Daratumumab plus bortezomib or daratumumab plus lenalidomide as salvage therapy for patients with myeloma: initial follow-up of an Italian multicentre retrospective clinical experience by 'Rete Ematologica Pugliese'.

We report herein a multicentre retrospective analysis of 192 consecutive patients with symptomatic refractory/relapsed multiple myeloma (RRMM) treated with daratumumab in combination with bortezomib or lenalidomide as salvage therapy at 9 haematological centres in Puglia. Choice of both regimens was based on previous treatment and/or physicians' preference. Considering the under-representation of older patients (very old patient ≥ 80 years) in clinical trials and the prognostic and predictive importance and value of frailty status, here, we further characterised the patient cohort by age. The overall response rate (ORR) was generally lower than what was previously reported in the CASTOR (ORR 72.6% vs 85%) and POLLUX (ORR 86.5% vs 93%) trials. The lower ORR in our analysis compared to the CASTOR and POLLUX trials could be related to a less selected population. Similarly, amongst very old patients, the ORR was encouraging: ORR to treatment with DVd (daratumumab + bortezomib + dexamethasone) was 66.7%, and ORR to treatment with DRd (daratumumab + lenalidomide + dexamethasone) was 92.3%. Median TTP (time to progression) was 10.8 months (1-year TTP: 44.7%; 2-year TTP: 25.3%) in the DVd group; median TTP was not reached in the DRd group (1-year TTP: 82.7%; 2-year TTP: 71.4%). Median OS (overall survival) was not reached either in the DRd group (1-year OS: 85.9%; 2-year OS: 73.7%) or the DVd group (1-year OS: 70.2%; 2-year OS: 58.9%).

Effect of dietary buriti oil on the quality, fatty acid profile and sensorial attributes of lamb meat.

Forty crossbred (Santa Ines × Dorper) male lambs were used to investigate the effect of dietary buriti oil (BOIL) intake on meat quality, fatty acid (FA) composition and sensory attributes. A completely randomized design with five BOIL intake levels (0, 12, 24, 36 and 48 g/kg DM) was used. Increasing dietary BOIL intake linearly reduced the DMI, slaughter weight, cooking loss, shear force, yellowness, 16:0, c9-18:1 FA concentrations, and the delta-9-desaturase activity index computed using c9-16:1 and 16:0 as product and substrate pair, cis-MUFA and Æ©MUFA/Æ©SFA ratio of lamb meat (P ≤ 0.05); however, increasing dietary BOIL intake quadratically increased the energy intake, lipid content and linearly increased the total FA intake, chroma, collagen, total BI, 18:0, 20:3n-6 concentration and sensory attributes of lamb meat (P ≤ 0.05), without affecting health indexes regarding fat consumption. BOIL addition at levels above 24 g/kg DM in lamb diet reduces growth, however, improves tenderness, flavor and "goat" aroma intensity and slightly changes meat FA levels, promoting better acceptance by panelists.

Recovering from chronic myeloid leukemia: the patients' perspective seen through the lens of narrative medicine.

PURPOSE: The main objective of this study is to gain a deeper understanding of how patients suffering from chronic myeloid leukemia (CML) cope with their illness. The study aims to reconstruct the subjective meaning-making process related to CML in order to gain insights into the impact the disease has on patients' emotions and everyday lives, as well as to explore the psychological impact of their being presented with the chance to suspend their therapy and recover from the disease. METHODS: Data were gathered from a qualitative study conducted in Italy on 158 Italian CML patients. Basing the study on the narrative inquiry approach, the patients were required to describe their patient journey in a qualitative narrative diary. These contained prompts to elicit the free expression of their needs, expectations, and priorities. A lexicographic analysis was carried out with T-LAB software and in particular a thematic analysis of elementary contexts (TAECs) and a word association analysis (WAA). RESULTS: The TAEC detected four thematic clusters related to two factors (temporal frame and contextual setting) that explained the variance among the narratives. The WAA evidenced a wide variety of emotions, both positive and negative, as patients reacted to the possibility of interrupting their therapy. CONCLUSIONS: A better understanding of patients' experiences can offer insights into promoting the development of more sustainable healthcare services and into therapeutic innovation aimed at improving patients' quality of life and at engaging them more in their treatment. The findings of this study can also help make medical professionals more aware of the patient's burden and help them identify potential interactions and emotional levers to improve clinical relationships.

