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Prevention of relapse is a key objective in the management of Crohn's disease. There is no current treatment available that completely maintains remission and is without significant side‐effects. Thalidomide is sometimes used in clinical practice to attempt to maintain remission in Crohn's disease. This review found no randomised controlled trial that had investigated the role of thalidomide or a similar drug lenalidomide, for the maintenance of remission in Crohn's disease. There is currently no evidence to support or refute the use of these agents as maintenance therapy for Crohn's disease. However, given the well known risk of severe birth defects the use of thalidomide is not recommended. Lenalidomide has a much lower risk of causing birth defects and well designed randomised controlled trials are needed to investigate the effectiveness and side effects of this drug for maintenance of remission in Crohn's disease. The use of lenalidomide is not recommended until data from a well designed study are available to support its use.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

This review aims to assess if thalidomide is an effective treatment for the wasting syndrome (know as cachexia) seen in patients with advanced cancer. However, there was not enough evidence to make an informed decision about the use of thalidomide for patients with advanced cancer who have this wasting syndrome. This means that thalidomide as a treatment for this wasting syndrome remains unproven and its use needs more testing. Additionally, this review highlighted that there may be undesirable side effects of thalidomide when used for this syndrome, which need to be looked at closely to ensure it is suitable for this group of patients.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

Crohn's disease is a chronic inflammatory disorder of the bowel. Thalidomide may help to reduce inflammation in the gut and might be effective for the treatment of Crohn's disease. One randomised controlled trial on the use of thalidomide for the treatment of active Crohn's disease (and ulcerative colitis) in children is in progress and should be completed in 2011. One randomised controlled trial using lenalidomide, a drug similar to thalidomide, was identified. This relatively small but well designed study did not demonstrate benefit for lenalidomide treatment of active Crohn's disease. Patients treated with high dose lenalidomide (25 mg/day) were more likely than patients receiving placebo (fake drug) to experience side effects. Side effects in the study included headache, rash and nausea. Known side effects of thalidomide include severe birth defects. The use of thalidomide or lenalidomide for the treatment of active Crohn's disease is not recommended.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Bibliographic details: Pan JQ, Lu GP, Yu ZJ.  [Thalidomide on anti-tumor research]. Chinese Journal of Cancer Prevention and Treatment 2012; 19(7): 552-555

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Multiple myeloma (MM) is the second most common haematological cancer in the UK. MM is not curable but can be treated with a combination of supportive measures and chemotherapy that aim to extend the duration and quality of survival. The majority of patients are not able to withstand intensive treatment, such as high-dose chemotherapy with autologous stem cell transplantation (SCT), and so they are offered single-agent or combination chemotherapy. Combination therapies typically include chemotherapy with an alkylating agent and a corticosteroid. More recently, combination therapies have incorporated drugs such as thalidomide (Thalidomide Celgene®, Celgene) and bortezomib (Velcade®, Janssen–Cilag).

Health Technology Assessment - NIHR Journals Library.

Version: December 2011

Bibliographic details: Zhu K, Liu Z G, Yang W, Jiang B C.  Effectiveness and safety of thalidomide for treating multiple myeloma in china: a meta-analysis. Chinese Journal of Evidence-Based Medicine 2009; 9(8): 899-903

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Multiple myeloma (MM) is the second most common haematological cancer in the UK, characterised by unregulated plasma cell proliferation. In England and Wales there are approximately 3600 new diagnoses recorded annually, and in 2007 most diagnoses were recorded in people aged 75–79 years. Symptoms and clinical features of MM include fatigue, bone pain and/or fracture, anaemia, the presence of M-protein in serum and/or urine, and hypercalcaemia. The aetiology of MM is unknown and malignant cells display a variety of cytogenetic abnormalities. Myeloma is not curable, but can be treated with a combination of supportive measures and chemotherapy. The aim is to extend the duration and quality of survival by alleviating symptoms and achieving disease control while minimising the adverse effects of the treatment. Survival of patients from diagnosis can vary from months to over a decade. Factors affecting prognosis include burden of disease, type of cytogenetic abnormality present, patient-related factors – such as age and performance status – and treatment response factors.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2011

Bibliographic details: Chen D, Xie X, Gao Y.  Meta-analysis of randomized clinical trials of thalidomide-chemotherapy combination regimen for non-small cell lung cancer patients in China. Chinese Journal of Clinical Oncology 2012; 39(22): 1818-1823 Available from: http://d.wanfangdata.com.cn/periodical_zgzllc201222031.aspx

