Interim Analysis of Clinical Trial

Interim Analysis of Clinical Trial

 

TRIAL DESIGN

Clinical setup

  • Patients suffering from any kind of pulmonary cancers are enrolled
  • Cancer specimen is obtained via surgery; biopsy or thoracocentesis
  • Staging
  • Therapy is selected and initiated according to treatment guidelines
  • RECIST (Response Evaluation Criteria of Solid Tumours) status is recorded after two cycles

Laboratory setup

  • Cancer specimen is processed according to Humeltis’ method within 24 hours upon intervention
  • Preparations are frozen and kept at –80 °C
  • When therapy is selected, cells are thawed, 3D aggregates are created and the in vitro treatment with the same medicines as used by clinicians are applied to aggregates
  • Aggregates are incubated for 48-72 hours
  • Readout: checking the viability of cells compared to controls (aggregates treated with solvents only) after 48-72 hours

RESULTS

  • 205 patients enrolled
  • 144 SCLC or NSCLC cases
  • 27 cases with RECIST status (15th February 2017)




 

Almost all patients received combination therapy, respectively. The in vivo response data reported by clinical oncologist were used to define the RECIST status of the patient. Any observable response (complete or partial remission) was considered in vivo sensitive, and all other responses were considered as in vivo resistant (stable disease, progressive disease).

Subsequently, a true-positive (TP) correlation corresponds to clinical response (complete or partial remission) while in vitro treatment induced at least a 15% drop in the viability index compared to controls (readout values below 85%).  A true-negative (TN) correlation corresponds to in vitro viability index higher than 85% (readout over the 85% cut-off point) and the patient showing no response. False-positive (FP) correlations correspond to patients showing no response but the in vitro viability index was below 85% and, finally, false-negative (FN) correlation means a viability index over 85% although the patient had a clinical response.

Sensitivity (%) was calculated as 100× TP/(TP+FN), specificity as 100 x TN/(TN+FP) and diagnostic accuracy was calculated as (TP+TN)/N, while “N” being the sample size

Based on the above, data showed that Humeltis’ Predictive Chemosensitivity Assay is highly sensitive (100%), highly specific (86%), which altogether leads to highly accurate (89%) treatment predictions.

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