Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer

Phase II southwest oncology group study S9504

David R Gandara, Kari Chansky, Kathy S. Albain, Bryan R. Leigh, Laurie E. Gaspar, Primo N Lara, Howard Burris, Paul Gumerlock, J. Philip Kuebler, James D. Bearden, John Crowley, Robert Livingston

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)2004-2010
Number of pages7
JournalJournal of Clinical Oncology
Volume21
Issue number10
DOIs
StatePublished - May 15 2003

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docetaxel
Chemoradiotherapy
Non-Small Cell Lung Carcinoma
Survival Rate
Radiation Pneumonitis
Neoplasm Metastasis
Combined Modality Therapy
Survival
Etoposide
Neutropenia
Cisplatin
Disease-Free Survival
Radiotherapy
Thorax

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer : Phase II southwest oncology group study S9504. / Gandara, David R; Chansky, Kari; Albain, Kathy S.; Leigh, Bryan R.; Gaspar, Laurie E.; Lara, Primo N; Burris, Howard; Gumerlock, Paul; Kuebler, J. Philip; Bearden, James D.; Crowley, John; Livingston, Robert.

In: Journal of Clinical Oncology, Vol. 21, No. 10, 15.05.2003, p. 2004-2010.

Research output: Contribution to journalArticle

Gandara, DR, Chansky, K, Albain, KS, Leigh, BR, Gaspar, LE, Lara, PN, Burris, H, Gumerlock, P, Kuebler, JP, Bearden, JD, Crowley, J & Livingston, R 2003, 'Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer: Phase II southwest oncology group study S9504', Journal of Clinical Oncology, vol. 21, no. 10, pp. 2004-2010. https://doi.org/10.1200/JCO.2003.04.197
Gandara, David R ; Chansky, Kari ; Albain, Kathy S. ; Leigh, Bryan R. ; Gaspar, Laurie E. ; Lara, Primo N ; Burris, Howard ; Gumerlock, Paul ; Kuebler, J. Philip ; Bearden, James D. ; Crowley, John ; Livingston, Robert. / Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer : Phase II southwest oncology group study S9504. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 10. pp. 2004-2010.
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title = "Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIb non-small-cell lung cancer: Phase II southwest oncology group study S9504",
abstract = "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.",
author = "Gandara, {David R} and Kari Chansky and Albain, {Kathy S.} and Leigh, {Bryan R.} and Gaspar, {Laurie E.} and Lara, {Primo N} and Howard Burris and Paul Gumerlock and Kuebler, {J. Philip} and Bearden, {James D.} and John Crowley and Robert Livingston",
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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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