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Protocol, L-Asparaginase, Cisplatin, Dexamethasone

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Protocol, L-Asparaginase, Cisplatin, Dexamethasone www.impactjournals.com/oncotarget/ Oncotarget, 2017, Vol. 8, (No. 30), pp: 50155-50163 Clinical Research Paper A phase II prospective study of the “Sandwich” protocol, L-asparaginase, cisplatin, dexamethasone and etoposide chemotherapy combined with concurrent radiation and cisplatin, in newly diagnosed, I/II stage, nasal type, extranodal natural killer/T-cell lymphoma Ming Jiang1,*, Li Zhang1,4,*, Li Xie2,*, Hong Zhang2, Yu Jiang1, Wei-Ping Liu3, Wen- Yan Zhang3, Rong Tian5, Yao-Tiao Deng1, Sha Zhao3 and Li-Qun Zou1 1 Department of Medical Oncology, State Key Laboratory, Cancer Center, West China Hospital of Sichuan University, Chengdu, China 2 Radiation Oncology of Cancer Center, West China Hospital of Sichuan University, Chengdu, China 3 Pathology Department, West China Hospital of Sichuan University, Chengdu, China 4 Department of Oncology, Dujiangyan Medical Center, Dujiangyan, Sichuan, China 5 Department of Nuclear Medicine, West China Hospital of Sichuan University, Chengdu, China * These authors have contributed equally to this work Correspondence to: Li-qun Zou, email: [email protected] Keywords: nasal-type, extranodal NK/T cell lymphoma, L-asparaginase, cisplatin, etoposide and dexamethasone (LVDP) Received: June 19, 2016 Accepted: January 27, 2017 Published: March 17, 2017 Copyright: Jiang et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License 3.0 (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT Nasal-type, extranodal NK/T cell lymphoma (ENKTCL) is a special type of lymphomas with geographic and racial specificity. Up to now, the standard first-line treatment is still not unified. In our previous report, the “sandwich” protocol produced good results. Continuing to use the “sandwich” mode, a new chemotherapy composed of L-asparaginase, cisplatin, etoposide and dexamethasone (LVDP) plus concurrent chemoradiotherapy (CCRT) was conducted in more patients with newly diagnosed, I/ II stage ENKTCL. The results showed that 66 patients were enrolled. Overall response rate was 86.4% including 83.3% complete response and 3.0% partial remission. With the median follow-up of 23.5 months, 3-year overall survival and 3-year progression- free survival were 70.1% and 67.4%, respectively. The survival rate in stage II and extra-cavity stage I was significantly less than that in limited stage I (p < 0.05). Therefore, we thought that the “sandwich” mode was worthy of being generalized and LVDP combined with CCRT was an effective protocol for I/II stage ENKTCL. But this regimen was not suitable for all stage I/II patients and warrants larger sample and layering investigation. This study was a registered clinical trial with number ChiCTR-TNC-12002353. INTRODUCTION 11% of all lymphomas [3]. About 60-90% of ENKTCL derive from nasal cavity and its adjacent sites and up to Nasal-type, extranodal NK/T cell lymphoma 75% of patients have I/II Ann Arbor stage at the initial (ENKTCL) is a special type of non-Hodgkin’s lymphoma, diagnosis [4, 5]. However, traditional therapy based on which is rare in Europe and North America, but relatively anthracyclines achieved unsatisfied effect—5-year overall common in Asia and South America [1, 2]. In China, survival (OS) rate is less than 50% [2, 6]. Chemotherapy the incidence of ENKTCL is higher and secondary to composed of non-anthracycline drugs showed superior diffuse large B cell lymphoma, accounting for about effect [7-9], especially L-asparaginase-based regimens www.impactjournals.com/oncotarget 50155 Oncotarget which are the mainstream choice. But the optimal and the ORR was 92.4%. At the end of therapy, 55 had CR chemotherapy, the way of chemotherapy combined with (83.3%), 3 had PR (3.0%) and the ORR was 86.4%. These radiotherapy and the dose of radiation are still undefined. were shown in Figure 1. In our previous report, the “sandwich” protocol, 2 cycles of systemic chemotherapy made up of L-asparaginase, Survival vincristine and prednisone (LVP) were followed by sequential radiotherapy with 56Gy and supplemented with 2-4 cycles of LVP, achieved good improvement and mild The 66 patients were followed up until April 2015. side effects [10] indicated that the “sandwich” protocol As shown in Figure 1, 13.6% (9/66) experienced disease deserves further research in I/II stage ENKTCL patients. progression during the therapy period including 1 local In order to improve the efficacy and further study progression and 8 system failure. 