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SIR ABSTRACT #1

SIR ABSTRACT #1 Safety, Response and Survival Outcomes of Y90 Microsphere Radioembolization for Liver Metastases: Results from a 151 Patient Investigational Device Exemption Multi-Institutional Study. Study Chair Dr. Al Benson III, Northwestern Memorial Hospital Principle Investigators

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SIR ABSTRACT #1

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  1. SIR ABSTRACT #1 Safety, Response and Survival Outcomes of Y90 Microsphere Radioembolization for Liver Metastases: Results from a 151 Patient Investigational Device Exemption Multi-Institutional Study • Study Chair • Dr. Al Benson III, Northwestern Memorial Hospital • Principle Investigators • Dr. Gary Siskin, Albany Medical Center • Dr. Jeff Geschwind, Johns Hopkins University Hospital • Dr. Gregory Wiseman, Mayo Clinic Rochester • Dr. William Rilling, Medical College of Wisconsin • Dr. Mary Mulcahy, Dr. Riad Salem, Northwestern Memorial Hospital

  2. TheraSphere Y-90 integral constituent of the insoluble, biocompatible glass microspheres Mean sphere diameter : 20-30 m 22,000 to 73,000 spheres / mg 6 dose sizes (3, 5, 7, 10, 15, 20 GBq) Dose by selected target volume Activity = [Desired Dose (Gy)] [Mass of Liver Target (kg)] 50 Arterial administration preferentially delivers microspheres to tumor; spares normal parenchyma Comparison of a Human Hair with TheraSphere (500x) TheraSphere Y-90 Glass microspheres Radiation

  3. Study Overview Design • Single-arm prospective, open-label • Investigational Device Exemption (Nordion) • Independent contract research organization • Patients with Liver Metastases: • Primary Colorectal Cancer (CRC) • Neuroendocrine (NE) • Non-Colorectal/Non-Neuroendocrine (Non-CRC/Non-NE) Objectives • Evaluate safety of TheraSphere at doses of 120 ± 10% Gy • Evaluate Imaging Outcomes (RECIST v1.0) • Response Rate (RR) • Progression Free Survival (PFS) • Independent central review • Evaluate Overall Survival (OS)

  4. Main Inclusion Criteria • ≥ 18 years of age • Metastatic disease refractory to, or inappropriate for other systemic or liver-directed therapies • Unresectable tumors • Measurable disease • Tumor replacement  50% by liver volume • ECOG PS 0-2 • ≥ 30 day from prior cancer therapy • Signed informed consent

  5. Main Exclusion Criteria • Risk of hepatic or renal failure • Serum creatinine >2.0 mg/dL, unless on dialysis • Serum bilirubin  2.0 mg/dL • Albumin < 2.0 g/dL • History of hepatic encephalopathy • Pulmonary insufficiency, clinically evident COPD • Contraindication to TheraSphere or radiology procedures • Cirrhosis or portal hypertension • Prior Y90 microspheres or EBRT to the liver • Intervention for, or compromise of the Ampulla of Vater • Clinically evident ascites • Co-morbidities or unresolved adverse events • Positive serum pregnancy test

  6. Trial Treatment Schedule • Pre-Treatment Procedures (< 28 days prior to Day 0) • Screening for eligibility, informed consent; medical history; labs; CT/MRI; 99TcMAA scan and hepatic angiography (coil embolization) • Develop treatment plan: determine target volume; activity to treat target volume; account for decay; schedule treatment, order dose vial • Day 0 - Treatment first lobe: position catheter, infuse microspheres • Week 2 – Telephone follow-up (safety) • Week 5 – Assess safety & response, treat 2nd lobe • Months 3, 6, 9, 12 then every 6 months – Assess safety & progression

  7. Study Enrollment • First patient enrolled: January 2007 • Last patient enrolled: October 2009 • Last patient visit: by March 1, 2011

  8. Results – Patient Population • Mean age 63.7 years • 55.6 % male • 91.4 % Caucasian • 95.4 % ECOG 0-1 • 68.9% bilobar disease • Mean 2.5 years from initial diagnosis • Medical history consistent with age/disease: • > 50% patients with histories in GI, Musculoskeletal, General Cardiac, Dermatology, Allergy/immunology & Endocrine body systems • Non CRC/Non NE included: cholangiocarcinoma, breast, ovarian, renal cell/bladder, esophageal/gastric, lung, pancreas

  9. Results – Prior Treatments

  10. Results – Dosing • 243 lobar treatments per protocol • Average 1.6 treatments per patient • All patients received 120 Gy +/– 20% • No USNRC reportable medical events • Median cumulative lung exposure <10 Gy • 2% of patients received > 30 Gy to lung without clinical sequelae

  11. Results – Total Liver Dosing (Gy)

  12. Study Analysis Populations • Safety and OS populations • all patients receiving TheraSphere (N = 151) • RR (CR+PR+SD) • patients with completed independent image review (N = 130) • PFS populations • CRC patients (N = 56), NE patients (N = 31) with complete independent image review

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  16. 4 & 5

  17. Response by RECIST v1.0

  18. Survival Estimates • CRC • Median PFS 2.8 months [95% CI: 1.2 - 3.1] • Median OS 9.4 months [95% CI: 6.6 - 11.9] • Neuroendocrine • Median PFS 14.6 months [95% CI: 9.0 - 18.4] • Median OS 24.0 months [95% CI: 17.5 - 36.3]

  19. Kaplan-Meier Progression-Free Survival K-M Estimate of Hepatic or Extra-Hepatic PFS Probability MONTHS

  20. Kaplan-Meier Overall Survival K-M Estimate of Survival Probability MONTHS

  21. Conclusions • TheraSphere demonstrated excellent tolerability and safety profile in patients with advanced metastatic liver disease • Highly reliable delivery of planned radiation dose • Prospective, multicenter confirmation of anti-tumor effect in patients without alternative therapeutic options • Results were reproducible among all centers; set the stage for international, multicenter phase 3 RCTs

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