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Background and Objective: The efficacy of standard chemotherapy regimen on aggressive non-Hodgkin's lymphoma (NHL) of certain pathologic types is unsatisfied. This study was to evaluate the safety and efficacy of modified Hyper-CVAD regimen on Chinese patients with aggressive NHL., Methods: Clinical records of 31 NHL patients who received modified Hyper-CVAD regimen in Cancer Hospital of Chinese Academy of Medical Sciences from June 2004 to June 2008 were analyzed in terms of toxicity and response., Results: The 31 patients totally received 91 cycles of regimen A and 41 cycles of regimen B with a median of 4 cycles (ranged 1-7 cycles). The major toxicity was myelosuppresion: the occurrence rates of neutropenia of grades III-IV, thrombocytopenia and febrile neutropenia were 49.5%, 3.3% and 12.1% during treatment of regimen A, and were 80.5%, 82.9% and 46.3% during treatment of regimen B. No treatment-related death was observed. The responses were assessable in 26 patients. The total response rate was 80.8%, and 12 patients achieved complete response (46.2%)., Conclusion: Modified Hyper-CVAD regimen is a promising regimen for the patients with intermediate and high grade NHL.

Background & Objective: Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is effective in the prophylaxis and management of chemotherapy-induced neutropenia, but requires daily administration because of its short half-life. Pegylated rhG-CSF (PEG-rhG-CSF) is a long-acting reagent that permits less frequent injection. This study was to evaluate the safety and tolerance of PEG-rhG-CSF in Chinese patients, and to explore its efficacy of enhancing absolute neutrophil count (ANC) and CD34+ cell count in peripheral blood., Methods: Naïve non-small lung cancer or breast cancer patients with normal bone marrow function were eligible for this open-labeled, dose-escalation trial. All patients received 2 cycles of chemotherapy of identical regimen. In cycle 1, rhG-CSF (150 microg/day) was administrated in case of febrile neutropenia or grade 4 neutropenia; in cycle 2, patients received a single injection of PEG-rhG-CSF (30 microg/kg, 60 microg/kg, 100 microg/kg, or 200 microg/kg) 48 h after administration of paclitaxel and carboplatin., Results: All the 16 patients enrolled (4 in each dose group) were evaluable for safety and efficacy of PEG-rhG-CSF. Main adverse events related to PEG-rhG-CSF were musculoskeletal pain or arthralgia (13/16), fatigue (10/16), dizziness (2/16), and injection-site pain (1/16). All adverse events were mild to moderate, and most of them were reversible without treatment. PEG-rhG-CSF enhanced ANC in a dose-dependent manner to some extent, and PEG-rhG-CSF at 60 microg/kg or higher doses prevented chemotherapy-induced neutropenia with sustained effect; CD34+ cells in peripheral blood were also increased., Conclusions: PEG-rhG-CSF is well tolerated, with no serious adverse event in this trial. The recommended dose of PEG-rhG-CSF for phase II trial is 100 microg/kg because of its adequate efficacy and less adverse events than those of 200 microg/kg.

