TY - JOUR
T1 - Phase II study of docetaxel and vinorelbine as adjuvant chemotherapy for resected non-small cell lung cancers
AU - Chaft, Jamie E.
AU - Rekhtman, Natasha
AU - Sima, Camelia S.
AU - Rusch, Valerie
AU - Kris, Mark G.
AU - Zakowski, Maureen
AU - Azzoli, Christopher G.
N1 - Funding Information:
Acknowledgments This trial was supported by a grant from Sanofi-Aventis Oncology.
PY - 2013/10
Y1 - 2013/10
N2 - Purpose: For patients with resected stage II-III non-small cell lung cancers (NSCLCs), adjuvant cisplatin-based chemotherapy improves survival over surgery alone. For cisplatin ineligible patients, there is no standard adjuvant option. We evaluated drug delivery and toxicity of docetaxel and vinorelbine in patients who could not receive cisplatin. Methods: Patients with completely resected stage IB-III NSCLCs were treated with up to 4 cycles of docetaxel and vinorelbine at the recommended phase II dose. The primary endpoint was drug delivery compared to historical delivery of adjuvant cisplatin plus vinorelbine. Secondary endpoints were toxicity and feasibility. Results: Twenty-five patients were enrolled. Overall, 13/25 (52 %, 95 % CI 34-70) completed 4 cycles, and 19/25 (76 %, 95 % CI 60-87) completed ≥3 cycles. Twenty of 25 patients (80 %) experienced a Grade 3 or 4 adverse event. Conclusions: Delivery of this dose and schedule of docetaxel and vinorelbine was difficult with a dose delivery comparable to cisplatin plus vinorelbine, and cisplatin plus docetaxel, used in this setting.
AB - Purpose: For patients with resected stage II-III non-small cell lung cancers (NSCLCs), adjuvant cisplatin-based chemotherapy improves survival over surgery alone. For cisplatin ineligible patients, there is no standard adjuvant option. We evaluated drug delivery and toxicity of docetaxel and vinorelbine in patients who could not receive cisplatin. Methods: Patients with completely resected stage IB-III NSCLCs were treated with up to 4 cycles of docetaxel and vinorelbine at the recommended phase II dose. The primary endpoint was drug delivery compared to historical delivery of adjuvant cisplatin plus vinorelbine. Secondary endpoints were toxicity and feasibility. Results: Twenty-five patients were enrolled. Overall, 13/25 (52 %, 95 % CI 34-70) completed 4 cycles, and 19/25 (76 %, 95 % CI 60-87) completed ≥3 cycles. Twenty of 25 patients (80 %) experienced a Grade 3 or 4 adverse event. Conclusions: Delivery of this dose and schedule of docetaxel and vinorelbine was difficult with a dose delivery comparable to cisplatin plus vinorelbine, and cisplatin plus docetaxel, used in this setting.
KW - Adjuvant chemotherapy
KW - Docetaxel
KW - Early-stage non-small cell lung cancer
KW - Vinorelbine
UR - https://www.scopus.com/pages/publications/84885375481
U2 - 10.1007/s00280-013-2263-1
DO - 10.1007/s00280-013-2263-1
M3 - Article
C2 - 23975243
AN - SCOPUS:84885375481
SN - 0344-5704
VL - 72
SP - 931
EP - 934
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 4
ER -