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Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

In season 2, episode 6 of Targeted Talks, Alexander B. Olawaiye, MD, associate professor of Gynecologic Oncology at the University of Pittsburgh and Magee-Women’s Hospital of UPMC Hillman Cancer Center (UPMC), lead a discussion with Haider S. Mahdi, MD, associate professor, Department of Obstetrics, Gynecology & Reproductive Sciences University of Pittsburgh and Magee-Women’s Hospital of UPMC about the modern approaches to treating cervical and endometrial cancers.

For cervical cancer, clinicians currently are faced with deciding upon radical surgery or chemoradiation for patients up to stage 1b. The ultimate goal for these patients is to focus on 1 modality because research has shown that patients who received both surgery and chemoradiation have greater complications later on. Patients who recur or present with stage IVB disease are typically treated with systemic therapy, and with these therapies, outcomes depend on the individual disease characteristics. Data around the benefits of bevacizumab (Avastin) for this patient population show potential for its use in the future.

Endometrial cancer is often diagnosed in the early stages due to its symptomatic nature. Because of this, endometrial cancer has high rates of remission. The current challenge oncologists face with treating the disease is when patients are diagnosed in the advanced stages. This is especially true for those with recurrent disease as few treatment options are available for these patients.

To push the field forward, both Olawaiye and Mahdi stress the importance of women have gynecologic symptoms checked out and being screened for cervical and endometrial cancers. Further, the use of biomarkers to determine with patients may benefit from immunotherapy is important for the future of treating cervical and endometrial cancers.

In season 2, episode 6 of Targeted Talks, Alexander B. Olawaiye, MD leads a discussion with Haider S. Mahdi, MD, about the modern approaches to treating cervical and endometrial cancers.

Advancing the Treatment of Cervical and Endometrial Cancers

In season 1, episode 2 of Targeted Talks, community physician Sarah M. Temkin, MD, a gynecologic oncologist at the Anne Arundel Medical Center in Annapolis, Maryland, leads a discussion with Daphne B. Stewart, MD, a medical oncologist and associate clinical professor at the City of Hope Comprehensive Cancer Center, in Duarte, California, around targeted therapies in ovarian cancer, whether offered in the academic or community setting.

The discussion covers the traditional methods for the frontline treatment of patients with recurrent ovarian cancer and how such methods compare with previous strategies and more modern strategies. Temkin and Stewart also touch upon the role of upfront genomic testing to provide precision medicine approaches to patients with germline or somatic 

 mutations, as well as those with homologous recombination deficiency. Although access to testing has improved over the years, they say, there are still barriers to getting access to testing for both germline and somatic mutations. The understanding of the necessity of dual testing and the results for homologous recombination deficiency testing also needs to be expanded, Stewart suggests.

As a conclusion to the topic, the experts review clinical trial research on single agents used for the treatment of patients in this population, in addition to combination therapies, and the management of toxicities from these treatment options.

Sarah M. Temkin, MD leads discussion with Daphne B. Stewart, MD, around targeted therapies in ovarian cancer, whether offered in the academic or community setting.


Precision Medicine Guiding Ovarian Cancer Treatment

Dostarlimab Shows Response in Endometrial Cancer

The Wee1 inhibitor adavosertib shows activity in recurrent uterine serous carcinoma, but the drug’s tolerability remains a challenge. 

Adavosertib Active in Uterine Cancer, But Tolerability Limits Use

Antibody-drug conjugates and their development remains a central theme in ongoing research within the realm of ovarian cancer.

ADC Development in Ovarian Cancer: What’s Next for FRα and Beyond?

The combination of relacorilant and nab-paclitaxel improved progression-free and overall survival in patients with platinum-resistant ovarian cancer.

Relacorilant Extends Survival in Platinum-Resistant Ovarian Cancer

A phase 3 trial will evaluate IMNN-001, the first immunotherapy to show an overall survival benefit in ovarian cancer.

FDA Backs Phase 3 Study of IMNN-001 in Advanced Ovarian Cancer

Nab-Sirolimus Yields Long-Lasting Benefits Across PEComa Subgroups

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the efficacy data seen in a subgroup analysis of the phase 2 AMPECT study (NCT02494570) evaluating nab-Sirolimus (Fyarro; ABI-009) for patients with perivascular epithelioid sarcoma (PEComa).

In the study, an overall response rate (ORR) of 37.5% (95% CI, 15.2%-64.6%) was observed among 16 female patients with malignant PEComa in uterine, ovarian, pelvic, and retroperitoneal sites, regardless of 

mutation status. All of the observed responses were confirmed partial responses.

