PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma
PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's
 lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the
 efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with
 gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.
Eligibility criteria The eligibility criteria were pathologically confirmed, previously
 untreated or refractory/relapsed ENKTL as defined by the World Health Organization
 classification; age≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status of
 0-2; at least one measurable lesion; adequate haematologic function (haemoglobin > 9.0 g/l,
 absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic function (total serum
 bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate
 aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤
 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and
 electrocardiogram results. Prior chemotherapy and radiotherapy should have been completed >4
 weeks earlier, willingness to provide written informed consent. Stage was defined according
 to the Ann Arbor system. The Sun Yat-Sen University Cancer Centre Research Ethics Board
 approved this study before subjects were enrolled.

 Treatment PA-Gemox dosages were as follows: days 1 and 8, 30-min intravenous infusion of 1000
 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 130 mg/m2 oxaliplatin; day 1, deep
 intramuscular injection of 2500 U/m2 PEG-ASP at two different sites. The regimen was repeated
 every 3 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles
 induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD.
 Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per
 daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.
 Refractory/relapsed patients underwent at least two cycles treatments unless there was
 disease progression or unacceptable side effects, or withdrawal of patient consent.
 Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after they
 achieved CR.
Inclusion Criteria:

 1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined
 by the World Health Organization classification;

 2. age≥18 years;

 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

 4. at least one measurable lesion;

 5. adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count >
 1500/ml, platelets > 75,000/l),

 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of
 normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper
 limit of normal),

 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50
 ml/min);

 8. normal coagulation function and electrocardiogram results.

 9. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier,

 10. willingness to provide written informed consent.

 Exclusion Criteria:

 -