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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.


Related in: MedlinePlus

Kaplan-Meier curves for progression-free survival in patients with poor QoL(A) and good QoL (B), and for overall survival in patients with poor QoL (C) and good QoL (D). Patients had been divided into good or poor QoL group according to the score of TOI at baseline (good: TOI > 62; poor: TOI ≤ 62). Cox proportional hazards regression model were used to estimate hazard ratio (HR). HR < 1 implied a lower risk of progression or death with gefitinib than with placebo.
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f6: Kaplan-Meier curves for progression-free survival in patients with poor QoL(A) and good QoL (B), and for overall survival in patients with poor QoL (C) and good QoL (D). Patients had been divided into good or poor QoL group according to the score of TOI at baseline (good: TOI > 62; poor: TOI ≤ 62). Cox proportional hazards regression model were used to estimate hazard ratio (HR). HR < 1 implied a lower risk of progression or death with gefitinib than with placebo.

Mentions: In our study, patients had been divided into good or poor QoL group according to the score of TOI at baseline. The key demographic and characteristics of each group was summarized in Table 2. Then the treatment effect of gefitinib versus placebo on prognosis by baseline QoL was analyzed. As shown in Fig. 6, the results indicate that PFS might not be affected by baseline QOL status, and the gefitinib arm shows a significant longer PFS in both poor QoL and good QoL status than placebo arm. However, the benefit in OS from gefitinib treatment was affected by baseline QoL status. In patients with good QoL at baseline, the treatment of gefitinib could not improve OS compared to placebo (18.5 vs. 18.7 months, P = 0.831), whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051).


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)

Kaplan-Meier curves for progression-free survival in patients with poor QoL(A) and good QoL (B), and for overall survival in patients with poor QoL (C) and good QoL (D). Patients had been divided into good or poor QoL group according to the score of TOI at baseline (good: TOI > 62; poor: TOI ≤ 62). Cox proportional hazards regression model were used to estimate hazard ratio (HR). HR < 1 implied a lower risk of progression or death with gefitinib than with placebo.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f6: Kaplan-Meier curves for progression-free survival in patients with poor QoL(A) and good QoL (B), and for overall survival in patients with poor QoL (C) and good QoL (D). Patients had been divided into good or poor QoL group according to the score of TOI at baseline (good: TOI > 62; poor: TOI ≤ 62). Cox proportional hazards regression model were used to estimate hazard ratio (HR). HR < 1 implied a lower risk of progression or death with gefitinib than with placebo.
Mentions: In our study, patients had been divided into good or poor QoL group according to the score of TOI at baseline. The key demographic and characteristics of each group was summarized in Table 2. Then the treatment effect of gefitinib versus placebo on prognosis by baseline QoL was analyzed. As shown in Fig. 6, the results indicate that PFS might not be affected by baseline QOL status, and the gefitinib arm shows a significant longer PFS in both poor QoL and good QoL status than placebo arm. However, the benefit in OS from gefitinib treatment was affected by baseline QoL status. In patients with good QoL at baseline, the treatment of gefitinib could not improve OS compared to placebo (18.5 vs. 18.7 months, P = 0.831), whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051).

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.


Related in: MedlinePlus