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Videos

Electra D. Paskett, PhD, Professor, College of Medicine, The Ohio State University, describes the use of vinegar (acetic acid) as a cervical cancer screening tool.

Using Vinegar as a Cervical Cancer Screening Tool

Articles

Carol Aghajanian, MD, from the Memorial Sloan-Kettering Cancer Center, discusses a phase III trial of pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Using the Angiogenesis Inhibitor Pazopanib to Treat Ovarian Cancer

Mark J. Levis, MD, PhD, discusses the design and results of a phase II trial of quizartinib in patients with FLT3-ITD positive or negative relapsed/refractory acute myeloid leukemia.

Phase II Trial Examining Quizartinib in AML

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

Findings from the patient-reported outcomes analysis of the phase 3 KEYNOTE-826 trial support the benefit of pembrolizumab in patients with recurrent, persistent, or metastatic cervical cancer.

KEYNOTE-826 Data Supports Pembrolizumab in Patients With Cervical Cancer

In the NORA study, a 16% reduction in the risk of death was achieved with maintenance niraparib in patients with platinum-sensitive recurrent ovarian cancer. 

Maintenance Niraparib Shows Favorable OS in Platinum-Sensitive Recurrent Ovarian Cancer 

CINtec PLUS Cytology is the only dual-stain triage test to be offered by BioReference Health LLC for patients with a high-risk human papillomavirus result.

Availability of FDA-Approved Dual-Stain Triage Test Expands for Cervical Cancer Screenings 

During a Targeted Oncology case-based roundtable event, Paul D. DiSilvestro, MD, discussed the long-term results from the SOLO-1 trial of olaparib maintenance for patients with ovarian cancer. 

This is the first of 3 articles based on this event. 

Long-Term Follow-Up Shows Olaparib’s Efficacy in Ovarian Cancer

In a phase 1 study, a peptide conjugated vaccine showed potent immunogenicity and was able to induce functional T-cell responses in almost
all vaccinated patients with HPV16-positive premalignancies.

Phase 1 Study Shows Signals of Response With Vaccine for HPV16+ Premalignancies

Anna Jo Bodurtha Smith, MD, a third year Gynecologic Oncology fellow at the University of Pennsylvania, fellow at the Penn Center for Cancer Care Innovation and Leonard Davis Institute of Health Economics, discusses background on her research regarding insurance-mediated disparities in gynecologic oncology.

Smith explains that she was inspired to learn more about the effects various insurance types have on the quality of care of patients with gynecologic cancer based on her prior research in this space, as well as her own personal experiences.

 It's both based on my prior research, as well as my own personal family experience. Starting with the family experience, my grandfather got diagnosed with cancer when he was around [my current age]. This was prior to us having a lot of the health programs we have now, prior to Medicaid, prior to Medicare, etc., and he and my mom lost everything. They lost their insurance; they ended up paying for everything out of pocket and it is sort of the formative family story we have about what happens when you get cancer and don't have insurance.

 That spurred my early interest in insurance and starting in college, I've worked since then on how insurance impacts health care outcomes. More recently as an OBGYN resident, I finished my medical training around the time of the Affordable Care Act and was very interested on how the Affordable Care Act could impact patients with gynecologic cancer. Much of my research that preceded this article was around the fact that the insurance gain under the Affordable Care Act did lead to earlier stage diagnosis, earlier access to care, and we were publishing data that improves survival. Insurance really does matter for patients with gynecologic cancer.

What we talk about a lot is whether having insurance or not matters. We know that patients who are uninsured are less likely to get screening, which for cervical cancer, breast cancer, or colorectal cancer, is so important. They're more likely to delay presentation to care and ultimately diagnosed with late stage less likely to be cured.

What I was interested in in this article, which sort of had been spurred by my research on the Affordable Care Act, is what happens when patients are insured, but their insurance isn't enough? Or there's something we call underinsured meaning they either struggle to afford care with their insurance, they aren't able to access it with their insurance, or it's not available with their insurance. We specifically looked at each of those stages for Medicaid, Medicare, and private insurance and looked at where the barriers were.

Anna Jo Bodurtha Smith, MD, discusses background on her research regarding insurance-mediated disparities in gynecologic oncology.


News

Acknowledging Insurance-Mediated Disparities in Gynecologic Cancers

Casey M. Cosgrove, MD, an assistant professor in the Department of Gynecologic Oncology at The Ohio State University College of Medicine in Columbus, discusses research exploring precision medicine concepts for endometrial cancer treatment.

