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- Title
Weekly, high-dose paclitaxel in advanced lung carcinoma.
- Authors
Wallace Akerley; James E. Herndon; Merrill J. Egorin; Alan P. Lyss; Hedy L. Kindler; Dianne M. Savarese; Carol A. Sherman; D. Marc Rosen; Donna Hollis; Mark J. Ratain; Mark R. Green
- Abstract
The Cancer and Leukemia Group B conducted a Phase II trial to evaluate the efficacy, toxicity, and pharmacokinetics of paclitaxel administered at a maximum dose density for patients with chemotherapy-naïve, advanced-stage nonsmall cell lung carcinoma (NSCLC). Patients with Stage IIIB/IV or recurrent NSCLC, a performance status (PS) score of 01, and no history of chemotherapy exposure were eligible. Paclitaxel, 150 mg/m2, was administered over 3 hours during Weeks 16 of an 8-week cycle. Doses were modified for ANC < 1500/μL or for ≥ Grade 2 neuropathy on the day of therapy. Treatment continued until toxicity or disease progression. Pharmacokinetics were assessed at Weeks 1, 3, and 5 of Cycle 1. Thirty-eight patients (median age, 64 years; range, 3181 years) were treated. There were 21 males (PS = 0 for 17). Eleven patients had received previous radiation, 2 had brain metastases, 25 had adenocarcinoma, 23 had Stage IV disease, 6 had StageIIIB disease, and 9 had recurrent disease. Grade 34 granulocytopenia occurred in 39% of patients. There were no deaths due to toxicity. Grade 2 or 3 neuropathy occurred in 29% and 24% of patients, respectively. Ten (27%) patients had Grade 3 hyperglycemia (glucose concentration > 250 mg/dL). There were 16 partial responses (42%; 95% confidence interval [CI], 2659%). The median survival period was 12.3 months (95% CI, 7.919.6%), and the 1-year and 2-year survival rates were 52% (95% CI, 3971%) and 26% (95% CI, 1545%), respectively. Paclitaxel pharmacokinetics were consistent with published values and clearance was not induced. Older age and hyperglycemia were associated with greater neurotoxicity. Paclitaxel at 150 mg/m2 per week × 6 every 8 weeks can be administered safely in the cooperative group setting. These Phase II data are comparable to those associated with combination therapy. The weekly dose-dense schedule may be more active than conventional schedules. Cancer 2003;10:24806. © 2003 American Cancer Society. DOI 10.1002/cncr.11375
- Subjects
CANCER patients; SMALL cell lung cancer; THERAPEUTICS; DRUG therapy; RADIOTHERAPY
- Publication
Cancer (0008543X), 2003, Vol 97, Issue 10, p2480
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.11375