Capecitabine combined with cisplatin as first-line therapy in Chinese patients with advanced gastric carcinoma-a phase II clinical study / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the effectiveness and safety of the combination chemotherapy of capecitabine (X) with fractionated administration of cisplatin (C) in Chinese patients with advanced gastric cancer (AGC).</p><p><b>METHODS</b>141 patients with AGC were enrolled between July 2002 and August 2004. All patients had measurable tumor according to the criteria of RECIST, Karnofsky performance status > or = 60, adequate bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant chemotherapy was not permitted. Patients received oral administration of capecitabine at a dose of 1000 mg/m(2) twice a day on D1-D14, and intravenous infusion of fractionated cisplatin at a dose of 20 mg/m(2)/day on D1-D5. The regimen was repeated every 3 weeks, totally for 6 cycles.</p><p><b>RESULTS</b>Of the 141 evaluable patients, there were 104 men and 37 women, with a median age of 54 years (range, 23 - 80 years). Metastases before chemotherapy were detected in lymph nodes (46.8%), liver (40.4%), lung (5.7%) and other area (10.6%). The median treatment duration was 6 cycles (range, 3 - 6 cycles). The objective response rate (RR) was 36.2% (51/141). The median follow-up period was 17.5 months. The median time to progress (TTP) was 9.0 months, and the median overall survival (OS) was 12.0 months. The most common treatment-related adverse events (grade 3/4) were: hand-foot syndrome (HFS) (2.1%), leucopenia (0.7%), abnormal alanine transaminase elevation (2.8%). There was no treatment-related death.</p><p><b>CONCLUSION</b>Capecitabine combined with fractionated cisplatin is highly effective and well tolerated as a first-line treatment for advanced gastric cancer, with comparable results to 5-Fu plus cisplatin combination therapy.</p>

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>

Prospective non-randomized study of chemotherapy combined with radiotherapy versus chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the time to progression (TTP) and overall survival in patients with previously untreated metastatic or relapsed esophageal squamous cell carcinoma treated with chemotherapy (paclitaxel plus cisplatin) combined with radiotherapy versus chemotherapy alone, and also to evaluate the efficacy and toxicity of the regimen.</p><p><b>METHODS</b>In this prospective and non-randomized study, 47 patients with definite measurable lesion and having no previous chemotherapy were enrolled. All patients were treated with paclitaxel 175 mg/m2 by 2-hour iv infusion on d1 and cisplatin 75 mg/m2 by iv infusion on d1, which were repeated every 21 days. After 2-6 cycles of chemotherapy, those who gained CR, PR or SD were non-randomly assinged into radiotherapy group (group A) or non-radiotherapy group (group B).</p><p><b>RESULTS</b>Totally, 47 patients were enrolled into this study, and all of them were valuable for response. One patient achieved complete response (CR), 19 partial response (PR), 24 stable disease (SD), and 3 were found to have disease progression (PD). The overall response rate of chemotherapy was 42.6% (95% CI, 0.28-0.58). Twenty-one of these 47 patients were sequentially treated with radiotherapy. The median survival and TTP was 13 months and 10 months in the group A , versus 11 months and 5 months in the group B (P < 0.024, P < 0.015), respectively. The most common toxicities were neutropenia and alopecia. There were no grade 4 clinical toxicity and treatment-related death in this series. Systemic adverse effects frequently occurred during radiotherapy were esophagitis and fatigue, which were tolerable.</p><p><b>CONCLUSION</b>The combined therapy using chemotherapy (paclitaxel + cisplatin) followed by radiotherapy is effective, tolerable, and statistically superior to chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma.</p>

Three-dimensional spiral CT in advanced gastric cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To study the usefulness of three-dimensional spiral CT (3DCT) in the diagnosis of advanced gastric cancer (AGC).</p><p><b>METHODS</b>Between June 1999 and December 2000, 54 patients with AGC were consecutively examined. On the 3D Virtuoso workstation, source images were uploaded to create a 3DCT volume block that was then processed with volume rendering technology (VA30C) to achieve virtual-reality endoscopy (VE), clipped volume block (CVB), and ray sum (RS). After the above scanning, all the patients were examined by a two-phase enhanced spiral CT (2DCT). The visualization, manifestation, and Borrman's classification of lesions in VE, CVB, RS, and 2DCT were evaluated and correlated with gastroscopic, surgical, and pathological findings. Respiratory artifact and gastric residue were also observed.</p><p><b>RESULTS</b>(1) CVB showed the excellent visualization in 88.9% of cases, in contrast to VE and RS (50.0% and 38.9%) (P < 0.01). (2) The accuracy in evaluating mucous membrane, ulceration, lumen, wall, cardia, pylorus, and extension of the tumor were more than 90.0% except mucosa by RS (84.4%) and ulceration by VE (87.5%) or RS (81.6%) which was significantly different from CVB (96.0%) and 2DCT (96.1%) (P < 0.05). VE demonstrated an accuracy of 95.8% in diagnosis of mucosal abnormality. (3) The correct Borrman's classification was obtained in 83.3% cases by VE, 79.6% by CVB, 72.2% by RS, 88.9% by 2DCT and 85.2% by 3DCT with significant difference between 2DCT and RS (P < 0.05), but not between 3DCT and 2DCT (P > 0.05). (4) In addition to 2DCT which had no step-like artifacts, they were invisible in 53.7% of VE, 40.7% of CVB, and 81.5% of RS, with RS showing the least artifacts among 3DCT (P < 0.01). A few of gastric residues caused by pre-scanning intake of water to swallow effervescent agent could be found on 3DCT images which caused no evident influence on diagnosis.</p><p><b>CONCLUSION</b>Additional information on the diagnosis of AGC can be obtained by use of 3DCT, especially the visualization of a lesion in clipped volume block and the observation of mucosa in virtual-reality endoscopy.</p>

