Search

Purpose: The objective of this study was to describe filgrastim biosimilar-Sandoz modalities of use in patients receiving cytotoxic chemotherapy regimens with a rest period of ≤14 days and to investigate the incidence of febrile neutropenia (FN) in routine clinical practice., Methods: This was a French, multicenter, prospective and descriptive, non-interventional study including patients with breast, lung, gastrointestinal cancer or a lymphoma initiating filgrastim biosimilar-Sandoz treatment and in the context of cytotoxic chemotherapy with a rest period not exceeding 14 days. Data were collected during two routine clinical visits on the modalities of use of filgrastim biosimilar-Sandoz, on the incidence of neutropenia events and on adverse events., Results: Between November 2015 and June 2018, 1080 patients were enrolled in the study in 129 centers. Overall, 941 patients were evaluable for efficacy and 937 for safety. Of the 941 patients, 84.8% had a solid tumor and 15.2% had a lymphoid hemopathy. Filgrastim biosimilar-Sandoz was prescribed as primary prophylaxis in 74.0% of the patients and as secondary prophylaxis in 22.4% of the patients. FN was reported in 1.5% of patients with a solid tumor and 12.6% of patients with a lymphoma. A chemotherapy relative dose intensity of over 85% with regard to the reference dose was achieved by more than 80% of the patients in all tumor localizations., Conclusions: The study showed that filgrastim biosimilar-Sandoz is safe to use and effective in preventing FN and in allowing to maintain the dose intensity of chemotherapy., Competing Interests: Declaration of Competing Interest Pierre-Jean Souquet has served as a member of an advisory board for Sandoz, has received support to attend congresses and has participated to research sponsored by Sandoz. Jean-Marc Phelip has received consulting fees from Roche, Merck, Amgen, Sanofi, Bayer, Servier, Lilly, MSD and Pierre Favre, contracted research support from Merck Serono and has participated to research sponsored by Sandoz. Maya Hacini has participated to research sponsored by Sandoz. Mohamad Chehimi has nothing to disclose related to this research. Vincent Bourgeois has received support to attend congresses from Mundi Pharma, IPSEN and Sanofi, has served as a member of an advisory board for Servier, has received grants for training from AMGEN, and has participated to research sponsored by Servier, Roche, Bayer and Sanofi. Ryma Bennoune is employee of Sandoz. Olivier Tredan has received funding grants from Roche, MSD-Merck and BMS, and has received personal fees from Roche, MSD-Merck, Novartis-Sandoz, Pfizer, Lilly, Astra-Zeneca and Daiichi Sankyo. He has nothing to disclose related to this research., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: The most appropriate criteria and timing for palliative care referral remain a critical issue, especially in patients with metastatic breast cancer for whom long-term chemosensibility and survival are observed. We aimed to compare the impact of early palliative care including formal concertation with oncologists on decision for an additional line of chemotherapy compared with usual oncology care., Methods: This randomized prospective study enrolled adult women with metastatic breast cancer and visceral metastases with a 3rd- or 4th-line chemotherapy (CT). Patients received usual oncology care with a palliative care consultation only upon patient or oncologist request (standard group, S) or were referred to systematic palliative care consultation including a regular concertation between palliative care team and oncologists (early palliative care group, EPC). The primary endpoint was the rate of an additional CT (4th or 5th line) decision. Quality of life, symptoms, social support and satisfaction were self-evaluated at 6 and 12 months, at treatment discontinuation or 3 months after discontinuation., Results: From January 2009 to November 2012, two authorized cancer centers included 98 women (EPC: 50; S: 48). Thirty-seven (77.1%, 95%CI 62.7-88%) patients in the EPC group had a subsequent chemotherapy prescribed and 36 (72.0%, 95%CI 57.5-83.8%) in the S group (p = 0.646). No differences in symptom control and global quality of life were observed, but less deterioration in physical functioning was reported in EPC (EPC: 0 [- 53-40]; S: - 6; 7 [- 60 to - 20]; p = 0.027). Information exchange and communication were significant improved in EPC (exchange, EPC: - 8.3 [- 30 to + 7]; S: 0.0 [- 17 to + 23]; p = 0.024; communication, EPC: 12.5 [- 8 to - 37]; S: 0.0 [- 21 to + 17]; p = 0.004)., Conclusion: EPC in metastatic breast cancer patients did not impact the prescription rate of additional chemotherapy in patients a 3rd- or 4th-line chemotherapy for metastatic breast cancer; however, EPC may contribute to alleviate deterioration in physical functioning, while facilitating communication., Trial Registration: ClinicalTrial.gov identifier: NCT00905281, May 20, 2009., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Patients with cancer are at high risk of severe or lethal COVID-19. The impact of SARS-COV-2 vaccination on the risk of developing COVID-19 was investigated in an exhaustive series of patients from a comprehensive cancer center., Methods: This is a study of the exhaustive population of 2391 cancer patients who were prescribed SARS-COV-2 vaccination until 09/21. Patient characteristics, documented SARS-COV-2 infection with RT-PCR, and survival were collected. The primary endpoint was the rate of