Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU: Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS)

G. Bodoky, Max E. Scheulen, Fernando Rivera, Jacek Jassem, Alfredo Carrato, Vladimir Moiseyenko, Ihor Vynnychenko, Jana Prausová, Jean Luc Van Laethem, Stefano Cascinu, Jaffer A. Ajani

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Purpose: Patient-reported outcomes (PRO) of health-related quality of life (HRQoL) and time to worsening of clinical benefit parameters were evaluated as secondary end points in the phase 3 first-line advanced gastric cancer study (FLAGS) trial of cisplatin/S-1 versus cisplatin/5-fluorouracil (5-FU) in patients with previously untreated advanced gastric cancer. Methods: The primary PRO end point was the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga). FACT-Ga was completed at the beginning of the first 4 cycles, cycle 6, and then every 3 cycles thereafter. The Chemotherapy Convenience and Satisfaction Questionnaire (CCSQ) was administered before the first 4 cycles; clinical benefit parameters (performance status, weight loss, and anorexia) were assessed at baseline, prior to study drug administration on day 1 of each cycle after cycle 1, and at the end of study treatment. Results: Compliance to questionnaire fulfillment was more than 80 % through cycle 9. Significantly, fewer patients treated with cisplatin/S-1 reported worsened physical well-being (PWB) scores (45.1 versus 51.7 %, p = 0.044) and experienced significantly longer time to worsening in PWB scores, with a median of 4.5 months (95 % confidence interval (CI), 3.1–5.1) compared to 3.0 months (2.8–4.6) with cisplatin/5-FU (CF) (p = 0.01). Patients receiving cisplatin/S-1 also reported significantly higher best and worst score of PWB as well as CCSQ scores and a longer median time to worsening in clinical benefit parameters. Conclusions: Differences in secondary end points of PWB, CCSQ scores, and clinical benefit parameters favoring the cisplatin/S-1 arm provide further evidence for considering this combination a standard therapeutic option for first-line treatment of advanced gastric cancer.

Original languageEnglish
Pages (from-to)109-117
Number of pages9
JournalJournal of Gastrointestinal Cancer
Volume46
Issue number2
DOIs
Publication statusPublished - Feb 24 2015

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Fluorouracil
Cisplatin
Stomach Neoplasms
Quality of Life
Drug Therapy
Therapeutics
Anorexia
Weight Loss
Confidence Intervals
Surveys and Questionnaires
Pharmaceutical Preparations
Patient Reported Outcome Measures

Keywords

  • Advanced gastric cancer
  • Cisplatin
  • FLAGS trial
  • Patient-reported outcomes
  • Quality of life
  • S-1

ASJC Scopus subject areas

  • Gastroenterology
  • Oncology

Cite this

Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU : Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS). / Bodoky, G.; Scheulen, Max E.; Rivera, Fernando; Jassem, Jacek; Carrato, Alfredo; Moiseyenko, Vladimir; Vynnychenko, Ihor; Prausová, Jana; Van Laethem, Jean Luc; Cascinu, Stefano; Ajani, Jaffer A.

In: Journal of Gastrointestinal Cancer, Vol. 46, No. 2, 24.02.2015, p. 109-117.

Research output: Contribution to journalArticle

Bodoky, G. ; Scheulen, Max E. ; Rivera, Fernando ; Jassem, Jacek ; Carrato, Alfredo ; Moiseyenko, Vladimir ; Vynnychenko, Ihor ; Prausová, Jana ; Van Laethem, Jean Luc ; Cascinu, Stefano ; Ajani, Jaffer A. / Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU : Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS). In: Journal of Gastrointestinal Cancer. 2015 ; Vol. 46, No. 2. pp. 109-117.
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abstract = "Purpose: Patient-reported outcomes (PRO) of health-related quality of life (HRQoL) and time to worsening of clinical benefit parameters were evaluated as secondary end points in the phase 3 first-line advanced gastric cancer study (FLAGS) trial of cisplatin/S-1 versus cisplatin/5-fluorouracil (5-FU) in patients with previously untreated advanced gastric cancer. Methods: The primary PRO end point was the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga). FACT-Ga was completed at the beginning of the first 4 cycles, cycle 6, and then every 3 cycles thereafter. The Chemotherapy Convenience and Satisfaction Questionnaire (CCSQ) was administered before the first 4 cycles; clinical benefit parameters (performance status, weight loss, and anorexia) were assessed at baseline, prior to study drug administration on day 1 of each cycle after cycle 1, and at the end of study treatment. Results: Compliance to questionnaire fulfillment was more than 80 {\%} through cycle 9. Significantly, fewer patients treated with cisplatin/S-1 reported worsened physical well-being (PWB) scores (45.1 versus 51.7 {\%}, p = 0.044) and experienced significantly longer time to worsening in PWB scores, with a median of 4.5 months (95 {\%} confidence interval (CI), 3.1–5.1) compared to 3.0 months (2.8–4.6) with cisplatin/5-FU (CF) (p = 0.01). Patients receiving cisplatin/S-1 also reported significantly higher best and worst score of PWB as well as CCSQ scores and a longer median time to worsening in clinical benefit parameters. Conclusions: Differences in secondary end points of PWB, CCSQ scores, and clinical benefit parameters favoring the cisplatin/S-1 arm provide further evidence for considering this combination a standard therapeutic option for first-line treatment of advanced gastric cancer.",
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AU - Scheulen, Max E.

AU - Rivera, Fernando

AU - Jassem, Jacek

AU - Carrato, Alfredo

AU - Moiseyenko, Vladimir

AU - Vynnychenko, Ihor

AU - Prausová, Jana

AU - Van Laethem, Jean Luc

AU - Cascinu, Stefano

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N2 - Purpose: Patient-reported outcomes (PRO) of health-related quality of life (HRQoL) and time to worsening of clinical benefit parameters were evaluated as secondary end points in the phase 3 first-line advanced gastric cancer study (FLAGS) trial of cisplatin/S-1 versus cisplatin/5-fluorouracil (5-FU) in patients with previously untreated advanced gastric cancer. Methods: The primary PRO end point was the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga). FACT-Ga was completed at the beginning of the first 4 cycles, cycle 6, and then every 3 cycles thereafter. The Chemotherapy Convenience and Satisfaction Questionnaire (CCSQ) was administered before the first 4 cycles; clinical benefit parameters (performance status, weight loss, and anorexia) were assessed at baseline, prior to study drug administration on day 1 of each cycle after cycle 1, and at the end of study treatment. Results: Compliance to questionnaire fulfillment was more than 80 % through cycle 9. Significantly, fewer patients treated with cisplatin/S-1 reported worsened physical well-being (PWB) scores (45.1 versus 51.7 %, p = 0.044) and experienced significantly longer time to worsening in PWB scores, with a median of 4.5 months (95 % confidence interval (CI), 3.1–5.1) compared to 3.0 months (2.8–4.6) with cisplatin/5-FU (CF) (p = 0.01). Patients receiving cisplatin/S-1 also reported significantly higher best and worst score of PWB as well as CCSQ scores and a longer median time to worsening in clinical benefit parameters. Conclusions: Differences in secondary end points of PWB, CCSQ scores, and clinical benefit parameters favoring the cisplatin/S-1 arm provide further evidence for considering this combination a standard therapeutic option for first-line treatment of advanced gastric cancer.

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