"Real world" outcome of lenalidomide plus dexamethasone in the setting of recurrent and refractory multiple myeloma: extended follow-up of a retrospective multicenter study by the "rete ematologica pugliese".

This current retrospective multicenter analysis represents, to our knowledge, the first Italian study evaluating the efficacy and toxicity profile of "lenalidomide plus dexamethasone" as salvage therapy in patients with recurrent-refractory MM in the real life contest. Our study included patients who are usually excluded from clinical trials because of unfavorable baseline characteristics. Median OS was significantly longer in patients receiving "lenalidomide plus dexamethasone" for more than 12 months compared with those who had received "lenalidomide plus dexamethasone" for a shorter interval (P<0.0001). Median OS was not affected by best response achieved (P 0.4) and age (P 0.3). Quality of response did not correlate with number of previous lines of therapy (P 0.77) and age. Higher ORRs were recorded in the patients group with relapsed MM compared to those with refractory disease, but this difference was not statistically significant (P 0.38).

Control of Salmonella Enteritidis in turkeys using organic acids and competitive exclusion product.

AIM: To evaluate the use of organic acids (OAs) and competitive exclusion (CE) product administered continuously in the feed and transiently in drinking water on the control of Salmonella enterica subspecie enterica serotype Enteritidis (SE) prior to slaughter. METHODS AND RESULTS: The influence of treatments were evaluated on pH, population of the lactic acid bacteria (LAB) and bacteria of the family Enterobacteriaceae, concentration of volatile fatty acids and SE colonization in the crop and caecum. The birds were challenged with SE 24 h before being slaughtered, and then, the caeca and crop were removed and subjected to SE counts. Continuous administration of OAs reduced the population of bacteria from the Enterobacteriaceae family in both crop and caecum, positively influenced the butyric acid concentration and reduced SE colonization in the caecum. The diet supplemented with CE product positively influenced the quantity of LAB in the crop and caecum, elevated the butyric acid concentration and reduced both Enterobacteriaceae quantity and SE colonization in the caecum. There was no effect from administering the treatments via drinking water on the variables measured. CONCLUSIONS: Continuous supplementation in feed with OAs and CE product reduced SE colonization of the caeca. SIGNIFICANCE AND IMPACT OF THE STUDY: Supplementation of OAs and CE product in diet to turkeys can reduce the SE load, potentially leading to a lower contamination risk of meat during slaughter.

Increased CD34+ cell peripheral traffic appears to be an unique feature of the allergic inflammation.

Evidence has been cumulated during the last years concerning the immaturity of the cells involved in the local and systemic aspects of allergic inflammation. Hematopoietic precursors (HPC) are mobilized from the bone matrix as multipotent cells or, more often, as progenitors that, after the initial white-lineage commitment reach through the peripheral blood (PB) their final destinations constituted by the target organs of allergy. Although several studies have investigated the CD34+ cells traffic and location at the level of the inflamed peripheral mucosae in allergic populations, limited information is available on their behaviour on the time-course of infectious diseases. The current study thus was designed to asses the peripheral traffic of CD34+ HPC during the infectious inflammation. To this end CD34+ HPCs have been enumerated, by flow-cytometric techniques, in PB of 24 adult healthy beings (Group A), 24 adult subjects with symptomatic extrinsic allergy (Group B) and in PB of 24 adult patients hospitalised for febrile infectious pathology (Group C). CD34+ cell values ranged 0.01-0.08% with a median of 0.03 in Group A. In Group B values ranged 0.17-0.75% with a median of 0.28 and in Group C values ranged 0.00-0.12% with a median of 0.07. Variance analysis test among the three groups was statistically significant (p<0.001) supporting the conclusion that CD34+ HPC mobilizing and increased peripheral traffic is an unique feature of the allergic inflammation.

