AIM To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine(GEM)-refractory unresectable pancreatic cancer(PC).METHODS This study was a prospective, multicenter, one-arm, ...AIM To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine(GEM)-refractory unresectable pancreatic cancer(PC).METHODS This study was a prospective, multicenter, one-arm, open-label, phase Ⅱ trial. Patients with unresectable PC, who showed disease progression during GEMbased chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin(RIO; irinotecan 120 mg/m^2 and oxaliplatin 60 mg/m^2), which was set according to the phase Ⅰ study of FOLFIRINOX. The objective response rate(ORR), disease control rate(DCR), progressionfree survival(PFS), overall survival(OS), adverse events were evaluated. Additionally, changes in quality of life(QoL) were assessed using a questionnaire on QoL.RESULTS Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval(CI): 3.7-7.9] and median OS was 9.0 mo(95%CI: 6.4-11.6). Neutropenia(64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia(16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment(45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548).CONCLUSION FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities.展开更多
Deuterium-depleted water (DDW) is a new promising agent in cancer therapy. The efficiency of the method is based on the discovery, that cancer cells are extremely sensitive to depletion of deuterium (D) and might caus...Deuterium-depleted water (DDW) is a new promising agent in cancer therapy. The efficiency of the method is based on the discovery, that cancer cells are extremely sensitive to depletion of deuterium (D) and might cause necrosis of the tumour. The purpose of this study was to show the efficacy of D-depletion in prostate cancer (PC) patients. In the double blind, four-month-long, randomized Phase II clinical trial the daily water intake was replaced with DDW in 22 PC patients. Other 22 PC patients took normal water while both groups received the same forms of conventional treatment. In the retrospective study, 91 DDW-treated PC patients were evaluated and median survival time (MST) in the subgroups was calculated. The time course of changes in DDW dose and PSA is presented in two cases. In the prospective trial seven patients in the treated group and one patient in the placebo group achieved partial response (p = 0.046). In the treated group, the net decrease in the prostate volume was three times higher (160.3 cm3 vs. 54.0 cm3;p = 0.0019), urination complaints ceased at a higher rate (8 vs. 0 patients, p = 0.0041), and the one-year survival rate was also higher (2 vs. 9 deaths;p = 0.034). The 91 retrospectively evaluated patients achieved an MST of 11.02 years, despite the fact that 46 of them suffered from distant metastasis. In the two monitored patients, drop of PSA level correlated with the DDW intake. In summary, D-depletion prolonged MST in patients with PC. The method proved to be safe thus its integration in the PC cure as an adjuvant or complementary therapy would be considered.展开更多
文摘AIM To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine(GEM)-refractory unresectable pancreatic cancer(PC).METHODS This study was a prospective, multicenter, one-arm, open-label, phase Ⅱ trial. Patients with unresectable PC, who showed disease progression during GEMbased chemotherapy were enrolled. All patients were administered FOLFIRINOX with reduced irinotecan and oxaliplatin(RIO; irinotecan 120 mg/m^2 and oxaliplatin 60 mg/m^2), which was set according to the phase Ⅰ study of FOLFIRINOX. The objective response rate(ORR), disease control rate(DCR), progressionfree survival(PFS), overall survival(OS), adverse events were evaluated. Additionally, changes in quality of life(QoL) were assessed using a questionnaire on QoL.RESULTS Between August 2015 and May 2016, a total of 48 patients were enrolled. The median follow-up time was 259 d with a median of 8.5 cycles. The ORR and DCR were 18.8% and 62.5%, respectively, including one patient who showed complete remission. The median PFS was 5.8 mo [95% confidence interval(CI): 3.7-7.9] and median OS was 9.0 mo(95%CI: 6.4-11.6). Neutropenia(64.6%) was the most common grade 3-4 adverse event, followed by febrile neutropenia(16.7%). Although 14.6% of patients experienced grade 3 fatigue, most non-hematologic AEs were under grade 2. In the QoL analysis, the global health status score before treatment was not different from the score at the last visit after treatment(45.43 ± 22.88 vs 48.66 ± 24.14, P = 0.548).CONCLUSION FOLFIRINOX with RIO showed acceptable toxicity and promising efficacy for GEM-refractory unresectable PC. However, this treatment requires careful observation of treatment-related hematologic toxicities.
文摘Deuterium-depleted water (DDW) is a new promising agent in cancer therapy. The efficiency of the method is based on the discovery, that cancer cells are extremely sensitive to depletion of deuterium (D) and might cause necrosis of the tumour. The purpose of this study was to show the efficacy of D-depletion in prostate cancer (PC) patients. In the double blind, four-month-long, randomized Phase II clinical trial the daily water intake was replaced with DDW in 22 PC patients. Other 22 PC patients took normal water while both groups received the same forms of conventional treatment. In the retrospective study, 91 DDW-treated PC patients were evaluated and median survival time (MST) in the subgroups was calculated. The time course of changes in DDW dose and PSA is presented in two cases. In the prospective trial seven patients in the treated group and one patient in the placebo group achieved partial response (p = 0.046). In the treated group, the net decrease in the prostate volume was three times higher (160.3 cm3 vs. 54.0 cm3;p = 0.0019), urination complaints ceased at a higher rate (8 vs. 0 patients, p = 0.0041), and the one-year survival rate was also higher (2 vs. 9 deaths;p = 0.034). The 91 retrospectively evaluated patients achieved an MST of 11.02 years, despite the fact that 46 of them suffered from distant metastasis. In the two monitored patients, drop of PSA level correlated with the DDW intake. In summary, D-depletion prolonged MST in patients with PC. The method proved to be safe thus its integration in the PC cure as an adjuvant or complementary therapy would be considered.
