Irinotecan plus fuorouracil/leucovorin (FOLFIRI) as a second line chemotherapy for refractory or metastatic colorectal cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>Irinotecan (CPT-11), a specific inhibitor of topoisomerase I, has been proven to be effective in the treatment of refractory or metastatic colorectal cancer. Furthermore, several first line phase III trials of the combination therapy (FOLFIRI) using CPT-11 and fuorouracil/leucovorin (5-Fu/LV) were reported to have significant improvement in treatment result. Therefore, we designed a multicenter clinical study to observe the overall survival (OS), time to death (TTD), time to progression (TTP), efficacy and safety of FOLFIRI regimen for patients with refractory or metastatic colorectal cancer after first line chemotherapy failure.</p><p><b>METHODS</b>Patients with metastatic or refractory colorectal cancer after first line oxaliplatin-based chemotherapy failure were enrolled into this prospective, one arm and open-labeled multicenter study. Irinotecan 180 mg/m2 was administered biweekly on D1, LV 200 mg/m2 by intravenous infusion in 2 hours before bolus intravenous injection of 5-Fu 400 mg/m2, then followed immediately by intravenous infusion of 5-Fu 2.4 g/m2 in 46 hours. OS, TTD, TTP, response rate (RR) and adverse events were assessed according to RSCIST criteria and NCIC-CTG CTCAE (3.0).</p><p><b>RESULTS</b>Sixty-six patients were valuable for safety assessment and and 61 for efficacy. There was no CR patient in this series. Ten patients had PR, 35 SD (57.4% ) and 16 PD (26.2%) with a response rate of 16.4% (10/61). The median TTP was 5.0 months (1-12 months), median TTD 9.9 months (5-27 months)and median OS 18.2 months (7-33 months). The adverse events including nausea,vomiting, anorexia,diarrhea, leucopenia and cholinergic syndrome were frequent, but usually in I - II degree. The rate of III/IV degree diarrhea and leucopenia was 7.6% and 22.7%, respectively.</p><p><b>CONCLUSION</b>The regimen of irinotecan plus fuorouracil/leucovorin (FOLFIRI) is effective and well-tolerated as a second-line chemotherapy and may prolong the overall survival for the patient with refractory or metastatic colorectal cancer.</p>

Cohort study on the effect of a combined treatment of traditional Chinese medicine and Western medicine on the relapse and metastasis of 222 patients with stage II and III colorectal cancer after radical operation / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine (TCM) in reducing the relapse and metastasis of stage II and III colorectal cancer based on conventional Western medicine (WM) therapy.</p><p><b>METHODS</b>Two hundred and twenty-two patients in total, diagnosed as stage II and III colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network (NCCN) clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy (orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year). Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM (combined group), and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone (WM group). The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011.</p><p><b>RESULTS</b>The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 (0/98), 2.04% (2/98), 11.69% (9/77), 14.06% (9/64), and 21.28% (10/47) in the combined group, and were 4.80%(5/104), 16.35% (17/104), 21.65% (21/97), 25.93% (21/81), and 38.18%(21/55) in the WM group, respectively. A significant difference was found in the second year between the two groups (chi (2)=12.117, P=0.000). Median relapse/metastasis time was 26.5 months in the combined group and 16.0 months in the WM group.</p><p><b>CONCLUSION</b>The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stage II and III colorectal cancer after conventional WM therapy.</p>

Irinotecan plus cisplatin for the treatment of advanced non-small cell lung cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and adverse events of irinotecan (CPT-11) combined with cisplatin (DDP) in the treatment of patients with advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Of 36 NSCLC patients consisting of 23 males and 13 females with a medium age of 52 years included, there were 26 adenocarcinomas, 7 squamous cell carcinomas, 1 adeno-squamous cell carcinoma and 2 unclassified types; 13 stage III B and 23 stage IV; 24 chemonaive and 12 previously treated by chemotherapy with a medium Karnofsky status of 90. All patients had measurable or evaluable parameters. The regimen was administered as following: CPT-11 60 mg/m2, IV, D1, 8 and 15; DDP 80 mg/m2, IV, D1; every 28 days as a cycle.</p><p><b>RESULTS</b>Totally, 97 cycles were carried out in these 36 patients with a medium cycles of 3. Of 35 evaluable patients, 22.9% (8/35) achieved partial response, 60.0% (21/35) had stable disease and 17.1% (6/35) progressive disease. The response rate was 29.2% (7/24) for chemonaive patients and 9.1% (1/11) for these previously treated. The 1-year survival rate was 45.4% with a medium time to tumor progression (TTP) of 199 days for the responders. The incidence rate of grade III/IV adverse events were: 16.7% for neutropenia, 13.9% alopecia, 5.6% diarrhea, 2.8% nausea and vomiting, respectively.</p><p><b>CONCLUSION</b>Irinotecan plus cisplatin is effective with tolerable adverse events in treating patients with advanced non-small cell lung cancer, but further investigation trials are needed.</p>

Selected CD34+ cell autologous transplantation for advanced malignant tumors / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To determine the clinical results of selected CD34(+) cell autologous transplantation in advanced malignant tumors.</p><p><b>METHODS</b>After pretreatment, fifteen patients aged 12 - 70 (49.5) years with various Stage III or IV malignant tumors were given the sorted CD34(+) cells collected by magnetic-activated cell sorting (Clini MACS, Milteny Biotech, Germany).</p><p><b>RESULTS</b>Peripheral blood progenitor cells (PBPC) from the patients were mobilized by chemotherapy and G-CSF 5 micro g/kg per day. CD34(+) cells gave 2.0 - 5 log depletion after cell sorting, with a median yield of CD34(+) selected cells of 2.4 (0.15 - 12.03) x 10(6)/kg. It gave a median recovery of 64 (52 - 81.4)% and median purity of 98.2 (83.2 - 99.7)%. The median time of neutrophil recovery > 1.0 x 10(9)/L and platelet recovery > 20 x 10(9)/L post-transplantation were 14 (8 - 26) days and 13 (11 - 35) days, respectively. On follow-up of 2 - 33 (11) months, the event-free survival rate was 53.3% (8/15) and the overall survival rate was 66.7% (10/15).</p><p><b>CONCLUSION</b>Transplantation of autologous selected PBPC CD34(+) cells gives prompt and stable engraftment. Selected CD34(+) cell transplantation, being a safe approach, may improve the clinical outcome even in patients with advanced malignant tumors.</p>