What are your top takeaways from SGO 2022?

So many great presentations at SGO 2022! The depth of the science was amazing and the ability to co-mingle in person with new friends and colleagues was more than fabulous. Although I am asked to discuss 3 pivotal abstracts, I encourage all readers to review the many great presentations via the “OnDemand” SGO meeting platform. 

Of particular importance are the disparity studies presented in Scientific Plenary I and Focused Plenary III with a fabulous distillation by Dr. Kemi Doll and outstanding ABOG Speaker Dr. Olayiwola “Health Equity is the Bullseye of the Quadruple Aim”. Also, I recommend the reader to review abstracts presented in Scientific Plenary V along with Dr. Matthew Powell’s excellent distillation where he emphasized the importance of performing molecular testing on all patients with endometrial cancer, even low-grade early stage. 

I will discuss in more detail 3 standout individual presentations, ones that have or will change practice patterns.

“Overspending Driven by Dose-Specific Packaging of Lenvatinib for Endometrial Cancer” – Speaker: @Dr. First Last, MD

A pivotal abstract led to a promise by Eisai (manufacturer of Lenvatinib), immediately prior to the presentation to completely revamp their dose exchange program to cover all indicated dose reductions and all pills that are unused by patients. The presenter eloquently presented how overspending due to dose packaging alone was tied to $168 million annually in the United States for patients on a combination of Pembrolizumab and Lenvatinib for endometrial cancer. Recommended starting dose for Lenvatinib is 20 mg orally with dose reductions to 14, 10, and 8 mg daily. Lenvatinib capsules are available in 2 doses, 4 and 10 mg capsules. Each 30-day supply package of the drug costs $23,624, irrespective of dose. In KEYNOTE-775, dose reductions of Lenvatinib occur in 70% of patients who had at least one dose reduction; 45% had 2 or more. 

“Efficacy and Safety of Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha Expression: Results from the SORAYA Study” – Speaker: Ursula Matulonis, MD

Data on the efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression were presented from the phase III SORAYA trial. Folate receptor alpha is highly expressed in up to 40% of high-grade serous ovarian cancers and its expression is associated with poor clinical outcomes. Patients with folate receptor alpha (FRalpha)-high platinum resistant ovarian cancer who received the study drug, mirvetuximab an antibody-drug conjugate (ADC) demonstrated an impressive objective response rate (ORR) = 32.4% in 106 patients, all of whom had previously received bevacizumab. 48% of patients had received PARPis and response rates were consistent regardless of a number of prior therapies or prior PARPi therapy. The presenter noted the RR in this trial is nearly triple that in prior platinum-resistant ovarian cancer trials. In her distillation of this study, Dr. @Dr. First Last commented on the need to further clarify the proportion of platinum resistant ovarian cancer patients with FRalpha high disease. She also identified the need for a consistent, reproducible, and user-friendly assay/biomarker for FRalpha-high expression. Clinicians are encouraged to consider patients with platinum-resistant ovarian cancer for enrollment in NCT04209855 or other clinical trials.

"Open vs. Minimally Invasive Radical Hysterectomy in Early Cervical Cancer: LACC Trial Final Analysis" – Speaker: Pedro Ramirez MD

The final analysis of the LACC trial (n=631 patients) was presented along, where 83% of patients completed 4.5 years of follow-up (100% of eligible patients). Also presented were data from an exploratory analysis. It was emphasized that the LACC trial was not powered to draw conclusions from any of the elements analyzed. Overall, the mature data confirmed the earlier findings presented in 2018 where patients undergoing minimally invasive surgery (MIS) had worse outcomes compared with patients undergoing open surgery. Disease-free survival (DFS) was 96% with open surgery compared with 85% with MIS. There were 43 recurrences in the MIS group compared to 11 in the open surgery group (Hazard Ratio= 4) at 4.5 years. Overall survival was 3 times worse (p=.007) for patients undergoing MIS compared with open surgery. Factors analyzed as part of the exploratory analysis that were not statistically powered to analyze include:

Impact of disease in hysterectomy specimen: 0 vs 0% (e.g. not evaluable)
Tumors > 2 cm: 21% vs 5% had DFS events MIS vs open (HR=4.25)
Tumors < 2 cm: 9% vs 0% had DFS events MIS vs open
Impact of prior conization HR = 1.27 (NS)
Rates of carcinomatosis: 24% vs 0 MIS vs open 
Patterns of recurrence: (see details in presentation)

Clinicians are encouraged to enroll patients with early-stage cervical cancer in GOG-3043, the ROCC trial, a randomized controlled trial of robotic vs open radical hysterectomy for cervical cancer to further clarify the potential role of MIS in this population. Patients should not undergo MIS for early-stage cervical cancer outside of a clinical trial.

My 3 most significant takeaways from the 2022 SGO Meeting on Women's Cancer:

1. Atezolizumab administered before and concurrently during chemoradiation appeared safe and demonstrated immune-modulating activity among women with node-positive locally advanced cervical cancer, according to the phase IB NRG 017study presented by Dr. @Dr. First Last et al.

The goal of combining immunotherapy with chemoradiation is to improve outcomes for women with node-positive cervical cancer. The study tried to find out the optimal sequence of immunotherapy with radiation and look for molecular markers of synergy (T-cell parameters). The phase 1/1b trial included 36 women (median age, 48 years) with locally advanced cervical cancer with positive lymph nodes randomly assigned to either one dose of 1,200 mg atezolizumab before and two doses during chemoradiation (arm A) or to all three doses during chemoradiation (arm B). 

So, concurrent immunoradio-therapy appears to be safe and synergistic. Longer follow-up is required for the outcome study.

