Efficacy of adjuvant chemotherapy after curative resection for gastric cancer: A meta-analysis of published randomised trials

Background:Several studies have investigated the possible roleof the adjuvant chemotherapy after curative resection for gastric cancerfailing to show a clear indication; previous meta-analyses suggested smallsurvival benefit of adjuvant chemotherapy, but the statistical methods usedwere open to criticisms. Materials and methods:Randomised trials were identified by meansof Medline and CancerLit and by selecting references from relevant articles.Systematic review of all randomised clinical trials of adjuvant chemotherapyfor gastric cancer compared with surgery alone, published before January 2000,were considered. Pooling of data was performed using the fixed effect model.Death for any cause was the study endpoint. The hazard ratio and its95% confidence intervals (95% CI), derived according to themethod of Parmar, were the statistics chosen for summarising the relativebenefit of chemotherapyversuscontrol. Results:Overall 20 articles (21 comparisons) were considered foranalysis. Three studies used single agent chemotherapy, seven combination of5-fluorouracil (5-FU) with anthracyclin, ten combination of 5-FU withoutanthracyclines. Information on 3658 patients, 2180 deaths, was collected.Chemotherapy reduced the risk of death by 18% (hazard ratio 0.82,95% CI: 0.75–0.89, P < 0.001). Association ofAnthracyclines to 5-FU did not show a statistically significant improvementwhen compared with the effect of the other regimens. Conclusions:Chemotherapy produces a small survival benefit inpatients with curatively resected gastric cancer. However, taking into accountthe limitations of literature based meta-analyses, adjuvant chemotherapy isstill to be considered as an investigational approach.     

An updated meta-analysis of adjuvant chemotherapy after curative resection for gastric cancer

Objectives

To investigate whether and how much gastric cancer patients after curative resection could benefit from chemotherapy.

Patients and methods

Meta-analysis was conducted with all the qualified clinical randomized trials which compared adjuvant chemotherapy with surgery alone. The database includes MEDLINE, EMBase and CBM disc, and the censor data were up to November 2007. Primary outcomes were relative risk (RR) on death and disease-free survival (DFS); secondary outcomes include RR of adverse reactions of the two arms. Sub-group analysis and sensitivity analysis were also performed. All the calculations and statistical tests were done with the RevMan 4.2.8 software.

Results

Finally, 23 trials which included 4919 patients (2441 in the adjuvant chemotherapy arm, 2478 in the observation arm) achieved all the criteria. Among them, 19 studies reported the survival rate at the end of follow-up, 60.6% alive among 2286 patients in the adjuvant chemotherapy arm, 53.4% alive among 2313 patients in the observation arm, with the RR on death of 0.85 (95%CI: 0.80–0.90). Eight studies reported the DFS, and the observation arm had a shorter DFS (RR: 0.88, 95%CI: 0.77–0.99). Grade 3/4 of myelosuppression and GI toxicity occurred more frequently in the treatment arm. Nine studies reported the recurrence rate and suggested that the treatment arm had a lower recurrence rate (RR: 0.78, 95%CI: 0.71∼0.86).

Conclusions

Statistically, adjuvant chemotherapy could improve the survival rate and disease-free survival rate in gastric cancer after curative resection and reduce the relapse rate. However, the clinical benefits of adjuvant chemotherapy still need to be improved. Additionally, post-operative chemotherapy could be tolerated.     

Adjuvant chemotherapy after curative resection for gastric cancer in non-Asian patients: revisiting a meta-analysis of randomised trials

The aim of this study was to assess whether adjuvant chemotherapy after curative resection of gastric cancer increases survival rates. Data sources: MEDLINE (1966–1999), CancerLit (1983–1999), bibliographies, personal reprint files, and review articles were searched for relevant articles. Studies had to be randomised controlled trials of adjuvant chemotherapy versus observation following curative resection of stomach cancer that took place in non-Asian countries. Two reviewers independently evaluated the trials for eligibility, quality assessment and data abstraction. 13 trials met the eligibility criteria. The odds ratio for death in the treated group was 0.80 (95% confidence interval (CI) 0.66–0.97), corresponding to a relative risk of 0.94 (95% CI 0.89–1.00). Subgroup analyses showed a trend towards a larger magnitude of the effect when analysis was restricted to trials in which at least 2/3 of patients had node-positive disease. Our results suggest that adjuvant chemotherapy may produce a small survival benefit of borderline statistical significance in patients with curatively resected gastric carcinoma. Continued trials to find and confirm an effective adjuvant strategy are warranted.     

