# RECIST 1.1 — Response Evaluation Criteria in Solid Tumours v1.1

> Patient-level anatomic response assessment using a fixed target-lesion set, unidimensional diameter sums, qualitative non-target review and explicit new-lesion and evaluability rules.

**Situação:** vigente · **Órgão:** Oncologia · **Órgão emissor:** RECIST Working Group · **Versão:** 1.1 (2009; committee clarifications current) · **Ano:** 2009

> ⚠️ Uma versão mais nova pode existir (em revisão).

## Procedência e vigência
- Família: léxico
- Tipo de lógica: flat
- Modalidade: CT, MRI
- Fonte primária: Eisenhauer EA, Therasse P, Bogaerts J, et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) (2009) — https://doi.org/10.1016/j.ejca.2008.10.026
- Última verificação: 2026-07-24
- Última checagem: 2026-08-12

## Lógica de decisão
Keep the fixed target set and the correct baseline-versus-nadir references. Synthesize target, nontarget, new-lesion and evaluability states before returning a patient-level category, and retain any confirmation requirement.

## Categorias

| Código | Rótulo | Critérios | Conduta | Risco | Localizador | Verificado |
| --- | --- | --- | --- | --- | --- | --- |
| CR | Complete response | Complete response: all target lesions disappear and every pathologic target or nontarget lymph node regresses to a short axis below 10 mm. Overall CR also requires disappearance of nontarget disease, any protocol-required tumor-marker normalization and no new lesion. Nodes are recorded at their actual short axis, so an overall target sum can remain above zero despite valid nodal CR. | Document target, nontarget and new-lesion synthesis, the confirmation requirement for the trial design and any residual nonmalignant morphology. RECIST CR is a trial response endpoint, not proof of cure or an autonomous instruction to stop therapy or surveillance. | CR is the most favorable RECIST 1.1 anatomic category but does not provide an individual probability of pathologic complete response, recurrence or survival. Microscopic disease and viable tumor below spatial resolution can remain. | Eisenhauer et al. 2009, Eur J Cancer 45:228-247, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.5 and Tables 1-2 define target, nontarget and overall CR and the below-10-mm nodal condition; Schwartz et al. 2016, PMC5737828, sections Lymph Nodes and Best Overall Response clarify actual short-axis recording and response synthesis. | ✓ |
| PR | Partial response | Partial response: the target-lesion sum of nonnodal longest axes plus nodal short axes decreases by at least 30% from the baseline sum, with no unequivocal nontarget progression and no new lesion. Target CR with persistent non-CR/non-PD nontarget disease yields overall PR. Under committee clarification, after PR is established a later nonprogressive assessment remains PR rather than requiring the sum to retain a 30% baseline reduction at every visit. | Return the fixed target set, baseline and current sums, percent change, nontarget state, new-lesion review and any protocol-required confirmation. PR standardizes response reporting but must not independently determine treatment duration, dose, operation or next-line therapy. | PR denotes substantial diameter reduction but is not a calibrated survival or cure estimate and does not exclude viable tumor or resistant nontarget disease. Choice of irregular targets, inconsistent technique and threshold-level measurement error can change the category. | Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.5 and Tables 1-2 define at least 30% target-sum decrease from baseline and overall synthesis; Schwartz et al. 2016, PMC5737828, Best Overall Response clarifies longitudinal response after an initial PR and confirmation requirements. | ✓ |
| SD | Stable disease | Stable disease: the target sum has insufficient shrinkage from baseline for PR and insufficient increase from the smallest on-study sum for PD, while nontarget disease has no unequivocal progression and no new lesion is present. Preserve the dual references and the minimum protocol interval; SD is not simply change below 30% from the previous scan. | Report baseline, current and nadir sums with actual change, follow-up interval, nontarget status and technical evaluability. SD can be clinically meaningful disease control but neither mandates continued therapy nor excludes the need for another disease-specific assessment. | SD combines biologically different trajectories and has no universal individual prognosis. Near-threshold error, mixed lesion behavior or non-size biological change can be obscured if only the category is returned. | Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, section 4.3.1 and Table 1 define SD as neither sufficient shrinkage for PR nor sufficient increase for PD using the appropriate baseline and smallest-sum references; Schwartz et al. 2016, PMC5737828, Best Overall Response and Target Lesions address longitudinal application and evaluability. | ✓ |
| PD | Progressive disease | Progressive disease is established by at least a 20% increase in the target sum from the smallest valid on-study sum and an absolute increase of at least 5 mm, or by one or more unequivocally new malignant lesions or substantial unequivocal progression of nontarget disease. Both target-sum thresholds are required. A new lesion need not be measurable; follow an equivocal focus and backdate PD if it is later confirmed. | Flag PD with its exact trigger, responsible lesions, comparison date and confidence for oncology or protocol review. Do not let the API autonomously stop treatment; adjudicate an equivocal new focus, technique change, healing flare or modest isolated nontarget increase before finalizing progression. | PD is a standardized progression endpoint but does not quantify survival, resistance mechanism or treatment benefit for an individual. Inflammation, treatment effect, different coverage, measurement noise and newly visible rather than truly new disease can produce false progression. | Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.4, Table 1 and Appendix II define the paired at-least-20% and at-least-5-mm target rule, unequivocal nontarget progression and new-lesion branch; Schwartz et al. 2016, PMC5737828, sections New Lesions, Non-target Lesions and Target Lesions clarify equivocal follow-up, backdating and substantial overall worsening. | ✓ |

