Assessment of Adult Women with Ovarian Masses and Treatment of Epithelial Ovarian Cancer Resource Stratified Guideline

An interview with Dr. Zeba Aziz from Hameed Latif Hospital in Lahore, Pakistan, Dr. William Burke from Stony Brook University Hospital in Stony Brook, NY, and Dr. Keiichi Fujiwara from Saitama Medical University International Medical Center in Saitama, Japan, authors on "Assessment of Adult Women with Ovarian Masses and Treatment of Epithelial Ovarian Cancer: ASCO Resource Stratified Guideline." This guideline provides recommendations in three resource-constrained settings on diagnosis and staging of adult women with ovarian masses and treatment of patients with epithelial ovarian (including fallopian tube and primary peritoneal) cancer. Read the full guideline at www.asco.org/resource-stratified-guideline.

TRANSCRIPT

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BRITTANY HARVEY: Hello, and welcome to the ASCO Guidelines podcast series brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all the shows, including this one, at podcast.asco.org. My name is Brittany Harvey, and today, I'm interviewing Dr. Zeba Aziz from Hameed Latif Hospital in Lahore, Pakistan, Dr. William Burke from Stony Brook University Hospital in Stony Brook, New York, and Dr. Keiichi Fujiwara from Saitama Medical University International Medical Center in Saitama, Japan, authors on Assessment of Adult Women with Ovarian Masses in Treatment of Epithelial Ovarian Cancer: ASCO Resource Stratified Guideline.

Thank you for being here, Doctors Aziz, Burke, and Fujiwara. First, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO conflict of interest policy is followed for each guideline. The full conflict of interest information for this guideline panel is available online with the publication of the guideline and the Journal of Clinical Oncology, Global Oncology. Dr. Burke, do you have any relevant disclosures that are directly related to this guideline topic?

DR. WILLIAM BURKE: I do not.

BRITTANY HARVEY: And Dr. Fujiwara, do you have any relevant disclosures that are related to this guideline topic?

DR. KEIICHI FUJIWARA: Yes. I have the consultancy for the PARP inhibitors development.

BRITTANY HARVEY: Thank you. And then Dr. Aziz, do you have any relevant disclosures that are related to this guideline?

DR. ZEBA AZIZ: No, I don't.

BRITTANY HARVEY: Thank you. OK, so first, Dr. Burke, can you give us a general overview of what this guideline covers?

DR. WILLIAM BURKE: Sure, Brittany. The purpose of this guideline is to provide expert guidance in treatment of adult women 18 years and older with epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer, to clinicians, public health leaders, patients, and policymakers in a resource-constrained setting. To do this, ASCO has established a process for development of resource stratified guidelines, which includes a mixed methods of evidence-based guideline development, adaptation of the clinical practice guidelines to other organizations, and formal expert consensus. This guideline summarizes the results of this process and presents resource-stratified recommendations. The recommendation of this guideline centers around the four key clinical questions pertaining to the care of women with ovarian cancer.

BRITTANY HARVEY: Great. And then, as you just mentioned, this is a resource-stratified guideline. So Dr. Fujiwara, can you tell our listeners about the four-tier resource stratification used for the development of this guideline?

DR. KEIICHI FUJIWARA: Oh, yes. So we have the four tiers resource stratification, which were basic, limited, enhanced, and maximum. So for the basic, it's the core resources or fundamental services that are absolutely necessary for any public health or primary health care systems to function. So the basic levels of this typically are applied in our single clinical interactions. For the limited, so this is the second tier resources or services that are intended to produce major improvements in outcomes such as, for instance, cost-effectiveness, and are attainable with a limited financial means and modest infrastructures. So the limited level of service may involve single or multiple interactions. And the third tier is enhanced. The third tier resources or services that are optional, that are important, enhance the level of resources should produce further improvements in the outcome and to increase the number of the quality of options in the individual choices. Lastly, the fourth tier is a maximal, so high-level or state of the art resources, or services that may be used or are available in some high-resource countries, and/or may be recommended for the high resource setting guidelines that do not adapt to resource constraints, but that nonetheless should be considered for a lower priority than those resources or services listed in the other categories on the basis of extreme cost and/or impracticality for the broad use of the resource-limited environment.

