Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: The Hoosier Oncology Group and U.S. Oncology

Nasser Hanna, Marcus Neubauer, Constantin Yiannoutsos, Ronald McGarry, James Arseneau, Rafat Ansari, Craig Reynolds, Ramaswamy Govindan, Anton Melnyk, William Fisher, Donald Richards, Daniel Bruetman, Thomas Anderson, Naveed Chowhan, Sreenivasa Nattam, Prasad Mantravadi, Cynthia Johnson, Tim Breen, Angela White, Lawrence Einhorn

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Abstract

Purpose: Concurrent chemoradiotherapy is standard treatment for patients with inoperable stage III non-small-cell lung cancer (NSCLC). A phase II study by the Southwest Oncology Group using consolidation docetaxel after cisplatin (P), etoposide (E), and radiation (XRT) resulted in a median survival time (MST) of 26 months. This randomized phase III trial evaluated whether consolidation docetaxel was responsible for this improved survival. Patients and Methods: Eligible patients had stage IIIA or IIIB NSCLC, baseline performance status of 0 to 1, forced expiratory volume in 1 second ≥ 1 L, and less than 5% weight loss. Patients received P 50 mg/m2 intravenously (IV) on days 1, 8, 29, and 36 and E 50 mg/m2 IV on days 1-5 and 29-33 concurrently with chest XRT to 59.40 Gy. Patients who did not experience progression were randomly assigned to docetaxel 75 mg/m2 IV every 21 days for three cycles versus observation. The primary end point was to compare overall survival (Kaplan-Meier analysis). Results: On the basis of evidence of futility, a data and safety monitoring board recommended early termination after an analysis of the initial 203 patients. Patient characteristics (n = 203) were as follows: 34% female; median age, 63 years; 39.4% stage IIIA; and 60.6% stage IIIB. One hundred forty-seven (72.4%) of 203 patients were randomly assigned to docetaxel (n = 73) or observation (n = 74). Grade 3 to 5 toxicities during docetaxel included febrile neutropenia (10.9%) and pneumonitis (9.6%); 28.8% of patients were hospitalized during docetaxel (v 8.1% in observation arm), and 5.5% died as a result of docetaxel. The MST for all patients (n = 203) was 21.7 months; MST was 21.2 months for docetaxel arm compared with 23.2 months for observation arm (P = .883). Conclusion: Consolidation docetaxel after PE/XRT results in increased toxicities but does not further improve survival compared with PE/XRT alone in patients with stage III inoperable NSCLC.

Original languageEnglish
Pages (from-to)5755-5760
Number of pages6
JournalJournal of Clinical Oncology
Volume26
Issue number35
DOIs
StatePublished - Dec 10 2008

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docetaxel
Etoposide
Non-Small Cell Lung Carcinoma
Cisplatin
Thorax
Radiation
Survival
Observation
Arm
Clinical Trials Data Monitoring Committees
Medical Futility
Febrile Neutropenia

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer : The Hoosier Oncology Group and U.S. Oncology. / Hanna, Nasser; Neubauer, Marcus; Yiannoutsos, Constantin; McGarry, Ronald; Arseneau, James; Ansari, Rafat; Reynolds, Craig; Govindan, Ramaswamy; Melnyk, Anton; Fisher, William; Richards, Donald; Bruetman, Daniel; Anderson, Thomas; Chowhan, Naveed; Nattam, Sreenivasa; Mantravadi, Prasad; Johnson, Cynthia; Breen, Tim; White, Angela; Einhorn, Lawrence.

In: Journal of Clinical Oncology, Vol. 26, No. 35, 10.12.2008, p. 5755-5760.

