Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study.

The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0×10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 µg/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 µg/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens.

[Preliminary result of multi-center clinical trial on the docetaxel, 5-Fu and DDP in the treatment of advanced, recurrent or metastatic nasopharyngeal carcinoma].

OBJECTIVE: This clinical study was designed to evaluate the efficacy and toxicity of the combined regimen of docetaxel, 5-Fu and DDP (TPF) in the treatment of advanced or relapsed nasopharyngeal carcinoma (NPC). METHODS: Fifty-six patients with newly diagnosed or recurrent/metastatic NPC following chemotherapy or radiotherapy were enrolled. Both docetaxel and DDP were administered intravenously for 6 hours at the dose of 70 mg/m2 on D1. 5-Fu was given at a dose of 400-500 mg/m2 for 6 hours from D1 to D5. Dexamethasone was routinely administered before injection of docetaxel. This combination was repeated every 3 to 4 weeks, and continued for 4-6 cycles or until PD for the responders. RESULTS: Fifty-one (91.1%) patients were evaluable for response assessment. The response rate for whole group was 72.5% (37/51) with a CR rate of 9.8% (5/51). The stable disease accounted for 17.6% (9/51). There were 17(30.4%) chemotherapy-naïve patients. The overall response rate in those was 82.4% with a CR rate of 29.4%. However, the response rate for previously treated patients was 64.7% without CR. Twelve patients had progressed disease, including 5 (8.9%) died of disease progression with a median follow-up of 11 month (ranged from 1 to 19 months). Totally, 196 courses of chemotherapy were administered. The major toxicity was myelosupression, nausea/vomiting. The incidence of leucopenia was 48% with 22.2% of these in NCI grade II or IV. But only 2 patients (3.6%) experienced leucopenia with a fever. Other mild toxicities including alopecia, asthenia, mucositis and diarrhea were also observed. CONCLUSION: Our preliminary outcome shows docetaxel, 5-Fu and DDP combination is effective and safe for the patients with advanced or relapsed nasopharyngeal carcinoma. But further clinical study is warranted.

[Treatment of moderate-grade and high-grade malignant lymphoma with autologous hematopoietic stem cell transplantation].

BACKGROUND & OBJECTIVE: High dose chemotherapy (HDCT) supported by autologous hematopoietic stem cell transplantation (ASCT) is one of the most effective approaches for the chemo-sensitive lymphoma. The purpose of this study was to investigate the effectiveness of HDCT combined with radiotherapy supported by HSCT in treatment of poor- prognostic moderate-grade and high-grade malignant lymphoma. METHODS: Eleven patients [11 cases of non-Hodgkin's lymphoma (NHL) and 2 cases of recurrent Hodgkin's lymphoma (HD)] were enrolled from December 1995 to May 2001. Status on ASCT was 8 cases with 1st complete remission (CR(1)), 4 cases with second complete remission (CR2), 1 case with second partial remission (PR2). The preparative regimens consisted of HDCT alone (4 patients), HDCT with involved-field (IF) radiotherapy (6 patients), total body irradiation (TBI) with HDCT (3 patients). Two patients were supported by bone marrow transplantation (ABMT) and 11 by autologous peripheral blood stem cell transplantation (APBSCT). RESULTS: The numbers of mono-nuclear cell (MNC) and granulocyte- macrophage colony-forming cells (CFU-GM) reinfused were 2.55 (range, 2.07-3.31) x 10(9)/L, 1.43 (range, 0.6-2.36) x 10(9)/L in this study, respectively. Hematopoietic reconstitution was observed in all patients when they were followed-up on October 2001. WBC>or=1.0 x 10(9)/L and Platelet >50 x 10(9)/L were at day 6 (range,7-35) and day 8 (range,6-32), respectively. The median CR duration was 16 months (range, 4-57 months). The 1- and 3-year survival rates were 76.9% and 46.2%, respectively. CONCLUSION: HDCT with ASCT is valuable to treatment in patients with chemo-sensitive moderate-grade and high-grade NHL and recurrent HD.

[Clinical trial on exemestane in the treatment of postmenopausal women with advanced breast cancer].

OBJECTIVE: To evaluate the response rate and adverse reactions of exemestane (a new aromatase inactivator) in the treatment of postmenopausal women with advanced breast cancer. METHODS: One hundred and seventy-three patients with advanced breast cancer entered this study with two patients excluded because of postmenopausal time being less than one year. Therefore, 173 patients could be evaluated for adverse events and 171 patients could be evaluated for efficacy. Exemestane, 25 mg orally daily for 4 weeks as one cycle was given. RESULTS: In the 171 patients evaluated for efficacy, 4 (2.3%) experienced a complete response (CR) and 40 (23.4%) a partial response (PR), with the overall response rate of 25.7%. Ninety patients (52.6%) had stable disease (SD), with 25 having SD for at least 24 weeks. The clinical benefit (CR + PR + SD > or = 24 weeks) was shown in 69 (40.4%) patients. Progressive disease (PD) was shown in 37 (21.6%) patients. The untreated patients had a higher objective response rate (33.8%) than the retreated ones (18.1%) with significant difference (P = 0.019 7). The response rates for soft-tissue, bone involvement and visceral metastasis were 32.8%, 23.9%, and 12.4% (P = 0.002). There was no significant difference in different ages, time of menopause, disease-free interval or receptor status (P > 0.05). Drug-related adverse events were gastric discomfort (17.9%), malaise (17.9%), nausea (13.9%), hot flushes (11.0%) and dysphoria (5.8%). Other side reactions and abnormal laboratory parameters were observed occasionally which were irrelevant. CONCLUSION: Exemestane can be used to treat postmenopausal women with advanced breast cancer giving only mild adverse reactions which are well tolerated.