Keywords:
Oncology, Molecular imaging, Computer applications, CT, MR, PET-CT, Computer Applications-Teleradiology, Efficacy studies, Structured reporting, Metastases, Outcomes, Multidisciplinary cancer care
Authors:
M. SHARMA1, O. Bohnsack2, D. Clark2, N. Rohra1; 1HYDERABAD/IN, 2Berlin/DE
DOI:
10.26044/ecr2019/C-2951
Methods and materials
Patient Population: Retrospective study and analysis of four randomized double-blind trials was performed in patients with Ovarian Cancer.
Study 1 included placebo controlled patient data with platinum sensitive ovarian cancer.
Study 2 included maintenance monotherapy in advanced (FIGO Stage III-IV) ovarian cancer following first line platinum-based chemotherapy.
Study 3 focused on patients who are in complete or partial response following platinum-based chemotherapy.
Study 4 involved patients with recurrent or persistent low-grade serous carcinomas of the ovary,
fallopian tube or primary peritoneum.
Data was analyzed from these studies using RECIST 1.1.
Post contrast Computed tomography (CT) and/or Magnetic resonance (MR) images were acquired involving a total of 1491 subjects involving 528,
367,
273 and 323 subjects respectively.
Data Acquisition and Imaging Schedule: Radiological Scans (CT or MRI) of the Chest,
Abdomen and Pelvis was acquired for each study based on a pre-defined imaging schedule.
A screening acquisition within 28 days of randomization was performed for every subject.
The follow-up tumor assessment was performed every 8 weeks to 12 weeks from randomization for these studies till treatment was discontinued due to multiple factors including progression was determined as per RECIST 1.1,
withdrawal of consent,
clinical progression,
lost to follow-up or death.
Data Analysis: A double read by independent radiologists was performed for each scan based on the RECIST 1.1 criteria between 2013 and 2018.
Baseline tumor burden was assessed for all subjects using RECIST 1.1 criteria with lesions selected as Target or Non-Target lesions.
At follow-up visits,
data was specifically analyzed for New lesions.
The readers had to select New lesion location from a pre-defined location list from a drop-down menu.
Data from each study was tabulated with frequency of subjects with New lesion per each location.