Table III.
Summary of GRADE findings for retinoids
| Outcomes | Estimated effect | Number of participants | Certainty of the evidence | Comments |
|---|---|---|---|---|
| Participant complete remission | 10%-60% | 127 (3 studies) | Low | Stage IA, IB, IIA, IIB: 21% (Breneman 2002) Stage IA, IB, IIA, IIB: 10% (Heald 2003) Stage IA, IB, IIA: 60% (Besner-Morin 2016) |
| Participant partial clearance/remission | 0-44% | 127 (3 studies) | Low | Stage IA, IB, IIA, IIB: 42% (Breneman 2002) Stage IA, IB, IIA, IIB: 44% (Heald 2003) Stage IA-IIA: 0% (Besner-Morin 2016) |
| Mean reduction in lesion counts/body surface area (BSA) from baseline to assessment | See comments | 69 (2 studies) | Low | BSA involvement mean change −22%; lesional area mean change −37% (Apisarnthanarax 2004) BSA involvement median change −4.5% at week 44 (Heald 2003) |
| Investigator/physician global assessment | See comments | 117 (2 studies) | Low | Stage IA, IB, IIA: CR 21%, Stage IA, IB, IIA: PR 42% (Breneman 2002) Stage IA, IB, IIA, IIB: CR 2%, Stage IA, IB, IIA, IIB: PR 42% (Heald 2003) Stage IA, IB, IIA: CR 60%, Stage IA, IB, IIA: PR 0% (Besner-Morin 2016) |
| Participants global assessment | Not estimable, lack of data. | No studies addressed this outcome. | ||
| Quality of life | >75% moderately or much improved by week 16 | 50 (1 study) | Low | Patients were asked to compare their general CTCL status on a 5-point scale: much, moderately worse, about the same, moderately, much better and at baseline and every 4 weeks until week 44 using the Spitzer questionnaire and CTCL-specific questionnaire (Heald 2003) |
| Adverse effect estimates | See comments | 146 (4 studies) | Low | Rash: 73%, pruritus: 33%, pain: 24%, headache: 6%, vesiculobullous rash: 6% (Breneman 2002) 94% of patients experienced at least 1 treatment-related adverse event including irritant dermatitis; low CD4 counts; high glucose; granulocytopenia (Heald 2003) Skin irritation; erythema, burning, peeling: 84%, fissuring of palms and soles: 11%, transient nausea: 5%, allergic dermatitis: 5% (Apisarnthanarax 2004) Mild treatment-related side effects: pruritus, burning, erythema, desquamation in 70% (Besner-Morin 2016) |
BSA, Body surface area; GRADE, Grading Recommendations Assessment, Development and Evaluation; CTCL, cutaneous T-cell lymphoma.