Cosgrove notes that the Proactive Molecular Risk Classifier for Endometrial Cancer System (ProMisE) is directly impacting treatment decision-making among oncologists who treat endometrial cancer.

There are several ongoing clinical trials…that are trying to refine the way we take care of a patient with endometrial cancer. What I hope we can see through all these clinical trials is that we have some easily applied clinical markers that are going to directly impact our decision-making. The ProMisE [Proactive Molecular Risk Classifier for Endometrial Cancer system] from the University of British Columbia, which establishes endometrial cancer into 4…molecular groups, has the most traction right now throughout the gynecologic oncology community.1 This is testing for 

 [positivity], and grouping endometrial cancers into 1 of 4 groups.

Depending on which group [patients] fall into, the next question is, what’s the best treatment for those individuals? This has been evaluated through several trials right now. There’s a lot of excitement that hopefully we’ll be getting some answers in the next couple of years. I think the endometrial cancer [setting] has a lot of opportunity for growth in patient care. And [we] as clinicians are going to have to start integrating a lot of this information quickly as it becomes more available. With the improvements in technology, we’re going to be getting more information for each cancer type…than we’ve ever had before. I can see assimilating that information into the clinical setting as a major barrier for patients and clinicians. But hopefully, we’ll have some standardized protocols that allow us to have the right way to take care of each individual patient.

Casey M. Cosgrove, MD, discusses research exploring precision medicine concepts for endometrial cancer treatment.



Interesting Research in the Endometrial Cancer Space

David O’Malley, MD, a professor in the department of obstetrics and gynecology at The Ohio State University College of Medicine and the director of the division of gynecologic oncology at the OSUCCC–James, discusses the background and updated results of the KEYNOTE-158 trial (NCT02628067) looking at pembrolizumab (Keytruda) monotherapy in patients with advanced endometrial cancer.

The phase 2 KEYNOTE-158 investigated pembrolizumab in patients with advanced solid tumors and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status. In patients with endometrial cancer, at a median follow-up of 42.8 months, there was an objective response rate (ORR) of 48% (95% CI, 37%-60%).

In updated results presented at the 2022 European Society for Medical Oncology Congress, there was a median time from first dose to data cutoff (January 12, 2022) of 54.5 months (range, 14.7-71.4). The ORR was 50% and median duration of response was 63.2 months (range, 2.9-63.2). At the data cutoff, out of 94 patients, 22 patients (23.4%) had completed therapy, 67 (71.3%) had discontinued therapy, and 5 (5.3%) remained on pembrolizumab treatment. According to O’Malley, the estimated rate of a DOR of at least 4 years with pembrolizumab was 66%.

 We presented updated long-term follow-up results of KEYNOTE-158. Recently, we published the results in the 

, which showed approximately 50% ORR with patients doing very well for long term and continuing the duration of response. That trial actually contributed to extending the approval of pembrolizumab, specifically to endometrial cancer for pembrolizumab in patients who [have] MSI-high or dMMR endometrial cancer.

The updated results that we presented are looking at longer-term follow-up. We had approximately 55 months of median follow-up with our patients and we show that the ORR is 50%. With that 50% ORR, we actually had two-thirds of patients [who] extended for 4 years or more of duration of response.

David O’Malley, MD, discusses the background and updated results of the KEYNOTE-158 trial looking at pembrolizumab monotherapy in patients with advanced endometrial cancer.

Long Duration of Response Seen for Pembrolizumab in Endometrial Cancer

Susana Banerjee, MBBS, PhD, a consultant medical oncologist and research lead for the gynecology unit at The Royal Marsden NHS Foundation Trust, discusses the significance of the long-term results of the MEDIOLA trial (NCT02734004) of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology Congress.

This phase 1/2 trial investigated the combinations of olaparib (Lynparza) and durvalumab (Imfinzi) as well as olaparib, durvalumab, and bevacizumab (Avastin) in patients with recurrent non-germline 

-mutated platinum-sensitive ovarian cancer. While the trial demonstrated efficacy for the doublet and triplet regimens, Banerjee says that it was also important to learn that there were no unexpected safety signals or additive toxicity from the combinations.

She says that the trial also demonstrated that signals of clinical activity seen in early trials can be valuable for planning further clinical trials such as phase 3 trials of these doublet and triplet combinations. The combination of olaparib, durvalumab, and bevacizumab is being investigated in the ongoing phase 3 DUO-O trial (NCT03737643) as a maintenance regimen for patients with no 

 mutation. That study is being performed by the European Network of Gynaecological Oncological Trial Groups (ENGOT) and GOG Foundation.

