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Serotonin receptor antagonists are no better than prochlorperazine for control of delayed nausea (DN) caused by
doxorubicin: A URCC CCOP study of 701 patients.
This study enrol ed 701 patients on a randomized trial to compare three regimens for control ing delayed nausea. The trial
compared scheduled prochlorperazine, prochlorperazine prn, and any 5-HT antiemetic using a standard dosing regimen. Researchers concluded that none of the three regimens was adequate to control delayed nausea (Hickok et al., 2005). Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0034-00_19-0033654,00.asp Comparison of aprepitant combination regimen with 4-day ondansetron + 4-day dexamethasone for prevention of acute and
delayed nausea/vomiting after cisplatin chemotherapy.
This study compared aprepitant plus ondansetron plus dexamethasone to ondansetron plus dexamethasone in patients
receiving highly emetogenic chemotherapy (HEC). This study evaluated whether the aprepitant regimen was superior to ondansetron plus dexamethasone, when both ondansetron and dexamethasone are given on multiple days to control delayed-phase CINV in patients receiving HEC. Complete response rates were significantly higher for the aprepitant regi- men for the overall period, as well as the acute and delayed periods. Researchers concluded that the aprepitant regimen was superior to ondansetron plus dexamethasone alone for preventing delayed CINV (Aapro et al., 2005). Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0034-00_19-0031109,00.asp Dronabinol treatment of delayed chemotherapy-induced nausea and vomiting (CINV).
This study added dronabinol to the prophylactic regimen for acute CINV to evaluate its effectiveness in treating delayed
CINV. Subjects received moderately to highly emetogenic chemotherapy and were treated with dexamethasone/ondan- setron prior to chemotherapy. Subjects who were randomized to receive dronabinol, ondansetron, or dronabinol plus on- dansetron also received dronabinol pre- and post chemotherapy. Researchers concluded that dronabinol was comparable to ondansetron in total response and that dronabinol was more effective in reducing nausea intensity and vomiting/retch- ing (Meiri et al., 2005).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0034-00_19-0031138,00.asp Tolerability of dronabinol alone, ondansetron alone and the combination of dronabinol plus ondansetron in delayed
chemotherapy-induced nausea and vomiting.
This study compared the tolerability of dronabinol versus ondansetron in subjects with delayed CINV. Subjects received
moderately to highly emetogenic chemotherapy and were treated with dexamethasone/ondansetron prior to chemo- therapy. Subjects who were randomized to receive dronabinol, ondansetron, or dronabinol plus ondansetron also received dronabinol pre- and post chemotherapy. Researchers concluded that dronabinol was well tolerated, with a low rate of central nervous system related adverse events, which may make it a suitable alternative to serotonin antagonist therapy for delayed CINV (Jhangiani et al., 2005). Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0034-00_19-0031146,00.asp 2004 ASCO Abstract Summaries
Effect of aprepitant for the prevention of nausea and vomiting after one cycle of moderately emetogenic chemotherapy:
A randomized double-blind trial in 866 patients.
This trial was the first phase III study to evaluate aprepitant for prevention of CINV with non-cisplatin-based moderately emetogenic
chemotherapy (MEC). Overall complete response was greater with the aprepitant regimen than with the standard regimen. Researchers concluded that the aprepitant regimen was more effective than the standard regimen in preventing CINV in patients receiving non- cisplatin-based MEC (Warr et al., 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-002270,00.asp A phase II trial of olanzapine for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Using the maximum tolerated dose of olanzapine in the phase I trial, a phase II trial was performed for the prevention of CINV in
chemotherapy-naive patients. Nausea was well controlled in the patients receiving both highly emetogenic chemotherapy and moderately emetogenic chemotherapy, with no grade 3 or 4 toxicities. Researchers concluded that olanzapine is safe and highly effective in controlling acute and delayed CINV in patients receiving HEC and MEC (Navari et al., 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-00755,00.asp Meta-analysis of neurokinin-1 receptor antagonists (NK 1 RAs) for chemotherapy-induced nausea and
vomiting (CINV).
