M. Di Nicola

High-dose ara-C with autologous peripheral blood progenitor cell support induces a marked progenitor cell mobilization: an indication for patients at risk for low mobilization

A high-dose (HD) chemotherapy scheme was designed for the collection of large numbers of peripheral blood progenitor cells (PBPC) in lymphoma patients who were candidates for myeloablative therapy with autograft. The scheme included the sequential administration of HD cyclophosphamide (CY) (7 g/m2) and HD ara-C (2 g/m2 twice a day for 6 consecutive days), followed by final consolidation with PBPC autograft. PBPC harvests were scheduled following both HD CY and HD ara-C. To minimize hematologic toxicity, small aliquots of PBPC (⩽3 × 106 CD34+ cells/kg) collected following HD CY were reinfused following HD ara-C. The treatment was delivered to 112 patients (median age: 43 years) with lymphoid malignancies (107 non-Hodgkins lymphoma, four Hodgkins lymphoma, one amyloidosis); 75 patients were at disease onset, whereas 37 had relapsed or were refractory after first-line conventional therapy. PBPC mobilization was assessed in terms of peak values of circulating CD34+ cells/μl, as well as total CD34+ cells/kg collected. In a few patients CFU-GM/kg were also evaluated. At the time of maximal mobilization following HD CY, 93 ‘high-mobilizer’ patients had >20 circulating CD34+ cells/μl, whereas the remaining 19 ‘low-mobilizer’ patients did not reach this cut-off value. In spite of poor mobilization after HD CY, 16 out of 19 low mobilizers provided good harvests following HD ara-C; overall, median collected CD34+ cells × 106/kg were 1.4 (0–3.1) and 10.2 (0–37) after HD CY and HD ara-C, respectively (P = 0.00007). Similar patterns were observed when PBPC were evaluated by CFU-GM/kg. Complete and durable hemopoietic reconstitution followed autograft with post HD ara-C PBPC. Within the high-mobilizer group, 88 patients received HD ara-C and 79 (90%) still showed high mobilization; overall, median collected CD34+cells × 106/kg were 17.8 (range 3–94) and 19 (range 0–107) after HD CY and HD ara-C respectively (P = NS). Thus, the scheme allowed sufficient PBPC collections for autografting in low mobilizer patients; in addition, the scheme could be considered whenever extensive chemotherapy debulking is needed prior to PBPC collection.

Efficacy of a nurse-led email reminder program for cardiovascular prevention risk reduction in hypertensive patients: A randomized controlled trial §

BACKGROUND Many strategies have been evaluated to improve the prevention and control of cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs have been found to improve blood pressure control and adherence to lifestyle recommendation. This study tested the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults. METHODS All participants received usual CVD prevention and a guideline-based educational program. Subjects in the NRP-e group also received weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contained a reminder program on the need for adherence with a healthy lifestyle based upon current guidelines. Follow-up visits were scheduled at 1, 3 and 6 months after enrollment; randomization was made centrally and blood samples were evaluated into a single laboratory. RESULTS The final sample consisted of 98 (control) and 100 (NRP-e) subjects (mean age 59.0 ± 14.5 years; 51.0% males). After 6 months, the following CVD risk factors significantly improved in both groups: body mass index, alcohol and fruit consumption, cigarette smoking, adherence to therapy hours, systolic and diastolic blood pressure, fasting blood glucose, low-density lipoproteins (LDL) and total cholesterol, triglycerides, and physical activity. In the NRP-e group, however, the prevalence of several behaviors or conditions at risk decreased significantly more than in the control group: obesity (-16%), low fruit consumption (-24%), uncontrolled hypertension (-61%), LDL (-56%), and total cholesterol (-40%). CONCLUSIONS The NRP-e improved a range of CVD risk factors. The program had low costs, required only an average of <20 min per day in addition to normal practice, and may deserve further evaluation for the inclusion among existing care management approaches.

High-dose sequential chemotherapy and in vivo rituximab-purged stem cell autografting in mantle cell lymphoma: a 10-year update of the R-HDS regimen

High-dose sequential chemotherapy and in vivo rituximab-purged stem cell autografting in mantle cell lymphoma: a 10-year update of the R-HDS regimen

Zyoptix wavefront-guided versus standard photorefractive keratectomy (PRK) in low and moderate myopia: Randomized controlled 6-month study