胃差分化腺癌根治术后辅助化疗的临床研究

目的:观察和比较HELF方案和HELF/HPLF交替方案对胃差分化腺癌(低分化腺癌、粘液腺癌、印戒细胞癌)根治术后患者无病生存期(DFS)、总生存期(OS)的影响。方法:经组织学证实为低分化腺癌、粘液腺癌及印戒细胞癌的Ⅱ~Ⅲ期胃癌根治术后患者,随机分配至A组(单独HELF方案化疗)或B组(HELF/HPLF方案交替化疗),术后3~5周开始化疗,化疗4~6周期。结果:共入组80例患者,72例可按要求随访及评价不良反应,A组、B组各36例。全组患者共随访7~98月,A组与B组中位随访期差异无统计学意义(30月vs.33月,P=0.383)。A组患者的DFS为4~97月(中位值20月),B组为5~98月(中位值39月),两组差异有统计学意义(P=0.025)。A组的OS为10~97月(中位值28月),B组为7~98月(中位值48月),以B组生存时间更长(P=0.042)。主要不良反应为骨髓抑制及消化道反应,多为Ⅰ~Ⅱ度。结论:HELF方案与HPLF方案交替用于差分化胃腺癌根治术后的辅助治疗,在推迟肿瘤复发转移及延长生存期方面可能优于单用HELF方案。     

Treatment of indolent B-Cell nonfollicular lymphomas: final results of the LL01 randomized trial of the Gruppo Italiano per lo Studio dei Linfomi.

PURPOSE: To evaluate the effect of epirubicin on therapeutic response and survival in patients with indolent nonfollicular B-cell lymphomas (INFL) treated with pulsed high-dose chlorambucil. PATIENTS AND METHODS: A total of 170 untreated patients with advanced/active INFL were randomly assigned to receive either eight cycles of high-dose chlorambucil (15 mg/m2/d) plus prednisone (100 mg/d) for 5 days (HD-CHL-P; arm A) or eight cycles of HD-CHL-P plus epirubicin 60 mg/m2 intravenous on day 1 (arm B). The responding patients were randomly assigned to either maintenance therapy with interferon alfa (IFNalpha-2a; 3 MU, three times weekly) for 12 months or observation. RESULTS: There were 160 assessable patients (82 males, 78 females; median age, 63 years; range, 33 to 77 years); 77 patients were assigned to arm A, and 83 were assigned to arm B. Induction therapy led to 47 complete responses (CRs; 29.4%) and 68 partial responses (PRs; 42.5%), with no significant difference between the two arms (60 CR + PR in arm A [77.9%] and 55 CR + PR in arm B [66.3%]; P =.07). After a median follow-up of 38 months (range, 2 to 103 months), there was no between-group difference in overall survival (OS; P =.45), failure-free survival (P =.07), or progression-free survival (PFS; P =.5). Eighty-eight patients were randomly assigned to either IFNalpha-2a (n = 43) or observation (n = 45), without any difference in 3-year PFS (44% and 42%, respectively). Univariate analysis showed that OS was influenced by age, anemia, serum lactate dehydrogenase levels, and International Prognostic Index distribution; multivariate analysis identified age and anemia as having influence on OS. CONCLUSION: HD-CHL-P treatment outcome in INFL patients was good (50% 3-year PFS, minimal toxicity, and low costs); epirubicin did not add any advantage. One-year IFNalpha maintenance treatment did not prolong response duration.     

