Christoph Blazejak, Rene Stranzenbach, Janika Gosman, Thilo Gambichler, Ulrike Wehkamp, Sarja Stendel, Claus-Detlev Klemke, Marion Wobser, Joanna Olk, Jan P Nicolay, Maria Weyermann, Rudolf Stadler, Chalid Assaf
{"title":"低剂量吉西他滨治疗晚期皮肤淋巴瘤的临床结果:来自德国皮肤淋巴瘤网络的真实数据","authors":"Christoph Blazejak, Rene Stranzenbach, Janika Gosman, Thilo Gambichler, Ulrike Wehkamp, Sarja Stendel, Claus-Detlev Klemke, Marion Wobser, Joanna Olk, Jan P Nicolay, Maria Weyermann, Rudolf Stadler, Chalid Assaf","doi":"10.1159/000517830","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Material and methods: </strong>A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m2 per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m2 per cycle (1,200 mg/m2 day 1, 8, 15). Evaluation of response to therapy and AE was done 4-6 weeks after the sixth cycle.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":144585,"journal":{"name":"Dermatology (Basel, Switzerland)","volume":" ","pages":"498-506"},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"7","resultStr":"{\"title\":\"Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network.\",\"authors\":\"Christoph Blazejak, Rene Stranzenbach, Janika Gosman, Thilo Gambichler, Ulrike Wehkamp, Sarja Stendel, Claus-Detlev Klemke, Marion Wobser, Joanna Olk, Jan P Nicolay, Maria Weyermann, Rudolf Stadler, Chalid Assaf\",\"doi\":\"10.1159/000517830\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Material and methods: </strong>A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m2 per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m2 per cycle (1,200 mg/m2 day 1, 8, 15). Evaluation of response to therapy and AE was done 4-6 weeks after the sixth cycle.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":144585,\"journal\":{\"name\":\"Dermatology (Basel, Switzerland)\",\"volume\":\" \",\"pages\":\"498-506\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"7\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology (Basel, Switzerland)\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000517830\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/9/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology (Basel, Switzerland)","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000517830","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/9/2 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network.
Background: 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.
Objectives: 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.
Material and methods: A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m2 per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m2 per cycle (1,200 mg/m2 day 1, 8, 15). Evaluation of response to therapy and AE was done 4-6 weeks after the sixth cycle.
Results: 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.
Conclusions: 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.