A pooled analysis of individual patient data from National Clinical Trials Network clinical trials of concurrent chemoradiotherapy for limited-stage small cell lung cancer in elderly patients versus younger patients

Thomas E. Stinchcombe, Wen Fan, Steven E. Schild, Everett E. Vokes, Jeff Bogart, Quynh Thu Le, Charles R. Thomas, Martin J. Edelman, Leora Horn, Ritsuko Komaki, Harvey J. Cohen, Apar Kishor P Ganti, Herbert Pang, Xiaofei Wang

Research output: Contribution to journalArticle

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Abstract

Background: Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited-stage small cell lung cancer (LS-SCLC). Many patients with LS-SCLC are elderly with comorbidities. Methods: Individual patient data were collected from 11 phase 2 or 3 trials for LS-SCLC conducted by the National Clinical Trials Network and activated from 1990 to 2010. The primary endpoint was overall survival (OS); the secondary endpoints were progression-free survival (PFS), the rate of severe adverse events, and off-treatment reasons. The outcomes were compared for patients 70 years old or older (elderly patients) and patients younger than 70 years (younger patients). Results: Individual patient data from 1049 younger patients (81%) and 254 elderly patients (19%) were analyzed. In the multivariate model, elderly patients, in comparison with younger patients, had worse OS (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.18-1.63; median OS for elderly patients, 17.8 months; OS for younger patients, 23.5 months) and worse PFS (HR, 1.19; 95% CI, 1.03-1.39; median PFS for elderly patients, 10.6 months; median PFS for younger patients, 12.3 months). Elderly patients, in comparison with younger patients, experienced more grade 5 adverse events (8% vs 3%; P <.01) and more grade 3 or higher dyspnea (11% vs 7%; P =.03) but less grade 3 or higher esophagitis/dysphagia (14% vs 19%; P =.04) and less grade 3 or higher vomiting (11% vs 17%; P =.01). Elderly patients completed treatment less often, discontinued treatment because of adverse events and patient refusal more frequently, and died during treatment more frequently. Conclusions: Elderly patients with LS-SCLC have worse PFS and OS and more difficulty in tolerating therapy. Future trials should incorporate assessments of elderly patients, novel monitoring of adverse events, and more tolerable radiation and systemic therapies.

Original languageEnglish (US)
Pages (from-to)382-390
Number of pages9
JournalCancer
Volume125
Issue number3
DOIs
StatePublished - Feb 1 2019

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Small Cell Lung Carcinoma
Chemoradiotherapy
Clinical Trials
Disease-Free Survival
Survival
Therapeutics
Confidence Intervals
Cranial Irradiation
Esophagitis

Keywords

  • adverse events related to age
  • chemotherapy
  • clinical trial
  • small cell lung cancer
  • thoracic radiation therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A pooled analysis of individual patient data from National Clinical Trials Network clinical trials of concurrent chemoradiotherapy for limited-stage small cell lung cancer in elderly patients versus younger patients. / Stinchcombe, Thomas E.; Fan, Wen; Schild, Steven E.; Vokes, Everett E.; Bogart, Jeff; Le, Quynh Thu; Thomas, Charles R.; Edelman, Martin J.; Horn, Leora; Komaki, Ritsuko; Cohen, Harvey J.; Ganti, Apar Kishor P; Pang, Herbert; Wang, Xiaofei.

In: Cancer, Vol. 125, No. 3, 01.02.2019, p. 382-390.

Research output: Contribution to journalArticle

Stinchcombe, TE, Fan, W, Schild, SE, Vokes, EE, Bogart, J, Le, QT, Thomas, CR, Edelman, MJ, Horn, L, Komaki, R, Cohen, HJ, Ganti, AKP, Pang, H & Wang, X 2019, 'A pooled analysis of individual patient data from National Clinical Trials Network clinical trials of concurrent chemoradiotherapy for limited-stage small cell lung cancer in elderly patients versus younger patients' Cancer, vol. 125, no. 3, pp. 382-390. https://doi.org/10.1002/cncr.31813
Stinchcombe, Thomas E. ; Fan, Wen ; Schild, Steven E. ; Vokes, Everett E. ; Bogart, Jeff ; Le, Quynh Thu ; Thomas, Charles R. ; Edelman, Martin J. ; Horn, Leora ; Komaki, Ritsuko ; Cohen, Harvey J. ; Ganti, Apar Kishor P ; Pang, Herbert ; Wang, Xiaofei. / A pooled analysis of individual patient data from National Clinical Trials Network clinical trials of concurrent chemoradiotherapy for limited-stage small cell lung cancer in elderly patients versus younger patients. In: Cancer. 2019 ; Vol. 125, No. 3. pp. 382-390.
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abstract = "Background: Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited-stage small cell lung cancer (LS-SCLC). Many patients with LS-SCLC are elderly with comorbidities. Methods: Individual patient data were collected from 11 phase 2 or 3 trials for LS-SCLC conducted by the National Clinical Trials Network and activated from 1990 to 2010. The primary endpoint was overall survival (OS); the secondary endpoints were progression-free survival (PFS), the rate of severe adverse events, and off-treatment reasons. The outcomes were compared for patients 70 years old or older (elderly patients) and patients younger than 70 years (younger patients). Results: Individual patient data from 1049 younger patients (81{\%}) and 254 elderly patients (19{\%}) were analyzed. In the multivariate model, elderly patients, in comparison with younger patients, had worse OS (hazard ratio [HR], 1.38; 95{\%} confidence interval [CI], 1.18-1.63; median OS for elderly patients, 17.8 months; OS for younger patients, 23.5 months) and worse PFS (HR, 1.19; 95{\%} CI, 1.03-1.39; median PFS for elderly patients, 10.6 months; median PFS for younger patients, 12.3 months). Elderly patients, in comparison with younger patients, experienced more grade 5 adverse events (8{\%} vs 3{\%}; P <.01) and more grade 3 or higher dyspnea (11{\%} vs 7{\%}; P =.03) but less grade 3 or higher esophagitis/dysphagia (14{\%} vs 19{\%}; P =.04) and less grade 3 or higher vomiting (11{\%} vs 17{\%}; P =.01). Elderly patients completed treatment less often, discontinued treatment because of adverse events and patient refusal more frequently, and died during treatment more frequently. Conclusions: Elderly patients with LS-SCLC have worse PFS and OS and more difficulty in tolerating therapy. Future trials should incorporate assessments of elderly patients, novel monitoring of adverse events, and more tolerable radiation and systemic therapies.",
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AU - Fan, Wen