Background & Objective: So far, there is still no standard salvage regimen for relapsed or refractory non-Hodgkin's lymphoma (NHL). The response rates (RR) of NHL patients received common salvage regimens, such as DICE, ESHAP, MINE, and EPOCH, are only 30%-70%. This study was to evaluate the efficacy and safety of DICE regimen, as a salvage regimen, in treating patients with relapsed or refractory intermediate and high grade NHL., Methods: Thirty-five patients with relapsed or refractory intermediate and high grade NHL, who had been pretreated with chemotherapy dominated by CHOP or CHOP-like regimen with a median of 6 cycles (ranged 2-12 cycles), were salvaged by DICE regimen from Jun. 1999 to Jan. 2004. Of the 35 patients, 14 were T-cell original, and 21 were B-cell original., Results: The 35 patients received DICE regimen with a median of 4 cycles (ranged 2-7 cycles). All patients were assessable in the efficacy and adverse events. The total RR was 74.3% with complete response (CR) rate of 31.4%, median response time (MST) of 4 months (ranged 1-30 months), median time to failure (TTF) of 7 months (ranged 2-34 months),median survival time (MST) of 14 months (ranged 3-51 months), and 2-year survival rate of 33.3%. The RRs of T-cell and B-cell NHL were 85.7% and 66.7%. The CR rate was higher in T-cells NHL than in B-cell NHL (50.0% vs. 19.0%, P=0.073). Elevated serum lactate dehydrogenase (LDH) and bulky disease were high risk factors of the efficacy of DICE regimen (P < 0.05). The response to DICE reginmen was an independent prognostic factor of patients with relapsed or refractory NHL (P = 0.001). The major toxicity was myelosuppression. Incidences of neutropenia and thrombocytopenia of grade III-IV were 71.4% and 8.6%., Conclusions: DICE regimen is a safe and effective salvage regimen for the patients with relapsed or refractory intermediate and high grade advanced NHL. Elevated serum LDH and bulky disease are the adverse prognostic factors. The response to DICE regimen may directly influence survival time of patients with relapsed or refractory NHL.

Background & Objective: High-dose conditioning regimens of chemo-radiotherapy with or without total body irradiation (TBI) frequently induces nausea and vomiting in patients who are supported with stem cell transplantation. 5-Hydroxytrypamine(3) (5-HT(3)) receptor antagonists, when used alone, are unsatisfactory in the attenuation of emesis; Furthermore, consensus about their optimal dose, optimal dosing frequency and the combined use with other anti-emetic drugs are still controversial. The main objective of this trial was to observe the anti-emetic effectiveness and side effects of tropisetron plus dexamethasone and diphenhydramine (Group A) and tropisetron alone (Group B) on the patients undergoing high-dose treatment for peripheral blood stem cell (PBSC) mobilization and transplantation., Methods: From December 1998 to September 2002, 68 patients undergoing autologous peripheral blood stem cell transplantation were allotted into this study. All the eligible patients were divided into group A or B non-randomly to compare the efficacy of the two regimens in the prevention of nausea and vomiting induced by high-dose treatment. Regimens:40 patients in group A were given tropisetron 5 mg,iv,every 12 h plus dexamethasone 5-10 mg, iv, daily, and diphenhydramine, 20 mg, im, daily. Twenty-eight patients in group B were received tropisetron alone,5 mg,iv,every 12h., Results: For nausea during the acute phase, complete response rates of group A and B were 55% and 46.4%, with an overall response rates of 97.5% and 85.7%,of which the difference was insignificant (P >0.05). For vomiting during the acute phase, complete response rates of group A and B were 77.5% and 78.6%, with an overall response rates of 90% and 92.9%, of which the difference was insignificant (P >0.05). For delayed phase, both the complete response and overall response rates were higher in group A, with the difference significant (P< 0.05). The side effects of both regimens were mild. Common side effects including abdomen discomfort,headache,heavy head and constipation did not necessitate the discontinuity of high-dose treatment., Conclusion: The combination of tropisetron with dexamethasone and diphenhydramine is more effective than tropisetron alone in the control of nausea and vomiting induced by high-dose chemotherapy with or without TBI, which is especially more effective in the delayed phase of nausea and vomiting. The side effects of the combination regimen were mild. Based on these findings, we stress the importance of large randomized trials in the future.