### Citações por categoria
- **CR**: Eisenhauer EA, Therasse P, Bogaerts J, et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) (2009) — https://doi.org/10.1016/j.ejca.2008.10.026 · Eisenhauer et al. 2009, Eur J Cancer 45:228-247, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.5 and Tables 1-2 define target, nontarget and overall CR and the below-10-mm nodal condition; Schwartz et al. 2016, PMC5737828, sections Lymph Nodes and Best Overall Response clarify actual short-axis recording and response synthesis.
- **PR**: Eisenhauer EA, Therasse P, Bogaerts J, et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) (2009) — https://doi.org/10.1016/j.ejca.2008.10.026 · Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.5 and Tables 1-2 define at least 30% target-sum decrease from baseline and overall synthesis; Schwartz et al. 2016, PMC5737828, Best Overall Response clarifies longitudinal response after an initial PR and confirmation requirements.
- **SD**: Eisenhauer EA, Therasse P, Bogaerts J, et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) (2009) — https://doi.org/10.1016/j.ejca.2008.10.026 · Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, section 4.3.1 and Table 1 define SD as neither sufficient shrinkage for PR nor sufficient increase for PD using the appropriate baseline and smallest-sum references; Schwartz et al. 2016, PMC5737828, Best Overall Response and Target Lesions address longitudinal application and evaluability.
- **PD**: Eisenhauer EA, Therasse P, Bogaerts J, et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) (2009) — https://doi.org/10.1016/j.ejca.2008.10.026 · Eisenhauer et al. 2009, DOI 10.1016/j.ejca.2008.10.026, sections 4.3-4.4, Table 1 and Appendix II define the paired at-least-20% and at-least-5-mm target rule, unequivocal nontarget progression and new-lesion branch; Schwartz et al. 2016, PMC5737828, sections New Lesions, Non-target Lesions and Target Lesions clarify equivocal follow-up, backdating and substantial overall worsening.

## Histórico de versões

| Data | Evento | Detalhe | Situação |
| --- | --- | --- | --- |
| 2026-08-12 | revised | Monitored source changed (content_hash). Detected automatically; awaiting reviewer confirmation. | needs_review |
| 2026-08-07 | revised | Monitored source changed (content_hash). Detected automatically; awaiting reviewer confirmation. | needs_review |
| 2026-07-29 | revised | Monitored source changed (content_hash). Detected automatically; awaiting reviewer confirmation. | needs_review |
| 2026-07-25 | revised | Monitored source changed (content_hash). Detected automatically; awaiting reviewer confirmation. | needs_review |
| 2016-06-01 | revised | The RECIST Committee published implementation clarifications covering measurability, target follow-up, progression, new lesions and confirmation without replacing RECIST 1.1. | confirmed |
| 2009-01-01 | revised | RECIST 1.1 revised guideline published. | confirmed |


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> Conteúdo de referência reescrito. Confira a publicação primária vigente. Não é dispositivo médico nem substitui o julgamento clínico. O radiologista responsável pelo laudo permanece o autor e o responsável.

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