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1.
Chinese Journal of Gastrointestinal Surgery ; (12): 1152-1158, 2019.
Article in Chinese | WPRIM | ID: wpr-800466

ABSTRACT

Objective@#To investigate the effect of tumor deposits (TD) on the prognosis of patients with stage III colon cancer, and to explore whether TD number included into regional lymph node count can predict the prognosis more accurately.@*Methods@#A retrospective cohort study was carried out. Case inclusion criteria: (1) primary colon cancer; (2) undergoing colon cancer radical operation; (3) definite pathological diagnosis; (4) colon cancer stage III according to AJCC 8th edition; (5) complete follow-up data; (6) without preoperative neoadjuvant treatment. Clinicopathological data of 296 patients undergoing colon cancer radical operation from January 2005 to December 2008 in the Cancer Hospital of Chinese Academy of Medical Sciences were retrospectively collected. The effect of TD and its amount on the prognosis was evaluated. Colon cancer TNM staging method based on the 8th edition of AJCC was compared with the modified TNM staging (mTNM) adjusted by the number of TD. The differences of the disease-free survival (DFS) and overall survival (OS) between groups were also examined. The Kaplan-Meier curve was used to analyze the survival, and prognostic factors were analyzed by Cox univariate and multivariate analyses.@*Results@#Among 296 patients with stage III colon cancer, 78 patients had TD. The median number of TD was 2 (1-10). Tumor T stage, N stage, vascular tumor thrombus and preoperative carcinoembryonic antigen (CEA) were associated with TD in patients with colon cancer (all P<0.05). The right hemicolon appears likely to have TD than left hemicolon, but the difference was not statistically significant (P=0.059). The median follow-up of the whole group was 71 (6-102) months. During the follow-up period, 129 patients (43.6%) had recurrence or metastasis, and 111 patients died (37.5%). The 5-year DFS in TD group was 44.9%, which was lower than that in the non-TD group (60.6%), with statistically significant difference (P=0.003). The 5-year OS in TD group was 50.0%, which was also lower than 67.0% in the non-TD group, and the difference was statistically significant (P=0.002). According to TD number, patients were divided into 3 groups: 1 TD (25 cases), 2-3 TD (32 cases), ≥4 TD (21 cases). The 5-year DFS in these 3 groups was 68%, 56.3%, and 0, respectively (P<0.001), and 5-year OS was 76%, 59.4%, and 4.8% respectively (P<0.001). Univariate analysis showed that TD presence (95% CI: 1.234-2.694, P=0.003) and TD number (95% CI: 3.531-14.138, P<0.001) were associated with the prognosis of patients with stage III colon cancer. At the same time, age, tumor N stage, tumor location, chemotherapy, and preoperative CEA elevation were also associated with the prognosis of stage III colon cancer patients (all P<0.05). Multivariate analysis revealed that TD presence (HR=1.957, 95%CI: 1.269-3.017, P=0.002) and TD number (HR=8.020, 95% CI: 3.414-18.842, P<0.001) were still independent risk factors for the prognosis of patients with stage III colon cancer.According to the TD number counted as metastatic lymph nodes, in 78 patients with TD, 24 patients were upstaged in N stage, and 16 patients upstaged from TNM stage IIIB to stage IIIC. For 16 stage IIIB cases with staging modification, 30 unadjusted stage IIIB cases with TD, and 148 stage IIIB cases without TD, the 5-year OS was 37.5%, 73.3% and 76.4%, respectively with significant difference (P<0.001). However, for 16 patients adjusted as stage IIIC (mTNM), 32 patients with unchanged stage IIIC with TD (TNM, AJCC 8th edition), and 63 stage IIIC cases without TD, the 5-year OS was 37.5%, 36.4%, and 41.3%, respectively without significant difference (P=0.707).@*Conclusions@#TD presence and TD number are independent risk factors for prognosis of stage III colon cancerpatients. TNM staging evaluation with lymph node number including TD number can predict the prognosis of patients more accurately.

