GEMSTONE Educational Case Summary

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Presentation transcript:

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.

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

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).

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.

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.

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.

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.

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?

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. TESARO, Inc. | 1000 Winter Street, Suite 3300 | Waltham, MA 02451 ©2018 TESARO, Inc. All rights reserved. PP-DS-US-0137 10/18