Multicenter phase II study of modified FOLFIRI regimen in the advanced colorectal cancer patient refractory to fluoropyrimidine and oxaliplatin / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of modified FOLFIRI regimen in advanced colorectal cancer (CRC) patients refractory to fluoropyrimidine and oxaliplatin.</p><p><b>METHODS</b>The modified FOLFIRI regimen consisted of intravenous infusion of irinotecan 180 mg/m2 d1 + LV 200 mg/m2 dl + 5-Fu 400 mg/m2 bolus dl plus 46-hour intravenous infusion of 5-Fu 2.4 g/m2, every 2 weeks as one cycle. The main selection criterion for this study was the advanced CRC refractory to fluoropyrimidine and oxaliplatin.</p><p><b>RESULTS</b>Of the 80 evaluable patients for efficacy: 10 (12.5%) had a partial response, 51 (63.7%) stable disease, and 19 (23.8%) progressive disease. The median time to progression was 96 days. Safety analysis was based on the data of 83 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia (24.1%), nausea/vomiting (8.4%), and diarrhea (2.4%).</p><p><b>CONCLUSION</b>Modified FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.</p>

Protective effect of amifostine on cisplatin-induced nephrotoxicity and its mechanism / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the sites and pattern of renal toxicity in rats treated with cisplatin and the protective effect of amifostine, and to understand whether Fas/FasL system is involved in cisplatin-induced nephrotoxicity.</p><p><b>METHODS</b>Forty-eight Sprague-Dawley rats were randomly divided into 3 groups: control group (0.9% saline solution), cisplatin group (6 mg/kg) and amifostine group (cisplatin 6 mg/kg + amifostine 200 mg/kg). Serum BUN and creatinine were measured by automatic biochemiscal analysis. Renal histopathological lesions were examined by light microscopy. TUNEL method was used for counting apoptotic cells. Immunohistochemistry and image analysis system were used for observing the expression of Fas/FasL system in renal tissues.</p><p><b>RESULTS</b>Compared with control group and amifostine group, serum BUN and creatinine were significantly elevated on day 3 (P < 0.05) and day 5 (P < 0.01 and P < 0.05, respectively), and recovered to normal on day 10. Severe necrosis and apoptosis of renal proximal tubular cells were revealed by elevated number of positively staining apoptotic cells examined by TUNEL method. Increased immunostaining intensity of Fas/FasL system in renal tissues in cisplatin-treated group was detected by immunohistochemistry and image analysis system.</p><p><b>CONCLUSION</b>Amifostine can reduce cisplatin-induced nephrotoxicity and its mechanism is probably associated with the suppression of Fas/FasL expression in renal tissues.</p>

Phase II clinical trial on China manufactured recombinant human interleukin-11 derivative in the prevention and treatment of chemotherapy-induced thrombocytopenia / 中华肿瘤杂志

<p><b>OBJECTIVE</b>This phase II clinical trial was designed to evaluate the efficacy and toxicity of recombinant human interleukin-11 (rhIL-11) derivative manufactured in China in the prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients.</p><p><b>METHODS</b>A total of 100 cancer patients with chemotherapy-induced thrombocytopenia (< or = 75 x 10(9)/L) were studied by self-cross control. Ninty-one of them received 2 cycles of chemotherapy. In the first cycle (control cycle) the patients received chemotherapy only, while in the second cycle (treatment cycle), the patients were given subcutaneous injection of rhIL-11 derivative (40 microg.kg(-1).d(-1)) once daily after chemotherapy for 10 consecutive days or more until platelet count reached > or = 300 x 10(9)/L.</p><p><b>RESULTS</b>1. The patients with platelet count of < or = 75 x 10(9)/L was 89/89 in the control cycle and 44/89 in the treatment cycle (P = 0.00). The recovery time to the normal platelet count was 1-47 days (median 9 days) in the control cycle, and 1-18 days (median 5.5 days) in treatment cycle (P = 0.00). 2. Patients with platelet count of < or = 50 x 10(9)/L was 56/89 in the control cycle and 20/89 in the treatment cycle (P = 0.00). The recovery time to normal platelet count was 1-31 days (median 9 days) in the control cycle and 3-13 days (median 6 days) in the treatment cycle (P = 0.05). 3. The median nadir platelet count was 44 x 10(9)/L (range: 10 x 10(9)/L-75 x 10(9)/L) in the control cycle, and 83 x 10(9)/L (range: 10 x 10(9)/L-310 x 10(9)/L) in the treatment cycle (P = 0.00). The time of recovery to the normal platelet count was 1-31 days (median 6 days) in the control cycle, and 0-13 days (median 2 days) in the treatment cycle (P = 0.00). 4. Nine of 89 evaluable patients required platelet transfusion in the control cycle versus 1 of 89 patients in treatment cycle (P = 0.01), and the total platelet transfusion was 10 times in the control cycle versus once in the treatment cycle (P = 0.01). 5. The major adverse events associated with rhIL-11 derivative were: headache, fatigue, myalgia/arthralgia, edema and palpitation, etc.</p><p><b>CONCLUSION</b>rhIL-11 derivative can be safely and effectively used for the prevention and treatment for chemotherapy-induced thrombocytopenia.</p>

Result of phase II clinical trial of herceptin in advanced Chinese breast cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To observe the clinical efficacy and adverse effects of herceptin for advanced Chinese breast cancer patients.</p><p><b>METHODS</b>Thirty-one pathologically proved advanced breast cancer women were treated by herceptin. In the first week, a loading dose 4 mg/kg was administered by intravenous infusion and from the second week, a routine dose of 2 mg/kg was given every week for at least 3 months.</p><p><b>RESULTS</b>There were 2 CR, 6 PR, 7 SD, and 16 PD among 31 patients after treatment by herceptin, the response rate being 25.8%. In factors influencing the prognosis, age and general condition were factors favoring the results, and pathological type, site of metastasis, grade of her-2 over expression and prior treatment were irrelevant to the results. The adverse effects were mild but different from those of the common anticancer drugs.</p><p><b>CONCLUSION</b>Herceptin is effective and well tolerated by the Chinese breast cancer patients.</p>

Vinorelbine plus cisplatin in the treatment of advanced non-small cell lung cancer previously treated with taxane-based chemotherapy / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and toxicity of vinorelbine plus cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC) previously treated with taxane-based chemotherapy.</p><p><b>METHODS</b>Thirty patients (0 - 1 score ECOG performance status) with stage IIIB/IV NSCLC previously treated with taxane-based chemotherapy were eligible for the study. Fifteen patients received the regimen of vinorelbine plus cisplatin (NP), the others received mitomycin, vindesine plus cisplatin (MVP).</p><p><b>RESULTS</b>The overall response rates were 13.3% in NP and 0 in MVP (P > 0.05). Time to progression was longer for NP patients than that for MVP ones (6 v 3 months, P < 0.05), so was median survival (9 v 6 months, P < 0.05). The 1-year survival rate of 40.0% in the NP group was significantly higher than that of 0 in MVP (P < 0.05). Grade III-IV toxicity was observed at a similar rate in both groups (P > 0.05), though both well tolerated.</p><p><b>CONCLUSION</b>Regimen of vinorelbine plus cisplatin is appropriate for good performance status patients with advanced non-small cell lung cancer previously treated with taxane-based chemotherapy. Time to progression, median survival and 1-year survival are satisfactory in patients treated with NP, which is complicated with acceptable toxicity.</p>