Seminars in oncology
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel plus carboplatin in the treatment of patients with advanced lung cancer: a Vanderbilt University Cancer Center phase II trial (LUN-46).
In studies conducted by the Eastern Cooperative Oncology Group, treatment with either paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) or carboplatin was associated with an improvement in 1-year survival in patients with stage IV non-small cell lung cancer (NSCLC). Based on these findings, a phase II trial of carboplatin plus paclitaxel was conducted in patients with advanced NSCLC to determine the activity and toxicity of this regimen. Eligibility requirements included stage IIIB or IV histologically confirmed NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 2, no prior chemotherapy, and adequate hematologic, renal, hepatic, and cardiac functions. ⋯ Median survival was 38 weeks and the survival rate at 1 year was 32%. Paclitaxel plus carboplatin, as given in this study, was found to be a moderately active regimen in patients with advanced NSCLC. This regimen warrants comparison with existing cisplatin-based regimens in a prospective randomized trial.
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Seminars in oncology · Dec 1996
Review Randomized Controlled Trial Comparative Study Clinical TrialThe North American experience with paclitaxel combined with cisplatin or carboplatin in lung cancer.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is a new cytotoxic chemotherapeutic agent with a novel mechanism of action. Single-agent paclitaxel studies have shown promising activity in both small cell and non-small cell lung cancers. In non-small cell lung cancer, response rates of 22% to 26% and 1-year survival rates of 40% were reported with both 3-hour and 24-hour infusions of paclitaxel. ⋯ Thrombocytopenia occurred less frequently than expected. One completed randomized study showed that the paclitaxel/cisplatin regimen was superior to the etoposide/cisplatin regimen with respect to response rate and survival. Additional randomized studies are necessary to determine whether the combinations are superior to single-agent paclitaxel, to define the optimal dose with the 3-hour infusion schedule, to define the optimal schedule (3 hours v 24 hours), and to determine whether paclitaxel can be combined with other new agents.
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Seminars in oncology · Dec 1996
Randomized Controlled Trial Clinical TrialOne-hour paclitaxel in the treatment of non-small cell lung cancer.
This review describes studies with two paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)-containing treatments for non-small cell lung cancer (NSCLC). In an ongoing study, 100 patients with previously untreated stage IIIB or IV NSCLC received combination therapy comprised of paclitaxel 225 mg/m2 via 1-hour infusion and carboplatin, dosed to an area under the concentration-time curve of 6.0. Both drugs were given intravenously and cycles were repeated every 21 days. ⋯ Grade 3/4 esophagitis was observed in 51% of participants and usually occurred during the final 2 weeks of combined-modality therapy. The combination of paclitaxel and carboplatin is active and well tolerated in patients with advanced NSCLC, and paclitaxel-based combined-modality therapy produced a high rate of complete and partial responses and encouraging survival data. Continued investigation and refinement of these regimens is ongoing.
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Seminars in oncology · Dec 1996
Multicenter Study Clinical TrialPaclitaxel plus carboplatin and concurrent radiation therapy for patients with locally advanced non-small cell lung cancer.
Previously untreated patients with stages IIIA or IIIB non-small cell lung cancer entered this phase II study to evaluate the activity and toxicity of combined paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin and concurrent radiation. Patients received paclitaxel 50 mg/m2/wk as a 1-hour infusion and carboplatin area under the concentration-time curve of 2/wk for 7 weeks with radiation to the primary tumor and regional lymph nodes (44 Gy) followed by a boost to the tumor (22 Gy). In addition, patients received two additional cycles of paclitaxel 200 mg/m2 and carboplatin (area under the concentration-time curve of 6) 3 weeks apart. ⋯ Seven of the nine patients recovered from the esophagitis within 2 weeks and received the additional two cycles of paclitaxel 200 mg/m2 and carboplatin (area under the concentration-time curve of 6). Only one patient (4%) had grade 4 pneumonitis; this patient also recovered within 2 weeks and received the final two doses of combined chemotherapy. Therapy with paclitaxel, carboplatin, and concurrent radiation is a promising treatment for patients with locally advanced non-small cell lung cancer; it has a high response rate and acceptable toxicity.
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Seminars in oncology · Dec 1996
Clinical TrialPhase I dose-escalation trial of paclitaxel and ifosfamide in patients with advanced non-small cell lung cancer.
This phase I dose-escalation study was undertaken to determine the maximum tolerated doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and ifosfamide that could be administered without growth factors to previously untreated patients with non-small cell lung cancer. Forty patients with advanced non-small cell lung cancer were treated with a 3-hour infusion of paclitaxel and a 1-hour infusion of ifosfamide, repeated every 3 weeks. Groups of three patients each entered at escalating dose levels in a traditional phase I design. ⋯ The median survival was 9.1 months (range, 1 to 12 months). In summary, outpatient paclitaxel given over 3 hours and single-dose ifosfamide given over 1 hour may be combined safely without hematopoietic growth factors for the treatment of patients with non-small cell lung cancer. The recommended doses for phase II study are paclitaxel 225 mg/m2 and ifosfamide 4 g/m2, every 3 weeks.