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Max-Adrien Garcia,1 Julie Kalecinski,1 Mathieu Oriol,1,2 Armand Bonne,1 Mohamed Lofti,1 Sophie Espenel,3 Fabien Tinquaut,1 Pierre Fournel,4 Olivier Collard,4 Cécile Vassal,4 Romain Rivoirard,4 Véronique Regnier,1,5 Franck Chauvin,1,2,5 Aurélie Bourmaud1,5 1Hygee Center, Lucien Neuwirth Cancer Institut, INSERM – CIC-EC, CIC 1408, Saint Priest en Jarez, France; 2Jean Monnet University, Saint Etienne, France; 3Radiotherapy Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France; 4Medical Oncology Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France; 5Quality Safety Performance in Health (HESPER) EA7425, Lyon 1 University, Lyon, France Introduction: The announcement of cancer coupled with initiation of its treatment impacts patients’ psychological and physical states as well as their lifestyles. The objective of this study was to identify and confirm the needs of patients starting off on anticancer chemotherapy treatment. Methods: This study was based on a qualitative–quantitative mixed method. In 2009, a qualitative study was conducted at the Lucien Neuwirth Cancer Institut for cancer patients undergoing intravenous chemotherapy for the first time. Exploratory and semi-directed interviews were carried out by a sociologist. In 2014, a questionnaire was hetero-administered to 100 patients starting off on chemotherapy. Results: Forty patients were interviewed in 2009. Ninety-seven patients answered the questionnaire in 2014. Food was a theme that was identified by a majority of patients in 2009 (13/40) and confirmed in 2014: 63% needed help in identifying favorable food and 67% in identifying those that had to be avoided. The other needs identified were those linked to better understanding of the treatment, of how it may affect the couple, its side effects, hygiene and beauty, and knowledge about other treatments. These needs were confirmed in 2014. New needs were elicited in 2014: activities and leisure (33%), psychological needs (32.6%), and family relations (29.9%). Conclusion: This study enabled us to identify, confirm, and enrich our knowledge of the needs of cancer patients starting off on intravenous chemotherapy. These results led to the modification of an existing patient education program for these patients, in order to fulfill their needs in an updated and tailored manner. Keywords: assessment of needs, patients’ needs, cancer, patient education, mixed qualitative–quantitative method, psychosocial needs

Objectives:Adult patients with refractory/relapsed ALL have poor survival outcomes with current chemotherapies. We aimed to determine safety and efficacy of lenalidomide, an oral immunomodulator, in these patients. Methods:This phase 1/2 trial (EUDRACT # 2009-009372-13) included 10 patients who received 28-day cycles of oral lenalidomide 25 mg/day, days 1 through 21, in combination with oral dexamethasone 40 mg/day on days 1, 8, 15, 22. Primary endpoints were tolerance and the overall response rate (ORR). Secondary endpoints included overall survival (OS) and quality of life. Results:The most common grade 3 or 4 adverse events were myelosuppression. The ORR among the participants who could be evaluated was 28.6% (95% confidence interval [CI], 0–62.2%). The median OS was 92 days (range, 43–133 days). All patients have died because of progressive disease. Quality of life remains stable during treatment cycles. Discussion and conclusion:The safety of combination therapy consisting of lenalidomide plus dexamethasone is consistent with ambulatory administration. Efficacy should be reevaluated in a larger series including patients less intensively previously treated. [ABSTRACT FROM PUBLISHER]

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Introduction: Literature suggests that patients from deprived backgrounds are less likely to adhere to their treatments, continue to expose themselves to risk factors and, as a result, have poorer health outcomes. It is therefore crucial to identify these vulnerable populations early on, in order to provide them with tailored and reinforced care. The primary aim of this research is to construct and validate a systematic screening tool for identifying patients at highest risk of social vulnerability due to deprivation, through the use of psychometric techniques. This tool is intended to be easily used by healthcare professionals, to provide tailored and targeted care throughout the patient's journey., Method: This study involves the development and assessment of a screening tool, along with a self-questionnaire and a decision support tool incorporating an artificial neural network. It is a prospective, monocentric, 2-stage psychometric validation study., Results: This study has demonstrated the successful development of the self-questionnaire using psychometric methodology. The tool was found a good performance in screening social vulnerabilities., Discussion: This validated self-questionnaire is an easy-to-use tool, allowing systematic screening for social vulnerabilities for cancer patients. This early identification allows to reinforce patient's pathway in order to avoid disruption. The integration of the tool in an artificial neuron network system allows to automate and disseminate this method of deprived patients' detection, while limiting the workload for the staff., (Copyright © 2024. Published by Elsevier Masson SAS.)

