695P - Quality of life in flags trial a randomized, comparative, open label, multicenter, phase 3 of S-1 + cisplatin (CS) compared to 5-FU + cisplatin (CF)...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Gyoergy Bodoky
Authors G. Bodoky1, A. Carrato2, A. Ravaioli3, J.A. Ajani4
  • 1Szent Laszlo Korhaz, 1097 - Budapest/HU
  • 2Medical Oncology, Hospital Ramon y Cajal, ES-28034 - Madrid/ES
  • 3Primario Oncologia Medica, Ospedale “Infermi” di Rimini, IT-47037 - Rimini (RN)/IT
  • 4Gastrointestinal Medical Oncology, MD Anderson, Cancer center, 77030 - Houston/US

Abstract

Background

FLAGS' primary objective was overall survival. We report below the Patient-Reported Outcomes (PRO) (i.e., Quality-of-Life [QoL]) which was one of the secondary objectives.

Methods

All patients who completed at least one PRO assessment were eligible for analysis. The primary PRO endpoint was the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy – Gastric (FACT-Ga). Patients completed the FACT-Ga at the beginning of Cycles 1, 2, 3, 4, 6 and then every 3 cycles prior to treatment administration. All individual subscales in the FACT-Ga were also evaluated as secondary endpoints. The Chemotherapy Convenience and Satisfaction Questionnaire (CCSQ) was administered at the beginning of the first 4 cycles.

Results

Of the 508 patients dosed at cycle 1 in the CF arm, and the 521 in the CS arm, 456 and 498 respectively completed at least one question on the FACT-Ga and 445 and 486 respectively completed at least 37 items.

Compliance to questionnaire fulfillment was more than 80% through Cycle 9. Although there were no overall difference in FACT-Ga scores between the treatment arms and minimal changes over time, an advantage for CS relative to CF was observed for Physical Well-Being (PWB) (51.7% versus 45.1%, p = 0.044). CS treated patients experienced significantly longer time to worsening in PWB scores, with a median time of 4.5 months (95% CI: 3.0 – 5.1) compared to 3.0 months (2.8 – 4.6) with CF (p = 0.014).Patients receiving CS reported higher best and worst score of PWB, Chemotherapy Convenience and Chemotherapy Concerns scores.

Conclusions

Even if there is little evidence to indicate any difference in FACT-Ga scores, some advantage to CS relative to CF was observed for PWB, one of the secondary PRO endpoints. This advantage was generally consistent across analysis method: time to worsening, best post-baseline score, and worst post-baseline score.

CS treated patients did report significantly better Chemotherapy Convenience and Concerns scores, the difference was approximately one-half of a standard deviation generally considered to be a meaningful difference.

Disclosure

All authors have declared no conflicts of interest.