Background & Objective: It is important to get high quality autologous peripheral blood stem cell (APBSC) for successful peripheral blood stem cell transplantation. Cyclophosphamide (CTX) plus recombined human granulocyte colony-stimulating factor (rhG-CSF) is standard regimen for APBSC mobilization. Etoposide plus rhG-CSF is another regimen for mobilization in recent years. The purpose of this study was to observe and compare the effects of these two regimens in APBSC mobilization for the patients with malignant lymphoma and germ cell tumors., Methods: Fifty-two patients were divided into two groups according to the regimen of mobilization. In CTX group, 26 patients were injected CTX 3.5 g/m(2) intravenously. The other 26 patients in VP-16 group, VP-16 1000 mg/m(2) or 1500 mg/m(2) were given intravenously at random. All patients received rhG-CSF once daily as subcutaneous injection at the dose of 5 microg x kg(-1) x day(-1) from the day of the nadir of white blood cell (WBC) till the day before the last APBSC harvest in both groups. APBSC harvest was performed daily when WBC recovered more than 2.5x10(9)/L in CTX group and 5.0x10(9)/L in VP-16 group. APBSC harvest finished when accumulated mononuclear cells (MNCs) were more than 5x10(8)/kg or CD34(+) cells were more than 2x10(6)/kg. Collected APBSC was infused following condition regimen. Blood parameters, account of harvested cells, the time of hematopoietic reconstitute, and adverse effects were compared between two groups., Results: Following administration of CTX or VP-16, the nadirs of WBC and PLT in CTX group appeared significantly earlier than that in VP-16 group. The doses and times of rhG-CSF administration were not significantly different between the two groups. The start was later and the times of APBSC apheresis were less significantly in VP-16 group. The processed blood volume in single apheresis was more in VP-16 group. Speed and duration of single apheresis were similar in the two groups. Total MNCs were similar in the two groups, but the numbers of MNCs and CD34(+) cells collected in the first harvest and total number of CD34(+) cells collected were significantly more in VP-16 group. With equal quantity infusion of MNCs and CD34(+) cells infusion, hematopoietic reconstitution was achieved in both groups and the time of reconstitution was similar. Nausea and vomiting were more frequent in CTX group. Obvious PLT decrease was observed in VP-16 group. Other adverse effects were similar., Conclusion: CTX or VP-16 plus rhG-CSF both were safe and effective regimens for APBSC mobilization. More CD34(+) cells can be harvested by mobilization with VP-16 plus rhG-CSF than mobilization with CTX plus rhG-CSF. And the APBSC mobilized with VP-16 plus rhG-CSF can assure successful hematopoietic reconstitution.

Background & Objective: High dose chemotherapy and radiotherapy supported by autologous hematopoietic stem cells transplantation(AHSCT) can improve the efficacy of some malignant solid tumors. Successful AHSCT should owe to rational usage of recombinant human granulocyte colony-stimulating factor (rhG-CSF) in some extent. The purpose of this study was to observe the role of rhG-CSF in hematological recovery after AHSCT for patients with solid tumors., Methods: A total of 130 patients with solid tumors were divided into two groups. The rhG-CSF group received rhG-CSF at the dose of 250-300 microg daily from day 6 until WBC recovering to 5.0 x 10(9)/L. The control group did not receive rhG-CSF after AHSCT., Results: A total of 132 person-times AHSCT were finished and 2 patients of them experienced twice transplantation. Twenty-four patients received autologous bone marrow transplantation (ABMT), 12 of them received rhG-CSF following AHSCT and the others did not. One hundred and six persons underwent autologous peripheral blood stem cells transplantation (APBSCT), 47 patients received rhG-CSF and 61 did not. (1)In rhG-CSF group and control group of ABMT,the median days of WBC up to 5.0 x 10(9)/L were 14 days and 24 days (P< 0.001),respectively. The median time of hospitalization was 33 days and 41 days (P< 0.05),respectively. There was no statistical difference in median time of PLT recovering to 20 x 10(9)/L and 50 x 10(9)/L in the two groups.(2)In rhG-CSF group and control group of APBSCT,the median time of WBC recovering to 5.0 x 10(9)/L were 10 days and 13 days (P< 0.01), respectively. The median time of hospitalization was 17 days and 20 days(P< 0.01),respectively. There was no significantly statistical difference in median time of PLT recovering to 50 x 10(9)/L in the two groups. (3)The frequency of infectious complication was no statistical difference between two groups (P=0.45)., Conclusion: rhG-CSF administration after AHSCT can obviously accelerate the recovery of WBC and shorten the time of hospitalization, but there is no significant effect on the recovery of PLT. Further study is needed to investigate whether rhG-CSF can reduce the infectious complication.