Abstract
The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by heavily pretreated MM, treated with pomalidomide-dexamethasone, in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim, in terms of haematological toxicity, febrile neutropenic episodes, antibiotic usage and hospedalization duration.
57 patients (31 M and 26 F) were enrolled, median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-12), every refractory to all the drugs previously received, received Pomalidomide-Dexamethasone (P 4 mg for 21 days, D 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression.
Since first course, received in domestic setting, with a very good compliance, patients performed blood counts once weekly and received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was <1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.6 (r. 3-6); nadir neutropenia was registered after a median of 10.4 days (r. 7-14); median of nadir neutrophil count was 1.13 x 10^9 cells/L (r.0.3 - 1.5), with maximum duration of 14 days. From the second course, all patients switched to prophylaxis with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. During pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patients for at least three courses of therapy (r. 3-6) registered at day +11, was 1.28 (r.0.9-2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain (21.2%).
In patients affected by heavily pretreated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment.
Disclosures
Cerchione:Takeda: Honoraria, Speakers Bureau; GlaxoSmithKline: Honoraria, Speakers Bureau; Sanofi: Honoraria, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau; Astellas: Honoraria, Speakers Bureau; Beigene: Honoraria, Speakers Bureau; Jazz Pharmaceutical: Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Servier: Honoraria, Speakers Bureau; Sierra Oncology: Honoraria, Speakers Bureau; Karyopharm: Honoraria, Speakers Bureau; Bristol Myers Squibb: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Glycomimetics: Consultancy; Menarini-Stemline: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau. Martinelli:Stemline: Consultancy; Roche: Consultancy; Jazz Pharmaceuticals: Consultancy; Pfizer: Consultancy, Speakers Bureau; Abbvie: Consultancy; Daiichi Sankyo: Consultancy; Incyte: Consultancy; Astellas: Consultancy, Speakers Bureau; Celgene/BMS: Consultancy, Speakers Bureau.
Author notes
Asterisk with author names denotes non-ASH members.
