REVIEW - Malignancies in patients with RA, PsA, and AS receiving anti-TNF-alpha therapy in RCTs: is there a need for more screening?

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Arthritis Rheum. 2009 May 28;61(6):801-812.

Single-center series and systematic review of randomized controlled

trials of malignancies in patients with rheumatoid arthritis,

psoriatic arthritis, and ankylosing spondylitis receiving anti-tumor

necrosis factor alpha therapy: Is there a need for more comprehensive

screening procedures?

Nannini C, Cantini F, Niccoli L, Cassarà E, Salvarani C, Olivieri I, Lally EV.

Hospital Misericordia e Dolce, Prato, Italy.

OBJECTIVE: To systematically review the occurrence of malignancies

among patients with rheumatoid arthritis (RA), psoriatic arthritis

(PsA), and ankylosing spondylitis (AS) treated with anti-tumor

necrosis factor alpha (anti-TNFalpha) therapy in randomized controlled

trials (RCTs), and to report a retrospective personal case series

evaluating the frequency of malignancies in patients with RA, PsA, and

AS requiring anti-TNF therapy selected with more comprehensive cancer

screening procedures compared with patients screened according to

previously published procedures.

METHODS: The primary outcome was the report of frequency of

malignancies in RCTs and the latency between the therapy introduction

and the occurrence of the neoplasm. A total of 363 consecutive RA,

PsA, and AS patients requiring anti-TNF therapy from 2002 to 2006

observed at the Rheumatology Unit in Prato, Italy, underwent extensive

cancer screening procedures. An historical controlled group of 73

patients treated between January 1999 and December 2001 underwent the

screening procedures accepted for the RCT procedures.

RESULTS: Thirty-six RCTs were included for analysis. Malignancies

occurred in 60 (0.75%) of 8,015 patients randomized to the active

treatment arm and in 21 (0.52%) of 3,991 patients in the placebo arms

(P = 0.15). In the personal retrospective case series, 1 study patient

(0.27%) and 3 controls (4.1%) developed cancer over the followup

period (P = 0.017). Mean +/- SD followup duration was 40.9 +/- 16.7

months in study patients and 50.6 +/- 18.1 months in controls.

CONCLUSION: The results of RCTs and our data showing 26% of

malignancies occurring within 12 weeks from enrollment suggest the

need for a revision of current cancer screening procedures in RCTs and

in clinical practice.

PMID: 19479708

http://www.ncbi.nlm.nih.gov/pubmed/19479708

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