Ibrutinib in patients with relapsed/refractory mantle cell lymphoma: a real-life, retrospective, multicenter trial on behalf of the "RTL" (regional Tuscan lymphoma network).

BACKGROUND: Relapsed or refractory (R/R) mantle-cell lymphoma (MCL) patients have a poor prognosis and their management is challenging, in absence of a golden standard as salvage treatment. Bruton's tyrosine kinase inhibitor ibrutinib represents an effective treatment for R/R MCL patients. We investigated ibrutinib efficacy and safety in daily clinical practice, together with factors that could predict disease outcome. PATIENTS AND METHODS: We retrospectively analyzed 69 consecutive R/R MCL patients managed in 10 Tuscan onco-hematological centers. The treatment regimen consisted of oral, continuous, single-agent ibrutinib, maximum dosage of 560 mg once per day, until disease progression. RESULTS: Overall response rate was 62.3%, with a CR rate of 39.1%. After a median follow-up of 15.6 months, 40/69 patients (58%) were alive, the main cause of death was progressive disease (PD, 22/69 cases, 31.9%). Median progression-free survival (PFS) and overall survival (OS) were 17 and 34.8 months. Inferior PFS was associated with >1 prior line of therapy and B symptoms. Ibrutinib refractoriness was associated with inferior OS, median OS after ibrutinib failure was only 5 months. DISCUSSION AND CONCLUSION: In this real-life setting ibrutinib treatment prolonged survival in R/R MCL patients, without unexpected adverse events. Patients receiving ibrutinib as 2nd line regimen had the most favorable outcome.

Self-perception and physician's awareness on early detection of tongue cancer: experience of the Oral Medicine Unit of Trieste.

BACKGROUND: The objective of this retrospective study was to characterize the outpatient oral medicine referral pattern for tongue lesions with particular emphasis on cancer. METHODS: Records of patients referred to the Oral Medicine department for any tongue lesions needing biopsy between 2009 and 2016 were retrospectively analyzed. All cases diagnosed as tongue cancer were screened for medical history, referral pattern, treatment/diagnosis/follow-up. RESULTS: Among 266 patients, 39 were diagnosed with cancer, 43.6% were smokers and 10.3% alcohol consumers, 38.5% felt pain, 53.8% noticed the lesion or felt its presence, 46.2% were referred from another specialist. For people aware or informed of the lesion. the mean time waited before consultation was 7.9 months. In 53.8% of cases, narrow-band-imaging guided the biopsy. In 29 patients, biopsy was performed the day of the visit. Patients were referred from dentists (42.1%), Primary-care-Physician (10.5%), Emergency-Dental-Unit (7.9%), Radiotherapist (7.9%), Otolaryngologist (7.9%), Dermatologist (26%), infectious diseases unit (2.6%), auto-referral in 18.4%. Lesion was defined by referring doctor as "suspicious" (13.1%), white (10.5%), vegentans (5.3%), Lichen-like (5.3%), ulcerative (2.6%), Tumoral (26.3%), Bollous (2.6%). An unweighted Kappa Value of 0.024, assessed low concordance between referral diagnosis and diagnosis performed by the Oral Medicine specialist before the biopsy. CONCLUSIONS: Patients are not always aware of the risk of oral cancer. Accurate information should be provided to patients as well as to specialists rather than just dentists as regard as the risk factors for oral cancer, the importance of referral to specialized departments and timing. The use of new technologies should be widespread.

Campaign to Increase Awareness of Oral Cancer Risk Factors Among Preadolescents.