Additional findings showed that the disease control rate (DCR) in the subgroup was 62.5%, and 4 of 16 patients (25%) experienced stable disease for at least 12 weeks. The subgroup was made up of over half of the evaluable study population. Further, the ORR from this analysis was similar to the 38.7% ORR observed in the overall population evaluation.

 With the overall response rate being the primary end point, the end point was very similar in terms of outcome between the subgroup analysis of the retroperitoneal gynecologic tumors compared with the whole AMPECT trial. [There was a] 37.5% overall response rate with a disease control rate of 63%, and that compared very favorably to 38.7% in the overall AMPECT trial with a disease control rate of 71%.

 The other important thing to remember, and looking at the spider plot really shows that the best, is the median time to response was extremely fast, about 1.4 months, and the duration of response was a little over 36 months. It is important to remember these responses occur often rapidly, and they are quite durable.

1. Herzog T, Dockery L, Dickson M, et al. Response to treatment with nab-sirolimus in patients with perivascular epithelioid cell sarcoma (PEComa) of gynecologic or peritoneal origin: subgroup analysis from AMPECT. Presented at: Society of Gynecologic Oncology 2024 Annual Meeting on Women's Cancer, March 16-18, 2024. San Diego, CA.

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Thomas J. Herzog, MD, discusses the efficacy data seen in a subgroup analysis of the phase 2 AMPECT study evaluating nab-Sirolimus for patients with perivascular epithelioid sarcoma.


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AMPECT Study Shows Promising Safety With Nab-Sirolimus in PEComa Subgroups

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the safety findings of nab-Sirolimus (Fyarro; ABI-009) in a subgroup analysis of the phase 2 AMPECT study (NCT02494570) looking at patients with perivascular epithelioid sarcoma (PEComa).

2024 Society of Gynecologic Oncology Annual Meeting

 and showed that 100% of patients experienced treatment-related adverse events (TRAEs) of any grade, while 63% of patients had a TRAE of grade 3. The most common any-grade TRAEs included stomatitis (81%), fatigue (63%), edema (56%), maculopapular rash (56%), diarrhea (50%), and nausea (50%).

For grade 3 TRAEs, stomatitis (25%), hyperglycemia (13%), hypokalemia (13%), increased amylase (6%), vomiting (6%), and diarrhea (6%) were observed. Additionally, there were no grade 4 or 5 TRAEs seen, TRAEs led to dose delay in 63% of patients, dose reduction in 31%, and treatment discontinuation in 6%.

So all the patients in the gynecologic retroperitoneal subgroup analysis, all 16 of them experienced some treatment-related adverse events. Most of them were grade 1 or 2 with the most frequent in that category or overall being stomatitis, fatigue, edema, rash, and anemia.

There were a number of patients that had grade 3 events, with almost two thirds experiencing that, and the most frequent there were stomatitis, anemia, dehydration, hyperglycemia, and hyperkalemia.

 The only thing that I would comment on is there were 4 patients that had interstitial lung disease or pneumonitis. Fortunately, in the subgroup only grade 1 and grade 2 was observed, and none of those patients had to come off treatment for this treatment-related adverse event.

Thomas J. Herzog, MD, discusses the safety findings of nab-Sirolimus in a subgroup analysis of the phase 2 AMPECT study looking at patients with perivascular epithelioid sarcoma.


Expert Guidance for Patients With PEComa and Sarcoma

Thomas J. Herzog, MD, Paul & Carolyn Flory professor, University of Cincinnati, deputy director, University of Cincinnati Cancer Center, Cincinnati, OH, discusses the importance of patients seeing a gynecologist oncologist or a sarcoma doctor for gynecologic perivascular epithelioid sarcoma (PEComas).

, Herzog presented on nab-Sirolimus (Fyarro; ABI-009), the first and only FDA-approved treatment for locally advanced or metastatic malignant unresectable PEComa, and findings from a subgroup analysis of the phase 2 AMPECT study (NCT02494570) in patients with PEComa. In the study, nab-Sirolimus led to rapid and durable responses in patients with PEComa.

For those diagnosed with a PEComa, Herzog explains that the choice of where to seek treatment depends on factors like location and resources. Ideally, it is recommended to visit a high-volume gynecologist or a facility with a dedicated sarcoma program. Additionally, he explains that confirming the pathology and consulting with a physician experienced in treating sarcomas is crucial for creating an effective treatment plan.

