RT Journal Article SR Electronic T1 Survival of 1,181 Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience JF Clinical Cancer Research JO Clin Cancer Res FD American Association for Cancer Research SP 2922 OP 2929 DO 10.1158/1078-0432.CCR-11-2217 VO 18 IS 10 A1 Wheler, Jennifer A1 Tsimberidou, Apostolia M. A1 Hong, David A1 Naing, Aung A1 Falchook, Gerald A1 Piha-Paul, Sarina A1 Fu, Siqing A1 Moulder, Stacy A1 Stephen, Bettzy A1 Wen, Sijin A1 Kurzrock, Razelle YR 2012 UL http://clincancerres.aacrjournals.org/content/18/10/2922.abstract AB Purpose: To determine whether the Royal Marsden Hospital (RMH; London, UK) prognostic score for phase I patients can be validated in a large group of individuals seen in a different center and whether other prognostic variables are also relevant, we present an analysis of 1,181 patients treated in the MD Anderson Cancer Center (MDACC; Houston, TX) phase I clinic. Experimental Design: Medical records of 1,181 consecutive patients who were treated on at least one trial in the phase I clinic were reviewed. Results: The median age was 58 years and 50% were women. The median number of prior therapies was four and median survival 10 months [95% confidence interval (CI), 9.1–10.9 months]. Independent factors that predicted shorter survival in a multivariate Cox model and could be internally validated included RMH score of >1 (P < 0.0001; albumin <3.5 g/dL; lactate dehydrogenase >upper limit of normal, and >two sites of metastases), gastrointestinal tumor type (P < 0.0001), and Eastern Cooperative Oncology Group performance status ≥1 (P = 0.0004). The median survival was 24.0, 15.2, 8.4, 6.2, and 4.1 months for patients with 0, 1, 2, 3, and 4 or 5 of the above risk factors, respectively. Conclusion: The RMH score was validated in a large group of patients at MDACC. Internal validation of the independent prognostic factors for survival led to the development of the MDACC prognostic score, a modification of the RMH score that strengthens it. Clin Cancer Res; 18(10); 2922–9. ©2012 AACR.