Lancet Haematol: Issue 3 | Set of cell lymphoma self-hematopoietic stem cell transplantation after the use of amine maintenance treatment

Patients aged 18-65 with set cell lymphoma usually receive a glycoside and lysocytopenia-based induction programmes and then undergo an autobiographic hematopoietic stem cell transplant (HSCT).
study was designed to assess whether maintenance after the use of amine in HSCT improved progress-free survival in this population.
This is an open, randomized, multi-center Phase 3 trial conducted in 49 blood and oncology departments in Italy and Portugal, recruiting patients with untreated heterocellular lymphoma (or stage II large volume tumor lesions (≥5 cm) or group B symptoms) in stage III.-IV, and requiring Cyclin D1 overexposed or chromosomal lipolosis t (11); 14)(q13; q32)。
18-59 years old require ECOG performance status 0-3 points, 60-65 years old patients require ECOG 0-2 points.
Patients who received complete or partial remission after conditioning received HSCT, hematologically recovered response patients (full or partial remission) were randomly divided into two groups, and oral amines were taken to maintain 24 courses (10 mg/day or 15 mg/day, with 21 days, 28 days/course of treatment), or simply observed for 24 months.
end point is progress-free survival.
May 4, 2010 - August 24, 2015, 303 patients were screened and 300 patients (the middle age was 57 years old and 78% male).
95 patients were excluded from random groupings due to disease progression, adverse events and inadequate rehabilitation.
104 patients were assertic to the innadamine maintenance group and 101 to the observation group.
11 (11%) patients in the amine maintenance group were excluded from the analysis for various reasons.
followed for 38 months (IQR 24-50) after random grouping, and the three-year progress-free survival rate of the amine group was 80% (95% CI 70-87), The observation group was 64% (53-73) (p-0.012; risk ratio 0.51,95% CI 0.30-0.87).
41 (39%) of the 104 patients in the amine group stopped using the amine for reasons such as death or progress.
2 out of 93 patients in the amine group (2%) had treatment-related deaths (1 case of pneumonia, 1 case of thrombocyte reduction cyanosis), and 1 out of 101 patients in the observation group (1%) died (pneumonia).
59 (63%) of the 93 patients in the amine group had a level 3-4 hematological adverse event, and 12 of the 101 patients in the observation group (12%) had a level 3-4 hematological adverse event (P-lt;0.0001), both groups There were also 29 cases (31%) and 8 cases (8%) of non-hematological adverse events in grades 3 to 4 (p-lt;0.0001), respectively, and the rates of serious adverse events were 24% (22/93) and 5/101 (5%), respectively.
and other infections are the most common serious adverse events.
addition, despite the toxicity that can not be ignored, the maintenance therapy used for amine maintenance after the transplantation of hematopoietic stem cells can improve the progression-free survival rate of patients with heterocellular lymphoma, emphasizing the important role of maintenance therapy in heterocytic lymphoma.