American journal of clinical oncology
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Am. J. Clin. Oncol. · Oct 1997
Randomized Controlled Trial Comparative Study Clinical TrialImpact of adding concurrent chemotherapy to hyperfractionated radiotherapy for locally advanced non-small cell lung cancer (NSCLC): comparison of RTOG 83-11 and RTOG 91-06.
A hyperfractionated radiation therapy (HFX RT) trial (1.2 Gy twice daily, b.i.d.) (HFX) for non-small cell lung cancer (NSCLC) showed that 69.6 Gy resulted in better survival than did lower total doses (Radiation Therapy Oncology Group, RTOG 83-11) and that cisplatin concurrent with irradiation improved local control and survival over RT alone (Radiation Therapy Oncology Group, RTOG 91-06). Concurrent combination chemotherapy and HFX could improve both local and systemic control. In a phase II trial (RTOG 91-06) for inoperable NSCLC, two cycles of PE were used [cisplatin 50 mg/m2 intravenously (i.v.) days 1 and 8, etoposide 50 mg orally (p.o.) b.i.d., 75 mg/day if body surface area (BSA) < 1.7 m2, days 1-14] starting on day 1 of HFX (69.6 Gy) and repeated on day 29. ⋯ Two-year survival rates were 36% for HFX/PE and 22% for HFX (p = 0.014). The differences in survival between HFX/PE and HFX remained borderline statistically significant (p = 0.0593) in the multivariate model, which included weight loss, Karnofsky performance status (KPS), sex, and stage. HFX/PE is an effective regimen in patients with inoperable NSCLC, although it is considerably more toxic, and is undergoing a comparison in a three-arm randomized phase III study against induction cisplatin/vinblastine plus standard once-daily RT and against cisplatin/vinblastine concurrent with standard RT.
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Am. J. Clin. Oncol. · Dec 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialAntiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy.
This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin-containing chemotherapy (> or = 75 mg/m2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high-dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. ⋯ More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high-dose cisplatin for the first time and should be evaluated further in clinical trials.
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Am. J. Clin. Oncol. · Dec 1994
Randomized Controlled Trial Clinical TrialOndansetron and dexamethasone versus standard combination antiemetic therapy. A randomized trial for the prevention of acute and delayed emesis induced by cyclophosphamide-doxorubicin chemotherapy and maintenance of antiemetic effect at subsequent courses.
The antiemetic efficacy of ondansetron and dexamethasone (Ondex) was randomly compared to that of high-dose metoclopramide, dexamethasone, and orphenadrine (Control) in the prevention of emesis induced by cyclophosphamide-doxorubicin chemotherapy in 64 chemotherapy-naive breast cancer patients. For the control of acute emesis (day 1), patients were randomized to receive either ondasetron 8 mg p.o. 1 hour prior to chemotherapy (CT) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v. 40 minutes prior to CT (Ondex) or dexamethasone 20 mg i.v. 40 minutes prior to CT, orphenadrine 40 mg i.m. 35 minutes prior to CT and metoclopramide 3 mg/kg i.v. 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o. every 3 hours for 4 times (Control). To control delayed emesis, patients on Ondex received ondansetron 8 mg PO t.i.d. days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o. q.i.d. and dexamethasone 8 mg i.m. b.i.d. days 2 and 3. ⋯ Acute nausea was absent in 38% and 34% of patients treated with Ondex and Control, respectively (p = NS). Complete and major control of delayed emesis (days 2-5) was observed in 65%/91% versus 44%/66% of patients in the Ondex and Control arms, respectively (p = NS/p < .01). In patients receiving 6 courses of FEC/FAC, control of acute emesis was significantly superior with Ondex at all treatment courses.
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Am. J. Clin. Oncol. · Apr 1994
Randomized Controlled Trial Comparative Study Clinical TrialA randomized double-blind trial of ondansetron alone versus in combination with dexamethasone versus in combination with dexamethasone and lorazepam in the prevention of emesis due to cisplatin-based chemotherapy.
To compare the effectiveness and side effects of antiemetic regimens using ondansetron alone (O) versus ondansetron plus dexamethasone (OD) versus ondansetron plus dexamethasone plus lorazepam (ODA) in the prevention of emesis induced by cisplatin-based chemotherapy. ⋯ Ondansetron was very effective in the prevention of nausea and vomiting during the acute phase after cisplatin administration. In treating delayed nausea and vomiting, although the results of three regimens were still disappointing, the combination of ondansetron plus dexamethasone or plus lorazepam provided superior results. Patients who received the lorazepam-containing regimen appeared more comfortable and less restless than those who were given other regimens.
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Am. J. Clin. Oncol. · Apr 1994
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapies. Ondansetron Study Group.
We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (> 500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups. ⋯ A higher incidence of headaches and gastrointestinal complaints (constipation, abdominal pain) were observed in the three ondansetron groups. In conclusion, oral ondansetron is an effective and well-tolerated antiemetic treatment in the management of cancer patients receiving ambulatory cyclophosphamide-based chemotherapy. These results support the view that serotonin and 5-HT3 receptors play an important role in cyclophosphamide-induced nausea and vomiting.