An INternational Frontline Ovarian Cancer Real World Management Study (INFORM)

A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study

The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study [AOCS]) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group

Study Overview

• Status: Completed
• Conditions: Ovarian Neoplasms

Detailed Description

Ovarian cancer is the eighth most commonly diagnosed cancer (295,414 cases reported in 2018) and the seventh leading cause of cancer-associated mortality (184,799 deaths reported in 2018) in women, worldwide. The increasing trends in the burden of ovarian cancer, coupled with other challenges, such as lack of awareness of ovarian cancer risk factors, lack of adequate screening tools, lack of access to diagnostics, and lack of trained clinicians, contribute to delays in diagnosis, resulting in a high proportion of patients presenting with advanced-stage ovarian cancer associated with high mortality. Over 75% of women with ovarian cancer have been reported to be diagnosed at a late stage with high relapse rates, despite first-line therapy. Studies in Asia have highlighted that about 65%-70% of women with ovarian cancer are diagnosed at an advanced stage. Further, the five-year net survival rate of advanced-stage ovarian cancer in Asia has been found to range from 14% to 41%.

Among the various ovarian cancer subtypes based on histology, epithelial ovarian cancer is the most common type, reported in about 90% of cases. Specifically, type II epithelial ovarian cancer (that includes serous carcinoma, mixed epithelial and stromal carcinoma, undifferentiated carcinomas, and other epithelial carcinoma) accounts for about 66%-73%, 56%, 73%, and 73% in the US, Asia, Europe, and Oceania, respectively. The corresponding rates for type I epithelial ovarian tumors (that include endometrioid, clear cell, mucinous, squamous, and transitional cell carcinomas) have been noted to be 19%-21%, 32.5%, 20.5%, and 20%, respectively. Regarding prognosis, the five-year net survival rate of type II epithelial ovarian cancer that includes serous carcinoma has been found to be low when compared to other subtypes across all regions. Of note, type II epithelial ovarian tumors have been reported to be highly aggressive and usually present at an advanced stage, with poor survival rates. The recurrence or relapse rates have also been noted to be high with epithelial serous ovarian cancer. Furthermore, a strong association has been noted between family history of ovarian cancer, a very strong risk factor, and the risk of developing aggressive serous carcinomas. Genetic (both germline and somatic) mutations in BRCA1/2 have been noted in about 22% of high-grade, serous, ovarian carcinomas, and the majority of hereditary cases (~44%). Also, mutations in homologous recombination response genes have been noted in about 50% of high-grade serous epithelial ovarian cancer cases.

Considering the high incidence, poor prognosis, and high morbidity and mortality from advanced epithelial ovarian cancer, it is important to have well-organized databases on the clinical characteristics, treatment patterns, and outcomes of these patients, to help identify the unmet needs and gaps and further optimize the survival outcomes in these patients. With exception of the UK, France, Germany, Italy, and Spain and the USA, there is paucity of databases, registries, or published literature on patient level data pertaining to treatment patterns, clinical characteristics, and outcomes of advanced ovarian cancer patients. Therefore, the current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group.

• Study Type: Observational
• Enrollment (Actual): 989

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, D0817R00028
      • Research Site
• Korea, Republic of
  • Seoul, Korea, Republic of, D0817R00028
    • Research Site
• Taiwan
  • New Taipei City, Taiwan, D0817R00028
    • Research Site
  • Taipei City, Taiwan, D0817R00028
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This is a non-interventional study that involves retrospective collection of data from medical records of all patients who have been newly diagnosed with advanced-stage epithelial ovarian cancer (high grade serous type epithelial ovarian cancer for Taiwan) between the period Jan 2014-Dec 2018.

Description

Inclusion Criteria:

• Female subjects above the age of 18
• Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous [high or low grade], mucinous, endometrioid, clear cell, mixed, and others) ovarian cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is available (not mandatory to be ovarian cancer related) as a proxy of healthcare use prior to the diagnosis of advanced-stage epithelial ovarian cancer

Exclusion Criteria:

• Patients being included in interventional clinical trials with PARPi for the treatment of advanced-stage high-grade epithelial ovarian cancer treatment during the study period
• Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
• Other malignancies within the past five years, except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. Patients with a history of localized breast cancer may have been eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and remained free of recurrent or metastatic disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platinum free interval	The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Time to progression	The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Duration of treatment	The length of time from the start of anti-cancer treatment to end of anti-cancer treatment	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Time to first subsequent treatment	The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
Overall survival	Duration from the index date to the date of death (if available)	Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• D0817R00028_CSR_v1.0_clean_0823

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2020
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: D0817R00028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No