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Open Access Research article

Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?

Nicole G Chau1, Ana Florescu2, Kelvin K Chan1, Lisa Wang3, Eric X Chen1, Philippe Bedard1, Amit M Oza1 and Lillian L Siu1*

Author Affiliations

1 Division of Medical Oncology and Hematology, Princess Margaret Hospital, University of Toronto, Toronto, Canada

2 Department of Internal Medicine, University of Toronto, Toronto, Canada

3 Department of Biostatistics; Princess Margaret Hospital, University Health Network, Toronto, Canada

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BMC Cancer 2011, 11:426  doi:10.1186/1471-2407-11-426

Published: 5 October 2011

Abstract

Background

Patient selection for phase I trials (PIT) in oncology is challenging. A typical inclusion criterion for PIT is 'life expectancy > 3 months', however the 90 day mortality (90DM) and overall survival (OS) of patients with advanced solid malignancies are difficult to predict.

Methods

We analyzed 233 patients who were enrolled in PIT at Princess Margaret Hospital. We assessed the relationship between 17 clinical characteristics and 90DM using univariate and multivariate logistic regression analyses to create a risk score (PMHI). We also applied the Royal Marsden Hospital risk score (RMI), which consists of 3 markers (albumin < 35g/L, > 2 metastatic sites, LDH > ULN).

Results

Median age was 57 years (range 21-88). The 90DM rate was 14%; median OS was 320 days. Predictors of 90DM were albumin < 35g/L (OR = 8.2, p = 0.01), > 2 metastatic sites (OR = 2.6, p = 0.02), and ECOG > 0 (OR = 6.3, p = 0.001); all 3 factors constitute the PMHI. To predict 90DM, the PMHI performed better than the RMI (AUC = 0.78 vs 0.69). To predict OS, the RMI performed slightly better (RMI ≥ 2, HR = 2.2, p = 0.002 vs PMHI ≥ 2, HR = 1.6, p = 0.05).

Conclusions

To predict 90DM, the PMHI is helpful. To predict OS, risk models should include ECOG > 0, > 2 metastatic sites, and LDH > ULN. Prospective validation of the PMHI is warranted.