scholarly journals The mTORC1 inhibitor everolimus has antitumor activity in vitro and produces tumor responses in patients with relapsed T-cell lymphoma

Blood ◽  
2015 ◽  
Vol 126 (3) ◽  
pp. 328-335 ◽  
Author(s):  
Thomas E. Witzig ◽  
Craig Reeder ◽  
Jing Jing Han ◽  
Betsy LaPlant ◽  
Mary Stenson ◽  
...  
Keyword(s):  
T Cell ◽  
Antitumor Activity ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Mtor Pathway ◽  
T Cell Lymphoma ◽  
Overall Response ◽  
Key Points

Key Points The mTOR pathway is constitutively activated in the TCL cells and is responsible for TCL proliferation. This is first trial to demonstrate that mTORC1 inhibitors (everolimus) have substantial antitumor activity (44% overall response rate) in patients with relapsed TCL.

Low Absolute Lymphocyte Count Predicts Chemotherapy Response and Survival In Peripheral T-Cell Lymphoma, NOS

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3135-3135
Author(s):  
Yu Ri Kim ◽  
yun Deok Kim ◽  
Jin Seok Kim ◽  
June-Won Cheong ◽  
soo Jeong Kim ◽  
...  
Keyword(s):  
T Cell ◽  
Prognostic Factor ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Prognostic Index ◽  
Independent Prognostic Factor ◽  
T Cell Lymphoma ◽  
Peripheral T Cell Lymphoma ◽  
Overall Response

Abstract Abstract 3135 Peripheral T cell lymphoma, not otherwise specified (PTCL, NOS) is heterogenous groups of aggressive T-cell lymphoma and treatment outcome is dismal. Lymphopenia is an independent prognostic factor for survival for B-cell lymphoma. The ALC at diagnosis on survival in T-cell lymphoma has not been studied. Thus, we studied the role of ALC at diagnosis on clinical outcome in patients with PTCL, NOS. Between 2001 and 2009, 32 patients with PTCL, NOS reviewed for the study. Median patient age was 57 (range 34–78) years. Median ALC at the time of diagnosis was 1.54 (range 0.41–12.64×109/L). Patients were divided two groups according to ALC count 1.0 ×109/L. Ten patients (31%) had lower ALC at diagnosis. Median follow up duration was 299 days (range 11–2164 days). Overall response rate was 61.5% (16 of 26 patients) and complete response (CR) rate was 42% (11 of 26 patients). Only two patients reached CR in low ALC group.There was no significant difference in overall response rate because of small number of patients. Superior overall survival was observed with an ALC 1.0 × 109/L (N = 22) versus an ALC < 1.0 × 109/L (N=10) (median OS: not reached vs 242 days, OS rates at 5 years, 57% vs 0%, p =0.016, respectively). Multivariate analysis demonstrated ALC to be an independent prognostic indicator for OS (Hazard Ratio 3.5, 95% confidence intervals 1.2–10.2; p<0.019) when compared to the International prognostic index (IPI) and Prognostic Index for PTCLU (PIT). This study suggested that low ALC is an independent prognostic factor for survival in patients with PTCL, NOS. Disclosures: No relevant conflicts of interest to declare.

Update of the NCI multiinstitutional phase II trial of romidepsin, FK228, for patients with cutaneous or peripheral T-cell lymphoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8027-8027 ◽  
Author(s):  
R. Piekarz ◽  
R. Frye ◽  
J. Wright ◽  
W. Figg ◽  
S. Allen ◽  
...  
Keyword(s):  
T Cell ◽  
Histone Deacetylase Inhibitors ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
T Cell Lymphoma ◽  
Cell Transplant ◽  
Overall Response ◽  
Prior Therapy