In terms of where to go if you have a PEComa, or even a sarcoma, I think it depends on obviously, where you live and what your resources are, and so forth. Ideally, you would go to a high volume gynecologist who treats a significant number of sarcomas. Or certainly if they have a sarcoma program, that is always a good choice as well.

The key upon diagnosis of a sarcoma or PEComa is to make sure that the pathology is confirmed, and that you are seeing a physician who has high volume in sarcoma. That may be your gynecologic oncologist, or it may be a sarcoma specialist. I think either of those are great places to start. I do think that getting that expert opinion, though, is really key in getting the best outcome and treatment plan.

Thomas J. Herzog, MD, discusses the importance of patients seeing a gynecologist oncologist or a sarcoma doctor for gynecologic perivascular epithelioid sarcomas.

Eric Schroeder on the Evolving Ovarian Cancer Treatment Landscape 

Schroeder on the Evolving Ovarian Cancer Treatment Landscape 

Eric Schroeder, MD, gynecologic oncologist at Baptist Health Miami Cancer Institute, discusses how treatments for patients with ovarian cancer have evolved in recent years.

Historically, chemotherapy regimens employed for the treatment of ovarian cancer frequently caused damage to healthy cells alongside cancerous ones. This resulted in notable adverse effects among patients. Now, advancements in precision chemotherapies and targeted therapies have ushered in a more discerning strategy, specifically targeting cancer cells.

Here, Schroeder expresses enthusiasm about recent advancements in ovarian cancer treatment and highlights the emergence of newer chemotherapies, targeted therapies, and biological agents, which enable a more selective targeting of cancer cells, marking an exciting development in the field.

 Recent years have been a little bit exciting for ovarian cancer. There has been the introduction of some new kinds of targeted therapies. For a long time, we used chemotherapies that are used in other disease sites as well, and they typically treat all the cells of the body. That is where you get a lot of the [adverse] effects from. With more recent chemotherapies and more targeted therapies and biologic agents, we have been able to affect the cancer cells more preferentially than the normal host cells, so that has been exciting.

The introduction of immunotherapy has been exciting. It has not panned out terribly well in ovarian cancer, not as well as in some of the other cancers, but still for some women, it does work. It has been a nice addition. I think more than anything is kind of a renewed interest and focus in research [with the] acceptance that we are nowhere near where we want to be. There are more products coming out and there have been some regulatory changes which have allowed some products to come to market faster than then previously.

Eric Schroeder, MD, discusses how treatments for patients with ovarian cancer have evolved in recent years.


Bradley J. Monk, MD, FACS, FACOG, discusses the enrollment criteria and dosing for the phase 3 KEYNOTE-A18 study.

KEYNOTE-A18 Eligibility: Pembro/Chemoradiotherapy in Cervical Cancer 

Bradley J. Monk, MD, FACS, FACOG, gynecologic oncologist with Florida Cancer Specialists & Research Institute, discusses the enrollment criteria and dosing for the phase 3 KEYNOTE-A18 study (NCT04221945) which evaluated the addition of pembrolizumab (Keytruda) to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.

The criteria are clear, but it's the context of the meaning of the result that is not. I have a history of designing trials for patients that are at higher-risk. There's no such thing as low-risk. If you look at the PARP inhibitor trial that we did called PRIMA [NCT02655016] with niraparib [Zejula], that was [with patients who were] high-risk, stage III and IV. If you look at the RUBY study [NCT03981796] adding dostarlimab [Jemperli] to chemotherapy in endometrial cancer, that was higher-risk patients, but the approval in both PRIMA and niraparib in ovarian [cancer] was all comer because there's no such thing as low-risk. The approval for RUBY of dostarlimab in endometrial cancer was all advanced and metastatic. Both of those studies, PRIMA and RUBY, have now FDA-approved medicines for patients that were not eligible for this study.

Now for [KEYNOTE-A18], it was high-risk, locally advanced cervical cancer, but there's no such thing as a low-risk patient who has a tumor like this, that can't be resected. So in order to be enrolled, you had to have stage III, the old staging, so sidewall involvement, or hydronephrosis, or at least 2 positive nodes. It will be interesting to see if the FDA follows suit, and does what they did in PRIMA and RUBY to now cervical cancer in [KEYNOTE-A18]. And why is this relevant? Because the patients who get cervical cancer are of a different demographic. More than half of the patients enrolled in [KEYNOTE-A18] are not White. I hope that the FDA sort of follows their consistency and allows this to get reimbursed for all women that have locally advanced cervical cancer, not just the high-risk because there's no such thing.

Bradley J. Monk, MD, FACS, FACOG, discusses the enrollment criteria and dosing for the phase 3 KEYNOTE-A18 study of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.