BRITTANY HARVEY: Great. Thank you for going over those. So next, I'd like to review the key recommendations of this guideline. This guideline addresses four overarching clinical questions. So first, Dr. Aziz, what are the key diagnostic and staging recommendations for patients with symptoms of epithelial ovarian cancer?

DR. ZEBA AZIZ: Thanks, Brittany. Basically, as pointed out, we have three levels. The basic level usually involves one or two encounters, and at the basic level, the doctor makes a clinical assessment of a suspected ovarian mass, takes a good history and physical, and the family history is also important at the same time. At the basic level, one can do a chest X-ray and an ultrasound to confirm the suspicion, and then the doctor should ideally send the patient to a limited or an enhanced level-- wherever the patient can go. At the limited and enhanced level, again, you have to do diagnostics, which include a CT scan and an MRI if it's available and feasible.

You can do the biomarker studies for CA125 and CEA level, and to make a diagnosis, you can do a CT-guided biopsy. You can also do a cell cytology and if a cell block preparation can be made through cell block. Very rarely, if need be, and if you think that you need to make a diagnosis and you can't do anything else, laparoscopy can be done. Once the diagnosis is made, you then go for staging. And the staging is usually done when you're doing a CT scan and you do an abdominal and pelvic CT scan. You do a CT scan of the chest if you think it's needed. Otherwise, a chest ray will suffice. And then you go forward and get a diagnostic workup done and send it to the surgeon for either and decide on a multidisciplinary with a neoadjuvant or surgical assessment testing.

BRITTANY HARVEY: Great. Then so next, Dr. Fujiwara, what are the overarching recommendations for surgery with women with stage one to four epithelial ovarian cancer?

DR. KEIICHI FUJIWARA: Yes. So the purpose of the surgery is to diagnose, stage, and/or for treatment. So we strongly recommended the ovarian cancer surgery should be performed by trained gynecological oncologists or surgeons with oncologists' surgical expertise. If it is not suitable, we strongly recommend to refer those patients to the highest-resourced level center with an oncology surgical care capacity.

For the staging purpose, where the feasible patients with a presumed early stage ovarian cancer should undergo surgical staging by train surgeons. In basic setting, surgical staging is not feasible. Thus, it is not recommended. For the treatment purpose of the women with advanced ovarian cancer, which is a stage three or four, should receive optimal surgical debulking to remove all visible disease to improve overall survival by trained surgeons.

BRITTANY HARVEY: Great. And then Dr. Burke, what are the key recommendations for optimal adjuvant and systemic therapy for patients with stage one to four epithelial ovarian cancer?

DR. WILLIAM BURKE: Sure. Well, one of the most important things is that access to appropriate evidence-based chemotherapy agents, contraindications to chemotherapy, and potential side effects of chemotherapy should be evaluated and managed in every patient. Basic resource settings that most likely lack the capacity to provide safe administration of chemotherapy should refer patients to a higher level center for evaluation. Limited settings without skilled capacity should refer patients to settings with access to specialized care. Some other notes include that clinicians should be able to document pathology and stage to determine eligibility for adjuvant chemotherapy.

If pathology confirmation is not possible due to patient or resource limitation, alternatives can be discussed. Clinicians should not administer systemic treatment, adjuvant chemotherapy, to patients with ovarian low malignant potential tumors or early stage, microinvasive borderline tumors, independent of stage. Combination chemotherapy with paclitaxel and carboplatin is the standard of care for adjuvant therapy in ovarian cancer. However, single agent carboplatin may be utilized due to resource limitation or patient characteristics. Only in enhanced settings, highly selected cases can be assessed for appropriate evidence based intraperitoneal chemotherapy following optimal debulking, where there are resources and expertise to manage the toxicities.

BRITTANY HARVEY: Great. And then the last overarching clinical question-- Dr. Aziz, what is recommended for patients with recurrent epithelial ovarian cancer?