Prospective study of indolent non-follicular non-Hodgkin's lymphoma: validation of Gruppo Italiano per lo studio dei linfomi (GISL) prognostic criteria for watch and wait policy

Only recently both the Revised European American Lymphoma (REAL) and World Health Organization (WHO) classifications clearly identified indolent non-follicular non-Hodgkin's lymphoma (NHL) as a distinct group of precise histological entities. Therefore, prognostic models, specifically designed for this NHL subset, are still lacking. In this study, we prospectically evaluated the prognostic criteria proposed by the Gruppo Italiano per lo studio dei linfomi (GISL) to identify patients with an indolent non-progressive clinical course, eligible for a watch and wait policy within this histological subset defined according to stringent criteria of histomorphology and immunophenotype. Fifty-three patients affected with small lymphocytic, marginal zone, lymphoplasmacytic lymphoma and lacking at presentation the following: B symptoms, bulky disease, anemia, thrombocytopenia, diffuse pattern of bone marrow infiltration and short tumor doubling time, were registered in a prospective therapeutic GISL trial and addressed to a watch and wait program. After 41.3 months of median follow-up, the median progression free survival (PFS) was not reached and 73% of cases did not progress. When additional variables were considered, in order to improve the prognostic model, it was evident that LDH level and the number of extranodal sites were of statistical significance in the multivariate analysis. Based on this finding, a prognostic score was devised which was able to further identify a small group of patients more likely to undergo early progression, and thus suitable for immediate treatment. In conclusion, the GISL definition of indolent disease is a reliable tool to design the appropriate therapeutic strategy in this histological setting.     

Vinorelbine, gemcitabine, procarbazine and prednisone (ViGePP) as salvage therapy in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL): results of a phase II study conducted by the Gruppo Italiano per lo Studio dei Linfomi

Patients with aggressive NHL who fail initial treatment or subsequently relapse have a very poor outcome and less than 20-25% achieve a prolonged disease-free interval with salvage therapies. To improve the outcome of patients with refractory aggressive NHL not suitable for High Dose Therapy (HDT) and Autologous Stem Cell Transplant (ASCT), the efficacy of a combination of gemcitabine, vinorelbine, procarbazine and prednisone (ViGePP) were tested. Between November 1999 and September 2002, 69 patients with relapsed or refractory aggressive NHL were treated with ViGePP regimen, every 4 weeks up to six courses. At the end of planned chemotherapy patients could receive additional radiotherapy on residual masses or on sites of previously bulky disease. Sixty-six patients were available for evaluation of study end-points. Thirty patients were refractory to therapy and 36 patients had relapsed after remission obtained with previous therapy. At the end of therapy, complete remission (CR) rate was 23%, 3-year relapse free survival rate was 40% and 3-year overall survival rate was 25% for the whole series (29% and 20% for relapsed and refractory patients, respectively). Patients achieving CR with ViGePP had a significantly better survival as compared with the remaining ones (p = 0.0003). ViGePP as used in the present setting has demonstrated a promising activity, comparable to other conventional dose regimens. Although CR was achieved only in a minority of patients, this was durable in a significant proportion of them. This regimen should be tested in less heavily pre-treated patients and probably in combination with new active agents such Rituximab. Further developments of this combination are warranted.     

Randomized trial of adjuvant chemotherapy versus control after curative resection for gastric cancer: 5-year follow-up

Adjuvant chemotherapy of gastric cancer after curative resection is still subject to discussion. In this study 137 patients with gastric adenocarcinoma, all with positive nodes, were randomized after curative resection so that 69 received epidoxorubicin (EPI), leucovorin (LV) and 5-fluorouracil (5-FU) on days 1-3 every 3 weeks for 7 months, whereas the remaining 68 did not. After a follow-up period of 5 years, 21 of the 69 treated patients (30%) and nine controls (13%) were still alive; median survival time was 18 months for the controls and 31 months for the patients treated with adjuvant chemotherapy (P< 0.01).     

