ABSTRACTand prednisone (CHOP), CHOP-like, or third-generation anthracycline-containing regimens, with or without rituximab; 521 patients (51%) received the above therapies with rituximab as part of the regimen. Statistical analysisSurvival was assessed by Kaplan-Meier estimates 14 and compared by risk groups using the log-rank test and Cox proportional hazard analysis. 15 The proportional hazard assumption was verified graphically by means of scaled Schoenfeld residuals. 16 The effect size was reported as a hazard ratio (HR) with the associated 95% confidence interval (95% CI).We 20 Thereafter we chose cut-off values with the best power in discriminating patients with either good or poor outcome, after adjusting for the IPI. The performance of the different cut-offs was checked by means of the hazard ratios and respective z-score (from Wald's test) and by comparing the discriminating power, expressed as Harrell's C index.21 The Harrell's C standard error and 95% confidence interval were estimated by means of a jackknife procedure. 22 We arbitrarily chose the cut-off on the basis of the compromise between the discriminative power of the factor and the size of the group at greatest risk. Whereas we analyzed different cut-off points for AMC and LMR, given the broad agreement regarding the definition of lymphopenia as an ALC<1000/mm 3 , we used this cut-off for ALC. 23,24The effect of rituximab on the prognostic power of AMC, ALC and LMR was evaluated by interacting prognostic factors with rituximab, after adjustment by IPI score. Results Patients' characteristicsWe analyzed data from 1191 patients with DLBCL diagnosed between 1993 and 2010. Patients with missing data on monocyte or lymphocyte counts or one of the IPI parameters before treatment were excluded, and the final cohort consisted of 1017 patients.The median age at diagnosis was 60 years (range, 25-81 years) and 47% of the patients were more than 60 years old; 53% were male and 54% of the patients had advanced, stage III-IV disease (Table 1); the clinical characteristics at diagnosis were comparable in the Israeli and Italian cohorts.A total of 496 patients (49%) were treated with chemotherapy alone, while 521 (51%) received immunochemotherapy including rituximab. The median follow-up of the entire cohort was 48 months (range, 0.2-180 months), and 64 months for patients still alive. Overall, 317 events were recorded with a death rate of 7.4x100 person-years (95% CI: 6.6-8.3x100 person-years) and a 5-year overall survival of 68% (95% CI: 65-71%). The overall survival at 5 years in patients treated with or without rituximab was 68% in both groups (HR 0.98, P=0.864). It is noteworthy that in our series there was an association between the use of rituximab and the IPI score; in the group of patients with IPI 0-2, only 43% of patients had been treated with rituximab compared to 70% of the patients with IPI 3-5. In a multivariate analysis, adjusted for IPI score, the risk of death in patients treated with rituximab was reduced by 30% (P=0.002). Absolute monocyt...
Our results indicate that NHL patients experience a higher risk for SMNs than the general population and that various treatments have different impact on RR. More information will be necessary to evaluate possible interactions with genetic susceptibility and environmental exposure.
SummaryNovel treatments for multiple myeloma (MM) have shown promising results in clinical trials, but the advantage in unselected patients is still unclear. In order to evaluate whether novel therapies impact survival of MM patients, we performed a population-based analysis on data collected Despite the limits of this study, these data refer to an unselected population, giving a picture of every day clinical practice.
Key Points• PCR negativity is a strong outcome predictor after rituximab-intensive immunochemotherapy at multiple posttreatment times.• PCR is predictive even when maintenance is delivered, and accumulation of PCR-negative results further reduces the likelihood of relapse.We assessed the prognostic value of minimal residual disease (MRD) within the ML17638 phase 3 trial from the Fondazione Italiana Linfomi, investigating the role of rituximab maintenance in elderly follicular lymphoma (FL) patients after a brief first-line chemoimmunotherapy. MRD for the bcl-2/IgH translocation was determined on bone marrow cells in a centralized laboratory belonging to the Euro-MRD consortium, using qualitative and quantitative polymerase chain reactions (PCRs). Of 234 enrolled patients, 227 (97%) were screened at diagnosis. A molecular marker (MM) was found in 51%. Patients with an MM were monitored at 8 subsequent times. Of the 675 expected follow-up samples, 83% were analyzed. Conversion to PCR negativity predicted better progression-free survival (PFS) at all post-treatment times (eg, end of therapy: 3-year PFS, 72% vs 39%; P < .007). MRD was predictive in both maintenance (83% vs 60%; P < .007) and observation (71% vs 50%; P < .001) groups. PCR positivity at the end of induction was an independent adverse predictor (hazard ratio, 3.1; 95% confidence interval, 1.36-7.07). MRD is a powerful independent outcome predictor in FL patients who receive rituximab-intensive programs, suggesting a need to investigate its value for decision-making. This trial was registered at www.clinicaltrial.gov as #NCT01144364. (Blood. 2013;122(23):3759-3766) IntroductionTreatment of follicular lymphoma (FL) has advanced in recent years. Because of rituximab-supplemented chemotherapy, most patients currently achieve complete remission (CR), and overall survival (OS) rates have improved since the 1990s. However, most patients still relapse, and a proportion die of the disease. [1][2][3] The risk for recurrence is more pronounced among patients older than 60 years, as they often receive less-intense treatments. 4 Considerable evidence indicates that the persistence of polymerase chain reaction (PCR)-detectable residual tumor cells in the bone marrow (BM) and, to a lesser extent, peripheral blood is an independent predictor of relapse in FL 5-24 ; nevertheless, a few studies have failed to confirm this observation. [25][26][27][28] Concerns about the value of minimal residual disease (MRD) detection as an effective prognostic tool have been raised, particularly when applied to The results of this study were the subject of an oral presentation at the 2012 American Society of Hematology annual meeting.The online version of this article contains a data supplement.The publication costs of this article were defrayed in part by page charge payment. Therefore, and solely to indicate this fact, this article is hereby marked "advertisement" in accordance with 18 USC section 1734. For personal use only. on May 10, 2018. by guest www.bloodjournal.org From r...
A new model on the basis of significant variables in the rituximab era and built on a large database of patients treated with rituximab is urgently needed. As prognostic models are changing with the efficacy and mechanisms of action of treatment utilized, looking for a new prognostic score is a never-ending story in which researchers are trying to hit a continuously moving target.
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