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Objective:To investigate the clinical efficacy and prognostic influencing factors of radical surgery for duodenal gastrointestinal stromal tumor (GIST).Methods:The retrospective cohort study was conducted. The clinicopathological data of 741 duodenal GIST patients who under-went radical surgery in 17 medical centers, including 121 cases in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 121 cases in Chinese PLA General Hospital, 116 cases in Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 77 cases in Fudan University Shanghai Cancer Center, 77 cases in West China Hospital, Sichuan University, 31 cases in Guangdong Provincial People′s Hospital, 24 cases in Fujian Cancer Hospital, 22 cases in Fujian Medical University Union Hospital, 25 cases in Shengjing Hospital of China Medical University, 19 cases in Xiangya Hospital, Central South University, 23 cases in Zhejiang Cancer Hospital, 17 cases in Liaoning Cancer Hospital＆Institute, 17 cases in the First Affiliated Hospital of Xiamen University, 15 cases in Sun Yat-sen University Cancer Center, 14 cases in the First Affiliated Hospital of Nanjing Medical University, 14 cases in Zhongshan Hospital Affiliated to Xiamen University and 8 cases in General Hospital of Chinese People′s Liberation Army Air Force, from January 2010 to April 2020 were collected. There were 346 males and 395 females, aged 55(range, 17?86)years. Observation indicators: (1) neoadjuvant treatment; (2) surgical and postoperative situations; (3) follow-up; (4) stratified analysis. Follow-up was conducted using outpatient examination or telephone interview. Patients were followed up once every 3?6 months during neoadjuvant therapy and once every 6?12 months after radical surgery to detect tumor recurrence and survival of patient up to April 2022. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using chi-square test or Fisher exact probability. The Kaplan-Meier method was used to draw survival curves and calculate survival rates. Log-rank test was used for survival analysis. The COX regression model was used for univariate and multivariate analyses. Propensity score matching was done by the 1∶1 nearest neighbor matching method, and the matching tolerance was 0.02. Results:(1) Neoadjuvant therapy. Of the 741 patients, 34 cases received neoadjuvant therapy for 8(range, 3?44)months. Cases assessed as partial response, stable disease and progressive disease before the radical surgery of the 34 cases were 21, 9, 4, respectively. The tumor diameter of the 34 patients before the neoadjuvant therapy and before the radical surgery were 8.0(range, 3.0?26.0)cm and 5.3(range, 3.0?18.0)cm, with the regression rate as 31.9%(range, ?166.7% to 58.3%). (2) Surgical and postoperative situations. Of the 741 patients, 34 cases underwent radical surgery after receiving neoadjuvant therapy, and 707 cases underwent radical surgery directly. All the 741 patients underwent radical surgery successfully, in which 633, 102 and 6 cases received open surgery, laparoscopic surgery and endoscopic treatment, respectively. Of the 633 cases receiving open surgery and the 102 cases receiving laparoscopic surgery, cases with surgical resection range as pancreatoduodenectomy (PD) was 238, and cases with surgical resection range as duodenal limited resection, including duodenal wedge resection, distal gastrectomy, segmental duodenal resection, local resection of duodenal tumor or segmental duodenum combined with subtotal gastrectomy, was 497, 226, 55, 204, 12. Of the 741 patients, 131 cases had post-operative complications including 113 cases with grade Ⅰ?Ⅱ complications and 18 cases with ≥ grade Ⅲ complications of the Clavien-Dindo classification. The duration of postoperative hospital stay of the 741 patients was 13(range, 4?120)days. Of the 707 patients receiving direct radical surgery, 371 cases were evaluated as extremely low risk, low risk, medium risk of the modified National Institutes of Health (NIH) risk classification after surgery, and 336 cases were evaluated as high risk in which 205 cases receive postoperative adjuvant imatinib therapy with the treatment time as 24(range, 6?110)months. (3) Follow-up. All the 741 patients were followed up for 58(range, 7?150)months. During the follow-up, 110 patients had tumor recurrence and metastasis. The 1-, 3-, 5-year overall survival rates and 1-, 3-, 5-year disease-free survival rates of the 741 patients were 100.0%, 98.6%, 94.5% and 98.4%, 90.9%, 84.9%, respectively. The 1-, 3-, 5-year overall survival rates and 1-, 3-, 5-year disease-free survival rates of the 707 patients receiving direct radical surgery were 100.0%, 98.5%, 94.3% and 98.4%, 91.1%, 85.4%, respectively. (4) Stratified analysis. ① Analysis of prognostic factors in patients undergoing radical surgery directly. Results of univariate analysis showed that primary tumor location, tumor diameter, mitotic count, modified NIH risk classification and tumor gene information were related factors affecting the overall survival of 707 patients with primary duodenal GIST who underwent direct radical surgery ( hazard ratio=0.43, 0.18, 0.22, 0.06, 0.29, 95% confidence intervals as 0.20?0.93, 0.09?0.35, 0.10?0.50, 0.03?0.12, 0.09?0.95, P<0.05). The primary tumor location, tumor diameter, mitotic count, modified NIH risk classification were related factors affecting the disease-free survival of 707 patients with primary duodenal GIST who underwent direct radical surgery ( hazard ratio=0.65, 0.25, 0.25, 0.10, 95% confidence intervals as 0.41?1.03, 0.17?0.37, 0.15?0.42, 0.07?0.15, P<0.05). Results of multivariate analysis showed that primary tumor located at the horizontal segment of duodenum, mitotic count >5/50 high power field, tumor gene KIT exon 9 mutation were independent risk factors affecting the overall survival of 365 patients with primary duodenal GIST after removing 342 patients without tumor gene information who underwent direct radical surgery ( hazard ratio=2.85, 2.73, 3.13, 95% confidence intervals as 1.12?7.20, 1.07?6.94, 1.23?7.93, P<0.05). Tumor diameter >5 cm and mitotic count >5/50 high power field were independent risk factors affecting the disease-free survival of 707 patients with primary duodenal GIST who underwent direct radical surgery ( hazard ratio=3.19, 2.98, 95% confidence intervals as 2.05?4.97, 1.99?4.45, P<0.05). ② Effect of postoperative adjuvant therapy on prognosis of high-risk patients of modified NIH risk classification. Of the 336 patients evaluated as high risk of the modified NIH risk classification, the 5-year overall survival rate and 5-year disease-free survival rate were 94.6% and 77.3% in the 205 cases with postoperative adjuvant therapy, versus 83.2% and 64.4% in the 131 cases without postoperative adjuvant therapy, showing significant differences between them ( χ2=8.39, 4.44, P<0.05). Of the 205 patients evaluated as high risk of the modified NIH risk classification who received postoperative adjuvant therapy, there were 106 cases receiving postoperative adjuvant therapy <36 months, with the 5-year overall survival rate and 5-year disease-free survival rate were 87.1% and 58.7%, and there were 99 cases receiving post-operative adjuvant therapy ≥36 months, with the 5-year overall survival rate and 5-year disease-free survival rate were 100.0% and 91.5%. There were significant differences in the 5-year overall survival rate and 5-year disease-free survival rate between the 106 patients and the 99 patients ( χ2=13.92, 29.61, P<0.05). ③ Comparison of clinical efficacy of patients with different surgical methods. Before propensity score matching, cases with primary tumor located at bulb, descending, horizontal, ascending segment of duodenum, cases with tumor diameter ≤5 cm and >5 cm were 95, 307, 147, 34, 331, 252, in the 583 patients receiving open surgery with complete clinical data, versus 15, 46, 17, 5, 67, 16 in the 83 patients receiving laparoscopic surgery with complete clinical data, showing no significant difference in the primary tumor location ( χ2=0.94, P>0.05), and a significant difference in the tumor diameter ( χ2=17.33, P<0.05) between them. After propensity score matching, the above indicator were 16, 39, 20, 8, 67, 16 in the 83 patients receiving open surgery, versus 15, 46, 17, 5, 67, 16 in the 83 patients receiving laparoscopic surgery, showing no significant difference between them ( χ2=1.54, 0.00, P>0.05). Cases with postoperative complications, cases with grade Ⅰ?