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    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

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    Authors
    Hoang, Tien
    Dahlberg, Suzanne E.
    Schiller, Joan H
    Mehta, Minesh P.
    Fitzgerald, Thomas J.
    Belinsky, Steven A.
    Johnson, David H.
    UMass Chan Affiliations
    Quality Assurance Review Center
    Department of Radiation Oncology
    Document Type
    Journal Article
    Publication Date
    2012-02-20
    Keywords
    Adult
    Aged
    Aged, 80 and over
    Antineoplastic Combined Chemotherapy Protocols
    Area Under Curve
    Carboplatin
    Carcinoma, Non-Small-Cell Lung
    therapy
    Chemoradiotherapy
    Disease-Free Survival
    Drug Administration Schedule
    Fatigue
    Female
    Humans
    Lung Neoplasms
    Male
    Middle Aged
    Neoplasm Micrometastasis
    Neoplasm Staging
    Paclitaxel
    Survival Rate
    Thalidomide
    Thromboembolism
    Neoplasms
    Oncology
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    Link to Full Text
    http://dx.doi.org/10.1200/JCO.2011.36.9116
    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.
    Source
    J Clin Oncol. Feb 20, 2012; 30(6): 616–622. doi: 10.1200/JCO.2011.36.9116 Link to article on publisher's site
    DOI
    10.1200/JCO.2011.36.9116
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/47931
    PubMed ID
    22271472
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2011.36.9116
    Scopus Count
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    Radiation Oncology Publications

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