Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was...Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was higher than that of younger patients. The aim of this study is to develop a less toxic schedule of S-1, while maintaining the anti-tumor effect. This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients (aged ≥75 years) with metastatic colorectal cancer. The primary endpoint is progression-free survival, and the secondary endpoints are safety, response rate, and overall survival. The expected median progression-free survival is 8.5 months, and the minimum efficacy threshold is 5.0 months. The total required sample size is calculated as 50 patients, with a 2-sided type I error of 0.10 and a power of more than 80%. This study is ongoing, and fifty-four patients were enrolled until October 2016. We hope that S-1 on alternate days combined with bevacizumab for elderly patients with colorectal cancer is well tolerated and can maintain effectiveness. Trial registration: UMIN clinical trials UMIN000010402.展开更多
Objective: To evaluate the feasibility of S-1 and high-dose cisplatin short hydration regimens for outpatients with unresectable metastatic gastric cancer. Methods: Data for individual outpatients treated in our insti...Objective: To evaluate the feasibility of S-1 and high-dose cisplatin short hydration regimens for outpatients with unresectable metastatic gastric cancer. Methods: Data for individual outpatients treated in our institution were retrospectively pooled to assess the feasibility of an S-1 and highdose cisplatin short hydration regimen (S-1: 80 to 120 mg on Days 1 to 21;cisplatin: 60 mg/m2?on Day 8, every 5 weeks), which included 2250 ml of intravenous fluids and 1000 ml oral hydration. Ten consecutive patients were treated with S-1 and high-dose cisplatin short hydration for unresectable metastatic gastric cancer from July 2011 to May 2012 and were included in the analysis. Results: With a median of 3.5 medication cycles, unscheduled admission occurred in two patients for 5 days each due to paralytic ileus and cerebral infarction. Four patients required dose reduction, in both S-1 and cisplatin in two patients, and in S-1 alone and cisplatin alone in one patient each. Renal function transiently declined after administration of cisplatin, but serum creatinine level and estimated glomerular filtration rate were both improved by the time of the next administration. Conclusion: This study suggests that an S-1 and high-dose cisplatin short hydration strategy for outpatients with unresectable metastatic gastric cancer might be feasible.展开更多
Background: Despite there are a few reports that assessed the S-1 + CDDP regimen with short hydration regimen for unresectable or metastatic gastric cancer, there is no consensus on the best regimen for short hydratio...Background: Despite there are a few reports that assessed the S-1 + CDDP regimen with short hydration regimen for unresectable or metastatic gastric cancer, there is no consensus on the best regimen for short hydration. The aim of study was to evaluate the safety and the efficacy of S-1 plus cisplatin doublet chemotherapy with short hydration. Methods: S-1 was administered orally (p.o.) twice daily for the first 3 weeks of a 5-week cycle. Dose of S-1 administered was calculated according to the body surface area. CDDP was given as an intravenous (i.v.) infusion of 60 mg/m2 on day 8 of each cycle. Patients received the total of 1900 ml infusion containing 1000 ml of acetate Ringer’s solution as pre- and post-hydraion. 300 ml of 20% mannitol was administered as a diuretic. Results: 35 patients with unresectable or recurrent gastric cancer were enrolled. The reasons for termination of S-1 + CDDP were as follows: 21 (63.6%) by progressive disease;12 (31.4%) by toxicity. Even though 12 of 35 patients (34.2%) were discontinued S-1 + CDDP chemotherapy, only one patient was discontinued by Grade 2 of increased creatinine. TTF (time to progression) was 174 days (3 - 586 days), and the median of the total number of treatment cycles of S-1 + CDDP was 3.31. Median overall survival, as secondary endpoint, was 518 days. Conclusions: Our study suggested that the short hydration regimen is as safe and efficient as the continuous hydration regimen.展开更多
Introduction: The survival rate of patients with Borrmann type 4 advanced gastric cancer is extremely poor in comparison to patients with gastric cancers of other histological types. An optimal chemotherapeutic regime...Introduction: The survival rate of patients with Borrmann type 4 advanced gastric cancer is extremely poor in comparison to patients with gastric cancers of other histological types. An optimal chemotherapeutic regimen has yet to be determined. Patients and Methods: We retrospectively examined the outcome of patients who were treated for Borrmann type 4 advanced gastric cancer from July 2011 and June 2015. Results: The data from 42 cases were collected for this study. Of the 42 cases, 13 cases (31.0%) were locally advanced and 29 cases (69.0%) were metastatic advanced. Median Overall Survival (OS) for locally advanced cancer was 29.6 months and for metastatic advanced cancer was 11.5 months. The presence or absence of peritoneal metastases did not affect survival (8.9 and 11.5 months, respectively;p = 0.831). In the 23 patients who received chemotherapy, S-1 plus cisplatin was prescribed as first-line treatment in 16 cases (69.5%). Other treatment regimens included capecitabine plus cisplatin and S-1 plus oxaliplatinin one each (4.3%), S-1 monotherapy in two (8.6%), and capecitabine monotherapy, paclitaxel, and docetaxel in one each (4.3%). We found no median OS difference between S-1 plus cisplatin and other treatments (20.7 and 19.3 months;p = 0.094). Conclusion: We found that S-1 plus cisplatin treatment does not improve OS in patients with Borrmann type 4 advanced gastric cancer compared with other chemotherapeutic regimens.展开更多
文摘Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was higher than that of younger patients. The aim of this study is to develop a less toxic schedule of S-1, while maintaining the anti-tumor effect. This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients (aged ≥75 years) with metastatic colorectal cancer. The primary endpoint is progression-free survival, and the secondary endpoints are safety, response rate, and overall survival. The expected median progression-free survival is 8.5 months, and the minimum efficacy threshold is 5.0 months. The total required sample size is calculated as 50 patients, with a 2-sided type I error of 0.10 and a power of more than 80%. This study is ongoing, and fifty-four patients were enrolled until October 2016. We hope that S-1 on alternate days combined with bevacizumab for elderly patients with colorectal cancer is well tolerated and can maintain effectiveness. Trial registration: UMIN clinical trials UMIN000010402.
