Ovarian Cancer Disease

Transform the Ovarian Cancer Disease Market Dynamics with DiseaseLandscape Insights!

Unyielding and resilient, ovarian cancer quietly emerges as a formidable adversary, demanding undivided attention. It spares no one, affecting women of all ages and backgrounds. This insidious disease conceals its presence, often only revealing itself later when the battle becomes even more daunting.

National Women's Health Network states that one of the reasons ovarian cancer is lethal is that it rarely exhibits signs in the early stages of the disease. Unfortunately, this means that it frequently goes unnoticed until the disease has advanced to the pelvis and abdomen, and it is too late to do anything about it. The analysis of the diagnosis and treatment of ovarian cancer disease by DiseaseLandscape Insights (DLI), is about new developments and technology that are changing the world of business and helping in the growth of the healthcare industry.

Ovarian cancer ranks 5th in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system, as stated by NCBI. A woman's risk of getting ovarian cancer during her lifetime is about 1 in 78 which shows how deadly it is and a relative 5-year survival rate of ~49.7% is achieved for all types of ovarian cancer if it is diagnosed in its early stages.

With an ASR mortality rate of 4.2 per 100,000 provided by the National Cancer Institute (NCI), ovarian cancer caused a total of 2,94,422 new cases and 198,412 fatalities in 2019 which increased to a total of 3,13,959 new cases and 207,252 in 2020, and in 2021, new cases of ovarian cancer were reduced to a total of 2,90,000, worldwide. Ovarian cancer is now more deadly due to the estimated 236,511 women who are living with ovarian cancer disease in the United States.

The following data is retrieved from the American Cancer Society depicting the incidence of ovarian cancer from 2019 to 2022 in the United States (US).

However, as per World Cancer Research, Brunei had the highest rate of ovarian cancer (17.4/100,000) in 2020, followed by Samoa (15.9/100,000).

Ovarian cancer is a cancerous tumor of an ovary. It originates from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. When abnormal cells in the fallopian tubes or ovaries proliferate and multiply uncontrollably, ovarian cancer develops. Estrogen, progesterone, and androgens (also known as ovarian hormones) these hormones play an essential role in reproductive development and menstruation.

Signs and symptoms of ovarian cancer:

• Abdominal bloating or swelling
• Excess weight loss/gain
• Discomfort in the pelvic area

An overall five-year relative ovarian cancer survival rate of 50.8 percent was placed by The National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program. However, survival rates vary depending on the ovarian cancer stages.

Types of ovarian cancer

Based on DLI analysis approximately 90% of ovarian cancers are of epithelial origin, including high-grade and low-grade serous carcinoma and clear cell, endometrioid, and mucinous carcinoma, while 7% of OCs are of stromal types, and OCs from germ cell tumors are rarely found.

1. Epithelial Ovarian Cancer:

   This type is the most common accounting for approximately 90% of ovarian cancer cases.

Symptoms of Epithelial Ovarian Cancer: Abdominal pain, difficulty eating or feeling full quickly, nausea and vomiting, bloating, and pelvic pain.

2. Stromal Ovarian Tumors:

   These rare tumors are usually diagnosed earlier than other ovarian cancers. These are less common than epithelial ovarian cancer and it is further categorized into granulosa cell tumors and sertoli-leydig cell tumors. Stromal tumors are benign (or) malignant.

Symptoms of Stromal Ovarian tumors: Bloating, endometrial hyperplasia, pain in the abdomen, feeling full quickly after eating & urge to use the bathroom more often than usual, and irregular periods (abnormal vaginal bleeding).

3. Germ Cell Ovarian Tumors:

   These rare ovarian cancers tend to occur at a younger age and tend to have a better prognosis compared to other ovarian cancer types. Subtypes of germ cell tumors include teratomas, dysgerminomas, endodermal sinus tumors (yolk sac tumors), and choriocarcinomas.

