It has been a busy June for me with family and personal commitments. I was able to attend the ASCO annual meeting virtually and have picked studies I found interesting to share with you. I'll start with two studies that were not gyn cancer focused.
1) A randomized phase III trial of the impact of a structured exercise program on disease-free survival (DFS) in stage 3 or high-risk stage 2 colon cancer: Canadian Cancer Trials Group (CCTG) CO.21 (CHALLENGE). lba 3510
This was a phase 3 trial of 889 patients with stage III and high-risk stage II colon cancer. Half the patients received a structured exercise program working with a physical activity consultant twice a month for coaching sessions and supervised exercise sessions . After six months they met with the consultant once a month. The other half of the group received educational materials on exercise and nutrition.
Conclusion:" ... exercise program initiated shortly after completion of adjuvant chemotherapy improves disease free survival, overall survival, patient-reported physical functioning, and health-related fitness. Health systems should incorporate structured exercise programs as standard of care for this patient population."
My Take: I'm happy to see a randomized clinical trial of exercise show results that improved overall survival. More info https://www.asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge
2) Glucagon-like peptide-1 receptor agonists (GLP-RAs) and incidence of obesity-related cancer in adults with diabetes: A target-trial emulation study.
The study of 85,015 adult patients from 43 U.S. health systems investigated whether GLP-1RAs reduce the risk of obesity-related cancer in adults with diabetes and obesity compared to dipeptidyl peptidase-4 inhibitors (DPP-4is), a weight-neutral class of diabetes medication.
Conclusion: GLP-1RAs were associated with a lower risk of obesity-related cancer compared with DPP-4is in a large, real-world cohort of patients with diabetes and obesity.
My take: Women in the study who used a GLP had an 8% less chance of developing obesity related cancers. Could use of GLPs impact the number of women diagnosed with endometrial cancers? https://www.moffitt.org/endeavor/archive/glp-1-drugs-may-lower-risk-of-obesity-related-cancers-in-people-with-diabetes/
3) ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC) (GOG-3073, ENGOT-ov72).
Relacorilant is an investigational, oral, selective glucocorticoid
receptor antagonist (SGRA) that increases tumor sensitivity to
chemotherapy-induced apoptosis.Patients were randomized to either relacorilant (150 mg the day
before, day of, and day after nab-paclitaxel) + nab-paclitaxel (80 mg/m2 on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel alone.
Patients in the Relacorilant arm had progression free survival(PFS) of 6.54 months compared to patients in the nab-paclitaxel arm with PFS of 5.52 months. At the Interim analysis the overall survival (OS) for those in the Relacorilant arm was 15.97 months versus the nab-paclitaxel arm of 11.50 months, which is clinically meaningful. It was found that patients in the relacorilant arm had less ascites. Adverse events:
Conclusion "Relacorilant + nab-paclitaxel is the first treatment regimen to
demonstrate a PFS and OS benefit in patients with PROC compared to a
weekly taxane, the most efficacious comparator. These positive efficacy
data and a favorable safety profile position relacorilant +
nab-paclitaxel as a new standard for patients with PROC, without the
need for biomarker selection."
My take: So many studies show good PFS numbers but then end up at final analysis showing no significant difference in overall survival. While there is a meaningful difference at this point, and it looks promising we'll have to wait for those final numbers to say if this will change care.
4) A phase II trial of pembrolizumab and lenvatinib in recurrent or persistent clear cell ovarian carcinoma ( CCOC) (NCT05296512).
This study was a single-arm two-stage phase 2 trial to investigate the clinical
activity of the combination of the PD-1 inhibitor pembrolizumab with the
anti-angiogenic tyrosine kinase inhibitor lenvatinib in patients with CCOC. The study combined an immune checkpoint inhibitor and an anti-VEGFR inhibitor. There were Seventeen of the 30 patients enrolled were alive and progression free at 6 months. No Grade 4/5 adverse events.
Conclusion :"The combination of pembrolizumab/lenvatinib demonstrates encouraging
evidence of clinical activity in CCOC, with 9 pts experiencing a
confirmed response and 16 pts alive and progression-free at 6 months. "
My Take: CCOC is a rare cancer and this combination seems promising. I look forward to the results of a Phase 3 trial.
5) TRUST: Trial of radical upfront surgical therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7). LBA5500
This study was an international randomized multicenter phase III trial in patients with stage
IIIB-IVB OC and good performance status (ECOG 0/1) comparing primary
cytoreductive surgery (PCS) followed by 6 cycles of intravenous (iv)
chemotherapy to 3 cycles of neoadjuvant iv chemotherapy (NACT) followed
by interval cytoreductive surgery (ICS) and 3 further iv cycles. Medium PFS was 22.1 months for the PCS arm and 19.7 for the ICS arm. Medium OS was 54.3 for the PCS arm and 48.3 for the ICS arm.
QOL:
Conclusion "In expert centers with proven surgical quality, PCS followed by iv chemotherapy resulted in a significantly longer median PFS and a numerically longer OS compared to NACT/ICS in non-frail OC pts." Statistical significance in the primary endpoint which was overall survival was not reached.
My Take: It has been known for some time that having surgery by a gyn onc at an expert / NCI center provided better results for women diagnosed with ovarian cancer. Better results were also found when the smallest amount of disease is left after initial surgery (R0). As stated during the study distillation by Dr Barber maybe there are subpopulations that could benefit - age, tumor size, molecular factors, stage III vs IV? I have a personal bias since I had surgery first on my stage 3 initial diagnosis and also again on my recurrence. But I feel the decision whether or not to have surgery first should be made between with the patient and her gyn onc based on the patients health, age and preference.
~~~~~~~~~~~
6) Since there is no screening test for ovarian cancer , I am always looking for abstracts about early detection methods. This poster discusses work to develop and validate a high-throughput Ovarian Cancer detection test based on plasma extracellular vesicle (EV)-associated biomarkers. (Carlos Salomon, Abstract 5582/Poster 480). Plasma from 1553 women ( healthy ,benign and ovarian cancer) was used to develop the test. The test achieve a sensitivity of 77% and a specificity of 99.6%. Though more validation work needs to be done these results are an improvement over the CA-125 and has promise in my opinion.
Every year after attending ASCO, in person or virtually, I hopeful for the future of cancer patients.
Dee
Every Day is a Blessing!
