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Abstract Background In this study, we investigated whether the association of curcumin and docetaxel among advanced and metastatic breast cancer patients in first or second‐line treatment potentiated the objective response rate. Patients/Methods A multicentre, randomized, open label, phase‐II study was conducted and included 42 patients from July 2009 to January 2017. The primary endpoint was the objective response rate of the docetaxel‐curcumin combination in comparison with docetaxel alone. The secondary endpoints were the assessment of clinical benefit, overall survival, time‐to‐progression, progression‐free survival, compliance, and safety. An interim analysis was planned to evaluate safety and efficacy. Results In this interim analysis conducted on 37 patients (19 in the control group vs. 18 in the experimental group), no difference was observed for the objective response rate (p = 0.25, control 73.7% vs. experimental 55.6%). Concerning clinical benefit, overall survival and time‐to‐progression, we also failed to show any difference between the two arms. A slight tendency towards longer progression‐free survival at 12 months after randomization was observed in the curcumin group (65.5% vs. 41.4%) but this difference did not reach significance (p = 0.14). Conclusion In this study, we showed for the first time that adding oral curcumin for advanced and metastatic breast cancer patients treated with first or second‐line docetaxel was not efficacious, although safe. Consequently, this study was stopped for reasons of futility. Further studies with a larger number of patients, a different curcumin preparation, a longer treatment period and a pharmacokinetic evaluation of curcumin are needed to explore the real efficacy of this compound.

Background and Aims: The treatment of metastatic non‐small‐cell lung cancer (NSCLC) has been revolutionized by the arrival of immune checkpoint inhibitors (ICI). For patients without immune related adverse events (irAEs), it is recommended to continue the treatment as long as it provides clinical benefit or until unacceptable toxicity appears. The aim of our study was to evaluate survival data among patients with advanced or metastatic NSCLC following ICI discontinuation for reasons of long‐term response or toxicity (irAEs). Methods: We included all patients with advanced or metastatic NSCLC treated with nivolumab and pembrolizumab at the Centre Jean Perrin, Clermont‐Ferrand, France (January 1, 2016 to May 31, 2019). We focused on two groups in this study population: "Voluntary treatment discontinuation" (medical decision as a result of long‐term response and patient decision) and "Treatment discontinuation due to toxicity" (irAEs). The primary endpoint was to evaluate the postdiscontinuation outcomes of these two groups: progression‐free survival (PFS) and overall survival (OS), and rechallenge in the "voluntary discontinuation" group. Results: The final analysis concerned 146 patients, including 10 (7%) in the "discontinuation due to toxicity" group, 11 (8%) in the "voluntary discontinuation" group, 100 (68%) who discontinued treatment as a result of progression and 25 (17%) whose treatment was still on‐going. The median PFS in the "discontinuation due to toxicity" group was not reached, and in the "voluntary discontinuation" group (n = 11) was 37 months (p = 0.4), versus 2 months in the progression group (p < 0.001). The median OS in "discontinuation due to toxicity," and in the "voluntary discontinuation" groups was not reached (p = 0.5), versus 10 months in the progression group (p < 0.001). Conclusion: Treatment discontinuation following long‐term response to ICI treatment showed sustained response and long‐term survival after discontinuation. The incidence of irAEs was associated with better long‐term survival, even after ICI discontinuation. [ABSTRACT FROM AUTHOR]

Background: Presently, there are few published reports on postoperative radiation therapy for oropharyngeal and oral cavity cancers treated with IMRT/VMAT technique. This study aimed to assess the oncological outcomes of this population treated with postoperative VMAT in our institution, with a focus on loco-regional patterns of failure. Material and methods: Between 2011 and 2019, 167 patients were included (40% of oropharyngeal cancers, and 60% of oral cavity cancers). The median age was 60 years. There was 64.2% of stage IV cancers. All patients had both T and N surgery. 34% had a R1 margin, 42% had perineural invasion. 72% had a positive neck dissection and 42% extranodal extension (ENE). All patients were treated with VMAT with simultaneous integrated boost with three dose levels: 66Gy in case of R1 margin and/or ENE, 59.4-60Gy on the tumor bed, and 54Gy on the prophylactic areas. Concomittant cisplatin was administrated concomitantly when feasible in case of R1 and/or ENE. Results: The 1- and 2-year loco-regional control rates were 88.6% and 85.6% respectively. Higher tumor stage (T3/T4), the presence of PNI, and time from surgery >45 days were significant predictive factors of worse loco-regional control in multivariate analysis (p=0.02, p=0.04, and p=0.02). There were 17 local recurrences: 11 (64%) were considered as infield, 4 (24%) as marginal, and 2 (12%) as outfield. There were 9 regional recurrences only, 8 (89%) were considered as infield, and 1 (11%) as outfield. The 1- and 2-year disease-free survival (DFS) rates were 78.9% and 71.8% respectively. The 1- and 2-year overall survival (OS) rates were 88.6% and 80% respectively. Higher tumor stage (T3/T4) and the presence of ENE were the two prognostic factors significantly associated with worse DFS and OS in multivariate analysis. Conclusion: Our outcomes for postoperative VMAT for oral cavity and oropharyngeal cancers are encouraging, with high rates of loco-regional control. However, the management of ENE still seems challenging. [ABSTRACT FROM AUTHOR]