Primary dose reduction (PDR) in the first course of chemotherapy is an empirical practice, commonly used in older population. Patients over 70 years old receiving a first course of chemotherapy for a solid tumor were enrolled. A total of 179 patients were included. Standard dose was used in 69.8% of patients, while 30.2% received PDR of chemotherapy. Only 29.6% received a standardized geriatric assessment. Patients receiving standard doses presented 83.2% of toxicities, while 68% of toxicities were reported in patients receiving PDR. The toxicity rate was significantly decreased in patients treated with reduced first-cycle dose of chemotherapy.

Introduction: MVAC (Methotrexate, Vinblastine, Adriamycin, and Cisplatin) neoadjuvant chemotherapy a standard treatment for invasive bladder cancer is associated with mainly haematological toxicities. Randomized clinical trials remain a gold standard for treatment outcomes and efficacy assessment. Patients enrolled in clinical trials are selected and tend to benefit from a stricter follow-up unlike everyday clinical practice patients. Conversely, real-life observational studies better define the effectiveness of treatments in clinical routine practice. The aim of this study is to analyse the impact of clinical trial monitoring on MVAC-related toxicities., Material and Methods: Patients with an infiltrative localized bladder cancer treated by MVAC neoadjuvant chemotherapy between 2013 and 2019 were enrolled, and divided into 2 groups: patients included in a clinical trial namely "VESPER study" during their treatment and patients treated in clinical routine practice., Results: Out of 59 patients were enrolled in this retrospective study, 13 patients were included in a clinical trial. Clinical characteristics were similar between the 2 groups. Comorbidities were more frequent in the nonclinical trial group (NCTG). Completed 6 cures treatment proportion was higher in the clinical trial group (CTG) (69.2% vs. 50%). Yet, in this group, patients had more doses reduction (38.5% vs. 19.6%). The proportion of complete pathologic response was higher in patients enrolled in clinical trial (53.8% vs. 39.1%). Statistically, the expected stricter monitoring due to clinical trial enrolment had no impact on the complete pathologic response and clinically relevant toxicities., Discussion: When compared to conventional clinical practice, clinical trial enrolment induced no significant difference on the pathologic complete response or toxicity rate. Further large prospective studies are needed to confirm these data., Competing Interests: Disclosure No conflicts of interest to disclose, (Copyright © 2023 Elsevier Inc. All rights reserved.)

The management (diagnostic and therapeutic) of cancer in the geriatric population involves a number of complex difficulties. The aim of this study was to assess the impact of a medical specialty on the diagnostic and therapeutic management of elderly cancer patients. Four clinical scenarios of cancer in the geriatric population, with a dedicated survey to gather information regarding each clinical case's diagnostic and therapeutic approaches, as well as the different criteria influencing physicians' therapeutic decisions, were exposed to geriatricians, oncologists, and radiotherapists in Saint-Etienne. The surveys were filled out by 13 geriatricians, 11 oncologists, and 7 radiotherapists. There was a homogeneity of responses regarding the confirmation of cancer diagnostics in the elderly. There were strong disparities (inter- and intra-specialties) for several clinical situations regarding the therapeutic management of cancer. There were significant disparities in terms of surgical management, the implementation of a chemotherapy protocol, and the adaptation of the chemotherapy dosage. Contrary to oncologists, who primarily consider the G8 and the Karnofsky score, geriatric autonomy scores and frailty with cognitive assessment were the key factors determining diagnostic/therapeutic therapy for geriatricians. These results raise important ethical questions, requiring specific studies in geriatric populations to provide the homogenous management of elderly patients with cancer.

Scarce data investigate the impact of radiotherapy (RT) on biology markers. An analysis of ancillary study of RIT (Radiation Impact on Thromboembolic events) prospective trial was carried out. All patients with non-metastatic solid tumors and treated with radiotherapy and/or brachytherapy in curative and consenting to have blood samples were included. A significant decrease in white blood count, (i.e. lymphocytes, monocytes, neutrophils and basophils) and platelet counts was observed after RT and maintained at 6 months. Whereas, eosinophils, D-dimers and hemoglobin levels were affected respectively 3 months and 6 months after RT initiation. Conversely, red cells count and CRP level were not affected by RT. This study is an advocacy to develop an understanding of basic immune system in relation with RT.

Objectives: To identify patients at high risk of developing cardiovascular disease through the identification of risk factors among a large population of breast cancer women and to assess the performance of Abdel-Qadir risk prediction model score., Materials and Methods: The medical records and baseline characteristics of all patients/tumors diagnosed with breast cancer from 2010 to 2011 in a French comprehensive cancer center were collected. Cardiovascular events were defined as arterial and cardiac events, atrial fibrillation and venous thromboembolism occurring during the 5-year follow-up. Abdel-Qadir multivariable prediction model for major adverse cardiovascular events were used with the concordance index (c-index) score to assess calibration by comparing predicted risks to observed probabilities., Results: Among the 943 breast cancer patients included, 83 patients (8.8%) presented with at least one cardiovascular event, leading to a cumulative incidence of 0.07 at 5 years (95% confidence interval [CI], 0.055-0.088). The cumulative incidence of atrial fibrillation at 5 years was 0.01 (95% CI, 0.005-0.018). Factors associated with the occurrence of cardiovascular events were pre-existing cardiovascular diseases including high blood pressure (hazard ratio [HR]=1.78, 95% CI=1.07-2.97, P=0.028), acute coronary syndrome (HR=5.28, 95% CI: 2.16-12.88, P<0.05) and grade 3 Scarff-Blool-Richardson (HR=1.95, 95% CI: 1.21-3.15, P=0.006). With a c-index inferior to 0.7, the Abdel-Qadir score was not fully validated in our population., Conclusion: These findings call for the assessment of the performance of risk prediction models such as Abdel-Qadir score coupled with other factors such as Scarff Bloom and Richardson grading in order to identify patients at high risk of experiencing cardiotoxicity., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Thromboembolic events frequently complicate the course of malignancy and represent a major cause of morbidity and mortality in cancer patients. In contrast to chemotherapy and other systemic therapies, little is known about the impact of ionizing radiations on the incidence of venous thromboembolism (VTE) in cancer patients., Methods: In the present prospective study, we aimed to investigate the incidence, management, and outcome of VTE in newly diagnosed cancer patients who received curative radiotherapy., Results: VTE was found in 8 patients, out of 401 patients at a median time of 80 days after radiotherapy initiation. The incidence rate of VTE at 6 months post-treatment was 2% (95% CI, 0.9-3.7), with 50% of cases occurring during the radiotherapy course and 50% of cases in patients who received or were receiving chemotherapy. As none of the patients harbored a personal history of VTE, no prophylactic measure was initiated during cancer therapy. Most patients received monotherapy with low-molecular-weight heparin and were still on surveillance at the end of the study. No specific clinical risk factor was identified that might systematically indicate the need of thromboprophylaxis in the context of curative radiotherapy., Conclusions: Although this pan-cancer descriptive study did not relate an increased risk of short-term thrombosis following ionizing radiation, it provides important insight as a basis for future studies with subcategories of cancer, in order to in fine guide further recommendations in frail patients., Clinical Trial Registration Number: NCT02696447., (© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background and Purpose: Limited data are available about non-anticancer treatment (NACTs)/radiation combinations. MORSE 02-17 was the first study to report on the interaction resulting from such combinations in a heterogeneous population. Therefore, the aim of this study was to describe acute and late toxicities in a homogenous cohort of cancer patients receiving NACTs and undergoing radiation therapy., Material and Methods: An analysis of the RIT (Radiation Impact on Thromboembolic events) prospective trial was carried-out. Patients with non-metastatic solid tumors and treated with radiotherapy and/or brachytherapy in a curative intent between 2016 and 2019 were included. Data about NACTs and toxicities were then collected., Results: Out of 382 patients, 293 were prescribed NACTs (76.7%) with a median number of 3.6 (range: 1-14) NACTs per patient. Among1006 NACTs, the most prescribed drugs were anti-hypertensive, in 153 patients (52.2%). In accordance with MORSE 02-17 data, four of the main side effects of radiotherapy were analysed: genitourinary, gastrointestinal, dermatitis/mucositis and fatigue. Regarding acute and late toxicities -whatever the grade- no statistical difference was found between NACTs classes and these toxicities., Conclusion: When we compared the rates of toxicities with literature data, NACTs did not seem to have a worsening effect. One could conclude that NACTs concomitantly given with RT do not influence toxicity outcome. We then advocate a development of new platform for toxicity profile investigation of drugs-RT combination., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Older patients with ovarian cancer represent a heterogeneous population. The French National Group of Investigators for the Study of Ovarian and Breast Cancer developed the geriatric vulnerability score (GVS) to identify geriatric parameters predictive of poor outcomes. A prospective validation of