 An important aspect we're looking at [with] combination treatments is also the safety. And what we learned with the long-term follow-up is that the safety profile was consistent with a known safety profile of the single agents. But the real implications of this treatment—I think it shows proof of concepts looking at signals, which is really important in earlier phase studies to see if there's some clinical activity, which is important to take forward in further clinical trials. That's what I think MEDIOLA brings to the table, looking at [the] combination of PARP inhibitors with immunotherapy and also the triplet combination with anti-angiogenic treatments. The next step is that the olaparib plus durvalumab and bevacizumab combination is actually under investigation, in the first-line setting of newly diagnosed advanced ovarian cancer as a maintenance treatment in patients with non­–BRCA-mutated advanced ovarian cancer. And that's in the phase 3 DUO-O study, [an] ENGOT and GOG study.

Susana Banerjee, MBBS, PhD, discusses the significance of the long-term results of the MEDIOLA trial of patients with ovarian cancer.

Ovarian Cancer

Implications of the MEDIOLA Trial Results in Relapsed Ovarian Cancer

Anna Jo Bodurtha Smith, MD, a third year Gynecologic Oncology fellow at the University of Pennsylvania, fellow at the Penn Center for Cancer Care Innovation and Leonard Davis Institute of Health Economics, discusses her research on insurance mediated disparities in gynecologic oncology.

In a review article, the major barriers which make it hard for patients to access and afford quality care for the treatment of their cancer are highlighted.

According to Smith, disparities lead to major problems for patients as they contribute to one-third of women with gynecologic cancer never visiting a gynecologic oncologist, even though this is the 

standard of care recommended by multiple sources.

One of my long-term interests has been on how insurance affects availability, access and affordability of care in the United States. This was a review article looking at every step of the gynecologic oncology process from screening or symptom presentation to diagnosis. From diagnosis to treatment, to surveillance, to insurance and whether patients have public insurance such as Medicare and Medicaid or private insurance where there are potential barriers based on their insurance type.

 We traditionally think about insurance alone being the biggest thing about access to care, but we know that there are specific barriers to care. There are issues with affordability, availability, and accessibility of care for insured patients.

Anna Jo Bodurtha Smith, MD, discusses her research on insurance mediated disparities in gynecologic oncology.


Discussing Insurance and Disparities in Gynecologic Oncology

Susana Banerjee, MBBS, PhD, a consultant medical oncologist and research lead for the gynecology unit at The Royal Marsden NHS Foundation Trust, discusses the updated results of the MEDIOLA trial (NCT02734004) of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology (ESMO) Congress.

The phase 1/2 MEDIOLA trial enrolled patients with relapsed non–germline 

-mutated platinum-sensitive ovarian cancer; 32 of whom received doublet olaparib (Lynparza) and durvalumab (Imfinzi), and 31 of whom received triplet olaparib, durvalumab, and bevacizumab (Avastin). Previous results showed an objective response rate (ORR) of 34% and median progression-free survival (PFS) of 5.5 months with the doublet, and an ORR of 87% and median PFS of 14.7 months for the triplet combination.

The updated results included a final analysis of overall survival (OS) and disease control rate (DCR) at 56 weeks. In the patients who received the triplet combination, median OS was 31.9 months and the DCR was 38.7%, whereas for the doublet median OS was 26.1 months and DCR was 9.4%. These data demonstrate continued efficacy for both the doublet and triplet combinations in patients with relapsed ovarian cancer with a 

 mutation who previously responded to chemotherapy.

 MEDIOLA is a phase 2 study, and it was designed to evaluate combined treatments with the PARP inhibitor olaparib plus the PD-L1 inhibitor durvalumab, in women with platinum-sensitive relapsed ovarian cancer. And the latest update is of a triplet combination of olaparib plus durvalumab and the anti-angiogenic agent bevacizumab. We also updated the combination, the doublet of olaparib plus durvalumab. And this was specifically in women without a germline 

Now, we already knew from our presentation back in 2020, at the ESMO Congress, that the response rate was around 34%, and median PFS was just over 5 and a half months with a doublet combination. And with the triplet that's really showed promising efficacy with a response rate of 87%, and a median PFS of 14.7 [months].

 What I updated in terms of the MEDIOLA study at the ESMO Congress 2022 was the OS and the DCR at 56 weeks. And what we saw was that in the triplet cohort, the median OS was almost 32 months, 31.9 months, and the 56-week DCR was almost 39%. Now in the doublet cohort of olaparib plus durvalumab, the median OS was [26] months, and the 56-week DCR was around 9%.

