3.4.2. Study Outcome: Efficacy of Treatment
Next, the efficacy of the combination in the four studies will be presented. The parameters evaluated
for this are median values for Overall Survival (months), and Overall Response Rates (Complete
Response plus Partial Response). Response rates are measured by the number of patients that respond
to the treatment as a percentage of the total number of test subjects that are evaluated.
Each of the four studies used appropriate imaging tests for tumor measurements to assess the response
of the solid tumor to the treatment. The studies used the RECIST (Response Evaluation Criteria in
Solid Tumor) criteria developed by collaboration between The National Cancer Institute of the United
States, the European Organisation for Research and Treatment of Cancer (EORTC), and the National
Cancer Institute of Canada Clinical Trials Group (Therasse, 2000). These criteria are used by most
clinical trials including solid tumors worldwide. Imaging as response assessment was done at regular
intervals in all four studies.
The efficacy of treatment in the four studies is summarized in Table 4 below. Whether the response
was complete or partial was determined using the criteria of RECIST.
Table 4: The efficacy of treatment In the 4 included studies
Study
Overall
Partial
Complete
Overall Response
Survival
Response
Response
Rate
Cortes, et al
61.4 Months
44.4%
53.7%
98.1%
Martin, et al
34.2 Months
56.25%
12.5%
68.75%
Chia, et al
1-year
-
-
52%
estimated OS: