Advertisement


Richard Finn, MD, on Advanced Breast Cancer: New Data on Palbociclib Plus Letrozole From PALOMA-2

2022 ASCO Annual Meeting

Advertisement

Richard Finn, MD, of the Geffen School of Medicine at UCLA and the Jonsson Comprehensive Cancer Center, discusses analyses from the PALOMA-2 trial on overall survival with first-line palbociclib plus letrozole vs placebo plus letrozole in women with ER-positive/HER2-negative advanced breast cancer. The study met its primary endpoint of improving progression-free survival but not the secondary endpoint of overall survival. Although patients receiving palbociclib plus letrozole had numerically longer overall survival than those receiving placebo plus letrozole, the results were not statistically significant (Abstract LBA1003).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The development of CDK 4/6 inhibitors in advanced breast cancer have really been a hallmark advance for the management of that group of patients. The first CDK 4/6 inhibitor was palbociclib, based on the PALOMA-1 study, which demonstrated a significant improvement in progression-free survival for that population. Since that time, there's been seven randomized studies with CDK 4/6 inhibitors, which have confirmed that observation. The PALOMA-2 study was the confirmatory study with palbociclib and letrozole versus placebo and letrozole, whose primary endpoint was to improve progression-free survival. And we demonstrated that, and that has served for the global approval of palbociclib in this population of patients. Now we are presenting the overall survival data from that study. This has been long awaited and with seven and a half years of follow-up, we're showing that there is a numerical improvement in overall survival, but this does not reach statistical significance. Really, in the context of advanced breast cancer, we have seen that as a class, CDK 4/6 inhibitors have improved overall survival. Specifically in PALOMA-2, there were some challenges that limits our assessment over overall survival. Specifically, we had about a third of the patients that had missing data for overall survival at the time of our analysis. Much of that was from patients withdrawing consent, as well as patients lost to follow up. We did demonstrate though, in those groups or subgroups of patients where the dropout was less pronounced. And actually there was also a disproportionate dropout in the control arm versus the treatment arm, so when we looked at subgroups where the dropout was a little closer, we did see that there was a trend towards an improvement in overall survival with palbociclib and letrozole versus the control arm of letrozole alone. The other thing to note is PALOMA-2 included about 20% of patients who had a disease-free interval of less than one year. And when we look at the largest group of patients in our study, which are those had a disease free interval of greater than 12 months, we actually see quite significant improvement in overall survival, given it's a subgroup analysis and is being looked at retrospectively. There was also a pre-planned analysis, combining data from PALOMA-1 and PALOMA-2. And in that analysis, we see again, a strong trend towards improvement in overall survival with palbociclib. And when we look again at this group of patients who had a long disease-free interval greater than 12 months from their adjuvant treatment, again, a very strong trend towards improving overall survival. So the take home message is PALOMA-2 met its primary endpoint of improving PFS, improved objective response rate. It has maintained quality of life. And with seven and a half years of follow-up, there's no new toxicity, there's no cumulative toxicity, and when we look at the overall survival for the whole population of patients, we see that it's over 50 months, which is really striking and tells us that the incorporation of CDK 4/6 inhibitors into the management of these women is really changing the natural history of this subtype of breast cancer.

Related Videos

Kidney Cancer
Immunotherapy

Jonathan E. Rosenberg, MD, and Thomas Powles, MD, PhD, on Renal Cell Carcinoma: New Data on Pembrolizumab Plus Axitinib vs Sunitinib as First-Line Therapy

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Thomas Powles, MD, PhD, of Barts Health NHS Trust, Queen Mary University of London, discuss phase III findings from the KEYNOTE-426 trial, which appear to support the long-term benefit of pembrolizumab plus axitinib for first-line treatment of patients with advanced clear cell renal cell carcinoma (Abstract 4513).

Issues in Oncology
Global Cancer Care

Clifford A. Hudis, MD, and Karen E. Knudsen, PhD, MBA, on How ASCO and the American Cancer Society Are Collaborating to Help Patients With Cancer

Clifford A. Hudis, MD, of the American Society of Clinical Oncology, and Karen E. Knudsen, PhD, MBA, of the American Cancer Society, discuss their collaboration, pooling their research and education resources to help empower patients with cancer and their families. Within 48 hours, Drs. Hudis and Knudsen were able to gear up a rapid response to the crisis in Ukraine, forming a clinical corps of volunteers to post information online in multiple languages, which helped patients navigate their care in the war-torn region. To date, 300 European cancer organizations have joined their efforts.

Breast Cancer

Nancy Davidson, MD: In It for the Long Haul: Outcomes in Hormone Receptor–Positive Breast Cancer

Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, reviews results from four abstracts about the importance of long-term follow-up in studies of adjuvant endocrine therapy for hormone receptor–positive breast cancer. Because the natural history of hormone receptor–positive breast cancer is long, an effort is underway to improve selection of patients by clinical parameters or biomarkers, refine the endocrine therapy background, and administer more effective combinations of endocrine therapy with other agents.

COVID-19

Jenny S. Guadamuz, PhD, on Racial and Socioeconomic Disparities in Telemedicine Use Among U.S. Patients With Cancer During the COVID-19 Pandemic

Jenny S. Guadamuz, PhD, of Flatiron Health, discusses the use of telemedicine services in community oncology clinics for patients initiating treatments for 21 common cancers during the COVID-19 pandemic. Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services. Although telemedicine may expand access to specialty care, the proliferation of these services may widen cancer care disparities if equitable access to these services is not ensured, according to Dr. Guadamuz (Abstract 6511).

Pancreatic Cancer

Alfredo Carrato, MD, PhD, on Pancreatic Cancer: Nab-Paclitaxel, Gemcitabine, and FOLFOX for Metastatic Disease

Alfredo Carrato, MD, PhD, of Alcala de Henares University in Spain, discusses phase II results from the SEQUENCE trial, which showed that nab-paclitaxel, gemcitabine, and modified FOLFOX showed significantly higher clinical activity than the standard nab-paclitaxel and gemcitabine in the first-line setting of patients with untreated metastatic pancreatic ductal adenocarcinoma (Abstract 4022).

Advertisement

Advertisement



Advertisement