2.
Chinese Journal of Oncology ; (12): 591-596, 2015.
Article in Chinese | WPRIM | ID: wpr-286775

ABSTRACT

<p><b>OBJECTIVE</b>To explore the relationship between DNA mismatch repair (MMR) and clinicopathologic features and prognosis in patients with stages II and III colon cancers.</p><p><b>METHODS</b>The clinical and pathological data of 440 patients with stage II/III colon cancer after radical resection were retrospectively reviewed and analyzed. Immunohistochemical staining was used to assess the expression of MMR proteins (MLH1, MSH2, MSH6 and PMS2), and the correlation between DNA MMR and clinicopathological features and prognosis of colon cancers was analyzed.</p><p><b>RESULTS</b>Of the 440 tumor samples tested for DNA mismatch repair status, 90 (20.5%) demonstrated defective DNA mismatch repair and 350 (79.5%) had proficient DNA mismatch repair. Defective DNA mismatch repair (dMMR) was associated with young patients (≤ 60), proximal colon cancer, stage II, poorly differentiated adenocarcinoma and mucinous adenocarcinoma (P<0.05 for all). Among the 440 patients, 126 (28.6%) cases had recurrence or metastasis and 93 (21.1%) died during the median follow-up of 61.0 months. The five-year disease-free survival (DFS) rate was 82.2% among the patients with tumor exhibiting dMMR, significantly higher than that in patients with tumors exhibiting pMMR (68.9%, P=0.02). The univariate and mutlivariate analyses showed that the MMR status is an independent factor affecting 5-year disease-free survival and overall survival (OS) in colon cancer patients (P<0.05 for both).</p><p><b>CONCLUSIONS</b>Defective DNA mismatch repair (dMMR) is associated with patients with proximal colon cancer, stage II and poorly defferentiated adenocarcinoma and mucinous adenocarcinoma. The prognosis for patients with dMMR is better than those with pMMR. dMMR may be a useful biomarker for the prognosis of colon cancer.</p>


Subject(s)
Humans , Adaptor Proteins, Signal Transducing , Metabolism , Adenocarcinoma , Genetics , Metabolism , Mortality , Pathology , Adenocarcinoma, Mucinous , Genetics , Metabolism , Mortality , Pathology , Adenosine Triphosphatases , Metabolism , Age Factors , Analysis of Variance , Colonic Neoplasms , Genetics , Metabolism , Mortality , Pathology , DNA Mismatch Repair , DNA Repair Enzymes , Metabolism , DNA-Binding Proteins , Metabolism , Disease-Free Survival , Mismatch Repair Endonuclease PMS2 , MutL Protein Homolog 1 , MutS Homolog 2 Protein , Metabolism , Neoplasm Recurrence, Local , Nuclear Proteins , Metabolism , Prognosis , Retrospective Studies , Survival Rate
3.
Chinese Journal of Oncology ; (12): 622-627, 2015.
Article in Chinese | WPRIM | ID: wpr-286769

