[Early phase trials at the "Institut de cancérologie de l'Ouest": Clinical outcome and validation of prognostic scores]

Abstract

Introduction: Early phase therapeutic trials in oncology are being offered to an increasing number of patients. The objective of this study is to retrospectively evaluate the treatment efficacy and survival of patients included in early phase trials at the "Institut de Cancérologie de l'Ouest" (ICO), as well as the interest of the Royal Marsden Hospital (RMH) and PRONOPALL scores in this population.

Patients and methods: All patients with cancer screened or included for an early phase trial at ICO between January 2012 and December 2015 have been identified.

Results: Out of 1312-screened patients, 710 were included in 115 trials (34 phase 1 trials). The absence of molecular anomaly was the main cause of inclusion failure (49.5%). The disease control rate was 90.9%, the median overall survival was 14.7 months (95% CI 12.7 to 16.4) and the median progression-free survival was 5.7 months (95% CI 5.5 to 6.6). The median overall survival was better for patients with good prognosis based on Royal Marsden Hospital score (16.6 months versus 6 months, P=0.0011) and PRONOPALL score (15.6 months versus 4.6 months, P<0.001).

Discussion: Our results are better than in the literature, mainly because of the high proportion of first-line treatments and the consideration of phase II trials. Patients with lung cancer particularly benefited from these treatments, in part because of the role of immunotherapy. The Royal Marsden Hospital score can guide the decision to include in early phase trials, whereas the PRONOPALL score is not enough efficient.

Keywords: Early phase trials; Essai thérapeutique de phase précoce; PRONOPALL score; Royal Marsden Hospital score; Score PRONOPALL; Score Royal Marsden Hospital.