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Quality of life (QoL) by response: An interim analysis of patients (pts) with squamous (SCC) NSCLC treated with nab-paclitaxel/carboplatin (nab-P/C) induction therapy in the phase III ABOUND.sqm study.
Journal of Clinical Oncology 2016 March
63 Background: The correlation of radiological response and pt-reported outcomes (PROs) in advanced NSCLC remains underreported. This interim analysis evaluated QoL by response (RECIST v1.1) in SCC NSCLC pts treated with nab-P/C during the induction part of the ABOUND.sqm study.
METHODS: In the ongoing phase III ABOUND.sqm study, pts with advanced SCC NSCLC are treated with first-line nab-P 100 mg/m(2) d 1, 8, 15 and C AUC 6 mg•min/mL d 1 (21-d cycles) for 4 cycles (induction). Pts not progressing are randomized 2:1 to maintenance nab-P 100 mg/m(2)d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until progression. The primary endpoint is PFS from randomization to maintenance. QoL, an exploratory endpoint, was assessed with predefined PRO instruments, LCSS and EQ-5D-5L, on d 1 of each cycle. Pts with a radiological CR/ PR are considered responders (R) in this analysis (57% of evaluable pts). As the study is ongoing, this pre-planned analysis included QoL and tumor response data that were reported up to the cutoff date.
RESULTS: Baseline (BL) characteristics were similar for Rs (n = 73) and non-Rs (n = 55). Over 80% of pts completed BL + ≥ 1 post-BL PRO assessments. For LCSS, average total score and symptom burden index improved during induction chemotherapy; a higher percentage of Rs vs non-Rs had clinically meaningful improvements (≥ 10 mm [VAS]) from BL in composite LCSS cough, shortness of breath, & hemoptysis (56% vs 38%). Of pts reporting BL EQ-5D-5L dimension problem(s), a higher percentage of Rs vs non-Rs reported complete resolution at least once during treatment (Table).
CONCLUSIONS: These results indicate that Rs and non-Rs maintained/improved QoL during induction therapy with nab-P/C. Rs appeared to have greater improvements in LCSS and EQ-5D-5L. Radiological response translates into meaningful QoL improvement.
CLINICAL TRIAL INFORMATION: NCT02027428. [Table: see text].
METHODS: In the ongoing phase III ABOUND.sqm study, pts with advanced SCC NSCLC are treated with first-line nab-P 100 mg/m(2) d 1, 8, 15 and C AUC 6 mg•min/mL d 1 (21-d cycles) for 4 cycles (induction). Pts not progressing are randomized 2:1 to maintenance nab-P 100 mg/m(2)d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until progression. The primary endpoint is PFS from randomization to maintenance. QoL, an exploratory endpoint, was assessed with predefined PRO instruments, LCSS and EQ-5D-5L, on d 1 of each cycle. Pts with a radiological CR/ PR are considered responders (R) in this analysis (57% of evaluable pts). As the study is ongoing, this pre-planned analysis included QoL and tumor response data that were reported up to the cutoff date.
RESULTS: Baseline (BL) characteristics were similar for Rs (n = 73) and non-Rs (n = 55). Over 80% of pts completed BL + ≥ 1 post-BL PRO assessments. For LCSS, average total score and symptom burden index improved during induction chemotherapy; a higher percentage of Rs vs non-Rs had clinically meaningful improvements (≥ 10 mm [VAS]) from BL in composite LCSS cough, shortness of breath, & hemoptysis (56% vs 38%). Of pts reporting BL EQ-5D-5L dimension problem(s), a higher percentage of Rs vs non-Rs reported complete resolution at least once during treatment (Table).
CONCLUSIONS: These results indicate that Rs and non-Rs maintained/improved QoL during induction therapy with nab-P/C. Rs appeared to have greater improvements in LCSS and EQ-5D-5L. Radiological response translates into meaningful QoL improvement.
CLINICAL TRIAL INFORMATION: NCT02027428. [Table: see text].
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