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

The aim of this systematic review was taken to investigate the efficacy and safety of docetaxel plus thalidomide vs. docetaxel alone for treating androgen-independent prostate cancer (AIPC). Data were collected from different databases independently by three researchers according to the pre-defined inclusion and exclusion criteria. Total three studies were finally included, indicating that docetaxel plus thalidomide exhibited better survival prognosis and greater prostate-specific antigen (PSA) decline than docetaxel alone. There were no significant differences of hematologic toxicities in two regimens, while the frequency of non-hematologic toxicities was higher in patients with docetaxel plus thalidomide. Briefly, the available evidence indicates potential survival advantage in docetaxel plus thalidomide over docetaxel alone.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

The aim of the study was to perform a meta-analysis of the efficacy and safety of (bortezomib plus lenalidomide/thalidomide)- vs. (bortezomib or lenalidomide/thalidomide)-containing regimens as induction therapy in newly diagnosed multiple myeloma. We searched electronic and printed sources for relevant articles published. Inclusion criteria was as follows: randomized controlled trials (RCT) of (bortezomib plus lenalidomide/thalidomide) vs. (bortezomib or lenalidomide/thalidomide)-containing regimens as induction therapy in newly diagnosed multiple myeloma. Two reviewers independently assessed potentially eligible studies and extracted relevant data. We retrieved five RCT studies including a total of 1,200 patients. Using the random-effects model to pool the five RCT with a statistically significant heterogeneity (P = 0.03; X² = 10.69; df = 4; I² = 63%), the weighted risk ratios of a complete response (CR) for (bortezomib plus lenalidomide/thalidomide)-containing regimens was 1.81 (P = 0.005; 95% CI: 1.20-2.73). When we excluded the study by Cavo et al. (Lancet 376:2075-2085, 2010), the pooled risk ratio for CR was 1.59 (P < 0.0001, 95% CI: 1.29-1.96) with no statistically significant heterogeneity (P = 0.54; X² = 2.14; df = 3; I² = 0%) among four RCT under the fixed effects mode. The pooled odds ratio for the main grade III/IV adverse events (the peripheral neuropathy, thrombotic events, and infections) were 1.76 (P = 0.32; 95% CI: 0.58-5.31), 0.92 (P = 0.76, 95% CI: 0.52-1.61), and 1.05 (P = 0.82, 95% CI: 0.70-1.57), respectively. Our analysis showed (bortezomib plus lenalidomide/thalidomide)-containing regimens as induction treatment in newly diagnosed multiple myeloma improved CR but did not increase the risk of major adverse events (the peripheral neuropathy, thrombotic events, and infections).

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

The aim of the study was to evaluate the clinical efficacy and safety of bortezomib-based regimens for the treatment of multiple myeloma through meta-analysis. The literature on three classes of bortezomib-based regimens - bortezomib and thalidomide (VT), bortezomib and lenalidomide (VR) and bortezomib and doxorubicin (VD) - was systematically retrieved and analyzed. The initial search yielded 4896 citations, of which 14 randomized controlled trials (RCTs) (a total of 5379 patients enrolled) met the pre-specified inclusion criteria. The results indicated that the VT regimen had an improved benefit in complete remission (CR) and overall response rate (ORR), but not in progression-free survival (PFS), overall survival (OS) and major grade III/IV adverse events such as peripheral neuropathy, thrombotic events and infection. In contrast, the VD regimen had an improved CR with fewer thrombotic events, while PFS, OS, ORR and the other adverse events showed no significant difference. No significant difference was observed in CR, ORR and major grade III/IV adverse events when comparing the VR regimen with bortezomib and cyclophosphamide (VC), but patients receiving VR regimen therapy had obviously longer PFS and OS.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Leprosy remains a public health issue in poorer parts of the world. In 2007 there were approximately 255,000 new cases reported worldwide. Leprosy (or Hansen's disease) is a chronic infectious disease. The skin and peripheral nerves of people with leprosy contain leprosy bacteria. Leprosy can be cured with a combination of antibiotics. The immune system plays an important role in leprosy and determines if and how the disease will develop. The response of the immune system to the antigens of the leprosy bacteria may cause periods of inflammation in the skin and nerves, called reactions. Reactions are the main cause of acute nerve damage and disability in leprosy and occur in about one third of people with leprosy. One type of reaction is erythema nodosum leprosum (ENL), a serious and often chronic complication of leprosy caused by the immune system. People with ENL have red, painful swellings in the skin and often feel ill due to fever and general malaise. There are several treatments for ENL, including the oral drugs prednisolone, thalidomide, and clofazimine. We undertook a systematic review on this topic as it was not clear which treatments were most beneficial.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

