TY - JOUR
T1 - Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer
T2 - Phase II southwest oncology group study S9504
AU - Gandara, David R.
AU - Chansky, Kari
AU - Albain, Kathy S.
AU - Leigh, Bryan R.
AU - Gaspar, Laurie E.
AU - Lara, Primo N.
AU - Burris, Howard
AU - Gumerlock, Paul
AU - Kuebler, J. Philip
AU - Bearden, James D.
AU - Crowley, John
AU - Livingston, Robert
PY - 2003/5/15
Y1 - 2003/5/15
N2 - Purpose: To test the concept of taxane sequencing in combined-modality therapy, this phase II trial (S9504) evaluated consolidation docetaxel after concurrent chemoradiotherapy in patients with pathologically documented stage IIIB non-small-cell lung cancer (NSCLC). Results were compared with those of the predecessor study (59019) with identical eligibility, staging criteria, and treatment, excepting docetaxel consolidation. Patients and Methods: Treatment consisted of cisplatin 50 mg/m2 on days 1, 8, 29, and 36, etoposide 50 mg/m2 on days 1 through 5 and 29 through 33, and concurrent thoracic radiotherapy (total dose of 61 Gy). Consolidation docetaxel started 4 to 6 weeks after chemoradiotherapy at an initial dose of 75 mg/m2. Results: Stage subsets (tumor-node-metastasis system) in 83 eligible patients were as follows: T4NO/1, 31 patients (37%); T4N2, 22 patients (27%), and T1-3N3, 30 patients (36%). Concurrent chemoradiotherapy was generally well tolerated, but two patients died from probable radiation-associated pneumonitis. Neutropenia during consolidation docetaxel was common (57% with grade 4) and most frequent during escalation to 100 mg/m2. Median progression-free survival was 16 months, median survival was 26 months, and 1-, 2-, and 3-year survival rates were 76%, 54%, and 37%, respectively. Brain metastasis was the most common site of failure. In 59019, median survival was 15 months and 1-, 2-, and 3-year survival rates were 58%, 34%, and 17%, respectively. Conclusion: Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB NSCLC is feasible and generally tolerable, and results compare favorably with the predecessor trial S9019. Nevertheless, this study remains hypothesis-generating and does not provide definitive evidence of the benefit of this approach. Phase III trials evaluating the S9504 regimen have been initiated to validate these results.
AB - Purpose: To test the concept of taxane sequencing in combined-modality therapy, this phase II trial (S9504) evaluated consolidation docetaxel after concurrent chemoradiotherapy in patients with pathologically documented stage IIIB non-small-cell lung cancer (NSCLC). Results were compared with those of the predecessor study (59019) with identical eligibility, staging criteria, and treatment, excepting docetaxel consolidation. Patients and Methods: Treatment consisted of cisplatin 50 mg/m2 on days 1, 8, 29, and 36, etoposide 50 mg/m2 on days 1 through 5 and 29 through 33, and concurrent thoracic radiotherapy (total dose of 61 Gy). Consolidation docetaxel started 4 to 6 weeks after chemoradiotherapy at an initial dose of 75 mg/m2. Results: Stage subsets (tumor-node-metastasis system) in 83 eligible patients were as follows: T4NO/1, 31 patients (37%); T4N2, 22 patients (27%), and T1-3N3, 30 patients (36%). Concurrent chemoradiotherapy was generally well tolerated, but two patients died from probable radiation-associated pneumonitis. Neutropenia during consolidation docetaxel was common (57% with grade 4) and most frequent during escalation to 100 mg/m2. Median progression-free survival was 16 months, median survival was 26 months, and 1-, 2-, and 3-year survival rates were 76%, 54%, and 37%, respectively. Brain metastasis was the most common site of failure. In 59019, median survival was 15 months and 1-, 2-, and 3-year survival rates were 58%, 34%, and 17%, respectively. Conclusion: Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB NSCLC is feasible and generally tolerable, and results compare favorably with the predecessor trial S9019. Nevertheless, this study remains hypothesis-generating and does not provide definitive evidence of the benefit of this approach. Phase III trials evaluating the S9504 regimen have been initiated to validate these results.
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U2 - 10.1200/JCO.2003.04.197
DO - 10.1200/JCO.2003.04.197
M3 - Article
C2 - 12743155
AN - SCOPUS:0038688474
SN - 0732-183X
VL - 21
SP - 2004
EP - 2010
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -