| BackgroundGastric cancer is one of the most common malignant cancers, ranking 4 behind lung cancer, breast cancer and colorectal cancer. Among cancer related deaths, gastric cancer take up the second place, which not only influence people’s health but also the economy, society and family. East Asia is the high-incidence area and at the last count, there are about 400 thousand patients annual in our country making gastric cancer one of the most dangerous cancers.Gastric cancer is a highly heterogeneous disease. There are varieties of clinical types such as Lauren classification, Singapore classification, ACRG classification and TCGA classification. The therapy of early gastric cancer consists of surgical treatment and chemotherapy, and that of the advanced one is chemotherapy with a bad prognosis for the early distant metastasis. Under some situations, a palliative surgery is always needed for the advanced gastric cancer. However, there are still no standard regimens. The common regimens clinically consist of two drug combinations such as 5-FU and platinum and the combination of their relative ramifications, three drug combinations such as DCF or DOF etc., and the FOLFOX4/6 derived from the changes of the way of drug uses. Because of the lack of regimens’ efficacy evaluation and different views of the results, it is of great significance to study the therapeutic evaluation of different regimens, which could show us the objective conclusions through specific data and guide the clinical decision making. And researches about prognostic factors are different as well. This retrospective study selects 205 cases to reveal the better one between different regimens and prognostic factors.Objects1. To compare the influence to PFS between different regimens.2. To compare the difference of toxic and side effects between different regimens.3. To detect the prognostic factors about the disease.Methods1. Data collecting and Disposing This study chooses gastric cancer patients who have been treated in chemotherapy center, cancer center of QiLu Hospital of Shandong University between 2008 and 2014. The information we have collected including name, hospitalization number, age, previous treatments, lines of chemotherapy, total cycles, pathological pattern, pathological stage, depth of invasion, numbers of lymph nodes, distant metastasis sites, tumor size, body surface area, ECOG stages, starting time, ending time, evaluation or not, the way of evaluate, the time of evaluate, death time, ORR data or not, ORR, PFS or not, PFS, OS or not, OS, myelosuppression, gastrointestinal reaction. Recurrence and survival status are acquired through telephone follow up, and previous medical records. Inclusion criteria:advanced gastric cancer, recurrence after radical operation adenocarcinoma, mucinous adenocarcinoma, and signet-ring cell carcinoma, more than 2 cycles with efficacy evaluations from QiLu Hospital of Shandong University. Exclusion criteria:adjuvant chemotherapy with none metastasis, two or more primary cancer, squamous carcinoma, gastrointestinal stromal tumor, patients without efficacy evaluations, accepted other therapies except operation and chemotherapy, the incomplete date.2. Statistical Analysis Use SPSS 17.0 to analyze dates. Baseline information:analyze the categorical variable through Chi-square test; univariate analysis:analyze the effect of different factors to survival through Kaplan-Meier method and Log-rank test.; multivariate analysis:through Cox-regression and p<0.05 was defined as meaningful.Results1. The data of the patients The number of the patients was 205 after excluding 56 which didn’t meet our criteria. Men took up 72.2% of the patients. Average age was 55.1. The average of the total cycles was 5. Mean body surface area was 1.70. Patients with radical operation history took up 37.1%. Patients with adjuvant chemotherapy took up 26.3%. Pathology type:adenocarcinoma:85.4%, signet-ring cell carcinoma:5.9%, mucinous adenocarcinoma:4.4%, unknown:4.4%. The rate of events was 65.4%. Median PFS was 143d. The gastrointestinal reaction level 0-3 took up 32.2%, 50.7%,13.2%, and 3.9% respectively. The myelosuppression level 0-4 occupied 50.7%,21.0%,22.4%,5.4%,0.5% respectively.2. Efficacy and safety between different regimens2.1. Regimens containing Docetaxel and not containing Docetaxel2.1.1 Baseline information:There were no obvious significance between the two regimens (p>0.05).2.1.2 Efficacy:The short term efficacy of the two regimens wasn’t significantly different. The 120d,150d and 180d survival rate of regimens containing docetaxel and not containing docetaxel was 57.6%,46.2%,39.7% and 60.2%,52.5%,45.3% respectively; the median PFS was 140d and 157d respectively.2.1.3 Toxic and side effects:The gastrointestinal reaction between regimens containing docetaxel and not containing docetaxel was significantly different.0 level and 1 level of the former took up 24.1% and 56.3%, and that of the latter took up 41.9% and 44.1%. The former is more severe.2.2. Regimens containing oxaliplatin and not containing oxaliplatin2.2.1 Baseline information:The two were different in the radical operation history. Regimens containing oxaliplatin had a rate of 27.1% about radical operation while the rate of regimens not containing oxaliplatin was 55.6% (p=0.05). And there were no obvious difference except for this.2.2.2 Efficacy:The short term efficacy of the two regimens wasn’t significantly different. The 120d,150d and 180d survival rate of regimens containing oxaliplatin and not containing oxaliplatin was 60.7%,49.6%, 46.6% and 55.3%,47.8%,36.2% respectively; The median PFS was 148d and 132d respectively.2.2.3 Toxic and side effects:The gastrointestinal reaction and myelosuppression between the two regimens was similar.2.3. Two medicine scheme and three medicine scheme2.3.1 Baseline information:The two were different in the age distribution. People more than 45 years old:two medicine regimens covered 85.6%, more than three medicines (67.9%). There was no other difference.2.3.2 Efficacy:The short term efficacy of the two regimens wasn’t significantly different. The 120d,150d and 180d survival rate of two medicine regimens and three medicine regimens was 58.5%,51.7%,44.1% and 59.4%, 43.8%,38.5% respectively; the median PFS was 153d and 140d respectively.2.3.3 Toxic and side effects:The gastrointestinal reaction:2 level took up 8.8% and 3 level took up 1.6% in two medicine regimen and 2 level and 3 level of three medicine regimen was 20.5% and 7.7% respectively, and the latter was more severe. Myelosuppression between the two regimens was similar.2.4. Regimens containing cisplatin and containing oxaliplatin2.4.1 Baseline information:There are no obvious difference between the two regimens (p>0.05).2.4.2 Efficacy:The short term efficacy of the two regimens wasn’t significantly different. The 120d,150d and 180d survival rate of regimens containing cisplatin and containing oxaliplatin was 49.4%,34.2%,26.6% and 60.7%,49.6%,46.6% respectively; The median PFS was 116d and 148d respectively.2.4.3 Toxic and side effects:regimens containing cisplatin were more severe than regimens containing oxaliplatin in gastrointestinal reaction, p<0.05. No other difference.2.5. DCF and DOF regimens2.5.1 Baseline information:There are no obvious significance between the two regimens (p>0.05).2.5.2 Efficacy:The short term efficacy of DCF regimen was inferior to DOF regimen, the rate of PD was 78.9% and 44.7% respectively. The 120d,150d, 180d and 210d survival rate of DCF and DOF regimens was 45.9%,39.4%, 26.2%,19.7% and 66.8%,54.0%,54.0%,54.0% respectively; The median PFS was 111d and 278d respectively.2.5.3 Toxic and side effects between the two regimens are similar to each other.2.6. DOF and OF regimens2.6.1 Baseline information:There are no obvious significance between the two regimens (p>0.05).2.6.2 Efficacy:The short term efficacy of the two regimens wasn’t significantly different. The 120d,150d,180d and 210d survival rate of DOF and OF regimens was 66.8%,54.0%,54.0%,54.0% and 54.8%,48.7%,45.5%, 38.5% respectively; the median PFS was 278d and 143d respectively.2.6.3 Toxic and side effects:The two regimens are different in gastrointestinal reaction. DOF:0 level:13.2%,3 level:7.9%; OF:0 level,45.8%,3 level:0. DOF was more severe. There was no other difference.3. Survival3.1. All patients3.1.1 Univariate analysis:The difference between total cycles were significant, p<0.05.3.1.2 Multivariate analysis:Total cycles≤5:HR=7.351,95% CI: 4.810-11.235, p<0.05. Body surface area>1.70:HR=1/0.689,95% CI: 1/0.989-1/0.480, p<0.05. Radical operation:HR=0.602,95% CI: 0.411-0.884, p<0.05. Regimens:p>0.05. Total cycles≤5, Body surface area>1.70, no-radical operation were prognostic risk factors. Regimens of the two were not different significantly.3.2. Patients with two medicine regimen and three medicine regimen3.2.1 Univariate analysis:The difference between total cycles were significant, p<0.05.3.2.2 Multivariate analysis:Total cycles≤5:HR= 7.750,95% CI: 5.033-11.934, p<0.05. Radical operation:HR=0.578,95% CI:0.393-0.851, p<0.05. Regimens:p>0.05. Total cycles≤5, no-radical operation were prognostic risk factors. Regimens of the two were not significantly different.3.3. Patients with regimens containing cisplatin or oxaliplatin3.3.1 Univariate analysis:The difference between total cycles was significant, p<0.05.3.3.2 Multivariate analysis:Total cycles ≤5:HR=8.046,95% CI: 4.932-13.126, p<0.05. Radical operation:HR=0.444,95% CI:0.276-0.716, p<0.05. Regimens:p>0.05. Total cycles≤5, no-radical operation were prognostic risk factors. Regimens of the two were not significantly different.3.4. Patients with DCF regimen and DOF regimen3.4.1 Univariate analysis:The difference between total cycles were significant, p<0.05.3.4.2 Multivariate analysis:Total cycles ≤5:HR=4.229,95% CI: 1.823-9.812, p<0.05. DCF regimens:HR=2.099,95%CI:1.016-4.337, p<0.05. Total cycles≤5 were prognostic risk factors. Regimen of DCF was inferior to DOF.3.5. Patients with DOF regimen and OF regimen3.5.1 Univariate analysis:The difference between total cycles and the radical operation history were significant, p<0.05.3.5.2 Multivariate analysis:Total cycles≤5:HR=10.944,95% CI: 4.798-24.963, p<0.05. Radical operation:HR=0.265,95% CI:0.119-0.590, p<0.05. DOF regimens:HR=0.496,95%CI:0.262-0.939, p<0.05. Total cycles ≤5, no-radical operation were prognostic risk factors. Regimen of OF was inferior to DOF.Conclusion1. In COX regression analysis, differences of PFS between DCF and DOF regimens are obvious, and DOF regimens are superior to DCF, so are DOF and OF regimens, with DOF regimen superior.2. Total cycles of first line chemotherapy ≤5, body surface area>1.70 and no radical operation are independent risk factors to PFS in the 205 patients.3. However, the lack of data volume may influence the results, which is considered necessarily to be studied in a larger crowd of patients. |
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