8027 Background: The histone deacetylase inhibitors (HDIs) are a class of differentiating agents undergoing clinical testing. Like other HDIs, romidepsin (FK228) modulates expression of genes involved in cell cycle regulation and markers of differentiation in cancer cell lines, leading to induction of differentiation or apoptosis. Romidepsin has demonstrated clinical activity in patients with T-cell lymphoma. Methods: Patients with CTCL (42) or PTCL (36) were enrolled in the NCI multi-institutional trial and assigned to cohorts based on extent of prior therapy and pathology. Romidepsin is administered on days 1, 8, and 15 of a 28 d cycle with a starting dose of 14mg/m2. Responses for patients with PTCL are measured using Cheson criteria, and CTCL using RECIST criteria. Results: Cohort one, composed of 27 patients who had previously received no more than 2 prior cytotoxic regimens of chemotherapy, has completed enrollment. Responses observed include 3 patients with CR and 7 patients with partial responses, yielding an overall response rate of 37%. Of note, responses were observed independent of stage of disease. Among 18 patients with stage IV disease, 6 patients had a complete or partial response, including 3 patients with Sézary syndrome. When including patients with greater than 2 prior cytotoxic regimens, the overall response rate was 31%. A replicate arm has been opened with the goal of confirming the response rate observed in the first cohort. Response data have not been evaluated from this arm at this time. Responses observed in 36 patients with refractory or relapsed PTCL includes 3 patients with CR and 8 patients with partial responses, comprising an overall response rate of 30%. Responses were observed independent of prior therapy, with some patients having undergone prior stem-cell transplant. Molecular endpoint analysis was performed on peripheral mononuclear cells (PBMNCs) and tumor biopsies from treated patients evaluating histone acetylation and changes in gene expression. Conclusions: Romidepsin as a single agent appears to have significant single agent activity in patients with CTCL and PTCL. Combination therapy with romidepsin may increase efficacy and should be pursued. This protocol remains open to accrual. No significant financial relationships to disclose.

scholarly journals A phase 1 study of romidepsin and pralatrexate reveals marked activity in relapsed and refractory T-cell lymphoma

Blood ◽  
2018 ◽  
Vol 131 (4) ◽  
pp. 397-407 ◽  
Author(s):  
Jennifer E. Amengual ◽  
Renee Lichtenstein ◽  
Jennifer Lue ◽  
Ahmed Sawas ◽  
Changchun Deng ◽  
...  
Keyword(s):  
T Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Phase 1 ◽  
T Cell Lymphoma ◽  
Phase 1 Study ◽  
Key Points ◽  
Marked Activity ◽  
Refractory Lymphoma

Key Points The combination of romidepsin and pralatrexate is safe and well tolerated in patients with relapsed/refractory lymphoma. The combination led to an overall response rate of 71% (10/14, with 4/14 complete responses) in patients with relapsed/refractory T-cell lymphoma.

scholarly journals Efficacy and Survival in Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized, Controlled, Multicenter and Open-Labled Study with Ddgp Regimen Versus SMILE Regimen

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 463-463 ◽  
Author(s):  
Xinhua Wang ◽  
Lei Zhang ◽  
Xiangli Liu ◽  
Xin Li ◽  
Ling Li ◽  
...  
Keyword(s):  
Overall Survival ◽  
T Cell ◽  
Overall Response Rate ◽  
Randomized Clinical Trials ◽  
Response Rate ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
Overall Response

