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Bernthal , Federman , Nelson, Eilber , Eckardt , Tap, Eilber UCLA Medical Center CTOS 2012

Lessons from the Past : Long-Term Follow Up of an Original Randomized Controlled Chemotherapy Trial for Stage IIB Osteosarcoma. Bernthal , Federman , Nelson, Eilber , Eckardt , Tap, Eilber UCLA Medical Center CTOS 2012 Prague, Czech Republic. Disclosures.

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Bernthal , Federman , Nelson, Eilber , Eckardt , Tap, Eilber UCLA Medical Center CTOS 2012

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  1. Lessons from the Past:Long-Term Follow Up of an Original Randomized Controlled Chemotherapy Trial for Stage IIB Osteosarcoma Bernthal, Federman, Nelson, Eilber, Eckardt, Tap, Eilber UCLA Medical Center CTOS 2012 Prague, Czech Republic

  2. Disclosures • None of the authors have any relevant disclosures

  3. Osteosarcoma Survival Estimates

  4. 1974

  5. 1974

  6. Osteosarcoma Survival Estimates

  7. 1981-1984 at UCLA • 78 Consecutive Osteosarcoma Patients • 19 Excluded for metastatic disease • 59 Patients Enrolled • All Received 1 Cycle Neoadjuvant Therapy • Adriamycin (30mg/day x 3 days) Intra-Arterial • Radiation (350 rads/day x 5 days) • Methotrexate (200mg/kg) • Citrovorum Factor Rescue • Vincristine (1.5mg) • All received surgical resection • 44 Limb salvage • 15 Amputations • 8 Tibia, 4 Less than 10 yo, 3 Large tumor burden • Randomized to chemotherapy vs expectant arm

  8. Randomization Arms • Treatment Arm (4 Total Cycles over 7 months) • Week 1 and 2 • Methotrexate (200mg/kg) • Citrovorum Factor Rescue • Vincristine (1.5mg) • Week 3 • Adriamycin (40mg/m2) x 2 days • Week 5 • Bleomycin (12U/m2) x 2 days • Cytoxan (600mg/m2) x 2 days • Actinomycin D (450mcg/m2) x 2 days

  9. The Trial

  10. Results

  11. Results

  12. Question #1 • Does the survival benefit of chemotherapy remain statistically significant at >25 year follow up?

  13. Survival Outcomes

  14. Survival Benefit at 25 Years P=0.02

  15. Univariate Analysis

  16. Question #2 • Does early response (i.e. tumor necrosis) portend a durable survival?

  17. The Ultimate “Early Responder” Study

  18. Survival by Tumor Necrosis (Among Patients Receiving Adjuvant Chemo) P<0.001

  19. Survival by Tumor Necrosis

  20. Discussion • >25 year follow up on one of the original randomized controlled trials of adjuvant chemotherapy for localized osteosarcoma: • The survival benefit of adjuvant chemotherapy for localized osteosarcoma is durable out to >25 years • Tumor necrosis is predictive of a survival benefit out to > 25 years among patients receiving adjuvant chemotherapy • Poor responders to one cycle of chemo/radiation (TN< 90) had as poor survivorship as those that received no adjuvant chemotherapy.

  21. Weaknesses • Small Sample Size (N = 59) • Crossover • 2 patients refused chemo • 2 did not complete chemo 2° to toxicity • Outdated Chemotherapy Protocols Yet, this is a randomized controlled clinical trial with long follow up and 100% patient retention

  22. Special Thanks • Co-Authors: • Frederick Eilber, M.D. • Jeffrey Eckardt, M.D. • Fritz Eilber, M.D. • Scott Nelson, M.D. • Noah Federman, M.D. • William Tap, M.D. • To the patients who were randomized to the observation arm in this clinical trial.

  23. Structured Illumination Microscopy of Osteosarcoma Burnette, Dylan (NIH). 3rd Place Nikon Microscope Picture of the Year 2012 Purple = Actin; Yellow = Mitochondria; Blue = DNA; Picture at 63x

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