ABSTRACT

<p><b>OBJECTIVE</b>To analyze the characteristics of recurrence in gastric cancer patients after radical gastrectomy and adjuvant chemotherapy.</p><p><b>METHODS</b>The clinicopathological data of 110 gastric cancer patients who developed recurrence or second primary malignancies after radical gastrectomy and adjuvant chemotherapy with FOLFOX4 regimen or docetaxel plus FOLFOX4 regimen were analyzed retrospectively.</p><p><b>RESULTS</b>The median time to recurrence was 13.9 months (range, 1.7 to 63.1 months), and the median overall survival was 27.4 months (range, 6.9 to 90.7 months) in the whole group. The median survival time after recurrence was 10.1 months (range, 0.3 to 73.9 months). 82 (74.5%) patients had recurrence within 2 years after gastrectomy. The modes of surgical procedure and lymph node dissection influenced significantly on the time to recurrence (P<0.05 for both). Among the 110 patients with recurrence, 46 (41.8%) patients had peritoneal metastases, 33 (30.0%) had hematogenous metastases and 32 (29.1%) had locoregional lymph node metastases. Single, double, triple and quatro recurrences were observed at the first time of relapse in 78 (70.9%), 21(19.1%), 9(8.2%) and 2 cases (1.8%), respectively. Patients who developed simultaneous quatro recurrence had the poorest prognosis with a median overall survival of 15.2 months, significantly shorter than that of patients with single recurrence (31.8 months, P=0.003). Patients with peritoneal recurrence died most quickly ( mean 5.6 months), and patients with surgical field recurrence alone survived longest (mean 17.1 months).</p><p><b>CONCLUSIONS</b>Peritoneal, hematogenous and locoregional lymph node metastases are the most frequent recurrences after radical gastrectomy and adjuvant chemotherapy in patients with gastric cancer. Single recurrence occurred in most patients at the first relapse. Combination with other adjuvant treatments should be considered besides adjuvant chemotherapy in gastric cancer patients after radical gastrectomy.</p>


Subject(s)
Humans , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Chemotherapy, Adjuvant , Fluorouracil , Gastrectomy , Methods , Leucovorin , Lymph Node Excision , Lymphatic Metastasis , Neoplasm Recurrence, Local , Mortality , Neoplasms, Second Primary , Organoplatinum Compounds , Prognosis , Retrospective Studies , Stomach Neoplasms , Mortality , Therapeutics , Taxoids , Time Factors
4.
Chinese Journal of Clinical Oncology ; (24): 319-323, 2014.
Article in Chinese | WPRIM | ID: wpr-445379

ABSTRACT

Objective:This study aims to determine the efficacy of chemotherapy and to identify potential chemotherapy agents for advanced primary duodenal carcinoma (PDC). Methods:Fifty-six patients with advanced PDC, who did and did not receive chemo-therapy, were involved in this study. Response rates (RR), disease control rates (DCR), progression-free survival (PFS), and overall sur-vival (OS) were analyzed. Results:The overall RR and DCR of 43 patients were 19.04%and 71.42%, respectively. The patients who re-ceived chemotherapy agents fluorourzcil and oxaliplatin exhibited higher RR compared with patients who received other chemotherapy combinations (35.29%vs. 7.69%, P=0.010 9). Palliative chemotherapy improved the OS of patients with advanced PDC compared with patients who did not receive chemotherapy (13.35 months vs. 5.65 months, HR=0.203, 95%CI:0.083 to 0.497, P=0.000 5). Compared with the use of other chemotherapy regimens, treatment with a fluorourzcil-based chemotherapy agent resulted in a longer PFS (5.08 months vs. 1.08 months, HR=0.004, 95%CI:0.000 to 0.315, P=0.013 2). Multivariate analysis indicated mucinous histology and lymph mode metastasis as factors predictive of poor prognosis in patients with advanced PDC. Conclusion:Palliative chemotherapy may im-prove the OS of patients with advanced PDC.

5.
Chinese Journal of Oncology ; (12): 346-350, 2014.
Article in Chinese | WPRIM | ID: wpr-328939

ABSTRACT

<p><b>OBJECTIVE</b>Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been reported to be effective in the treatment of esophageal and esophagogastric junction cancers. The aim of this study was to detect the frequency of EGFR mutation and expression in Chinese patients with esophageal, esophagogastric junction and gastric cancers, and to clarify the value of EGFR mutation and expression in predicting the efficacy of TKI in the treatment of these tumors.</p><p><b>METHODS</b>In this study, 180 tumor samples with histologically confirmed esophageal cancer (39 cases), cancer of the esophagogastric junction (92 cases) and gastric cancer (49 cases) were collected. Twenty-nine different EGFR mutations in exons 18-21 were assessed by real-time PCR-optimized oligonucleotide probe method. EGFR protein expression was evaluated by immunohistochemistry (IHC) in 89 tumor samples.</p><p><b>RESULTS</b>The mutation analysis for EGFR (exons 18-21) showed no mutations in any of the hotspots of the gene in the 180 tumor samples analyzed. EGFR expression was negative in 12 tumor samples, 1+ in 31 tumor samples, 2+ in 24 tumor samples, and 3+ in 22 tumor samples. EGFR expression was 2+ or 3+ in 12 (92.3%) of the 13 esophageal squamous cell carcinomas, 29 (47.5%) of the 61 esophagogastric junction cancers, and 5 (33.3%) of the 15 gastric adenocarcinomas.</p><p><b>CONCLUSIONS</b>Our results indicate that EGFR mutation in exons 18-21 is absent in the examined samples of esophageal, esophagogastric junction and gastric cancers. More studies are warranted to explore the predictive biological markers for the therapeutic response to EGFR TKI.</p>