Research output: Contribution to journalArticle

Hanna, N, Neubauer, M, Yiannoutsos, C, McGarry, R, Arseneau, J, Ansari, R, Reynolds, C, Govindan, R, Melnyk, A, Fisher, W, Richards, D, Bruetman, D, Anderson, T, Chowhan, N, Nattam, S, Mantravadi, P, Johnson, C, Breen, T, White, A & Einhorn, L 2008, 'Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: The Hoosier Oncology Group and U.S. Oncology', Journal of Clinical Oncology, vol. 26, no. 35, pp. 5755-5760. https://doi.org/10.1200/JCO.2008.17.7840
Hanna, Nasser ; Neubauer, Marcus ; Yiannoutsos, Constantin ; McGarry, Ronald ; Arseneau, James ; Ansari, Rafat ; Reynolds, Craig ; Govindan, Ramaswamy ; Melnyk, Anton ; Fisher, William ; Richards, Donald ; Bruetman, Daniel ; Anderson, Thomas ; Chowhan, Naveed ; Nattam, Sreenivasa ; Mantravadi, Prasad ; Johnson, Cynthia ; Breen, Tim ; White, Angela ; Einhorn, Lawrence. / Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer : The Hoosier Oncology Group and U.S. Oncology. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 35. pp. 5755-5760.
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abstract = "Purpose: Concurrent chemoradiotherapy is standard treatment for patients with inoperable stage III non-small-cell lung cancer (NSCLC). A phase II study by the Southwest Oncology Group using consolidation docetaxel after cisplatin (P), etoposide (E), and radiation (XRT) resulted in a median survival time (MST) of 26 months. This randomized phase III trial evaluated whether consolidation docetaxel was responsible for this improved survival. Patients and Methods: Eligible patients had stage IIIA or IIIB NSCLC, baseline performance status of 0 to 1, forced expiratory volume in 1 second ≥ 1 L, and less than 5{\%} weight loss. Patients received P 50 mg/m2 intravenously (IV) on days 1, 8, 29, and 36 and E 50 mg/m2 IV on days 1-5 and 29-33 concurrently with chest XRT to 59.40 Gy. Patients who did not experience progression were randomly assigned to docetaxel 75 mg/m2 IV every 21 days for three cycles versus observation. The primary end point was to compare overall survival (Kaplan-Meier analysis). Results: On the basis of evidence of futility, a data and safety monitoring board recommended early termination after an analysis of the initial 203 patients. Patient characteristics (n = 203) were as follows: 34{\%} female; median age, 63 years; 39.4{\%} stage IIIA; and 60.6{\%} stage IIIB. One hundred forty-seven (72.4{\%}) of 203 patients were randomly assigned to docetaxel (n = 73) or observation (n = 74). Grade 3 to 5 toxicities during docetaxel included febrile neutropenia (10.9{\%}) and pneumonitis (9.6{\%}); 28.8{\%} of patients were hospitalized during docetaxel (v 8.1{\%} in observation arm), and 5.5{\%} died as a result of docetaxel. The MST for all patients (n = 203) was 21.7 months; MST was 21.2 months for docetaxel arm compared with 23.2 months for observation arm (P = .883). Conclusion: Consolidation docetaxel after PE/XRT results in increased toxicities but does not further improve survival compared with PE/XRT alone in patients with stage III inoperable NSCLC.",
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TY - JOUR

