Clinical Research Papers:
Validation of prognostic scoring and assessment of clinical benefit for patients with bone sarcomas enrolled in phase I clinical trials
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J. Andrew Livingston1, Kenneth R. Hess2, Aung Naing3, David S. Hong3, Shreyaskumar Patel4, Robert S. Benjamin4, Joseph A. Ludwig4, Anthony Conley4, Cynthia E. Herzog5, Pete Anderson6 Funda Meric-Bernstam3, Razelle Kurzrock7 and Vivek Subbiah3
1 Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
2 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
3 Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
4 Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
5 Department of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
6 Pediatric Hematology Oncology, The Cleveland Clinic, Cleveland, Ohio, USA
7 Experimental Therapeutics Program, University of California – San Diego, San Diego, California, USA
Correspondence to:
Vivek Subbiah, email:
Keywords: bone sarcoma; phase 1 trials; prognosis scores; Ewing sarcoma; osteosarcoma
Received: June 13, 2016 Accepted: June 26, 2016 Published: July 28, 2016
Abstract
Background: We sought to validate the Royal Marsden Hospital (RMH) and MD Anderson Cancer Center (MDACC) prognostic scoring systems for the selection of bone sarcoma patients for phase I clinical trials and to identify additional risk factors related to survival.
Patients and Methods: We retrospectively reviewed the baseline characteristics and outcomes of 92 bone sarcoma patients who were referred to MDACC’s Phase I Clinical Trials Program.
Results: Ninety-two patients with Ewing sarcoma (N = 47), osteosarcoma (N = 22), chondrosarcoma (N = 16), and other tumors (N = 7) were evaluated; 78 were enrolled in at least 1 of 43 different phase I trials. The median overall survival (OS) was 8.8 months (95% confidence interval [CI] = 6.8–13.7 months). Independent factors that predicted shorter survival were male sex, >2 metastatic sites, >3 previous therapies, hemoglobin level <10.5 g/dL, platelet count >200 x103/L, creatinine level ≥1.3 mg/dL, and lactate dehydrogenase level >ULN. Patients with good RMH scores (0-1) had longer OS than patients with poor RMH scores (2-3) (HR = 5.8, 95% CI = 2.9–11.0; P < 0.0001), as did patients with low MDACC scores (0-1) as compared to patients with higher MDACC scores (2–4) (HR = 3.2, 95% CI = 1.9–5.6; P < 0.0001).
Conclusion: The RMH prognostic score can be used to predict the OS of bone cancer patients referred for phase I trials. The MDACC score added no value to the RMH score and therefore does not have a role in assessment of patients with bone tumors. Patients with advanced bone sarcomas should be considered for phase I trials.