Background: 70% of ovarian cancer cases are diagnosed at an advanced stage (III or IV) of the disease and, in turn, with a high prevalence of peritoneal carcinosis and ascites, which leads to progressive malnutrition ...Background: 70% of ovarian cancer cases are diagnosed at an advanced stage (III or IV) of the disease and, in turn, with a high prevalence of peritoneal carcinosis and ascites, which leads to progressive malnutrition in patients, with the consequent deterioration of their general condition. There is a very important relationship between nutritional status, quality of life, survival, and the ability to tolerate multidisciplinary treatment of peritoneal carcinosis. Methods: A phase II, open-label, single-center, non-randomised clinical trial was conducted that included 36 patients with advanced disease who were administered the nutritional supplement Ocoxin, 30 ml twice a day, beginning one week before chemotherapy (CT) based on carboplatin/paclitaxel, of which they receive three cycles with neoadjuvant intent. Ocoxin treatment was continued during chemotherapy and for three weeks after completion of the last cycle, as well as during any periods for which this treatment was discontinued due to toxicity. The effect of Ocoxin on the quality of life was assessed through the QLQ C30 and QLQ OV28 questionnaires from the start of treatment until the end of the follow-up period. In addition, the Karnofsky Index and nutritional parameters were assessed. Results: There were no significant differences between adverse events versus baseline values, except in leukocytes, lymphocytes, neutrophils, ALT, and AST. There was no deterioration of the QoL scales, except for those related to the effects of chemotherapy and alopecia. Conclusions: Ocoxin as an adjuvant to chemotherapy appears to improve better tolerance to chemotherapy, showed a good safety profile, and improved quality of life. For further information on Ocoxin neoadjuvant therapy benefits, a phase III clinical trial will be needed.展开更多
Time-to-event has become one of the primary endpoints of many clinical trials. Comparing treatments and therapies using time-to-event (or “survival”) data requires some care, since survival differences may occur eit...Time-to-event has become one of the primary endpoints of many clinical trials. Comparing treatments and therapies using time-to-event (or “survival”) data requires some care, since survival differences may occur either early or late in the follow-up period, depending on various factors such as the initial potency or the duration of efficacy of the drugs. In this work, we investigate the effect of the CIMAvax?EGF vaccine therapy on the survival of patients with non-small cell lung cancer, using stratified and unstratified weighted log-rank tests. Weighted log-rank tests are designed to identify early and late survival differences between treatments. Using these tests, we conclude that the vaccine is more efficient than the standard therapy among patients less than 60 years of age.展开更多
文摘Background: 70% of ovarian cancer cases are diagnosed at an advanced stage (III or IV) of the disease and, in turn, with a high prevalence of peritoneal carcinosis and ascites, which leads to progressive malnutrition in patients, with the consequent deterioration of their general condition. There is a very important relationship between nutritional status, quality of life, survival, and the ability to tolerate multidisciplinary treatment of peritoneal carcinosis. Methods: A phase II, open-label, single-center, non-randomised clinical trial was conducted that included 36 patients with advanced disease who were administered the nutritional supplement Ocoxin, 30 ml twice a day, beginning one week before chemotherapy (CT) based on carboplatin/paclitaxel, of which they receive three cycles with neoadjuvant intent. Ocoxin treatment was continued during chemotherapy and for three weeks after completion of the last cycle, as well as during any periods for which this treatment was discontinued due to toxicity. The effect of Ocoxin on the quality of life was assessed through the QLQ C30 and QLQ OV28 questionnaires from the start of treatment until the end of the follow-up period. In addition, the Karnofsky Index and nutritional parameters were assessed. Results: There were no significant differences between adverse events versus baseline values, except in leukocytes, lymphocytes, neutrophils, ALT, and AST. There was no deterioration of the QoL scales, except for those related to the effects of chemotherapy and alopecia. Conclusions: Ocoxin as an adjuvant to chemotherapy appears to improve better tolerance to chemotherapy, showed a good safety profile, and improved quality of life. For further information on Ocoxin neoadjuvant therapy benefits, a phase III clinical trial will be needed.
基金supported by a UICC International Cancer Technology Transfer Fellowship.
文摘Time-to-event has become one of the primary endpoints of many clinical trials. Comparing treatments and therapies using time-to-event (or “survival”) data requires some care, since survival differences may occur either early or late in the follow-up period, depending on various factors such as the initial potency or the duration of efficacy of the drugs. In this work, we investigate the effect of the CIMAvax?EGF vaccine therapy on the survival of patients with non-small cell lung cancer, using stratified and unstratified weighted log-rank tests. Weighted log-rank tests are designed to identify early and late survival differences between treatments. Using these tests, we conclude that the vaccine is more efficient than the standard therapy among patients less than 60 years of age.
