Quality of life analysis of a radiation dose-escalation study of PATIENTS with non-small-cell lung cancer a secondary analysis of the radiation Therapy Oncology Group 0617 randomized clinical trial

Benjamin Movsas, Chen Hu, Jeffrey Sloan, Jeffrey Bradley, Ritsuko Komaki, Gregory Masters, Vivek Kavadi, Samir Narayan, Jeff Michalski, Douglas W. Johnson, Christopher Koprowski, Walter J. Curran, Yolanda I. Garces, Rakesh Gaur, Raymond B. Wynn, John Schallenkamp, Daphna Y. Gelblum, Robert M. MacRae, Rebecca Paulus, Hak Choy

Research output: Contribution to journalArticle

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Abstract

IMPORTANCE: A recent randomized radiation dose-escalation trial in unresectable stage III non-small-cell lung cancer (NSCLC) (Radiation Therapy Oncology Group [RTOG] 0617) showed a lower survival rate in the high-dose radiation therapy (RT) arm (74 Gy) than in the low-dose arm (60 Gy) with concurrent chemotherapy. OBJECTIVE: The primary QOL hypothesis predicted a clinically meaningful decline in quality of life (QOL) via the Functional Assessment of Cancer Therapy (FACT)-Lung Cancer Subscale (LCS) in the high-dose RT arm at 3 months. DESIGN, SETTING, AND PATIENTS: The RTOG 0617 trial was a randomized phase 3 study (conducted from November 2007 to November 2011) in stage III NSCLC using a 2 × 2 factorial design and stratified by histology, positron emission tomography staging, performance status, and irradiation technique (3-dimensional conformal RT [3D-CRT] vs intensity modulated RT [IMRT]). A total of 185 institutions in the United States and Canada took part. Of 424 eligible patients with stage III NSCLC randomized, 360 (85%) consented to QOL evaluation, of whom 313 (88%) completed baseline QOL assessments. INTERVENTION: Treatment with 74-Gy vs 60-Gy RT with concurrent and consolidation carboplatin/paclitaxel with or without cetuximab. MAIN OUTCOMES AND MEASURES: The QOL data were collected prospectively via FACT Trial Outcome Index (FACT-TOI), calculated as the sum of the following measures: Physical Well Being (PWB), Functional Well Being (FWB), and the LCS. Data are presented at baseline and 3 and 12 months via minimal clinically meaningful changes of 2 points or more for PWB, FWB, and LCS or 5 points or more for TOI. RESULTS: Of the 313 patients who completed baseline QOL assessments, 219 patients (70%) completed the 3-month QOL assessments, and 137 of the living patients (57%) completed the 12-month assessment. Patient demographics and baseline QOL scores were comparable between the 74-Gy and 60-Gy arms. Significantly more patients in the 74-Gy arm than in the 60-Gy arm had clinically meaningful decline in FACT-LCS at 3 months (45% vs 30%; P =.02). At 12 months, fewer patients who received IMRT (vs 3D-CRT) had clinically meaningful decline in FACT-LCS (21% vs 46%; P =.003). Baseline FACT-TOI was associated with overall survival in multivariate analysis. CONCLUSIONS AND RELEVANCE: Despite few differences in clinician-reported toxic effects between treatment arms, QOL analysis demonstrated a clinically meaningful decline in QOL in the 74-Gy arm at 3 months, confirming the primary QOL hypothesis. Baseline QOL was an independent prognostic factor for survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00533949.

Original languageEnglish (US)
Pages (from-to)359-367
Number of pages9
JournalJAMA oncology
Volume2
Issue number3
DOIs
StatePublished - 2016

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Radiation Oncology
Non-Small Cell Lung Carcinoma
Radiotherapy
Randomized Controlled Trials
Quality of Life
Radiation
Lung Neoplasms
Therapeutics
Radiation Dosage
Survival
Poisons
Carboplatin
Paclitaxel
Positron-Emission Tomography
Canada
Neoplasms
Histology
Multivariate Analysis
Survival Rate

ASJC Scopus subject areas

  • Medicine(all)