The effectiveness of intravenous 5-fluorouracil-containing chemotherapy after curative resection for gastric carcinoma: A systematic review of published randomized controlled trials

This is a review of randomized controlled trials of intravenous 5-flurorouracil (5-FU)-containing chemotherapy after curative resection versus surgery alone in patients with gastric carcinoma to determine the impact on survival rate, safety and economics. Data sources were the Cochrane Library (2006, Issue 2), Pub-Medline and Chinese Biomedical Database. We included 22 randomized controlled trials comparing 4501 patients. Intravenous 5-FU-containing chemotherapy after curative resection had a slightly significant improvement in 3-, 5- and 7-year overall survival rate (OR 1.49, 1.41 and 1.32). No benefit of postoperative disease-free survival rate was induced by 5-FU-containing chemotherapy. Sensitivity analysis was restricted to trials with the highest methodological quality, and the result was similar when the studies with Jadad score less than 3' were excluded. Subgroup analyses found borderline improved overall survival rate in both Western and Eastern countries but the statistical significance was stronger in the Eastern subset. The combinations of 5-FU plus mitomycin C, 5-FU plus cytosine arabinoside and 5-FU plus adriamycin or epidoxorubicin induced potentially more improvement of 3- and 5-year overall survival rates. Severe toxicities were reported in 1629 patients from 15 included trials, and hematological and gastrointestinal toxicities were the most remarkable side effects, around 5%-15% respectively. The chemotherapy-related overall mortality was 1.1%. No trials mentioned cost-effectiveness analysis. Although the results provide some evidence of a beneficial effect of adjuvant chemotherapy with 5-FU-containing regimens, they are inconclusive due to the limitations of methodological quality of including randomized controlled trials. Large scale randomized controlled trials with a positive result are still mandatory before postoperative chemotherapy are recommended.     

The efficacy of adjuvant immunochemotherapy with OK-432 after curative resection of gastric cancer: an individual patient data meta-analysis of randomized controlled trials

Gastric Cancer - OK-432 has been used as a cancer treatment for 40&nbsp;years, and the immunostimulatory effects of OK-432 therapy have been intensely investigated in Japan. Recently, it has...     

Adjuvant chemotherapy after gastric resection in node-positive cancer patients: a multicentre randomised study.

After curative resection for gastric adenocarcinoma, 103 patients, all with positive nodes, were randomised so that 48 received adjuvant chemotherapy of epidoxorubicin (EPI) 75 mg m-2 on day 1, leucovorin (LV) 200 mg m-2 on days 1-3 and 5-fluorouracil (5-FU) 450 mg m-2 on days 1-3, every 21 days for 7 months, whereas the remaining 55 did not. During the first year of observation, 21 control patients (38%) and five treated patients had recurrences. After a follow-up period of 36 months, 12 of the treated patients (25%) and only seven controls (13%) were still alive. At that point, the median survival was 13.6 months for the 55 untreated patients and 20.4 months for the 48 treated patients, a significant difference. We found a survival advantage for patients treated with the EPI-LV-5-FU regimen and a consistent delay in the appearance of recurrent or metastatic cancer. Acute toxicity was mild and treatment was well accepted by all patients. There was no long-term toxicity or any cardiac toxicity. We conclude that this particular chemotherapy, administered shortly after gastric resection, improves survival rate in node-positive gastric cancer patients, even although final assessment of this particular adjuvant approach must await completion of the trial.     

Five or more years of adjuvant endocrine therapy in breast cancer: a meta-analysis of published randomised trials

