Clinical value of negative 68Ga-PSMA PET/CT in the management of biochemical recurrent prostate cancer patients.

PURPOSE: To evaluate the clinical value of 68Ga-PSMA PET/CT negativity in patients with biochemical recurrent prostate cancer (BCR). METHODS: One hundred three BCR patients (median age, 70 years; median PSA, 0.47 ng/mL) with negative 68Ga-PSMA PET/CT, followed up for at least 1 year, were retrospectively identified in a database of 1003 consecutive patients undergoing 68Ga-PSMA PET/CT for BCR. Clinical recurrence (CR) was determined or excluded on follow-up imaging selected as per clinical practice. Clinical recurrence-free survival (CRFS) was computed from the date of negative 68Ga-PSMA PET/CT to the date of evident disease; frequencies of CRFS were described as per ISUP patient subset (subset 1: ISUP grades 1 and 2; subset 2: ISUP grade 3; subset 3: ISUP grades 4 and 5) and other conventional variables. RESULTS: In 57 patients out of 103 (55.3%), CR was detected in the prostatic fossa (45.6%), nodes (38.6%), and bone (15.8%). The median CRFS was 15.4 months (range, 12.1-20.5), with a CRFS at 12 months in 61.4% of cases (range, 50.9-70.4) whereas the 24-month CRFS was 34.8% (range, 24-45.8). ISUP subset 1 benefited from significantly longer CRFS compared to subset 2 and subset 3 (median CRFS, 20.5 months, 12.6 months, and 12.1 months, respectively). ISUP subset 3 had significantly poorer 24-month CRFS (9.3%) compared to subset 1 (47.8%) and subset 2 (33.5%). At the univariate and multivariate analyses, the ISUP subset was the only significant risk factor for clinical relapse; ISUP subset 3 and subset 2 patients held a higher risk of CR compared to subset 1 patients (HR of 2.75 [1.35-5.57] for subset 3 versus subset 1; HR of 2.08 [1.11-3.88] for subset 2 versus subset 1). CONCLUSION: 68Ga-PSMA PET/CT negativity in early BCR patients (PSA < 0.5 ng/mL) with low-grade primary prostate cancer (ISUP1 and 2) may support the exploration of a clinical surveillance approach in future prospective studies.

Microbiological evaluation of environmental cleanliness in haematopoietic cell transplant patient rooms: implementing JACIE standards.

BACKGROUND: Environmental hygiene is one of the most important strategies to prevent hospital-acquired infections by reducing pathogens in haematopoietic cell transplant (HCT) patient rooms. This study was designed in response to JACIE requirements for microbiological monitoring, and aimed to assess environmental hygiene in protective isolation rooms. METHODS: Environmental cleanliness was assessed by measuring microbial loads in at-rest and operational conditions sampled from target surfaces, and in passive and active air from rooms occupied by patients with different grades of neutropenia. The study also evaluated whether microbial loads were influenced by isolation precautions. RESULTS: The failure rate of cleanliness on target surfaces in at-rest conditions was 0% compared with 37% for surfaces and 13% for passive and active air samples in operational conditions. Differences in failure rates were observed in the rooms of patients with different levels of neutropenia (P=0.036 for surfaces, 0.028% for passive air). No relationship was found between infections and microbial loads. CONCLUSIONS: Microbiological assessment integrated with an enhanced monitoring programme for hospital hygiene provides invaluable information to drive infection control policies in HCT patients. These results highlight the need to set and validate strict standards for the assessment of cleanliness in a clinical setting.

Metformin plus chemotherapy versus chemotherapy alone in the first-line treatment of HER2-negative metastatic breast cancer. The MYME randomized, phase 2 clinical trial.

PURPOSE: To investigate the efficacy of metformin (M) plus chemotherapy versus chemotherapy alone in metastatic breast cancer (MBC). METHODS: Non-diabetic women with HER2-negative MBC were randomized to receive non-pegylated liposomal doxorubicin (NPLD) 60 mg/m2 + cyclophosphamide (C) 600 mg/m2 × 8 cycles Q21 days plus M 2000 mg/day (arm A) versus NPLD/C (arm B). The primary endpoint was progression-free survival (PFS). RESULTS: One-hundred-twenty-two patients were evaluable for PFS. At a median follow-up of 39.6 months (interquartile range [IQR] 24.6-50.7 months), 112 PFS events and 71 deaths have been registered. Median PFS was 9.4 months (95% CI 7.8-10.4) in arm A and 9.9 (95% CI 7.4-11.5) in arm B (P = 0.651). In patients with HOMA index < 2.5, median PFS was 10.4 months (95% CI 9.6-11.7) versus 8.5 (95% CI 5.8-9.7) in those with HOMA index ≥ 2.5 (P = 0.034). Grade 3/4 neutropenia was the most common toxicity, occurring in 54.4% of arm A patients and 72.3% of the arm B group (P = 0.019). M induced diarrhea (G2) was observed in 8.8% of patients in Arm A. The effect of M was similar in patients with HOMA index < 2.5 and ≥ 2.5, for PFS and OS. CONCLUSIONS: The MYME trial failed to provide evidence in support of an anticancer activity of M in combination with first line CT in MBC. A significantly shorter PFS was observed in insulin-resistant patients (HOMA ≥ 2.5). Noteworthy, M had a significant effect on CT induced severe neutropenia. Further development of M in combination with CT in the setting of MBC is not warranted.