Ⅱ complica-tions and ≥grade Ⅲ complications of the Clavien-Dindo classification, duration of postoperative hospital stay, the 5-year overall survival rate and 5-year disease-free survival rate were 17, 12, 5, 11(range, 5?120)days, 92.0%, 100.0% in the 83 patients receiving open surgery, versus 9, 7, 2, 11(range, 5?41)days, 91.6%, 97.3% in the 83 patients receiving laparoscopic surgery, showing no signi-ficant difference in postoperative complications, duration of postoperative hospital stay, the 5-year overall survival rate and 5-year disease-free survival rate ( χ2=2.91, Z=3 365.50, χ2=3.02, 1.49, P>0.05) between them. There was no significant difference in complications of the Clavien-Dindo classification between them ( P>0.05). ④ Comparison of clinical efficacy of patients with primary tumor located at the descending segment of duodenum who underwent surgery with different surgical resection scopes. Before propensity score matching, cases with tumor diameter ≤5 cm and >5 cm, cases with tumor located at opposite side of mesangium and mesangium were 71, 85, 28, 128 in the 156 patients with primary tumor located at the descending segment of duodenum who underwent PD with complete clinical data, versus 92, 41, 120, 13 in the 133 patients with primary tumor located at the descending segment of duodenum who underwent duodenal limited resection with complete clinical data, showing significant differences between them ( χ2=16.34, 150.10, P<0.05). After propensity score matching, the above indicator were 28, 13, 16, 25 in the 41 patients with primary tumor located at the descending segment of duodenum who underwent PD with complete clinical data, versus 28, 13, 16, 25 in the 41 patients with primary tumor located at the descending segment of duodenum who underwent duodenal limited resection with complete clinical data, showing no significant difference between them ( χ2=0.00, 0.00, P>0.05). Cases with postopera-tive complications, cases with grade Ⅰ?Ⅱ complications and ≥grade Ⅲ compli-cations of the Clavien-Dindo classification, duration of postoperative hospital stay, the 5-year overall survival rate and 5-year disease-free survival rate were 13, 11, 2, 15(range, 9?62)days, 94.2%, 64.3% in the 41 patients with primary tumor located at the descending segment of duodenum who underwent PD with complete clinical data, versus 9, 8, 0, 15(range, 7?40)days, 100.0%, 78.8% in the 41 patients with primary tumor located at the descending segment of duodenum who underwent duodenal limited resection with complete clinical data, showing no significant difference in post-operative complica-tions, the 5-year overall survival rate and 5-year disease-free survival rate ( χ2=0.99, 0.34, 1.86, P>0.05) between them. There was no significant difference in complications of the Clavien-Dindo classification ( P>0.05) and there was a significant difference in duration of postopera-tive hospital stay ( Z=614.50, P<0.05) between them. Conclusions:The clinical efficacy of radical surgery for duodenal GIST are ideal. Primary tumor located at the horizontal segment of duodenum, mitotic count >5/50 high power field, tumor gene KIT exon 9 mutation are independent risk factors affec-ting the overall survival of patients undergoing direct radical surgery and tumor diameter >5 cm and mitotic count >5/50 high power field are independent risk factors affecting the disease-free survival of patients. There is no significant difference in the short-term efficacy and long-term prognosis between patients undergoing open surgery and laparoscopic surgery. For patients with primary tumor located at the descending segment of duodenum, the duration of postoperative hospital stay is longer in patients undergoing PD compared with patients undergoing duodenal limited resection. For patients evaluated as high risk of the modified NIH risk classification, posto-perative adjuvant therapy and treatment time ≥36 months are conducive to improving the prognosis of patients.
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For resectable gastric cancer, although radical surgery is still the main treatment, methods of operation and the curative effect of operation are still in the stage of exploration for metastatic gastric cancer. Radiotherapy, chemotherapy and molecular targeted therapy also play an important role in prolonging the survival period of patients with gastric cancer. Postoperative radiotherapy and chemotherapy can prolong the survival time, but for patients with locally advanced gastric cancer, the preoperative radiotherapy and chemotherapy can also further improve the survival period of patients compared with direct operation. In addition, with the development and using of molecular targeted drugs, such as antiangiogenic agents, immunosuppressive drugs and so on, the survival period of patients with gastric cancer has been further extended.
