Skip to main content
Top
Published in: Supportive Care in Cancer 10/2018

01-10-2018 | Original Article

Toxicity and quality of life in published clinical trials for advanced lung cancer

Author: Matjaz Zwitter

Published in: Supportive Care in Cancer | Issue 10/2018

Login to get access

Abstract

Background

In every report on incurable disease, clear presentation of toxicity and of quality of life (QoL) is of essential importance. This postulate was assessed on a series of publications on systemic treatment for advanced lung cancer.

Materials and methods

The analysis covered papers on original phase II–IV clinical trials published between 2013 and 2015 and included in the PubMed database.

Results

Selected for analysis were 349 publications on 333 trials with a total of 78.977 patients. Only 33 trials (10%) dealt with small cell lung cancer. Most trials (56.5%) included only information on frequency and grade of specific toxic phenomena and did not provide data on the frequency of any serious toxicity. The ratio between the frequency of any grade ≥ 3 toxicity and response rate was often unfavorable, especially for second-line treatment of non-small cell lung cancer (3.0) and second-line treatment of small cell lung cancer (5.3). Assessment of QoL was mentioned in 68 (20.4%) trials, of which only 46 publications provided adequate data.

Conclusions

A substantial proportion of publications on trials for advanced lung cancer do not offer adequate information for decisions in clinical practice. Presentation of toxicity should include information on the frequency of any serious toxicity. Quality of life should be monitored and reported in every trial of an incurable disease. Simple instruments for the assessment of QoL are strongly recommended, so as to alleviate burden to patients and to staff, avoid bias due to poor compliance and enable clear analysis and presentation.
Appendix
Available only for authorised users
Literature
1.
go back to reference Zwitter M (2017) Endpoints in reports on clinical trials for advanced lung cancer. J Thorac Oncol 12(S1):S749 Zwitter M (2017) Endpoints in reports on clinical trials for advanced lung cancer. J Thorac Oncol 12(S1):S749
2.
go back to reference Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E (2015) Validity and reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 1:1051–1059. https://doi.org/10.1001/jamaoncol.2015.2639 CrossRefPubMedPubMedCentral Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E (2015) Validity and reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 1:1051–1059. https://​doi.​org/​10.​1001/​jamaoncol.​2015.​2639 CrossRefPubMedPubMedCentral
3.
go back to reference Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, Wenzel K, Chauhan C, Eppard W, Frank ES, Lipscomb J, Raymond SA, Spencer M, Tunis S (2012) Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol 30:4249–4255. https://doi.org/10.1200/JCO.2012.42.5967 CrossRefPubMed Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, Wenzel K, Chauhan C, Eppard W, Frank ES, Lipscomb J, Raymond SA, Spencer M, Tunis S (2012) Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol 30:4249–4255. https://​doi.​org/​10.​1200/​JCO.​2012.​42.​5967 CrossRefPubMed
6.
go back to reference Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D (2004) Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141:781–788CrossRefPubMed Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D (2004) Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141:781–788CrossRefPubMed
8.
go back to reference Silvestri G, Pritchard R, Welch HG (1998) Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. Br Med J 317:771–775CrossRef Silvestri G, Pritchard R, Welch HG (1998) Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. Br Med J 317:771–775CrossRef
10.
go back to reference Seruga B, Templeton AJ, Vera Badillo FE, Ocana A, Amir E, Tannock IF (2016) Under-reporting of harm in clinical trials. Lancet Oncol 17:e209–e219CrossRefPubMed Seruga B, Templeton AJ, Vera Badillo FE, Ocana A, Amir E, Tannock IF (2016) Under-reporting of harm in clinical trials. Lancet Oncol 17:e209–e219CrossRefPubMed
11.
go back to reference Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F (2015) Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33:910–915. https://doi.org/10.1200/JCO.2014.57.9334 CrossRefPubMed Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F (2015) Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33:910–915. https://​doi.​org/​10.​1200/​JCO.​2014.​57.​9334 CrossRefPubMed
15.
17.
go back to reference Fairclough DL, Peterson HF, Chang V (1998) Why are missing quality of life data a problem in clinical trials of cancer therapy? Stat Med 17:667–677CrossRefPubMed Fairclough DL, Peterson HF, Chang V (1998) Why are missing quality of life data a problem in clinical trials of cancer therapy? Stat Med 17:667–677CrossRefPubMed
18.
go back to reference Schandelmaier S, Conen K, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KA, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Sun X, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M, Kasenda B (2016) Planning and reporting of quality-of-life outcomes in cancer trials. Ann Oncol 27:209. https://doi.org/10.1093/annonc/mdv559 CrossRefPubMed Schandelmaier S, Conen K, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KA, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Sun X, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M, Kasenda B (2016) Planning and reporting of quality-of-life outcomes in cancer trials. Ann Oncol 27:209. https://​doi.​org/​10.​1093/​annonc/​mdv559 CrossRefPubMed
Metadata
Title
Toxicity and quality of life in published clinical trials for advanced lung cancer
Author
Matjaz Zwitter
Publication date
01-10-2018
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 10/2018
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-018-4214-1

Other articles of this Issue 10/2018

Supportive Care in Cancer 10/2018 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine