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QoL analyses from INFORM study, a phase III study of gefitinib versus placebo as maintenance therapy in advanced NSCLC.

Yang YP, Ma YX, Huang Y, Zhao YY, Fang WF, Hong SD, Tian Y, Xue C, Sheng J, Zhang L - Sci Rep (2015)

Bottom Line: Patients with an improvement in QoL had longer PFS (FACT-L: 9.4 m vs. 2.8 m vs. 2.7 m, P < 0.001; TOI: 9.9 m vs. 2.8 m vs. 2.1 m, P < 0.001; LCS: 9.4 m vs. 2.9 m vs. 2.1 m, P < 0.001) and OS (FACT-L: 25.4 m vs. 19.9 m vs. 14.4 m, P = 0.003; TOI: 25.7 m vs. 19.0 m vs. 12.7 m, P = 0.002; LCS: 25.4 m vs. 19.3 m vs. 14.7 m, P = 0.004) compared with patients with stable or worsened QoL.Furthermore, in patients with good QoL at baseline, the treatment of gefitinib couldn't improve OS compared to placebo, whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051).Our study indicated that gefitinib could improve patients' QoL, confirmed the prognostic value of QoL changes during treatment, and implied patients with low QoL at baseline may be the potential population which will gain OS benefit from maintenance EGFR-TKI therapy.

View Article: PubMed Central - PubMed

Affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

ABSTRACT
This report aimed to provide the full results of QoL assessment in INFORM study. QoL was assessed by FACT-L questionnaire. QoL improvement ratio in gefitinib arm was higher than placebo arm (FACT-L: 46% vs. 22%, p < 0.001; TOI: 41% vs. 18%, p < 0.001; LCS: 46% vs. 22%, p < 0.001). Gefitinib prolonged time-to-worsening of QoL (FACT-L: 2.8 m vs 1.4 m, p = 0.019; TOI: 3.5 m vs 1.4 m, p = 0.006; LCS: 2.8 vs 1.4 m, p = 0.028). Patients with an improvement in QoL had longer PFS (FACT-L: 9.4 m vs. 2.8 m vs. 2.7 m, P < 0.001; TOI: 9.9 m vs. 2.8 m vs. 2.1 m, P < 0.001; LCS: 9.4 m vs. 2.9 m vs. 2.1 m, P < 0.001) and OS (FACT-L: 25.4 m vs. 19.9 m vs. 14.4 m, P = 0.003; TOI: 25.7 m vs. 19.0 m vs. 12.7 m, P = 0.002; LCS: 25.4 m vs. 19.3 m vs. 14.7 m, P = 0.004) compared with patients with stable or worsened QoL. Furthermore, in patients with good QoL at baseline, the treatment of gefitinib couldn't improve OS compared to placebo, whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051). Our study indicated that gefitinib could improve patients' QoL, confirmed the prognostic value of QoL changes during treatment, and implied patients with low QoL at baseline may be the potential population which will gain OS benefit from maintenance EGFR-TKI therapy.

No MeSH data available.


The proportion of patients with different quality of life (QoL) change during the treatment accodring to the results of FACT-L(A), TOI (B) and LCS (C). The change in QoL score were analyzed for patients with a baseline and at least one post-baseline QoL assessment (123 in gefitinib arm and 116 in placebo arm). The improvement ratios in gefitinib arm were significantly higher than placebo arm.
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f4: The proportion of patients with different quality of life (QoL) change during the treatment accodring to the results of FACT-L(A), TOI (B) and LCS (C). The change in QoL score were analyzed for patients with a baseline and at least one post-baseline QoL assessment (123 in gefitinib arm and 116 in placebo arm). The improvement ratios in gefitinib arm were significantly higher than placebo arm.

Mentions: As mentioned in the methods section, we defined the patients’ QoL change during the treatment as improved, stable or deteriorated. As illustrated by Fig. 4, the improvement ratios in gefitinib arm are significantly higher than placebo arm (FACT-L: 55% vs. 24%, p < 0.001; TOI: 51% vs. 21%, p < 0.001; LCS: 50% vs. 22%, p < 0.001). Additionally, gefitinib also prolonged time-to-worsening of QoL when compared with placebo (FACT-L: 2.8 m vs 1.4 m, p = 0.019; TOI: 3.5 m vs 1.4 m, p = 0.006; LCS: 2.8 vs 1.4 m, p = 0.028).