Symptoms of Germ cell ovarian cancer: Pain or a feeling of pressure, caused by the tumor, in the pelvis or tummy area (abdomen), swelling of the tummy, irregular periods, pregnancy-like symptoms – the tumor makes proteins like those produced in early pregnancy, a high temperature (fever), and chills. Later-stage ovarian cancer can be caused if an ovarian cyst is very large, ruptures, or blocks blood supply to the ovaries. Most ovarian cysts are non-cancerous (benign) but occasionally they can be cancerous (malignant).

Ovarian Cyst:

Based on NCBI 18% of postmenopausal women experience the development of one or more Graffian follicles, which show up on imaging as cysts.  These cysts are typically benign. More than 10% of all ovarian neoplasms are mature cystic teratomas or dermoids. With a prevalence of more than 30%, ovarian cysts are the most prevalent malignancy in children and fetuses. Ovarian cancer is diagnosed in more than 21000 women in the US each year, and it results in 14,600 fatalities.

Solid masses of cancer cells are called ovarian cancer cysts (tumors). The majority of ovarian cysts are asymptomatic functional (physiologic) cysts with a straightforward look and small size (1-3 cm), although they can occasionally grow to larger sizes (>5 cm) and hardly ever become clinically obvious by rupturing or causing ovarian torsion.

Symptoms:

• The primary cause of ovarian cysts is ovulation.
• An ovarian cyst leads to lower back pain in ~45% of women.

Larger cysts cause:

• A feeling of fullness (bloating) that is felt more pronounced on one side of the body.
• Pain during intercourse (Dyspareunia).

Persistent symptoms suggest polycystic ovarian syndrome (PCOS). PCOS is a condition that causes irregular periods as well as other hormone-related issues such as obesity and infertility.

Types of Ovarian cysts include:

• Functional Ovarian cysts:

  (Sometimes, called simple cysts.) These are the most frequent types of ovarian cysts and are not associated with any disease. Ovulation (the release of an egg from the ovary) causes them. Without specific therapy, functional cysts normally disappear over time, usually within 60 days.

• Follicular cysts:

  Each month, a tiny sac in the ovary called a follicle releases an egg as part of the menstrual cycle. A follicular cyst forms when the follicle is unable to release an egg. Instead, the follicle fills with fluid and grows bigger.

• Corpus luteum cysts:

  The corpus luteum is a hormone-producing clump of cells formed after the follicle releases an egg. When fluid gathers in the corpus luteum, it causes a cyst to form.

Not all ovarian cysts develop because of the menstrual cycle. They are not always signs of disease; it is mandatory to monitor them to ensure that they do not cause complications. They include:

• Cystadenomas:

  These cysts are formed on the surface of the ovary. They are filled with fluid that is thin and watery or thicker and mucous-like.

• Dermoid cysts (teratomas):

  Dermoid cysts are made up of cells that make up every form of tissue in the human body, including skin, hair, teeth, and even brain tissue.

• Endometriomas:

  These cysts are filled with endometrial tissue, the same tissue that bleeds each month during the period in females.

Diagnostic Techniques: Ovarian Cancer

Understanding the Most Recent Developments and Trends in Ovarian Cancer Diagnostics Enables Businesses to Create Groundbreaking Products, Increase Customer Trust, and Grab Untapped Market Opportunities.

So, the following are some diagnostic techniques listed to detect ovarian cancer that are already being used in the market:

1. Pelvic Examination:

   During a pelvic exam, a healthcare provider manually feels the ovaries and surrounding tissues for any abnormalities, such as masses or enlarged ovaries. While this method is likely to raise suspicion, it is not sufficient on its own to confirm the presence of ovarian cancer. According to the National Cancer Institute, the bimanual pelvic examination is insufficient for detecting benign from malignant lesions and for ovarian cancer screening.

