Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer

Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial

Hiran C. Fernando, Rodney J. Landreneau, Sumithra J Mandrekar, Francis C. Nichols, Thomas A. Dipetrillo, Bryan F. Meyers, Dwight E. Heron, Shauna L. Hillman, David R. Jones, Sandra L. Starnes, Angelina D. Tan, Benedict D T Daly, Joe B. Putnam

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Background Prior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. Methods Global QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-Average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. Results Two hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P =.03) at 12 months, with thoracotomy versus video-Assisted thoracic surgery (VATS) (38.8% vs 20.4%, P =.03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P =.020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P =.02). Conclusions In high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.

Original languageEnglish (US)
Pages (from-to)718-726
Number of pages9
JournalJournal of Thoracic and Cardiovascular Surgery
Volume149
Issue number3
DOIs
StatePublished - Mar 1 2015

Fingerprint

Multicenter Studies
Video-Assisted Thoracic Surgery
Lung Neoplasms
Dyspnea
Quality of Life
Thoracotomy
Survival
Segmental Mastectomy
Brachytherapy
Health Surveys
Recurrence
Surveys and Questionnaires
Neoplasms

Keywords

  • lung cancer
  • quality of life
  • surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer : Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial. / Fernando, Hiran C.; Landreneau, Rodney J.; Mandrekar, Sumithra J; Nichols, Francis C.; Dipetrillo, Thomas A.; Meyers, Bryan F.; Heron, Dwight E.; Hillman, Shauna L.; Jones, David R.; Starnes, Sandra L.; Tan, Angelina D.; Daly, Benedict D T; Putnam, Joe B.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 149, No. 3, 01.03.2015, p. 718-726.

Research output: Contribution to journalArticle

Fernando, HC, Landreneau, RJ, Mandrekar, SJ, Nichols, FC, Dipetrillo, TA, Meyers, BF, Heron, DE, Hillman, SL, Jones, DR, Starnes, SL, Tan, AD, Daly, BDT & Putnam, JB 2015, 'Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial', Journal of Thoracic and Cardiovascular Surgery, vol. 149, no. 3, pp. 718-726. https://doi.org/10.1016/j.jtcvs.2014.11.003
Fernando, Hiran C. ; Landreneau, Rodney J. ; Mandrekar, Sumithra J ; Nichols, Francis C. ; Dipetrillo, Thomas A. ; Meyers, Bryan F. ; Heron, Dwight E. ; Hillman, Shauna L. ; Jones, David R. ; Starnes, Sandra L. ; Tan, Angelina D. ; Daly, Benedict D T ; Putnam, Joe B. / Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer : Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial. In: Journal of Thoracic and Cardiovascular Surgery. 2015 ; Vol. 149, No. 3. pp. 718-726.
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abstract = "Background Prior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. Methods Global QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-Average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. Results Two hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5{\%} vs 21.9{\%}, P =.03) at 12 months, with thoracotomy versus video-Assisted thoracic surgery (VATS) (38.8{\%} vs 20.4{\%}, P =.03) at 12 months, and T1b versus T1a tumors (46.9{\%} vs 23.5{\%}, P =.020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5{\%} vs 3.6{\%}, P =.02). Conclusions In high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.",
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TY - JOUR

T1 - Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer

T2 - Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial

AU - Fernando, Hiran C.

AU - Landreneau, Rodney J.

AU - Mandrekar, Sumithra J

AU - Nichols, Francis C.

AU - Dipetrillo, Thomas A.

AU - Meyers, Bryan F.

AU - Heron, Dwight E.

AU - Hillman, Shauna L.

AU - Jones, David R.

AU - Starnes, Sandra L.

AU - Tan, Angelina D.

AU - Daly, Benedict D T

AU - Putnam, Joe B.

PY - 2015/3/1

Y1 - 2015/3/1

N2 - Background Prior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. Methods Global QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-Average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. Results Two hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P =.03) at 12 months, with thoracotomy versus video-Assisted thoracic surgery (VATS) (38.8% vs 20.4%, P =.03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P =.020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P =.02). Conclusions In high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.

AB - Background Prior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. Methods Global QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-Average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. Results Two hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P =.03) at 12 months, with thoracotomy versus video-Assisted thoracic surgery (VATS) (38.8% vs 20.4%, P =.03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P =.020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P =.02). Conclusions In high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.

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KW - quality of life

KW - surgery

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