the GVS was needed., Methods: The EWOC-1 study (NCT02001272) was an international, open-label, phase 2, three-arm trial designed according to a two-step process. Patients aged 70 years or older with newly diagnosed stage III or IV ovarian cancer were identified and the GVS determined. Those with a GVS of 3 or greater were randomly assigned to the EWOC-1 trial, stratified by country and surgical outcome, to receive three different carboplatin with or without paclitaxel regimens; those not included in the EWOC-1 trial were followed up in the EWOC-1 registry. External validation of the GVS was a secondary endpoint of the trial. Three validation cohorts were identified: the total population (validation cohort 1 [V1], n=447), the registry-only population (validation cohort 2 [V2], n=327), and the carboplatin-paclitaxel-treated population (validation cohort 3 [V3], n=320)., Findings: From Dec 11, 2013, to Nov 16, 2018, 447 patients were included in 48 academic centres in six countries; 120 in the EWOC-1 trial and 327 in the EWOC-1 registry. Median follow-up was 19·7 (95% CI 8·5-29·7) months for the total cohort; missing values were low (<2%). According to the maximum likelihood analysis, the hazard ratio (HR) of death in V1 was 1·8 (95% CI 1·1-3·1, p=0·029) for those with a GVS of 1; 2·4 (1·4-4·0, p=0·0009) with a GVS of 2; 4·1 (2·5-7·0, p<0·0001) for a GVS of 3; 5·5 (3·3-9·3, p<0·0001) for a GVS of 4; and 9·1 (4·7-17·5, p<0·0001) for a GVS of 5 compared with a score of 0. Whatever the validation cohort, GVS of 3 or more significantly segregated two groups with different overall survival: V1 (median 13·2 [95% CI: 10·8-18·7] vs 40·8 [32·0-45·6] months; HR 2·8 [95% CI 2·2-3·7]; p<0·0001); V2 (11·9 [95% CI 8·8-18·1] vs 40·8 [32·0-45·6] months, HR 3·5 [2·5-4·9]; p<0·0001); and V3 (18·1 [95% CI 15·8-31·8] vs 43·0 [40·6-49·7] months, HR 2·6 [1·9 to 3·7]; p<0·0001)., Interpretation: The GVS has high prognostic performance for overall survival in patients with advanced ovarian cancer, independently of geographic and historic effect (V1), as well as treatment patterns (V3), validated in an international population. Even though the GVS is time consuming it will allow the stratification of populations for clinical research and might permit the orientation of the geriatric intervention to specific domains., Funding: French National Cancer Institute., Translation: For the French translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests CF reports a grant from the French National Cancer Institute during the conduct of the study; personal fees from Leo Pharma, Pfizer, MSD Oncology, Teva, AstraZeneca, Baxter, Eisai, Janssen Oncology, Novartis, Chugai Pharma, and Astellas Pharma, outside the submitted work; grants from Chugai Pharma, Pfizer, Pierre Fabre, and Astellas Pharma, outside the submitted work; and non-financial support from Janssen Oncology, Pierre Fabre, AstraZeneca, and Leo Pharma, outside the submitted work. FT reports grants from French National Institute (via Hospices Civils de Lyon), during the conduct of the study. DL reports grants from PharmaMar, Merck Serono, Novartis, AstraZeneca, Clovis Oncology, Tesaro, GSK, Roche, Genmab, and Immunogen, during the conduct of the study. AF reports personal fees from MSD, AstraZeneca, GSK, and Clovis Oncology, outside the submitted work. FR reports participation in a specialist advisory board for Bristol Myers Squibb. OT reports grants and personal fees from Roche and MSD, grants from BMS, and personal fees from Novartis-Sandoz, Pfizer, Lilly, AstraZeneca, Daiichi Sankyo, Eisai, Pierre Fabre, and Seagen, outside the submitted work. EP-L reports personal fees and non-financial support from AstraZeneca, Tesaro, and Roche; personal fees from Clovis, Incyte, and Pfizer; and other from Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY) Research, outside the submitted work. All other authors declare no competing interests., (Copyright © 2022 The Authors. Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: The aim of the study was to identify risk factors related to human errors in the preparation of anticancer drugs in order to improve the pharmaceutical process by setting corrective actions., Method: Risk factors which could increase the probability of error were identified: daily workload, workload on the previous day and subcontractors' workload, time slot of the preparation, understaffing, incidents which could affect workflow, individual experience of technicians and cleanrooms layout. Drug reconstitution or complex fabrications were also considered as risk factors. We used univariate and multivariate logistic regression analyses to screen for correlation between risks and errors., Result: Among 11 278 preparations analyzed, 115 were non-compliant. Univariate analysis shows significant variables: individual experience of technicians, technicians working in the same cleanrooms and technicians' rotations. 2 technicians are significantly associated with a higher risk of error and 5 with a lower risk. The multivariate analysis confirmed the conclusions of the univariate., Discussion: As expected, time slot of the manufacture, cleanrooms layout and some technicians increase the risk of error. Surprisingly, technicians' experience led to increase the risk. This study is a first approach to evaluate the human error aspect in non-compliant preparations, in order to optimize security of antineoplastic drugs preparations.