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Adenocarcinoma , Genetics , Metabolism , Carcinoma, Adenosquamous , Genetics , Metabolism , Carcinoma, Squamous Cell , Genetics , Metabolism , Esophageal Neoplasms , Genetics , Metabolism , Esophagogastric Junction , Metabolism , Pathology , Exons , Mutation , ErbB Receptors , Genetics , Metabolism , Stomach Neoplasms , Genetics , Metabolism
6.
Chinese Journal of Oncology ; (12): 844-848, 2014.
Article in Chinese | WPRIM | ID: wpr-272278

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the role of DNA mismatch repair (MMR) as a prognostic indicator of radical resection and a predictor of fluorouracil-based adjuvant therapy benefit in patients with stage II/III colon cancer.</p><p><b>METHODS</b>The clinicopathological characteristics of 172 patients with stage II/III colon cancer who underwent radical resection were retrospectively analyzed. Immunohistochemical staining was used to detect the expression of DNA mismatch repair (MLH1/MSH2/MSH6/PMS2) in the tumor tissues.</p><p><b>RESULTS</b>Among a total of 172 patients, there were 38 (22.1%) cases with defective DNA mismatch repair (dMMR) and 134 (77.9%) cases with proficient DNA mismatch repair (pMMR). Among the 115 patients who did not receive adjuvant chemotherapy, those with tumor displaying dMMR had a better 5-year overall survival (OS) rate and disease-free survival (DFS) rate than the patients with proficient DNA mismatch repair (pMMR) (88.0% vs. 66.7%, P = 0.040; 84.0% vs. 60.0%, P = 0.034). The benefit of adjuvant chemotherapy differed significantly according to the MMR status. Adjuvant 5-Fu chemotherapy improved the 5-year overall survival rate among 134 patients with pMMR (86.4%) than that in patients treated by surgery alone (66.7%, P = 0.012). By contrast, there was no benefit of adjuvant 5-Fu chemotherapy in the patients with dMMR (61.5% vs. 86.4%, P = 0.062), which was even more clear the 5-year disease-free survival rate (53.8% vs. 84.0%, P = 0.038).</p><p><b>CONCLUSIONS</b>MMR status is a predictor of the benefit of adjuvant chemotherapy with fluorouracil in stage II/III colon cancer. Patients with stage II/III colon cancer displaying dMMR have a better prognosis than those with pMMR.</p>


Subject(s)
Humans , Antineoplastic Combined Chemotherapy Protocols , Chemotherapy, Adjuvant , Colonic Neoplasms , Diagnosis , Therapeutics , Combined Modality Therapy , DNA Mismatch Repair , Disease-Free Survival , Fluorouracil , Neoplasm Staging , Prognosis , Retrospective Studies , Survival Rate , Treatment Outcome
7.
Chinese Journal of Oncology ; (12): 212-216, 2014.
Article in Chinese | WPRIM | ID: wpr-328984