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Quality of life analysis of a radiation dose-escalation study of PATIENTS with non-small-cell lung cancer a secondary analysis of the radiation Therapy Oncology Group 0617 randomized clinical trial. / Movsas, Benjamin; Hu, Chen; Sloan, Jeffrey; Bradley, Jeffrey; Komaki, Ritsuko; Masters, Gregory; Kavadi, Vivek; Narayan, Samir; Michalski, Jeff; Johnson, Douglas W.; Koprowski, Christopher; Curran, Walter J.; Garces, Yolanda I.; Gaur, Rakesh; Wynn, Raymond B.; Schallenkamp, John; Gelblum, Daphna Y.; MacRae, Robert M.; Paulus, Rebecca; Choy, Hak.

In: JAMA oncology, Vol. 2, No. 3, 2016, p. 359-367.

Research output: Contribution to journalArticle

Movsas, B, Hu, C, Sloan, J, Bradley, J, Komaki, R, Masters, G, Kavadi, V, Narayan, S, Michalski, J, Johnson, DW, Koprowski, C, Curran, WJ, Garces, YI, Gaur, R, Wynn, RB, Schallenkamp, J, Gelblum, DY, MacRae, RM, Paulus, R & Choy, H 2016, 'Quality of life analysis of a radiation dose-escalation study of PATIENTS with non-small-cell lung cancer a secondary analysis of the radiation Therapy Oncology Group 0617 randomized clinical trial', JAMA oncology, vol. 2, no. 3, pp. 359-367. https://doi.org/10.1001/jamaoncol.2015.3969
Movsas, Benjamin ; Hu, Chen ; Sloan, Jeffrey ; Bradley, Jeffrey ; Komaki, Ritsuko ; Masters, Gregory ; Kavadi, Vivek ; Narayan, Samir ; Michalski, Jeff ; Johnson, Douglas W. ; Koprowski, Christopher ; Curran, Walter J. ; Garces, Yolanda I. ; Gaur, Rakesh ; Wynn, Raymond B. ; Schallenkamp, John ; Gelblum, Daphna Y. ; MacRae, Robert M. ; Paulus, Rebecca ; Choy, Hak. / Quality of life analysis of a radiation dose-escalation study of PATIENTS with non-small-cell lung cancer a secondary analysis of the radiation Therapy Oncology Group 0617 randomized clinical trial. In: JAMA oncology. 2016 ; Vol. 2, No. 3. pp. 359-367.
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abstract = "IMPORTANCE: A recent randomized radiation dose-escalation trial in unresectable stage III non-small-cell lung cancer (NSCLC) (Radiation Therapy Oncology Group [RTOG] 0617) showed a lower survival rate in the high-dose radiation therapy (RT) arm (74 Gy) than in the low-dose arm (60 Gy) with concurrent chemotherapy. OBJECTIVE: The primary QOL hypothesis predicted a clinically meaningful decline in quality of life (QOL) via the Functional Assessment of Cancer Therapy (FACT)-Lung Cancer Subscale (LCS) in the high-dose RT arm at 3 months. DESIGN, SETTING, AND PATIENTS: The RTOG 0617 trial was a randomized phase 3 study (conducted from November 2007 to November 2011) in stage III NSCLC using a 2 × 2 factorial design and stratified by histology, positron emission tomography staging, performance status, and irradiation technique (3-dimensional conformal RT [3D-CRT] vs intensity modulated RT [IMRT]). A total of 185 institutions in the United States and Canada took part. Of 424 eligible patients with stage III NSCLC randomized, 360 (85{\%}) consented to QOL evaluation, of whom 313 (88{\%}) completed baseline QOL assessments. INTERVENTION: Treatment with 74-Gy vs 60-Gy RT with concurrent and consolidation carboplatin/paclitaxel with or without cetuximab. MAIN OUTCOMES AND MEASURES: The QOL data were collected prospectively via FACT Trial Outcome Index (FACT-TOI), calculated as the sum of the following measures: Physical Well Being (PWB), Functional Well Being (FWB), and the LCS. Data are presented at baseline and 3 and 12 months via minimal clinically meaningful changes of 2 points or more for PWB, FWB, and LCS or 5 points or more for TOI. RESULTS: Of the 313 patients who completed baseline QOL assessments, 219 patients (70{\%}) completed the 3-month QOL assessments, and 137 of the living patients (57{\%}) completed the 12-month assessment. Patient demographics and baseline QOL scores were comparable between the 74-Gy and 60-Gy arms. Significantly more patients in the 74-Gy arm than in the 60-Gy arm had clinically meaningful decline in FACT-LCS at 3 months (45{\%} vs 30{\%}; P =.02). At 12 months, fewer patients who received IMRT (vs 3D-CRT) had clinically meaningful decline in FACT-LCS (21{\%} vs 46{\%}; P =.003). Baseline FACT-TOI was associated with overall survival in multivariate analysis. CONCLUSIONS AND RELEVANCE: Despite few differences in clinician-reported toxic effects between treatment arms, QOL analysis demonstrated a clinically meaningful decline in QOL in the 74-Gy arm at 3 months, confirming the primary QOL hypothesis. Baseline QOL was an independent prognostic factor for survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00533949.",
author = "Benjamin Movsas and Chen Hu and Jeffrey Sloan and Jeffrey Bradley and Ritsuko Komaki and Gregory Masters and Vivek Kavadi and Samir Narayan and Jeff Michalski and Johnson, {Douglas W.} and Christopher Koprowski and Curran, {Walter J.} and Garces, {Yolanda I.} and Rakesh Gaur and Wynn, {Raymond B.} and John Schallenkamp and Gelblum, {Daphna Y.} and MacRae, {Robert M.} and Rebecca Paulus and Hak Choy",
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TY - JOUR

