Seminars in oncology
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Seminars in oncology · Dec 1996
Clinical TrialPhase II study of paclitaxel and cisplatin in patients with non-small cell lung cancer.
Few cytotoxic agents tested in adequate phase II trials involving patients with non-small cell lung cancer have produced single-agent response rates greater than 15%. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is one of them, with reported response rates ranging from 21% to 36%. Platinum-based regimens have been key to the development of the most effective combination therapies for NSCLC. ⋯ Grade 1 or 2 peripheral neuropathy occurred in 26% and grade 3 or 4 in only 1% of all courses. Of 67 patients evaluable for response, complete remission was noted in three (5%) patients, partial remission in 25 (37%) patients, stable disease in 22 (33%) patients, and progressive disease in 17 (25%) patients. These results suggest that combination paclitaxel/cisplatin is active and well tolerated in the treatment of non-small cell lung cancer.
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Seminars in oncology · Dec 1996
Paclitaxel and simultaneous radiation in the treatment of stage IIIA/B non-small cell lung cancer.
In a clinical phase II trial, escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) were given with concurrent radiation to patients with stage IIIA/B non-small cell lung cancer. Radiotherapy was given in daily doses of 2 Gy, 5 days a week, in weeks 1 through 3 and 6 through 8. Paclitaxel was given on day 1 of weeks 1 through 3 and 6 through 8, at a starting dose level of 50 mg/m2. ⋯ The overall response rate was 75%. In summary, the maximum tolerated dose of paclitaxel in this study has been determined to be 86 mg/m2 weekly. Pulmonary infections represent the major clinical toxicity, and the high response rate merits further clinical evaluation of this regimen.
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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
Paclitaxel and radiotherapy in the treatment of advanced non-small cell lung cancer.
Sixteen patients affected by previously untreated non-small cell lung cancer stage IIIB or IV received radiotherapy and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as radiation sensitizer in an open, nonrandomized pilot study to find the maximum tolerated dose of the drug concomitantly combined with radiation. Paclitaxel was given as a 3-hour infusion once weekly at a dose escalating by 10 mg/m2/wk for every patient cohort, starting at 40 mg/m2/wk and continuing to 80 mg/m2/wk. Conventionally fractionated (2 Gy/d for 5 d/wk for 5 weeks) radiotherapy up to 50 Gy was delivered to the primary tumor and mediastinum with a 6-mv linear accelerator. ⋯ Paclitaxel may be safely combined with radiation at the maximum tolerated dose of 70 mg/m2/wk. Our data seem to confirm the radiosensitizing effect of the drug, independent of the dose level. Low doses of paclitaxel given as a single agent are unable to control metastatic disease.
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Seminars in oncology · Oct 1996
Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is active against advanced breast cancer and anthracycline-resistant breast cancer. We assessed the efficacy and toxicity of doxorubicin followed by a 3-hour infusion of paclitaxel in women with advanced breast cancer. Participants could have received at most one prior adjuvant chemotherapy regimen, but no previous exposure to anthracyclines or taxanes was permitted. ⋯ Main toxicities were neutropenia, paresthesia, nausea/vomiting, alopecia, myalgia, and cardiotoxicity. In 15 patients (50%), the left ventricular ejection fraction decreased to below normal levels; six patients (20%) developed congestive heart failure. In conclusion, the combination of doxorubicin and paclitaxel is highly active; dose-limiting toxicities are neutropenia, neuropathy, and cumulative cardiotoxicity.