Rossi A et al. Proc ASCO 2011;Abstract 8008.

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Presentation transcript:

Rossi A et al. Proc ASCO 2011;Abstract 8008. Incidence of Second Primary Malignancies (SPM) After 6 Years of Follow-Up of Continuous Lenalidomide in First-Line Treatment of Multiple Myeloma Rossi A et al. Proc ASCO 2011;Abstract 8008.

BiRD: A Phase II Study of Clarithromycin, Lenalidomide and Dexamethasone in Newly Diagnosed MM (N = 72) Day 1 8 15 21 22 28 Dex 40 mg Lenalidomide 25 mg daily Clarithromycin 500 mg twice daily SPM endpoints included incidence, incidence rate (IR) and time from treatment initiation to SPM diagnosis SPM incidence was compared to the background incidence of all invasive cancers reported to the United States SEER database (2003-2007) Rossi A et al. Proc ASCO 2011;Abstract 8008.

Initial BiRD Efficacy Results* Endpoint BiRD (N = 72) ORR 90% CR/nCR 53% VGPR 21% PR 17% Mean time to first response 54 days 2-yr EFS 97.2% * Niesvizky R et al. Blood 2008;111(3):1101-9. Rossi A et al. Proc ASCO 2011;Abstract 8008.

Updated Survival Analyses: 6-Year Follow-Up PFS for Patients Receiving BiRD OS for Patients Receiving BiRD Proportion of Patients Median PFS: 70.8 mos 5-yr PFS: 54.5% 4-yr OS: 82.2% Median 5-yr OS: Not reached Median PFS: 70.8 months (range, 47.6-NR) 5-year PFS rate: 54.5% (95% CI: 40.5%-66.4%) 4-year OS rate: 82.2% (95% CI: 70.7%-89.5%) Median 5-year OS has not been reached Time (Weeks) Time (Weeks) With permission from Rossi A et al. Proc ASCO 2011;Abstract 8008.

SPMs in Patients Receiving BiRD (N = 68) Median time to SPM Dx ASCT On study Hematologic tumors — Solid tumors Metastatic melanoma Colon Pancreas Prostate 5 1 31.2 mo 8 mo 25 mo 31 mo 39 mo 53 mo No Yes On Off Non-invasive skin cancer Basal cell carcinoma SCC 6 4 2 34 mo 42 mo 29.5 mo On/off Rossi A et al. Proc ASCO 2011;Abstract 8008.

SPM Incidence Rates of Patients Treated with BiRD Are Not Above Expectations Variable BiRD (n = 68) Person-years of follow-up 175.7 SPM cases 5 IR per 100 person-years (95% CI) 2.85 (1.04-6.31) US SEER (2003-2007) IR of all invasive primary cancers reported among patients >65 years old: 2.1 per 100 person years Rossi A et al. Proc ASCO 2011;Abstract 8008.

Conclusions With 6 years of follow-up, BiRD remains a highly effective regimen in newly diagnosed MM No cases of second primary MDS/AML observed Frequency of SPMs was low and similar to the incidence of invasive cancers reported to US SEER (2003-2007) for individuals of similar age A number of patients were diagnosed with invasive cancers prior to diagnosis of MM Routine screening and prevention measures should continue as medically indicated, including examination for skin cancers As survival in patients with MM continues to improve, so will our understanding of their risk for developing SPM Rossi A et al. Proc ASCO 2011;Abstract 8008.

Investigator Commentary: BiRD and the Incidence of Second Primary Cancer After 6 Years of Follow-Up of Continuous Lenalidomide in First-Line Treatment of MM In the BiRD study, Drs Rossi and Niesvizky evaluated the risk of developing second primary cancer in patients who received the combination of clarithromycin/lenalidomide/dexamethasone. The most important finding was that the risk of secondary primary cancer was extremely low, with 5 solid tumors and 6 cases of noninvasive skin cancer. This is probably within the realm of probability for the development of invasive cancer in this patient population, even if they had not received lenalidomide therapy. Sergio Giralt, MD