Autotransplant with and without induction chemotherapy in older multiple myeloma patients: long-term outcome of a randomized trial

Autor: Christian Straka, Peter Liebisch, Hans Salwender, Burkhard Hennemann, Bernd Metzner, Stefan Knop, Sigrid Adler-Reichel, Christian Gerecke, Hannes Wandt, Martin Bentz, Tim Hendrik Bruemmendorf, Marcus Hentrich, Michael Pfreundschuh, Hans-Heinrich Wolf, Orhan Sezer, Ralf Bargou, Wolfram Jung, Lorenz Trümper, Bernd Hertenstein, Else Heidemann, Helga Bernhard, Nicola Lang, Norbert Frickhofen, Holger Hebart, Ralf Schmidmaier, Andreas Sandermann, Tobias Dechow, Albrecht Reichle, Brigitte Schnabel, Kerstin Schäfer-Eckart, Christian Langer, Martin Gramatzki, Axel Hinke, Bertold Emmerich, Hermann Einsele
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Haematologica, Vol 101, Iss 11 (2016)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2016.151860
Popis: Autologous transplantation is controversial for older patients with multiple myeloma. The role of age-adjusted high-dose melphalan and the impact of induction chemotherapy cycles is still unclear. A total of 434 patients aged 60–70 years were randomly assigned to 4 cycles of standard anthracycline-based induction chemotherapy or no induction. For all patients, double autologous transplantation after melphalan 140 mg/m2 (MEL140) was planned. The primary end point was progression-free survival. Of 420 eligible patients, 85% received a first transplant and 69% completed double transplantation. Treatment duration was short with a median of 7.7 months with induction chemotherapy cycles and 4.6 months without induction. On an intention-to-treat basis, median progression-free survival with induction chemotherapy cycles (207 patients) was 21.4 months versus 20.0 months with no induction cycles (213 patients) (hazard ratio 1.04, 95% confidence interval 0.84–1.28; P=0.36). Per protocol, progression-free survival was 23.7 months versus 23.0 months (P=0.28). Patients aged 65 years or over (55%) did not have an inferior outcome. Patients with low-risk cytogenetics [absence of del17p13, t(4;14) and 1q21 gains] showed a favorable overall survival and included the patients with sustained first remission. MEL140 was associated with a low rate of severe mucositis (10%) and treatment-related deaths (1%). Based on hazard ratio, the short treatment arm consisting of mobilization chemotherapy and tandem MEL140 achieved 96% of the progression-free survival, demonstrating its value as an independent component of therapy in older patients with multiple myeloma who are considered fit for autologous transplantation. (clinicaltrials.gov identifier: 02288741)
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