QoL analyses from INFORM study, a phase III study of gefitinib versus placebo as maintenance therapy in advanced NSCLC.

Yang YP, Ma YX, Huang Y, Zhao YY, Fang WF, Hong SD, Tian Y, Xue C, Sheng J, Zhang L - Sci Rep (2015)

The proportion of patients with different quality of life (QoL) change during the treatment accodring to the results of FACT-L(A), TOI (B) and LCS (C). The change in QoL score were analyzed for patients with a baseline and at least one post-baseline QoL assessment (123 in gefitinib arm and 116 in placebo arm). The improvement ratios in gefitinib arm were significantly higher than placebo arm.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4490396&req=5

f4: The proportion of patients with different quality of life (QoL) change during the treatment accodring to the results of FACT-L(A), TOI (B) and LCS (C). The change in QoL score were analyzed for patients with a baseline and at least one post-baseline QoL assessment (123 in gefitinib arm and 116 in placebo arm). The improvement ratios in gefitinib arm were significantly higher than placebo arm.
Mentions: As mentioned in the methods section, we defined the patients’ QoL change during the treatment as improved, stable or deteriorated. As illustrated by Fig. 4, the improvement ratios in gefitinib arm are significantly higher than placebo arm (FACT-L: 55% vs. 24%, p < 0.001; TOI: 51% vs. 21%, p < 0.001; LCS: 50% vs. 22%, p < 0.001). Additionally, gefitinib also prolonged time-to-worsening of QoL when compared with placebo (FACT-L: 2.8 m vs 1.4 m, p = 0.019; TOI: 3.5 m vs 1.4 m, p = 0.006; LCS: 2.8 vs 1.4 m, p = 0.028).

Bottom Line: Patients with an improvement in QoL had longer PFS (FACT-L: 9.4 m vs. 2.8 m vs. 2.7 m, P < 0.001; TOI: 9.9 m vs. 2.8 m vs. 2.1 m, P < 0.001; LCS: 9.4 m vs. 2.9 m vs. 2.1 m, P < 0.001) and OS (FACT-L: 25.4 m vs. 19.9 m vs. 14.4 m, P = 0.003; TOI: 25.7 m vs. 19.0 m vs. 12.7 m, P = 0.002; LCS: 25.4 m vs. 19.3 m vs. 14.7 m, P = 0.004) compared with patients with stable or worsened QoL.Furthermore, in patients with good QoL at baseline, the treatment of gefitinib couldn't improve OS compared to placebo, whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051).Our study indicated that gefitinib could improve patients' QoL, confirmed the prognostic value of QoL changes during treatment, and implied patients with low QoL at baseline may be the potential population which will gain OS benefit from maintenance EGFR-TKI therapy.

View Article: PubMed Central - PubMed

Affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.

ABSTRACT
This report aimed to provide the full results of QoL assessment in INFORM study. QoL was assessed by FACT-L questionnaire. QoL improvement ratio in gefitinib arm was higher than placebo arm (FACT-L: 46% vs. 22%, p < 0.001; TOI: 41% vs. 18%, p < 0.001; LCS: 46% vs. 22%, p < 0.001). Gefitinib prolonged time-to-worsening of QoL (FACT-L: 2.8 m vs 1.4 m, p = 0.019; TOI: 3.5 m vs 1.4 m, p = 0.006; LCS: 2.8 vs 1.4 m, p = 0.028). Patients with an improvement in QoL had longer PFS (FACT-L: 9.4 m vs. 2.8 m vs. 2.7 m, P < 0.001; TOI: 9.9 m vs. 2.8 m vs. 2.1 m, P < 0.001; LCS: 9.4 m vs. 2.9 m vs. 2.1 m, P < 0.001) and OS (FACT-L: 25.4 m vs. 19.9 m vs. 14.4 m, P = 0.003; TOI: 25.7 m vs. 19.0 m vs. 12.7 m, P = 0.002; LCS: 25.4 m vs. 19.3 m vs. 14.7 m, P = 0.004) compared with patients with stable or worsened QoL. Furthermore, in patients with good QoL at baseline, the treatment of gefitinib couldn't improve OS compared to placebo, whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051). Our study indicated that gefitinib could improve patients' QoL, confirmed the prognostic value of QoL changes during treatment, and implied patients with low QoL at baseline may be the potential population which will gain OS benefit from maintenance EGFR-TKI therapy.

No MeSH data available.