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56 result(s) for "Valentini, Valentino"
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Pembrolizumab-based first-line treatment for PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma: a retrospective analysis
Background The KEYNOTE-048 trial showed that pembrolizumab-based first-line treatment for R/M HNSCC led to improved OS in the PD-L1 CPS  ≥  1 population when compared to the EXTREME regimen. However, the R/M HNSCC real-world population is generally frailer, often presenting with multiple comorbidities, worse performance status and older age than the population included in phase III clinical trials. Methods This is a retrospective, single-centre analysis of patients with R/M HNSCC treated with pembrolizumab-based first-line treatment. Results From February 2021 to March 2023, 92 patients were treated with pembrolizumab-based first-line treatment. Patients treated with pembrolizumab-based chemoimmunotherapy had better ECOG PS and younger age than those treated with pembrolizumab monotherapy. Median PFS and OS were 4 months and 8 months, respectively. PFS was similar among patients treated with pembrolizumab-based chemoimmunotherapy and pembrolizumab monotherapy, while patients treated with pembrolizumab monotherapy had worse OS (log-rank p  =.001, HR 2.7). PFS and OS were improved in patients with PD-L1 CPS > = 20 (PFS: log-rank p  =.005, HR 0.50; OS: log-rank p  =.04, HR 0.57). Patients with higher ECOG PS scores had worse PFS and OS (PFS, log-rank p  =.004; OS, log-rank p  = 6e-04). In multivariable analysis, ECOG PS2 was associated with worse PFS and OS. Conclusions PFS in our real-world cohort was similar to the KEYNOTE-048 reference while OS was numerically inferior. A deeper understanding of clinical variables that might affect survival outcomes of patients with R/M HNSCC beyond ECOG PS and PD-L1 CPS is urgently needed.
Neck Management in Malignant Parotid Tumors: A Retrospective Analysis of Elective Neck Dissection Indications and Outcomes
Management of the clinically negative neck in malignant parotid tumors remains controversial. We aimed to identify clinicopathologic predictors of nodal involvement and to evaluate whether elective neck dissection (END) improves disease-free survival (DFS) versus observation in cN0 patients. We performed a retrospective cohort study of adults undergoing surgery for malignant parotid tumors at a single tertiary center (2013-2023) with ≥24 months of follow-up. Collected variables included demographics, tumor T category and histologic grade (AJCC 8th), parotidectomy type, neck management [END vs. therapeutic neck dissection (TND) vs. observation], lymph node yield, and outcomes. Associations were tested with Fisher's exact tests; disease-free survival (DFS) was analyzed using Kaplan-Meier curves, log-rank tests and an exploratory multivariable Cox proportional hazards model. Seventy-four patients were included (mean age 54.3 years; 12.2% preoperative facial nerve impairment). Parotidectomy was partial (41.9%), total (31.1%), radical (21.6%), or extended (5.4%). Neck dissection was performed in 40.5% (END 23.0%; TND 17.6%). Overall pathologic nodal positivity (pN+) was 18.9%. T3-T4 tumors had greater odds of nodal metastasis than T1-T2 (OR 10.58; < 0.05). Among cN0 patients, occult metastasis was 17.6%; notably, all high-grade cN0 tumors that underwent END were pN+. Intraparotid nodal metastases occurred in 28.6% and always co-occurred with cervical metastases. DFS did not differ significantly between cN0 patients managed with END versus observation (log-rank > 0.05). Patients with pN0 had superior DFS versus pN+ ( < 0.05). Lymph node yield groupings (0-17 vs. 18-40 vs. >40) were not associated with recurrences. In the exploratory multivariable Cox model, high/intermediate-grade and T3-T4 tumors and nodal positivity were associated with reduced DFS. Higher T category and high/intermediate grade strongly predict nodal involvement, and pN+ status portends worse DFS. Although END did not show a DFS advantage over observation in cN0 patients, the 17.6% occult metastasis rate-especially in high-grade disease-and the linkage between intraparotid and cervical metastases support a risk-adapted END strategy and intraoperative assessment of intraparotid nodes to guide neck management.