POEMS syndrome is a rare disorder of the blood which can cause a polyneuropathy (nerve symptoms such as numbness, tingling, pain, and muscle weakness) but can also involve many of the organs of the body, causing enlarged organs or organomegaly (usually liver, spleen, and lymph nodes), changes in hormone production or endocrinopathy (gynecomastia in men), abnormal blood protein (M‐protein), and skin changes such as increased pigmentation or skin thickening. Its cause is not known. The quality of life of people with POEMS deteriorates because of progressive neuropathy, and accumulation of fluid in the limbs or in the abdominal cavity or cavity around the lungs. It is a potentially fatal disease, and serious complications can arise due to multiorgan failure. There is no established treatment regimen, but potentially effective treatments that have been tried include chemotherapy, irradiation, corticosteroids, thalidomide or lenalidomide, and blood stem cell transplantation. This review found no randomized controlled trials of treatments for POEMS syndrome. Prospective treatment trials are needed to establish the relative values of different treatments.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Toxic epidermal necrolysis (TEN or Lyell's disease) is a rare life‐threatening skin condition. It is probably an immune response triggered by some drugs or infection, which is more likely to happen in people with suppressed immunity. TEN causes extensive blistering and shedding of skin, similar to burns. Drugs used include oral steroids, thalidomide, immunosuppressants and immunoglobulins. This review of trials did not find any reliable evidence for the treatment of TEN. The only trial available used thalidomide, but this trial did not show any benefit from treatment compared against placebo but highlighted increased chances of dying from the treatment. Thalidomide is not safe or effective for the skin condition toxic epidermal necrolysis, but there is not enough evidence to show which treatments are effective.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Novel agents thalidomide and bortezomib have significantly improved myeloma treatment. However, it remains unclear whether patients will benefit more from the combination therapy of these two agents. Our meta-analysis aims to compare the efficiency, and more importantly, the safety of bortezomib-thalidomide-based (VT-based) versus bortezomib-based or thalidomide-based (V-based/T-based) regimens as induction therapy in patients with previously untreated myeloma. Overall, five phase III RCTs including 1765 patients were identified. Compared with V-based or T-based regimens, VT-based regimens significantly improved CR (OR=2.22, 95% CI [1.44, 3.43]), ORR (OR=2.19, 95% CI [1.51, 3.19]) as well as PFS (HR=0.69, 95% CI [0.54, 0.88]), but not OS (HR=1.04, 95% CI [0.91, 1.19]). Notably, most expected side effects of bortezomib or thalidomide were comparable in both groups, including hematologic (anemia, neutropenia, thrombocytopenia), nonhematologic (peripheral neuropathy, deep venous thrombosis, infections, gastrointestinal events) side effects and discontinuation during or after induction therapy. These results suggest that combination of thalidomide and bortezomib might be a better first-line choice for patients with untreated myeloma.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

This review has been conducted to assess the effects of different interventions, administered systemically or topically, for the prevention or treatment of oral ulcers in people with Behçet's disease. The interventions could be compared with an alternative intervention, no intervention or the administration of a placebo.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

To define whether or not thalidomide exposure upfront to newly diagnosed patients with multiple myeloma would adversely impact postrelapse survival (PRS), we performed a meta-analysis of randomized controlled trials. Medline, Embase, the Cochrane controlled trials register and the Science Citation Index were searched. Thirteen trials were identified, covering a total of 6097 subjects, and PRS data were available from eight trials. The summary hazard ratio (thalidomide vs control) of all those trials for PRS was 1.23 [95% CI, 1.05-1.45]. The HRs of thalidomide maintenance subgroups were 0.90 [0.57-1.41] for PRS, 0.61 [0.44-0.83] for progression-free survival (PFS) and 0.54 [0.36-0.80] for overall survival, respectively. The corresponding ratios of thalidomide induction and maintenance subgroups were 1.41 [1.13-1.76] for PRS, 0.68 [0.59-0.79] for PFS and 0.87 [0.73-1.04] for overall survival, respectively. In conclusion, thalidomide exposed upfront correlated with shorter PRS that partially compensated for prolonged initially PFS and resulted in no survival benefit when it is given as both induction pre-autologous and maintenance post-autologous stem cell transplantation; shorter PRS was not observed, and survival was improved when it is given only during maintenance phase following autologous stem cell transplantation in the patients with myeloma and who are eligible for transplant.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Trials comparing efficacy of melphalan prednisone (MP) with MP plus thalidomide in transplant ineligible, elderly patients with multiple myeloma have provided conflicting evidence. Although there is agreement regarding improved response rates (RRs) and higher toxicity with the addition of thalidomide to MP, the impact on progression free survival (PFS) and overall survival (OS) is less clear. We performed a meta-analysis comparing efficacy of melphalan, prednisone and thalidomide (MPT) and MP by pooling results on RR, PFS and OS reported in all the identified randomized controlled trials (RCTs) under a random effects model. Overall, six prospective RCTs, with data extractable from five published trials (n=1571) [corrected] were identified. The pooled odds ratio of responding to therapy with MPT vs MP was 3.39 (P<0.001, 95% CI: 2.24-5.12). The pooled hazard ratios for PFS and OS were and 0.68 (P<0.001; 95% CI: 0.55-0.82) and 0.80 (P=0.07; 95% CI: 0.63-1.02), respectively, in favor of MPT. The odds ratios for high grade peripheral neuropathy and deep venous thrombosis were 6.6 and 2.4, respectively, in favour of MP. There was significant heterogeneity among the RCTs. Our meta-analysis demonstrates that in previously untreated, transplant ineligible, elderly myeloma patients, the addition of T to MP results in significantly improved RR and PFS with a trend towards improvement in OS compared with MP alone, but at a cost of significantly greater toxicity.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

