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Poster lunch

1810 - Clinical Outcome and Prognostic Factors for Patients Treated in a Phase I Study at the National University Cancer Institute, Singapore (NCIS) (138P)

Date

18 Nov 2017

Session

Poster lunch

Topics

Cytotoxic Therapy;  Clinical Research

Presenters

Cheng Ean Chee

Citation

Annals of Oncology (2017) 28 (suppl_10): x39-x41. 10.1093/annonc/mdx658

Authors

C.E. Chee1, R. Soo1, B. Goh1, W.P. Yong1, S.C. Lee1, D.S. Tan1, A. Wong1, W.J. Chng1, V. Heong1, B.C. Tai2

Author affiliations

  • 1 Haematology-oncology, National University Cancer Institute Singapore, 119074 - Singapore/SG
  • 2 Epidemiology, NUS Saw Swee Hock School of Public Health, 117549 - Singapore/SG
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Resources

Abstract 1810

Background

Patient selection for phase I trials in oncology is challenging. A typical inclusion criterion for phase I studies is 'life expectancy >3 months', however overall survival (OS) of patients with advanced solid malignancies are difficult to predict. Other studies have demonstrated that despite the use of traditional eligibility criteria for enrollment into a Phase I (P1) study, about 1/3 of patients fail to meet all the necessary eligibility criteria at screening and ∼15-20% die within the first 90 days of P1 trial entry. The P1 Unit at the Royal Marsden Hospital (RMH), UK has found that a prognostic score is a helpful tool in the process of patient selection for P1 trial entry. We aim to develop a similar prognostic score predicting OS in our P1 patient population here at the NCIS.

Methods

Patients in P1 studies completed between Oct. 2013 – Jan. 2016 at NCIS and had EMR available were reviewed. Patient characteristics and survival data were analysed.

Results

120 pts from 10 completed P1 studies were included. Median age was 44.5 years (range: 23-79). Baseline variables were: age >60 (56%), male (53%), ECOG 0-1 (98%), comorbidities ≥2 (26%), no. of prior therapies ≥3 (65%), no. of metastatic sites ≥3 (40%). Univariate analysis revealed that albumin 2 sites) was also at the threshold of significance (HR: 1.62, 95% CI: 0.99 – 2.64, p 

Conclusions

Risk scoring based on objective clinical parameters indicated that patients with a high score had a significantly shorter OS and this may assist in the selection of patient entry into P1 studies. A prospective study will be needed to test the validity of the prognostic score.

Legal entity responsible for the study

National University Cancer Institute, Singapore

Clinical trial identification

Legal entity responsible for the study

National University Cancer Institute, Singapore

Funding

National University Cancer Institute, Singapore

Disclosure

All authors have declared no conflicts of interest.

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