Original Versus Generic Lenalidomide in Patients with Relapsed/ Refractory Multiple Myeloma: Comparison of Efficacy and Adverse Events

Objective: Lenalidomide is an effective immunomodulatory derivative drug used in the treatment of multiple myeloma (MM). It is available in original and generic forms in Turkey, but there is no clinical study that has compared the effectiveness and adverse events (AEs) of the generic and original forms of lenalidomide. We compared the effectivity and AEs of generic and original lenalidomide in patients with relapsed/refractory MM (RRMM). Materials and Methods: Patients with RRMM using original or generic lenalidomide were evaluated retrospectively. Overall response (OR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease, and progressive disease rates and hematologic and nonhematologic AEs were evaluated in these RRMM patients. The results were described as numbers, frequencies, and percentages and were analyzed using PASW 19.0 for Windows with chi-square and Fisher exact tests. Results: The number of patients using original lenalidomide was 55 and the number of patients using generic lenalidomide was 43. The OR rate was 67.2% for patients using original lenalidomide and 60.4% for those on generic lenalidomide. CR and VGPR rates were 14.5% and 45.4% in the original group while the CR and VGPR rates were 20.9% and 18.6%, respectively, in patients using generic lenalidomide. Hematologic AEs were similar in the two groups while some nonhematologic AEs were less common in the original lenalidomide group than the generic group. Only pyrexia as a grade 3-4 AE was more common in the original lenalidomide than the generic lenalidomide group. Conclusion: This study showed that the generic form of lenalidomide has similar efficacy with the original form of lenalidomide in the treatment of RRMM. The AEs of original lenalidomide were generally fewer than those of generic lenalidomide. Further studies involving a larger number of patients with RRMM would be useful for comparing the efficacy and AEs of original and generic lenalidomide.

Relaps/Refrakter Multipl Myelomlu Hastalarda Orijinal ve Jenerik Lenalidomid Etkinliği ve Yan Etkilerin Karşılaştırılması

Amaç: Lenalidomid, multipl myelom (MM) tedavisinde kullanılan, etkili bir immünmodülatuvar ilaçtır. Türkiye’de orijinal ve jenerik formları mevcuttur ve bu formların etkinliğini ve yan etkilerini karşılaştıran klinik çalışma yoktur. Bu çalışmada relaps/refrakter MM (RRMM) hastalarda jenerik ve orijinal lenalidomidin etkinliği ve yan etkileri karşılaştırılmıştır. Gereç ve Yöntemler: Orijinal veya jenerik lenalidomid kullanan RRMM hastaları, geriye dönük olarak değerlendirildi. RRMM hastalarında genel yanıt (OR), tam yanıt (CR), çok iyi kısmi yanıt (VGPR), kısmi yanıt (PR), stabil hastalık ve progresif hastalık oranları ve ayrıca hematolojik/hematolojik olmayan yan etkiler değerlendirildi. Sonuçlar, SPSS 19.0 programı yardımıyla, ki-kare ve Fisher testleri kullanılarak analiz edildi. Bulgular: Orijinal lenalidomid kullanan hasta sayısı 55, jenerik lenalidomid kullanan hasta sayısı 43 idi. OR oranı, orijinal lenalidomid kullananlarda %67,2, jenerik lenalidomid kullananlarda %60,4 idi. Orijinal grupta CR ve VGPR oranları %14,5 ve %45,4 iken, jenerik lenalidomid kullanan hastalarda CR ve VGPR oranları sırasıyla %20,9 ve %18,6 idi. Hematolojik yan etkiler her iki grupta da benzer iken, bazı hematolojik olmayan yan etkiler orijinal lenalidomid grubunda jenerik gruba göre daha düşüktü. Orijinal lenalidomid grubunda derece 3-4 yan etki olarak sadece ateş sıklığı, jenerik lenalidomid grubuna göre daha yüksekti. Sonuç: Bu çalışma, lenalidomidin jenerik formunun RRMM tedavisinde orijinal lenalidomid formu ile benzer etkinliğe sahip olduğunu göstermiştir. Orijinal lenalidomidin yan etkileri genel olarak jenerik lenalidomidden daha düşüktü. RRMM’li çok sayıda hastayı içeren daha ileri çalışmalar, bu iki formun etkinliğini ve yan etkilerini karşılaştırmak açısından yararlı olacaktır.

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Kaynak Göster

Turkish Journal of Hematology
  • ISSN: 1300-7777
  • Yayın Aralığı: Yılda 4 Sayı
  • Başlangıç: 1999

330

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