T1 - Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer

T2 - The Hoosier Oncology Group and U.S. Oncology

AU - Hanna, Nasser

AU - Neubauer, Marcus

AU - Yiannoutsos, Constantin

AU - McGarry, Ronald

AU - Arseneau, James

AU - Ansari, Rafat

AU - Reynolds, Craig

AU - Govindan, Ramaswamy

AU - Melnyk, Anton

AU - Fisher, William

AU - Richards, Donald

AU - Bruetman, Daniel

AU - Anderson, Thomas

AU - Chowhan, Naveed

AU - Nattam, Sreenivasa

AU - Mantravadi, Prasad

AU - Johnson, Cynthia

AU - Breen, Tim

AU - White, Angela

AU - Einhorn, Lawrence

PY - 2008/12/10

Y1 - 2008/12/10

N2 - Purpose: Concurrent chemoradiotherapy is standard treatment for patients with inoperable stage III non-small-cell lung cancer (NSCLC). A phase II study by the Southwest Oncology Group using consolidation docetaxel after cisplatin (P), etoposide (E), and radiation (XRT) resulted in a median survival time (MST) of 26 months. This randomized phase III trial evaluated whether consolidation docetaxel was responsible for this improved survival. Patients and Methods: Eligible patients had stage IIIA or IIIB NSCLC, baseline performance status of 0 to 1, forced expiratory volume in 1 second ≥ 1 L, and less than 5% weight loss. Patients received P 50 mg/m2 intravenously (IV) on days 1, 8, 29, and 36 and E 50 mg/m2 IV on days 1-5 and 29-33 concurrently with chest XRT to 59.40 Gy. Patients who did not experience progression were randomly assigned to docetaxel 75 mg/m2 IV every 21 days for three cycles versus observation. The primary end point was to compare overall survival (Kaplan-Meier analysis). Results: On the basis of evidence of futility, a data and safety monitoring board recommended early termination after an analysis of the initial 203 patients. Patient characteristics (n = 203) were as follows: 34% female; median age, 63 years; 39.4% stage IIIA; and 60.6% stage IIIB. One hundred forty-seven (72.4%) of 203 patients were randomly assigned to docetaxel (n = 73) or observation (n = 74). Grade 3 to 5 toxicities during docetaxel included febrile neutropenia (10.9%) and pneumonitis (9.6%); 28.8% of patients were hospitalized during docetaxel (v 8.1% in observation arm), and 5.5% died as a result of docetaxel. The MST for all patients (n = 203) was 21.7 months; MST was 21.2 months for docetaxel arm compared with 23.2 months for observation arm (P = .883). Conclusion: Consolidation docetaxel after PE/XRT results in increased toxicities but does not further improve survival compared with PE/XRT alone in patients with stage III inoperable NSCLC.

AB - Purpose: Concurrent chemoradiotherapy is standard treatment for patients with inoperable stage III non-small-cell lung cancer (NSCLC). A phase II study by the Southwest Oncology Group using consolidation docetaxel after cisplatin (P), etoposide (E), and radiation (XRT) resulted in a median survival time (MST) of 26 months. This randomized phase III trial evaluated whether consolidation docetaxel was responsible for this improved survival. Patients and Methods: Eligible patients had stage IIIA or IIIB NSCLC, baseline performance status of 0 to 1, forced expiratory volume in 1 second ≥ 1 L, and less than 5% weight loss. Patients received P 50 mg/m2 intravenously (IV) on days 1, 8, 29, and 36 and E 50 mg/m2 IV on days 1-5 and 29-33 concurrently with chest XRT to 59.40 Gy. Patients who did not experience progression were randomly assigned to docetaxel 75 mg/m2 IV every 21 days for three cycles versus observation. The primary end point was to compare overall survival (Kaplan-Meier analysis). Results: On the basis of evidence of futility, a data and safety monitoring board recommended early termination after an analysis of the initial 203 patients. Patient characteristics (n = 203) were as follows: 34% female; median age, 63 years; 39.4% stage IIIA; and 60.6% stage IIIB. One hundred forty-seven (72.4%) of 203 patients were randomly assigned to docetaxel (n = 73) or observation (n = 74). Grade 3 to 5 toxicities during docetaxel included febrile neutropenia (10.9%) and pneumonitis (9.6%); 28.8% of patients were hospitalized during docetaxel (v 8.1% in observation arm), and 5.5% died as a result of docetaxel. The MST for all patients (n = 203) was 21.7 months; MST was 21.2 months for docetaxel arm compared with 23.2 months for observation arm (P = .883). Conclusion: Consolidation docetaxel after PE/XRT results in increased toxicities but does not further improve survival compared with PE/XRT alone in patients with stage III inoperable NSCLC.

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