BACKGROUND Autologous stem cell transplantation (ASCT) is an effective treatment for patients with relapsing myeloma or lymphoma, diseases associated with unsuccessful peripheral blood stem cell (PBSC) collection. Plerixafor is a potent mobilizing agent, allowing more CD34+ cells to be obtained; however, the main obstacle for its use is its high cost. Our aim was to demonstrate that of the use of reduced doses of plerixafor (RD‐plerixafor) can be sufficient to collect at least 2 × 106/Kg CD34+ PBSC in patients with multiple myeloma (MM) or lymphoma undergoing ASCT. STUDY DESIGN AND METHODS Twenty patients were mobilized with filgrastim (10 μg/kg/4 days) plus a single dose of plerixafor 0.12 mg/kg in Day 4. Apheresis collection was performed on Day 5. One vial of plerixafor was used for two patients. http://clinicaltrials.gov NCT03244930. RESULTS Cell mobilization and collection was successful in 85% of patients (≥2 × 106 CD34+ cells per kilogram). The median collected CD34+ cell count was 4.62 × 106/kg (range, 1.27‐24.5). A 4.1‐fold‐increase in the median CD34+ PBSC pre‐count was observed (from 10.4/μl to 42.4/μl) after RD‐plerixafor administration. Seven patients had mild to moderate adverse events. CONCLUSION RD‐plerixafor is an effective, safe, and affordable strategy to ensure adequate PBSC mobilization in patients with MM or lymphoma who undergo ASCT.
Introduction. Hematopoietic stem cell donors (HSCD) frequently suffer from anxiety and feelings that are usually unnoticed by the physician o their relatives. The origin is multifactorial: fear of pain, fear of the procedure, adverse effects of growth factor, feelings of responsibility regarding the success of the transplant, family pressure, etc. HSCD could show ambivalence of feelings about the donation, which may be related to the moral obligation to help a sick relative and fear of the donation procedure, thus originating anxiety and moral distress (MD). We evaluated the incidence of MD, anxiety, and other symptoms in a group of HSCD regarding donor related allogeneic transplantation. Materials and methods. A prospective observational study was carried out through a survey applied to 60 consecutive HSCD from April, 2014 to January, 2017. Protocol was approved by Institutional Ethics Review Committee and was carried out according to the Declaration of Helsinki. HSCD completed 3 written self-answered questionnaires (Questionnaire to assess moral distress (MDQ) elaborated by the researcher, State Trait Anxiety Index (STAI®) and Edmonton Symptom Assessment System (ESAS)) in three stages: right before initiating stem cell mobilization, immediately before the apheresis procedure, and 24 hours after the donation. Cell mobilization was done with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day/4 days while the apheresis collection was performed on the fifth day as an outpatient basis in all cases. Results. Sixty donors, 36 male and 24 female with a mean age of 38.2 years (SD = 13.6) were included. HSCD was a brother/sister of the patient in 39 cases (65%), and one parent in 21 cases. Regarding donor educational level, only 24 (40%) donors had university level. MDQ: Most donors felt happy to be the donor (97%), but 28% said they were not given the opportunity to accept or refuse being the donor, 10% would have preferred that another person had been the donor, and 5% mentioned that donation worsened their family relationship and they would not donate cells again if necessary. The number of donors with negative feelings regarding the donation decreased through the 3MD questionnaires (Table 1). STAI: In the first, second, and third questionnaire, the mean score for the state of anxiety was 12.1 (SD = 7.6), 10.3 (SD = 6.6), and 7.9 (SD = 5.7), respectively. In first STAI, mild to moderate anxiety was observed in 33% of the donors and severe anxiety was observed in 7%, observing a higher score in the first questionnaire, just before starting cell mobilization; however, that score gradually decreased in the following questionnaires. ESAS: In the first questionnaire, although no procedure was still performed, all donors had symptoms, including insomnia (33%), anxiety (33%), and tiredness (30%). In the second ESAS questionnaire, symptoms worsened, mainly pain (78%), tiredness (63%), and insomnia (55%), which was probably related to G-CSF. In the third ESAS questionnaire, there was a significant decrease in the symptoms: pain (60%), tiredness (50%), and discomfort (40%). The average global score for 10 symptoms evaluated was 10.5 (SD = 14.2), 20.1 (SD = 16.0), and 12.3 (SD = 14.4) for the first, second, and third ESAS questionnaires, respectively. According to the score given to each symptom, the most frequent disabling symptoms in each questionnaire were hyporexia (10%), pain (23%), and discomfort (15%) in ESAS questionnaire 1, 2, and 3, respectively. Higher scores for MD correlated with higher scores in STAI questionnaires as well as with lower levels of education (r=0.456, p< .005). Conclusions MD in the donor can manifest both clinically and socially through insomnia, fatigue, loss of appetite, anxiety, and ambivalence of feelings (happy to be the donor but feel morally obligated to donate) which may affect family relationships. Although there is no instrument to measure the MD before performing any procedure in the present study, the donors had different symptoms, such as negative feelings, anxiety, tiredness, difficulty to sleep, and even pain; all of them without an apparent physical reason. It is desirable that donors receive bioethical counseling and psychological guidance before the donation process in order to provide them with the necessary information regarding the experience they are about to endure. Disclosures Gomez-Almaguer: Amgen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.
