Abstract | INTRODUCTION: METHODS:
Chemotherapy-naive patients >/=70-years-old with stage IIIB-IV NSCLC and a performance status (PS) </=2 were eligible. Primary endpoints were the maximum tolerated dose (phase I) and time-to-progression (phase II) of oral exisulind with 25 mg/m/wk of intravenous vinorelbine on a 28-day cycle. Patients with clinical benefit after 6 cycles of this combination received exisulind alone. RESULTS: Fourteen phase I patients (median PS 1; median age 78 years) were enrolled. Dose-limiting toxicities included grade 3 constipation (one patient), grade 3 febrile neutropenia (one patient) and grade 3 diarrhea (one patient). The maximum tolerated dose of oral exisulind with 25 mg/m/wk of intravenous vinorelbine was 125 mg twice daily. Thirty phase II patients (median PS 1; median age 78 years) were enrolled. Grade >/=3 neutropenia occurred in 14/30 patients. Two patients experienced neutropenic fever. There were no complete responses, one partial response and 12 patients with stable disease as their best response. The objective response rate was 4.0% (95% CI: 0.1-20.4%). Phase II median time-to-progression was 4.7 months (95% CI: 3.1-9.3 months) and median OS was 9.6 months (95% CI: 6.6-19.1 months). CONCLUSIONS: This combination is safe, seems to have activity in the elderly with advanced NSCLC and a PS </=2, and warrants further investigation.
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Authors | Steven Attia, Anne M Traynor, Kyungmann Kim, Joseph J Merchant, Tien Hoang, Harish G Ahuja, Peter A Beatty, Richard M Hansen, Gregory A Masters, Kurt R Oettel, Gary R Shapiro, Martha M Larson, Marilyn L Larson, Joan H Schiller |
Journal | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
(J Thorac Oncol)
Vol. 3
Issue 9
Pg. 1018-25
(Sep 2008)
ISSN: 1556-1380 [Electronic] United States |
PMID | 18758305
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Sulindac
- Vinblastine
- sulindac sulfone
- Vinorelbine
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Topics |
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Female
- Humans
- Lung Neoplasms
(drug therapy, pathology)
- Male
- Maximum Tolerated Dose
- Neoplasm Staging
- Prognosis
- Sulindac
(administration & dosage, analogs & derivatives)
- Survival Rate
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
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