A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer: Results of CALGB 30605 (Alliance)/RTOG 0972 (NRG)

Rogerio Lilenbaum, Michael Samuels, Xiaofei Wang, Feng Ming Kong, Pasi A. Jänne, Gregory Masters, Sreedhar Katragadda, Lydia Hodgson, Jeffrey Bogart, Jeffrey Bradley, Everett Vokes

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Introduction: Patients with stage III non-small-cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radiation, we designed a trial of induction chemotherapy followed by thoracic radiotherapy and concurrent erlotinib. Methods: Patients with poor-risk unresectable stage III non-small-cell lung cancer received two cycles of carboplatin at an AUC of 5 and nab-paclitaxel at 100 mg/m2 on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with thoracic radiotherapy. Maintenance was not permitted. Molecular analysis was performed in available specimens. Seventy-two eligible patients were required to test whether the 1-year survival rate was less than 50% or greater than or equal to 65% with approximately 90% power at a significance level of 0.10. Results: From March 2008 to October 2011, 78 patients were enrolled, three of whom were ineligible. The median age was 68 (range, 39-88) and 32% were aged greater than or equal to 75 years. Patients were evenly distributed between stages IIIA and IIIB and the majority had performance status 2. The overall response rate was 67% and the disease control rate was 93%. Treatment was well tolerated. The median PFS and OS were 11 and 17 months, respectively. The overall 12-month OS was 57%, which narrowly missed the prespecified target for significance. Conclusions: Patients with poor-risk stage III non-small-cell lung cancer had better than expected outcomes with a regimen of induction carboplatin/nab-paclitaxel followed by thoracic radiotherapy and erlotinib. However, as per the statistical design, the 12-month OS was not sufficiently high to warrant further studies.

Original languageEnglish (US)
Pages (from-to)143-147
Number of pages5
JournalJournal of Thoracic Oncology
Volume10
Issue number1
DOIs
StatePublished - Jan 1 2015

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Induction Chemotherapy
Non-Small Cell Lung Carcinoma
Radiotherapy
Thorax
Carboplatin
Epidermal Growth Factor Receptor
Area Under Curve
Erlotinib Hydrochloride
Weight Loss
Survival Rate
Maintenance
Radiation
Therapeutics

Keywords

  • NSCLC
  • Poor risk
  • Stage III

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer : Results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). / Lilenbaum, Rogerio; Samuels, Michael; Wang, Xiaofei; Kong, Feng Ming; Jänne, Pasi A.; Masters, Gregory; Katragadda, Sreedhar; Hodgson, Lydia; Bogart, Jeffrey; Bradley, Jeffrey; Vokes, Everett.

In: Journal of Thoracic Oncology, Vol. 10, No. 1, 01.01.2015, p. 143-147.

Research output: Contribution to journalArticle

Lilenbaum, Rogerio ; Samuels, Michael ; Wang, Xiaofei ; Kong, Feng Ming ; Jänne, Pasi A. ; Masters, Gregory ; Katragadda, Sreedhar ; Hodgson, Lydia ; Bogart, Jeffrey ; Bradley, Jeffrey ; Vokes, Everett. / A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer : Results of CALGB 30605 (Alliance)/RTOG 0972 (NRG). In: Journal of Thoracic Oncology. 2015 ; Vol. 10, No. 1. pp. 143-147.
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abstract = "Introduction: Patients with stage III non-small-cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radiation, we designed a trial of induction chemotherapy followed by thoracic radiotherapy and concurrent erlotinib. Methods: Patients with poor-risk unresectable stage III non-small-cell lung cancer received two cycles of carboplatin at an AUC of 5 and nab-paclitaxel at 100 mg/m2 on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with thoracic radiotherapy. Maintenance was not permitted. Molecular analysis was performed in available specimens. Seventy-two eligible patients were required to test whether the 1-year survival rate was less than 50{\%} or greater than or equal to 65{\%} with approximately 90{\%} power at a significance level of 0.10. Results: From March 2008 to October 2011, 78 patients were enrolled, three of whom were ineligible. The median age was 68 (range, 39-88) and 32{\%} were aged greater than or equal to 75 years. Patients were evenly distributed between stages IIIA and IIIB and the majority had performance status 2. The overall response rate was 67{\%} and the disease control rate was 93{\%}. Treatment was well tolerated. The median PFS and OS were 11 and 17 months, respectively. The overall 12-month OS was 57{\%}, which narrowly missed the prespecified target for significance. Conclusions: Patients with poor-risk stage III non-small-cell lung cancer had better than expected outcomes with a regimen of induction carboplatin/nab-paclitaxel followed by thoracic radiotherapy and erlotinib. However, as per the statistical design, the 12-month OS was not sufficiently high to warrant further studies.",
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T1 - A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non-small-cell lung cancer

