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Investigational New Drugs

, Volume 26, Issue 1, pp 53–58 | Cite as

Prognostic factors among cancer patients with good performance status screened for phase I trials

  • Nicolas PenelEmail author
  • Marie Vanseymortier
  • Marie-Edith Bonneterre
  • Stéphanie Clisant
  • Eric Dansin
  • Yvette Vendel
  • Régis Beuscart
  • Jacques Bonneterre
PHASE I STUDIES

Summary

Background

Selecting patients for phase I trials in order to investigate cytotoxic agents is challenging, since there is no clear and reliable guidance to estimate life expectancy among these patients. We retrospectively assessed prognostic factors in cancer patients screened for Phase1 trials between October 1997 and October 2002.

Methods

148 consecutive patients, screened for inclusion in phase I trials investigating cytotoxic agents, were included in the present study. 70 out of them actually received phase I trial regimens. Univariate and multivariate analysis were undertaken to determine the prognostic factors for overall survival (OS) from the date of screening.

Results

The median OS of the 148 patients was 5.7 months. Ninety-two percent of them had PS ≤ 1. The Cox model identified serum albumin <38 g/l [HR 2.51 (1.51–4.18), p = 0.0001] and lymphocyte count <700/mm3 [HR 2.27 (1.13–4.62), p = 0.024] as independent prognostic for overall survival. All patients presenting both prognostic factors died within 90 days.

Conclusions

We propose a simple model, easily obtained at the bedside, which can discriminate patients who are likely to be alive at 3 months and thus could be included in a phase 1 anti-cancer trial. This model now needs to be validated on an independent cohort.

Keywords

Cancer Decision making Lymphopenia Phase I trial Prognosis Serum albumin 

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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Nicolas Penel
    • 1
    • 2
    Email author
  • Marie Vanseymortier
    • 3
  • Marie-Edith Bonneterre
    • 4
  • Stéphanie Clisant
    • 3
  • Eric Dansin
    • 1
  • Yvette Vendel
    • 3
  • Régis Beuscart
    • 2
  • Jacques Bonneterre
    • 5
  1. 1.Département de Cancérologie GénéraleCentre Oscar LambretLilleFrance
  2. 2.Equipe d’Accueil 2694 : Santé Publique, Epidémiologie et modélisation des maladies chroniquesUniversité Lille IILilleFrance
  3. 3.Unité de Recherche Clinique, Centre Oscar LambretLilleFrance
  4. 4.Marcq en BaroeulFrance
  5. 5.Département de SénologieCentre Oscar LambretLilleFrance

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