ABSTRACT

<p><b>OBJECTIVE</b>The aim of this study was to analyze the clinical characteristics, treatment and prognosis of advanced urothelial carcinoma of the bladder (AUCB).</p><p><b>METHODS</b>The clinicopathological data of 117 patients with AUCB admitted in our hospital from 1998 to 2009 were reviewed. All patients received first-line chemotherapy. The survival rate was calculated by Kaplan-Meier analysis and log-rank test.</p><p><b>RESULTS</b>The median age of all patients was 56 years and the male-to-female ratio was 3.33:1. Their 6-, 12-, 24-, 36- and 60-month survival rates were 90.3%, 61.3%, 32.3%, 24.2% and 8.1%, respectively. In the first-line chemotherapy regimen, the effectiveness rate of gemcitabine + platinum drugs was 49.3% (37/75), the median progression-free survival(PFS) was 7.9 months and overall survival (OS) was 18.7 months. The effectiveness of cyclophosphamide + epirubicin + platinum drug regimen was 45.5% (10/22), Median PFS was 7.1 months and OS was 15.3 months. The effectiveness of paclitaxel + platinum drug regimen was 47.1% (8/17), median PFS was 6.5 months and OS was 13.7 months. Among them, the effectiveness rate of the gemcitabine + cisplatin regimen in 67 patients was 47.8%, the median PFS was 7.0 months and OS was 15.3 months. In the 13 patients who received paclitaxel + carboplatin regimen, the effectiveness rate was 53.8%, median PFS was 7.7 months and OS was 16.0 months. The major side effects were leucopenia and thrombocytopenia, mostly were tolerable, of grade I to II.</p><p><b>CONCLUSIONS</b>In advanced unresectable and metastatic urothelial carcinoma of the bladder, GC regimen is recognized as a standard first-line chemotherapy, with a higher effectiveness and tolerable side effects. Taxane and molecular targeted drugs may further improve the therapeutic effect of the treatment of advanced urothelial carcinomas of the bladder in the future.</p>


Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Bone Neoplasms , Drug Therapy , Carboplatin , Carcinoma, Transitional Cell , Drug Therapy , Pathology , Cisplatin , Cyclophosphamide , Deoxycytidine , Disease-Free Survival , Epirubicin , Follow-Up Studies , Leukopenia , Liver Neoplasms , Drug Therapy , Lung Neoplasms , Drug Therapy , Lymphatic Metastasis , Neoplasm Staging , Paclitaxel , Retrospective Studies , Survival Rate , Thrombocytopenia , Urinary Bladder Neoplasms , Drug Therapy , Pathology , Urothelium , Pathology
8.
Chinese Journal of Clinical Oncology ; (24): 988-991, 2013.
Article in Chinese | WPRIM | ID: wpr-437334

ABSTRACT

Objective:To examine metastatic gastric cancer patients who underwent surgery after chemotherapy and to determine the factors affecting survival. Methods:Clinical data on metastatic gastric cancer patients who underwent surgery after chemotherapy were retrospectively analyzed. The overall survival data were evaluated through the Kaplan-Meier method, Log-rank test, and Cox haz-ards regression. Results:The median age was 46 (22~74), and the median overall survival rate (OS) was 19 months (4~59 months). Response to chemotherapy (23.0 m for PR and 14.5 m for SD, P=0.045) and resection of the primary tumor (23.0 and 5.5 m, respective-ly, P=0.017) affected OS. No single factor was related to OS according to Cox regression. Conclusion:Surgical removal of the primary tumor is recommended for metastatic gastric cancer patients with positive response to chemotherapy and with a primary tumor that can be resected.