Background Extranodal NK/T cell lymphoma (ENKTL) is rare in western countries but rather common in Asia and South America, characterized with Epstein-Barr virus (EBV) infection. Patients with advanced stage (III/IV) ENKTL has a poor survival and low response to conventional CHOP-like chemotherapy, with a 5-year overall survival rate of only 30%. Retrospective study showed that SMILE regimen had a certain effect on ENKTL, but the toxicity limited its further clinical application. More effective treatment regimens are required to be explored for systematic, prospective, controlled, randomized clinical trials. Recently, studies revealed that asparaginase-based combination chemotherapy such as P-Gmox(Pegaspargase, Gemcitabine, Oxaliplatin)is effective in patients of ENKTL. However standard treatment for newly untreated advanced ENKTL is still controversial. We developed a refined chemotherapeutic DDGP (dexamethasone, cisplatin, gemcitabline, and peg-asparaginase) regimen and proceeded a prospective randomized, multicenter and open-label clinical trial to evaluate and compare the efficacy and safety of DDGP with SMILE regimen in patients with newly diagnosed stage III/IV ENKTL in January 2011. Based on the encouraging interim results in 2016(Li, L et al.Clin Cancer Res, 2016), we presented the final results of this clinical investigation (ClinicalTrials.gov, No. NCT01501149). Patients and methods: The study was initiated at 9 centers in China in January 2011. Patients aged 14-70 with newly diagnosed ENKTL in stages III/IV, and ECOG performance score of 0-2 were enrolled. According to a computer-generated randomization schedule, eligible patients were assigned either DDGP regimen (cisplatin 20 mg/m² on day 1-4; dexamethasone 15mg/m2 on d1-5; gemcitabine 800mg/m2 on d1,8; pegaspargase 2500 IU/m2 on d1; 21 days per cycle)or SMILE regimen (methotrexate 2g/m2 on d1; dexamethasone 40mg/m2 on d2-4; ifosfamide 1500mg/m2 on d2-4; L-asparaginase 6000 U/m2 on d3-9; etoposide 100 mg/m2 on d2-4; 21 days per cycle) for up to 6 cycles unless disease progression, unacceptable toxicity or patient rejection. Efficacy was evaluated every two cycles. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall response rate (ORR) and overall survival (OS). In addition we compared the safety and tolerability between DDGP and SMILE regimens. The Kaplan-Merier method was used to evaluate for survival of freedom from events, and the log-rank test was used to evaluate differences among two groups. Results: A total of 87 eligible newly diagnosed advanced ENKTL patients were randomly assigned for the study and 80 patients were included into intention-to-treat population (40 patients in DDGP group and 40 patients in SMILE group). Data were collected from January 2011 to February 2019. Baseline characteristics of the two group patients were well balanced. At median follow-up of 41.5 months, the median PFS and OS in the SMILE group were 6.83 months and 75.2 months, respectively, while the median PFS and OS in the DDGP group have not been reached (Fig 1). The 3-year PFS rate and 5-year OS rate in DDGP group were higher than in SMILE group (56.6% vs. 41.8% for 3-year PFS, P=0.004; 74.3% vs. 51.7% for 5-year OS, P=0.02). No difference of the complete remission (CR) rate was observed between two groups, while overall response rate (ORR) in DDGP group was higher than in SMILE group (90.0% vs. 60.0%, p=0.002) (Table 1). More frequently 3/4 grade hematologic toxicities such as leucopenia and netropenia were observed in SMILE group than in DDGP group (p=0.022, p=0.015). Non-hematologic toxicities included elevated transaminase, mucositis and allergy were higher in SMILE group than in DDGP group(p=0.027, p&lt;0.001, p=0.024). Pancreatitis occurred in 2 patients in SMILE group, but not in DDGP group (Table 2). In addition, treatment-related deaths rate was up to 17.5% in SMILE regimen which was mainly caused by infection and hemorrhage due to bone marrow suppression. Such event was only 10% in DDGP regimen. Conclusion: DDGP regimen produced prolonged survival, better tolerability and safety than SMILE regimen in newly diagnosed advanced ENKTL. Disclosures No relevant conflicts of interest to declare.

scholarly journals Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

2019 ◽  
Vol 37 (8) ◽  
pp. 613-623 ◽  
Author(s):  
Owen A. O’Connor ◽  
Muhit Özcan ◽  
Eric D. Jacobsen ◽  
Josep M. Roncero ◽  
Judith Trotman ◽  
...  
Keyword(s):  
T Cell ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
T Cell Lymphoma ◽  
Phase Iii ◽  
Lower Percentage ◽  
Peripheral T Cell Lymphoma ◽  
Overall Response

