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Observational Prospective Study to Determine the Evolution of the Symptomatic Profile of Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients and Its Relation to the Control of the Disease

  • Manuel DómineEmail author
  • Bartomeu Massuti
  • Javier Puente
  • Antonio Calles
  • Emilio Esteban
  • Eduardo Triguboff
  • Yashmin Silvana Afonzo
  • Regina Gironés
  • Francisco Aparisi
  • Juana Oramas
Study Protocol

Abstract

Objective

To evaluate the evolution of disease-related symptoms and its relationship with the control of the disease in first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC).

Methods

This was an observational, prospective, national and multicentre study with two visits in which the following were collected: (1) baseline visit: sociodemographic and clinical variables (2) visit after completing the 4–6 chemotherapy cycles: criteria for ending treatment, control of the disease and clinical variables. Ad hoc questionnaires were collected to assess the frequency of symptoms (evaluated by the patient), and quality-of-life questionnaires to assess the intensity of symptoms (using the Lung Cancer Symptom Scale, LCSS), and interference in the patient’s daily life, assessed by the patient and by the investigator.

Results

A total of 155 patients were included. Patients predominantly described tiredness (24.1%) and pain (23.9%) as the symptoms that appeared “frequently or continuously”. A statistically significant decrease in scores for symptoms of cough (15.4 points), dyspnoea (8.5 points), pain (9.5 points) and discomfort related to their illness (9 points) was observed between visits. Patients who achieved a complete or partial response showed a statistically significant reduction in the cough, dyspnoea, pain and disconfort frequency. Regarding the intensity, cough was the only symptom that showed  a statistically significant decrease for both the patient and the investigator. Tiredness/asthenia and pain were the symptoms with the greatest interference in daily life at baseline according to the patient; however, according to the investigator, they were mood and quality/quantity of sleep, although none of them were significant. But changes in the score of the interference questionnaire between visits were not statistically significantly related to the control of the disease. However, average score according to both investigator and patients showed a significant correlation with ECOG status.

Conclusion

The first-line treatment of NSCLC is correlated with an improvement in the symptomatic evolution of advanced NSCLC patients.

Funding

Roche.

Keywords

Disease-related symptoms Metastatic Non-small cell lung cancer Oncology RECIST 

Notes

Acknowledgements

The authors would like to thank all the researchers for their participation in the study.

Funding

Sponsorship for this study and article processing charges were funded by Roche. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing and Other Assistance

The realization of this study has been possible thanks to the funding of Roche and the logistical and technical support (including medical writing) of IQVIA.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

Manuel Dómine, Bartomeu Massuti, Javier Puente, Antonio Calles, Emilio Esteban, Eduardo Triguboff, Yashmin Silvana Afonzo, Regina Gironés, Francisco Aparisi and Juana Oramas have nothing to disclose.

Compliance with Ethics Guidelines

The study was approved by the Spanish Agency of Medicines and Medical Devices and by the Ethics Committee of the Hospital Universitario de Canarias. The data was collected between May 2011 and April 2012. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee of Hospital Universitario de Canarias (Spain) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Data Availability

The data contained in our database contains proprietary elements owned by Roche and, therefore, cannot be broadly disclosed or made publicly available. The datasets generated and/or analyzed during the current study are available on reasonable request.

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Copyright information

© Springer Healthcare Ltd., part of Springer Nature 2019

Authors and Affiliations

  • Manuel Dómine
    • 1
    Email author
  • Bartomeu Massuti
    • 2
  • Javier Puente
    • 3
  • Antonio Calles
    • 4
  • Emilio Esteban
    • 5
  • Eduardo Triguboff
    • 6
  • Yashmin Silvana Afonzo
    • 7
  • Regina Gironés
    • 8
  • Francisco Aparisi
    • 9
  • Juana Oramas
    • 10
  1. 1.Hospital Universitario Fundación Jiménez Díaz, IIS- FJDMadridSpain
  2. 2.Hospital General Universitario de AlicanteAlicanteSpain
  3. 3.Hospital Clínico San CarlosMadridSpain
  4. 4.Hospital General Universitario Gregorio Marañón / Centro Integral Oncológico Clara Campal (CIOCC)MadridSpain
  5. 5.Hospital Universitario Central de AsturiasOviedoSpain
  6. 6.Hospital Comarcal de MelillaMelillaSpain
  7. 7.Hospital Mateu OrfilaMaóSpain
  8. 8.Hospital Lluís AlcanyísXàtivaSpain
  9. 9.Hospital Virgen de los LiriosAlcoySpain
  10. 10.Hospital Universitario de CanariasLa LagunaSpain

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