المؤلفون: Charlotte Mussini, S. Laghouati, A. Buisson, Christine Mateus, Stéphane Champiat, Clélia Coutzac, A.L. Voisin, Franck Carbonnel, J-C. Soria, Nathalie Chaput, Michael Collins, Jean-Marie Michot, Aurélien Marabelle, Emilie Soularue, F.X. Danlos, Delphine Loirat, I. Rosa, Caroline Robert, Olivier Lambotte

المصدر: Annals of Oncology. 28:2860-2865

مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Abdominal pain, Gastrointestinal Diseases, Nausea, medicine.medical_treatment, Programmed Cell Death 1 Receptor, Antineoplastic Agents, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Microscopic colitis, Neoplasms, Internal medicine, Humans, Medicine, 030212 general & internal medicine, Adverse effect, Acute colitis, Aged, Retrospective Studies, Colectomy, Aged, 80 and over, Inflammation, business.industry, Antibodies, Monoclonal, Retrospective cohort study, Hematology, Middle Aged, Prognosis, medicine.disease, Survival Rate, Oncology, 030220 oncology & carcinogenesis, Vomiting, Female, medicine.symptom, business, Follow-Up Studies

الوصف: Background Immune check-point blockade agents have shown clinical activity in cancer patients but are associated with immune-related adverse events that could limit their development. The aim of this study was to describe the gastrointestinal immune-related adverse events (GI-irAE) in patients with cancer treated with anti-PD-1. Methods this is a retrospective study of consecutive adult patients who had a suspected GI-irAE due to anti-PD-1 antibodies between 2013 and 2016. Patients were recruited through a pharmacovigilance registry. Patients’ data were reviewed by a multidisciplinary committee that included gastroenterologists, oncologists and a pathologist. Quantitative variables are described by median (range), qualitative variable by frequency (percentage). Results Forty-four patients were addressed to a Gastroenterology unit for a suspected GI-IrAE. Twenty patients had a confirmed GI-irAE related to anti-PD-1, which occurred 4.2 months (0.2; 22.1) after the initiation of anti-PD-1. GI-IrAE incidence rate under anti-PD-1 treatment was estimated to be 1.5%. Among patients with GI-IrAE, main symptoms were diarrhoea (n = 16, 80%), abdominal pain (n = 13, 65%), nausea and vomiting (n = 11, 55%), intestinal obstruction (n = 1, 5%), and haematochezia (n = 2, 10%). No patient had colectomy. Four distinct categories of GI-irAE were observed: acute colitis (n = 8, 40%), microscopic colitis (n = 7, 35%), upper gastrointestinal tract inflammation (n = 4, 20%) and pseudo-obstruction (n = 1, 5%). Response rates to corticosteroids were 87.5% (7/8) in acute colitis, 57% (4/7) in microscopic colitis and 75% (3/4) in upper gastrointestinal tract inflammation. Median time to resolution was 36 days (6–172) in acute colitis, and 98 days (42–226) in microscopic colitis. Conclusion This study suggests that GI-irAE are different and less frequent with anti PD-1 than with anti CTLA-4.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a53e88057ca9b27d1be4c33f99f8ccabTest
https://doi.org/10.1093/annonc/mdx403Test

المؤلفون: Paolo A. Ascierto, Amy P. Abernethy, Georgina V. Long, Fiona Taylor, Homa Dastani, Victoria Atkinson, Isabelle Gilloteau, Piotr Rutkowski, Caroline Robert, Kerry J. Savage, Ian M. Waxman, C. Coon, Jessica C. Hassel

المصدر: Annals of Oncology

مصطلحات موضوعية: Oncology, advanced melanoma, Adult, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Dacarbazine, Programmed Cell Death 1 Receptor, Checkmate, Kaplan-Meier Estimate, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, In patient, programmed death-1 receptor, CTLA-4 Antigen, 030212 general & internal medicine, Melanoma, Advanced melanoma, Aged, Health related quality of life, nivolumab, Aged, 80 and over, Chemotherapy, business.industry, Antibodies, Monoclonal, Hematology, Original Articles, Middle Aged, humanities, Surgery, health-related quality of life, 030220 oncology & carcinogenesis, Quality of Life, Female, Nivolumab, business, medicine.drug