PURPOSE The aim of this open-label, first-in-setting, randomized phase III trial was to evaluate the efficacy of alisertib, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). PATIENTS AND METHODS Adult patients with relapsed/refractory PTCL—one or more prior therapy—were randomly assigned 1:1 to receive oral alisertib 50 mg two times per day (days 1 to 7; 21-day cycle) or investigator-selected single-agent comparator, including intravenous pralatrexate 30 mg/m2 (once per week for 6 weeks; 7-week cycle), or intravenous gemcitabine 1,000 mg/m2 or intravenous romidepsin 14 mg/m2 (days 1, 8, and 15; 28-day cycle). Tumor tissue (disease subtype) and imaging were assessed by independent central review. Primary outcomes were overall response rate and progression-free survival (PFS). Two interim analyses and one final analysis were planned. RESULTS Between May 2012 and October 2014, 271 patients were randomly assigned (alisertib, n = 138; comparator, n = 133). Enrollment was stopped early on the recommendation of the independent data monitoring committee as a result of the low probability of alisertib achieving PFS superiority with full enrollment. Centrally assessed overall response rate was 33% for alisertib and 45% for the comparator arm (odds ratio, 0.60; 95% CI, 0.33 to 1.08). Median PFS was 115 days for alisertib and 104 days for the comparator arm (hazard ratio, 0.87; 95% CI, 0.637 to 1.178). The most common adverse events were anemia (53% of alisertib-treated patients v 34% of comparator-treated patients) and neutropenia (47% v 31%, respectively). A lower percentage of patients who received alisertib (9%) compared with the comparator (14%) experienced events that led to study drug discontinuation. Of 26 on-study deaths, five were considered treatment related (alisertib, n = 3 of 11; comparator, n = 2 of 15). Two-year overall survival was 35% for each arm. CONCLUSION In patients with relapsed/refractory PTCL, alisertib was not statistically significantly superior to the comparator arm.

scholarly journals Belinostat Induces High Overall Response Rate (ORR) in Patients with Relapsed or Refractory Angioimmunoblastic T-Cell Lymphoma (AITL)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4050-4050
Author(s):  
Ahmed Sawas ◽  
Helen Ma ◽  
Andrei Shustov ◽  
Pamela Hsu ◽  
Gajanan Bhat ◽  
...  
Keyword(s):  
T Cell ◽  
Board Of Directors ◽  
Research Funding ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Single Agent ◽  
T Cell Lymphoma ◽  
Advisory Committees ◽  
Overall Response