文摘Objective: To evaluate the feasibility of S-1 and high-dose cisplatin short hydration regimens for outpatients with unresectable metastatic gastric cancer. Methods: Data for individual outpatients treated in our institution were retrospectively pooled to assess the feasibility of an S-1 and highdose cisplatin short hydration regimen (S-1: 80 to 120 mg on Days 1 to 21;cisplatin: 60 mg/m2?on Day 8, every 5 weeks), which included 2250 ml of intravenous fluids and 1000 ml oral hydration. Ten consecutive patients were treated with S-1 and high-dose cisplatin short hydration for unresectable metastatic gastric cancer from July 2011 to May 2012 and were included in the analysis. Results: With a median of 3.5 medication cycles, unscheduled admission occurred in two patients for 5 days each due to paralytic ileus and cerebral infarction. Four patients required dose reduction, in both S-1 and cisplatin in two patients, and in S-1 alone and cisplatin alone in one patient each. Renal function transiently declined after administration of cisplatin, but serum creatinine level and estimated glomerular filtration rate were both improved by the time of the next administration. Conclusion: This study suggests that an S-1 and high-dose cisplatin short hydration strategy for outpatients with unresectable metastatic gastric cancer might be feasible.
文摘Background: Despite there are a few reports that assessed the S-1 + CDDP regimen with short hydration regimen for unresectable or metastatic gastric cancer, there is no consensus on the best regimen for short hydration. The aim of study was to evaluate the safety and the efficacy of S-1 plus cisplatin doublet chemotherapy with short hydration. Methods: S-1 was administered orally (p.o.) twice daily for the first 3 weeks of a 5-week cycle. Dose of S-1 administered was calculated according to the body surface area. CDDP was given as an intravenous (i.v.) infusion of 60 mg/m2 on day 8 of each cycle. Patients received the total of 1900 ml infusion containing 1000 ml of acetate Ringer’s solution as pre- and post-hydraion. 300 ml of 20% mannitol was administered as a diuretic. Results: 35 patients with unresectable or recurrent gastric cancer were enrolled. The reasons for termination of S-1 + CDDP were as follows: 21 (63.6%) by progressive disease;12 (31.4%) by toxicity. Even though 12 of 35 patients (34.2%) were discontinued S-1 + CDDP chemotherapy, only one patient was discontinued by Grade 2 of increased creatinine. TTF (time to progression) was 174 days (3 - 586 days), and the median of the total number of treatment cycles of S-1 + CDDP was 3.31. Median overall survival, as secondary endpoint, was 518 days. Conclusions: Our study suggested that the short hydration regimen is as safe and efficient as the continuous hydration regimen.
文摘Introduction: The survival rate of patients with Borrmann type 4 advanced gastric cancer is extremely poor in comparison to patients with gastric cancers of other histological types. An optimal chemotherapeutic regimen has yet to be determined. Patients and Methods: We retrospectively examined the outcome of patients who were treated for Borrmann type 4 advanced gastric cancer from July 2011 and June 2015. Results: The data from 42 cases were collected for this study. Of the 42 cases, 13 cases (31.0%) were locally advanced and 29 cases (69.0%) were metastatic advanced. Median Overall Survival (OS) for locally advanced cancer was 29.6 months and for metastatic advanced cancer was 11.5 months. The presence or absence of peritoneal metastases did not affect survival (8.9 and 11.5 months, respectively;p = 0.831). In the 23 patients who received chemotherapy, S-1 plus cisplatin was prescribed as first-line treatment in 16 cases (69.5%). Other treatment regimens included capecitabine plus cisplatin and S-1 plus oxaliplatinin one each (4.3%), S-1 monotherapy in two (8.6%), and capecitabine monotherapy, paclitaxel, and docetaxel in one each (4.3%). We found no median OS difference between S-1 plus cisplatin and other treatments (20.7 and 19.3 months;p = 0.094). Conclusion: We found that S-1 plus cisplatin treatment does not improve OS in patients with Borrmann type 4 advanced gastric cancer compared with other chemotherapeutic regimens.
