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Review of Cancer Incidence in Raltegravir (RAL) Clinical Trials
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Reported by Jules Levin CROI 2009 Feb 8-12 Montreal, Canada
David A. Cooper1, Roy Steigbigel2, Jeffrey Lennox3, Beatriz Grinsztejn4, Martin Markowitz5, Peter Sklar6, Randi Leavitt6, Bach-Yen Nguyen6, Xia Xu6, Hedy Teppler6
1University of New South Wales, Sydney, Australia; 2SUNY at Stony Brook, NY; 3Emory University, Atlanta, GA; 4Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation,
Rio de Janerio, Brazil; 5Aaron Diamond AIDS Research Center, New York, NY; 6Merck Research Laboratories, West Point, PA
CONCLUSIONS
In 5 randomized clinical trials,
-- with follow-up of at least 48 to 120 weeks (over 1700 PYR RAL exposure),
cancer rates were lower for RAL but not significantly different from comparator during double-blind treatment
-- with approximately 600 PYR additional RAL exposure during open-label phases, cancer rates remained similar to those during double-blind phase
In expanded access setting,
-- with median follow-up of 24 weeks for over 5400 patients (over 2200 PYR RAL exposure), cancer rates were similar to those observed in clinical trials
Data to date showed no difference in risk of cancer in HIV-infected patients receiving RAL vs. other ARTs, regardless of case defi nitions used
ABSTRACT
Background: Cancer is a known complication of HIV infection. Across 4 controlled clinical trials, the relative risk, RR, (95% CI) for occurrence of cancer for RAL vs Comparators (COMP) was previously reported as 1.2 (0.4, 4.1). This report summarizes the most recent and complete cancer rates for 5 randomized, double blind, clinical trials of RAL in treatment naive and experienced patients (pt) (Protocols P004, 005, 018, 019, 021) and the open label expanded access program (EAP-P023).
Methods: Data were available through at least 48 weeks (wk) in phase III trials (P 018, 019, 021) and at least 96 wk in phase II trials (P004, 005)*; 1039 patients (pt) were assigned to RAL and 605 pt to COMP; all pts received a background ART regimen. Double blind (DB) and open label (OL) data were included. Cancer defi nition was broad and included recurrences, non-melanoma skin cancers and carcinoma in situ; supportive (Supp) analysis excluded these 3 categories. Time-to-fi rst-event approach was used to estimate event rate per 100 patient-years (PYR). RR was determined for DB data only. For EAP, 5438 pt received OL RAL; reporting of serious adverse experiences including cancers was required. Cancer rate for EAP was analyzed separately from trials using a consistent time-to-fi rst-event approach.
Results: Overall efficacy and safety have been presented previously for the clinical trials. Cancer rates and RR are in Table 1 for the 5 DB clinical trials. Cancer rates including OL phase for clinical trials and EAP are in Table 2.
Conclusion: With follow-up to at least 48 wk in clinical trials, cancer rates were slightly lower for RAL but not signifi cantly different from COMP. With median follow-up of 24 wk for over 5400 pt in expanded access setting, cancer rates were similar to clinical trials. Data to date showed no difference in risk of cancer in HIV-infected pts receiving RAL vs. other ARTs.
*Data cutoff dates: P004 04Sep07; P005 10Dec07; P018 03Aug07; P019 31Jul07.
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