Abstract |
In a retrospective pooled analysis of 11 clinical trials of lenalidomide-based therapy for relapsed/refractory multiple myeloma (MM; N = 3846), the overall incidence rate (IR, events per 100 patient-years) of second primary malignancies (SPMs) was 3.62. IR of invasive (hematologic and solid tumor) SPMs was 2.08, consistent with the background incidence of developing cancer. In a separate analysis of pooled data from pivotal phase 3 trials of relapsed or refractory MM (N = 703), the overall IR of SPMs was 3.98 (95% confidence interval [CI], 2.51-6.31) with lenalidomide/ dexamethasone and 1.38 (95% CI, 0.44-4.27) with placebo/ dexamethasone; IRs of nonmelanoma skin cancers were 2.40 (95% CI, 1.33-4.33) and 0.91 (95% CI, 0.23-3.66), respectively; IRs of invasive SPMs were 1.71 (95% CI, 0.86-3.43) and 0.91 (95% CI, 0.23-3.66), respectively. The risk of SPMs must be taken into account before initiating lenalidomide treatment. In the context of the observed survival benefit in relapsed or refractory MM patients, the benefit/risk profile of lenalidomide/ dexamethasone remains positive.
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Authors | Meletios A Dimopoulos, Paul G Richardson, Nancy Brandenburg, Zhinuan Yu, Donna M Weber, Ruben Niesvizky, Gareth J Morgan |
Journal | Blood
(Blood)
Vol. 119
Issue 12
Pg. 2764-7
(Mar 22 2012)
ISSN: 1528-0020 [Electronic] United States |
PMID | 22323483
(Publication Type: Journal Article, Review)
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Chemical References |
- Antineoplastic Agents
- Thalidomide
- Lenalidomide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects)
- Female
- Humans
- Incidence
- Kaplan-Meier Estimate
- Lenalidomide
- Male
- Middle Aged
- Multiple Myeloma
(drug therapy, mortality)
- Neoplasms, Second Primary
(epidemiology)
- Risk Assessment
- Thalidomide
(adverse effects, analogs & derivatives)
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