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Keywords:

  • prognostic score;
  • phase 1 trial;
  • survival;
  • albumin;
  • outcome

BACKGROUND

Several prognostic indices have been devised to optimize patient selection for phase 1 oncology trials with no consensus as to the optimal score and none qualifying as a marker of treatment response.

METHODS

Multivariate predictors of overall survival (OS) were tested on 118 referred patients to develop the Hammersmith Score (HS). The score's ability to predict OS, progression-free survival (PFS), and 90-day mortality (90DM) was compared with other prognostic indices. Changes in HS were recalculated during treatment.

RESULTS

Albumin < 35 g/L, lactate dehydrogenase > 450 U/L, and sodium < 135 mmol/L emerged as independent prognostic factors. These were used with equal weighting to devise the HS, a compound prognostic index ranging from 0 to 3. High (HS = 2-3) score predicted worse OS (hazard ratio [HR] = 6.5, P < .001), PFS (HR = 2.8, P = .01), and 90DM (OR = 9.0, P < .001). HS was a more accurate multivariate predictor of OS (HR = 6.4, P < .001, C-index = 0.72), PFS (HR = 2.7, P = .03), and 90DM (area under the ROC curve 0.703) compared with other scores. Worsening of the HS during treatment predicted for shorter OS (P < .001). HS retained prognostic and predictive ability following external validation.

CONCLUSIONS

HS is a simple, validated index to optimize patient selection and predict survival benefit from phase 1 oncology treatments. Prospective validation is ongoing. Cancer 2014;120:262–270. © 2013 American Cancer Society.