Real-world data on Len/Dex combination at second-line therapy of multiple myeloma: treatment at biochemical relapse is a significant prognostic factor for progression-free survival

• Published in: Annals of hematology 2018-09, Vol.97 (9), p.1671-1682
• Main Authors: Katodritou, Eirini, Kyrtsonis, Marie-Christine, Delimpasi, Sosana, Kyriakou, Despoina, Symeonidis, Argiris, Spanoudakis, Emmanouil, Vasilopoulos, Georgios, Anagnostopoulos, Achilles, Kioumi, Anna, Zikos, Panagiotis, Aktypi, Anthi, Briasoulis, Evangelos, Megalakaki, Aikaterini, Repousis, Panayiotis, Adamopoulos, Ioannis, Gogos, Dimitrios, Kotsopoulou, Maria, Pappa, Vassiliki, Papadaki, Eleni, Fotiou, Despoina, Nikolaou, Eftychia, Giannopoulou, Evlambia, Hatzimichael, Eleftheria, Giannakoulas, Nikolaos, Douka, Vassiliki, Kokoviadou, Kyriaki, Timotheatou, Despoina, Terpos, Evangelos
• Format: Article
• Language: English
• Subjects: Hematology; Medical prognosis; Medicine; Medicine & Public Health; Multiple myeloma; Multivariate analysis; Oncology; Original; Original Article; Steroids
• ISSN: 0939-5555; 1432-0584
• DOI: 10.1007/s00277-018-3361-2

We evaluated progression-free survival (PFS) rate of patients treated with lenalidomide/dexamethasone (Len/Dex), the efficacy of the combination, and the prognostic significance of treatment at biochemical vs. clinical relapse on PFS in 207 consecutive myeloma patients treated with Len/Dex in second line, according to routine clinical practice in Greece. First-line treatment included bortezomib-based (63.3%) or immunomodulatory drug-based (34.8%) therapies; 25% of patients underwent autologous stem cell transplantation. Overall response rate was 73.4% (17.8% complete response and 23.7% very good partial response); median time to best response was 6.7 months. Overall, median PFS and 12-month PFS rate was 19.2 months and 67.6%, respectively. 67.5% of patients had biochemical relapse and 32.5% had clinical relapse prior to initiation of Len/Dex. Median PFS was 24 months for patients treated at biochemical relapse vs. 13.2 months for those treated at clinical relapse (HR:0.63, p  = 0.006) and the difference remained significant after adjustment for other prognostic factors. Type of relapse was the strongest prognostic factor for PFS in multivariate analysis. These real-world data confirm the efficacy of Len/Dex combination at first relapse; more importantly, it is demonstrated for the first time outside a clinical trial setting that starting therapy with Len/Dex at biochemical, rather than at clinical relapse, is a significant prognostic factor for PFS, inducing a 37% reduction of the probability of disease progression or death.