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Humans , Antineoplastic Combined Chemotherapy Protocols , Gastrectomy , Neoadjuvant Therapy , Splenic Neoplasms , Stomach Neoplasms , Drug TherapyABSTRACT
Objective:To explore the expression of R-spondin family in colorectal cancer tissues and adjacent tissues,and to evaluate its relationship with clinic-pathological stage.Methods:A total of 64 samples of colorectal cancer tissues and adjacent tissues were collected from the patients,who received radical surgery in Xiangya Hospital,Central South University between January 2014 and August 2014.The mRNA and protein expression levels of R-spondin 1-4 and β-catenin in the colorectal cancer tissues and adjacent tissues were detected by qRT-PCR and immunohistochemistry.The relationship between the expression level of R-spondin 1-4 and the clinic-pathological factors were analyzed to explore the correlation between the expression level of R-spondin 1-4 and β-catenin in colorectal cancer.Results:Compared with the adjacent tissues,the mRNA and protein expression levels of R-spondin 1 were elevated in the colorectal cancer tissues (P＜0.05).The mRNA and protein expression levels of R-spondin 2-4 were increased in the colorectal cancer tissues than those in the normal tissues (P＜0.05),but there was no significant difference between the colorectal cancer tissues and adjacent tissues (P＞0.05).The expression level of R-spondin i was positively correlated with the nuclear expression of β-catenin in the colorectal cancer tissues (r=0.6307,P＜0.05).Conclusion:Compared with the adjacent tissues,the mRNA and protein expression levels of R-spondin 1 are significantly elevated in the colorectal cancer tissues.R-spondin 1 may play a role in promoting carcinogenesis by regulating the activity of β-catenin in the downstream of Wnt signaling pathway.
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OBJECTIVE@#To investigate the clinical features, diagnosis, treatments and prognosis for gastrointestinal neuroendocrine tumors (GI-NETs). @*METHODS@#Clincal data of 52 patients, who were diagnosed as GI-NETs between January 2004 and October 2014, were reviewed. The patients were divided into a local excision group (n=21) and a transabdominal excision group (n=30), and the major clinical features, treatment modalities and outcomes were analyzed. @*RESULTS@#The clinical features of GI-NETs were nonspecific, and most of the clinical manifestation were local invasiveness. CT scan was lack of specific findings. GI-NETs greater than 1 cm often showed local incrassation, upheaval and soft tissue shadow. In the case of lager GI-NETs, necrosis and moderate enhancement could be seen. Positive ratio for expression of chromogranin A (CgA) and synaptophysin (Syn) in the 52 cases of specimen were 63.5% and 88.5%, respectively. Except 1 patient, whose surgery was canceled because of poor health, other 51 patients were treated with surgery through different approaches. Among them, 30 cases were transabdominal resection (57.7%) and 21 were local resection (40.4%). Chemotherapy and/or radiotherapy was only applied for 7 patients. After a follow-up of 40 (3-132) months, 7 patients died, the rest were alive. The median survival in the local resection group and the transabdominal resection group was 43.0 and 39.5 months, respectively (P>0.05). @*CONCLUSION@#Under the condition of fully understanding the biological characteristics of GI-NETs, early diagnosis and timely personalized treatment is hopeful to reach the relative good prognosis and survival.
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Humans , Chromogranin A , Gastrointestinal Neoplasms , Neuroendocrine Tumors , PrognosisABSTRACT
OBJECTIVE@#To assess the value of proximal gastrectomy (PG) and total gastrectomy (TG) for the treatment of cancer of cardia and fundus.@*METHODS@#Publications on comparision between PG and TG in the treatment of cancer of cardia and fundus were collected, the data from the publications were matched with the PG group and the TG group respectively according to its corresponding surgical resection, and the data on postoperative complications, motality and 5-year survival rate were meta-analyzed by fixed effect model and random effect model.@*RESULTS@#Thirteen reseaches on 2 219 patients were included in this study, 2 of which were randomly controlled studies. There were no significant differences in the postoperative complications (OR=1.00, 95%CI: 0.44-2.28,P>0.05) and mortality (OR=1.25, 95%CI: 0.62-2.48,P>0.05) between the PG group and the TG group, while there was significant difference in the 5-year survival rate (HR=0.87, 95%CI: 0.76-0.99,P=0.04). The 5-year survival rate in the TG group was higher than that in the PG group.@*CONCLUSION@#Total gastrectomy for the treatment of cancer of cardia and fundus has better long-term therapetic effect.