Five years of adjuvant hormonal therapy is the standard of care in early breast cancer (BC) expressing oestrogen receptors (ER+). Prolonged duration of adjuvant endocrine therapy is implemented to prevent recurrence and death; in particular, its carryover effect may prevent very late events. This meta-analysis compares the efficacy of 5 years of hormonal therapy alone with that of additional years of hormonal therapy, in patients with early BC. Randomised trials comparing 5 years versus more than 5 years of hormonal therapy in BC were identified by electronic searches of PubMed, EMBASE, ISI Web of Science and the Cochrane Central Register of Controlled Trials. Meta-analysis was performed using the fixed- or random-effects models. The primary endpoints were overall survival (OS), BC-specific survival (BCSS) and relapse-free survival (RFS) reported as odds ratios (ORs) and 95 % confidence interval (CI). Eight trials, including 29,138 patients, were identified. Overall, in ER+ BCs, extended endocrine therapy beyond 5 years of tamoxifen significantly improved OS (OR, 0.89; 95 % CI 0.80–0.99; P = 0.03), BCSS (OR, 0.78; 95 % CI 0.69–0.9; P = 0.0003) and RFS (OR 0.72; 95 % CI 0.56–0.92; P = 0.01) compared with 5 years of hormonal therapy alone. Loco-regional and distant relapses were reduced by 36 and 13 %, respectively. Compared with 5 years of tamoxifen, additional adjuvant endocrine therapy reduced risk of death and relapse of ER+ BC by ~10 and 30 %, respectively. This strategy should be considered in patients free of disease after 5 years of hormonal therapy.     

胃癌术后辅助放化疗与辅助化疗比较的荟萃分析

目的 采用偱证医学荟萃分析的方法比较胃癌术后辅助放化疗与辅助化疗间的疗效差异。方法 计算机检索PubMed、EMbase、Cochrane图书馆、万方、维普、CNKI及中国生物医学等数据库,搜集有关胃癌术后辅助放化疗和辅助化疗比较的临床对照研究资料,汇总数据采用RevMan 5.2.5和Stata 12.0软件进行分析。两组间差异采用优势比(OR)及95%可信区间(95% CI)描述。结果 根据纳入和排除标准,最终纳入12个包括1674例患者的临床对照研究资料。荟萃分析结果显示,与胃癌术后辅助化疗相比,辅助放化疗的3、5年生存率更高(OR=2.96,95% CI= 1.75~5.03,P=0.000;OR=1.45,95% CI=1.06~1.99,P=0.020),辅助放化疗的局部复发率更低(OR=0.50,95% CI=0.34~0.72,P=0.000),但远处转移率两组相似(OR=0.79,95% CI=0.58~1.07,P=0.130)。结论 现有研究结果的荟萃分析显示,与胃癌术后辅助化疗相比,胃癌术后辅助放化疗是一种较为安全和有效的治疗方法。     

希罗达为基药的同步放化疗用于胃癌D1/D2根治术后疗效观察

目的:研究希罗达为基本药物的同步放化疗治疗胃癌D1/D2根治术的临床效果。方法:112例胃癌D1/D2根治术后的患者,在放疗期间(45Gy/25次),接受奥沙利铂与希罗达方案化疗(希罗达1000mg/m2,2次/d,d1-14,奥沙利铂100 mg/m2,d1),共4周期。选择同时期资料相似且化疗方案相同的110例患者做对照研究。结果:同步放化疗组与对照组1、2、3年总生存率分别为71.4%、61.6%、50.9%和70.0%、51.8%、36.4%(P=0.058);无复发生存率分别为67.0%、58.9%、46.4%和60.9%、37.3%、28.2%(P=0.003)。两组的主要毒性为1/2级血液学及胃肠道毒性。同步放化组发生3/4级白细胞减少为17.9%,恶心呕吐为6.3%,腹泻为4.5%;对照组发生3/4级白细胞减少为10.9%,恶心呕吐为2.7%,腹泻为2.7%。全组无3/4级手足综合征。结论:奥沙利铂与希罗达联合放疗治疗胃癌D1/D2根治术后患者,可以提高无复发生存率,毒性反应可以耐受。     

Does delayed initiation of adjuvant chemotherapy following the curative resection affect the survival outcome of gastric cancer patients: A systematic review and meta-analysis