9.
Chinese Journal of Urology ; (12): 8-11, 2010.
Article in Chinese | WPRIM | ID: wpr-391573

ABSTRACT

Objective To evaluate the safety and efficacy of sorafenib for patients with advanced stage renal cell carcinoma.Methods The clinical data of 85 patients with advanced renal cell carcinoma were reviewed.These patients were treated by sorafenib 400 mg Bid,dose escalation of sorafenib(400 mg Bid 1-4 weeks;600 mg Bid 5-8 weeks;800 mg Bid since then) or sorafenib 400 mg Bid+NF-α,respectively,until intolerance or disease progression occurred.The primary end points were objective response,disease control rate and adverse effects rate.Results The data of 80 patients can be evaluated.The median follow-up duration was 72 weeks (4-108 weeks).One patient (1.2%) reached complete remission(CR),17 cases(21.2%) reached partial remission(PR),50 cases (62.5%) maintained stable disease (SD),and 12 cases (15%) progressed.The objective response (CR+PR) was 22.5%,disease control rate (CR+PR-SD)was 85.0%.By May 2009,only 18 patients died,progression free survival and overall survival were not available.The common side effects included hand-foot skin reaction (55.0%),mucosa hemorrhage (52.5%),diarrhea(40.0%),lassitude (35.0%),anorexia(22.5%),mucosa ulcer(20.0%),hypertension(15.0%) and baldness(15.0%)etc.Most of these side effects could be released by symptomatic treatment.Conclusion Sorafenib has good short term effect for patients with advanced renal cell carcinoma and is well tolerated.

10.
Chinese Journal of Urology ; (12): 15-17, 2009.
Article in Chinese | WPRIM | ID: wpr-397002

ABSTRACT

Objective To evaluate the safety and efficacy of sorafenib as first line treatment in patients with metastatic renal cell carcinoma. Methods Eleven patients with metastatic renal cell carcinoma after radical nephrectomy and 1 patient with locally advanced renal cell carcinoma and unre-sectable primary renal tumor were eligible for this study. The regimen was oral intake of sorafenib (400 mg twice daily) until the disease progression or toxicity becoming intolerable. Results All pa-tients were evaluable for response and toxicity assessment. The overall objective response rate and dis-ease control rate were 25%(3/12) and 83%(10/12, 3 partial responses and 7 disease stabilizations). The actuarial 6-month progression-free survival was 83% (10/12), while the median survival time was 16 months. The most common adverse effects included hand-foot skin reaction, rash, alopecia and hy-pertension. Conclusion Sorafenib is effective and safe as first line treatment for patients with meta-static renal cell carcinoma.

11.
Chinese Journal of Urology ; (12): 10-14, 2009.
Article in Chinese | WPRIM | ID: wpr-396922

ABSTRACT

Objective To evaluate the efficacy and safety of sorafenib in the treatment of Chi-nese patients with metastatic renal cell carcinoma. Methods This muhicenter phase Ⅱ clinical trial was performed from May 2006 to December 2006. Sixty-two patients with metastatic renal cell carci-noma not suitable for curative treatment were enrolled. All patients received oral sorafenib as single a-gent at the dose of 400 mg twice a day until disease progression or intolerable toxicities occurred. Re-salts Partial responses were recorded as best response in 11 patients, while complete remission was found in 1 patient and stable diseases were found in another 35 patients. According to the intents-to-treatment population, the overall response rate was 19.4% (12/62), and the disease control rate was 77.4%(48/62). The median progression free survival time was 9.6 months with 1-year progression-free survival rate of 41.9%. However, the median survival time had not reached due to the short fol-low-up. The most frequent adverse events included alopecia (66.1%), diarrhea (62.9%), hand-foot syndrome (58.1%), anorexia (40.3%), rash(37.1%), fatigue (37.1%), hypertension (35.5%), hoarseness(32.3%), joint pain (25.8%), hypophosphatemia (21.0%), fever (19.4%), nausea (19.4%), abnormal transeaminase( 11.3% ), elevated total bilirubicin( 16.1% ), leucopenia( 12.9% ), bleeding under nail(16.1%), and gum bleeding(11.3%). Grade 3 adverse events included hand-foot syndrome (16.1%), hypertension (12.9%), diarrhea(6.5%), hypophosphatemia (4.8%), joint pain (3.2%), and leucopenia(3.2%). Conclusions Sorafenib has prominent anti-tumor activity in Chi-nese metastatic renal cell cancer patients with most adverse events being grade 1 or 2. More attention should be paid to hypertension and cardio-cerebral vascular events during the application of sorafenib.

