Seminars in oncology
-
Seminars in oncology · Aug 1997
Clinical TrialPaclitaxel, carboplatin, and oral etoposide: a phase II trial in limited-stage small cell lung cancer.
Carboplatin/etoposide is an active regimen in the treatment of small cell lung cancer. This phase II trial evaluated whether adding paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) to this two-drug combination might increase its efficacy. Since April 1996, 55 patients were entered into the ongoing protocol. ⋯ Nonhematologic adverse events included minor nausea/vomiting (1.5% grade 3, 9.2% grade 2), polyneuropathy (2.3% grade 2, 17.5% grade 1), and myalgia/arthralgia (8.2% grade 2, 16.4% grade 1). Paclitaxel/carboplatin/etoposide is active in small cell lung cancer with moderate toxicity and good subjective tolerance. There were no life-threatening hematologic or nonhematologic complications in this phase II trial.
-
Seminars in oncology · Aug 1997
Clinical TrialDocetaxel (Taxotere) and vinorelbine in the treatment of advanced non-small cell lung cancer: preliminary results of a phase I/II trial.
We undertook a phase I/II study of the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine in the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC). Nineteen patients with unresectable NSCLC received a combination of docetaxel 50 mg/m2 and vinorelbine 15 to 45 mg/m2 every 2 weeks. All patients received prophylactic granulocyte-colony stimulating factor 5 microg/kg/d and corticosteroids. ⋯ Further dose escalation is needed to determine the maximum tolerated dose of the combination. A partial response was observed in five patients (26%; 95% confidence interval, 15% to 57%), and nine (47%) patients showed stable disease. Based on these preliminary results, the combination of these two drugs appears to have antitumor activity against NSCLC and warrants continued study.
-
Seminars in oncology · Aug 1997
Clinical TrialPaclitaxel (1-hour) and carboplatin (area under the concentration-time curve 7.5) in advanced non-small cell lung cancer: a phase II study of the Fox Chase Cancer Center and its network.
We previously reported a 62% response rate and 54% 1-year survival rate for paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) administered by 24-hour infusion in combination with fixed-dose carboplatin to treat patients with advanced non-small cell lung cancer (NSCLC). Myelosuppression proved dose limiting, but was substantially reduced by the routine use of granulocyte colony-stimulating factor during the second and subsequent cycles. Activity for paclitaxel 135 mg/m2 and 200 mg/m2 by 1-hour infusion every 3 weeks in patients with NSCLC, with minimal myelosuppression and the suggestion of a dose-response relationship, has been reported. ⋯ Paclitaxel given by 1-hour infusion in combination with carboplatin at a fixed target area under the concentration-time curve of 7.5, although active in advanced NSCLC, is associated with problems that compromise its efficacy. Higher dose levels yield intolerable toxicity, evidenced by the incidence of neurotoxicity (rather than myelosuppression) that was dose and protocol limiting at paclitaxel doses exceeding 215 mg/m2. Lower doses, while more tolerable, appear to be associated with lower response rates.
-
Seminars in oncology · Aug 1997
Clinical TrialPreliminary results of neoadjuvant paclitaxel and carboplatin in the treatment of early stage non-small cell lung cancer.
The purpose of this study is to determine the feasibility of delivering neoadjuvant paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin to patients with clinical early stage (stage I and II) non-small cell lung cancer. Although neoadjuvant chemotherapy appears to prolong survival in patients with stage IIIA non-small cell lung cancer, several studies have demonstrated an increase in perioperative mortality associated with this approach. This study is designed to address whether three cycles of paclitaxel (200 mg/m2/3 hour, day 1) and carboplatin (area under the concentration-time curve 5, day 2) can be given preoperatively to patients with clinical stage I and II non-small cell lung cancer and to assess the associated toxicities, pathologic response rate, disease-free survival, and overall survival of this group of patients. ⋯ Three have successfully undergone resection, with no perioperative complications noted. One patient had a pathologic complete remission and two had pathologic partial remissions. Preliminary results indicate that this approach is well tolerated and results in major tumor response.
-
Seminars in oncology · Aug 1997
Clinical TrialWeekly paclitaxel in patients with advanced lung cancer: preliminary data from a phase II trial.
We conducted a phase II trial in chemotherapy-naive patients with advanced non-small cell lung cancer to determine the efficacy of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) delivered at a maximum tolerated dose of 175 mg/m2 on an extended weekly schedule. Patients with stage IIIB/IV non-small cell lung cancer were eligible if they had an Eastern Cooperative Oncology Group performance status of 0 to 2, had received no previous chemotherapy, demonstrated normal hematologic and hepatic function, and could provide informed consent. Paclitaxel 175 mg/m2 was administered as an intravenous infusion weekly over 3 hours with standard premedication, for 6 weeks of an 8-week cycle. ⋯ Median duration of response was 6.5 months, and the 1-year survival rate was 53%. The extended weekly paclitaxel schedule results in enhanced dose intensity, marked activity, and acceptable toxicity. Paclitaxel given weekly at maximum dose intensity may be more effective than conventional paclitaxel administration schedules.