RWD is an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. However, it is important to determine if such data are fit for purpose.

OBJECTIVE To compare length of stay (LOS), costs, mechanical ventilation (MV), and mortality in preterm infants treated in the Neonatal Intensive Care Unit (NICU) with beractant (BE), calfactant (CA), and poractant alfa (PA) for Respiratory Distress Syndrome (RDS). METHODS This study evaluated preterm infants born between 2010 and 2013 with RDS diagnosis, gestational age of 25 to 36 weeks, birthweight of ≥500 g, and age of ≤2 days on first surfactant administration. Multivariable regression was used to evaluate all NICU outcomes. RESULTS Of 13,240 infants meeting the study criteria, 4136 (31.2%) received BE, 2502 (18.9%) received CA, and 6602 (49.9%) received PA. Adjusted analyses estimated similar mean LOS (BE 26.7 days, CA 27.8 days, and PA 26.2 days) and hospital costs (BE: $50,929; CA: $50,785; and PA: $50,212). Compared to PA, BE and CA were associated with greater odds of MV use on day 3 (OR = 1.56 and 1.60, respectively) and day 7 (OR = 1.39 and 1.28, respectively; all p < 0.05). Adjusted NICU mortality was significantly higher only with CA vs PA (OR = 1.51; p = 0.015). CONCLUSION Adjusted NICU LOS and costs were similar among BE, CA, and PA. Infants receiving PA were less likely to be on MV at 3 and 7 days, and PA treatment was associated with lower odds of NICU mortality when compared to CA.

54 Background: In the FAST study, IMAB362 (loading dose 800 mg/m2 then 600 mg/m2 d1 qd21) plus EOX (epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 d1, and capecitabine 625 mg/m2 bid) was compared with EOX alone in patients with advanced/metastatic gastric (GA), gastroesophageal (GE), and gastroesophageal junction (GEJ) adenocarcinoma. The FAST study exhibited a clinically relevant benefit in PFS and OS with a manageable safety profile in patients treated with IMAB362. Here we present the HRQoL results from the FAST study. Methods: CLDN18.2-positive patients (intermediate/strong membrane staining in ≥40% of cells) with advanced/metastatic GA/GE/GEJ adenocarcinoma were randomized 1:1 to first-line EOX for a maximum of 8 cycles with or without 600 mg/m2 q3w IMAB362, which after 8 cycles could be continued as monotherapy until disease progression (DP). The EORTC QLQC30 and a gastric cancer specific measure EORTC STO22 were collected at baseline (BL), Cycle 5, end of EOX therapy (EOT) and post-EOT every 12 weeks until DP. Change from BL in EORTC scores over 8 cycles of EOX treatment were analyzed using mixed model repeated measures. Time to deterioration in HRQoL was defined as time from randomization to first minimally clinically important difference (MCID) decline in each HRQoL domain. Results: The HRQoL analysis included 74 EOX and 68 IMAB362 + EOX per protocol patients. There were no significant differences in mean changes from BL in EORTC QLQC30 Global Health Status/QoL Score and STO22 Total Score across the 8 cycles of treatment with EOX. The QLQC30 Nausea and Vomiting domain showed a statistical difference (p = 0.0108) in favor of EOX-only. The median time to first HRQoL MCID deterioration for the QLQC30 Global Health Status was 8.6 mo for EOX + IMAB362 and 6.0 mo for EOX alone (p = 0.008). For patients who remained on IMAB362 post EOT, HRQoL improved from BL. Conclusions: HRQoL was maintained for a longer duration in pts with advanced/metastatic GA/GE/GEJ adenocarcinoma who received EOX + IMAB362 therapy vs EOX alone. HRQoL post EOT was improved for EOX + IMAB362 therapy vs EOX alone. Clinical trial information: NCT01630083.

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