RESUMEN
BACKGROUND: The combination of chemotherapy and L-asparaginase (L-ASP) treatment significantly increased survival rate in an adult patient with extranodal natural killer (NK)/T-cell lymphoma (NKTCL). However, hypersensitivity reactions of L-ASP in some patients limited its application. Polyethylene glycol-conjugated asparaginase (PEG-ASP) has a lower immunogenicity and longer circulating half-life than unconjugated L-ASP, and has been reported to be effective and well-tolerated in children with acute lymphoblastic leukemia. Cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisolone (CHOP) is the most common chemotherapy for non-Hodgkin lymphoma. In this report, we sought to study the efficacy and safety of PEG-L- CHOP in NKTCL in adult Chinese patients. METHODS: Our study is a prospective, multi-center, open-label clinical trial. Patients with newly diagnosed adult NKTCL and an ECOG performance status of 0 to 2 were eligible for enrollment. Treatment included six cycles of PEG-L-CHOP regimen. Radiotherapy was scheduled after 2-4 cycles of PEG-L-CHOP regimen, depending on the stage and primary anatomic site. RESULTS: We enrolled a total of 33 eligible patients. All 33 patients completed 170 cycles of chemotherapy combined with radical radiotherapy. The overall response rate was 96.9% (32/33) with 75.8% (25/33) achieving complete responses and 21.2% (7/33) achieving partial responses. The overall survival (OS) at 1, 2, 3-year were 100, 90.61 and 80.54%, respectively. The major adverse effects were bone marrow suppression, reduction of fibrinogen level, liver dysfunction, and digestive tract toxicities. No allergic reaction and no treatment-related mortality or severe complications were recorded. CONCLUSIONS: PEG-L-CHOP chemotherapy in combination radiotherapy is safe and durably effective treatment for adult extranodal NK/T-cell lymphoma with fewer allergic reactions. This study was approved by the Peking University Beijing Cancer Hospital Ethics Review Committee (reference number: 2011101104). The clinical trial registration number ChiCTR1800016940 was registered on July 07, 2018 at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/index.aspx ). The clinical trial was registered retrospectively.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Resistencia a Antineoplásicos , Linfoma Extranodal de Células NK-T/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Asparaginasa/administración & dosificación , Biomarcadores , Ciclofosfamida/efectos adversos , Ciclofosfamida/uso terapéutico , Doxorrubicina/efectos adversos , Doxorrubicina/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Linfoma Extranodal de Células NK-T/diagnóstico , Linfoma Extranodal de Células NK-T/radioterapia , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Estadificación de Neoplasias , Polietilenglicoles/administración & dosificación , Prednisona/efectos adversos , Prednisona/uso terapéutico , Resultado del Tratamiento , Vincristina/efectos adversos , Vincristina/uso terapéuticoRESUMEN
BACKGROUND: Rituximab plus CHOP (R-CHOP) significantly improved the outcome of diffuse large B cell lymphoma (DLBCL), a common sub-type of non-Hodgkin lymphoma. But 40% - 50% of DLBCL patients cannot be cured by this regimen. Some clinical trials showed that bevacizumab might be useful in the treatment of DLBCL. This study evaluated the safety and efficacy of bevacizumab combined with the R-CHOP (A-R-CHOP) regimen in Chinese patients with previously untreated DLBCL. METHODS: Patients with previously untreated DLBCL received A-R-CHOP regimen therapy. All patients with complete response (CR)/ unconfirmed complete response(CRu) after 8 cycles of A-R-CHOP received the bevacizumab maintenance therapy once every 3 weeks. The remained bulky disease was treated with radiotherapy. RESULTS: Seven Chinese patients were treated. All of them had bulky diseases. One patient had progressive disease after 4 cycles of A-R-CHOP therapy. The rest six patients completed 8 cycles of A-R-CHOP treatment. All of these six patients reached CR/CRu (5 CR, 1 CRu). Bevacizumab maintenance therapy was given to 4 CR patients. All 7 patients experienced Grade 3/4 hematologic adverse events; additionally, one had Grade 3 gastrointestinal toxicity and one had Grade 1 epistaxis. During bevacizumab maintenance therapy, one patient had Grade 1 gingival bleeding, another experienced Grade 1 proteinuria and then Grade 3 congestive heart failure 4 months after completion of maintenance therapy. At the end of July 2013, the patient who had progressive disease after 4 cycles of A-R-CHOP died of progressive disease, the other six remained CR response. CONCLUSIONS: The A-R-CHOP regimen is effective for untreated DLBCL, but may cause bevacizumab-specific toxicities, which should be monitored.
RESUMEN
Anthracycline-related cardiotoxicity is an important dose-limiting toxicity for Hodgkin lymphoma (HL) treatment. This study aimed to assess the efficacy and safety of pegylated liposomal doxorubicin (PLD) for HL treatment. Patients with newly diagnosed HL treated with at least two cycles of PLD-containing chemotherapy were retrospectively analyzed. The dosing and scheduling of the PLD-containing regimen (the PBVD regimen) were as follows: PLD 25 mg/m2, vincristine 1.4 mg/m2 (maximum dose of 2 mg), bleomycin 10 mg/m2, and dacarbazine 375 mg/m2 at days l and 15, repeated every 28 days. Forty-six HL patients were analyzed. The median age was 41.5 years (range 12-77 years), with a male/female ratio of 0.9:1. Fourteen (30%) patients had an Eastern Cooperative Oncology Group (ECOG) performance status score > 1, and 32 (70%) had a history of cardiovascular disease (CVD) or related risk factors. The median chemotherapy cycle number with the PBVD regimen was 6 (range, 2-8). The overall response rate (ORR) was 91% for the whole cohort; 35 (76%) patients achieved complete remission (CR), and 7 (15%) achieved partial remission. The efficacy of the PBVD regimen was similar in patients with or without CVD or related risk factors (ORR 93% vs. 91%, P = 1.00; CR 86% vs. 72%, P = 0.46). With a median follow-up of 28.5 months, the 3-year progression-free survival (PFS) and overall survival (OS) rates were 70% and 82%, respectively, for the whole cohort. The differences in the PFS and OS rates between the groups with or without CVD or related risk factors were not significant. Cardiotoxicity was observed in 6 (13%) patients. All adverse events were grades 1-2. The PBVD regimen is an effective chemotherapy option with tolerable toxicity, and it could be a substitute in HL patients who cannot be treated with conventional doxorubicin, especially those with CVD or related risk factors.