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AU - Lilenbaum, Rogerio

AU - Samuels, Michael

AU - Wang, Xiaofei

AU - Kong, Feng Ming

AU - Jänne, Pasi A.

AU - Masters, Gregory

AU - Katragadda, Sreedhar

AU - Hodgson, Lydia

AU - Bogart, Jeffrey

AU - Bradley, Jeffrey

AU - Vokes, Everett

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N2 - Introduction: Patients with stage III non-small-cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radiation, we designed a trial of induction chemotherapy followed by thoracic radiotherapy and concurrent erlotinib. Methods: Patients with poor-risk unresectable stage III non-small-cell lung cancer received two cycles of carboplatin at an AUC of 5 and nab-paclitaxel at 100 mg/m2 on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with thoracic radiotherapy. Maintenance was not permitted. Molecular analysis was performed in available specimens. Seventy-two eligible patients were required to test whether the 1-year survival rate was less than 50% or greater than or equal to 65% with approximately 90% power at a significance level of 0.10. Results: From March 2008 to October 2011, 78 patients were enrolled, three of whom were ineligible. The median age was 68 (range, 39-88) and 32% were aged greater than or equal to 75 years. Patients were evenly distributed between stages IIIA and IIIB and the majority had performance status 2. The overall response rate was 67% and the disease control rate was 93%. Treatment was well tolerated. The median PFS and OS were 11 and 17 months, respectively. The overall 12-month OS was 57%, which narrowly missed the prespecified target for significance. Conclusions: Patients with poor-risk stage III non-small-cell lung cancer had better than expected outcomes with a regimen of induction carboplatin/nab-paclitaxel followed by thoracic radiotherapy and erlotinib. However, as per the statistical design, the 12-month OS was not sufficiently high to warrant further studies.

AB - Introduction: Patients with stage III non-small-cell lung cancer and poor performance status and/or weight loss do not seem to benefit from standard therapy. Based on the preclinical interaction between epidermal growth factor receptor inhibitors and radiation, we designed a trial of induction chemotherapy followed by thoracic radiotherapy and concurrent erlotinib. Methods: Patients with poor-risk unresectable stage III non-small-cell lung cancer received two cycles of carboplatin at an AUC of 5 and nab-paclitaxel at 100 mg/m2 on days 1 and 8 every 21 days, followed by erlotinib administered concurrently with thoracic radiotherapy. Maintenance was not permitted. Molecular analysis was performed in available specimens. Seventy-two eligible patients were required to test whether the 1-year survival rate was less than 50% or greater than or equal to 65% with approximately 90% power at a significance level of 0.10. Results: From March 2008 to October 2011, 78 patients were enrolled, three of whom were ineligible. The median age was 68 (range, 39-88) and 32% were aged greater than or equal to 75 years. Patients were evenly distributed between stages IIIA and IIIB and the majority had performance status 2. The overall response rate was 67% and the disease control rate was 93%. Treatment was well tolerated. The median PFS and OS were 11 and 17 months, respectively. The overall 12-month OS was 57%, which narrowly missed the prespecified target for significance. Conclusions: Patients with poor-risk stage III non-small-cell lung cancer had better than expected outcomes with a regimen of induction carboplatin/nab-paclitaxel followed by thoracic radiotherapy and erlotinib. However, as per the statistical design, the 12-month OS was not sufficiently high to warrant further studies.

KW - NSCLC

KW - Poor risk

KW - Stage III

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