T1 - Quality of life analysis of a radiation dose-escalation study of PATIENTS with non-small-cell lung cancer a secondary analysis of the radiation Therapy Oncology Group 0617 randomized clinical trial

AU - Movsas, Benjamin

AU - Hu, Chen

AU - Sloan, Jeffrey

AU - Bradley, Jeffrey

AU - Komaki, Ritsuko

AU - Masters, Gregory

AU - Kavadi, Vivek

AU - Narayan, Samir

AU - Michalski, Jeff

AU - Johnson, Douglas W.

AU - Koprowski, Christopher

AU - Curran, Walter J.

AU - Garces, Yolanda I.

AU - Gaur, Rakesh

AU - Wynn, Raymond B.

AU - Schallenkamp, John

AU - Gelblum, Daphna Y.

AU - MacRae, Robert M.

AU - Paulus, Rebecca

AU - Choy, Hak

PY - 2016

Y1 - 2016

N2 - IMPORTANCE: A recent randomized radiation dose-escalation trial in unresectable stage III non-small-cell lung cancer (NSCLC) (Radiation Therapy Oncology Group [RTOG] 0617) showed a lower survival rate in the high-dose radiation therapy (RT) arm (74 Gy) than in the low-dose arm (60 Gy) with concurrent chemotherapy. OBJECTIVE: The primary QOL hypothesis predicted a clinically meaningful decline in quality of life (QOL) via the Functional Assessment of Cancer Therapy (FACT)-Lung Cancer Subscale (LCS) in the high-dose RT arm at 3 months. DESIGN, SETTING, AND PATIENTS: The RTOG 0617 trial was a randomized phase 3 study (conducted from November 2007 to November 2011) in stage III NSCLC using a 2 × 2 factorial design and stratified by histology, positron emission tomography staging, performance status, and irradiation technique (3-dimensional conformal RT [3D-CRT] vs intensity modulated RT [IMRT]). A total of 185 institutions in the United States and Canada took part. Of 424 eligible patients with stage III NSCLC randomized, 360 (85%) consented to QOL evaluation, of whom 313 (88%) completed baseline QOL assessments. INTERVENTION: Treatment with 74-Gy vs 60-Gy RT with concurrent and consolidation carboplatin/paclitaxel with or without cetuximab. MAIN OUTCOMES AND MEASURES: The QOL data were collected prospectively via FACT Trial Outcome Index (FACT-TOI), calculated as the sum of the following measures: Physical Well Being (PWB), Functional Well Being (FWB), and the LCS. Data are presented at baseline and 3 and 12 months via minimal clinically meaningful changes of 2 points or more for PWB, FWB, and LCS or 5 points or more for TOI. RESULTS: Of the 313 patients who completed baseline QOL assessments, 219 patients (70%) completed the 3-month QOL assessments, and 137 of the living patients (57%) completed the 12-month assessment. Patient demographics and baseline QOL scores were comparable between the 74-Gy and 60-Gy arms. Significantly more patients in the 74-Gy arm than in the 60-Gy arm had clinically meaningful decline in FACT-LCS at 3 months (45% vs 30%; P =.02). At 12 months, fewer patients who received IMRT (vs 3D-CRT) had clinically meaningful decline in FACT-LCS (21% vs 46%; P =.003). Baseline FACT-TOI was associated with overall survival in multivariate analysis. CONCLUSIONS AND RELEVANCE: Despite few differences in clinician-reported toxic effects between treatment arms, QOL analysis demonstrated a clinically meaningful decline in QOL in the 74-Gy arm at 3 months, confirming the primary QOL hypothesis. Baseline QOL was an independent prognostic factor for survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00533949.

