Limits...
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.


CONSORT diagram.OS = overall survival, PFS = progression free survival, ITT = intend-to-treat. (*)Two patients discontinued the study before randomization. (†) Cut off dates: June 17, 2014, for overall survival (OS) and progression-free survival (PFS). (‡) All patients who were randomly assigned to a study group were included in the intent-to-treat (ITT) analysis. (¶) All patients who received at least one dose of study treatment were included in the safety analysis. (‖)All patients received quality of life assessment at baseline were included in QoL analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4490396&req=5

f1: CONSORT diagram.OS = overall survival, PFS = progression free survival, ITT = intend-to-treat. (*)Two patients discontinued the study before randomization. (†) Cut off dates: June 17, 2014, for overall survival (OS) and progression-free survival (PFS). (‡) All patients who were randomly assigned to a study group were included in the intent-to-treat (ITT) analysis. (¶) All patients who received at least one dose of study treatment were included in the safety analysis. (‖)All patients received quality of life assessment at baseline were included in QoL analysis.

Mentions: Of the 296 patients randomized, the evaluable for quality-of-life (EFQ) analyses population is 290 (gefitinib arm 145, placebo arm 145). The EGFR-mutation status is known in 79 patients (30 positive: gefitinib arm 15, placebo arm 15; 49 negative: gefitinib arm 25, placebo arm 24). Patient disposition is presented in Fig. 1. The key demographics and characteristics of the ITT population and the EFQ population are shown in Table 1. The percentages of basic characteristics like age, gender, histology type, smoking status, disease stage, PS, smoking history and those who received treatment with 1st line chemotherapy are comparable between EFQ and ITT population, and also show a favorable equilibrium in gefitinib and placebo group.


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)

CONSORT diagram.OS = overall survival, PFS = progression free survival, ITT = intend-to-treat. (*)Two patients discontinued the study before randomization. (†) Cut off dates: June 17, 2014, for overall survival (OS) and progression-free survival (PFS). (‡) All patients who were randomly assigned to a study group were included in the intent-to-treat (ITT) analysis. (¶) All patients who received at least one dose of study treatment were included in the safety analysis. (‖)All patients received quality of life assessment at baseline were included in QoL analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

f1: CONSORT diagram.OS = overall survival, PFS = progression free survival, ITT = intend-to-treat. (*)Two patients discontinued the study before randomization. (†) Cut off dates: June 17, 2014, for overall survival (OS) and progression-free survival (PFS). (‡) All patients who were randomly assigned to a study group were included in the intent-to-treat (ITT) analysis. (¶) All patients who received at least one dose of study treatment were included in the safety analysis. (‖)All patients received quality of life assessment at baseline were included in QoL analysis.
Mentions: Of the 296 patients randomized, the evaluable for quality-of-life (EFQ) analyses population is 290 (gefitinib arm 145, placebo arm 145). The EGFR-mutation status is known in 79 patients (30 positive: gefitinib arm 15, placebo arm 15; 49 negative: gefitinib arm 25, placebo arm 24). Patient disposition is presented in Fig. 1. The key demographics and characteristics of the ITT population and the EFQ population are shown in Table 1. The percentages of basic characteristics like age, gender, histology type, smoking status, disease stage, PS, smoking history and those who received treatment with 1st line chemotherapy are comparable between EFQ and ITT population, and also show a favorable equilibrium in gefitinib and placebo group.

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.