Thalidomide (T) and lenalidomide (R) have been used as first-line therapy for previously untreated myeloma. However, direct head-to-head comparison between them is lacking. We performed an indirect meta-analysis to assess the treatment effects of lenalidomide- versus thalidomide-based regimens using common comparators. A comprehensive literature search was undertaken. The initial search yielded 1345 citations, of which 11 randomized controlled trials (RCTs) enrolling 4162 patients met the inclusion criteria. Indirect comparison of lenalidomide versus thalidomide maintenance after autologous stem cell transplant (ASCT) showed a progression-free survival (PFS) benefit (hazard ratio [HR] 0.75, 95% confidence interval [CI] [0.67, 0.85], p < 0.001) but no survival difference (HR 0.83, [0.63, 1.09], p = 0.19) when using observation/placebo as the common comparator. Similarly, the indirect comparison of melphalan-prednisone plus lenalidomide followed by lenalidomide maintenance (MPR-R) versus melphalan-prednisone-thalidomide induction followed by thalidomide maintenance (MPT-T) showed a statistically significant PFS advantage for MPR-R (HR 0.53, 95% CI [0.46, 0.60], p < 0.001), but no difference for overall survival (OS) (HR 0.97, [0.81, 1.17], p = 0.74). Additionally, the significant heterogeneity among pooled studies for the outcome of discontinuation rate due to treatment-related adverse events between MPT-T and MPR-R subgroups (p = 0.007) indicated that the discontinuation rate from thalidomide trials seems to be higher than that from lenalidomide trials. In conclusion, lenalidomide seems to be a more potent and less toxic agent than thalidomide in the treatment of patients with multiple myeloma. Further, a direct head-to-head trial comparing lenalidomide versus thalidomide is clearly warranted.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Treatment with melphalan-prednisone-thalidomide improves the outcome of patients with multiple myeloma and is now considered a standard of care for patients not eligible for transplantation. However, this treatment is a major source of morbidity. A meta-analysis of data from individual patients (n=1680) in six randomized trials was performed, comparing the effects of melphalan-prednisone-thalidomide versus melphalan-prednisone. The main objective was to estimate the risk of serious adverse events and their impact on outcome. The primary endpoints were the 2-year cumulative incidence of grade 3-4 hematologic and non-hematologic toxicities. At least 75% of the grade 3-4 toxicities occurred during the first 6 months of treatment in both treatment groups. The cumulative incidence of grade 3-4 hematologic toxicities was higher in the melphalan-prednisone-thalidomide group than in the melphalan-prednisone group (28% versus 22%; HR 1.32, 95% CI 1.05-1.66) as was the cumulative incidence of non-hematologic toxicities (39% versus 17%, HR 2.78, 95% CI 2.21-3.50). Grade 3-4 non-hematologic toxicities were significantly increased in patients with poor Performance Status. Occurrence of grade 3-4 non-hematologic toxicities had a negative impact on both progression-free survival (HR 1.24, 95% CI 1.07-1.45) and overall survival, (HR 1.23, 95% CI 1.03-1.47). Besides toxicities, progression-free and overall survival were also negatively affected by advanced International Staging System stage, high creatinine levels and poor Performance Status. Age had a negative impact on survival as well. Although melphalan-prednisone-thalidomide improved outcome, it increased toxicities, especially non-hematologic ones. Serious non-hematologic toxicities, older age, poor Performance Status, and high creatinine levels negatively affected survival.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

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