American journal of clinical oncology
-
Am. J. Clin. Oncol. · Jun 2003
Randomized Controlled Trial Comparative Study Clinical TrialAnastrozole versus tamoxifen as first-line therapy in postmenopausal patients with hormone-dependent advanced breast cancer: a prospective, randomized, phase III study.
A prospective phase III trial comparing anastrozole with tamoxifen as first-line therapy in postmenopausal, hormone-dependent, advanced breast cancer (ABC). Patients were randomized to anastrozole 1 mg daily (n = 121) or tamoxifen 40 mg daily (n = 117). Efficacy and tolerability were evaluated after 3 months' therapy, and survival was evaluated at median time of follow-up. ⋯ Therapy was well tolerated in both groups. Anastrozole showed significant advantages over tamoxifen for CB, median TTP in patients gaining CB, and survival. These data further support routine use of anastrozole as first-line treatment for postmenopausal hormone-dependent ABC.
-
Am. J. Clin. Oncol. · Apr 2000
Randomized Controlled Trial Comparative Study Clinical TrialComparative efficacy of three 5-HT3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: a randomized crossover study.
The purpose of this study was to compare the antiemetic efficacy of three 5-HT3 antagonists (granisetron, ondansetron, tropisetron) plus dexamethasone for the prevention of acute emesis induced by high-dose cisplatin chemotherapy. This was a randomized, open label, crossover study. Recruited into the study were 94 chemotherapy-naive patients of whom five were excluded because chemotherapy was not given, noncisplatin regimen was used instead, or presence of anticipatory vomiting. ⋯ The three 5-HT3 antagonists, when used in combination with steroids, had similar major efficacy for prophylaxis against cisplatin-induced acute emesis. Although GRADEX was superior to TRODEX in terms of complete response, this may not be of clinical significance. The choice of antiemetic regimens should therefore depend on patient preference and drug cost.
-
Am. J. Clin. Oncol. · Apr 1999
Randomized Controlled Trial Clinical TrialProspective randomized comparison of tropisetron with and without dexamethasone against high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting.
Several studies have confirmed the efficacy of high-dose metoclopramide and, more recently, serotonin antagonists, with and without dexamethasone, in the prophylaxis of cisplatin-induced nausea and vomiting. Most of these trials have been reported from Western countries. There is little or no information about the efficacy and tolerability of these agents in ethnic groups in other countries. ⋯ The authors conclude that metoclopramide-based combination antiemetic therapy continues to be a cheaper alternative to serotonin antagonists and equally effective. Metoclopramide-based therapy, however, is more labor intensive, and issues related to administrative errors, side effects, and compliance gain increasing importance. The identification of persons at a higher risk for metoclopramide-induced side effects may help minimize the unacceptable consequences of therapy.
-
Am. J. Clin. Oncol. · Aug 1998
Randomized Controlled Trial Multicenter Study Clinical TrialAnticachectic efficacy of megestrol acetate at different doses and versus placebo in patients with neoplastic cachexia.
Anorexia and cachexia are present in the majority of patients with advanced-stage cancer. Several agents have been tested for their ability to reverse weight loss in these patients. Megestrol acetate has been demonstrated to improve appetite and weight, independent of tumor response, when used in the treatment of metastatic breast cancer. ⋯ There were no thromboembolic events. This trial supports the efficacy of megestrol acetate at 480 mg/day in the treatment of cancer-related cachexia and anorexia, with mild toxicity. However, performance status and quality of life were not influenced by this treatment.
-
Am. J. Clin. Oncol. · Dec 1997
Randomized Controlled Trial Comparative Study Clinical TrialA comparative study of intravenous granisetron versus intravenous and oral ondansetron in the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy.
We conducted a prospective, randomized, open, single-center, parallel group study comparing the anti-emetic efficacy and toxicity of granisetron with that of ondansetron in patients receiving moderately emetogenic chemotherapy. From December 1994 to May 1995, patients who were to receive moderately emetogenic chemotherapy for the first time or who had not received chemotherapy (80 to 100 mg/m2 of cisplatin or 40 mg/m2 of doxorubicin) within 4 weeks previously were enrolled in this study. The following anti-emetic regimens were used: 3 mg of granisetron were given intravenously before chemotherapy for a single dose; 8 mg of ondansetron were given intravenously before chemotherapy and then every 8 hours for a total of 3 doses, plus 8 mg of an oral maintenance dose every 12 hours for 5 consecutive days. ⋯ In the first 24 hours after chemotherapy, complete and major responses were achieved in 76.6% of the patients receiving granisetron and in 72.9% of patients receiving ondansetron (p = 0.9033). Additionally, there was no difference in the control of delayed nausea and vomiting between the two groups (51.1% versus 54.2%, p = 0.9200), and there were no significant adverse effects or toxicities. We have concluded that a single dose of granisetron is as effective in prophylaxis of emesis induced by moderately emetogenic chemotherapy as a triple dose of ondansetron plus oral maintenance.