Sl to apl how long
Outcomes by risk subsets. A Event-free survival by risk group. B Disease-free survival by risk group. C Overall survival by risk group. Outcomes by age. A Event-free survival by age group. B Disease-free survival by age group. C Overall survival by age group.
Survival for specified subsets. A Gemtuzumab vs idarubicin among high-risk APL patients. B Overall survival by cytogenetics. Most severe adverse events occurred at induction and were related to the disease and its complications. The most common treatment-related grade 3 and 4 adverse events included infections in 44 patients Only 2 APL-related deaths occurred beyond the first year after study entry, with unrelated malignancies being the major cause of death after the first year.
Here, we have demonstrated similar results while eliminating chemotherapy completely. In an attempt to improve outcomes in high-risk patients, we added GO to the ATRA plus ATO combination and reported significant improvement in the CR and survival rates compared with historical reports.
These results confirm previously reported data suggesting the synergistic activity of the combination of ATRA and ATO in eradicating the leukemic clone in APL, thereby negating the need for chemotherapy. The major limitation of our data is its single-group nonrandomized nature, including that patients were only treated at our institution. However, the similarity of outcomes to those in other recently reported randomized studies confirms the utility of this regimen.
Compared with our study, the UK investigators used a higher doses of ATO administered less frequently, providing a more convenient schedule and thereby potentially improving compliance without jeopardizing efficacy. Furthermore, in the study conducted by Lo-Coco et al, low- to intermediate-risk APL patients who developed leukocytosis were successfully treated with hydroxyurea with no effect on survival when compared with our study.
This is in concordance with other reports suggesting that early mortality resulting from a delay in diagnosis remains a major obstacle to achieving a close to universal success rate in patients with APL.
Taken together, these findings strongly suggest the feasibility of treatment deescalation, with the complete omission of chemotherapy. In conclusion, our long-term data confirm that the chemotherapy-free strategy of ATRA plus ATO, with or without GO, is effective and safe, providing long-term and durable leukemia-free survival for both standard-risk and high-risk patients, with rare relapses after the first year.
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Anyway I am at shoulder currently how long do yall think it will be unroll inreach Apl? July 3rd, , AM 2. Re: So at Sl how ling untill Apl yall reckon Measure it for yourself, that is the best way to go. Measure the distance and then calculate. July 3rd, , AM 3. Re: So at Sl how ling untill Apl yall reckon I would say months depending on how fast your hair grows. July 3rd, , AM 4. Re: So at Sl how ling untill Apl yall reckon It depends on so many things.
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Preserve the integrity of pharmaceutical products during transportation with a Good Distribution Practice GDP solution. At APL, we are continuously reinventing to take care of those we serve. Details of APL93 trial, approved by ethics committees in all participating countries, have been previously published.
Induction treatment was stratified by age and initial white blood cell WBC count. Patients in the elderly group received only the first consolidation course. Hematologic CR was defined by normal bone marrow cellularity without abnormal promyelocytes, neutrophil count higher than 1. In this trial started in , when reverse-transcription—polymerase chain reaction was not widely available, molecular CR was not considered. Early death was defined by death occurring during ATRA, before CR had been reached, or during or after chemotherapy, especially during the phase of aplasia, without evidence of leukemic resistance.
Maintenance treatment was scheduled for 2 years. In agreement with recommendations made for similar maintenance CT in acute lymphoblastic leukemia ALL for many years, blood counts were to be monitored very regularly, and investigators were asked to administer full dose of 6MP and MTX if WBC count and platelets were higher than 3. After a few fatal cases of sepsis were recorded, those recommendations were regularly repeated.
Maintenance CT was also to be temporarily stopped if liver enzymes were more than 5 times normal values, or bilirubin was more than 2N. If liver dysfunction persisted, treatment was to be restarted at lower dose. No systematic molecular follow-up using reverse-transcription—polymerase chain reaction analysis of PML-RAR alpha transcript was planned.
The present analysis was performed 10 years after the last patient inclusion at the reference date of October 15, , with a median follow-up of months. Analysis was made on an intention-to-treat basis in the patients with confirmed diagnosis of APL.
For induction treatment, event-free survival calculated from the date of initial randomization was the primary end point, whereas for maintenance treatment the primary end point was time to relapse, measured from randomization to maintenance. Secondary end points were as follows: for induction treatment, time to relapse and survival measured from trial inclusion ; for maintenance treatment, survival.
Censored criteria, except the incidence of relapse, were analyzed with the Kaplan-Meier estimate, the log-rank test, and a Cox model. For each end point, treatment comparison was adjusted, using the appropriate regression model, on a predetermined subset of prognostic parameters including age, sex, WBC count, platelet count, absolute number of circulating blasts, APL subtype classical vs microgranular variant APL , and fibrinogen level.
Continuous covariates were entered into native form after checking for log linear relationships. We tested for interaction in the maintenance factorial design. In the absence of interaction, we decided to analyze separately each maintenance treatment, with the main analysis adjusted or unadjusted for baseline covariates being stratified on the other treatment. All tests were 2 sided. All statistical analyses were carried out on SAS 9. Between April and October , newly diagnosed APL patients from 97 Europeans centers listed in the supplemental Appendix, available on the Blood website; see the Supplemental Materials link at the top of the online article were included in APL93 trial Table 1.
A total of patients The CR rate was With a median follow-up of months, Based on patient stratification at inclusion, the year cumulative incidence of relapse CIR was Survival and incidence. B Overall survival according to initial stratification. D Cumulative incidence of relapse according to initial stratification.
Five of the first relapses representing 3. Baseline WBC count in those patients was 8. Two of them, in whom relapse involved the central nervous system, achieved long-term salvage. Median time to late relapse was 72 months range, months. Nine relapses occurred after more than 6 years; 2, after more than 8 years; and the last, at months.
In the groups randomized at diagnosis, the year CIR was The year event-free survival EFS was Incidence and randomization. Cumulative incidence of A relapse, B overall survival, and C event-free survival, according to randomization for induction treatment.
Of the patients randomized for maintenance treatment, 79 were allocated to no maintenance; 76, to intermittent ATRA; , to continuous CT; and , to the combination of both Table 2. Inclusion in groups without maintenance CT was stopped after the second interim analysis, causing the imbalance.
The year CIR was Maintenance with CT significantly improved survival year survival: Analysis of the instantaneous hazard of relapse over time showed that maintenance treatment, particularly with 6MP and MTX CT, reduced the incidence of relapse during the first 3 to 4 years of follow-up, without increasing the risk of later relapses Figure 3 D.
Incidence and maintenance.
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