In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 4011-4011
Abstract:
4011 Background: While pt PS is a known prognostic factor in MCRC, most phase III CTs enroll 〈 10% PS2 pts. This pooled analysis compares safety and efficacy in PS 0–1 versus (v) PS 2 MCRC pts on first-line CTs testing both single agents and combination rx. Methods: This retrospective analysis included 6,286 MCRC pts (509 PS 2) from 9 CTs (control arms: 5 5FU/LV, 2 FOLFOX, 1 FUFOX, 1IFL). Five CTs specifically compared mono to combination rx (3,814 pts; 335 PS 2). The primary endpoint was progression-free survival (PFS). Other endpoints included grade 3+ adverse events, 60-day all cause mortality, overall survival (OS), and response rate (RR). Efficacy endpoints were explored in both the full set of 9 CTs & the subset of 5 CTs that compared mono to combination rx. Results: Severe (grade 3+) nausea (7.0% v 13.0%; P 〈 .0001), vomiting (6.4% v 10.5%; P = .0002), and stomatitis (2.0% v 4.2%; P = .0332) were significantly higher in PS 2 pts. PS 2 was not associated with incidence of severe diarrhea or neutropenia. 60-day all cause mortality was significantly higher in PS 2 pts (2.8% v 12.0% in PS 0–1 v PS 2 respectively, P 〈 .0001). PS 2 was a prognostic factor for PFS (HR=1.52, P 〈 .0001, median 7.6 v 4.9 months (mos) in PS 0–1 v 2), OS (HR=2.18, P 〈 .0001, median 17.3 v 8.5 mos in PS 0–1 v 2), & RR (OR=0.60, P 〈 .0001, 43.5% v 32.0% in PS 0–1 v 2). The relative benefit of experimental (exp) v control rx did not differ in PS 0–1 v PS 2 pts for RR, PFS, or OS (see table ). This was true both when assessing all 9 CTs and the subset of 5 mono v combination rx CTs. Conclusions: In CTs, pts with PS 2 derive similar advantages with regard to efficacy from superior Rx as do pts with PS 0–1, but with higher risk of some gastrointestinal toxicities. Twelve percent of PS 2 pts die within 60 days of rx start. Median OS is 〈 9 months. While current Rx does provide benefit, new approaches are required to approach 1 year median survival for PS 2 pts. [Table: see text] No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.4011
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
detail.hit.zdb_id:
604914-X
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