The objective of our study was to evaluate high-dose cytarabine in consolidation therapy in patients with newly diagnosed acute promyelocytic leukemia (APL). Patients (age 16-60 years) received ...induction therapy according to the AIDA protocol (all-trans retinoic acid, idarubicin) followed by one cycle of ICE (idarubicin, cytarabine, etoposide) and two cycles of HAM (cytarabine 3 g/m(2) q12h, days 1-3; mitoxantrone 10 mg/m(2), days 2 and 3). From 1995 to 2003, 82 patients were enrolled. In total, 72 patients (88%) achieved a complete remission, and 10 patients (12%) died from early/hypoplastic death (ED/HD). A total of 71 patients received at least one cycle of HAM. Relapse-free survival (RFS) and overall survival (OS) after 46 months were 83 and 82%, respectively. White blood cell count above 10.0 x 10(9)/l at diagnosis and additional chromosomal aberrations were unfavorable prognostic markers for OS, whereas no prognostic markers for RFS were identified including FLT3 mutations. In conclusion, high-dose cytarabine in consolidation therapy for patients with newly diagnosed APL is an effective treatment approach.
Multiples Myelom Goldschmidt, H.; Salwender, H.-J.; Knauf, W.
Best practice onkologie,
02/2009, Letnik:
4, Številka:
1
Journal Article
Recenzirano
Das multiple Myelom ist eine maligne lymphoproliferative B-Zell-Erkrankung. Hierbei kommt es im Knochenmark zu einer Akkumulation und Proliferation maligner Plasmazellen. In den letzten Jahren ...konnten die Behandlungsmöglichkeiten durch die Optimierung der Hochdosistherapie und durch die Einführung neuer Substanzen weiter verbessert werden. Die konventionell dosierte Kombination von Melphalan und Prednison (MP-Schema) oder Dexamethason mit neuen Substanzen (Thalidomid, Bortezomib oder Lenalidomid) erhöht die Remissionsrate entscheidend, verlängert die Überlebenszeit und ist der derzeit empfohlene neue Standard der Primärtherapie für Patienten mit Kontraindikationen für eine Hochdosistherapie.
Outcome of patients with primary refractory acute myeloid leukemia remains unsatisfactory. We conducted a prospective phase II clinical trial with gemtuzumab ozogamicin (3 mg/m(2) intravenously on ...day 1), all-trans retinoic acid (45 mg/m(2) orally on days 4-6 and 15 mg/m(2) orally on days 7-28), high-dose cytarabine (3 g/m(2)/12 h intravenously on days 1-3) and mitoxantrone (12 mg/m(2) intravenously on days 2-3) in 93 patients aged 18-60 years refractory to one cycle of induction therapy. Primary end point of the study was response to therapy; secondary end points included evaluation of toxicities, in particular, rate of sinusoidal obstruction syndrome after allogeneic hematopoietic cell transplantation. Complete remission or complete remission with incomplete blood count recovery was achieved in 47 (51%) and partial remission in 10 (11%) patients resulting in an overall response rate of 61.5%; 33 (35.5%) patients had refractory disease and 3 patients (3%) died. Allogeneic hematopoietic cell transplantation was performed in 71 (76%) patients; 6 of the 71 (8.5%) patients developed moderate or severe sinusoidal obstruction syndrome after transplantation. Four-year overall survival rate was 32% (95% confidence interval 24%-43%). Patients responding to salvage therapy and undergoing allogeneic hematopoietic cell transplantation (n=51) had a 4-year survival rate of 49% (95% confidence intervaI 37%-64%). Patients with fms-like tyrosine kinase internal tandem duplication positive acute myeloid leukemia had a poor outcome despite transplantation. In conclusion, the described regimen is an effective and tolerable salvage therapy for patients who are primary refractory to one cycle of conventional intensive induction therapy. (clinicaltrials.gov identifier: 00143975).
The results of 319 cases of belt-restrained front seat car occupants (234 drivers and 85 passengers) from 241 vehicles in car-to-car head-on collisions were examined. Ninety-five occupants were ...uninjured, 195 sustained a total injury severity of Maximum Abbreviated Injury Score (MAIS) 1–3 and 29, MAIS 4–6. There were 27 fatalities, and the main causes of death were polytrauma and hemorrhage. The main factors influencing occupant injury severity were: the energy equivalent speed (EES); the change of velocity (delta
v); the maximum deformation depth; and the collision angle. With an
EES > 50 km/h fatal injuries can be expected, and above 60 km/h no occupant remained uninjured. The results of a multivariate analysis were: EES influenced the injury severity at all body locations except the spinal cord; occupant position effected only head injury severity, with drivers being more severely injured; occupant age influenced the injury severity at the thorax, abdomen, and extremities and MAIS as well. Age was a further factor influencing injury severity, e.g. with an EES of 50 km/h the probability of being fatally injured was 30%–45% higher for occupants over 59 years than those under 20.
This study describes preferences of German relapsed refractory multiple myeloma (RRMM) patients with novel proteasome inhibitor-based combination treatments.
Patients with a minimum age of 18 years ...and a diagnosis of RRMM were included. Their preferences were assessed using a discrete choice experiment design, which was developed based on a literature review and two patient focus group discussions. The final discrete choice experiment design consisted of four attributes, namely "therapy application regimen," "time without progression of disease," "possibility of grade ≥3 adverse events (AEs) affecting the blood," and "possibility of grade ≥3 AE heart failure."
Analysis was based on 84 patients (36.9% females, mean age 62.7 years, mean multiple myeloma disease duration 5.5 years). Among the tested attributes, "therapy application regimen" was assigned the highest importance for treatment decisions (38.8%), the second important attribute was "time without progression of disease" (38.7%), followed by "possibility of AE heart failure" (13.9%) and "possibility of AEs affecting the blood" (8.6%). Patients preferred oral intake once a day and once a week over other application modes such as oral intake once a day and once a week plus twice-weekly infusions. Furthermore, they preferred longer disease progression-free time and lower risk of grade ≥3 AEs. The highest overall utility was derived for ixazomib + lenalidomide + dexamethasone (utility: 3.218), compared with lenalidomide + dexamethasone (2.769), and carfilzomib + lenalidomide + dexamethasone (1.928).
RRMM patients prefer treatments with an all-oral application, a longer disease-progression-free time, and a lower probability of AEs. If patients face tradeoffs, they accept a lower progression-free time and/or higher AE rates to get an all-oral therapy.