Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network

Abstract

<b><i>Background:</i></b> Gemcitabine is an effective single-agent chemotherapy used in advanced stages of cutaneous T-cell lymphoma (CTCL). However, gemcitabine used in the current standard regimen is frequently associated with adverse events (AE), such as an increased risk for myelosuppression and severe infections. <b><i>Objectives:</i></b> We investigated in this retrospective study the effect of low-dose gemcitabine in pretreated advanced-stage CTCL and in blastic plasmacytoid dendritic cell neoplasia (BPDCN) regarding overall response (OR), progression-free survival (PFS), and AE. <b><i>Material and Methods:</i></b> A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m<sup>2</sup> per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m<sup>2</sup> per cycle (1,200 mg/m<sup>2</sup> day 1, 8, 15). Evaluation of response to therapy and AE was done 4–6 weeks after the sixth cycle. <b><i>Results:</i></b> OR was 62% with 11% demonstrating a complete response. The median time of PFS was 12 months and median time to next treatment was 7 months. Only 3/63 patients showed serious side effects, e.g., port infection or acute renal failure. Almost 73% of the patients experienced minor to moderate side effects (CTCAE grade 0–2). Fatigue (27.2%), fever (22.7%), and mild blood count alteration (18.2%) were the most common AE. <b><i>Conclusions:</i></b> This retrospective analysis supports the use of low-dose gemcitabine therapy in CTCL, demonstrating with 62% OR and PFS of 12 months an almost identical response rate and survival as compared to the standard dose therapy reported in previous studies but with a significantly improved safety profile and tolerability.

Kutane T-Zell Lymphome: Low-dose Gemcitabin in der Therapie fortgeschrittener CTCL

“…Die niedrigste erforderliche und wirksame Dosierung der Gemcitabin-Chemotherapie ist jedoch noch nicht ausreichend für CTCL-Patienten untersucht. Daher untersuchten wir in einer retrospektiven Analyse des deutschen Netzwerkes kutaner Lymphome, ob mit einer niedrigeren Gemcitabin-Dosis ein gleich gutes Ansprechen in Bezug auf progressionsfreies Überleben (PFS) und Zeit bis zur nächsten Behandlung («time-to-next-treatment»: TTNT) bei weniger Nebenwirkungen erreicht werden kann [5, 6].…”

Current treatment strategies and emerging therapies for cutaneous lymphoma

“…on days 1, 8, and 15 of a 28‐day cycle. Recently, a German group has reported their multicenter retrospective study of 64 patients with stage IIB or higher CTCL or blastic plasmacytoid dendritic neoplasm 63 . In this study, 37 patients with MF were enrolled.…”

“…Recently, a German group has reported their multicenter retrospective study of 64 patients with stage IIB or higher CTCL or blastic plasmacytoid dendritic neoplasm. 63 In this study, 37 patients with MF were enrolled. ORR was 69.4% (25/36 evaluable patients) and median PFS was 13 months.…”

“…Grade 3 and 4 AE with low-dose gemcitabine occurred in 17.5-39.4% and 6.4-9.5% of patients, respectively. 63 Low-dose gemcitabine can be used in outpatient clinics and it is tolerable with reasonable therapeutic effects.…”