DR. ZEBA AZIZ: You know, with recurrent ovarian epithelial cancer is a tough option, especially in patients residing in the low-middle income countries. Supportive care treatment should be started together with whatever we have to do. So there are three options. There's one patient who presents with a rising CA125 with no evidence of disease and asymptomatic. We can elect to follow these patients, and it's easier to follow them until they become symptomatic or they have evidence of disease. If you have small volume disease which is resectable, you send them to an enhanced level setting, ideally where surgery can be done.

Then you also look at patients and divide them into platinum resistant or platinum sensitive. If they're platinum sensitive, you can give a platinum-containing regimen, but if they're platinum resistant, you can put them on a non-platinum chemotherapy-- a single agent or whatever-- but these patients are tough to manage in that part of the world.

BRITTANY HARVEY: Definitely. Well, thank you all for reviewing each of those key recommendations. The full recommendations are available in the guideline, but those are some important highlights. Thank you very much. So Dr. Burke, in your view, what is the importance of this guideline, and how will it change practice?

DR. WILLIAM BURKE: Sure. Well, I think the importance of this guideline is that it globally targets health care providers, including gynecologic oncologists, surgeons, nurses, and palliative care clinicians, as well as non-medical community members, including patients, caregivers, and members of advocacy groups, providing them with resource-stratified clinical guidelines, recommendations that can be implemented across many health settings. The guideline will hopefully raise awareness among frontline practitioners, and provide guidance to provide adequate services in the face of varied and sometimes limited resources we see throughout the world.

BRITTANY HARVEY: Great. And Dr. Aziz, how do you envision that these guidelines can be applied in low and middle income regions?

DR. ZEBA AZIZ: These are extremely important guidelines for our part of the world. Remember that there are about 70 low-middle income countries, and all these countries-- and within each country-- there's marked variability in training of physicians who encounter cancer patients. There's also difficulty by the patients in accessing a few tertiary care centers, cancer care centers which are present, and most of all, financial implications, because you have to go there, you have to stay there, you have to get your chemotherapy, and this is true for the marginalized population.

You also have to remember that more than 50% of our patients are treated in a limited resource setting, and the availability of enhanced resources are very difficult for them. And these limited settings are in public sector hospitals, where the doctors-- some of the doctors are very good, but the physicians or surgeons are overworked. They have resources ranging from minimal to moderate, depending on the funds available. And because they're overworked and there are few working hours, detailed counseling of the patient is infrequent because there are a large number of patients there. And the majority of surgeries, which is the cornerstone of ovarian cancer, is done by the postgraduate fellows who are there. Sometimes the senior consultants do surgeries, but most of the time, it is done by them.

First time chemotherapy is easier to deliver because it does not have any expensive medicines. There are a lot of generics for carboplatin and taxanes regimen available, so it's not a major problem. But treating the side effects, again, becomes very expensive, and the patients have to come back and forth. The relapsed disease is very difficult to treat because we don't have too many options there and it is expensive. We've also seen that patients who are treated at an enhanced level do much better. Their survival outcomes are better, the supportive care treatment is better, and the progression-free survival is also better.

BRITTANY HARVEY: Great. Thank you for reviewing that information. And then finally, Dr. Fujiwara, Dr. Aziz touched on this a bit on how it impacts patients, but how else do you view that these guideline recommendations will affect patients?

DR. KEIICHI FUJIWARA: Yes. As Dr. Aziz said and Dr. Burke said, this guideline is written for the patients around the world in a different medical environment. So I think that it is very useful resource of information for patients to receive the best ovarian cancer treatment that suits the actual situation of each country or regions.

BRITTANY HARVEY: Great. Well, thank you all for your work on these important guidelines. It sounds like they're going to have a real impact globally, and so I really appreciate both all of your work on these guidelines, and also for taking the time to speak with me today, Dr. Aziz, Dr. Burke, and Dr. Fujiwara.

DR. ZEBA AZIZ: Thank you, Brittany.

BRITTANY HARVEY: And thank you to all of our listeners for tuning in to the ASCO Guidelines Podcast Series. To read the full guideline, go to www.asco.org/resource-stratified-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO guidelines available on iTunes or the Google Play store. If you have enjoyed what you've heard today, please rate and review the podcast, and be sure to subscribe so you never miss an episode.