Results According to Age in Avex, a Randomized Phase 3 Trial of Bevacizumab with Capecitabine for Elderly Patients with Mcrc
2013; Elsevier BV; Volume: 24; Linguagem: Inglês
10.1093/annonc/mdt201.30
ISSN1569-8041
AutoresMark Saunders, István Láng, Eugenio Marcuello, Vito Lorusso, Janja Ocvirk, Derek J. Jonker, Stuart Osborne, Markus Loeffler, Daniel Waterkamp, David Cunningham,
Tópico(s)Cancer Genomics and Diagnostics
ResumoBackground: As with many malignancies, metastatic colorectal cancer (mCRC) is primarily a disease of the elderly. The median age of patients with CRC at diagnosis has been estimated at 69 years, and approximately 61% of patients are initially diagnosed at an age of 65 years or older (Howlader, 2012). However, elderly patients are frequently underrepresented in clinical trials. The open-label phase 3 trial AVEX evaluated the benefit of adding bevacizumab (BEV) to capecitabine (cape) in elderly pts with previously untreated mCRC. This analysis explores clinical outcomes by age subgroup. Methods: In AVEX, 280 pts ≥70 y with mCRC for whom single-agent chemotherapy was deemed appropriate, were randomized to first-line cape (1000 mg/m2 bid days 1–14) alone (n = 140) or with BEV (7.5 mg/kg) q3w (n = 140). The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), overall response rate, and safety. The study was powered to show a difference in PFS but not OS. A post hoc analysis was conducted to assess PFS, OS, and safety in pts 70–74 y, 75–79 y, and ≥80 y. Results: Median age was 76 y (range, 70–87). In the overall population, BEV + cape significantly prolonged PFS compared with cape (median 9.1 vs 5.1 mo; hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.41–0.69; P <.001). Differences in OS did not reach statistical significance in the overall population (HR, 0.79; 95% CI, 0.57–1.09; P =.182). Treatment was well tolerated. Results according to age are shown (Table). Conclusion: The addition of BEV to cape was associated with significant improvements in PFS in the overall elderly mCRC population and within age subgroups. The safety profile of BEV + cape was consistent across age groups.Table 1 Open table in a new tab
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