The observational clinical registry (cohort design) of the European Reference Network on Rare Adult Solid Cancers: The protocol for the rare head and neck cancers
Care for head and neck cancers is complex in particular for the rare ones. Knowledge is limited and histological heterogeneity adds complexity to the rarity. There is a wide consensus that to support clinical research on rare cancer, clinical registries should be developed within networks specializing in rare cancers. In the EU, a unique opportunity is provided by the European Reference Networks (ERN). The ERN EURACAN is dedicated to rare adults solid cancers, here we present the protocol of the EURACAN registry on rare head and neck cancers (ClinicalTrials.gov Identifier: NCT05483374). Registry-based cohort study including only people with rare head and neck cancers. to help describe the natural history of rare head and neck cancers;to evaluate factors that influence prognosis;to assess treatment effectiveness;to measure indicators of quality of care. Settings and participants It is an hospital based registry established in hospitals with expertise in head and neck cancers. Only adult patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear will be included in the registry. This registry won't select a sample of patients. Each patient in the facility who meets the above mentioned inclusion criteria will be followed prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for the patient follow-up. Variables Data will be collected on patient characteristics (eg. patient demographics, lifestyle, medical history, health status); exposure data (eg. disease, procedures, treatments of interest) and outcomes (e.g. survival, progression, progression-free survival, etc.). In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will be also collected. Statistical methods The data analyses will include descriptive statistics showing patterns of patients' and cancers' variables and indicators describing the quality of care. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause specific mortality will be used to determine independent predictors of overall survival, recurrence etc. Variables to include in the multivariable regression model will be selected based on the results of univariable analysis. The role of confounding or effect modifiers will be evaluated using stratified analysis or sensitivity analysis. To assess treatment effectiveness, multivariable models with propensity score adjustment and progression-free survival will be performed. Adequate statistical (eg. marginal structural model) methods will be used if time-varying treatments/confounders and confounding by indication (selective prescribing) will be present. The registry initiated recruiting in May 2022. The estimated completion date is December 2030 upon agreement on the achievement of all the registry objectives. As of October 2022, the registry is recruiting. There will be a risk of limited representativeness due to the hospital-based nature of the registry and to the fact that hospital contributing to the registry are expert centres for these rare cancers. Clinical Follow-up could also be an issue but active search of the life status of the patients will be guaranteed.
Functional Rehabilitation in Non-Reconstructed Hemimandibulectomy Patients
Background and Objectives: Functional rehabilitation in patients with hemimandibulectomy remains a challenge no matter what method of reconstruction is chosen by physicians. In this paper, we aim to evaluate the feasibility of an acceptable occlusal restoration in patients who have undergone hemimanidublectomy without the reestablishment of mandibular continuity. Materials and Methods: Data were collected retrospectively on 10 patients with varying degrees of mandible resection. The greatest challenge in the restoration of an acceptable occlusion form is the natural latero-deviation that occurs in patients whose mandibular continuity was not restored. This causes an unbalanced and uncoordinated occlusal plane. Based on our research, this deviation is highly dependent on three main factors: the presence of teeth (which allow for a proprioceptive stimulus that counteracts the deviation), the extension of the defect and the presence or lack of the coronoid process. Results: Based on the presence of dental elements or lack thereof, patients were either rehabilitated with implant-supported dentures or removable partial dentures. Although the gold standard of care for these patients remains the restoration of mandible continuity through use of bone grafts, an acceptable rehabilitation of occlusion and therefore function may be acquired in non-grafted patients. Conclusions: Both physicians and patients must manage their expectations carefully and be eager to find a compromise to provide the best possible solution given the challenges of the premises.
HPV Vaccination after Primary Treatment of HPV-Related Disease across Different Organ Sites: A Multidisciplinary Comprehensive Review and Meta-Analysis
Objective: To assess evidence on the efficacy of adjuvant human papillomavirus (HPV) vaccination in patients treated for HPV-related disease across different susceptible organ sites. Methods: A systematic review was conducted to identify studies addressing the efficacy of adjuvant HPV vaccination on reducing the risk of recurrence of HPV-related preinvasive diseases. Results were reported as mean differences or pooled odds ratios (OR) with 95% confidence intervals (95% CI). Results: Sixteen studies were identified for the final analysis. Overall, 21,472 patients with cervical dysplasia were included: 4132 (19.2%) received the peri-operative HPV vaccine, while 17,340 (80.8%) underwent surgical treatment alone. The recurrences of CIN 1+ (OR 0.45, 95% CI 0.27 to 0.73; p = 0.001), CIN 2+ (OR 0.33, 95% CI 0.20 to 0.52; p < 0.0001), and CIN 3 (OR 0.28, 95% CI 0.13 to 0.59; p = 0.0009) were lower in the vaccinated than in unvaccinated group. Similarly, adjuvant vaccination reduced the risk of developing anal intraepithelial neoplasia (p = 0.005) and recurrent respiratory papillomatosis (p = 0.004). No differences in anogenital warts and vulvar intraepithelial neoplasia recurrence rate were observed comparing vaccinated and unvaccinated individuals. Conclusions: Adjuvant HPV vaccination is associated with a reduced risk of CIN recurrence, although there are limited data regarding its role in other HPV-related diseases. Further research is warranted to shed more light on the role of HPV vaccination as adjuvant therapy after primary treatment.