AB - IMPORTANCE: A recent randomized radiation dose-escalation trial in unresectable stage III non-small-cell lung cancer (NSCLC) (Radiation Therapy Oncology Group [RTOG] 0617) showed a lower survival rate in the high-dose radiation therapy (RT) arm (74 Gy) than in the low-dose arm (60 Gy) with concurrent chemotherapy. OBJECTIVE: The primary QOL hypothesis predicted a clinically meaningful decline in quality of life (QOL) via the Functional Assessment of Cancer Therapy (FACT)-Lung Cancer Subscale (LCS) in the high-dose RT arm at 3 months. DESIGN, SETTING, AND PATIENTS: The RTOG 0617 trial was a randomized phase 3 study (conducted from November 2007 to November 2011) in stage III NSCLC using a 2 × 2 factorial design and stratified by histology, positron emission tomography staging, performance status, and irradiation technique (3-dimensional conformal RT [3D-CRT] vs intensity modulated RT [IMRT]). A total of 185 institutions in the United States and Canada took part. Of 424 eligible patients with stage III NSCLC randomized, 360 (85%) consented to QOL evaluation, of whom 313 (88%) completed baseline QOL assessments. INTERVENTION: Treatment with 74-Gy vs 60-Gy RT with concurrent and consolidation carboplatin/paclitaxel with or without cetuximab. MAIN OUTCOMES AND MEASURES: The QOL data were collected prospectively via FACT Trial Outcome Index (FACT-TOI), calculated as the sum of the following measures: Physical Well Being (PWB), Functional Well Being (FWB), and the LCS. Data are presented at baseline and 3 and 12 months via minimal clinically meaningful changes of 2 points or more for PWB, FWB, and LCS or 5 points or more for TOI. RESULTS: Of the 313 patients who completed baseline QOL assessments, 219 patients (70%) completed the 3-month QOL assessments, and 137 of the living patients (57%) completed the 12-month assessment. Patient demographics and baseline QOL scores were comparable between the 74-Gy and 60-Gy arms. Significantly more patients in the 74-Gy arm than in the 60-Gy arm had clinically meaningful decline in FACT-LCS at 3 months (45% vs 30%; P =.02). At 12 months, fewer patients who received IMRT (vs 3D-CRT) had clinically meaningful decline in FACT-LCS (21% vs 46%; P =.003). Baseline FACT-TOI was associated with overall survival in multivariate analysis. CONCLUSIONS AND RELEVANCE: Despite few differences in clinician-reported toxic effects between treatment arms, QOL analysis demonstrated a clinically meaningful decline in QOL in the 74-Gy arm at 3 months, confirming the primary QOL hypothesis. Baseline QOL was an independent prognostic factor for survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00533949.

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