Effectiveness of service screening: a case-control study to assess breast cancer mortality reduction.

The aim of this study was the evaluation of the impact of service screening programmes on breast cancer mortality in five regions of Italy. We conducted a matched case-control study with four controls for each case. Cases were defined as breast cancer deaths occurred not later than 31 December 2002. Controls were sampled from the local municipality list and matched by date of birth. Screening histories were assessed by the local, computerised, screening database and subjects were classified as either invited or not-yet-invited and as either screened or unscreened. There were a total of 1750 breast cancer deaths within the 50 to 74-year-old breast cancer cases and a total of 7000 controls. The logistic conditional estimate of the cumulative odds ratios comparing invited with not-yet-invited women was 0.75 (95% CI: 0.62-0.92). Restricting the analyses to invited women, the odds ratio of screened to never-respondent women corrected for self-selection bias was 0.55 (95% CI: 0.36-0.85). The introduction of breast cancer screening programmes in Italy is associated with a reduction in breast cancer mortality attributable to the additional impact of service screening over and above the background access to mammography.

Alcohol protracted withdrawal syndrome: the role of anhedonia.

AIMS: The aim of the present study is to characterize the relevance of withdrawal symptoms during the first 12 months of abstinence and their relation to anhedonia and craving. METHODS: 102 detoxified subjects meeting clinical criteria for Alcohol Dependence in Remission were recruited at various time since the detoxification and subdivided into four groups according to the length of abstinence (group 1: 15-30 days; group 2: 30-90 days; group 3: 90-180 days; group 4: 180-360). Withdrawal symptomatology was assessed through the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). The Visual Analogue Scale (VAS) for craving, the Snaith-Hamilton Pleasure Scale (SHAPS) and the Subscale for Anhedonia in the Scale for the Assessment of Negative Symptoms (SANSanh) where the other instruments employed. RESULTS: Both anhedonia and withdrawal symptoms were identified in all the groups considered. SHAPS score and VAS for craving showed a significant difference between group 1 and groups 2, 3, and 4. As to CIWA-Ar items, apart from "orientation/clouding of sensorium" that was higher in groups 3 and 4 with respect to both groups 1 and 2, withdrawal symptoms were not significantly different between the periods considered. SHAPS and SANSanh were positively correlated to CIWA-Ar total score, "nausea and vomiting," and "headache/fullness in head." DISCUSSION: The results of this study suggest the relevance of protracted withdrawal well beyond the limited period following the abrupt cessation of alcohol intake. The clinical dimension of anhedonia cannot be separated from the other behavioral symptoms of withdrawal and should be considered as part of the same process.

Differences and similarities in the personality structure of 327 women with eating disorders.

The symptomatology of Eating Disorders (ED) varies considerably and it is of interest to determine whether one can attribute this to different personality structures and hence establish the most effective treatment. The present study investigates the psychopathological characteristics of clinical ED subjects divided by diagnostic subtypes, age at onset and duration of disorder on admission. Three hundred and twenty-seven women were administered the EAT 40 and MMPI. One-way ANOVA and Bonferroni post-hoc multiple comparisons were performed on subsamples: no significant differences emerged with regard to age at onset and duration of ED, whereas the diagnostic subtypes obtained significantly different MMPI validity scale scores. These results can be referred to a common core of ED represented by cognitive organization and personal meaning.

Motor and sensory neuropathy secondary to excessive pyridoxine ingestion.

This report documents a case of mixed motor and sensory neuropathy that resulted from ingestion of excessive amounts of pyridoxine. An 81-year-old woman was admitted to the hospital because of difficulty in walking and frequent falls. History revealed that she had been taking large doses of pyridoxine daily for several months as treatment for carpal tunnel syndrome. Diagnostic work-up failed to suggest a cause for her symptoms. Nerve conduction studies revealed slowing of motor conduction velocities, prolonged F wave latencies, and prolonged sensory latencies in both lower extremities. We believe the patient's complaints and the results of nerve conduction studies were secondary to pyridoxine neurotoxicity. Since the bases for this neurotoxicity are unknown, we suggest that treatment of carpal tunnel syndrome with oral pyridoxine be carefully monitored and that dosage limits not be exceeded.