Jaw Reconstruction with Scapular Bone Flap and Prosthetic Implant Rehabilitation: A Comprehensive Systematic Review
A rising demand for prosthetic-driven jaw reconstruction is encountered in maxillo-facial surgery. The free scapula flap is a workhorse of cervico-facial reconstructions, but an implant-based prosthetic rehabilitation on this flap is a debated topic. A systematic review of the papers on this subject has been conducted on Embase, MEDLINE, and Cochrane libraries following PRISMA guidelines, in order to analyze the results described in the literature. A total of nine papers were eligible for inclusion, with 83 scapula flaps overall being used for an implant-based prosthetic rehabilitation. The mandible was the reconstructed jaw in 58.0% of the cases. Overall, 249 implants were positioned (mean 3.0 implant per flap) with a 3.6% implant failure rate. In 95.2% of the cases, delayed rehabilitation was performed. Radiotherapy and the timing of implant placement did not seem to influence implant failure. Only two papers analyzed the quality of life following the rehabilitation, highlighting a functional improvement. Scapula-based implant-prosthetic rehabilitation is a feasible technique that can also benefit from the new CAD/CAM technologies and digital workflows. Nonetheless, further studies focused on this topic and on its impact on the quality of life are needed in order to analyze risk factors and to optimize the outcomes.
Tobacco, Alcohol and Family History of Cancer as Risk Factors of Oral Squamous Cell Carcinoma: Case-Control Retrospective Study
The aim of the study is to observe retrospectively the correlation between Oral Squamous Cell Carcinoma (OSCC) and risk factors; including tobacco, alcohol and Family History of Cancer (FHC). A total of 478 patients were included retrospectively from the database of the Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome. A Test Group (TG) consisted of 239 patients with a confirmed diagnosis of OSCC. A Control Group (CG) consisted of 239 patients without history and/or diagnosis of oral cancer. The logistic regression models were used to calculate the adjusted Odd Ratios (ORs) associated with alcohol, tobacco and FHC; including the General Family History of Cancer (GFHC) and Family History of Head and Neck Cancer (FHHNC) and their 95% Confidence Intervals (CI). The high rate of tobacco consumption was associated with an OR of 1.035 (95% CI 1.001–1.070) and a statistical significance (p = 0.041). Drinker patients showed a significant risk of developing OSCC (p = 0.05) and the OR was 1.035 (95% CI 1.010–1.061). The GFHC was associated with a marginal risk of OSCC with an OR of 1.095 (95% CI 0.953–1.259), without significance (p = 0.199). The FHHNC showed a notable risk increase with an OR of 1.871 (95% CI 0.902–3.882), without significance (p = 0.092). Alcohol and tobacco may be associated with an increase in the risk of OSCC.
Severe Odontogenic Infections during Pregnancy and Related Adverse Outcomes. Case Report and Systematic Literature Review
Odontogenic infections have the potential to develop into deep-space infections and may cause severe diseases with possible life-threatening complications. Dental infections during pregnancy require special attention in terms of possible complications and treatments due to the potential to affect the lives of two individuals. A case of a 36-year-old pregnant patient with a submandibular abscess caused by an odontogenic infection is reported, followed by a comprehensive systematic review of the literature in order to retrieve information regarding severe odontogenic infections and adverse pregnancy outcomes. The review was conducted according to the PRISMA guidelines using PubMed, Scopus, and Google Scholar databases. A total of 69 cases were included in the qualitative analysis. The mean age was 27.72 years. Patients were managed with surgery in combination with antibiotics. Nine infectious-related cesarean sections were detected, and preterm birth was associated in 3 cases, low birth weight in 2 cases, death of the fetus in 9 cases (13%), and maternal death in 4 cases (5.8%). The possible compromise of oral health during pregnancy is well known; however, severe odontogenic infections are rarely considered in the literature, and they may be associated with severe and life-threatening complications for both mother and the fetus.
Weekly chemotherapy as first line treatment in frail head and neck cancer patients in the immunotherapy era
Objective First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, which have shown a significant improvement in overall survival (OS) gaining approval in a first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to 3-weeks treatment, was retrospectively evaluated in a frail patient population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach. Methods A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in a first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicities were analysed. Results Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients in weekly group (21) were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35% (36 patients) and 34% (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%). Conclusion The weekly schedule appears to be an active and safe strategy in frail patients with R/M HNSCC. Based on these data, a weekly schedule could be considered as a first line treatment in all frail patients excluded from pembrolizumab treatment and a study on the combination of weekly chemotherapy and immunotherapy should be performed.