Subject(s)
Humans , Cardia , Pathology , Gastrectomy , Methods , Gastric Fundus , Pathology , Prognosis , Stomach Neoplasms , Mortality , General Surgery , Survival RateABSTRACT
Objective: To assess the clinical features, diagnosis and treatment of gastrointestinal stromal tumor in the rectum.Methods: Records of 18 patients diagnosed as GIST in the rectum between January 2002 and April 2009 were re-viewed and the major clinical features, treatment modalities and outcomes were analyzed.Results: The clinical features of GIST in the rectum were nonspecific.Most patients manifested with bloody stool or changes in bowel habits.CT scan or MRI findings showed necrosis and/or hemorrhage in the tumor and well defined tumor margins.Even in the case of large GIST, no lymphadenopathy was not found, which could be a factor for the differential diagnosis of GIST from other rectal neoplasms.All of the resected tumor specimens showed positive expression of CD117 and CD34 in immunohistochemical staining.Low and very low risk patients accounted for 44.4% (8/18).All patients received surgery.Twelve patients were treated with local excision with different approaches.Anterior resection of the rectum (Dixon) was undertaken in three pa-tients and abdominoperineal resection (Miles) in three patients.Neoadjuvant therapy with imatinib was applied for three pa-tients with partial response.After a median follow-up of 34 months (1～84 months), recurrence and/or metastasis occurred in five patients, and three of them were treated with imatinib.One patient received Miles surgery after repeated local exci-sions.Only one patient died of bone metastasis.Recurrence-free survival (RFS) of the local excision group was longer than that of abdominoperineal resection (APR) group (75.0±8.4 months vs 26.0±11.1 months, P=0.023).Conclusion: The treatment for rectal GIST should be individualized and be different from that of rectal cancer.Treatment decision and choice of procedures should be based on careful preoperative evaluation of tumor size, location, extent and risk level.Most of the anorectal GIST were rated as low-risk in this cohort and could be excised locally by different approaches with satisfactory outcome.Neoadjuvant therapy with imatinib may benefit some patients to obtain the opportunity of sphincter-saving.
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Objective To study the effect of age on the recurrence-free survival rate after hepatic resection for hepatocellular carcinoma(HCC)and the relationship between microvessel density (MVD)and recurrence of HCC in the elderly. Methods Severty one cases of elderly patients with HCC were analyzed retrospectively with 352 cases of non-elderly HCC patients as control,and the effect of age on the recurrence-free survival rate was studied.The expressions of CD34 and endocan in HCC tissues were detected by immunohistochemistry in 30 elderly and 30 non-elderly patients.Results The 1-,3- and 5-year recurrence free survival rates were 75.7%,43.0% and 43.0% in the elderly group respectively,which were higher than those in the non-elderly group(53.6%,38.5% and 33.4%,respectively,Log Rank value=10.25,P＜0.05).The positive rate of alpha fetoprotein (AFP)in the elderly group was 47.9%,which was lower than that in the non-elderly group(62.2%)(X2=23.68,P＜0.05).The median survival times in the high CD34-MVD group and high endocan MVD group were shorter than those in the low CD34-MVD group and low endocan-MVD group(260 d vs.850 d,360 d vs.800 d,Log Rank value was 22.18 and 20.56 respectively,both P＜0.05).Conclusions The long-term prognosis of hepatic resection for HCC is better in elderly patients than in non-elderly patients.The recurrence of HCC in the elderly is closely related with angiogenesis.
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OBJECTIVE@#To explore the clinicopathologic and molecular characteristics of hereditary nonpolyposis colorectal cancer (HNPCC), and to improve the level of diagnosis and treatments of HNPCC.@*METHODS@#Thirty HNPCC patients (HNPCC group) who were treated in Xiangya Hospital were retrospectively analyzed, and 25 patients with sporadic colorectal cancer in the same duration were randomly chosen as a control group. The onset of age, location of tumor, pathological type, treatment method, and prognosis were compared in the 2 groups. The expression loss rate of mismatch repair gene (MMR) MLH1 and MSH2 in the 2 groups was detected by immunohistochemistry.@*RESULTS@#The onset age in the HNPCC group was earlier than that in the control group (P0.05).@*CONCLUSION@#HNPCC patients are characterized with early onset associating with multiple tumors. The accuracy of diagnosis can be improved by combining the detection of MMR gene. Optimal surgical treatment and close follow-up may bring good result to HNPCC patients.
