Document Detail

The impact of adjuvant brachytherapy with sublobar resection on pulmonary function and dyspnea in high-risk patients with operable disease: preliminary results from the American College of Surgeons Oncology Group Z4032 trial.
MedLine Citation:
PMID:  21724195     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Z4032 was a randomized study conducted by the American College of Surgeons Oncology Group comparing sublobar resection alone versus sublobar resection with brachytherapy for high-risk operable patients with non-small cell lung cancer (NSCLC). This evaluates early impact of adjuvant brachytherapy on pulmonary function tests, dyspnea, and perioperative (30-day) respiratory complications in this impaired patient population.
METHODS: Eligible patients with stage I NSCLC tumors 3 cm or smaller were randomly allocated to undergo sublobar resection with (SRB group) or without (SR group) brachytherapy. Outcomes measured included the percentage predicted forced expiratory volume in 1 second (FEV1%), percentage predicted carbon monoxide diffusion capacity (DLCO%), and dyspnea score per the University of California San Diego Shortness of Breath Questionnaire. Pulmonary morbidity was assessed per the Common Terminology Criteria for Adverse Events version 3.0. Outcomes were measured at baseline and 3 months. A 10% change in pulmonary function test or 10-point change in dyspnea score was deemed clinically meaningful.
RESULTS: Z4032 permanently closed to patient accrual in January 2010 at 224 patients. At 3-month follow-up, pulmonary function data are currently available for 148 (74 SR and 74 SRB) patients described in this report. There were no differences in baseline characteristics between arms. In the SR arm, 9 patients (12%) reported grade 3 respiratory adverse events, compared with 12 (16%) in the SRB arm (P = .49). There was no significant change in percentage change in DLCO% or dyspnea score from baseline to 3 months within either arm. In the case of FEV1%, percentage change from baseline to 3 months was significant within the SR arm (P = .03), with patients reporting improvement in FEV1% at month 3. Multivariable regression analysis (adjusted for baseline values) showed no significant impact of treatment arm, tumor location (upper vs other lobe), or surgical approach (video-assisted thoracoscopic surgery vs thoracotomy) on 3-month FEV1%, DLCO%, and dyspnea score. There was no significant difference in incidence of clinically meaningful (10% pulmonary function or 10-point dyspnea score change) change between arms. Twenty-two percent of patients with lower-lobe tumors and 9% with upper-lobe tumors demonstrated 10% decline in FEV1% (odds ratio, 2.79; 95 confidence interval, 1.07-7.25; P = .04).
CONCLUSIONS: Adjuvant intraoperative brachytherapy in conjunction with sublobar resection did not significantly worsen pulmonary function or dyspnea at 3 months in a high-risk population with NSCLC, nor was it associated with increased perioperative pulmonary adverse events. Lower-lobe resection was the only factor significantly associated with clinically meaningful decline in FEV1%.
Hiran C Fernando; Rodney J Landreneau; Sumithra J Mandrekar; Shauna L Hillman; Francis C Nichols; Bryan Meyers; Thomas A DiPetrillo; Dwight Heron; David R Jones; Benedict D T Daly; Sandra L Starnes; Jeffrey E Hatter; Joe B Putnam
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-07-02
Journal Detail:
Title:  The Journal of thoracic and cardiovascular surgery     Volume:  142     ISSN:  1097-685X     ISO Abbreviation:  J. Thorac. Cardiovasc. Surg.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-16     Completed Date:  2011-10-13     Revised Date:  2013-06-28    
Medline Journal Info:
Nlm Unique ID:  0376343     Medline TA:  J Thorac Cardiovasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  554-62     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
Department of Cardiothoracic Surgery, Boston Medical Center, 88 E Newton St, Boston, MA 02118, USA.
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MeSH Terms
Aged, 80 and over
Carcinoma, Non-Small-Cell Lung / complications,  physiopathology,  radiotherapy*,  surgery*
Dyspnea / etiology
Forced Expiratory Volume
Lung Neoplasms / complications,  physiopathology,  radiotherapy*,  surgery*
Middle Aged
Prospective Studies
Pulmonary Diffusing Capacity
Radiotherapy, Adjuvant
Thoracic Surgery, Video-Assisted
Treatment Outcome
Grant Support
U10 CA076001/CA/NCI NIH HHS; U10 CA076001-02/CA/NCI NIH HHS

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