BackgroundGiven the increasing incidence in cutaneous malignant melanoma (CMM) and the recent changes in the treatment landscape, it is important to understand stage-specific overall and recurrence-free survival patterns in Europe. Despite publications such as EUROCARE-5, there is limited information on stage-specific survival for CMM in Europe.MethodWe carried out a systematic literature review to provide an up-to-date summary of stage-specific survival and recurrence-free survival patterns in patients with CMM in Europe. Studies were included if they were published in Medline during the past 12 years and included information on stage-specific survival and/or recurrence in CMM.ResultsOf the 8,749 studies identified, 26 studies were included, representing nine countries. Collectively, the studies covered a population of 152,422 patients and included data from 1978 to 2011. Randomized clinical trials and single-center observational studies comprised the most common study designs, including five large registry-based studies. Stage-specific information for survival and recurrence varied: 5-year overall survival: 95%–100% (stage I), 65%–92.8% (stage II), 41%–71% (stage III), and 9%–28% (stage IV); 5-year relapse-free survival was reported less frequently: 56% (stage II), and 28%–44% (stage III). Studies reporting survival by sentinel node (SN) status reported 5-year overall survival as 80%–95% for negative SN (stage I/II) and 35%–75% for positive SN (stage III) status; recurrence-free survival at 5 years: 76%–90% for negative and 35%–58% for positive SN status. Some studies included comparisons of survival by key patient sociodemographic characteristics, suggesting that these have a substantial influence on survival and recurrence estimates.ConclusionThe studies identified in this review show large variations in stage-specific overall and recurrence-free survival by study type and by country. Owing to differing study designs and populations, it is difficult to make detailed comparisons. Large population-based studies that include stage-specific survival and recurrence in Europe are therefore important.

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BackgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).ObjectivesThe incidence of non-melanoma skin cancer (NMSC) in the tofacitinib RA programme was evaluated using data from randomised Phase (P) 1, 2, 3 and open-label long-term extension (LTE) RA studies (P1P2P3LTE studies).MethodsNMSC data (cut-off date: 30 Aug 2013) were pooled from two P1, eight P2, six P3 and two LTE studies; LTE data collection and analyses are ongoing; study databases unlocked. Patients (pts) with RA in P1, P3 and LTE studies received tofacitinib 5 or 10 mg twice daily (BID) either as monotherapy or with background disease-modifying antirheumatic drugs (DMARDs). LTE pts were enrolled from qualifying P1, P2 and P3 studies; pts from P2 studies received tofacitinib 1 to 30 mg BID or 20 mg once daily. Incidence rates (IRs) per 100 pt-years (py) of exposure for first NMSC were calculated for combined doses (all doses) of tofacitinib in the P1P2P3LTE pt population. The overall NMSC IR was analysed as well as IRs for subgroup analyses according to the following conditions: tofacitinib dose (5 mg vs 10 mg BID); tofacitinib monotherapy vs tofacitinib + background DMARDs; prior tumour necrosis factor inhibitors (TNFi); pt age (≥65 vs <65); ethnic background; and time period.Results6092 pts (15103 py of exposure) received tofacitinib (all doses) in the P1P2P3LTE studies. ≥1 events of NMSC occurred in 83 pts receiving tofacitinib (all doses), of which squamous cell carcinomas (SCC) and basal cell carcinomas (BCC) occurred in 39 and 52 pts, respectively. Five pts had a history of NMSC prior to tofacitinib exposure; 78 pts did not. In the P1P2P3LTE population, IRs were 0.55 (95% confidence interval [CI] 0.45, 0.69), 0.26 (0.19, 0.35) and 0.35 (0.26, 0.45) for NMSC overall, SCC and BCC, respectively. NMSC IRs for pts from the P1/2/3 and LTE cohorts receiving tofacitinib 5 mg BID were 0.61 (0.34, 1.10) and 0.41 (0.26, 0.66), respectively; for pts receiving tofacitinib 10 mg BID, NMSC IRs were 0.47 (0.24, 0.90) and 0.79 (0.60, 1.05), respectively. P1P2P3LTE pts on background DMARDs had a numerically higher IR (IR 0.64, 95% CI 0.49, 0.84) than tofacitinib monotherapy pts (IR 0.43, 95% CI 0.30, 0.64). There was a higher rate of NMSC in pts with prior TNFi (IR 1.01, 95% CI 0.67, 1.51) vs TNFi-naïve pts (IR 0.47, 95% CI 0.37, 0.61). Pts ≥65 years had a higher rate of NMSC (IR 1.67, 95% CI 1.19, 2.35) vs pts <65 years (IR 0.38, 95% CI 0.29, 0.51). Pts of White ethnicity had the highest IR of NMSC vs pts of Asian, Black or Other ethnicity (0.86 vs 0.03, 0.00 or 0.14). NMSC IRs, analysed in 6-month intervals (through >84 months), were stable over time.ConclusionsNMSC IRs appeared consistent with published estimates in pts with RA treated with TNFi (IR 0.22-0.66).1 The overall NMSC IR in the tofacitinib clinical development programme remained stable over time.ReferencesAskling J et al. Pharmacoepidemiol Drug Saf 2011;20:119-130.AcknowledgementsPreviously presented (Curtis JR et al. Arthritis Rheum 2014; 66(11): S196 ...

Special attention should be given for maintaining the oral health of patients with special health care needs as compared to their physically and mentally normal counterparts.

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