Mayadev J, et al. Abstract 24. Presented at: Society of Gynecologic Oncology 2022 Annual Meeting on Women’s Cancer (hybrid meeting); March 18-21, 2022; Phoenix. 

2. Updated results of the LACC (The Laparoscopic Approach to Cervical Cancer (LACC) trial, Ramirez P et al.

LACC was looking at whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) were equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer. 

In a final analysis of trial data, Ramirez and colleagues compared the long-term outcomes of both patient groups. Analyses showed poorer DFS among women who underwent minimally invasive surgery correlated with larger tumor size (2 cm), indicating that open hysterectomy is still the standard of care.

Ramirez PT, et al. Abstract LBA10. Presented at Society of Gynecologic Oncology 2022 Annual Meeting on Women's Cancer (hybrid meeting); March 18-21, 2022; Phoenix.

3. Race linked to increased treatment interruptions among women with gynecologic cancer 

Race-based Stress was studied for an association with treatment interruptions among 72 women attending visits for gynecologic cancer treatment or surveillance at a single institution. Race was associated with treatment interruptions and higher prevalence and urgency of social needs among gynecologic cancer patients. Results showed black women had a significantly higher median IRRS-B score compared with white women (38 vs. 10; false discovery rate-adjusted P < .001). 

Black women undergoing treatment for gynecologic cancer reported significantly higher levels of race-associated stress compared with white women, according to this study's results. 

Their race-related stress resulted in increased treatment interruptions, longer time to treatment initiation, and longer treatment interruptions. These findings give one explanation for why black patients do worse than white. 

Alvarez A, et al. Abstract 16. Presented at: Society of Gynecologic Oncology 2022 Annual Meeting on Women’s Cancer (hybrid meeting); March 18-21, 2022; Phoenix. 

1.  SIENDO. For patients without actionable and/or predictive biomarkers, maybe we can extend treatment-free intervals with a once-weekly maintenance therapy. I am curious how this will fit into the treatment algorithms. 
2. Cost-effectiveness abstracts on Pembro for cervical cancer and dosing in lenvatinib. These abstracts make me think about cost and where this cost falls. For these patients with high co-pays, my experience is patient assistance programs. For my patients with private insurance, cost doesn’t seem to be an issue. I would like to see a deeper dive into these questions. Where is the waste and/or cost felt? Do we save money by controlling the disease? Are the biggest costs related to the hospital and surgery costs? Decisions about continued care versus hospice need to be factored into this. When lives are improved by therapy and patients are allowed to enter back into society and their lives, how do we account for this?
3. Patient-reported outcomes in KEYNOTE-826. Great to see improved quality of life for these patients. This is an excellent advancement in a desperate patient population.

1. SIENDO trial
2. SORAYA trial
3. Mersana ADC
4. HRD assay in Leuvin
5. Niraparib maintenance in PRIME trial.

1) NRG GY017: A Phase I/Ib trial conducted by the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group NRG Oncology, concluded that the addition of the immunotherapy drug atezolizumab prior to and concurrently given with chemoradiation treatment was safe for women with node-positive, locally advanced cervical cancer. Trial data also showed that a combination of atezolizumab with CRT exhibited immune-modulating activity.

2) Biomarker analysis of NRG GY004: occurred as part of a preplanned translational endpoint for the study, concluded that homologous recombination repair (HRR) mutation type was prognostic of progression-free survival and predictive for activity of olaparib when compared to the standard of care—platinum-based chemotherapy—for women with recurrent platinum-sensitive ovarian cancer.

3) SORAYA trial: mirvetuximab soravtansine, a novel antibody-drug conjugate therapy, produced a substantially better response than standard treatments and generated an objective response in nearly 33% of patients participating in the trial. That compares with response rates in the single digits for current treatments in patients whose ovarian cancer doesn’t respond to platinum-based chemotherapy.

1. Selinexor Mx in TP53wt - Endometrial
2. PRIME niraparib 1L HRP - Ovary
3. SORAYA or everything else (exciting meeting!)

The top abstract that I was excited about was the iPocc study which presented a PFS benefit for patients undergoing IP carboplatin, especially in the suboptimally debulked patient. 

This was a long-awaited study, and its results are definitely thought-provoking. For myself and among other GOs I spoke to, this definitely instilled consideration about “bringing back” IP chemo! And it also placed into question our long-held beliefs about doing IP chemo only in optimally debulked patients. Perhaps this is a new road towards IP carbo in suboptimally debulked patients? We will certainly discuss this at our institution!

1. SIENDO
2. SORAYA
3. Cost-effectiveness dose-packaging Lenvatinib

My 3 most interesting abstracts included:

1. SORAYA: Mirvetuximab Soravtansine in platinum resistant recurrent ovarian cancer.

As a single agent in the PROC population, the identified ORR was promising and may establish this drug as an alternate treatment strategy for folate receptor alpha high patients.

2. KEYNOTE-826 QOL:

Important data shows no decrement in QOL for patients treated with chemotherapy +/- bevacizumab + pembrolizumab when compared to placebo. 

3. SIENDO:

This LBA reported on the efficacy of Selenexor as a maintenance strategy in patients with metastasis or recurrent endometrial cancer. Although the study had limitations, the exploratory analysis in the p53 wt population was exciting and will inform future trials in this specific patient population.

I thought that the follow-up of the radical hysterectomy study presented by Dr. Ramirez would continue to have a major impact. (Plenary presentation on “Open vs. Minimally Invasive Radical Hysterectomy in Early Cervical Cancer: LACC Trial Final Analysis”)