2. Imaging Tests:

• Transvaginal Ultrasound: This imaging test uses a small probe inserted into the vagina to produce detailed images of the ovaries and pelvic structures. It helps in detecting ovarian masses or cysts and assesses their characteristics. A transvaginal ultrasound is typically the 1^st type of imaging test used if any issues with the ovaries are suspected or for early-stage ovarian cancer.

American Diabetes Association (ADA) asserts that malignant ovarian lesions have typical sonographic features, and thus ultrasound is the imaging of choice for the initial evaluation of suspected ovarian neoplasm. But still, transvaginal ultrasounds are performed to investigate symptoms at first, although they are only approximately 75% accurate at finding ovarian cancer.

• CT Scan: A CT scan combines X-rays and computer technology to create detailed cross-sectional images of the abdomen and pelvis. It provides a more comprehensive view of the ovaries and surrounding structures.
• PET-CT scan: It is a more advanced imaging technique used to stage ovarian cancer. It helps determine if the cancer has spread to other areas of the body.
• MRI: MRI uses powerful magnets and radio waves to generate detailed images of the pelvic region, helping to identify abnormal structures, including ovarian tumors.

3. Blood Tests:

• CA-125 (Cancer Antigen- 125): CA-125 is a tumor marker that is measured through a blood test. Elevated levels of CA-125 indicate the presence of ovarian cancer, although this marker is not specific to ovarian cancer and is also elevated in other conditions.

The blood level of CA125 is elevated in about 50% of women with early-stage ovarian cancer. Raised CA125 values are present in ~90 out of 100 women (90%) with more advanced ovarian cancer. So, this is the main reason to make this test the most accurate to detect ovarian cancer in its early stages. When examining a postmenopausal woman with an ovarian cyst, an increased CA 125 result is most beneficial when paired with an ultrasound. The 2020 FDA-approved VIDAS CA 125 II assay is utilized as a tool for the early diagnosis of recurrence in Stage II and III ovarian cancer that has already undergone treatment.

Elecsys® CA 125 II assay is intended to help detect remaining or recurrent ovarian cancer in individuals who have received first-line therapy.

Efficacy and reliability of Elecsys® CA 125 II assay in the lab:

• Displays accuracy over the whole measuring range to ensure accurate readings.
• Uses a small sample size (20 l for cobas e 411, 601, and 602, and 12 l for cobas e 402 and 801).
• Is quick with an assay time of ~18 minutes.
• Is readily available for use in both the plasma and serum forms.

• HE4 (Human Epididymis Protein 4): HE4 is another tumor marker used in combination with CA-125 to improve the sensitivity and specificity of blood tests for ovarian cancer. The usage of HE4 and CA 125 together with the ROMA (Risk of Ovarian Malignancy Algorithm) improves the sensitivity and specificity in determining the risk of ovarian cancer.

4. Biopsy:

   A biopsy involves the removal of a small tissue sample from the ovary or a suspected mass. This sample is then examined under a microscope to determine if cancer cells are present. Biopsies are performed through various techniques, such as fine-needle aspiration, core biopsy, or surgical biopsy. Image-guided biopsy has a conclusive diagnosis rate between 87% and 97%, according to data from case series retrieved by NIH.

5. Exploratory Laparotomy/Laparoscopy:

   In cases where other tests are inconclusive or further evaluation is necessary, a surgical procedure called Laparotomy or Laparoscopy is likely to be performed. Laparoscopy is a minimally invasive technique, while laparotomy involves a larger incision.

As per the information provided by the Ovarian Cancer Research Alliance, for all types of ovarian cancer taken together, about 78% of those with ovarian cancer live for at least 1 year after diagnosis. More than 60% live for at least 3 years after being diagnosed, and over 50% of patients with ovarian cancer are still alive at least 5 years after diagnosis. This is predominantly solved with the two procedures most frequently used for ovarian cancer screening Transvaginal Ultrasound (TVUS) and the CA-125 blood test (in addition to a thorough pelvic exam) stated by the American Cancer Society.

