Seminars in oncology
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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
Randomized Controlled Trial Clinical TrialPaclitaxel and carboplatin as neoadjuvant chemotherapy in operable (stage I and II) and locally advanced (stage IIIA-N2) non-small cell lung cancer.
In 1995, a randomized intergroup study of neoadjuvant chemotherapy followed by either surgery or radiotherapy in the treatment of non-small cell lung cancer was started under the auspices of the European Organization for Research and Treatment of Cancer (EORTC 08941). The objective of this study is to investigate whether surgery or radiotherapy represents superior locoregional treatment, in terms of survival and quality of life, for patients with stage IIIA(N2) non-small cell lung cancer who have achieved a response after three courses of neoadjuvant chemotherapy. A phase II side study will investigate the clinical and pathologic response rate (if applicable), as well as acute and late side effects during or after consecutive surgery and/or radiotherapy of combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin. ⋯ Depending on the response rate and early and late side effects observed in this well-defined, prognostically favorable group of patients, it will be decided whether and how to use the same combination chemotherapy in an ongoing randomized trial currently being conducted by the Dutch Lung Cancer Study Group (DLCSG 94-2). In the latter trial, patients with stage I and II non-small cell lung cancer are randomized to immediate surgery or two courses of neoadjuvant chemotherapy. Responding patients will receive another two courses of chemotherapy before surgery; nonresponders will go directly to surgery.
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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.
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Seminars in oncology · Dec 1996
Clinical TrialPreliminary results of a phase I/II clinical trial of paclitaxel and carboplatin in non-small cell lung cancer.
Forty-nine patients with non-small cell lung cancer were treated in a study designed to establish the maximum tolerated dose of outpatient paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), given by 3-hour infusion, combined with a fixed dose of carboplatin (area under the concentration-time curve [AUC] = 6, Calvert method). The study population included 31 men and 18 women with previously untreated, unresectable stage III or IV non-small cell lung cancer. Patients had a median age of 62 years (age range, 46 to 81 years) and a median Southwest Oncology Group performance status of 1 (range, 0 to 2). ⋯ Objective responses were documented in 26 of 42 patients with objectively measurable disease, for an overall response rate of 62%. Although these data are preliminary, this regimen appears to be efficacious and cost-effective, and warrants further study. Paclitaxel 225 mg/m2 combined with carboplatin (AUC = 6) every 3 weeks is recommended for follow-up phase II and III clinical trials.
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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.