[Show abstract][Hide abstract]ABSTRACT: A prospective, single-arm, open-label, multicenter, nonrandomised phase II trial to evaluate efficacy and safety of short fludarabine, mitoxantrone, and rituximab (FMR) induction followed by radioimmunotherapy, in untreated, intermediate/high-risk follicular non-Hodgkin's lymphoma (NHL) patients.
Fifty-five patients were treated using a sequential treatment schedule of four induction cycles of FMR chemoimmunotherapy, and a subsequent consolidating single administration of (90)Y-ibritumomab tiuxetan ((90)Y-IT), 8-14 weeks later. Patients were eligible for radioimmunotherapy if at least in partial response (PR) after induction, with normal platelet and granulocyte counts and a bone marrow infiltration ≤ 25%. Primary study end points were response rate and hematologic toxic effects; secondary end points were overall survival (OS) and progression-free survival (PFS).
All the 55 patients received four induction cycles with an overall response rate of 96% (38 complete responses [CR] and 15 PR). Fifty-one patients (38 in CR and 13 in PR) received (90)Y-IT. By the end of the treatment, 49/55 patients achieved a CR. With a median follow-up of 21 months, the estimated 3-year PFS was 81% and the 3-year OS 100%.
This study has established feasibility, tolerability, and efficacy of a regimen composed by short FMR induction with (90)Y-IT consolidation in untreated intermediate/high-risk follicular NHL patients.
Full-text · Article · May 2011 · Annals of Oncology
[Show abstract][Hide abstract]ABSTRACT: Sensorineural hearing loss is one of the most common congenital abnormalities in infants and it affects approximately one to two neonates in every 1000 births. Early identification of hearing loss in the newborn is the first step for a successful rehabilitation programme. The introduction of Otoacoustic Emission responses as a useful tool in hearing screening programmes, allowed the identification of hearing loss in the well-baby nursery and in targeted populations of the neonatal intensive care unit. Recently, a new concept of breastfeeding during hospitalization after birth has been developed. Indeed, the so-called "rooming-in" allows a mother to stay with her child in the same room, located in the nursery. This new trend has been developed to avoid any psychological adverse consequences of birth on the child-mother relationship. To enhance how "rooming-in" could affect the Universal Neonatal Hearing Screening (UNHS) programmes, an analysis has been made of the data coming from two maternity wards using different breastfeeding protocols. Data obtained demonstrate a worse performance on obtaining essential benchmark in the UNHS in the maternity ward where rooming-in is adopted (60% of newborns tested). UNHS programme efficacy could be affected by the wider adoption of the "rooming-in" regimen in the maternity wards and early detection of hearing loss revealed by UNHS could be vanished by dispersion of patients. In fact, more data are necessary to evaluate the impact of rooming, even though our data show a worsening in the UNHS results.
Full-text · Article · Nov 2008 · Acta otorhinolaryngologica Italica: organo ufficiale della Società italiana di otorinolaringologia e chirurgia cervico-facciale
[Show abstract][Hide abstract]ABSTRACT: The Child Hearing Early Assessment Programme (CHEAP) regional project, was a combined departmental approach (Audiology, Neonatology) of the University Hospital of Ferrara, aimed at identifying neonatal hearing impairment and defining early intervention strategies. Aims of this project have been: (i) construction of a neonatal screening programme using evoked otoacoustic emission and auditory brainstem responses; (ii) the calculation of a precise estimate of cost-benefits for every child tested; (iii) the development of an information flow instrument (database) for the storage of data and the statistical analysis of the results. The present report refers only to the results of the project related to the otoacoustic emission data from well-babies and intensive care unit residents. In the period January 2000-December 2004, 4269 full-term newborns and 654 Neonatal Intensive Care Unit babies were tested at the Neonatology Department. The cost of the Universal Neonatal Hearing Screening was estimated at Euro 9.20 per child, considering the use of the ILO-292 apparatus, and Euro 8.28 per child in the case of an automatic screener. In this screening model, the initial hardware costs can be re-iterated into budget in a period of two years, if 1000 children per year are tested.
Full-text · Article · Mar 2007 · Acta otorhinolaryngologica Italica: organo ufficiale della Società italiana di otorinolaringologia e chirurgia cervico-facciale
[Show abstract][Hide abstract]ABSTRACT: Within the context of a hospital-based newborn hearing screening program, we have studied the application of two OAE protocols (TEOAE and DPOAE) on a group of 250 well babies. The main goal of this study was to evaluate the performance of DPOAE protocol in a relatively large population sample. using a preset number of five tested frequencies, in comparison with a default TEOAE screening protocol. The data were collected on the second day of life and during spontaneous sleep. The TEOAE recordings were acquired with linear protocols using click stimuli of 70-75 dB SPL and were used as indicators of normal cochlear function. The cubic distortion product DPOAE responses were evoked by an asymmetrical 75-65 dB SPL protocol, with a frequency ratio of 1.22. Five frequencies (referring to F2) were tested at 1.5, 2.0, 3.0, 4.0 and 5.0 kHz. The data from the DPOAE responses show a similar pass rate (similarity = 0.98) to the linear TEOAE protocol. The data presented suggest that a DPOAE cochlear evaluation, at 5 pre-selected frequencies, has clinical potential.
No preview · Article · Feb 2001 · Acta Oto-Laryngologica
[Show abstract][Hide abstract]ABSTRACT: We conducted a comparison of three DPOAE protocols, testing cubic 2F1 - F2 distortion products, in order to define the most feasible protocol for a universal hearing screening programme. The protocols used asymmetrical stimulus intensities (L1 > L2) with a frequency ratio of 1.22, in the following format: (P1), L1 = 60, L2 = 50 dB SPL; (P2), L1 = 65, L2 = 55 dB SPL; and (P3), L1 = 75, L2 = 65 dB SPL. Linear TEOAE responses evoked by click stimuli of 75 dB p.e. SPL were used as controls of the normal cochlear function. Five 2F1 - F2 frequencies, 1.5, 2.0, 3.0, 4.0, 5.0 kHz, were tested with a ILO-92 macro subroutine. The project included randomly selected recordings from 1,200 well-baby nursery (WBN) infants (age 48 hours) and 50 very low birth weight NICU infants. Statistical analyses comparing the signal-to-noise ratios (S/N), at the predefined F2 frequencies, indicated that the P1 and P2 DPOAE protocols perform similarly. Significant S/N differences were observed in the P3 to P2 and P3 to P1 data-set comparisons. DPOAE scoring criteria were estimated from the P3 data set, using one-sided distribution-free tolerance boundaries. The scoring criteria for a 'pass' were estimated as a minimum S/N of 6.0, 7.0 and 6.0 dB at 2.0, 3.0 and 4.0 kHz respectively. In terms of feasibility, the P3 protocol generated responses in 98% of the WBN and 76% of the NICU infants. All three DPOAE protocols demonstrated smaller time-recording requirements than the TEOAE standard. The false-positive ratio for the NICU infants was estimated as 8%.
No preview · Article · Jan 2001 · Journal of Audiological Medicine