1. GEMSTONE Educational Case Summary
How do you decide between standard-of-care treatment and clinical trial enrollment for individual patients with ovarian cancer?
GEMSTONE Educational Case Summary
Last Update: June 23, 2018
GEMSTONE, a committee of ovarian cancer experts, provided direction and approval of the hypothetical patient scenario presented in this educational resource. TESARO, Inc. provided writing and organizational support to GEMSTONE in the generation of this material.

2. Case Objectives
Describe the role of clinical trials in advancing treatment paradigms for patients with ovarian cancer
Review the standard-of-care treatment options for patients with ovarian cancer
Discuss how platinum sensitivity impacts treatment decisions for patients with ovarian cancer
Assess patient and provider factors that affect the decision of whether to enroll a patient on a clinical trial
Discuss talking to patients about the risks and benefits of clinical trials

3. Patient History and Baseline Characteristics
Age
67 years
Gravidity and parity
G3P1
Occupation
Retired school teacher
Medical history
Postmenopausal; hypertension on ACE inhibitor
Family history
Hypertension in father; CAD on mother’s side
Baseline Characteristics
Performance status
Symptoms
Mild pelvic discomfort, mass detected during routine pelvic examination
Comorbidities
Hypertension
ACE, angiotensin-converting enzyme; CAD, coronary artery disease; G, gravida (pregnancy); P, para (birth).

4. Laboratory Tests, Imaging, and Biomarkers
Laboratory Testing
Liver function
Normal
Renal function
CBC findings
Chemistry findings
Other
BMI 34
Imaging
Central cystic and solid pelvic mass measures 6 cm in largest dimension
Moderate amount of abdominal ascites present, with omental studding noted
Biomarkers Testing
BRCA1
Wild-type
BRCA2
CA-125 (<35 U/mL)
623 U/mL
Other tests
None performed
BMI, body mass index; BRCA, breast cancer susceptibility gene; CA, cancer antigen; CBC, complete blood count.

5. Surgical Interventions, Findings, and Diagnosis
TAH/BSO
Omentectomy
Tumor debulking
Ascites removal
Findings
Tumor involving both ovaries, uterine serosa, pelvic peritoneum, and omentum
All visible disease resected (R0)
Diagnosis & Staging
Stage IIIC high-grade serous carcinoma
BSO, bilateral salpingo-oophorectomy; TAH, total abdominal hysterectomy.

6. Primary Treatment and Outcomes
IV carboplatin and dose-dense paclitaxel
×6 cycles
Treatment Outcomes
No evidence of disease by examination, CA-125 levels, and imaging
Posttreatment
Monitor with physical examination and CA-125 levels every 3 mo
CA, cancer antigen; IV, intravenous.

7. First Recurrence: Detection, Treatment, and Outcomes
9 mo following completion of primary chemotherapy
CA-125 elevated to 93 U/mL from low of 21 U/mL
CT shows several new nodules in pelvis, right paracolic gutter, and small bowel
Recurrence Treatment
IV carboplatin and dose-dense paclitaxel
×3 cycles
Treatment Outcomes
PR by CT scan
3 additional cycles of carboplatin and paclitaxel planned
CA, cancer antigen; CT, computed tomography; IV, intravenous; PR, partial response.

8. Key Discussion Questions?
Key Discussion Questions
How do you explain the risks and benefits of clinical trials to your patients? What are the biggest challenges?
What factors affect your decision to consider a clinical trial (patient factors, provider factors, etc)?
Why are clinical trials important?

9. GEMSTONE
GEMSTONE, a committee of ovarian cancer experts, provided direction and approval of the material in this educational resource. TESARO, Inc. provided writing and organizational support to GEMSTONE in the generation of this material.
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