Oral squamous cell carcinoma (OSCC) represents one of the most common but scarcely known malignancies worldwide. The etiology of OSCC is strongly related to lifestyle habits and behavior, especially tobacco smoking and alcohol abuse. The mean age of individuals who start smoking and drinking alcohol is decreasing; thus, the aim of our campaign was to test the awareness and increase knowledge of oral cancer and its risk factors among young preadolescents. Six schools with 460 students aged 12-14 years were included in the campaign. A lecture about carcinogenesis and oral cancer was provided. Anonymous questionnaires were submitted to the students before and after the lecture, to test their knowledge, awareness, and understanding. Before the lecture, the students showed very little awareness of oral cancer (26.8%), although almost all of them identified tobacco smoking as a risk factor (92.2%). After the lecture, the students showed a significant understanding of the provided information, thus increasing their awareness. On scales of 1-10, the students rated the appropriateness of the campaign at 8.9 and their overall appreciation at 8.7. Social campaigns, especially among young students, seem to be appreciated and may represent a powerful strategy for increasing knowledge about cancer risk factors, especially when they are highly related to lifestyle habits and behavior.

Efficacy of ultramicronized palmitoylethanolamide in burning mouth syndrome-affected patients: a preliminary randomized double-blind controlled trial.

OBJECTIVES: This preliminary randomized double-blind controlled trial was performed to test the efficacy of ultramicronized palmitoylethanolamide treatment in the burning mouth syndrome. MATERIALS AND METHODS: Patients with referred burning mouth intensity greater than 4, according to the Numeric Rating Scale, were included in the study according to established inclusion and exclusion criteria. Patients were randomized into two groups and received either placebo or ultramicronized palmitoylethanolamide 600 mg twice daily for 60 days. Patients were assessed at baseline, 30 and 60 days after treatment start, and 4 months after treatment discontinuation. In order to evaluate the change in the burning mouth sensation over time, the generalized linear mixed model was employed. RESULTS: A total of 35 patients were considered eligible, among which 6 withdrew prior to the end of treatment. A statistically significant reduction of burning mouth sensation (p < 0.0132) was registered at the end of the active treatment in the ultramicronized palmitoylethanolamide group compared to the placebo one. Any side effect related to the active treatment was neither observed nor reported both by patients and by physicians. CONCLUSIONS: The significant decrease of burning sensation in the ultramicronized palmitoylethanolamide group compared to the placebo group suggests to consider this naturally occurring molecule as a viable therapy in the management of burning mouth syndrome. CLINICAL RELEVANCE: The use of an effective compound to manage the burning mouth syndrome, devoid of adverse effects for the patient and that does not interfere with other pharmacological therapies, could find wide employability from clinicians.

Scoring systems for Oral Lichen Planus used by differently experienced raters

Background: Scoring systems have been widely used to evaluate the severity and activity of oral lichen planus (OLP). The aim of the present study was to compare two existing (one modified) scoring systems in the evaluation of OLP severity and correlation with pain. Three differently experienced raters were involved. Material and Methods: Consecutive patients with OLP were assessed for pain using the Visual Analogue Scale and examined at 10 intraoral sites before starting (T0) and three weeks after (T1) steroid therapy (Clobetasol). Three differently experienced raters evaluated photographs using two scoring systems designated White-Erosive-Atrophic (WEA) modified from an older WEA system (WEA-MOD) and Reticular-erythematous-Ulcerative (REU) systems. WEA-MOD Kendall's W and interclass correlation coefficient were calculated and correlation between REU/WEA-MOD and pain was calculated using Spearman coefficient. Results: Most patients showed lesions on buccal mucosa (85-93,5%) and maxillary/mandibular gingivae (31,8- 31,2%), predominantly reticular. At T0, Kendall-W coefficients of 0.89 and 0.74 were obtained for the REU and WEA respectively. At T1, Kendall-W coefficients of 0.83 and 0.58 were obtained for the REU and WEA respectively. Interclass correlation coefficient ranged from 0.87 to 0.90 for REU and from 0.58 to 0.87 for WEA. REU and WEA scores significantly decreased after therapy (p< 0.000) as well as VAS (p< 0.05). REU score showed correlation with VAS. Conclusions: All the raters achieved comparable measures using REU whereas WEA and WEA-MOD seem less reproducible. REU seems to correlate to disease activity and pain (AU)

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