Background: To assess the impact of nutritional status on tolerance to induction chemotherapy by docetaxel, cisplatin and 5‐fluorouracil (ICT) in head and neck cancer (HNC). Methods: Ninety‐two HNC patients were included. Toxicity was assessed according to common terminology criteria for adverse events. Nutritional status was assessed by body mass index (BMI), serum albumin, nutritional risk index (NRI), and CT scan (skeletal muscle mass index [SMI] at the first lumbar vertebral level). Results: Before treatment, average BMI was 22.7 ± 4.6 kg/m2, serum albumin 38.7 ± 5.8 g/L, NRI 97.6 ± 10.6, and SMI 36.4 ± 7.9 cm2/m2. After treatment, BMI was 23 ± 4.5, serum albumin 30.2 ± 7.1, and NRI 88.1 ± 9.2. During ICT, 52 (62%) patients developed at least one toxicity ≥ Grade 3. Pre‐treatment SMI was the only predictive factor of toxicity irrespective of BMI (p = 0.04). Conclusion: Low skeletal muscle mass is a predictive factor of toxicity to ICT in HNC. [ABSTRACT FROM AUTHOR]

Objectives: To determine the importance of nutritional status, social status, and inflammatory status in the prognosis of head and neck cancer. Study Design: Single-center retrospective study of prospectively collected data. Setting: Tertiary referral center. Methods: Ninety-two consecutive patients newly diagnosed for cancer of the upper aerodigestive tract without metastases were assessed at time of diagnosis for several prognostic factors. Nutritional status was assessed by the nutritional risk index, social status by the EPICES score, and inflammatory status by the systemic inflammatory response index. The primary endpoint was overall survival. Results: In multivariable analysis, the main prognostic factors were the TNM classification (hazard ratio [HR] = 3.34, P =.002, for stage T3-4), malnutrition as assessed by the nutritional risk index (HR = 3.64, P =.008, for severe malnutrition), and a systemic inflammatory response index score ≥1.6 (HR = 3.32, P =.02). Social deprivation was not a prognostic factor. Conclusion: Prognosis in head and neck cancer is multifactorial; however, malnutrition and inflammation are important factors that are potentially reversible by early intervention. [ABSTRACT FROM AUTHOR]

Background/aim: Triple-negative breast cancer (TNBC) is the most heterogeneous breast cancer subtype, posing numerous challenges in clinical decision-making. Biomarkers are essential to personalize management of TNBC patients. While tumor infiltrating lymphocytes (TILs) are validated prognostic biomarkers, the requirement for tumor biopsy limits their routine use. Therefore, more accessible and reliable quantitative biomarkers are needed. Given the significant role of systemic inflammatory response in tumor onset and progression, assessing inflammatory cells via liquid biopsies emerges as a promising alternative., Patients and Methods: The PERCEPTION study, conducted at Centre Jean Perrin in France, aims to determine the correlation between TILs and peripheral blood components at diagnosis. An interim analysis was conducted after enrolling 50% of the estimated population, to evaluate study feasibility and preliminary correlations between blood cell counts and TILs., Results: Sixty-one patients were enrolled over 4.5 years, demonstrating a good inclusion rate with minimal missing data. Preliminary results for 36 analyzable patients showed no correlation between the neutrophil-to-lymphocyte ratio (NLR) and TILs (r s =-0.19, 95%CI=-0.49-0.16, p=0.3). However, a moderate, positive, statistically significant correlation was found between NLR and the CD8/FoxP3 TILs ratio (r s =0.36, 95%CI=0.03-0.64, p=0.043). The probabilistic index of 0.7 (p=0.06) between NLR-high and NLR-low groups for this ratio supports the correlation., Conclusion: The interim analysis of the PERCEPTION study confirms the feasibility of correlating blood cell counts with TILs in TNBC. Although no significant correlation was observed between NLR and TILs, the moderate positive correlation between the CD8/FoxP3 ratio and TILs suggests a potential link between systemic inflammation and local immune response. These findings underscore the potential of blood-based markers as non-invasive surrogates for TILs, encouraging further research to enhance prognosis and guide treatment strategies in TNBC., (Copyright © 2024 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)