Abstract
Neoplasm development in Multiple Sclerosis (MS) patients treated with disease-modifying therapies (DMTs) has been widely discussed. The aim of this work is to determine neoplasm frequency, relationship with the prescription pattern of DMTs, and influence of the patients’ baseline characteristics. Data from 250 MS outpatients were collected during the period 1981–2019 from the medical records of the Neurology Service of the HUPM (Hospital Universitario Puerta del Mar)—in Southern Spain—and analysed using Cox models. Neoplasm prevalence was 24%, mainly located on the skin, with cancer prevalence as expected for MS (6.8%). Latency period from MS onset to neoplasm diagnosis was 10.4 ± 6.9 years (median 9.30 [0.9–30.5]). During the observation period β-IFN (70.4% of patients), glatiramer acetate (30.4%), natalizumab (16.8%), fingolimod (24.8%), dimethyl fumarate (24.0%), alemtuzumab (6.0%), and teriflunomide (4.8%) were administered as monotherapy. Change of pattern in step therapy was significantly different in cancer patients vs unaffected individuals (p = 0.011) (29.4% did not receive DMTs [p = 0.000]). Extended Cox model: Smoking (HR = 3.938, CI 95% 1.392–11.140, p = 0.010), being female (HR = 2.006, 1.070–3.760, p = 0.030), and age at MS diagnosis (AGE-DG) (HR = 1.036, 1.012–1.061, p = 0.004) were risk factors for neoplasm development. Secondary progressive MS (SPMS) phenotype (HR = 0.179, 0.042–0.764, p = 0.020) and treatment-time with IFN (HR = 0.923, 0.873–0.977, p = 0.006) or DMF (HR = 0.725, 0.507–1.036, p = 0.077) were protective factors. Tobacco and IFN lost their negative/positive influence as survival time increased. Cox PH model: Tobacco/AGE-DG interaction was a risk factor for cancer (HR = 1.099, 1.001–1.208, p = 0.049), followed by FLM treatment-time (HR = 1.219, 0.979–1.517). In conclusion, smoking, female sex, and AGE-DG were risk factors, and SPMS and IFN treatment-time were protective factors for neoplasm development; smoking/AGE-DG interaction was the main cancer risk factor.
Highlights
Survival after the onset of Multiple Sclerosis (MS) has historically increased for 17 years, as reflected in the first works 41 years ago, patient life expectancy is, on average, 7 years below the general population d ata[1]
We found a disparity in the data for both neoplasm frequency in MS patients and the role of Disease-modifying therapies (DMTs) in the neoplasm development, from an increase in cancer-related deaths (1.9-fold)[6] to normal or decreased cancer prevalence, the hazard risk depends on the type of tumour[7,8]
We found in our sample that TIFN and TDMF protected against neoplasm development, INF and glatiramer acetate (GA) have been linked to cancer development[9,25,26,27]
Summary
Survival after the onset of Multiple Sclerosis (MS) has historically increased for 17 years, as reflected in the first works 41 years ago, patient life expectancy is, on average, 7 years below the general population d ata[1]. Disease-modifying therapies (DMTs) have been the most important advance in MS treatment, from the so-called first-generation drugs, β-interferon (IFN) and glatiramer acetate (GA), approved in the mid-1990s, until the introduction of the latest drugs in the 2010s, such as fingolimod (FLM), alemtuzumab (ALB), dimethyl fumarate (DMF), teriflunomide (TRF), or the most recently approved purine analogue, c ladribine[4]. Despite their benefits, undesirable effects are expected, especially in relation to infection and m alignancy[5]. Patients’ baseline characteristics were considered for their possible contribution to the development of neoplasms
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