[Neoadjuvant radiochemotherapy of rectal carcinoma: retrospective analysis of a personal experience]. / Radiochemioterapia neoadiuvante nel carcinoma del retto analisi retrospettiva di un'esperienza personale.

Even if surgical resection continues to be the mainstay of treatment in rectal cancer, preoperative chemoradiation may downstage locally advanced rectal cancer, in some cases with no residual tumors. Compared with surgery alone, preoperative radiotherapy and chemotherapy improves outcomes in patients with locally advanced rectal cancer. In the present review we summarize the results of preoperative chemoradiation therapy in a group of 15 patients who underwent surgical resection with total mesorectal excision (TME) for advanced mid and low rectal cancer from February 2002 to February 2004.

[Multimodal treatment of gastric MALT lymphoma: our experience]. / Trattamento multimodale del linfoma malt gastrico nostra esperienza.

Primary gastric lymphoma (PGL) is rare, but its incidence is increasing. It represents 52% of all extranodal GI tract lymphomas. The majority of PGLs are B cell non-Hodgkin's lymphomas or a high grade, diffuse, large cell lymphoma. The development of gastric mucosa associated lymphoid tissue is dependent on Helicobacter pylori infection. From January 2000 to February 2004, 10 patients were observed in the Unit of Surgical Oncology at Morgagni-Pierantoni Hospital in Forlì (6 F, 4 M), mean age was 68.3 (range, 45-86). Diagnosis was made in all patients by endoscopy and biopsies of gastric mucosa, US endoscopy and TC-PET. According to the Ann-Arbor classification modified by Musshoff, 6 patients were stage IE(1), 1 IE(2), 1 IIIE. 2 IV. Four and two patients underwent distal or total gastrectomy. respectively. Chemotherapy was performed in three patients, RT in one patient. Complete remission was observed in patients submitted to surgery and chemotherapy alone. No mortality and morbidity were observed. The treatment of LGP is not standardized yet. The role of surgery in the treatment of primary gastric lymphoma has been recently re-evaluated. Traditionally surgical treatment was aggressive, more recently radical gastrectomy is disputed and considered unnecessary. Conservative surgery and combined treatment is considered more appropriate for localized gastric lymphoma.

[Intraperitoneal chemotherapy with oxaliplatin after complete cytoreduction for peritoneal carcinomatosis from colorectal carcinoma: preliminary experience]. / Chemioipertermia intraperitoneale con oxaliplatino dopo citoriduzione completa per carcinosi peritoneale da carcinoma colorettale: esperienza preliminare.

Colorectal cancer with peritoneal carcinomatosis is usually considered incurable. Intraperitoneal carcinomatosis accounts for 25-35% of recurrences of colorectal cancer. Studies demonstrate that peritoneal carcinomatosis is not necessarily a terminal condition with no options for treatment or cure. Encouraging results were obtained in many studies by cytoreductive surgery followed by hyperthermic intraoperative intraperitoneal chemotherapy (HIIC). Oxaliplatin is a new agent whose clinical use with intraperitoneal administration has been pioneered by Elias et al. Eight patients with peritoneal carcinomatosis (PC) of colo-rectal origin underwent complete cytoreductive surgery from March 2004 to January 2005. Six of them were submitted to HIIC with semi-closed technique; in one patient mitomycin C (2 mg/m2/l) was used for intraperitoneal perfusion at 41.5-42 degrees for 60 minutes; in five patients IPCH was carried out for 30 minutes at 41.5-42 degrees with intraperitoneal oxaliplatin (460 mg/m2). Patients received intravenous leucovorin (10 mg/m2) and 5-fluorouracil (400 mg/m2) just before HIIC to maximize the effect of oxaliplatin. Preliminary results are reported.

The "T" vein of the leg.