12.
Chinese Journal of Urology ; (12): 18-20, 2009.
Article in Chinese | WPRIM | ID: wpr-396908

ABSTRACT

Objective To evaluate the safety and efficacy of dosage-escalated sorafenib in pa-tients with metastatic renal cell carcinoma. Methods Twelve male patients and 4 female patients with median age of 53 (37-71 years) were included in this study. They were with refractory meta-static renal-clear-cell carcinoma and received sorafenib from 800 mg/d to 1200mg/d or 1800 mg/d gradually until intolerable or disease progression occurred. Overall response rate, toxicity and progres-sion free survival (PFS) were recorded and analyzed. Results The median follow-up was 11 months (9-16 months). The overall rate of objective response and disease control rate were 44%(7/16)and 81%(13/16), respectively. Serious adverse effects (≥Grade Ⅲ) included hand-foot skin reaction (25%, 4/16), mucositis (19%, 3/16), diarrhea (19%, 3/16), hypertension (12%, 2/16) and my-elosuppression (12%, 2/16). PFS for high risk patient was 9.2 months at the end of this study. Conclusions The dosage-escalated sorafenib could obtain a high response rate and prolong PFS of high-risk patients. The toxicities are tolerable for metastatic renal cell carcinoma patients treated with sorafenib.

13.
Chinese Journal of Lung Cancer ; (12): 283-290, 2005.
Article in Chinese | WPRIM | ID: wpr-313355

ABSTRACT

<p><b>BACKGROUND</b>Endostar™ (rh-endostatin, YH-16) is a new recombinant human endostatin developed by Medgenn Bioengineering Co. Ltd., Yantai, Shandong, P.R.China. Pre-clinical study indicated that YH-16 could inhibit tumor endothelial cell proliferation, angiogenesis and tumor growth. Phase I and phase II studies revealed that YH-16 was effective as single agent with good tolerance in clinical use.The current study was to compare the response rate , median ti me to progression (TTP) ,clinical benefit andsafety in patients with advanced non-small cell lung cancer ( NSCLC) , who were treated with YH-16 plus vi-norelbine and cisplatin (NP) or placebo plus NP.</p><p><b>METHODS</b>Four hundred and ninety-three histologically or cy-tologically confirmed stage IIIB and IV NSCLC patients , withlife expectancy > 3 months and ECOG perform-ance status 0-2 , were enrolledin a randomized ,double-blind ,placebo-controlled , multicenter trial ,either trialgroup : NP plus YH-16 (vinorelbine 25 mg/m² on day 1 and day 5 ,cisplatin 30mg/m² on days 2 to 4 , YH-167.5mg/m² on days 1 to 14) or control group : NP plus placebo (vinorelbine 25 mg/m² on day 1 and day 5 ,cis-platin 30 mg/m² on days 2 to 4 ,0.9% sodium-chloride 3 .75 ml on days 1 to 14) every 3 weeks for 2-6 cycles .The trial endpoints included response rate ,clinical benefit rate ,time to progression,quality of life and safety .</p><p><b>RESULTS</b>Of 486 assessable patients , overall response rate was 35.4% in trial group and 19.5% in controlgroup (P=0 .0003) . The median TTP was 6 .3 months and 3 .6 months for trial group and control group respectively (P < 0 .001) . The clinical benefit rate was 73 .3 %in trial group and 64.0% in control group (P=0 .035) .In untreated patients of trial group and control group ,the response rate was 40 .0% and 23.9%(P=0 .003) ,the clinical benefit rate was 76 .5 % and 65 .0 % (P=0 .023) ,the median TTP was 6 .6 and 3 .7months (P=0 .0000) ,respectively .In pretreated patients of trial group and control group ,the response ratewas 23.9% and 8.5%(P=0 .034) ,the clinical benefit rate was 65.2% and 61.7%(P=0 .68) ,the median TTP was 5 .7 and 3 .2 months (P=0 .0002) ,respectively . The relief rate of clinical symptoms in trial groupwas higher than that of those in control group ,but no significance existed (P > 0 .05) . The score of quality oflife in trial group was significantly higher than that in control group (P=0 .0155) after treatment . There were no significant differences in incidence of hematologic and non-hematologic toxicity , moderate and severe sideeffects betweentrial group and control group .</p><p><b>CONCLUSIONS</b>The addition of YH-16 to NP regimen results in significantly and clinically meaningful improvement in response rate , median time to tumor progression,and clinical benefit rate compared with NP alone in advanced NSCLC patients . YH-16 in combination with chemotherapy shows a synergic activity and a favorable toxic profile in advanced cancer patients .</p>

