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Impact of Sublobar Resection on Pulmonary Function: Long-Term Results from American College of Surgeons Oncology Group Z4032 (Alliance).

ABSTRACT: Sublobar resection (SR) in high-risk operable patients may result in a long-term decrease in pulmonary function. We previously reported 3-month pulmonary function outcomes from a randomized phase III study of SR alone compared with SR with brachytherapy in patients with non-small cell lung cancer. We now report long-term pulmonary function after SR.Pulmonary function was measured at baseline and at 3, 12, and 24 months. A decline of 10% or more from baseline in the percentage predicted forced expiratory volume of 1 percentage or in the diffusion capacity of the lung for carbon monoxide was considered clinically meaningful. The effect of study arm, tumor location, size, approach (video-assisted thoracoscopic surgery vs thoracotomy), and SR type (wedge vs segmentectomy) on pulmonary function was assessed using a Wilcoxon rank sum test. A generalized estimating equation model was used to assess the effect of each factor on longitudinal data, including all four time points.Complete pulmonary function data at all time points was available in 69 patients. No significant differences were observed in pulmonary function between SR and SR with brachytherapy, thus the study arms were combined for all analyses. A decline of 10% or more (p = 0.02) in the percentage predicted forced expiratory volume in 1 second was demonstrated for lower-lobe resections at 3 months but was not at 12 or 24 months. A decline of 10% or more (p = 0.05) in the percentage predicted diffusion capacity of the lung for carbon monoxide was seen for thoracotomy at 3 months but was not at 12 or 24 months.Clinically meaningful declines in pulmonary function occurred after lower lobe resection and after thoracotomy at 3 months but subsequently recovered. This study suggests that SR does not result in sustained decreased pulmonary function in high-risk operable patients.

SUBMITTER: Kent MS

PROVIDER: S-EPMC4993049 | biostudies-other | 2016 Jul

REPOSITORIES: biostudies-other

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Impact of Sublobar Resection on Pulmonary Function: Long-Term Results from American College of Surgeons Oncology Group Z4032 (Alliance).

Kent Michael S MS Mandrekar Sumithra J SJ Landreneau Rodney R Nichols Francis F DiPetrillo Thomas A TA Meyers Bryan B Heron Dwight E DE Jones David R DR Tan Angelina D AD Starnes Sandra S Putnam Joe B JB Fernando Hiran C HC

The Annals of thoracic surgery 20160419 1

<h4>Background</h4>Sublobar resection (SR) in high-risk operable patients may result in a long-term decrease in pulmonary function. We previously reported 3-month pulmonary function outcomes from a randomized phase III study of SR alone compared with SR with brachytherapy in patients with non-small cell lung cancer. We now report long-term pulmonary function after SR.<h4>Methods</h4>Pulmonary function was measured at baseline and at 3, 12, and 24 months. A decline of 10% or more from baseline in ...[more]

PMID: 27101728

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Project description:Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) -positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole. For the trial ACOSOG Z1031B, the protocol was amended to include a tumor Ki67 determination after 2 to 4 weeks of AI. If the Ki67 was > 10%, patients were switched to neoadjuvant chemotherapy. A pCR rate of > 20% was the predefined efficacy threshold. In patients who completed neoadjuvant AI, stratified Cox modeling was used to assess whether time to recurrence differed by PEPI = 0 score (T1 or T2, N0, Ki67 < 2.7%, ER Allred > 2) versus PEPI > 0 disease. Results Only two of the 35 patients in ACOSOG Z1031B who were switched to neoadjuvant chemotherapy experienced a pCR (5.7%; 95% CI, 0.7% to 19.1%). After 5.5 years of median follow-up, four (3.7%) of the 109 patients with a PEPI = 0 score relapsed versus 49 (14.4%) of 341 of patients with PEPI > 0 (recurrence hazard ratio [PEPI = 0 v PEPI > 0], 0.27; P = .014; 95% CI, 0.092 to 0.764). Conclusion Chemotherapy efficacy was lower than expected in ER-positive tumors exhibiting AI-resistant proliferation. The optimal therapy for these patients should be further investigated. For patients with PEPI = 0 disease, the relapse risk over 5 years was only 3.6% without chemotherapy, supporting the study of adjuvant endocrine monotherapy in this group. These Ki67 and PEPI triage approaches are being definitively studied in the ALTERNATE trial (Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment in Postmenopausal Women: A Phase III Study; clinical trial information: NCT01953588).

Dataset Information

Impact of Sublobar Resection on Pulmonary Function: Long-Term Results from American College of Surgeons Oncology Group Z4032 (Alliance).

Publications

Impact of Sublobar Resection on Pulmonary Function: Long-Term Results from American College of Surgeons Oncology Group Z4032 (Alliance).

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