BACKGROUND: We frequently observe a tributary of the saphenous vein with the origin in the saphenous compartment of the medial aspect of the upper third of the leg. It runs transversally in the interfascial compartment toward the lateral aspect of the leg. Constantly it feeds by reflux varicose veins clinically visible in the paratibial region and/or in the lateral aspect of the leg. For the peculiarity of its anatomical shape as well as duplex appearance, we defined it as the "T" vein. OBJECTIVES: To assess how frequently the "T" vein of the leg is involved in varicose networks. METHODS: A total of 218 consecutive patients affected by primary varicose veins have been evaluated by the means of duplex scanning. We assessed both the presence of the above-mentioned tributary and the frequency of its hemodynamic involvement in the varicose network. RESULTS: In 15 of 218 cases (7%) we demonstrated the above-mentioned tributary with an interfascial length ranging between 5 and 12 cm involved in varicose networks. CONCLUSIONS: The anterior tributary of the saphenous vein of the anterolateral aspect of the leg is a neglected clinical entity, whose existence is important to know for the treatment of varicose veins of the lateral aspect of the leg.

[PHS Repair in femoral hernia surgery]. / La chirurgia dell'ernia femorale con sistema PHS.

BACKGROUND: Since December 2000 we began to treat femoral hernias, for the first time in emergency, placing the underlay mesh of a PHS 168; device in the properitoneal space using the same anterior way well known in plug technique repair. The technical description and short term effectiveness, safeness and comfort of our new femoral prosthetic repair are reported. METHODS: Prospective analysis of 12 unselected consecutive female patients who underwent 12 PHS device femoral hernia repairs (6 in emergency with 2 intestinal resections and 6 in elective settings), performed from December 2000 to December 2001 at the Institute of General Surgery, University of Ferrara. Mean age was 61,7 (range 25-94) and mean follow-up was 6 months (from 1 to 11). RESULTS: Mean hospital stay was 2.1 days (from 1 to 5). No recurrences or complications occurred. We report one (8.3%) 25 year old woman with moderate cruralgia which required analgesics assumption form more then 24 hours. CONCLUSIONS: Although our report is not statistical significant (recent introduction of this new technique for a low incidence rate pathology) actually we perform PHS device femoral hernia repair systematically, both in elective and emergency surgery. This new procedure appears as a simple, safe, effectiveness and comfortable, anterior properitoneal "tension-free" repair of the myopectineal region (direct inguinal hernias prophylaxis).

Myeloablative therapy and bone marrow transplantation in Jehovah's Witnesses with malignancies: single center experience.

Hematological malignancies in Jehovah's Witnesses are often difficult to cure since these patients deny transfusions. By a retrospective analysis, we report the possibility of treating some tumors, mostly hematological, with either autologous or allogeneic bone marrow transplantation (BMT) without blood support. Eight patients were evaluated, including lymphoma (two patients), acute lymphoblastic (one patient) and myeloblastic (one patient) leukemia, chronic lymphocytic leukemia (one patient), refractory anemia with blasts in transformation (one patient), chronic myeloid leukemia (one patient) and metastatic breast cancer (one patient). All patients experienced a severe cytopenia with no major side effects or life-threatening complications. We had four deaths: three from relapse and progression of the disease (at 5, 8 and 15 months after the stem cell infusion), and one from acute intestinal GVHD (at 2 months after the stem cell infusion). Four patients are in complete clinical remission (at 8, 10, 16 and 26 months after the stem cell infusion), and this was related to the disease outcome. We conclude that autologous and allogeneic BMT are feasible without the support of transfusions. We believe that this should be performed as soon as possible in the course of the disease.

Diversity of Actinoplanes and related genera isolated from an Italian soil.

Actinoplanes and related genera are good producers of bioactive secondary metabolites. However, many strains within these genera present similar morphological characteristics, and this prevents an effective discrimination of replicate strains during industrial isolation and screening programs. Using PCR-RFLP analysis of the 23S rDNA gene and of the 16S-23S intergenic spacer, we have analyzed 182 strains of Actinoplanes and related genera obtained through a selective isolation method from a single Italian soil. Combining the 23S and IGS data, 99 unique profiles were observed, and morphologically undistinguishable strains were discriminated. Further analyses on a restricted number of strains through 16S sequencing and hybridization to a probe for secondary metabolism established a good correlation between strain diversity seen by PCR-RFLP and that seen by the other methods. Overall, the data indicate the presence of a high diversity of Actinoplanes and related genera isolated from a single Italian soil.