BackgroundAdjuvant chemotherapy(AC) following the curative resection could improve the survival outcome of advanced gastric cancer(GC) patients. However, there is no specific timing interval from radical surgery to initiation of AC. Whether delayed initiation of AC could affect the survival outcome of these patients remains unclear. In this study, we performed a systematic review and meta-analysis to evaluate the relationship between delaying AC and the survival outcome of GC patients.MethodsPubMed, Embase and Cochrane Library databases were systematically searched for eligible studies that evaluated the relationship between time to AC and survival outcome. Survival data for HR and 95% CI were extracted and converted to a regression coefficient(β) corresponding to a continuous representation per 4-week delay of AC. Individual adjusted β were combined using a fixed-effects or random-effects model. Heterogeneity was assessed by I² statistic and publication bias was detected using standard error-based funnel plots.ResultsA total of 11 eligible studies involving 6,017 patients were included in this meta-analysis. Eight studies evaluated the impact of delaying AC on overall survival(OS) and five evaluated the impact of delaying AC on disease-free survival(DFS). The pooled results demonstrated that the initiation of AC per 4-week delay was associated with a significant decrease in OS(HR:1.05, 95% CI: 1.03–1.08, P < 0.001; I² = 18.5%) and DFS (HR:1.06, 95% CI: 1.02–1.10, P = 0.001; I² = 40.6%).ConclusionThe initiation of AC per 4-week delay was associated with worse survival outcomes in GC patients. If physical status and postoperative recovery were appropriated, GC patients should be recommended to receive adjuvant chemotherapy timely.     

Efficacy of taxanes as adjuvant treatment of breast cancer: a review and meta-analysis of randomised clinical trials

Objectives

To evaluate the magnitude of benefit obtained by taxanes as adjuvant treatment of breast cancer and to assess the best method for their administration.

Material and methods

We performed a systematic search of phase III randomised clinical trials that included patients with non-metastatic breast cancer in whom comparisons were chemotherapy (CT) containing a taxane (docetaxel or paclitaxel) vs. CT without taxanes (first-generation trials), or CT with taxane in both treatment arms (second-generation trials), administered after surgery. The parameters of efficacy evaluated were disease-free survival (DFS) and overall survival (OS). The data obtained in the first-generation trials (number of relapses and deaths) were submitted to a meta-analysis. The odds ratio (OR) combined with DerSimonian and Laird (OR DL) and 95% confidence interval (95%CI) were calculated. Further, an analysis was performed of those trials that included only patients with nodal involvement (N+). In both cases, the results were also analysed as a function of the taxane used, and with indirect comparisons between the two. The second-generation trials were analysed to assess the optimum method of administration.

Results

A total of 17 trials were selected for the metaanalysis (30,672 patients). The OR DL was 0.82 (95%CI: 0.76=2–0.88) for DFS and 0.83 (95%CI: 0.75–0.91) for OS. In N+ patients the results were 0.80 (95%CI: 0.74–0.86) and 0.79 (95%CI: 0.69–0.89), respectively. Docetaxel and paclitaxel significantly increased the DFS and OS. In our indirect comparison, the benefit of docetaxel on OS was significantly superior to that obtained with paclitaxel in N+ patients (OR: 0.79; 95%CI: 0.63–0.98).

Conclusions

The administration of adjuvant CT-based taxanes reduces the risk of relapse and death. This reduction is superior in clinical trials that included only N+ patients. With the available evidence, it would appear that the best method of administering paclitaxel is weekly and for docetaxel tri-weekly.

     

Expression of thymidylate synthase in gastric cancer patients treated with 5-fluorouracil and doxorubicin-based adjuvant chemotherapy after curative resection

We evaluated the expression of thymidylate synthase (TS) in locally advanced gastric cancer patients treated with adjuvant chemotherapy after curative resection and investigated the association between TS expression and clinicopathologic characteristics including prognosis of the patients. TS expression was evaluated by immunohistochemical staining using TS106 monoclonal antibody in 103 locally advanced gastric cancer patients (stage IB-IV) who underwent 5-fluorouracil (5-FU) and doxorubicin-based adjuvant chemotherapy after curative resection. 65 patients (63%) had primary tumours with high TS expression (> or = 25% of tumour cells positive), and 38 patients (37%) demonstrated low TS expression (< 25% of tumour cells positive or no staining). High TS expression was associated with male gender (P = 0.002), poorly differentiated histology (P = 0.015), and mixed type in Lauren's classification (P = 0.027). There were no statistically significant differences in 4-year disease-free survival (60.0% vs. 57.2%, P = 0.548) and overall survival (59.6% vs. 59.3%, P = 0.792) between high-TS group and low-TS group. In conclusion, although high TS expression was associated with poorly differentiated histology and mixed type in Lauren's classification, it did not predict poor disease-free and overall survival in gastric cancer patients treated with 5-FU and doxorubicin-based adjuvant chemotherapy after curative resection. Further prospective studies including the evaluation of other biological markers associated with the resistance to 5-FU and doxorubicin are necessary.     