This meta-analysis evaluated the effectiveness of NK1 RAs for the control of acute and delayed CINV. The meta-analysis reviewed seven
trials (n = 1,568 evaluable patients) between 1990-2003 that compared NK1 RAs with control therapy. Researchers concluded that NK1 RAs in addition to standard therapy significantly increased complete response rates from delayed CINV, with no significant effect on acute CINV (Tremont-Lukats, Gonzalez-Barboteo, Bruera, & Bresciam, 2004). Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-0099,00.asp A meta-analysis comparing the efficacy of five 5-HT -receptor antagonists (5-HT -RAs) for acute chemotherapy
induced emesis.
This meta-analysis compared the efficacy of granisetron, tropisetron, ondansetron, dolasetron, and palonosetron.
This was the first meta-analysis to review all randomized trials between 1992-2003 to compare all 5-HT -RAs. Researchers concluded that granisetron, ondansetron, and dolasetron had uniform efficacy. However, 3 mg granisetron showed a possible superiority to 8 mg ondansetron (Jordan, Hinke, Grothey, & Schmoll, 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-002062,00.asp Prevention of delayed nausea and vomiting (D-CINV): Carryover effect analysis of pooled data from 2 phase III
studies of palonosetron (PALO).
This study evaluated the efficacy of palonosetron in delayed CINV to determine if the benefit was a carryover effect from well-controlled
acute CINV. This study showed that the level of improvement in delayed CINV was similar, with or without acute CINV. Researchers con- cluded that palonosetron shows true pharmacologic effect in preventing delayed CINV rather than building on a carryover effect from bet- ter prevention of acute CINV (Grunberg, Vanden Burgt, Berry, Rubenstein, & Berry, 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001054,00.asp Granisetron plus alprazolam versus granisetron alone in the control of emesis in patients with operable breast cancer
receiving anthracycline containing chemotherapy: A phase I I trial.
This trial compared granisetron plus alprazolam versus granisetron alone in 19 operable patients with breast cancer receiving
anthracycline regimens. Alprazolam is a newer benzodiazepine that has an antidepressant effect. Control of emesis was
significantly better in the granisetron plus alprazolam arm (97%) than in the granisetron arm (79%) in the acute period.
Researchers concluded that alprazolam increases the efficacy of granisetron in patients with breast cancer who received
anthracycline regimens (Abali, Oyan, Azisik, & Guler, 2004).
Link to the ASCO abstract:
http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-002552,00.asp Effect of aprepitant on antiemetic protection in patients receiving moderately emetogenic chemotherapy plus
high-dose cisplatin: Analysis of combined data from 2 phase III randomized clinical trials.
This study analyzed data from two large trials (Hesketh et al., 2003; Poli-Bigelli et al., 2003) to evaluate patients receiving mod-
erately emetogenic chemotherapy (MEC) plus cisplatin. 142 patients in these trials received additional MEC (doxorubicin and/or cyclophosphamide). Complete response rates were significantly higher with aprepitant versus the control group for the overall, delayed, and acute phases. Researchers concluded aprepitant significantly improved control of emesis when added to ondansetron plus dexamethasone in patients receiving MEC with cisplatin. This suggests activity in MEC, although additional research is needed in patients receiving MEC only (Gralla, Warr, Carides, Evans, & Horgan, 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001018,00.asp Palonosetron (PALO) plus aprepitant (APREP) and dexamethasone (DEX) for the prevention of chemotherapy-induced
nausea and vomiting (CINV) after emetogenic chemotherapy (CT).
This was the first study to combine two novel antiemetics, aprepitant and palonosetron, in patients receiving moderately to
moderate-highly emetic chemotherapy. This study was a multi center, phase II, open-label study to evaluate the efficacy and safety of combining palonosetron, aprepitant, and dexamethasone for prevention of CINV. Researchers concluded that palonosetron, aprepitant, and dexamethasone may be combined safely and may improve overall prevention of CINV (Grote et al., 2004).