الوصف: In patients with advanced melanoma in the CheckMate 066 study, baseline health-related quality of life (HRQoL) with nivolumab was maintained over time, with statistically significant and clinically meaningful improvements in some exploratory analyses, and no HRQoL improvements with dacarbazine. Added to the survival benefit of nivolumab, the benefit-to-risk ratio favors nivolumab over dacarbazine.
Background Nivolumab has shown significant survival benefit and a favorable safety profile compared with dacarbazine chemotherapy among treatment-naïve patients with metastatic melanoma in the CheckMate 066 phase III study. Results from the health-related quality of life (HRQoL) analyses from CheckMate 066 are presented. Patients and methods HRQoL was evaluated at baseline and every 6 weeks while on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D). Via a multi-step statistical plan, data were analyzed descriptively, cross-sectionally, and longitudinally, adjusting for baseline covariates, in patients having baseline plus ≥1 post-baseline assessment. Results Baseline-adjusted completion rates for all HRQoL questionnaires across treatment arms were 65% and 70% for dacarbazine and nivolumab, respectively, and remained similar throughout treatment. The mean baseline HRQoL scores were similar for patients treated with nivolumab and dacarbazine. Baseline HRQoL levels with nivolumab were maintained over time. This exploratory analysis showed a between-arm difference in favor of nivolumab on the EQ-5D utility index and clinically meaningful EQ-5D improvements from baseline at several time points for patients receiving nivolumab. Patients treated with nivolumab did not show increased symptom burden as assessed by the EORTC QLQ-C30. No HRQoL change was noted with dacarbazine patients up to week 43, although the high attrition rate after week 13 did not allow any meaningful analyses. Patients receiving nivolumab deteriorated significantly later than those receiving dacarbazine on several EORTC QLQ-C30 scales and the EQ-5D utility index. Conclusions In addition to prolonged survival, these exploratory HRQoL results show that nivolumab maintains baseline HRQoL levels to provide long-term quality of survival benefit, compared with dacarbazine in patients with advanced melanoma.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2c7407a5a8ba2595d743659fa62f544fTest
http://europepmc.org/articles/PMC5035785Test

المؤلفون: J.-M. Coindre, Sylvie Bonvalot, Eleonora De Martin, Pierre Pouillart, Blay Jy, Sophie Piperno-Neumann, A. Le Cesne, J. Fayette, D. Ranchère, Caroline Robert

المصدر: Annals of Oncology. 18:2030-2036

مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Adolescent, Hemangiosarcoma, Gastroenterology, Internal medicine, medicine, Humans, Angiosarcoma, Progression-free survival, Aged, Retrospective Studies, Aged, 80 and over, Performance status, business.industry, Retrospective cohort study, Hematology, Middle Aged, medicine.disease, Chemotherapy regimen, Surgery, Oncology, Relative risk, Female, Sarcoma, business

الوصف: Background Angiosarcomas are rare, heterogeneous and a retrospective study was conducted to describe their natural history. Patients and methods We reviewed 161 files of angiosarcoma treated in three institutions of the French Sarcoma Group from 1980 to 2004. Survival and prognostic factors for survival were analyzed. Results Median age was 52 years. Primary sites were the breast (35%), skin (20%) and soft tissues (13%). At initial diagnosis, 31 (19%) had metastases. Surgery was the first treatment in 121 (75%) patients combined with chemotherapy or radiotherapy in 34 and 32, respectively. Ninety (74%) of these 121 patients relapsed, mostly locally (50). With an average time since initial diagnosis of 8.1 years, 123 (76%) patients progressed and 76 (47%) died. Median survival was 3.4 years [95% confidence interval (CI) 2.4–5.8], and the 5-year overall survival (OS) rate was 43% (95% CI 33–53). In multivariate analysis, liver primary site [relative risk (RR) = 12.62], performance status (PS) of two or more (RR = 3.83), presence of metastases at diagnosis (RR = 2.50), soft tissue tumor (RR = 0.31) were correlated to OS. PS, liver and soft tissue tumors were identified as independent prognostic factors for progression-free survival. Conclusions Angiosarcomas have an overall poor outcome, but with a clearly distinct prognosis depending on the primary site.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c2867664a4b28854a331587671d480e0Test
https://doi.org/10.1093/annonc/mdm381Test