Susana Banerjee, MBBS, PhD, discusses the updated results of the MEDIOLA trial of patients with ovarian cancer presented at the 2022 European Society for Medical Oncology Congress.

MEDIOLA Update Shows Continued Efficacy for Triplet Therapy in Ovarian Cancer

Amit M. Oza, MD, a senior scientist in the Princess Margaret Cancer Centre Cancer Clinical Research Unit at Princess Margaret Cancer Centre and co-leader of the Ovarian Cancer Translational Research Initiative at the Ontario Institute for Cancer Research, discusses progression-free survival (PFS) findings from the phase 3 ARIEL4 clinical trial (NCT02855944).

 indicate that rucaparib prolong PFS compared with platinum-based chemotherapy.

The previous studies have been looking at early phase studies followed by randomized studies that have looked at its role in the maintenance setting. In ARIEL4, we were looking at patients with a deleterious 

 mutation, and then really looking at the role of single-agent rucaparib in treating recurrent disease. And there were 3 different types of patients that were identified. These included patients that are fully platinum sensitive, patients who are in partially platinum sensitive, and then patients who are deemed to be platinum resistant.

 In this study, rucaparib was compared head-to-head with platinum-based chemotherapy in platinum sensitive patients. The progression-free survival results were presented about 18 months to 2 years ago, which really showed that there was an improvement in progression-free survival that was seen in the intent-to-treat population as well as the subgroups.

Amit M. Oza, MD, discusses progression-free survival findings from the phase 3 ARIEL4 clinical trial.

Rucaparib Extends PFS in Deleterious BRACA1/2-Mutated Relapsed Ovarian Cancer

Anna Jo Bodurtha Smith, MD, MPH, MSc, an obstetrics and gynecology oncology fellow at the Perelman School of Medicine, University of Pennsylvania, discusses how oncologists and health systems can overcome barriers to access to the best available care for patients with gynecologic cancers.

Smith’s research into disparities in cancer care found that many patients with gynecologic cancers do not visit a specialized gynecologic oncologist due to reasons such as lack of in-network physicians, long travel distances, or high copays. She recommends that clinicians ask their patients about any issues that would keep them from continuing to receive recommended care so they can help address these issues with the patients and their insurance companies.

In addition, health systems should do more to encourage patients to see a gynecologic oncologist and push for insurance companies to support these visits considering that it is the standard of care.

Smith says that policymakers should advocate for nationwide rules in which cancer care therapies should be provided by all insurance companies at an affordable cost, and she believes that policymakers are currently working toward this goal.

 We traditionally think about insurance alone being the biggest thing about access to care. But we know that there are specific barriers to care; there’s issues with affordability, availability, and accessibility of care for insured patients. A couple of takeaways for clinicians: ask patients about what their barriers are once they get in the door. Are they going to struggle seeing you because it's far away? Are they going to struggle with the copay? Are there ways you can work with them or their insurances to make their care go the best possible without breaking the bank or providing time-prohibitive care with whatever limitations they have? When I see my patients, I ask them about this.

 For health systems also thinking about this, are there ways you can work with insurers to make sure that all of their patients are getting incentivized to see a gynecologic oncologist and to work with insurers to encourage them to help their patients get the standard of care? And then for policymakers, [do] we have good national guidelines about what cancer treatments should be? Making sure that every patient regardless of where they live, regardless of what insurance, has access to those cancer therapies at an affordable cost to them, is so important. I've been really excited to see on both sides of the political spectrum, a lot of people committed to making cancer care affordable for all patients.

Anna Jo Bodurtha Smith, MD, MPH, MSc, discusses how oncologists and health systems can overcome barriers to access to the best available care for patients with gynecologic cancers.

How to Address Barriers to Accessing Gynecologic Oncology Specialists

Melissa M. Hardesty, a gynecologic oncologist at Alaska Women's Cancer Care, discusses the key takeaways of the phase 2 OVARIO study (NCT03326193) examining the combination of a PARP inhibitor and VEGF inhibitor in women with advanced ovarian cancer as well as research still needs to examine in this space.

According to findings of the study presented by Hardestly, this combination as maintenance therapy may be an efficacious strategy for this patient population.

Melissa M. Hardesty discusses the key takeaways of the phase 2 OVARIO study of a PARP inhibitor plus a VEGF inhibitor in women with advanced ovarian cancer as well as research still needs to examine in this space.


GYNECOLOGIC CANCERS

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