Phase II clinical trial of first-line combination of radiation followed by gemcitabine, dexamethasone, and cisplatin (GDP) chemotherapy for early-stage extranodal natural killer/T-cell lymphoma with unfavorable prognostic factors: The GREEN study (NCT02276248).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7540-7540
Author(s):  
Fei Qi ◽  
Wei-Hu Wang ◽  
Ye-Xiong Li ◽  
Mei Dong ◽  
Xiao-hui He ◽  
...  

7540 Background: Currently concomitant or sequential chemotherapy with radiotherapy has been recognized as the standard treatment for extranodal natural killer/T-cell lymphoma, nasal type (ENKTL). However, the optimal schedule has not been fully defined. Methods: We designed a phase II prospective study to investigate the efficacy and toxicity profile of sequential radiation followed by systemic GDP (gemcitabine, dexamethasone and cisplatin) chemotherapy on previously untreated early-staged (stage IE/IIE) ENKTL patients with at least one unfavorable prognostic factor. The primary endpoint was 2-year progression-free survival (PFS). Secondary endpoints were 2-year overall survival (OS), overall response rate (ORR), and toxicity. Results: A total of40 patients were enrolled and completed the entire course of treatment between June 2010 and June 2014. The median age was 38 (range 25-63) years old. All the enrolled patients presented with at least one unfavorable prognostic feature: age > 60 years (5.0%), B symptom (40%), elevated serum LDH (40.0%), regional lymph node involvement (32.5%) and primary tumor invasion (87.5%). At the completion of the whole treatment, ORR was 97.5% and the complete remission rate was 95.0%. Median follow-up time was 43.7 months (range 9.4-72.3 months). 2-, 3-, 5-year PFS rates were 84.7%, 82.1%, 77.5%, and OS rates were 89.9%, 87.1%, 79.7%, respectively. Recurrence within the RT field was observed in four patients and systemic failure in three individuals. Grade 1-2 skin reaction and mucositis were the main toxicity related to radiation. Grade 3-4 neutropenia (12/40), thrombocytopenia (7/40) and anemia (2/40) were observed during GDP chemotherapy. No clinically significant late toxicities were observed during follow-up visits. Conclusions: The current results indicates that first-line radiation followed by GDP chemotherapy can be one of the most effective and feasible treatment schedule for early-stage ENKTL patients, especially those with poor prognostic factors. Clinical trial information: NCT02276248.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4535-4535
Author(s):  
Jule F Vasquez ◽  
Melanie Castro ◽  
Alonso Diaz ◽  
Carlos Barrionuevo ◽  
Cesar Samanez-Figari

Abstract Background Natural killer/T-cell lymphoma (NKTCL) is an aggressive lymphoma with poor prognosis mainly seen in Asian and South American countries, most patients have nasal involvement. Non-nasal NKTCL have a dismal prognosis. However, data about this very specific population is mostly known in Asians but little known in Latin American (LATAM) population. Our aim is to describe the clinical characteristics and survival of newly diagnosed NKTCL patients in Peru Methods: This is a retrospective study, including all patients with a pathological diagnosis of NKTCL patients >13 years at the Instituto Nacional de Enfermedades Neoplasicas (INEN) and Oncosalud between 2002 and 2019. The estimate of the survival curves was performed by the Kaplan-Meier method, and the difference was computed by the log-rank test. Results: 60 patients were included for the analysis. The median age was 37 years (range 15-83). 62% were male, 51% had B-symptoms, 56% had stage III/IV disease, 54% had elevated serum LDH, 29% had nodal involvement. The most frequent non-nasal sites were oropharynx, soft tissue, cutaneous, gastrointestinal and orbit with 24%, 17%, 12%, 7% and 5%, respectively. 79% patients received systemic chemotherapy, 7% received radiotherapy alone and 14% did not received chemotherapy because poor performance status. Of patients who received chemotherapy only 20% received a L-asparaginase-based chemotherapy. The median follow-up time was 8 months (1-103). The median overall survival (OS) was 14 months (interquartile range [IQR] 4-29), 1y OS was 51% (95% CI 33-67), 3y OS 21% (95% CI 7-40), 5y OS 14% (95% CI 3-34), figure 1. The median overall survival according to LDH level was 10 months regardless of the levels (p=0.84), figure 2. The median OS for female and male were 8 and 10 months, respectively p=0.59) Conclusions: Peruvian patients with non-nasal NKTCL are younger, with presence of B-symptoms, advance stage and elevated LDH levels compared to those reported in nasal NKTCL. The most frequent non nasal NKTCL is located on the oropharynx. OS of non-nasal NKTCL is extremely poor. Elevated LDH and sex are not prognostic factors for OS. A larger cohort and follow-up are needed to evaluate prognostic factors in this population. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5086-5086
Author(s):  
Xi-Wen Bi ◽  
Wen-Wen Zhang ◽  
Jia-Jia Huang ◽  
Zhongjun Xia ◽  
Zhi-Ming Li ◽  
...  