Westin Discusses Insights From the DUO-E Trial in Endometrial Cancer

Shannon Westin, MD, MPH, FACOG, director, Early Drug Development, professor, Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery, The University of Texas MD Anderson Cancer Center, discusses her hopes following the presentation of promising data from the phase 3 DUO-E/GOG-3041/ENGOT-EN10 trial (NCT04269200) of durvalumab (Imfinzi) plus chemotherapy followed by durvalumab and olaparib (Lynparza) maintenance in patients with newly diagnosed advanced or recurrent endometrial cancer.

Congress, Westin presented the primary analysis of progression-free survival (PFS) and the first pre-planned interim analysis of overall survival.

According to Westin, the combination of immunotherapy with chemotherapy shows promise for patients with advanced endometrial cancer and can better outcomes. Findings showed that the benefit of PFS was greatest in patients with mismatch repair-deficient disease treated with durvalumab, and the addition of  olaparib to durvalumab maintenance therapy improved PFS in patients who were mismatch repair-proficient and those positive for PD-L1.

While I am hopeful that we will soon see this available for our patients on a day to day basis, I think the mismatch repair-deficient group, we know we need to give checkpoint with chemotherapy followed by checkpoint maintenance, and so that is what we should be doing. 

Now for this mismatch repair-proficient group, we really can be considering the addition, not only of the durvalumab to chemotherapy, but then that follow-up of durvalumab and olaparib maintenance to help patients live longer without their cancer coming back. 

Now, there's a lot of interests in teasing out molecular subtypes and understanding, can we parse out even more who truly benefits and I'm 100% behind that, but those are going to be exploratory analyses. And the bottom line is our primary analysis was positive, and that combination does work more than control arm of chemotherapy.

Shannon Westin, MD, MPH, FACOG, discusses her hopes following the presentation of promising data from the phase 3 DUO-E trial of durvalumab plus chemotherapy followed by durvalumab and olaparib maintenance in patients with newly diagnosed advanced or recurrent endometrial cancer.


Bradley J. Monk, MD, FACS, FACOG, a professor in the Division of Gynecologic Oncology at the University of Arizona College of Medicine in Tucson and the medical director of the US Oncology Research Network–Gynecologic Program, discusses the phase 3 KEYNOTE-A18 study (NCT04221945) of pembrolizumab (Keytruda) added to external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.


With a median follow-up 17.9 months (range, 0.9-31.0), the median progression-free survival (PFS) was not yet reached (NR) among patients treated with pembrolizumab plus chemoradiotherapy (n = 528) or patients given placebo plus chemoradiotherapy (n = 530; HR, 0.70; 95% CI, 0.55-0.89; P = .0020). At 24 months, the PFS rates in these arms were 67.8% (95% CI, 61.8%-73.0%) vs 57.3% (95% CI, 51.2%-62.9%), respectively.

According to Monk, the OS data not yet mature refer to less than 43% of the information fraction. These data come from the first interim analysis of the trial which were recently presented during the 

 First of all, there was a reduction of progression-free survival and death. Overall survival was immature, but there was an important trend in the right direction. And I would like to venture and say that there's no detriment, but with 43% of the informational fraction, meaning 43% of the patients that you need for maturity, not 43% of the patients that have died, but 43% of the patients that you need for maturity, there's a 27% hazard ratio reduction 0.73 in overall survival. So we'll continue to watch this.


value or the alpha and the PFS now is carried forward of overall survival. This was the final PFS result at this interim analysis as [presented] at ESMO 2023 in Madrid, Spain.

Bradley J. Monk, MD, FACS, FACOG, discusses the phase 3 KEYNOTE-A18 study of pembrolizumab with chemoradiotherapy for the treatment of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.


Monk on KEYNOTE-A18 Data of Pembro/Chemoradiotherapy in Cervical Cancer

Ruchi Garg, MD, chair of gynecologic oncology at City of Hope Atlanta, Chicago, and Phoenix, discusses the impact of targeted therapies studies in patients with early and recurrent endometrial cancer.

HER2-targeted therapy, which is widely used in breast cancer, has been investigated in endometrial cancer successfully. Trastuzumab (Herceptin) was effective in patients with advanced serous endometrial cancer in a randomized phase 2 trial (NCT01367002), showing profession-free survival (PFS) benefit with chemotherapy vs chemotherapy alone.

Ruchi Garg, MD, discusses the impact of targeted therapies studies in patients with early and recurrent endometrial cancer.

GYNECOLOGIC CANCERS

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