COVID-19 after vaccination. Secondary endpoints included risk factors to develop COVID-19 after vaccination, with a comparison with the cohort of vaccinated health care workers (HCW), and risk factors for death., Results: From January to September 2021, among 2391 patients with cancer under active treatment in whom a SARS-COV-2 vaccine was prescribed, 659 (28%), 1498 (63%) and 139 (6%) received 1, 2, and 3 doses, respectively. Ninety five patients received a single dose of vaccine after a previous COVID-19. Two thousand two hundred eighty five health care workers (HCW) received one (N = 17, 0.7%), 2-3 (N = 2026, 88.7%) vaccine doses and one dose after COVID-19 (N = 242, 10.6%). With a median follow-up of 142 and 199 days for patients and HCW, respectively. Thirty nine (1.6%) patients and 35 (1.5%) HCW developed COVID-19 after vaccination. Six of 39 cancer patients and no HCW died because ofCOVID-19 within 50 days after diagnosis. Independent risk factors for COVID-19 in vaccinated patients were age, single dose of vaccine without previous COVID-19 and anti-CD20 treatment in the last three months. Independent risk factors for death included metastatic disease, gender, cancer type, but also documented COVID-19 before vaccination., Conclusions: Patients receiving two or more doses of COVID-19 vaccine have reduced risk of COVID-19. The risk of death of vaccinated cancer patients presenting COVID-19 remains high. COVID-19 before vaccination is associated with an increased overall risk of death., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors: research support from Astra-Zeneca and Innate Pharma for a research program not directly related to the present work., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Cancer patients presenting with COVID-19 have a high risk of death. In this work, predictive factors for survival in cancer patients with suspected SARS-COV-2 infection were investigated., Methods: PRE-COVID-19 is a retrospective study of all 302 cancer patients presenting to this institute with a suspicion of COVID-19 from March 1st to April 25th 2020. Data were collected using a web-based tool within electronic patient record approved by the Institutional Review Board. Patient characteristics symptoms and survival were collected and compared in SARS-COV-2 real-time or reverse-transcriptase PCR (RT-PCR)-positive and RT-PCR-negative patients., Results: Fifty-five of the 302 (18.2%) patients with suspected COVID-19 had detectable SARS-COV-2 with RT-PCR in nasopharyngeal samples. RT-PCR-positive patients were older, had more frequently haematological malignancies, respiratory symptoms and suspected COVID-19 pneumonia of computed tomography (CT) scan. However, respectively, 38% and 20% of SARS-COV-2 RT-PCR-negative patients presented similar respiratory symptoms and CT scan images. Thirty of the 302 (9.9%) patients died during the observation period, including 24 (80%) with advanced disease. At the median follow-up of 25 days after the first symptoms, the death rate in RT-PCR-positive and RT-PCR-negative patients were 21% and 10%, respectively. In both groups, independent risk factors for death were male gender, Karnofsky performance status <60, cancer in relapse and respiratory symptoms. Detection of SARS-COV-2 on RT-PCR was not associated with an increased death rate (p = 0.10). None of the treatment given in the previous month (including cytotoxics, PD1 Ab, anti-CD20, VEGFR2…) correlated with survival. The survival of RT-PCR-positive and -negative patients with respiratory symptoms and/or COVID-19 type pneumonia on CT scan was similar with a 18.4% and 19.7% death rate at day 25. Most (22/30, 73%) cancer patients dying during this period were RT-PCR negative., Conclusion: The 30-day death rate of cancer patients with or without documented SARS-COV-2 infection is poor, but the majority of deaths occur in RT-PCR-negative patients., Competing Interests: Conflict of interest statement The authors declare no conflict of interest., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Validated predictive biomarkers for multi-tyrosine kinase inhibitors (MTKI) efficacy are lacking. We hypothesized that interindividual response variability is partially dependent on somatic DNA copy number alterations (SCNAs), particularly those of genes encoding the protein tyrosines targeted by MTKI (called target genes). Genomic alterations were investigated in MTKI responsive and non responsive patients with different histological subtypes included in the ProfiLER protocol (NCT 01774409). From March 2013 to August 2014, 58 patients with advanced cancer treated with one of 7 MTKIs were included in the ProfiLER trial and split into one discovery cohort (n = 13), and 2 validation cohorts (n = 12 and 33). An analysis of the copy number alterations of kinase-coding genes for each of 7 MTKIs was conducted. A prediction algorithm (SUMSCAN) based on the presence of specific gene gains (Tumor Target Charge, TTC) and losses (Tumor Target Losses, TTL) was conceived and validated in 2 independent validation cohorts. MTKI sensitive tumors present a characteristic SCNA profile including a global gain profile, and specific gains for target genes while MTKI resistant tumors present the opposite. SUMSCAN favorable patients achieved longer progression-free and overall survival. This work shows that the copy number sum of kinase-coding genes enables the prediction of response of cancer patients to MTKI, opening a novel paradigm for the treatment selection of these patients.