Background: Genome analysis could provide tools to assess predictive molecular biomarkers of radioresistance., Methods: Head and neck squamous cell carcinoma patients included in ProfiLER study and who underwent a curative radiotherapy were screened. Univariate and Cox multivariate analyses were performed to explore the relationships between molecular abnormalities, infield relapse and complete tumor response after radiation., Results: One hundred and forty-three patients were analyzed. PIK3CA mutation and genomic instability of MAP kinases pathway were found to be prognostic factors of loco-regional relapse in multivariate analysis with respectively HR 0.33, 95% CI 0.13-0.83, p = 0.005 and HR 0.61, 95% CI 0.38-0.96, p = 0.025. Instability of apoptosis pathway was found to be a prognostic factor of complete response after radiotherapy with HR 0.24, 95% CI 0.07-0.88, p = 0.04., Conclusion: This sub analysis suggests that PIK3CA mutation, variation of copy number of MAP kinases and apoptosis pathways play a significant role in the radioresistance phenomenon., (© 2021 Wiley Periodicals LLC.)

After chemotherapy, fewer than 30% of patients with T-cell lymphoma (T-NHL) are long-term disease-free survivors. Thus, there is a growing interest in allogeneic stem cell transplantation (alloSCT) and its potential graft-versus-lymphoma effect (GVL) for patient with high-risk or recurrent T-NHL with the aim at providing durable disease control in T-NHL. We conducted this registry study to evaluate the outcome of recipients of alternative donor alloSCT for T-NHL. Patients transplanted with Haploidentical donor (Haplo, n = 41) or Umbilical Cord Blood (UCB, n = 54) were analyzed for overall survival (OS), non-relapse mortality (NRM), relapse, and acute/chronic graft-versus-host disease (aGVHD/cGVHD) incidence. At 2 years, OS and PFS were, respectively, of 59% and 53%, without significant difference between Haplo and UCB. In multivariate analysis, disease status at transplant was an independent risk factor for OS and PFS, and aGVHD III-IV was the main factor for OS and NRM. While no major impact of donor source on survival and mortality was noted, this study suggests that alternative donor transplantation appears feasible and offers benefits to patients with T-cell lymphoma., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Objectives: The main standard of care for locally advanced cervix carcinoma (LACC) is radiochemotherapy (RCT) followed by brachytherapy. A surgical approach may still be discussed based on pelvic MRI-derived residual tumour evaluation. As no interobserver agreement study has ever been conducted to our knowledge, the aim of the present study was to report on pelvic MRI accuracy and interobserver agreement in LACC., Methods: We carried out a retrospective study in a French university hospital. Medical records of all consecutive patients treated with curative intent for LACC by RCT followed by brachytherapy and completion pelvic surgery between January 2014 and January 2020 were reviewed. Local response was assessed through pelvis MRI and histological analysis after completion surgery. MRI data were independently evaluated by two radiologists with varying experience. The two main interobserving criteria we used were complete response and residual tumour., Results: 23 patients fulfilled the inclusion criteria. Agreement between the junior and senior radiologist was moderate to strong. Indeed, regarding main criteria, κ was 0.65 for complete response and 0.57 for residual tumour. Interestingly, the present study shows a lower sensitivity whatever the radiologists than in the international literature., Conclusion: The present study highlights a low interobserver variability regarding pelvic MRI in the assessment of RCT followed by brachytherapy in LACC. Yet, sensitivity was lower than in literature., Advances in Knowledge: Radiology is part of treatment decision-making, the issue of heterogeneity regarding radiologists' training and experience to cancer (sensitivity and specificity) turns essential, so does MRI accuracy.