Seminars in oncology
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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
Multicenter Study Clinical TrialCombination paclitaxel (1-hour) and carboplatin (AUC 7.5) in advanced non-small cell lung cancer: a phase II study by the Fox Chase Cancer Center Network.
We have previously reported a 62% response rate and 54% 1-year survival rate for patients with advanced non-small cell lung cancer (NSCLC) treated with paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) by 24-hour infusion in combination with carboplatin, using area under the concentration-time curve dosing (FCCC 93-024). Myelosuppression proved dose limiting, but was substantially reduced by the routine use of granulocyte colony-stimulating factor during the second and subsequent cycles. Antitumor activity has been reported with minimal myelosuppression, with paclitaxel 135 and 200 mg/m2 given every 3 weeks by 1-hour infusion to patients with NSCLC. ⋯ It is too early to report survival data. In conclusion, paclitaxel by 1-hour infusion in combination with carboplatin at a fixed targeted area under the concentration-time curve of 7.5 is an active regimen in advanced NSCLC. Neurotoxicity, rather than myelosuppression, is dose and protocol limiting at paclitaxel doses exceeding 215 mg/m2.
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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
Review Clinical TrialPaclitaxel via 1-hour infusion: clinical experience.
In phase II trials, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) can be safely administered via a 1-hour infusion. One-hour infusions of paclitaxel also have been administered safely in combination with many other cytotoxic regimens, including cisplatin/etoposide/radiation, carboplatin/etoposide (with or without radiation), mitoxantrone/5-fluorouracil/leucovorin, carboplatin, and carboplatin/5-fluorouracil. Notable activity has been seen in patients with several neoplasms, including stages III/IV non-small cell lung cancer, small cell lung cancer, advanced breast cancer, carcinoma of unknown primary site, urothelial carcinomas, and other advanced squamous cell carcinomas. Further study will determine whether these or similar combinations represent improved therapeutic alternatives.
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Seminars in oncology · Dec 1996
Clinical TrialPaclitaxel and carboplatin in nonoperable non-small cell lung cancer.
Based on the high activity of single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in non-small cell lung cancer (NSCLC) and the superior 1-year survival rates of patients with NSCLC treated with carboplatin, the Hellenic Cooperative Oncology Group initiated a phase II trial to investigate the efficacy and toxicity of the combination of both agents in patients with nonoperable stage III and IV NSCLC. Since July 1995, 31 eligible patients have entered into this study. All patients received paclitaxel 175 mg/m2 as a 3-hour infusion plus carboplatin dosed to an area under the concentration-time curve of 7, every 3 weeks. ⋯ Grade 2/3 neutropenia was experienced by 10.7% of patients, whereas grade 2 thrombocytopenia was seen in only 3.3%. One patient died following complications of severe allergic reaction. In conclusion, although this study is ongoing, it is clear that the combination of paclitaxel and carboplatin is effective and well tolerated in patients with nonoperable NSCLC.