Kategorie: Mnohočetný myelom
Téma: Multiple myeloma - Translational and clinical studies
Číslo abstraktu: P807
Autoři: Prof. MD Heinz Ludwig; Elisabeth Rauch; prof. MUDr. Zdeněk Adam, CSc.; MD Hedwig Kasparu; MD Richard Greil, Ph.D.; MD Clemens Leitgeb; Dr. Adalbert Weissmann (Weißmann); MD Eva-Maria Autzinger; Univ.-Prof. Dr.med.univ. Werner Linkesch; Dr. Thomas Kuehr (Kühr); Doc.MUDr. Luděk Pour, Ph.D.; Dr. Niklas Zojer
Treatment with bendamustine-bortezomib-dexamethasone (BBD) exerts significant activity in patients with relapsed/refractory multiple myeloma even in those pretreated with bortezomib or lenalidomide or both, but may be associated with clinically relevant side effects.
Here we analyze the side effect profile with specific emphasis on infections, cytopenias and neuropathy in patients enrolled in a trial with BBD for relapsed/refractory multiple myeloma.
Seventy-nine patients with relapsed/refractory MM have been enrolled. Median age: 64 years (range 40-86), male/female: 37/42, ISS stage I/II/III: 27, 31, and 21, respectively. ECOG status 0-I/≥II: 75, and 4 patients, respectively. Previous treatment lines: 1-2: 50, 3-4: 23, >4: 6 patients, respectively. Treatment regimen: bendamustine 70 mg/m2 day 1+4, bortezomib 1.3 mg/m2 days 1, 4, 8 and 11, dexamethasone 20 mg on days 1, 4, 8 and 11, repeated every 4 weeks. Planned number of treatment cycles was 8, with discontinuation after 4 cycles in case of no response. Toxicity grading was performed using the CTC v 3.0 scale. The FACT-GOG/NTX instrument was used for patients self-assessment of neuropathic side effects.
G3/4 infections were noted in 16 (20%) patients and 2 patients died due to infection/sepsis (G5). Low baseline ANC (<2.800/ml), a higher number of cycles (>4 cycles), and age >65 years showed a weak, but statistically non-significant correlation with G3/4 infections.
G3/4 thrombopenia was recorded in 28 (35%) patients; 18 of them presented with more than one episode (median: 3, range 2-8). Severe thrombopenia resulted in treatment discontinuation in 2, and in delay of therapy in 7 patients, respectively. Lower baseline platelet levels (<182.000/µL) were associated with higher risk for G3/4 thrombopenia (p<0.021).
Peripheral neuropathy assessed by the clinical care team was reported in 44 (56%) patients. G3/4 neuropathy was observed in 5 patients only. The occurrence of neuropathy increased, albeit not statistically significant, with increasing number of treatment cycles. Self-assessment of neuropathy by patients revealed a much higher PNP incidence with G1/2 PNP reported by 37 (47%) and G3/4 PNP reported by 38 (48%) patients. Pretreatment with bortezomib or thalidomide, or both bortezomib and thalidomide was not associated with higher incidence of G3/4 PNP.
Summary / Conclusion:
Low baseline ANC and were associated with a higher risk for G3/4 neutropenia (p<0.012) and low baseline platelets counts were associated with G3/4 thrombopenia (p<0.021). Lower baseline ANC levels correlated with shorter PFS (p<0.01). Higher age, longer therapy and low baseline ANC tended to correlate with G3/4 infections. Furthermore, incidence of G3/4 neuropathy was low, but increased slightly with increased treatment duration. In stark contrast to evaluations by care givers, a much higher incidence of PNP was revealed when patients graded the incidence and severity of PNP by using a self-assessement instrument. Physicians should be aware of the substantial underrating of PNP by health professionals.
Datum přednesení příspěvku: 15. 6. 2013