Cancers can now be classified by multidimensional criteria including tumour site, histology, primary - "driver" - molecular alterations, secondary molecular alterations, characteristics of the immune stroma, and genetic profile of the patient. The development of tools for the characterisation of the cancers, as well as novel molecular and immune therapeutics are evolving at an unprecedented pace. In 2012, a list of future challenges was identified at the occasion of the European Organisation for Research and Treatment of Cancer (EORTC) 50(th) anniversary. Three years after, it is interesting to look back at the questions addressed then and to assess the progress of these questions. We propose here a novel set questions which have emerged from the recent publications in this area., (Copyright © 2015 Société Françise du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés. Published by Elsevier Masson SAS. All rights reserved.)

Background: Cancer patients with CD4 lymphopenia have an increased risk of severe toxicity after administration of cytotoxic chemotherapy. The impact of CD4 lymphopenia on long term overall survival (OS) of cancer patients was explored in this work., Patients and Methods: The first prospective series (test series) included 219 patients with solid tumours, lymphomas or myelomas receiving chemotherapy within an oncology department in 1999 and 2000. A phenotypic analysis of lymphocyte subsets by flow cytometry was performed before chemotherapy on day 1. The prognostic value of total, CD4, CD8 and CD56 lymphocyte count for OS was tested in a multivariate analysis. The prognostic value of low CD4 counts was then tested in a validation series of 269 patients with metastatic solid tumours in second line treatment included in a prospective observational study in the Centre Leon Berard., Results: In the test series, all patients with metastatic cancers and CD4 lymphopenia ≤ 200/μL (12% of metastatic patients) died within 18 months with a median OS of 5.9 months. CD4 count was an independent prognostic factor for OS and PFS in multivariate analysis. In the validation series, 83 (30%) of patients had CD4 count ≤ 200/μL: their median overall survival was 3.9 months with an 18-month survival rate of 6%. CD4 count was also an independent prognostic factor for overall survival in this series., Conclusions: CD4 lymphopenia <200/μL is frequent in advanced cancer patients and associated with a very short life expectancy. These patients should be proposed for specific treatment and research approaches., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Objective: Depression is a frequent problem in cancer patients, which is known to reduce quality of life; however, many cancer patients with depression are not treated because of the difficulties in assessing depression in this population. Our aim was to evaluate and improve the depression assessment strategies of palliative care (PC) physicians and oncologists., Method: We invited all medical oncologists and PC physicians from three cancer centers to participate in this multicenter prospective study. They were asked to classify 22 symptoms (related and specific to depression in cancer patients, related but not specific, and unrelated) as "very important," "important," "less important," or "not important" for the diagnosis of depression in cancer patients, at three different time points (at baseline, after a video education program, and after 4 weeks). They were also asked to complete a questionnaire exploring physicians' perceptions of depression and of their role in its systematic screening., Results: All 34 eligible physicians participated. Baseline performance was good, with >70% of participants correctly classifying at least seven of nine related and specific symptoms. We found no significant improvement in scores in the immediate and 4-week follow-up tests. Additionally, 24 (83%) and 23 (79%) participants expressed support for systematic depression screening and a role for oncologists in screening, respectively., Significance of Results: Oncologists had good baseline knowledge about depression's main symptoms in cancer patients and a positive attitude toward being involved in screening. Underdiagnosis of depression is probably related to problems associated with the oncology working environment rather than the physicians' knowledge.

Purpose: Depression occurs among an estimated 15% of cancer patients (range, 1-77.5%). Our main objective was to identify the frequency of reported depression by using the Brief Edinburgh Depression Scale (BEDS) among cancer outpatients. Our secondary objective was to identify associated symptoms of cancer using the Edmonton Symptom Assessment System (ESAS) and to evaluate the screening performance of depression between ESAS and BEDS., Methods: In this multicenter prospective study conducted, we used the ESAS to collect information on nine symptoms: pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, lack of appetite, and feeling of well-being (each rated from 0 to 10). The BEDS was used to assess for "probable depression" (score >6). Data were analyzed using a parametric and nonparametric test., Results: A total of 146 patients completed the study. The prevalence of probable depression was 43/146 (29%). Probable depression was associated with increased fatigue (p = 0.008), depression (p < 0.0001), anxiety (p < 0.0001), shortness of breath (p = 0.01), and decreased feeling of well-being (p < 0.001). Among patients with probable depression, 42 (98%) patients were not using antidepressants. Regarding the sensitivity and the specificity, we determined that the optimal cutoff for using the ESAS as a depression screening tool was ≥ 2., Conclusion: We found significant associations between probable depression as determined with the BEDS and five symptoms as detected with the ESAS. The vast majority of patients with probable depression were not receiving pharmacological treatment. Depression should be suspected in patients with higher symptom distress as for any one of these 5 ESAS items.