Definition of Best Overall Response (BOR)
Best Overall Response (BOR) is the best treatment response a patient achieves during a clinical trial.
It is determined based on tumor size changes and classified into four categories:
1.Complete Response (CR) – The tumor disappears completely.
2.Partial Response (PR) – The tumor shrinks significantly but is still present.
3.Stable Disease (SD) – The tumor neither shrinks nor grows significantly.
4.Progressive Disease (PD) – The tumor grows or worsens.
Imagine 5 patients are taking a new cancer drug.
Each patient’s response is tracked over time.
•If a patient improves over time, the best response is counted (e.g., PR → CR → CR is recorded as CR).
•If a patient worsens after improvement, the worst response is counted if the patient does not recover
•(e.g., PR → PD is recorded as PD).
Imagine 5 patients are taking a new cancer drug.
Each patient’s response is tracked over time.
•If a patient improves over time, the best response is counted (e.g., PR → CR → CR is recorded as CR).
•If a patient worsens after improvement, the worst response is counted if the patient does not recover
•(e.g., PR → PD is recorded as PD).
| Patient | Response Type | Best Overall Response (BOR) |
| Patient 1 | CR (Tumor disappeared) | CR |
| Patient 2 | PR (Tumor shrank) | PR |
| Patient 3 | SD (No significant change) | SD |
| Patient 4 | PR first, then PD later | PD (worst response counts) |
| Patient 5 | PR first, then CR later | CR (best response counts) |
PR → CR → CR → CR
👉 BOR = CR (Best was 100%)SD → PR → PR → SD
👉 BOR = PR (Best was 80%)PR → SD → PD → PD
👉 BOR = PD (Got worse at the end)SD → SD → SD → SD
👉 BOR = SD (No change)PR → CR → PD
👉 BOR = PD (Got worse at the end)Definition of Objective Response Rate (ORR)
Objective Response Rate (ORR) is a measure used in oncology clinical trials to assess how well a treatment works.
It is the percentage of patients whose cancer shrinks (Partial Response – PR) or disappears (Complete Response – CR) after treatment.
ORR does not include Stable Disease (SD) or Progressive Disease (PD).
A 95% Confidence Interval (CI) is a range of values that tells us where the true result is likely to be.
What is a 95% Confidence Interval (CI)?
95% Confidence Interval (CI) for Objective Response Rate
•Drug A: (0.1941 – 0.993) → This means we are 95% sure that the true response rate for Drug A is between 19.41% and 99.3%.
•Drug B: (0.0250 – 1.000) → The response rate for Drug B is between 2.5% and 100% (very wide range due to low patient count).95% Confidence Interval (CI) for Objective Response Rate
•Drug A: (0.1941 – 0.993) → This means we are 95% sure that the true response rate for Drug A is between 19.41% and 99.3%.
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•Drug B: (0.0250 – 1.000) → The response rate for Drug B is between 2.5% and 100% (very wide range due to low patient count).Difference in Objective Response Rate
•0.75 (75%) → Drug A had a 75% higher response rate than Drug B.95% CI for the Difference in ORR
•0.3257 → This means the actual difference could vary, but there’s a 32.57% chance that Drug A is better than Drug B.P-value
•0.2207 → The p-value tells us if the difference between Drug A and Drug B is statistically significant.
•Since 0.2207 > 0.05, this means the difference is not statistically significant, meaning we cannot be sure that Drug A is truly better than Drug B (the result could be due to chance).