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Treatment Techniques - Ovarian Cancer:

Navigating Health Horizons: Embrace Treatment Techniques and its Market with DLI:

1. Surgery:

   Surgery is the initial and often crucial step in treating ovarian cancer. It involves the removal of the tumor and the affected surrounding tissues. Depending on the extent of cancer and its spread, the surgeon performs a total hysterectomy (removal of the uterus), bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes), and omentectomy (removal of the omentum, a fatty tissue layer in the abdomen).

2. Chemotherapy:

   Chemotherapy uses powerful drugs to kill cancer cells or stop their growth. It is administered before surgery (neoadjuvant chemotherapy) to shrink the tumor, or after surgery (adjuvant chemotherapy) to target any remaining cancer cells. Commonly used chemotherapy drugs for ovarian cancer include Carboplatin and Paclitaxel.

• Chemotherapy for Epithelial Ovarian Cancer

In accordance with the American Cancer Society, chemo for ovarian cancer usually involves getting two different types of drugs together. As a first-line treatment for ovarian cancer, using a mix of medications rather than just one drug appears to be more effective. The combination usually contains a Platinum compound (commonly Cisplatin or Carboplatin), and another type of chemo medication called a Taxane, such as Paclitaxel (Taxol®) or Docetaxel (Taxotere®). These medications are typically administered as an IV (through a vein) every 3 to 4 weeks.

Depending on the stage and type of ovarian cancer, the average course of chemo for epithelial ovarian cancer involves 3 to 6 cycles of treatment. A cycle is a set of regular pharmacological dosages followed by a time of rest.

Other chemotherapy medications that are used to treat ovarian cancer include:

• Capecitabine (Xeloda®)
• Cyclophosphamide (Cytoxan®)
• Paraplatin ®

Prominently, patients with ovarian cancer who have returned after receiving prior chemotherapy are treated palliatively with Paraplatin®, including those who have already received cisplatin therapy.

Contraindications of Paraplatin® include patients who have previously experienced severe allergic responses to cisplatin or other platinum-containing substances should not receive the Paraplatin® injection and patients who have considerable bleeding or severe bone marrow depression should not use Paraplatin®.

• Chemotherapy for Germ Cell Tumors

A female with a germ cell tumor is likely to be treated with combination chemo (several different drugs at once). BEP is the most used combination, and it contains the chemotherapeutic medicines Bleomycin, Etoposide, and Cisplatin (Platinol). Drug combinations used to treat cancer that has recurred include High-dose chemotherapy (the exact drugs used, vary depending on what cancer centre is giving the treatment)

• TIP (paclitaxel/Taxol, Ifosfamide, and Cisplatin/Platinol)
• VAC (Vincristine, Dactinomycin, and Cyclophosphamide)
• Chemotherapy for stromal tumors

When ovarian stromal tumors are treated with chemotherapy, the combination of carboplatin with paclitaxel or PEB (cisplatin/Platinol, etoposide, and bleomycin) is most employed.

3. Immunotherapy:

   Immunotherapy is a treatment approach that stimulates the body's immune system to recognize and attack cancer cells. While not as commonly used in ovarian cancer as in other cancers, ongoing research is exploring its potential benefits in this context.

4. Hormone Therapy:

   Hormone therapy is used for certain types of ovarian cancers that are hormone sensitive. These treatments work by altering hormone levels to slow down or prevent tumor growth.

5. Radiation Therapy:

   Radiation therapy uses high-energy rays to kill cancer cells. It is not typically used as a primary treatment for ovarian cancer but is used in specific situations, such as to shrink tumors that are causing symptoms or as palliative treatment for advanced cases.

In compliance with NCBI, the combination of surgery and chemoradiotherapy is the most frequently used treatment option for ovarian cancer (OC). However, serious side effects have been linked to chemo- and radiation (RT), whereas the only little therapeutic advantage from RT eventually leads to disease death and poor survival results.

Emerging Treatment Techniques for Ovarian Cancer

6. PARP Inhibitors (PARPi or poly-ADP ribose polymerase):

   A newer type of targeted standard of care treatment, have increased survival for ovarian cancer patients, but, like chemotherapy, these therapies eventually stop working for many patients, leaving them without treatment options. Women with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer participated in the studies, which investigated the PARP inhibitors Olaparib (Zejula), Olaparib (Lynparza), and Veliparib, respectively.

Some of the prominent companies manufacturing PARP inhibitors for ovarian cancer include:

• AstraZeneca: They manufacture the PARP inhibitor Olaparib, marketed under the brand name Lynparza. Lynparza has been used to treat over 75,000 patients worldwide in 2022. Lynparza is developed independently by the companies in conjunction with their respective programmed death-ligand 1 (PD-L1) and programmed cell death protein 1 (PD-1) drugs. Lynparza is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.
• GlaxoSmithKline (GSK): GSK manufactures the PARP inhibitor Niraparib, marketed under the brand name Zejula.
• Pfizer: Pfizer manufactures the PARP inhibitor Talazoparib, marketed under the brand name Talzenna.
• Clovis Oncology: They manufacture the PARP inhibitor Rucaparib, marketed under the brand name Rubraca.

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Regulatory Guidelines: Ovarian Cancer

"Regulatory Insights, the Key to Success! Embrace the Change, Seize the Day, and Watch the Business Pave the Way."

In the fast-paced realm of ovarian cancer research, staying ahead is the key to unlocking boundless opportunities for business growth. This is possibly achieved with the help of DLI Services and by meticulously analyzing recent updates in regulatory guidelines, companies harness the power of compliance to soar to new heights.

Recently on November 14, 2022, the FDA granted Mirvetuximab Soravtansine-gynx (Elahere, ImmunoGen, Inc.) expedited clearance, for the treatment of FR-positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.

Initially approved for all-comer populations in ovarian cancer, PARP inhibitors showed potential harm in overall survival for patients without tumor BRCA mutations, leading the FDA to restrict indications for two PARP medicines in December 2022 to patients with tumor BRCA mutations.

The FDA approved Cytalux (Pafolacianine) on Nov 29, 2021, as an imaging drug to help surgeons locate hard-to-detect ovarian cancer lesions during surgery, enhancing the detection of risky ovarian cancers.

Cytalux's approval improves surgeons' ability to find elusive ovarian cancers, according to Alex Gorovets, M.D. from the FDA. It provides an additional imaging approach for ovarian cancer screening during surgery.

Clinical Trial Assessment:

Unlocking Cures, One Trial at a Time: Illuminating DLI Services through Clinical Trial Assessment.

Ongoing clinical trials are shown in the table below along with their title, study condition, and the stages they are in:

Conclusion:

DiseaseLandscape Insights (DLI) plays a crucial role in providing valuable information and comprehensive analysis of Ovarian cancer within the healthcare market.

Firstly, DLI Services helps market players, such as pharmaceutical companies and healthcare providers, identify potential areas for investment and research. By gaining a deep understanding of prevalent diseases and unmet medical needs, businesses align their strategies to develop and market products that address specific health challenges effectively.

Secondly, our services aid in assessing the competitive landscape by highlighting existing treatments and therapies, allowing businesses to identify white spaces in the market where opportunities for innovation and market entry lie. Additionally, understanding disease dynamics helps businesses anticipate future market demands and make informed decisions about resource allocation, ultimately leading to more successful and impactful products and services in the healthcare industry.

In conclusion, DLI serves as a powerful tool for market intelligence, helping businesses and healthcare organizations to identify opportunities, analyze competition, and navigate the regulatory landscape effectively. By leveraging these insights, companies are provided with assistance in making informed decisions, developing targeted therapies, and providing better healthcare solutions to meet the needs of patients and medical professionals alike.