AU - Schild, Steven E.

AU - Vokes, Everett E.

AU - Bogart, Jeff

AU - Le, Quynh Thu

AU - Thomas, Charles R.

AU - Edelman, Martin J.

AU - Horn, Leora

AU - Komaki, Ritsuko

AU - Cohen, Harvey J.

AU - Ganti, Apar Kishor P

AU - Pang, Herbert

AU - Wang, Xiaofei

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Background: Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited-stage small cell lung cancer (LS-SCLC). Many patients with LS-SCLC are elderly with comorbidities. Methods: Individual patient data were collected from 11 phase 2 or 3 trials for LS-SCLC conducted by the National Clinical Trials Network and activated from 1990 to 2010. The primary endpoint was overall survival (OS); the secondary endpoints were progression-free survival (PFS), the rate of severe adverse events, and off-treatment reasons. The outcomes were compared for patients 70 years old or older (elderly patients) and patients younger than 70 years (younger patients). Results: Individual patient data from 1049 younger patients (81%) and 254 elderly patients (19%) were analyzed. In the multivariate model, elderly patients, in comparison with younger patients, had worse OS (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.18-1.63; median OS for elderly patients, 17.8 months; OS for younger patients, 23.5 months) and worse PFS (HR, 1.19; 95% CI, 1.03-1.39; median PFS for elderly patients, 10.6 months; median PFS for younger patients, 12.3 months). Elderly patients, in comparison with younger patients, experienced more grade 5 adverse events (8% vs 3%; P <.01) and more grade 3 or higher dyspnea (11% vs 7%; P =.03) but less grade 3 or higher esophagitis/dysphagia (14% vs 19%; P =.04) and less grade 3 or higher vomiting (11% vs 17%; P =.01). Elderly patients completed treatment less often, discontinued treatment because of adverse events and patient refusal more frequently, and died during treatment more frequently. Conclusions: Elderly patients with LS-SCLC have worse PFS and OS and more difficulty in tolerating therapy. Future trials should incorporate assessments of elderly patients, novel monitoring of adverse events, and more tolerable radiation and systemic therapies.

AB - Background: Platinum and etoposide with thoracic radiation followed by prophylactic cranial irradiation constitute the standard treatment for limited-stage small cell lung cancer (LS-SCLC). Many patients with LS-SCLC are elderly with comorbidities. Methods: Individual patient data were collected from 11 phase 2 or 3 trials for LS-SCLC conducted by the National Clinical Trials Network and activated from 1990 to 2010. The primary endpoint was overall survival (OS); the secondary endpoints were progression-free survival (PFS), the rate of severe adverse events, and off-treatment reasons. The outcomes were compared for patients 70 years old or older (elderly patients) and patients younger than 70 years (younger patients). Results: Individual patient data from 1049 younger patients (81%) and 254 elderly patients (19%) were analyzed. In the multivariate model, elderly patients, in comparison with younger patients, had worse OS (hazard ratio [HR], 1.38; 95% confidence interval [CI], 1.18-1.63; median OS for elderly patients, 17.8 months; OS for younger patients, 23.5 months) and worse PFS (HR, 1.19; 95% CI, 1.03-1.39; median PFS for elderly patients, 10.6 months; median PFS for younger patients, 12.3 months). Elderly patients, in comparison with younger patients, experienced more grade 5 adverse events (8% vs 3%; P <.01) and more grade 3 or higher dyspnea (11% vs 7%; P =.03) but less grade 3 or higher esophagitis/dysphagia (14% vs 19%; P =.04) and less grade 3 or higher vomiting (11% vs 17%; P =.01). Elderly patients completed treatment less often, discontinued treatment because of adverse events and patient refusal more frequently, and died during treatment more frequently. Conclusions: Elderly patients with LS-SCLC have worse PFS and OS and more difficulty in tolerating therapy. Future trials should incorporate assessments of elderly patients, novel monitoring of adverse events, and more tolerable radiation and systemic therapies.

KW - adverse events related to age

KW - chemotherapy

KW - clinical trial

KW - small cell lung cancer

KW - thoracic radiation therapy

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