Introduction Ovarian tumors remain one of the leading malignancies of the female genital tract, with a high mortality rate due to their insidious onset and ...
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Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center presents trial results at The Society of Gynecologic ...
In support of our dedication to transforming the standard of care in gynecologic oncology, the GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. In some instances, through sponsorship and in collaboration with individuals or companies, the GOG will work collaboratively with these entities that provide partial support, drugs or technology. The GOG physician leadership provides mentorship for the next generation of investigators leading these IITs. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. Ovarian cancer is the eighth leading cause of cancer-related death among women worldwide. MIAMI BEACH, FL, March 25, 2023 — Mount Sinai Medical Center (MSMC) is pleased to announce the results of a clinical trial led by Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center in Miami Beach, Florida. Mount Sinai’s Centers of Excellence combine technology, research, and academics to provide innovative and comprehensive care in cardiology, neuroscience, oncology, urology, and orthopedics. Slomovitz added, “Our next steps are to compare this regimen of ribociclib and letrozole vs the best current therapies in a head-to-head study. The progression-free survival and duration of response are both 6 months greater than what we have observed with the current standard treatments,” stated Dr.
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John Diaz, MD, discusses some of the challenges with using targeted therapies in the ovarian cancer space.
This has been a big breakthrough for those of us in gynecologic oncology to utilize precision medicine for the treatment of our patients. We've been a little bit slow to uptake, but over the last few years, there have been a lot of advancements in identifying those women with ovarian cancer who would benefit from precision medicine. As gynecologic oncologists, we're a little bit behind our colleagues in medical oncology who have had the opportunity to utilize precision medicine in the treatment of lung cancer and melanoma.
Minimally invasive surgery for interval debulking resulted in a lower mortality at the 30- and 90-day time points compared with laparotomy in advanced ...
We did find that there was lower mortality at the 30- and 90-day mark in the minimally invasive group. The major finding was that there was no worse overall survival for minimally invasive surgery when compared with laparotomy. Additionally, we did find that for the laparotomy group, there was more extensive surgery, but this didn’t come with any added mortality benefit.
Overall, 23% of 48 patients had partial responses, increasing to 26% in those who had baseline and confirmatory CT scans. Almost 80% obtained clinical benefit.
Slomovitz said 38 of 48 (79%) patients obtained clinical benefit from the treatment, 90% in those with pretreatment and posttreatment CT scans. Chemotherapy [produces responsesopens in a new tab or window](https://pubmed.ncbi.nlm.nih.gov/19361839/) in 0%-15% of LGSOC. Other AEs included decreased white blood cell count (46%), anemia (42%), nausea (42%), decreased lymphocytes (21%), anorexia (19%), myalgia (13%), and weight loss (11%). Two-thirds of the 42 patients with confirmatory CT scans had some degree of tumor shrinkage. The 19.1-month median DOR also exceeded all the other alternative therapies (5.9-13.6 months). [copy-number variant studiesopens in a new tab or window](https://pubmed.ncbi.nlm.nih.gov/32357912/) showing frequent loss of chromosome 9p in the region that contains CDKN2A, which encodes for p16. [aromatase inhibitorsopens in a new tab or window](https://pubmed.ncbi.nlm.nih.gov/22406638/), but are less sensitive to other types of endocrine therapy. Of the 51 patients enrolled, 48 were included in the data analysis. All patients received ribociclib and letrozole for 3 weeks of a 28-day cycle. The results showed that 11 of the 48 patients had partial responses to ribociclib and letrozole, increasing to 11 of 42 when the analysis was limited to patients who had confirmatory CT scans. Two-thirds of patients with LGSOC absence of p16 expression, and loss of p16 could be a predictive marker for response to CDK4/6 inhibition. Overall, 23% of 48 patients had partial responses, increasing to 26% in those who had baseline and confirmatory CT scans.
Administration of hyperthermic intraperitoneal chemotherapy with cytoreductive surgery did not have a negative impact on health-related quality of life ...
The 24-month FACT-O mean was 125.2±20.8 vs 120.6±29.1 in the experimental and control groups, respectively. The median patient age at the time of surgery was 59.5 years in the HIPEC group vs 65.0 years in the control group. The 24-month response rate was 50.0% compared with 31.3% in each respective group. Additionally, most patients had tubo-ovarian as the primary disease site (81.2% vs 75.0%, respectively) and underwent bowel resection (87.7% vs 87.7%). All patients who were included in the analysis had underwent full cytoreductive surgery. “We concluded that HIPEC in this particular study did not negatively affect QOL in patients after cytoreductive surgery for ovarian cancer done in primary setting,” according to Vadim Gushchin, MD, a surgical oncologist and director of the HIPEC Program at Mercy Medical Center in Baltimore, Maryland, during a presentation on the findings. However, multiple studies from the Netherlands, Brazil, Spain, and Korea did not show that patients do worse with HRQOL, irrespective of the HIPEC in this setting.” The FACT-O Questionnaire had 5 subscales: physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and ovarian cancer concerns. Complete cytoreductive surgery was defined as residual disease of less than 2.5 mm. The control group (n = 16) underwent cytoreductive surgery with intraperitoneal port placement followed by the same chemotherapy backbone delivered either intravenously or through the port. “Patients actually call this operation ‘the mother of all the surgeries.’ … Investigators did not report any significant differences in baseline scores and response rates were similar between groups through the follow-up period.