Tracking Treatment Response

1. What cancer type and treatment is the patient receiving? (Default: [VERIFY])
2. What response criteria system is applicable (RECIST 1.1, iRECIST, Lugano, RANO, mRECIST)? (Default: RECIST 1.1 for solid tumors)
3. What is the baseline imaging date and documented baseline measurements? (Default: provide)
4. What target lesions were identified at baseline? (Default: document with measurements)
5. Are there non-target lesions and/or new lesions to track? (Default: document)
6. What imaging modality is being used for follow-up (CT, MRI, PET/CT)? (Default: same modality as baseline)
7. What is the assessment schedule per protocol or NCCN guideline? (Default: every 2–3 cycles or per guideline)
8. Are tumor markers being tracked concurrently? (Default: document if applicable)

Documents to Request

• Baseline imaging with radiologist measurements of target lesions
• Current follow-up imaging with measurements
• All interval imaging studies for trend analysis
• Tumor marker serial values if applicable
• Treatment administration records (cycle dates, dose modifications)
• Clinical assessment notes (symptom changes, performance status)
• Prior response assessments for comparison
• Clinical trial protocol response assessment requirements if applicable

Step 1: Apply RECIST 1.1 Criteria

Baseline target lesion selection (at start of treatment):

• Select up to 5 target lesions total, maximum 2 per organ
• Target lesions must be measurable: ≥10mm in longest diameter for non-nodal lesions, ≥15mm in short axis for lymph nodes
• Measure by CT with ≤5mm slice thickness; use calipers for consistent measurement
• Document each target lesion: location, measurement (mm), imaging modality, date

Non-target lesions: All other disease sites documented but not measured — tracked qualitatively as present/absent/unequivocal progression.

Response categories:

Key measurement rules:

• Always compare current sum to baseline (for PR) AND to nadir (for PD)
• Lymph nodes: use short axis measurement; nodes that decrease to <10mm are considered normal but still included in sum
• Lesions too small to measure: record as 5mm (not zero) to avoid artificial "complete response"
• Lesion that cannot be measured due to coalescence: assign estimated measurement

Step 2: Apply Modified Criteria for Special Contexts

iRECIST (for immunotherapy):

• First apparent progression = iUPD (immune unconfirmed progressive disease)
• Confirm progression with repeat imaging 4–8 weeks later
• If confirmed: iCPD (immune confirmed progressive disease) — true progression
• If not confirmed (stable/shrinkage): reset baseline — pseudoprogression resolved
• Pseudoprogression occurs in 5–10% of immunotherapy patients; most common in melanoma

Lugano Classification (for lymphoma):

• Uses PET/CT (Deauville 5-point scale) for FDG-avid lymphomas
• Deauville 1–3 = metabolic CR; Deauville 4–5 with decreased uptake = PR; Deauville 4–5 with increased uptake or new lesions = PD
• CT-based criteria used for non-FDG-avid lymphomas

RANO Criteria (for CNS tumors):

• Measures enhancing and non-enhancing disease separately
• Requires consideration of corticosteroid dose (steroid increase without tumor growth is not response)
• Pseudoprogression common after temozolomide + radiation (occurs within first 3–6 months)

mRECIST (for HCC):

• Measures viable (arterially enhancing) tumor, not total tumor size
• Necrotic/non-enhancing areas after locoregional therapy are not measured

Step 3: Integrate Imaging with Clinical and Biomarker Assessment

Response assessment should integrate three data streams:

1. Imaging response per applicable criteria (RECIST 1.1, iRECIST, etc.)
2. Biomarker response (tumor markers trending per interpreting-tumor-markers skill)
3. Clinical response (symptom improvement, performance status change, weight change)

Discordance management:

When discordance exists, document each data stream separately and provide an integrated clinical assessment with rationale.

Step 4: Document the Response Assessment

Structure each response assessment as:

1. Assessment date and imaging modality/date
2. Target lesion measurements: Each lesion with current measurement, baseline measurement, nadir measurement, and percent change from baseline and from nadir
3. Sum of target lesions: Current, baseline, nadir, percent change
4. Non-target lesion status: Present/absent/unequivocal progression for each
5. New lesions: Present/absent — if present, document location and size
6. Overall response: CR, PR, SD, PD (or iCR, iPR, iSD, iUPD, iCPD for immunotherapy)
7. Best overall response to date
8. Biomarker correlation if applicable
9. Clinical correlation: Symptom trajectory, PS change
10. Treatment recommendation: Continue, modify dose, switch regimen, proceed to next planned phase

Checkpoint B: Post-Draft Alignment (Mandatory)

1. Are the same target lesions measured at each time point using the same imaging modality?
2. Is the response category correctly assigned per RECIST 1.1 (or applicable criteria) with supporting measurements?
3. Has progression been assessed against both baseline (for PR) and nadir (for PD)?
4. For immunotherapy patients, has iRECIST been applied with confirmation of suspected progression?
5. Is the response assessment correlated with biomarker trends and clinical status?

Quality Audit

• Response criteria system specified (RECIST 1.1, iRECIST, Lugano, RANO, mRECIST)
• Baseline target lesions documented with measurements (up to 5 total, max 2 per organ)
• Same target lesions measured at each assessment time point
• Same imaging modality used across assessments (CT→CT, not CT→MRI)
• Sum of target lesion diameters calculated and compared to baseline and nadir
• Non-target lesion status documented (present/absent/progression)
• New lesions assessed and documented
• Response category correctly assigned per criteria with supporting arithmetic
• Pseudoprogression considered for immunotherapy and post-radiation contexts
• Biomarker correlation documented when applicable
• Clinical correlation (symptoms, PS) integrated into overall assessment
• Best overall response tracked across all assessments
• Treatment recommendation linked to response assessment
• Assessment timing aligned with protocol or NCCN guideline schedule

Guidelines

• Always measure the same target lesions at each assessment — changing target lesions invalidates the response calculation
• Use the same imaging modality and ideally the same scanner for serial assessments — modality changes introduce measurement variability
• RECIST 1.1 response requires confirmation: PR must be confirmed on a subsequent scan ≥4 weeks later in clinical trial settings; SD must be documented at a minimum interval of 6–8 weeks from baseline
• A single new lesion, regardless of size, constitutes progressive disease in RECIST 1.1 — this is frequently missed
• For immunotherapy, always consider pseudoprogression before declaring PD — apply iRECIST and confirm with 4–8 week repeat imaging
• Bone-only disease is generally non-measurable per RECIST 1.1 — response in bone metastases requires supplementary criteria (sclerotic healing, decreased uptake on PET)
• Effusions (pleural, peritoneal) are non-measurable per RECIST 1.1 — do not use effusion volume for response assessment
• Radiologic response does not always equal clinical benefit — SD maintained for many months may represent meaningful clinical benefit, especially in indolent diseases