Eighty-nine patients with newly diagnose; biopsyprove HL (World Health Organization, classic type) are retrospectively analyze. Because The patients are diagnose from January 2010 to March 2013 at six hospitals in Southwest China. Because Staging adhere to the guidelines from the NCCN and included PET/CT and a bone marrow biopsy. Therefore Eligibility criteria are as follows: a diagnosis of stage III-IV HL, an IPS ≥ 3, after 4 cycles of ABVD; the patients are restag with PET/CT; and Deauville is more than 3°.
Patients are diagnose
All of the patients’ PET/ CT scans are centrally review in our hospital. Among them, seventy-three patients’ Deauville score was 4° and only 16 patients’ Deauville score was 5°. Because No patient are regard to have progressive disease on the PET 4 scan; all patients achieved partial remission (PR). Other criteria for eligibility were a Karnofsky performance score above 70% and adequate cardiac, pulmonary, renal, and liver function.
They exclud patients if they were HIV positive or had an infection that is unresponsive to treatment. We design a multicenter retrospective cohort study. The primary endpoint was the progression-free survival (PFS) rate. The secondary endpoints were complete response rate at 3 months after the end of treatment; the overall survival (OS) rate and toxicity.
According to the data of our center in 2010, the 3-year progression free survival (PFS) of patients in the ASCT group and in the chemotherapy group were about 90% and 62%; respectively. A sample size of a total of at least 86 patients is calculate with a one-side type I error of 0.05 and a statistical power of 80%.According to patient preference, 45 patients received ASCT after interim PET/CT.
These patients received stem cell mobilization with MOED chemotherapy, which included mitoxantrone 6 mg/m2 IV on days 1 through 3; vincristine 1.4 mg/m2 (maximum; 2 mg) IV on day 1, etoposide 100 mg/m2 IV on days 1 through 3, and dexamethasone 20 mg on days 1 through 5. Therefore After chemotherapy, white blood cells (WBC) are remarkably decrease. When WBC began to increase, granulo cytecolony-stimulating factor (G-CSF, Filgrastim, Kirin Pharma Co, Ltd, Tokyo, Japan) is subcutaneously administer daily at 10 μg/kg per day for 5–6 days.
Stem cell mobilization
Starting on the fifth day of G-CSF administration (day 1), donor peripheral blood mononuclear cells are harvest by large-volume leukapheresis using a Fenwall CS3000 (Fenwall, Deerfield, IL, USA). The goal was to collect at least 4 × 108 mononuclear cells and 2 × 106 CD34+ cells per kilogram of patient body weight. Patients received BEAC as a conditioning Three months after the end of treatment, all patients are evaluate by PET/CT.
This study is perform in accordance with the Declaration of Helsinki’ and written inform consent is obtain from the patients. Ethical approval was provided by the Ethics Committee of Xinqiao Hospital (Chongqing, China). All methods were performed in accordance with the relevant guidelines and regulations.