Background: Angioimmunoblastic T-cell lymphoma (AITL) is a relatively common subtype of peripheral T-cell lymphoma (PTCL) that typically presents with lymphadenopathy, extranodal disease, including rash, and is associated with frequent infections due to immune dysregulation. Patients with AITL generally have a poor prognosis, even with aggressive chemotherapy as responses to standard chemotherapy are often suboptimal. Recent advances in cancer biology suggest that AITL is derived from T-follicular helper cells and is often characterized by gross epigenetic dysregulation. Histone deacetylase (HDAC) inhibitors have demonstrated significant activity in T-cell neoplasms. The BELIEF trial established an overall response rate of 25% in patients with relapsed/refractory PTCL who were treated with belinostat, with a duration of response of about 1 year, leading to accelerated approval. Herein, we present a subset analysis of the data for patients with AITL. Methods: Patients with histologically confirmed PTCL (N = 129) who experienced failure with or refractory to ≥ 1 prior systemic therapy received belinostat 1,000 mg/m(2) as daily 30-minute infusions on days 1 to 5 every 21 days. Central assessment of response used International Working Group criteria. Primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DoR) and progression-free and overall survival (PFS). Results: Of 129 patients, 22 patients had AITL; most had advanced disease (91% stage III/IV; 36% with bone marrow involvement). The median number of prior therapies was 2 (range, 1-5), and 3 (14%) patients were refractory to their last line of therapy. The ORR for patients with AITL was 46% (10/22; 95%CI: 24 - 68%), with a complete response (CR) in 4 of 22 patients (18%). Of the ten responders, the median time to response of 11.3 weeks (range, 4.7 - 24.4 weeks) in the AITL subgroup. After a median follow up of 21.5 months, the median PFS was 4.2 months (95%CI: 1.5 -13.9) and the median DOR was 13.6 months (95%CI: 1.4 - 29.4) as shown in Figure 1. For all patients with AITL treated with belinostat, the median OS was 9.2 months (95%CI: 6.8 - 21.5). The most common grade 3 to 4 adverse events were asthenia (n=2), fatigue (n=2), anemia (n=2), thrombocytopenia (n=2), neutropenia (n=2), and septic shock (n=2). Conclusions: Single-agent belinostat induced rapid and durable responses in patients with relapsed/refractory AITL. At the end of the study, there were 37% patients with ongoing responses at 2 years. Patients with clinical benefit from belinostat continued treatment until progression of disease. These results support the use of belinostat in relapsed/refractory AITL as a single agent and provide rationale for combination therapies in clinical trials. Disclosures Sawas: Seattle Genetics, Gilead, Daiichi Sanko: Consultancy; Affimed: Research Funding. Shustov:Spectrum Pharmaceuticals: Consultancy, Research Funding. Hsu:Spectrum Pharmaceuticals: Employment. Bhat:Spectrum Pharmaceuticals: Employment. Acosta:Acrotech Biopharma: Employment. Horwitz:Astex: Consultancy; Kyowa Hakko Kirin: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Kyowa Hakko Kirin: Consultancy; Trillium: Research Funding; Affimed: Consultancy; ADCT Therapeutics: Research Funding; Kura: Consultancy; ADCT Therapeutics: Research Funding; Aileron: Research Funding; Seattle Genetics: Consultancy, Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Trillium: Research Funding; Aileron: Research Funding; Trillium: Research Funding; Miragen: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Kura: Consultancy; Forty-Seven: Research Funding; Millennium/Takeda: Consultancy, Research Funding; ADCT Therapeutics: Research Funding; Mundipharma: Consultancy; Kura: Consultancy; Miragen: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundipharma: Consultancy; Astex: Consultancy; Seattle Genetics: Consultancy, Research Funding; Astex: Consultancy; Portola: Consultancy; Celgene: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Aileron: Research Funding; Trillium: Research Funding; Forty-Seven: Research Funding; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Miragen: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Mundipharma: Consultancy; Portola: Consultancy; Mundipharma: Consultancy; Portola: Consultancy; Aileron: Research Funding; Forty-Seven: Research Funding; Kura: Consultancy; Kyowa Hakko Kirin: Consultancy; Seattle Genetics: Consultancy, Research Funding; Portola: Consultancy; ADCT Therapeutics: Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astex: Consultancy; Innate Pharma: Consultancy; Kyowa Hakko Kirin: Consultancy; Miragen: Consultancy; Affimed: Consultancy; Affimed: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Innate Pharma: Consultancy; Seattle Genetics: Consultancy, Research Funding; Forty-Seven: Research Funding; Affimed: Consultancy; Millennium/Takeda: Consultancy, Research Funding. O'Connor:Mundipharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; ADCT Therapeutics, Affimed, Agensys, Merck, Seattle Genetics, Spectrum, Trillium, and Verastem Oncology.: Research Funding; TG Therapeutics: Other: Travel Support, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

scholarly journals Gemcitabine, Navelbine, and Doxorubicin as Treatment for Patients with Refractory or Relapsed T-Cell Lymphoma

2015 ◽  
Vol 2015 ◽  
pp. 1-7
Author(s):  
Zhengzi Qian ◽  
Zheng Song ◽  
Huilai Zhang ◽  
Xianhuo Wang ◽  
Jing Zhao ◽  
...  
Keyword(s):  
T Cell ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Treatment Protocol ◽  
T Cell Lymphoma ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

