Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

Kristin Toftaker Killingberg; Tarje Onsøien Halvorsen; Øystein Fløtten; Odd Terje Brustugun; Seppo W Langer; Jan Nyman; Kjersti Hornslien; Tesfaye Madebo; Tine Schytte; Signe Risum; Georgios Tsakonas; Jens Engleson; Bjørn Henning Grønberg

doi:10.1016/j.lungcan.2022.02.002

Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

Kristin Toftaker Killingberg, Tarje Onsøien Halvorsen, Øystein Fløtten, Odd Terje Brustugun, Seppo W Langer, Jan Nyman, Kjersti Hornslien, Tesfaye Madebo, Tine Schytte, Signe Risum, Georgios Tsakonas, Jens Engleson, Bjørn Henning Grønberg

Department of Oncology

Abstract

OBJECTIVES: In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.

MATERIALS AND METHODS: 170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.

RESULTS: Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.

CONCLUSION: TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.

Original language	English
Journal	Lung Cancer
Volume	166
Pages (from-to)	49-57
Number of pages	9
ISSN	0169-5002
DOIs	https://doi.org/10.1016/j.lungcan.2022.02.002
Publication status	Published - Apr 2022

Keywords

Antineoplastic Combined Chemotherapy Protocols
Cisplatin/therapeutic use
Convalescence
Deglutition Disorders/epidemiology
Dose Fractionation, Radiation
Dyspnea
Etoposide
Humans
Lung Neoplasms/drug therapy
Neoplasm Staging
Patient Reported Outcome Measures
Quality of Life
Radiotherapy/adverse effects
Small Cell Lung Carcinoma/drug therapy

Access to Document

10.1016/j.lungcan.2022.02.002

Cite this

Killingberg, K. T., Halvorsen, T. O., Fløtten, Ø., Brustugun, O. T., Langer, S. W., Nyman, J., Hornslien, K., Madebo, T., Schytte, T., Risum, S., Tsakonas, G., Engleson, J., & Grønberg, B. H. (2022). Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer. Lung Cancer, 166, 49-57. https://doi.org/10.1016/j.lungcan.2022.02.002

Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer. / Killingberg, Kristin Toftaker; Halvorsen, Tarje Onsøien; Fløtten, Øystein et al.
In: Lung Cancer, Vol. 166, 04.2022, p. 49-57.

Research output: Contribution to journal › Journal article › Research › peer-review

Killingberg, KT, Halvorsen, TO, Fløtten, Ø, Brustugun, OT, Langer, SW, Nyman, J, Hornslien, K, Madebo, T, Schytte, T, Risum, S, Tsakonas, G, Engleson, J & Grønberg, BH 2022, 'Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer', Lung Cancer, vol. 166, pp. 49-57. https://doi.org/10.1016/j.lungcan.2022.02.002

@article{9a52456be73e41dd9de8659f651717e4,

title = "Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer",

abstract = "OBJECTIVES: In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.MATERIALS AND METHODS: 170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.RESULTS: Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.CONCLUSION: TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.",

keywords = "Antineoplastic Combined Chemotherapy Protocols, Cisplatin/therapeutic use, Convalescence, Deglutition Disorders/epidemiology, Dose Fractionation, Radiation, Dyspnea, Etoposide, Humans, Lung Neoplasms/drug therapy, Neoplasm Staging, Patient Reported Outcome Measures, Quality of Life, Radiotherapy/adverse effects, Small Cell Lung Carcinoma/drug therapy",

author = "Killingberg, {Kristin Toftaker} and Halvorsen, {Tarje Ons{\o}ien} and {\O}ystein Fl{\o}tten and Brustugun, {Odd Terje} and Langer, {Seppo W} and Jan Nyman and Kjersti Hornslien and Tesfaye Madebo and Tine Schytte and Signe Risum and Georgios Tsakonas and Jens Engleson and Gr{\o}nberg, {Bj{\o}rn Henning}",

year = "2022",

month = apr,

doi = "10.1016/j.lungcan.2022.02.002",

language = "English",

volume = "166",

pages = "49--57",

journal = "Lung Cancer",

issn = "0169-5002",

publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

AU - Killingberg, Kristin Toftaker

AU - Halvorsen, Tarje Onsøien

AU - Fløtten, Øystein

AU - Brustugun, Odd Terje

AU - Langer, Seppo W

AU - Nyman, Jan

AU - Hornslien, Kjersti

AU - Madebo, Tesfaye

AU - Schytte, Tine

AU - Risum, Signe

AU - Tsakonas, Georgios

AU - Engleson, Jens

AU - Grønberg, Bjørn Henning

PY - 2022/4

Y1 - 2022/4

N2 - OBJECTIVES: In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.MATERIALS AND METHODS: 170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.RESULTS: Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.CONCLUSION: TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.

AB - OBJECTIVES: In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.MATERIALS AND METHODS: 170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.RESULTS: Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.CONCLUSION: TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Cisplatin/therapeutic use

KW - Convalescence

KW - Deglutition Disorders/epidemiology

KW - Dose Fractionation, Radiation

KW - Dyspnea

KW - Etoposide

KW - Humans

KW - Lung Neoplasms/drug therapy

KW - Neoplasm Staging

KW - Patient Reported Outcome Measures

KW - Quality of Life

KW - Radiotherapy/adverse effects

KW - Small Cell Lung Carcinoma/drug therapy

UR - http://www.scopus.com/inward/record.url?scp=85126124518&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2022.02.002

DO - 10.1016/j.lungcan.2022.02.002

M3 - Journal article

C2 - 35183991

SN - 0169-5002

VL - 166

SP - 49

EP - 57

JO - Lung Cancer

JF - Lung Cancer

ER -

Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this