In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 10073-10073
Abstract:
10073 Background: In IMspire150, A+C+V significantly improved investigator-assessed progression-free survival vs placebo (Pbo)+C+V in previously untreated pts with unresectable stage IIIc/IV BRAF V600+ melanoma. PRO data from this trial are now reported. Methods: 514pts were randomized 1:1 to 28-day cycles of A+C+V or Pbo+C+V. Pts received C+V in cycle 1; A or Pbo was added on days 1 and 15 from cycle 2 onward. Pts completed the EORTC QLQ-C30 questionnaire on day 1 of cycle 1 (baseline), days 1 and 15 of cycle 2 and cycle 3, day 1 from cycle 4 onward, within 28-d of treatment discontinuation, and ≤6 months post-treatment. Prespecified secondary PRO endpoints were time to confirmed deterioration (TTCD; defined as time from randomization to first ≥10-point decrease from baseline held for 2 consecutive assessments, or 1 assessment followed by death on treatment) in quality of life (QoL) and physical functioning (PF). Prespecified exploratory endpoints were TTCD in role functioning (RF); mean change from baseline and percentage of pts with a clinically meaningful change (≥10 points from baseline) in QoL, PF, and RF. Results: Questionnaire completion rates were 〉 80% for most of the treatment period. At baseline, mean QoL, PF, and RF scores were moderate to high (Table). At week 6 (cycle 2), following initiation of A, QoL, PF, and RF scores declined, but returned to near-baseline levels at week 10 (cycle 3) and were largely maintained until week 36 (cycle 10), when 〈 50% of pts contributed data. In this time, ≥56% pts in both arms did not experience a clinically meaningful deterioration in QoL, PF, and RF. TTCD on QoL (hazard ratio [HR] 1.23; 95% CI 0.90-1.67), PF (HR 1.27; 95% CI 0.93-1.74), and RF (HR 1.15; 95% CI 0.86-1.55) favored Pbo, but only one-third of pts overall experienced a confirmed deterioration. Conclusions: PRO data showed that A+C+V did not worsen QoL, PF, and RF in pts with advanced BRAF V600+ melanoma, thus supporting its use as a treatment option. Clinical trial information: NCT02908672. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2020.38.15_suppl.10073
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2020
detail.hit.zdb_id:
2005181-5
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