© F e r r a t a S t o r t i F o u n d a t i o ncomparable, with different timing of the interim PET during the course of treatment and differing PET methodologies. Most studies used stand-alone PET, which has now been replaced by PET-CT. Reporting methods were not consistent making it difficult to judge how these results should be applied in clinical practice.In 2009 an international meeting attended by hematologists and nuclear medicine specialists was held in Deauville, France, with the intention of defining simple and reproducible criteria for interim-PET reporting in lymphoma.11 A five-point scale (5-PS) developed at Guy's and St. Thomas' Hospital in London was adopted 12 as the "Deauville criteria". An international study was launched to compare previous reports on the accuracy of interim PET in predicting treatment outcome in Hodgkin lymphoma with an international cohort of patients scanned using PET-CT after two cycles of ABVD and to evaluate the reproducibility of the 5-PS among reporters. The criteria for enrollment, the breakdown of patients according to stage (early unfavorable and advanced-stage) and the endpoints were the same as in the JID. Methods Retrieval of patients' dataConsecutive patients affected by Hodgkin lymphoma from participating centers worldwide diagnosed between January 2002 and December 2009 were retrospectively enrolled with the following inclusion criteria: (i) stage IIB to stage IVB or stage IIA Hodgkin lymphoma with adverse prognostic factors (at least three nodal sites involved, sub-diaphragmatic presentation, bulky disease, and erythrocyte sedimentation rate > 40 mm/h); (ii) treatment with four to eight cycles of ABVD with or without involved-field radiotherapy or consolidation radiotherapy; (iii) staging with PET/CT at baseline and after two courses of ABVD (PET-0 and PET-2, respectively); (iv) no change to treatment based on interim-PET results; and (v) a minimum follow-up of 1 year after completion of firstline treatment. Patients escalated to salvage treatment during ABVD chemotherapy were eligible only if the treatment change was based on clinical and/or radiological evidence of disease progression/resistance.The study was approved by the ethical committee of the coordinating center in Cuneo (Italy) and conducted according to the Helsinki declaration. Specific informed written consent was not required as all data were retrospectively collected in an anonymized format, in agreement with specific institutional and national requirements. AG, SC and ER analyzed the data and all co-authors had access to the primary data.Clinical data on 400 patients were collected; however only 335 paired scans (baseline and interim) were available for review. Of these, 75 were then excluded because there were no CT data (n=21), no baseline PET (n=25), no interim PET (n=1), missing CT slices (n=3), missing PET slices (n=10), poor quality PET images (n=6) or miscellaneous reasons (n=9). Complete data from 260 patients were available for analysis from 17 international academic institut...
Purpose To investigate the progression-free survival (PFS) of patients with advanced Hodgkin lymphoma (HL) after a risk-adapted treatment strategy that was based on a positive positron emission tomography scan performed after two doxorubicin, vinblastine, vincristine, and dacarbazine (ABVD) cycles (PET2). Patients and Methods Patients with advanced-stage (IIB to IVB) HL were consecutively enrolled. After two ABVD cycles, PET2 was performed and centrally reviewed according to the Deauville five-point scale. Patients with a positive PET2 were randomly assigned to four cycles of escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) followed by four cycles of standard BEACOPP with or without rituximab. Patients with a negative PET2 continued ABVD, and those with a large nodal mass at diagnosis (≥ 5 cm) in complete remission with a negative PET at the end of chemotherapy were randomly assigned to radiotherapy or no further treatment. The primary end point was 3-year PFS. Results Of 782 enrolled patients, 150 (19%) had a positive and 630 (81%) a negative PET2. The 3-year PFS of all patients was 82%. The 3-year PFS of those with a positive and negative PET2 was 60% and 87%, respectively ( P < .001). The 3-year PFS of patients with a positive PET2 assigned to BEACOPP with or without rituximab was 63% versus 57% ( P = .53). In 296 patients with both interim and post-ABVD-negative PET who had a large nodal mass at diagnosis, radiotherapy was randomly added after chemotherapy without a significant PFS improvement (97% v 93%, respectively; P = .29). The 3-year overall survival of all 782 patients was 97% (99% and 89% for PET2 negative and positive, respectively). Conclusion The PET-driven switch from ABVD to escalated BEACOPP is feasible and effective in high-risk patients with advanced-stage HL.
PURPOSE We compared 2 years of rituximab maintenance (RM) with a response-adapted postinduction approach in patients with follicular lymphoma who responded to induction immunochemotherapy. METHODS We randomly assigned treatment-naïve, advanced-stage, high-tumor burden follicular lymphoma patients to receive standard RM or a response-adapted postinduction approach on the basis of metabolic response and molecular assessment of minimal residual disease (MRD). The experimental arm used three types of postinduction therapies: for complete metabolic response (CMR) and MRD-negative patients, observation; for CMR and MRD-positive (end of induction or follow-up) patients, four doses of rituximab (one per week, maximum three courses) until MRD-negative; and for non-CMR patients, one dose of ibritumomab tiuxetan followed by standard RM. The study was designed as noninferiority trial with progression-free survival (PFS) as the primary end point. RESULTS Overall, 807 patients were randomly assigned. After a median follow-up of 53 months (range 1-92 months), patients in the standard arm had a significantly better PFS than those in the experimental arm (3-year PFS 86% v 72%; P < .001). The better PFS of the standard vs experimental arm was confirmed in all the study subgroups except non-CMR patients (n = 65; P = .274). The 3-year overall survival was 98% (95% CI, 96 to 99) and 97% (95% CI, 95 to 99) in the reference and experimental arms, respectively ( P = .238). CONCLUSION A metabolic and molecular response-adapted therapy as assessed in the FOLL12 study was associated with significantly inferior PFS compared with 2-year RM. The better efficacy of standard RM was confirmed in the subgroup analysis and particularly for patients achieving both CMR and MRD-negative.
We assessed the effects of music therapy (MT) on behavioral and psychological symptoms (BPSD) in dementia associated with changes in physiological parameters, as heart rate (HR) and heart rate variability (HRV). Twenty subjects were randomly assigned to MT treatment or standard care; all patients underwent neuropsychological assessment and ECG Holter recordings before and after the 15-week treatment. The treatment included 30 MT sessions. Depression significantly decreased (p=0.021) in the MT group. PNN50 improved in 50% patients of the MT group, but in none of the control group (p=0.013). MT may improve symptoms of depression and increase HRV in demented patients.
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