Limits...
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.

Curran D, Pozzo C, Zaluski J, Dank M, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Bugat R - Qual Life Res (2009)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Omega Research, Santry, Dublin 9, Ireland. currandes@omega-research.eu.com

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.

Show MeSH

Related in: MedlinePlus

Testing the treatment effect using the delta method. EQ-5D HUI is on a different scale and consequently is not included in this figure
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC2724642&req=5

Fig2: Testing the treatment effect using the delta method. EQ-5D HUI is on a different scale and consequently is not included in this figure

Mentions: Several baseline clinical variables were considered as covariates in the model. The final model included an autoregressive order 1 variance–covariance structure, the baseline variables pain and WHO performance status and the treatment by pattern interaction and the main time effect. As there was an interaction between the treatment effect and pattern the treatment effect was estimated using the delta method. Figure 2 presents the treatment estimates for all the QL variables investigated except for the EQ5D HUI score (P = 0.518) which is on a different scale. Significant treatment differences were observed for the physical functioning scale, nausea\vomiting and EQ-5D thermometer in favour of the IF treatment arm. All the other scales illustrated non-significant results.Fig. 2


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.

Curran D, Pozzo C, Zaluski J, Dank M, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Bugat R - Qual Life Res (2009)

Testing the treatment effect using the delta method. EQ-5D HUI is on a different scale and consequently is not included in this figure
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2724642&req=5

Fig2: Testing the treatment effect using the delta method. EQ-5D HUI is on a different scale and consequently is not included in this figure
Mentions: Several baseline clinical variables were considered as covariates in the model. The final model included an autoregressive order 1 variance–covariance structure, the baseline variables pain and WHO performance status and the treatment by pattern interaction and the main time effect. As there was an interaction between the treatment effect and pattern the treatment effect was estimated using the delta method. Figure 2 presents the treatment estimates for all the QL variables investigated except for the EQ5D HUI score (P = 0.518) which is on a different scale. Significant treatment differences were observed for the physical functioning scale, nausea\vomiting and EQ-5D thermometer in favour of the IF treatment arm. All the other scales illustrated non-significant results.Fig. 2

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Omega Research, Santry, Dublin 9, Ireland. currandes@omega-research.eu.com

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.

Show MeSH
Related in: MedlinePlus