Minimally invasive surgical management of primary venous ulcers vs. compression treatment: a randomized clinical trial.

OBJECTIVES: to compare minimally invasive surgical haemodynamic correction of reflux (CHIVA) with compression in the treatment of venous ulceration. DESIGN: prospective randomised study. MATERIALS AND METHODS: from a cohort of 80 patients with 87 venous leg ulcers, 47 were randomised to either surgery or compression. RESULTS: at a mean follow-up of 3 years, healing was 100% (31 days) in the surgical and 96% (63 days), in the compression group (p<0.02). The recurrence rate was 9% in the surgical and 38% in the compression group (p<0.05). In the surgical group, all plethysmographic parameters except ejection fraction, had improved significantly at 6 months in the surgical group, and at 3 years residual volume fraction remained in the normal range. Finally, quality of life significantly improved in the operated group. CONCLUSIONS: this study supports the effectiveness of surgical therapy for leg ulceration secondary to superficial venous reflux.

Randomized trial of 8-week versus 12-week VNCOP-B plus G-CSF regimens as front-line treatment in elderly aggressive non-Hodgkin's lymphoma patients.

BACKGROUND: Among the third-generation chemotherapy regimens specifically adapted in the last decade for elderly aggressive non-Hodgkin's lymphoma (NHL) patients, we designed an 8-week cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin and prednisone (VNCOP-B) plus granulocyte colony-stimulating factor (G-CSF) regimen which, in a national multicenter trial, induced good complete response (CR) and relapse-free survival rates with only moderate toxic effects. Here we report a prospective, multicenter, randomized trial comparing the efficacy and toxicity of 8- and 12-week regimens of VNCOP-B plus G-CSF. PATIENTS AND METHODS: From February 1996 to June 2001, 306 consecutive previously untreated stage II-IV aggressive NHL patients > or =60 years of age were enrolled from 12 Italian cooperative institutions. Of the 297 evaluable patients, 149 and 148 received 8- and 12-week regimens, respectively, of VNCOP-B. RESULTS: The CR rates were 63% and 56% in the 8- and 12-week groups; at a median of 32 months (range 3-62 months), relapse-free survival rates were 59% and 55%, respectively. Hematological and non-hematological toxicities were similar in both treatment groups. CONCLUSIONS: Our data show that extending induction treatment with the VNCOP-B plus G-CSF regimen from 8 to 12 weeks does not raise the CR rate or provide a more durable remission.

A comparison between radiographic and sonographic assessment of hand and wrist bones for the estimation of skeletal age in the child patient.

AIM: The purpose of this study was to examine, with a sonographic investigation, the hand and wrist bones of a group of young patients and to compare the results with those obtained with a classical radiographic assessment. MATERIALS AND METHODS: Some 25 subjects, 9-18 years of age, who presented problems concerning their short stature or precocious puberty, were evaluated. Each subject was examined by a standard radiographic assessment and by a sonographic investigation with real-time imaging. Sonographic examination was performed on the metacarpus-phalanx articulation of the first finger in order to locate the sesamoid bone. Sonographic examination was also performed on the second and third phalanxes of the third finger and on the distal portion of the radius to evaluate the characteristics of growth cartilage in the area. RESULTS AND STATISTICS: In all the cases where a sesamoid bone was present, this was correctly identified by the sonogram, even up to the initial appearance of its ossification nucleus. Sensitivity, specificity, and diagnostic accuracy were all 100%. The capping phenomenon seen in radiographs was not detected by sonographic investigation in any of the cases. Sonographic evaluation of the fertile cartilage of the third finger distal phalanx demonstrated a sensitivity of 89%, a specificity of 100% and a diagnostic accuracy of 92%. Sonographic evaluation of the radius cartilage showed a sensitivity of 95%, a specificity of 100% and a diagnostic accuracy of 96%. CONCLUSION: Sonographic evaluation of hand and wrist bones cannot accurately reproduce the results of the classical radiographic evaluation. However, the sonographic investigation may be useful, when integrated in a radiographic investigation.