Introduction Acute myeloid leukemia (AML) with hyperleukocytosis is associated to high early mortality rates and needs aggressive treatment. Induction chemotherapy (ICH), leukapheresis and hydroxyurea (HU) are the most frequent used leukoreductive strategies. Delay in ICH is very common, leukapheresis is not widely available and hydroxyurea and leukapheresis do not modify early mortality rates. Therefore alternative strategies to leukoreduce patients with AML and hyperleukocytosis are needed. Vinblastine is widely available, cheap, with preclinical activity and promising results in relapsed AML. We explored the leukoreductive power of a single dose of vinblastine in patients with newly diagnosed AML and hyperleukocytosis. Patients and methods We conducted a prospective pilot study that included consecutive patients with newly diagnosed non-M3 AML, aged 16 to 60 years, and with a WBC ≥50,000/µL at time of presentation and in whom immediate ICH with 7+3 was not possible because of hospital limitations (i.e. delay in ICH drug availability). We excluded patients with PML/RAR-alfa rearrangement and/or t(15;17), poor performance status (ECOG >2), any preceding chemotherapy, organic dysfunction (defined as a modified Marshall score ≥2) or pregnancy. After diagnostic confirmation, a single dose of vinblastine at 6 mg/m2 i.v. was administered. We documented leukocytes (WBC) and number of blasts on the day of vinblastine administration (0h) and 48 hours later. We represented the achieved leukoreduction with boxplots and compared the absolute reduction in WBC (delta WBC) and blasts (delta blasts) after vinblastine administration. We compared the leukoreductive power of vinblastine to other leukoreductive strategies (HU, leukapheresis). We calculated toxicities (grade 4 neutropenia and thrombocytopenia), median length of hospitalization and parental antibiotics, and overall survival (OS). We documented cases of disseminated intravascular coagulation, leukostasis and tumor lysis syndrome. This study complies with the Declaration of Helsinki, and our local ethics committee. Results A total of 11 patients were enrolled in the study, seven were men (63.6%), with a median age of 48 (21-78) years. Median follow-up was 21 days (2-833 days). The most frequent morphologic subtype was M4 (3, 27.3%), M5 (2, 18.2%) and M2 (2, 18.2%). Cytogenetics were obtained in three cases (27.3%) and all of them were classified as intermediate risk. Forty eight hours after vinblastine administration the WBC lowered from 122x109/L (50.1-380) to 47.3x109/L (22.1-170) representing a 54% (26.7-84.2) decrese (p=0.0001) (figure 1) while blasts number lowered from 204 x 109/L (47.8-361) to 6.4 x 109/L (0-1.6) representing a 85.7% (75-100) decrease (p=0.005) (figure 1). In Table 1 we compare our results with other strategies. All patients experienced grade 4 neutropenia and thrombocytopenia. There were no cases of disseminated intravascular coagulation, leukostasis or tumor lysis syndrome. Severe infections (grade III-IV) occurred in 8 patients (two patients presented neutropenic colitis, five with severe pneumonia, and one SARS-COV2). Four patients presented septic shock and died during induction therapy. Median length of hospitalization and parental antibiotics were 19 days (2-30) and 7 days (range, 2-24), respectively. A CR was achieved in 4 patients (36.4%) after one induction cycle. One patient presented refractory disease and five died before response evaluation. One patient relapsed at 16 months of follow-up. Median OS was 11 months (0-31.8). Allogeneic stem cell transplantation was performed in 1 patient. Conclusion We documented a marked reduction in both WBC and blasts after 48 hours of vinblastine administration. Our study suggests that the leukoreductive power of a single dose of vinblastine is similar to HU and leukapheresis in patients with AML with hyperleukocytosis. Vinblastine is a widely available, cheap and myelotoxic drug that could extend the arsenal to treat newly diagnosed AML with hyperleukocytosis. Disclosures Gomez-Almaguer: AstraZeneca:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Roche:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Pfizer:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Celgene/BMS:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Amgen:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Novartis:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;AbbVie:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Janssen:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.
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