What is disease control rate?

Disease Control Rate (DCR): Definition and Clinical Significance

Disease control rate (DCR) is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria in cancer clinical trials. 1

Standard Definition Across Cancer Types

DCR represents a composite endpoint that captures all patients whose disease does not progress during treatment:

• Complete Response (CR): Disappearance of all target lesions 1
• Partial Response (PR): At least 30% decrease in sum of target lesion diameters 1
• Stable Disease (SD): Neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease 1

The measurement is typically assessed using RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors), though WHO criteria may also be used in some contexts 1

Clinical Trial Context and Limitations

Important Caveats About DCR

DCR is neither a validated nor recommended primary endpoint for clinical trials. 1 The Gynecologic Cancer InterGroup consensus explicitly states that DCR "is neither a defined nor validated primary endpoint" for ovarian cancer trials, and this principle extends broadly across oncology 1

Why DCR Has Limited Value

• Lacks standardization: The duration of stable disease required for inclusion in DCR varies across trials and is often not specified 1
• Ambiguous information: DCR likely exaggerates anticancer activity because it includes patients with stable disease who may not have derived meaningful clinical benefit 2
• Disingenuous terminology: The terms "disease control" and "clinical benefit" are misleading in non-randomized trials, as neither tumor regression nor stable disease (without consideration of duration or symptom reduction) constitute evidence of true disease control in individual patients 2

Appropriate Use in Clinical Trials

Secondary Endpoint Only

DCR should be reported as a secondary endpoint only, never as a primary outcome measure 1:

• Appropriate for phase II single-arm studies as a descriptive measure 1
• Can provide context when reported alongside validated endpoints like progression-free survival (PFS) and overall survival (OS) 1
• Must be clearly defined with specific criteria for what constitutes "stable disease" (e.g., minimum duration of 6 months) 1

Reporting Requirements

When DCR is reported, investigators must 1:

• Clearly define how disease control is measured
• Specify the frequency and method of assessment
• Provide clear definition of baseline (time 0)
• Describe what occurrences are considered censored versus events

Correlation with Survival Outcomes

Weak Predictive Value

Research demonstrates that DCR has limited correlation with overall survival 3:

• In lung cancer trials, DCR showed a weighted correlation coefficient of only 0.470 with OS hazard ratios 3
• The adjusted coefficient of determination was 0.176, indicating DCR explains less than 18% of OS variation 3
• Objective response rate (ORR) showed stronger correlation with OS than DCR (0.570 vs 0.470) 3

Context-Specific Utility

DCR may have some utility in specific settings 1:

• In hepatocellular carcinoma trials, DCR showed moderate evidence of improvement with certain therapies (e.g., atezolizumab + bevacizumab: 657 per 1,000 vs sorafenib: 553 per 1,000) 1
• In maintenance therapy contexts, DCR requires validation assessment before use 1

Practical Implications for Clinicians

When evaluating clinical trial results, prioritize PFS and OS over DCR. 1 DCR should be viewed as supplementary descriptive information rather than evidence of meaningful clinical benefit, particularly when:

• Duration of stable disease is not specified 1
• The trial is non-randomized 2
• No quality of life or symptom improvement data accompany the DCR 2

The inclusion of stable disease in DCR calculations means this metric captures patients whose tumors neither shrank nor grew significantly, which may not represent true therapeutic benefit compared to natural disease history 2