Abstract The optimal treatment strategy and prognosis for patients with relapsed natural killer/T-cell lymphoma (NKTCL) remain largely unknown. The treatment modalities and prognosis of fifty-six patients with relapsed NKTCL were retrospectively reviewed. Twenty-three (41.1%) patients had locoregional relapse alone, while 33 (58.9%) had distant with or without locoregional relapse. Chemotherapy was the initial salvage treatment, followed by radiotherapy (RT) or autologous hematopoietic stem cell transplantation (AHSCT) as consolidative therapy, depending on the status of remission and the pattern of relapse. The 5-year overall survival (OS) after relapse was 41.4% for the entire cohort. Complete remission (CR) after salvage treatment was associated with a substantially better survival (5-year OS after relapse: 74.7 vs. 7.8%, P < 0.001). For patients with locoregional relapse alone, consolidative RT after response to salvage chemotherapy significantly improved prognosis compared with follow-up (5-year OS: 83.3 vs. 41.7%, P = 0.047). For patients with distant relapse, the addition of consolidative AHSCT after response to chemotherapy significantly prolonged survival than follow-up (2-year OS: 100.0 vs. 20.0%, P = 0.004). Patients without consolidative treatment after response to salvage chemotherapy had a comparable survival to those who experienced stable or progressive disease after chemotherapy, regardless of the relapse pattern. Asparaginase (ASP)-containing salvage chemotherapy failed to convey a survival advantage over ASP-absent chemotherapy (5-year OS: 44.2 vs. 39.3%, P = 0.369). Patients who received ASP-containing chemotherapy in the first-line treatment had a poorer response to salvage chemotherapy and worse prognosis after relapse, compared with those receiving ASP-absent first-line chemotherapy. Consolidative RT or AHSCT improved prognosis in patients with relapsed NKTCL who responded to initial salvage chemotherapy. The role of ASP in salvage chemotherapy after relapse required further exploration in prospective studies. Disclosures No relevant conflicts of interest to declare.


2017 ◽  
Vol 35 (1) ◽  
pp. 32-39 ◽  
Author(s):  
Motoko Yamaguchi ◽  
Ritsuro Suzuki ◽  
Masahiko Oguchi ◽  
Naoko Asano ◽  
Jun Amaki ◽  
...  

Purpose To elucidate the management and outcomes of patients with extranodal natural killer/T-cell lymphoma, nasal type (ENKL), who were diagnosed between 2000 and 2013 in Japan. Patients and Methods Data from 358 patients with ENKL diagnosed between 2000 and 2013 from 31 institutes were retrospectively analyzed. Results Patients’ median age was 58 years, and 257 (72%) had localized disease. The most common first-line treatment was radiotherapy with dexamethasone, etoposide, ifosfamide, and carboplatin (RT-DeVIC) (66%) for localized ENKL and L-asparaginase–containing chemotherapy (30%) for advanced ENKL. With a median follow-up of 5.8 years, overall survival (OS) rates at 5 years for localized and advanced ENKL were 68% and 24%, respectively. The prognostic index of natural killer lymphoma was validated in our study, although only 4% of patients with localized ENKL were classified as high risk. With a median follow-up of 5.6 years, OS and progression-free survival at 5 years in the 150 patients who received RT-DeVIC in clinical practice were 72% (95% CI, 63% to 78%) and 61% (95% CI, 52% to 69%), respectively. Toxicities of RT-DeVIC were comparable to those in a previous trial. Multivariate analysis in patients with localized ENKL who received RT-DeVIC identified elevated soluble interleukin-2 receptor as an independent predictive factor for worse OS and progression-free survival (adjusted hazard ratios, 2.28 and 2.46; 95% CI, 1.24 to 4.23 and 1.42 to 4.28; P = .008 and .0014, respectively). Conclusion Favorable OS in response to new treatments was demonstrated in a large number of patients. Improved treatment approaches are needed for localized ENKL exhibiting elevated pretreatment soluble interleukin-2 receptor.


2017 ◽  
Vol 8 (6) ◽  
pp. 1030-1037 ◽  
Author(s):  
Qiao-xuan Wang ◽  
Shao-hua Li ◽  
Bao-yan Ji ◽  
Han-yu Wang ◽  
Yi-yang Li ◽  
...  

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