Table II.
Summary of GRADE findings for nitrogen mustard
| Outcomes | Estimated effect | Number of participants | Certainty of the evidence | Comments |
|---|---|---|---|---|
| Participant complete remission | 12%-82% (for all 11 studies) | 1035 (11 studies) | Low | Stage IA: 75%; Stage IB: 50%, Stage IIA: 100% (Ferreira 1990) Stage I: 59% (Foulc 2002) Stage I, IIA: 82% (Hamminga 1982) T1 disease: 65%, T2: 34% (Kim 2003∗) T1: 70%, T2: 60% (Lamberg 1986∗) Stage IA, IB, IIA: 14% for gel, 12% for ointment in ITT group (Lessin 2013) T1: 79%, T2: 51% (Lindahl 2013) Stage I: 76%, Stage II: 45% (Ramsay 1988∗) Slight repigmentation of MF lesions in 66% of patients (Stone 2001) 49% in early-stage skin-only disease (Thomsen 1979) Stage IA: 80%, Stage IB: 68%, Stage IIA: 61% (Vonderheid 1989∗) |
| Participant partial remission | 13%-45% (for 7 studies) | 633 (7 studies) | Low | Stage IA: 0%, IB: 13 %, IIA: 0% (Ferreira 1990) Stage IA/B: 23% (Foulc 2002) Stage IB, IIA: 18% (Hammiga 1982) T1 disease: 28%, T2: 38% (Kim 2003) Early-stage ITT group: gel: 45%, ointment: 36% (Lessin 2013) T1: 21%, T2: 40% (Lindahl 2013) 44% in early-stage skin-only disease (Thomsen 1979) |
| Mean reduction in lesion counts/body surface area (BSA) from baseline to assessment | Not estimable, lack of data | No studies addressed this outcome. | ||
| Investigator/physician global assessment | Not estimable, lack of data | No studies addressed this outcome. | ||
| Participants global assessment | Not estimable, lack of data | No studies addressed this outcome. | ||
| Adverse effect estimates | See comment | 834 (8 studies) | Low | Contact dermatitis (CD), hyperpigmentation (Ferreira 1990) Allergic contact dermatitis (ACD), irritant contact dermatitis (ICD), mild pruritus, pigmentation, xerosis (Foulc 2002) Hyperpigmentation, irritant dermatitis, dry skin, pruritus, urticaria, telangiectasia, ACD (Hammiga 1982) ICD or ACD, secondary cutaneous malignancies (Kim 2003) Skin irritation (18% patients using ointment, 20% using gel); pruritus (20%, 25% gel); erythema (18%, 22% gel); CD; (19% gel and ointment); (skin hyperpigmentation 9%, 7% gel); folliculitis (5%, 7% gel) (Lessin 2013) CD, secondary cutaneous malignancies (Lindahl 2013) CD (Thomsen 1979) ACD (12 patients); carcinogenicity (RR for SCC 7.8, 31 cases; RR BCC 1.8, 27 cases; colon cancer, Hodgkins disease, leukemia, stomach cancer, melanoma) (Vonderheid 1989) CD: 12.8%, pruritus: 9.7%, skin irritation 7.4%, erythema 5% (Kim 2020) |
ACD, Allergic contact dermatitis; BCC, basal cell carcinoma; CD, contact dermatitis; CR, complete remission defined as 100% clearance of disease or disappearance of all lesions; GRADE, Grading Recommendations Assessment, Development and Evaluation; ICD, irritant contact dermatitis; ITT, intention-to-treat; MF, mycosis fungoides; PR, partial remission defined as a minimum of 50% improvement and less than 100%; RR, relative risk; SCC, squamous cell carcinoma; Stage IA, limited skin involvement (T1, N0, M0, B0 or B1); Stage IB, skin-only disease (T2, N0, M0, B0 or B1); Stage IIA, T1-2, N1-2, M0, B0 or B1; T1 Stage, patch/plaque disease <10% of the skin surface; T2 Stage, patch/plaque disease 10% or more of the skin surface.
When there were multiple studies on the same cohort, only the most recent study with information on our primary outcomes was cited.