14.
Chinese Journal of Lung Cancer ; (12): 375-377, 2003.
Article in Chinese | WPRIM | ID: wpr-345885

ABSTRACT

<p><b>BACKGROUND</b>To evaluate the efficacy and side effects of weekly administration of gemcitabine combined with docetaxel in the treatment of advanced non-small cell lung cancer.</p><p><b>METHODS</b>Twenty-six patients with advanced non-small cell lung cancer, with or without prior chemotherapy, were entered into this study. Gemcitabine and docetaxel were administrated weekly for 3 consecutive weeks, followed by 1 week rest. Gemcitabine was given as 800-1 200 mg/m² by intravenous infusion on days 1, 8, 15; while docetaxel was 35 mg/m² intravenously on the same days as gemcitabine. The efficacy including response rate and median survival duration and toxicity were observed.</p><p><b>RESULTS</b>Of the 26 patients, one achieved complete response (CR), and 6 achieved partial response (PR), with an overall response rate of 27%. The median survival duration was 9.5 months and 1-year survival rate was 38% (10/26). The main toxicities were neutropenia and thrombocytopenia. One patient died from allergic shock.</p><p><b>CONCLUSIONS</b>The combination of docetaxel and gemcitabine is effective and well-tolerated in the treatment of advanced NSCLC.</p>

15.
Chinese Journal of Oncology ; (12): 602-604, 2002.
Article in Chinese | WPRIM | ID: wpr-301925

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the efficacy of combined modality treatment and determine the prognostic factors for small cell lung cancer (SCLC).</p><p><b>METHODS</b>From January 1974 to December 1995, 1260 patients with SCLC treated were retrospectively evaluated, with limited lesions in 732 patients, extensive lesions in 500 and stage unrecorded in 28. 553 patients were alloted into chemotherapy + radiotherapy (C + R) group, 355 into C + R + C group, 97 into R + C group, 126 into C group, 64 into R group and 65 into surgery (S + C + R) group. Patients with limited lesions received 2 - 4 cycles of chemotherapy including COMC, COMP, COMVP and CE-CAP. Radiotherapy was given to a dose of 40 - 70 Gy/4 - 7 w. Radiation portals for patients with limited lesions encompassed the primary tumor, hilar lymphatic drainage areas, partial mediastinum and bilateral supraclavicular regions. Patients with extensive lesions mainly received chemotherapy with or without palliative irradiation.</p><p><b>RESULTS</b>The overall CR and PR rates were 26.7% and 52.3%. Local recurrence and distant metastasis rates were 58.8% and 61.5%. The 1-, 3- and 5-year survival rates were 50.2%, 14.7% and 11.7%, with median survival time of 12 months. The era, sex, age, tumor stage and treatment modality were all significant prognostic factors by both uni-variate and multi-variate analyses (P < 0.05). The result of S + C + R rated the best among these modalities and the result of C + R + C was superior to C + R, though the difference of which was not significant.</p><p><b>CONCLUSION</b>Surgical resection should be considered as one part of comprehensive therapy for small cell lung cancer patients with limited lesions whenever possible. On top of routine chemotherapy early administration of radiotherapy is advisable.</p>


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , Carcinoma, Small Cell , Mortality , Therapeutics , Combined Modality Therapy , Lung Neoplasms , Mortality , Therapeutics , Radiotherapy , Survival Rate , Treatment Outcome
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