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Adaptor Proteins, Signal Transducing , Genetics , Metabolism , Adenocarcinoma , Diagnosis , Genetics , Pathology , General Surgery , Case-Control Studies , Colorectal Neoplasms, Hereditary Nonpolyposis , Diagnosis , Genetics , Pathology , General Surgery , Endometrial Neoplasms , Pathology , MutL Protein Homolog 1 , MutS Homolog 2 Protein , Genetics , Metabolism , Mutation , Neoplasms, Second Primary , Pathology , Nuclear Proteins , Genetics , Metabolism , Retrospective StudiesABSTRACT
<p><b>OBJECTIVE</b>To investigate the correlation between epidermal growth factor (EGF) and overexpression of vascular endothelial growth factor (VEGF) in hepatocellular carcinoma (HCC).</p><p><b>METHODS</b>Expressions of EGF, VEGF and microvessel density were studied through immunohistochemical SABC method in 36 HCC specimens, their paraneoplastic liver tissues and 6 normal liver tissues with the correlation between these parameters analyzed. Recombinant human EGF was used to stimulate HepG(2) cells and semi-quantitative reverse transcription PCR was adopted to detect the expression of VEGF in HepG(2) cells.</p><p><b>RESULTS</b>The positive rates of EGF and VEGF expression in HCC tissue were 75.0% and 88.9%. There was positive correlation between EGF and VEGF expression (P < 0.01, r = 0.462). Recombinant human EGF could induce the expression of VEGF in HepG(2) cells in a dose and time dependent manner.</p><p><b>CONCLUSION</b>The expression of EGF in HCC underlies the overexpression of VEGF in HCC.</p>
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Carcinoma, Hepatocellular , Metabolism , Endothelial Growth Factors , Epidermal Growth Factor , Intercellular Signaling Peptides and Proteins , Liver Neoplasms , Metabolism , Lymphokines , Neovascularization, Pathologic , Statistics as Topic , Vascular Endothelial Growth Factor A , Vascular Endothelial Growth FactorsABSTRACT
Objective To study the expression of integrin ?v subunit(?v) in hepatocellular carcinoma(HCC )and its effect. Methods With the method of immunohistochemistry, specimens from 43 HCC patients and 6 control patients were studied. The relationship between the ?v expression and pathological features,microvessel density(MVD) was evaluated.Results The difference of the expression of ?v in tumor cells between HCC with satellite lesions and without it was significant(H=9 008, P =0 003).The MVD of HCC with positive and negative expression of ?v in endothelia was 151?54 and 115?39 respectively,difference of which was significant( t =2 503, P =0 016).Conclusions Integrin ?v subunit may play an important role in the angiogenesis, invasiveness and metastasis of hepatocellular carcinoma.
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Objective To investigate the expressions of vascular endothelial growth factor (VEGF) , hypoxia inducible factor 1 alpha (HIF 1?) and epidermal growth factor (EGF) in hepatocellular carcinoma (HCC) and their clinical significance. Methods The expressions of VEGF, HIF 1? and EGF in 36 cases of HCC and corresponding paraneoplastic tissues and normal liver tissues (6 cases) were studied by immunohistochemistry assay. ResultsThe expression rate of VEGF, HIF 1? and EGF in HCC tissue was 89%, 67% and 75% respectively, higher than those in paraneoplastic tissues and normal liver tissues ( P
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Objective This study was to investigate the effect of exogenous thyroid hormone on serum NO and iNOS activity of intestinal mucosa in septic rats. Methods Septic model was established by cecal ligation puncture(CLP) in male SD rats. Triiodothyronine(T 3) was administered intraperitoneally to correct the low T 3 syndrome of septic rats. Blood was collected to examine serum NO and thyroid hormone concentration. Intestinal mucosa iNOS activity was assayed using immunochemical stain. Results Mortality rate in the prevention group was significantly lower than the septic group(Log rank=3.85, P