To the Editor:
Limited evidence on the use of biologic treatments in psoriatic patients with a history of malignancy is currently available in the literature. The recently published European guidelines recommend the use of anti-TNF, anti-IL17, and anti-23 biological drugs in this special population after discussion case-by-case with a cancer-specialist.1 Recent data show successful treatment on biologics despite concurrent or previous malignancy in psoriatic patients but to date, there are poor experiences about Guselkumab in these patients.2,3 The role of IL-23 in tumorigenesis is contradictory: high levels are correlated with poor prognosis in many human neoplasms, but in contrast, it proved effective in inhibiting cell proliferation in some cases of leukemia.4 IL-23 inhibitors have shown efficacy and safety in the treatment of psoriasis.5,6 Guselkumab was the first IL-23 subunit p19 inhibitor monoclonal antibody to be approved in the United States and Europe. In phase III pre-clinical trials (VOYAGE 1 and VOYAGE 2) two cases of prostate cancer, one case of breast cancer, and three cases of non-melanoma skin cancers (NMSC) were reported.5,6 Kamiya et al. reported successful treatment of psoriasis Vulgaris with guselkumab in a patient with non-small lung cancer.7
In our clinic, Guselkumab was prescribed to 75 psoriatic patients, all with uncontrolled psoriasis and eligible for treatment with biological therapy, seven of whom had a previous diagnosis of cancer (Table 1).
Three patients (1,4,5) had a history of previous NMSC, a category of tumors whose incidence is higher in psoriatic patients. One patient among these had a history of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) and Guselkumab was the first biological drug he received. Only patients 4 and 5 received other biological treatments before Guselkumab (Etanercept, Adalimumab, and Ustekinumab) and both have experienced the onset of BCCs since the start of biological treatment. In particular, patient 4 reports a history of multiple BCCs (the first dating back to 2000) whose frequency did not increase after the introduction of the first biological drug in 2011, despite the risk associated with the use of anti-Tumor Necrosis Factor an (anti-TNFa) drugs.4 These patients needed only surgical treatment.
Patient 7 is a biologic-naive woman reporting previous stage Ia melanoma, surgically treated, which occurred 8 years before starting Guselkumab therapy and for which regular follow-up is ongoing.
History of leiomyosarcoma of stage Ib dating back to 2000 and of stage I clear cell renal carcinoma dating back to 2014 were respectively reported by patients 2 and 3. In both cases, given the low degree of illness, only a surgical approach was necessary. Both patients are biological-naive and report a regular follow-up from the beginning of treatment.
Patient 6 experienced stage IIA ductal breast cancer, treated with surgery, radiotherapy, and hormone therapy until February 2020. A favorable opinion from the oncologist was obtained before starting treatment with Guselkumab. To date, the follow-up has been regular.
Only patient 1 reported a period of immunosuppressive agent treatment that occurred before cancer diagnosis.
All the patients have been treated with Guselkumab for at least 11 months reaching PASI>70 in 6 out of 7 cases. Only patients 4 interrupted Guselkumab after almost one year due to intolerance.
To our knowledge, this is the first case series of cancer patients receiving Guselkumab for the treatment of moderateto- severe psoriasis. All patients experienced low-grade neoplasia for which Guselkumab does not seem to raise concerns about possible cancer recurrence, showing more safety and resulting in more reliability than traditional immunosuppressive agents for this category of patients. Surely proof of concept studies is required to clearly define the safety profiles of this biological therapy in patients with a history of neoplasia.
Table 1.
Summary.
| Patient | Age | Sex | Cancer/year of diagnosis | Stage | Treatment | Follow-up | Previous immunosuppressive treatment | Previous biologic treatment | Date of first biologic therapy | Years from cancer diagnosis and Guselkumab start | Follow-up under Guselkumab | Absolute PASI at start date | Absolute PASI at 48 weeks |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 81 | F | Scc 2017 | Bcc 2017 | Ii | Surgery | Regular | Methotrexate | None | 3 | 14 months | 4 | 1 |
| 2 | 90 | M | Leiomyosarcoma 2000 | Ib | Surgery | Regular | None | None | 20 | 11 months | 3.5 | 2 | |
| 3 | 61 | M | Clear cell kidney cancer 2014 | I | Radical nefrectomy+ lymphoadenectomy | Regular | None | None | 6 | 12 months | 9.5 | 1.9 | |
| 4 | 66 | F | Multiple bccs since 2000 | Surgery | BCCs insurgent during tratment with biologics | Methotrexate | Etanercept, adalimumab | 2011 | 12 months | 9.5 | 1 | ||
| 5 | 74 | M | Bccs 2015 and 2020 | Surgery | Regular | None | Ustekinumab | 2015 | 14 months | 15 | 4 | ||
| 6 | 52 | F | Breast cancer 2014 | Iia | Wide resection+SLN+RT+ OT with tamoxiphene | Regular | None | None | 6 | 14 months | 10 | 0 | |
| 7 | 57 | F | Melanoma 2012 | Ia | Surgery | Regular | None | None | 8 | 15 months | 12,6 | 0 |
PASI: Psoriasis Area Severity Index, BCC: Basal Cell Carcinoma, SCC: Squamous Cell Carcinoma, SLN: sentinel lymphonode, RT: radiotherapy, OT: ormonetherapy.
Funding Statement
Funding: None.
References
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