13 of 55 (23.6%) on “sandwich” regimen, we designed and administrated patients with CR experienced recurrence. Among of a new chemotherapy regimen including L-asparaginase them, two patients (3.6%) experienced relapses in the (L-ASP), cisplatin, etoposide and dexamethasone (LVDP) previous radiation field, and eleven (20%) experienced combined with concurrent radiation and cisplatin. A systemic recurrence, with five in skin soft tissue (one prospective clinical study was conducted in more patients with pulmonary metastasis and one with liver and bone with newly diagnosed, I/II stage ENKTCL. The primary metastasis), two in bone marrow (one with splenic end points of this study: (1) short term efficacy (overall metastasis), one in lung, two in gastrointestinal tract response rate (ORR), complete response (CR), (2) 3-year and one in the central nervous system. Only one of progress-free survival (PFS) and OS. The secondary these thirteen patients survived at the deadline of endpoints: short term side effects. follow-up, living with stable condition after second-line chemotherapy. Eleven patients didn’t achieve CR after first-line treatment. Up to the end of follow-up, 8 of them RESULTS died (8/11, 72.7%) and 3 (3/11, 27.3%) survived. With the median follow-up of 23.5 months (range: 12 to 51 months), a total of 22 (33.3%) had disease progression Basic characteristics including 4.5% for local failure and 28.8 % for systemic failure. For patients who had disease progression, their Sixty-six ENKTCL patients with newly diagnosed, median survival was 15 months. For whole group, the stage I/II were enrolled. Basic characteristics were shown 3-year OS rate was 70.1% (Figure 2A), and the 3-year in Table 1. The median age was 41.5y (rang: 13 to 70y). PFS rate was 67.4% (Figure 2B), the median OS had not There were 44 male patients with 2.0 times as many as been reached. the female (22 cases). 14 cases (21.2%) were in limited IE stage, 29 (43.9%) in extra-cavity IE stage and 23 (34.8%) Toxicity in IIE stage. Twenty- five cases (37.9%) had B symptom. Twenty- three (34.8%) had regional lymph nodes invasion. As shown in Table 2, the most common toxicity According to the NK/T cell lymphoma international was that patients were allergic to L-ASP (45.5%). Among prognostic index (NKIPI) [11], 25 patients (37.9%) were of them, 3.0% with negative skin test underwent slight 0 score, 22 patients (33.3%) were 1 score, 16 patients allergic reaction including skin rash and itching, and (24.2%) were 2 score and 3 patients (4.5%) were 3 score. recovered soon after stopping the infusion, administrating hormone and calcium. Hematological toxicities were also Response common during chemotherapy, but most of them were mild. 11 patients (16.7%) had grade 3 or 4 leukopenia and A total of 336 cycles of chemotherapy (4.8 cycles 2 patients (3.0%) had grade 3 thrombocytopenia. Severe in average, 1-6 cycles) were administrated, pegaspargase non-hematologic toxicities included two patients (3.0%) was used in 50 cycles of them. 59 patients (89.4%) with grade 3 vomiting and one (1.5%) with pancreatitis. received 4-6 cycles of chemotherapy. 7 patients (10.6%) Toxicities were minimal during CCRT, with 4 patients had 1-3cycles of chemotherapy. Chemotherapy was (6.1%) showing grade 3 radiation-related mucositis and stopped in one patient due to the onset of pancreatitis 1 (1.5%) with grade 3 radiation-related dermatitis. There after 3 cycles. Two refused to continue chemotherapy was no treatment-related death. after 3 courses. 4 patients’ treatments, because of disease progression, were terminated, 2 of whom died soon and DISCUSSION 2 received second-line therapy. The patients completed radiotherapy according to schedule, except the two died Radiotherapy and chemotherapy are both important early. After two-cycle chemotherapy and CCRT, 51 cases for treatment of ENKTCL. Radiotherapy specialists agree had CR (77.3%), 10 had partial response (PR) (15.2%) that early or ‘up-front’ radiotherapy improves the ORR and www.impactjournals.com/oncotarget 50156 Oncotarget Table 1: Basic characteristics of the patients Characteristics Number of patients (%) Age , y (median, range, 41.5 (13-70)) <60 58 (87.9) ≥60 8 (12.1) Sex Male 44 (66.7) Female 22 (33.3) ECOG Score 0 45 (68.2) 1 20 (30.3) 2 1 (1.5) Stage Limited IE 14 (21.2) Extra-cavity IE 29 (43.9) IIE 23 (34.8) Serum LDH Normal 47 (71.2) Increase 19 (28.8) “B” symptom No 41 (62.1) Yes 25 (37.9) IPI 0 41 (62.1) 1 25 (37.9) NKIPI 0 25 (37.9) 1 22 (33.3) 2 16 (24.2) 3 3 (4.5) Regional lymph nodes metastasis No 43 (65.2) Yes 23 (34.8) Perforation No 60 (90.9) Yes 6(9.1) Platelet count Normal 51 (77.3) Decrease 4 (6.1) Increase 11 (16.7) Lymphocyte count Normal 52 (78.8) Decrease 12 (18.2) Increase 2 (3.0) CSWOG staging* I 18 (27.3) II 26 (39.4) III 22 (33.3) ECOG, Eastern Cooperative Oncology Group; LDH, Lactic dehydrogenase; IPI, International Prognostic Index; NKIPI, NK/T-cell lymphoma International Prognostic Index; *Extranodal NK/T-cell lymphoma, nasal-type new staging system by Chinese Southwest Clinical Oncology Group (CSWOG) (http://meetinglibrary.asco.org/content/128647-144 ) www.impactjournals.com/oncotarget 50157 Oncotarget Figure 1: Treatment response and prognosis in patients.
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