Prognostic factors after curative resection for gastric cancer. A population-based study

The aim of this study was to document patterns of survival after resection for cure for gastric cancer in a well-defined population. A population-based series of 649 gastric cancers resected for cure between 1976 and 1995 in a 494000 population, was used. Resection for cure was performed in 44.4% of the diagnosed cases. This proportion increased from 36.8% (1976-1979) to 45.0% (1992-1995) (P=0.03) whilst operative mortality decreased from 18.3 to 12.7% (P=0.003). The overall crude 5-year survival rate (excluding operative mortality) was 32.6% (95% confidence interval (CI) 28.7-36. 5) and the corresponding relative survival rate was 40.9%. Prognosis did not improve during the study period. Stage at diagnosis was the most important prognostic factor, the 5-year relative survival rate being 81.2% (+/-5.9) in TNM stage IA, 76.9% (+/-8.0) in stage IB, 50. 4% (+/-4.6) in stage II, 24.4% (+/-3.7) in stage IIIA, 5.6% (+/-3.2) in stage IIIB and 5.2% (+/- 2.2) in stage IV. Stage at diagnosis, age, subsite and macroscopic type of growth were independent prognostic factors, in a multivariate relative survival model. Earlier detection or development of an effective adjuvant therapy could contribute to improvement in prognosis.     

Evaluation of effectiveness of chemotherapy in patients with gastric cancer after curative resection

Background. A prospective randomized study involving gastric cancer patients was undertaken to evaluate combined adjuvant chemotherapy and the prognostic value of biologic markers. Methods. One hundred and eighty-five patients under 75 years of age who underwent a curable resection of pathologic stage II or III gastric cancer were randomly assigned to receive adjuvant chemotherapy containing either: mitomycin C (MMC) plus oral 5-fluorouracil (FU) (MF), epirubicin plus oral FU (EF), or oral FU (F). Tumor tissue collected at surgery was immunohistochemically analyzed for p53 and proliferating cell nuclear antigen, and DNA ploidy was determined. Results. All prognostic factors were equally distributed in each arm. There was no significant difference among the groups in the 5-year overall survival. When the relationship between the biologic markers and prognosis was analyzed, the overall survival of all patients and stage III patients was poorer in those with p53 positivity, but the difference did not achieve significance. For patients with positive nodes, irrespective of the treatment regimen, p53-positivity was significantly associated with poorer prognosis (P = 0.05). In stage III patients, the survival of those with p53-positivity and DNA aneuploidy was significantly worse than that for patients with any other combination (P = 0.02). Conclusion. No survival benefit was observed with the combined chemotherapeutic regimens compared with FU alone. p53 positivity was negatively correlated to survival for node-positive and stage III patients. Received: July 3, 2000 / Accepted: September 21, 2000     

胃癌术后腹膜种植转移与腹腔温热化疗

胃癌术后腹膜种植转移是手术治疗失败的主要原因之一。相当一部分胃癌患者在手术前其腹膜腔内就有游离癌细胞(FCC)存在,手术时大量被断的血管、淋巴管、标本切缘等都可能溢漏癌细胞。这些癌细胞具有活力,可以造成腹膜种植转移,检测腹膜腔内是否有FCC对决定进一步治疗有重要意义。腹腔温热化疗利用高温、化疗药物的双重作用杀灭腹膜腔内FCC,具有独特的药代动力学和药效学优势。