Imatinib mesylate alone for refractory advanced gastrointestinal stromal tumor / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of imatinib mesylate in the treatment of patients as preoperative supplement, or used alone for unresectable and(or) metastatic gastrointestinal stromal tumor (GIST).</p><p><b>METHODS</b>A total of 30 cases with advanced GIST were proved pathologically. Among them, CD117 was detected positive in 29 patients; 2 patients received imatinib mesylate before operation and 28 patients with unresectable and(or) metastatic GIST received oral imatinib mesylate daily at dose of 200-600 mg. Three patients were lost in follow-up and the objective effect was evaluated in 25 patients.</p><p><b>RESULTS</b>Fifteen of 25 patients (60.0%) achieved partial response (PR); 5 (20.0%) had stable disease (SD) and 5 (20.0%) had progression disease (PD). Median time to progression (mTTP) was more than 13 months during which most experienced benefit. Twenty-two patients had been followed-up more then 1 year. The 1-year survival rate was 86.4%. The overall median survival has not been obtained to date. Twenty-seven patients were valuable for the toxicity assessment according to the WHO standard. The main toxicity included grade I-II edema of periorbital area and lower limb in 85.2% (23/27) patients, leukopenia was present in 40.7% (11/27) and intratumoral bleeding in 7.4% (2/27). Other toxicities included mild fatigue (29.6%), abdominal pain (14.8%), efflorescence (11.1%), nausea and vomiting (18.5%).</p><p><b>CONCLUSION</b>As an inhibitor of tyrosine kinase, imatinib mesylate is generally well tolerated and has been proved to be effective and safe during prolonged treatment of patients with advanced gastrointestinal stromal tumors.</p>

The evaluation of LFH or LFPH in the treatment of advanced cancer of gastric cardia and colorectal cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the therapeutic effects of hydroxycamptothecin (H) combined with leucovorin (L), fluorouracil (F) and cisplatin (P) on advanced cancer of gastric cardia and colorectal cancer.</p><p><b>METHODS</b>Sixty-five patients with advanced cancer of gastric cardia or colorectal cancer were treated by LFH or LFPH regimen. All patients completed four cycles of treatment, in 21 days per cycle.</p><p><b>RESULTS</b>The overall response rate (RR) was 26.2% (17/65) with partial response (PR) in 17 patients, stable disease (SD) in 31 and progressive disease (PD) in 17. The clinical benefit response rate (CR + PR + SD) was 73.8% (48/65). The RR were 32.3% (10/31) for untreated patients and 20.6% (7/34) for retreated patients. The stable rate was 47.7% (31/65). The RR of patients with cancer of gastric cardia were 33.3% (5/15) for untreated treatment and 29.4% (5/17) for retreated ones. Median survival time (MST) was 10 months. Median time to progression (MTTP) was 8 months. Grade 3 - 4 toxicities were stomatitis (10.8%), nausea and vomiting (12.3%) and leukopenia (6.2%). Most patients (> 80%) developed Grade 1 - 2 alopecia.</p><p><b>CONCLUSION</b>The regimen of HCPT combined with LV, 5-Fu and DDP appears to be an effective and tolerable therapeutic option for advanced cancer of gastric cardia and colorectal cancer, especially for the former and retreated patients, giving a satisfactory stable rate though not very high.</p>

Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the effects and safety of OXA-LV5FU2 regimen for patients with advanced/metastatic gastric cancer.</p><p><b>METHODS</b>OXA 100 mg/m(2) i.v. 2hr d1, LV200 mg/m(2) i.v. 2hr followed by 5-Fu 400 mg/m(2) i.v. bolus and 5-Fu 600 mg/m(2) i.v. 22hr d1, 2 were given, and repeated every 2 weeks. Efficacy was evaluated at 4 cycles (8 weeks).</p><p><b>RESULTS</b>Forty three patients have been entered into the study. Patients with primary tumor resected or non-resected were 17 and 26. The evaluable lesions were 26 primary lesions, 22 lymph node metastases, 12 liver metastases, 1 pancreas metastasis and 2 soft tissue metastases. Forty patients were evaluable for clinical response. Four patients achieved CR (10.0%), 13 PR (32.5%), ORR 42.5% (95% CI 27.2 - 57.8), 17 SD (42.5%) and 6 PD (15.0%). Overall response rate (ORR) for chemotherapy naive (1(st) line) and pretreated (2(nd) line) patients were 50.0% (14/28) and 25.0% (3/12), respectively. Median time to progress (mTTP) was 5 months and median overall survival (mOS) was 8 months. Forty-three patients were evaluable for toxicity, with Grade 3, 4 WHO toxicity of neutropenia in 7 patients (16.3%), thrombocytopenia in 3 patients (7.0%), nausea/vomiting in 1 patient (2.3%). There were no Grade 3, 4 peripheral neuropathy toxicity or any deaths during treatment.</p><p><b>CONCLUSION</b>OXA-LV5FU2 is a high response regimen for advanced gastric cancer with mild toxicity, which can be practiced safely.</p>