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Clinical Trial
. 2009 Sep;18(7):853-61.
doi: 10.1007/s11136-009-9493-z. Epub 2009 Jul 1.

Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial

Desmond Curran  1 , Carmelo Pozzo, Jerzy Zaluski, Magdalena Dank, Carlo Barone, Vahur Valvere, Suayib Yalcin, Christian Peschel, Miklós Wenczl, Erdem Goker, Roland Bugat
Affiliations
Clinical Trial

Quality of life of palliative chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction treated with irinotecan combined with 5-fluorouracil and folinic acid: results of a randomised phase III trial

Desmond Curran et al. Qual Life Res. 2009 Sep.

Abstract

Purpose: The quality of life (QL) of advanced gastric cancer patients receiving irinotecan, folinic acid and 5-fluorouracil (5-FU) (IF arm) or cisplatin with 5-FU (CF arm) is presented.

Methods: Patients with measurable or evaluable advanced gastric cancer received IF weekly for 6/7 weeks or CF q4 weeks. QL was assessed using the EORTC QLQ-C30 at baseline, subsequently every 8 weeks until progression and thereafter every 3 months until death. The QL data were analysed using several statistical methods including summary measures and pattern-mixture modelling.

Results: A total of 333 patients were randomised and treated (IF 170, CF 163). The time-to-progression for IF and CF was 5.0 and 4.2 months (P = 0.088), respectively. The overall compliance rates for QL questionnaire completion were 60 and 56% in the IF and CF arms, respectively. Significant treatment differences were observed for the physical functioning scale (P = 0.024), nausea\vomiting (P = 0.001) and EQ-5D thermometer (P = 0.020) in favour of the IF treatment arm.

Conclusion: There was a trend in favour of IF over CF in time-to-progression. The IF group also demonstrated a better safety profile than CF and a better QL on a number of multi-item scales, suggesting that IF offers an alternative first-line platinum-free treatment option for advanced gastric cancer.

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Figures

Fig. 1
Fig. 1
Plot of the least squares means estimates of the EORTC QLQ-C30 mean global health status by treatment group and dropout pattern. A higher score represents a better QL. Full green line represents pattern 4 (i.e. dropout after week 32). Other lines represent patterns 1–3, i.e. dropout at baseline, dropout at week 8 or 16, dropout at week 24 or 32, respectively
Fig. 2
Fig. 2
Testing the treatment effect using the delta method. EQ-5D HUI is on a different scale and consequently is not included in this figure
See this image and copyright information in PMC

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