Link to the ASCO abstract: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-003896,00.asp Aapro, M.S., Schmoll, H.J., Poli-Bigelli, S., Jordan, K., von Pawel, J., Giezek, H., et al. (2005). Comparison of aprepitant combination regimen with 4-day ondansetron + 4-day dexamethasone for prevention of acute and delayed nausea/vomiting after cisplatin chemotherapy [Abstract]. Journal of Clinical Oncology, 23(16S). Abstract No. 8007.
Abali, H., Oyan, B., Ozisik, Y., & Guler, N. (2004). Granisetron plus alprazolam versus granisetron alone in the control of emesis in patients with operable breast cancer receiv- ing anthracycline containing chemotherapy: A phase III trial [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8081.
Gralla, R.J., Warr, D.G., Carides, A.D., Evans, J.K., & Horgan, K.J. (2004). Effect of aprepitant on antiemetic protection in patients receiving moderately emetogenic chemothera- py plus high-dose cisplatin: Analysis of combined data from 2 phase III randomized clinical trials [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8137.
Grote, T., Hajdenberg, J., Cartmell, A., Ferguson, S., Ginkel, A., Gallagher, S., et al. (2004). Palonosetron (PALO) plus aprepitant (APREP) and dexamethasone (DEX) for the pre- vention of chemotherapy-induced nausea and vomiting (CINV) after emetogenic chemotherapy (CT) [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8262.
Grunberg, S.M., Vanden Burgt, J.A., Berry, S., Rubenstein, E.B., & Berry, D. (2004). Prevention of delayed nausea and vomiting (D-CINV): Carryover effect analysis of pooled data from 2 phase III studies of palonosetron (PALO) [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8051.
Hickok, J.T., Morrow, G.R., Roscoe, J.A., Wade, J.L., Dakhil, S.R., Kuebler, J.P., et al. (2005). Serotonin receptor antagonists are no better than prochlorperazine for control of delayed nausea (DN) caused by doxorubicin: A URCC CCOP study of 701 patients [Abstract]. Journal of Clinical Oncology, 23(16S). Abstract No. 8006.
Jhangiani, H., Meiri, E., Vredenburgh, J., Barbato, L., Yang, H., Li, D., et al. (2005). Tolerability of dronabinol alone, ondansetron alone and the combination of dronabinol plus ondansetron in delayed chemotherapy-induced nausea and vomiting [Abstract]. Journal of Clinical Oncology, 23(16S). Abstract No. 8196.
Jordan, K., Hinke, A., Grothey, A., & Schmoll, H.J. (2004). A meta-analysis comparing the efficacy of five 5-HT -receptor antagonists (5-HT -RAs) for acute chemotherapy in- duced emesis [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8048.
Meiri, E., Jhangiani, H., Vredenburgh, J., Barbato, L., Yang, H., Li, D., et al. (2005). Dronabinol treatment of delayed chemotherapy-induced nausea and vomiting (CINV) [Ab- stract]. Journal of Clinical Oncology, 23(16S). Abstract No. 8018.
Navari, R.M., Einhorn, L.H., Loehrer, P.J., Passik, S.D., Vinson, J., Mayer, M.L., et al. (2004). A phase II trial of olanzapine for the prevention of chemotherapy induced nausea and vomiting (CINV) [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8046.
Tremont-Lukats, I.W., González-Barboteo, J., Bruera, E., & Bresciam, F.J. (2004). Meta-analysis of neurokinin-1 receptor antagonists (NK-1 RA) for chemotherapy-induced nau- sea and vomiting (CINV) [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8047.
Warr, D.G., Eisenberg, P., Hesketh, P.J., Gralla, R.J., Raftopolous, H., Gabriel, M., et al. (2004). Effect of aprepitant for the prevention of nausea and vomiting after one cycle of moderately emetogenic chemotherapy: A randomized double-blind trial in 866 patients [Abstract]. Journal of Clinical Oncology, 22(14S). Abstract No. 8007.

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