Michael S. Epstein, MD, FACG1, Juha Halonen, PhD2, Bharat Amlani, PharmD2, Cesare Hassan, MD, PhD3
1Investigative Clinical Research, Annapolis, MD; 2Norgine, Ltd., Harefield, England, United Kingdom; 3Ospedale Nuovo Regina Margherita, Roma, Lazio, Italy
Introduction: Interval cancers may occur due to missed neoplasia during colonoscopy. ‘Adequate’ cleansing quality permits stool presence in the colon, however high-quality (stool-free) cleansing is now known to improve polyp detection. The 1 L polyethylene glycol (PEG) NER1006 improves high-quality colon cleansing, but whether it primarily reduces stool or liquid is unknown. We characterized the segmental high-quality cleansing with NER1006 versus two comparators, and its effect on mean polyp detection per patient.
Methods: A post hoc analysis of two similarly designed phase 3 clinical trials NOCT and MORA examined overnight split-dosing regimens. NER1006 was compared with oral sulfate solution (OSS; NOCT) and 2 L polyethylene glycol + ascorbate (2LPEG; MORA). Treatment-blinded central readers assessed colon cleansing quality using the Harefield Cleansing Scale (HCS) with segmental scores 0-1 (failures; irremovable stool), 2 (adequate; removable stool), 3 (high-quality; clear liquid) or 4 (high-quality; liquid-free). Site endoscopists detected polyps. Patients with full segmental scoring were included. The segmental scores distribution and mean number of polyps per patient (MPP; in patients with at least 1 to 10 polyps) were analysed per treatment group. MPP was also assessed in pooled NER1006 versus pooled OSS and 2LPEG. One-sided t-tests assessed potential differences between groups.
Results: Totally 1037/1103 patients were included (94% primary analysis set = 5185 segments). NER1006 attained more stool-free segments (HCS 3) than OSS (30% [388/1275] vs 25% [331/1300]; P=0.002) [Figure 1] or 2LPEG (28% [368/1310] vs 15% [191/1300]; P< 0.001) [Figure 2]. NER1006 attained more liquid-free segments (HCS 4) than 2LPEG (22% [285/1310] vs 17% [220/1300]; P=0.001), and less stool-containing segments (HCS 2) than OSS (48% [612/1275] vs 53% [687/1300]; P=0.007 or 2LPEG (49% [641/1310] vs 66% [854/1300]; P< 0.001). Pooled NER1006 showed a higher MPP than pooled OSS and 2LPEG for at least 1 (2.8 vs 2.3; P=0.036), 2 (4.4 vs 3.5; P=0.020), 3 (5.7 vs 4.5; P=0.033), 4 (7.3 vs 5.8; P=0.049), 5 (9.7 vs 6.8; P=0.017) and 6 polyps per patient (10.9 vs 7.5; P=0.020) [Figure 3]. In all other patients NER1006 had a numerically higher MPP per trial and when pooled.
Discussion: Finding multiple polyps in a patient is difficult. NER1006 improves high-quality cleansing over OSS or 2LPEG primarily by delivering more stool-free segments. This improved high-quality cleansing enables detection of more polyps per patient.
Citation: Michael S. Epstein, MD, FACG; Juha Halonen, PhD; Bharat Amlani, PharmD; Cesare Hassan, MD, PhD. P2030 - 1 L NER1006 IMPROVES HIGH-QUALITY COLON CLEANSING AND MEAN POLYP DETECTION VERSUS ORAL SULFATE SOLUTION AND 2 L POLYETHYLENE GLYCOL PLUS ASCORBATE. Program No. P2030. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.