression screening when assessing African-Americans for schizophrenia
March 23, 2019 - New electronic support system for choosing drug treatment based on patient’s genotype
March 23, 2019 - First-of-its-kind study provides pregnancy statistics of imprisoned U.S. women
March 23, 2019 - Marinus Pharmaceuticals Initiates Phase 3 Study in Children with PCDH19-Related Epilepsy
March 23, 2019 - Laparoscopy: MedlinePlus Lab Test Information
March 23, 2019 - Shellfish allergies: can they be treated?
March 23, 2019 - Toilet seat heart monitoring system
March 23, 2019 - Researchers identify way to improve common treatment for PTSD
March 23, 2019 - High potency cannabis use linked to psychosis finds study
March 23, 2019 - Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
March 23, 2019 - Tracking HIV’s ever-evolving genome in effort to prioritize public health resources
March 23, 2019 - Scientists grow most sophisticated brain organoid to date
March 23, 2019 - ADHD drug raising risk of psychosis
March 22, 2019 - FDA approves brexanolone, first drug developed to treat postpartum depression
March 22, 2019 - Gruesome cat and dog experiments by the USDA exposed
March 22, 2019 - Ball pits used in children’s physical therapy may contribute to germ transmission
March 22, 2019 - Long-term use of inexpensive weight-loss drug may be safe and effective
March 22, 2019 - FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
March 22, 2019 - Anti-Müllerian Hormone Test: MedlinePlus Lab Test Information
March 22, 2019 - Finding the right exercise, diet aids for HIV patients
March 22, 2019 - Health Plans For State Employees Use Medicare’s Hammer On Hospital Bills
March 22, 2019 - Researchers develop new tool for imaging large groups of neurons in living animals
Study reveals new treatment option for women with advanced breast cancer resistant to hormone therapy

Study reveals new treatment option for women with advanced breast cancer resistant to hormone therapy

image_pdfDownload PDFimage_print

Treatment with the cyclin dependent kinase (CDK) 4/6 inhibitor palbociclib achieves a clinically meaningful improvement in overall survival in patients with hormone receptor positive (HR+) human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer that has relapsed or progressed on hormonal therapy, according to the final analysis of overall survival results from the PALOMA-3 study reported at ESMO 2018.

Most patients with HR+ breast cancer become resistant to hormonal therapies over time and inhibiting CDK4/6 has been identified as a target for overcoming or delaying resistance to hormonal therapy in advanced HR+/HER2-breast cancer. The prospective, randomized phase 3 PALOMA-3 trial showed that the first-in-class CDK 4/6 inhibitor palbociclib in combination with fulvestrant significantly improved progression-free survival (PFS) in 521 women with HR+/HER2- metastatic breast cancer that had progressed on previous hormonal therapy.

The new analysis assessed overall survival (OS), a key secondary endpoint of PALOMA-3, after a median follow-up of 44.8 months in 521 patients with HR+/HER2- advanced breast cancer. The patients had relapsed or progressed on prior endocrine therapy before being randomized to palbociclib (125mg/day orally, schedule 3/1) plus fulvestrant (500mg per standard of care) or placebo plus fulvestrant. Researchers carried out the OS analysis when approximately 60% (n?310) of the 521 patients in the study had died.

Results showed that median overall survival improved by 6.9 months with palbociclib plus fulvestrant (median OS 34.9 months, 95% confidence interval [CI] 28.8-40.0) compared to placebo plus fulvestrant (median OS 28.0 months, 95% CI 23.6-34.6, p=0.043).

The improvement was even greater in patients with sensitivity to prior endocrine therapy, with an absolute improvement in median OS of 10.0 months. Median OS improved significantly by 11.5 months in patients without visceral disease. No new safety signals were observed with longer follow-up.

“Here, we present the first-ever overall survival results from a phase 3 study for a CDK4/6 inhibitor in a pre-planned analysis of the PALOMA-3 trial. Importantly, this is the first report demonstrating that the absolute gain in survival is similar to the absolute gain in progression-free survival in the whole population. Moreover, this prolongation of life is of a large magnitude in patients with prior sensitivity to endocrine therapy, “said lead author Massimo Cristofanilli, Professor of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Feinberg School of Medicine, Chicago, USA.

“This is very important for patients, as it shows that the improvement in PFS observed in previous studies may have a positive impact on overall survival, an ultimate goal of treatment, therefore improving the chance for a long-term life in spite of advanced disease,” said Cristofanilli. He added: “The demonstration of a positive impact on OS also provides additional confidence to clinicians and patients as to the benefits of this combination as an appropriate and effective treatment approach.”

Commenting on the findings for ESMO, Dr Carmen Criscitiello, European Institute of Oncology Milan, Italy, said: “These data were much awaited, as the clinical benefit obtained with CDK 4/6 inhibitors was incontestable, but there was the hot question whether the PFS benefit translates into OS benefit. This randomized Phase III trial shows for the first time an improvement in OS with a CDK4/6 inhibitor in the metastatic setting for ER+/HER2- breast cancer.” However, she added: “The study was unpowered for OS so the data should be cautiously interpreted. Although the results strongly suggest that the PFS benefit may translate into OS benefit, the other trials conducted with CDK4/6 inhibitors will contribute to confirm the estimate of the OS benefit observed in this study.”

Dr Matteo Lambertini, ESMO fellow at the Institut Jules Bordet, Brussels, Belgium, agreed: “Collecting mature OS data at longer follow-up from randomized trials that investigated the combination of endocrine therapy and CDK 4/6 inhibitors is crucial to have a clearer understanding on the benefit of these expensive agents. The limited OS data that we had so far from these trials are now supported by the PALOMA-3 updated results, which strongly suggest that this treatment should become widely available for women with advanced HR+/HER2- disease.” He said: “Further research is needed to better understand how to optimize the sequencing of the available treatment options in this setting as well as to identify patients who may benefit from endocrine therapy alone.”

Looking to the future, Cristofanilli said: “The significant impact of CDK 4/6 inhibitors on disease-free and overall survival in metastatic disease lead us to be excited about the potential of this class of agents in early-stage breast cancer, where our goal is to improve the cure rate. On that front, two large randomized adjuvant trials of palbociclib in early stage breast cancer, PENELOPE-B and PALLAS, are ongoing.”

Source:

https://www.esmo.org/Press-Office/Press-Releases/PALOMA3-breast-cancer-palbociclib-fulvestrant-Cristofanilli

Tagged with:

About author

Related Articles