Lung cancer symptom scale outcomes in relation to standard efficacy measures: An analysis of the phase III study of pemetrexed versus docetaxel in advanced non-small cell lung cancer

Filippo De Marinis, Jose Rodrigues Pereira, Frank Fossella, Michael C. Perry, Martin Reck, Marc Salzberg, Jacek Jassem, Patrick Peterson, Astra M. Liepa, Patti Moore, Richard J. Gralla

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) require care that emphasizes symptom palliation in addition to extending survival. The low response rates and minimal survival gains observed in second-line studies underscore the need to assess treatment efficacy with symptomatic end points. METHODS: To characterize the relationship between patient-reported health-related quality of life outcomes and efficacy end points (tumor response, overall survival [OS], progression-free survival [PFS]), retrospective analyses were performed on Lung Cancer Symptom Scale (LCSS) data (n = 488) from the phase III study of pemetrexed (500 mg/m once every 3 weeks) versus docetaxel (75 mg/m once every 3 weeks) in advanced NSCLC. The LCSS data consisted of patient ratings of six symptoms and three summary items using 100-mm visual analogue scales. The mean maximum improvement for each item was categorized according to best tumor response, with statistical analyses based on a two-factor interaction model (with treatment arm and response group as fixed factors). Additional analyses pooled data between treatment arms and examined correlation (nonparametric and Pearson's) of time to first worsening of symptoms (TWS) with PFS and OS. RESULTS: All LCSS items, except hemoptysis, showed mean maximum improvement over baseline for responders and patients with stable disease (p < 0.01), with greater improvement associated with response. Median TWS for each LCSS item ranged between 2.3 months (fatigue) and 7.0 months (cough), with correlation between TWS and PFS and OS (all p values ≤0.017). CONCLUSIONS: For most NSCLC patients, second-line chemotherapy provides symptomatic improvement that is linked to standard efficacy outcomes. Health-related quality of life data provides complementary efficacy information that can guide routine clinical practice.

Original languageEnglish (US)
Pages (from-to)30-36
Number of pages7
JournalJournal of Thoracic Oncology
Volume3
Issue number1
DOIs
StatePublished - Jan 2008
Externally publishedYes

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docetaxel
Pemetrexed
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Disease-Free Survival
Survival
Quality of Life
Hemoptysis
Survival Analysis
Visual Analog Scale
Cough
Fatigue
Neoplasms
Survival Rate
Drug Therapy

Keywords

  • Docetaxel
  • Lung Cancer Symptom Scale (LCSS)
  • NSCLC
  • Pemetrexed
  • Time to worsening of symptoms (TWS)

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Lung cancer symptom scale outcomes in relation to standard efficacy measures : An analysis of the phase III study of pemetrexed versus docetaxel in advanced non-small cell lung cancer. / De Marinis, Filippo; Pereira, Jose Rodrigues; Fossella, Frank; Perry, Michael C.; Reck, Martin; Salzberg, Marc; Jassem, Jacek; Peterson, Patrick; Liepa, Astra M.; Moore, Patti; Gralla, Richard J.

In: Journal of Thoracic Oncology, Vol. 3, No. 1, 01.2008, p. 30-36.

Research output: Contribution to journalArticle

De Marinis, Filippo ; Pereira, Jose Rodrigues ; Fossella, Frank ; Perry, Michael C. ; Reck, Martin ; Salzberg, Marc ; Jassem, Jacek ; Peterson, Patrick ; Liepa, Astra M. ; Moore, Patti ; Gralla, Richard J. / Lung cancer symptom scale outcomes in relation to standard efficacy measures : An analysis of the phase III study of pemetrexed versus docetaxel in advanced non-small cell lung cancer. In: Journal of Thoracic Oncology. 2008 ; Vol. 3, No. 1. pp. 30-36.
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abstract = "BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) require care that emphasizes symptom palliation in addition to extending survival. The low response rates and minimal survival gains observed in second-line studies underscore the need to assess treatment efficacy with symptomatic end points. METHODS: To characterize the relationship between patient-reported health-related quality of life outcomes and efficacy end points (tumor response, overall survival [OS], progression-free survival [PFS]), retrospective analyses were performed on Lung Cancer Symptom Scale (LCSS) data (n = 488) from the phase III study of pemetrexed (500 mg/m once every 3 weeks) versus docetaxel (75 mg/m once every 3 weeks) in advanced NSCLC. The LCSS data consisted of patient ratings of six symptoms and three summary items using 100-mm visual analogue scales. The mean maximum improvement for each item was categorized according to best tumor response, with statistical analyses based on a two-factor interaction model (with treatment arm and response group as fixed factors). Additional analyses pooled data between treatment arms and examined correlation (nonparametric and Pearson's) of time to first worsening of symptoms (TWS) with PFS and OS. RESULTS: All LCSS items, except hemoptysis, showed mean maximum improvement over baseline for responders and patients with stable disease (p < 0.01), with greater improvement associated with response. Median TWS for each LCSS item ranged between 2.3 months (fatigue) and 7.0 months (cough), with correlation between TWS and PFS and OS (all p values ≤0.017). CONCLUSIONS: For most NSCLC patients, second-line chemotherapy provides symptomatic improvement that is linked to standard efficacy outcomes. Health-related quality of life data provides complementary efficacy information that can guide routine clinical practice.",
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AU - Pereira, Jose Rodrigues

