Survival of 1,181 Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience
A partir de données portant sur 1 181 patients ayant été inclus dans un essai clinique de phase I au Centre MD Anderson, cette étude évalue l'intérêt d'un indicateur, le score du Royal Marsden Hospital, pour déterminer la survie des patients
ABSTRACT Background: In order to determine if the Royal Marsden Hospital (RMH) prognostic score for phase I patients can be validated in a large group of individuals seen in a different center, and if other prognostic variables are also relevant, we present an analysis of 1,181 patients treated in the MD Anderson Cancer Center (MDACC) Phase I clinic. Methods: 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; median survival, 10 months (95% CI-9.1 to 10.9 months). Independent factors that predicted shorter survival in a multivariate Cox model and could be internally validated included: RMH score >1 (p<0.0001) (albumin <3.5 mg/dL, LDH >upper limit of normal, and >2 sites of metastases); gastrointestinal tumor type (p<0.0001); and, ECOG 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.
Clinical Cancer Research , résumé, 2012