Purpose To evaluate the refractive and aberrometric outcome of wavefront-guided photorefractive keratectomy (PRK) compared to standard PRK in myopic patients. Methods Fifty-six eyes of 56 patients were included in the study and were randomly divided into two groups. The study group consisted of 28 eyes with a mean spherical equivalent (SE) of -2.25±0.76 diopters (D) (range: -1.5 to -3.5 D) treated with wavefront-guided PRK using the Zywave ablation profile and the Bausch & Lomb Technolas 217z excimer laser (Zyoptix system) and the control group included 28 eyes with a SE of-2.35±1.01 D (range: -1.5 to -3.5 D) treated with standard PRK (PlanoScan ablation) using the same laser. A Zywave aberrometer was used to analyze and calculate the root-mean-square (RMS) of total high order aberrations (HOA) and Zernike coefficients of third and fourth order before and after (over a 6-month follow-up period) surgery in both groups. Preoperative and postoperative SE, uncorrected visual acuity (UCVA), and best-corrected visual acuity (BCVA) were evaluated in all cases. Results There was a high correlation between achieved and intended correction. The differences between the two treatment groups were not statistically significant for UCVA, BCVA, or SE cycloplegic refraction. Postoperatively the RMS value of high order aberrations was raised in both groups. At 6-month control, on average it increased by a factor of 1.17 in the Zyoptix PRK group and 1.54 in the PlanoScan PRK group (p=0.22). In the Zyoptix group there was a decrease of coma aberration, while in the PlanoScan group this third order aberration increased. The difference between postoperative and preoperative values between the two groups was statistically significant for coma aberration (p=0.013). No statistically significant difference was observed for spherical-like aberration between the two groups. In the study group eyes with a low amount of preoperative aberrations (HOA RMS lower than the median value; <0.28 μm) showed an increase of HOA RMS while eyes with RMS higher than 0.28 μm showed a decrease (p<0.05). Conclusions Zyoptix wavefront-guided PRK is as safe and efficacious for the correction of myopia and myopic astigmatism as PlanoScan PRK. Moreover this technique induces a smaller increase of third order coma aberration compared to standard PRK. The use of Zyoptix wavefront-guided PRK is particularly indicated in eyes with higher preoperative RMS values.

Efficacy and safety of high-dose chemotherapy with in vivo purged auto-SCT in relapsed follicular lymphoma: long-term follow-up

Efficacy and safety of high-dose chemotherapy with in vivo purged auto-SCT in relapsed follicular lymphoma: long-term follow-up

Interobserver variability of clinical target volume delineation in soft-tissue sarcomas

PURPOSE The present observational study reports the results of a multi-institutional dummy-run designed to estimate the consistency of interobserver variability in clinical target volume delineation in two different cases of soft-tissue sarcomas in which postoperative and preoperative radiotherapy were prescribed, respectively. The purpose of this work was to quantify interobserver variability in routine clinical practice. PATIENTS AND METHODS Two different cases of soft-tissues sarcomas were chosen: a case of postoperative and a case of preoperative radiation therapy. Participating centres were requested to delineate clinical target volumes according to their experience in both cases. Descriptive statistic was calculated for each variable (volume, diameters) separately for two cases. Box-whiskers plots were used for presentation of clinical target volume. A Shapiro-Wilks test was performed to evaluate the departures from normality distribution for each variable. The comparison between relative variations of diameters was evaluated using the Students t test. RESULTS Several variations affecting both volumes and diameters were observed. Main variations were observed in the craniocaudal and laterolateral diameters. Each case showed similar dispersion, indicating a lack of reproducibility in volumes definition. CONCLUSIONS This observational study highlighted that, in the absence of specific instructions or guidelines, the interobserver variability can be significant both in postoperative and preoperative radiotherapy of soft-tissue sarcomas.

Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis

The importance of early therapy intensification in B-cell CLL (B-CLL) patients remains to be defined. Even though several studies have been published, no randomized trials comparing directly autologous stem cell transplant (ASCT) and the accepted conventional therapy (that is, rituximab, fludarabine and CY; R-FC) have been reported so far. To assess the benefit of a first-line aggressive therapy, we designed a multicenter, randomized, phase 3 trial comparing R-FC and high-dose chemotherapy supported by ASCT in patients under 65 years of age, with stage B(II) or C B-CLL. Primary end point was CR: 96 patients were enrolled (48 in each arm). On an intent-to-treat basis, the CR rates in the ASCT and R-FC arms were 62.5% and 58%, respectively. After 5 years of follow-up, PFS was 60.4% in the ASCT arm and 65.1% in the R-FC arm, time to progression 65.8 and 70.5%, and overall survival 88% vs 88.1%, respectively. Our trial demonstrates, for the first time in a randomized manner, that frontline ASCT does not translate into a survival advantage when compared with benchmark chemoimmunotherapy in B-CLL patients; the possibility of its clinical benefit in certain subgroups remains uncertain.

Ultrasoundelastography: Can it provide valid information for differentiation of benign and malignant thyroid nodules?

Ultrasoundelastography (USE) is a new imaging technique that is performed with a normal ultrasound transducer. It provides improved characterization of a tissue or nodule based on the latters elasticity and stiffness. The aim of the present, prospective study was to assess the validity of USE in characterizing thyroid nodules. USE patterns were analyzed in light of nodule cytology (British Thyroid Association classification) to determine whether these patterns can be used to decide whether or not fine-needle aspiration cytology (FNAC) is indicated. We examined a consecutive series of 617 thyroid nodules in patients referred for the first time to the Endocrinology Unit of Atri Hospital (Atri, [TE]). Patients underwent ultrasonographic and USE examinations of their thyroid nodules, which were then subjected to FNAC. All nodules with Thy 1 cytology were excluded, leaving 567 nodules for analysis. USE findings were classified on the basis of the degree and distribution of elasticity within the lesion: four patterns were identified (1, 2, 3a, 3b, or 4).None of the nodules with Thy 4 cytology (malignant) had USE pattern 1 or 2; patterns 3 and 4 were associated with higher cytologic grades. In conclusion, USE provides additional information on thyroid nodules, which can be used with ultrasound features of the nodules, to decide whether FNAC is indicated. In fact, patterns 1 and 2 do not seem to be associated with Thy 4 cytology.

Successful second autologous engraftment after long duration storage of hematopoietic stem cells

Successful second autologous engraftment after long duration storage of hematopoietic stem cells