AU - Fossella, Frank

AU - Perry, Michael C.

AU - Reck, Martin

AU - Salzberg, Marc

AU - Jassem, Jacek

AU - Peterson, Patrick

AU - Liepa, Astra M.

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N2 - BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) require care that emphasizes symptom palliation in addition to extending survival. The low response rates and minimal survival gains observed in second-line studies underscore the need to assess treatment efficacy with symptomatic end points. METHODS: To characterize the relationship between patient-reported health-related quality of life outcomes and efficacy end points (tumor response, overall survival [OS], progression-free survival [PFS]), retrospective analyses were performed on Lung Cancer Symptom Scale (LCSS) data (n = 488) from the phase III study of pemetrexed (500 mg/m once every 3 weeks) versus docetaxel (75 mg/m once every 3 weeks) in advanced NSCLC. The LCSS data consisted of patient ratings of six symptoms and three summary items using 100-mm visual analogue scales. The mean maximum improvement for each item was categorized according to best tumor response, with statistical analyses based on a two-factor interaction model (with treatment arm and response group as fixed factors). Additional analyses pooled data between treatment arms and examined correlation (nonparametric and Pearson's) of time to first worsening of symptoms (TWS) with PFS and OS. RESULTS: All LCSS items, except hemoptysis, showed mean maximum improvement over baseline for responders and patients with stable disease (p < 0.01), with greater improvement associated with response. Median TWS for each LCSS item ranged between 2.3 months (fatigue) and 7.0 months (cough), with correlation between TWS and PFS and OS (all p values ≤0.017). CONCLUSIONS: For most NSCLC patients, second-line chemotherapy provides symptomatic improvement that is linked to standard efficacy outcomes. Health-related quality of life data provides complementary efficacy information that can guide routine clinical practice.

AB - BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) require care that emphasizes symptom palliation in addition to extending survival. The low response rates and minimal survival gains observed in second-line studies underscore the need to assess treatment efficacy with symptomatic end points. METHODS: To characterize the relationship between patient-reported health-related quality of life outcomes and efficacy end points (tumor response, overall survival [OS], progression-free survival [PFS]), retrospective analyses were performed on Lung Cancer Symptom Scale (LCSS) data (n = 488) from the phase III study of pemetrexed (500 mg/m once every 3 weeks) versus docetaxel (75 mg/m once every 3 weeks) in advanced NSCLC. The LCSS data consisted of patient ratings of six symptoms and three summary items using 100-mm visual analogue scales. The mean maximum improvement for each item was categorized according to best tumor response, with statistical analyses based on a two-factor interaction model (with treatment arm and response group as fixed factors). Additional analyses pooled data between treatment arms and examined correlation (nonparametric and Pearson's) of time to first worsening of symptoms (TWS) with PFS and OS. RESULTS: All LCSS items, except hemoptysis, showed mean maximum improvement over baseline for responders and patients with stable disease (p < 0.01), with greater improvement associated with response. Median TWS for each LCSS item ranged between 2.3 months (fatigue) and 7.0 months (cough), with correlation between TWS and PFS and OS (all p values ≤0.017). CONCLUSIONS: For most NSCLC patients, second-line chemotherapy provides symptomatic improvement that is linked to standard efficacy outcomes. Health-related quality of life data provides complementary efficacy information that can guide routine clinical practice.

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