T-cell lymphoma (TCL) is resistant to conventional chemotherapy. We retrospectively evaluated the therapeutic efficiency and toxicity of gemcitabine, navelbine, and doxorubicin (GND) in patients with refractory or relapsed TCL. From 2002 to 2012, 69 patients with refractory or relapsed TCL received GND treatment in our hospital. The treatment protocol comprised gemcitabine (800 mg/m2, group 1; 1000 mg/m2, group 2) on days 1 and 8, navelbine (25 mg/m2) on day 1, and doxorubicin (20 mg/m2) on day 1, repeated every 3 weeks. The overall response rate (ORR) was 65.2%. The median overall survival (OS) was 36 months. The 5-year estimated OS rate was 32.4%. The GND regimen was well tolerated. Subgroup analysis demonstrated that the ORR and CR for group 1 were similar. A longer median OS was observed for group 1. Significant difference in grades 3-4 toxicities was observed between groups 1 and 2 (P=0.035). Our study indicated that gemcitabine (800 mg/m2) on days 1 and 8 every 21 days was favorable for pretreated TCL patients.

Interferon Alpha-2B (IFN-a) Is an Effective Agent for the Treatment of Primary Cutaneous T- and B-Cell Lymphoma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2643-2643
Author(s):  
Marina P. Siakantaris ◽  
Marie-Christine Kyrtsonis ◽  
Tatiana Tzenou ◽  
Evangelia M. Dimitriadou ◽  
Maria N. Dimopoulou ◽  
...  
Keyword(s):  
T Cell ◽  
Side Effects ◽  
B Cell ◽  
Median Time ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Low Grade ◽  
Overall Response

Abstract Primary cutaneous lymphoma comprise a wide range of rare diseases of which the commonest T- cell subtypes include mycosis fungoides (MF), Sezary syndrome (SS) and peripheral T-cell lymphoma (PTCL) while follicle center cell lymphoma (FCL), diffuse large B-cell lymphoma (DLBL) and extranodal marginal zone B-cell lymphoma (MZL) represent the B-cell subtypes. The behavior of these diseases is different from nodal NHL and it has been shown that IFN-a can produce long-lasting remissions in early stages MF. On the contrary, there are no reports on the efficacy of IFN- a for primary cutaneous B-cell lymphomas (CBCL). The purpose of this study was to present our experience on IFN -a treatment for patients with both primary T-cell and B-cell cutaneous NHL. Forty-one patients, 25 with primary cutaneous T-cell NHL (CTCL) (16 MF, 4 SS, 5 PTCL) and 16 with CBCL (4 MZL, 3 FCL, 8 DLBL, 1 lymphoblastic NHL) were included in this study. Of the 25 CTCL patients, 20 were males (median age 48y); 16 received IFN-a as first line treatment, 5 after PUVA and 4 after failure of other treatment modalities. Of the 16 CBCL patients, 8 were males (median age 57y); 14 received IFN-a frontline and 2 after treatment failure. Three to 5 MU IFN-a were administered subcutaneously daily with paracetamol prophylactically 1 hour before injection and two hours after. 17 out of 24 CTCL patients responded (overall response rate 71%, 42% CR and 29% PR) (12/16 MF, 1/4 SS and 3/5 PTCL). Median time to response was 4 months (1–17). Median duration of response was 15 months (8–38). 11 patients relapsed, 1 responder rapidly discontinued treatment because of side effects (cataract), the others are still under treatment with IFN-a. Among patients with CBCL 12/14 responded (overall response rate 86%, 64% CR and 22% PR). Median time to response was 2 months (1–4) and median response duration 23 months (13–30); 4 patients relapsed, 1 discontinued treatment because of side effects (depression), another continued with Peg- IFN because of chronic fatigue and the others are still under IFN-a treatment. With respect to histologic subtype, all 4 MZL patients responded; 2/3 FCL and 4/8 DLBL also responded. Flu-like syndrome was observed in the majority of patients at treatment initiation and 60% of patients presented mild leukopenia. In conclusion IFN-a is an effective treatment in primary cutaneous NHL and is usually well tolerated. As already reported response rate is satisfactory in MF. The high response rate observed in CBCL, especially in low-grade subtypes, but also in half of DLBL patients has not been reported previously.

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