Seminars in oncology
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Seminars in oncology · Feb 1999
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialIrinotecan versus infusional 5-fluorouracil: a phase III study in metastatic colorectal cancer following failure on first-line 5-fluorouracil. V302 Study Group.
In a multicenter phase III trial, 267 patients with nonbulky metastatic colorectal cancer who had failed first-line 5-fluorouracil (5-FU) therapy were randomized to receive second-line treatment with either the new topoisomerase agent, irinotecan (Rhône-Poulenc Rorer, Antony, France), or a high-dose infusional 5-FU regimen. Patients treated with irinotecan survived significantly longer than those treated with infusional 5-FU. The 1-year survival rate was 45% for patients receiving irinotecan compared with 32% for patients receiving 5-FU. ⋯ Overall, mean global quality of life scores were similar in the two arms of the study throughout the period of treatment and follow-up, demonstrating that the more effective disease control achieved by irinotecan at least maintains quality of life. Indeed, deterioration in quality of life (defined as >50% decrease from baseline score) occurred significantly later in irinotecan-treated patients. In light of these data, irinotecan should be considered the reference treatment for patients with 5-FU-refractory advanced colorectal cancer.
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Seminars in oncology · Dec 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialPhase III studies of single-agent docetaxel in patients with metastatic breast cancer who have progressed despite previous chemotherapy regimens: preliminary results.
A recent large phase III trial has for the first time demonstrated that choice of treatment can influence survival duration in patients with metastatic breast cancer who have progressed despite previous anthracycline-containing therapy. In a multicenter study, patients who received docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) experienced a longer median survival time (II.4 months v 8.7 months; P = .0097) as well as a longer time to progression (19 weeks v II weeks; P < .001) and higher overall response rate (30% v II.6%; P < .0001) than patients receiving treatment with mitomycin C and vinblastine. The toxicity profile was manageable and tolerable for both arms. ⋯ In this study, the duration of survival was not influenced by treatment. However, the higher response rate with docetaxel was achieved without the risk of potentially fatal cardiac toxicity seen in some patients who received doxorubicin. To date, docetaxel is the only single agent shown to have a potential superior activity when compared with doxorubicin in patients with progressive metastatic disease.
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Seminars in oncology · Oct 1997
Multicenter Study Clinical TrialDose-escalated paclitaxel in 1-hour infusion with a fixed dose of cisplatin in previously untreated advanced ovarian cancer: a phase II trial of the Spanish Group for Ovarian Cancer.
This phase II trial was planned to study the efficacy and toxicity of a fixed dose of cisplatin plus paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given over 1 hour with intrapatient dose escalation. Patients with advanced epithelial ovarian cancer (stages IIB-IV); Eastern Cooperative Oncology Group performance status < or = 2; normal renal, liver, and bone marrow function; and evaluable residual disease after debulking surgery were accrued. Paclitaxel was given over 1-hour infusion and dose was escalated from 175 to 200 and 225 mg/m2 if nadir neutrophil counts were > or = 1000/microL, platelets were > or = 100,000/microL, and neurotoxicity was less than grade 2. ⋯ Peripheral neurotoxicity (grade 1, 39.7%; grade 2, 42.6%; and grade 3, 8.8%) was dose-limiting. It is too early to report on time to progression and survival, and these data are not yet available. This combination of cisplatin with escalating doses of paclitaxel is feasible and very active, but the high incidence of peripheral neurotoxicity may limit its use.
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Seminars in oncology · Oct 1997
Multicenter Study Clinical TrialEfficacy and safety of the combination paclitaxel/carboplatin in patients with previously treated advanced ovarian carcinoma: a multicenter French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens phase II study.
The French Groupe des Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) conducted a multicenter phase II study of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) to evaluate the efficacy and side effects of this combination in pretreated advanced ovarian cancer. Patients with progressive ovarian carcinoma during or after platinum-based chemotherapy received paclitaxel 175 mg/m2 intravenously over 3 hours followed by intravenous carboplatin over 30 minutes every 4 weeks. The dose of carboplatin was calculated using a projected area under the concentration-time curve of 5 mg/mL x min. ⋯ Transitory peripheral neuropathy was present in 45% of patients but was severe in only one patient. One early death was observed due to progressive disease and possibly to therapy. The combination of paclitaxel 175 mg/m2 as a 3-hour infusion and carboplatin dosed to an area under the concentration-time curve of 5 is an effective therapy in patients previously treated with platinum-based chemotherapy and may be administered safely to outpatients who relapse after one or two lines of chemotherapy.
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Seminars in oncology · Oct 1997
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialPaclitaxel with carboplatin versus paclitaxel with carboplatin alternating with cisplatin as first-line chemotherapy in advanced epithelial ovarian cancer: preliminary results of a Hellenic Cooperative Oncology Group study.
Ninety previously untreated patients with advanced epithelial ovarian cancer (International Federation of Gynecology and Obstetrics stages IIC, III, and IV) were randomized, after initial cytoreductive surgery, to receive paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 175 mg/m2 as a 3-hour infusion with either carboplatin at an area under the concentration-time curve of 7 (group A) or carboplatin at an area under the concentration-time curve of 7 on courses 1, 3, and 5, alternating with cisplatin 75 mg/m2 on courses 2, 4, and 6 (group B). Treatment was given every 3 weeks, up to a total of six courses. Sixty-one patients (33 and 28 patients in groups A and B, respectively) had residual disease after the initial cytoreductive surgery. ⋯ Treatment was generally well tolerated. Grade 3 and 4 neutropenia was 20% and 32% for groups A and B, respectively, while grade 3 and 4 thrombocytopenia was 4% and 7%, respectively, with no significant difference between the two groups. In conclusion, both combinations seem very active for the treatment of advanced epithelial ovarian cancer and are associated with acceptable toxicity.