Randomized phase III study of thoracic radiation in combination with paclitaxel and carboplatin with or without thalidomide in patients with stage III non-small-cell lung cancer: The ECOG 3598 study

Tien Hoang, Suzanne E. Dahlberg, Joan H. Schiller, Minesh P. Mehta, Thomas J. Fitzgerald, Steven A. Belinsky, David H. Johnson

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Purpose: The primary objective of this study was to compare the survival of patients with unresectable stage III non-small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods: Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m 2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m 2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results: A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0%, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2% (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion: The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.

Original languageEnglish (US)
Pages (from-to)616-622
Number of pages7
JournalJournal of Clinical Oncology
Volume30
Issue number6
DOIs
StatePublished - Feb 20 2012

Fingerprint

Thalidomide
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Thorax
Radiation
Chemoradiotherapy
Area Under Curve
Survival
Radiation Dosage
Hypokalemia
Thromboembolism
Dizziness
Tremor
Constipation
Exanthema
Consciousness
Dyspnea
Aspirin
Disease-Free Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Randomized phase III study of thoracic radiation in combination with paclitaxel and carboplatin with or without thalidomide in patients with stage III non-small-cell lung cancer : The ECOG 3598 study. / Hoang, Tien; Dahlberg, Suzanne E.; Schiller, Joan H.; Mehta, Minesh P.; Fitzgerald, Thomas J.; Belinsky, Steven A.; Johnson, David H.

In: Journal of Clinical Oncology, Vol. 30, No. 6, 20.02.2012, p. 616-622.

Research output: Contribution to journalArticle

Hoang, Tien ; Dahlberg, Suzanne E. ; Schiller, Joan H. ; Mehta, Minesh P. ; Fitzgerald, Thomas J. ; Belinsky, Steven A. ; Johnson, David H. / Randomized phase III study of thoracic radiation in combination with paclitaxel and carboplatin with or without thalidomide in patients with stage III non-small-cell lung cancer : The ECOG 3598 study. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 6. pp. 616-622.
@article{f09cd5eba21a4d4fb724149865b28cb6,
title = "Randomized phase III study of thoracic radiation in combination with paclitaxel and carboplatin with or without thalidomide in patients with stage III non-small-cell lung cancer: The ECOG 3598 study",
abstract = "Purpose: The primary objective of this study was to compare the survival of patients with unresectable stage III non-small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods: Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m 2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m 2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results: A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0{\%}, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2{\%} (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion: The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.",
author = "Tien Hoang and Dahlberg, {Suzanne E.} and Schiller, {Joan H.} and Mehta, {Minesh P.} and Fitzgerald, {Thomas J.} and Belinsky, {Steven A.} and Johnson, {David H.}",
year = "2012",
month = "2",
day = "20",
doi = "10.1200/JCO.2011.36.9116",
language = "English (US)",
volume = "30",
pages = "616--622",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "6",

}

TY - JOUR

T1 - Randomized phase III study of thoracic radiation in combination with paclitaxel and carboplatin with or without thalidomide in patients with stage III non-small-cell lung cancer

T2 - The ECOG 3598 study

AU - Hoang, Tien

AU - Dahlberg, Suzanne E.

AU - Schiller, Joan H.

AU - Mehta, Minesh P.

AU - Fitzgerald, Thomas J.

AU - Belinsky, Steven A.

AU - Johnson, David H.

PY - 2012/2/20

Y1 - 2012/2/20

N2 - Purpose: The primary objective of this study was to compare the survival of patients with unresectable stage III non-small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods: Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m 2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m 2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results: A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0%, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2% (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion: The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.

AB - Purpose: The primary objective of this study was to compare the survival of patients with unresectable stage III non-small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods: Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m 2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m 2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results: A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0%, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2% (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion: The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.

UR - http://www.scopus.com/inward/record.url?scp=84863116718&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84863116718&partnerID=8YFLogxK

U2 - 10.1200/JCO.2011.36.9116

DO - 10.1200/JCO.2011.36.9116

M3 - Article

C2 - 22271472

AN - SCOPUS:84863116718

VL - 30

SP - 616

EP - 622

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 6

ER -