25 research outputs found

    Does COVID‐19 pandemic impact cancer outcomes in metastatic setting? A comparative cohort study among metastatic patients treated at day care hospital

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    Abstract Introduction COVID‐19 outbreak rapidly spread since early 2020 leading to the implementation of nationwide lockdowns. To cope with this sudden change, management guidelines were quickly published to adapt oncological care, with potential impact on cancer outcomes. Methods We conducted a retrospective comparative cohort study to assess the impact of the COVID‐19 outbreak in 2020 on cancer outcomes in metastatic patients. Two cohorts of metastatic patients receiving intravenous (iv) therapy in a French oncological day care hospital were assessed: a 2020 cohort during the first French lockdown, and a 2018 historical cohort before the COVID‐19 pandemic. We performed a propensity score analysis to match patients from the two cohorts. After one‐year follow‐up, we compared progression‐free survival (PFS) and overall survival (OS) between cohorts. Adaptations of medical oncological treatments in 2020 were also analysed. Results The 376 patients of the 2020 cohort were matched with 376 of the 2018 cohort. No SARS‐CoV‐2 infection was observed in the 2020 cohort. The adjusted PFS was significantly shorter in 2020 compared to 2018 (HR = 1.23; 95% CI: 1.03–1.46), as well as among patients without treatment adaptation compared to matched patients of the 2018 cohort (HR = 1.33; 95% CI: 1.10–1.61). We did not observe any significant difference of PFS among the group with treatment adaptations. OS was not significantly different. Conclusion Metastatic cancer patients treated during the first lockdown had a higher risk of disease progression 1 year after COVID‐19 outbreak. However, oncological treatment adaptations or SARS‐CoV‐2 infections do not explain these results. A longer follow‐up is needed to observe the impact on OS

    Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study

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    International audienceBACKGROUND: Regorafenib has proven activity in patients with pretreated gastrointestinal stromal tumours and colorectal and hepatocellular carcinoma. We designed REGOBONE to assess the efficacy and safety of regorafenib for patients with progressive metastatic osteosarcoma and other bone sarcomas. This trial comprised four parallel independent cohorts: osteosarcoma, Ewing sarcoma, chondrosarcoma, and chordoma. In this Article, we report the results of the osteosarcoma cohort.METHODS: In this non-comparative, double-blind, placebo-controlled, phase 2 trial, patients aged 10 years or older with histologically confirmed osteosarcoma whose disease had progressed after treatment with one to two previous lines of chemotherapy for metastatic disease and an Eastern Cooperative Oncology Group performance status of 0 or 1 were enrolled. Patients were randomly assigned (2:1) to receive either oral regorafenib (160 mg/day, for 21 of 28 days) or matching placebo. Patients in both groups also received best supportive care. Randomisation was done using a web-based system and was stratified (permuted block) by age at inclusion (<18 vs ≄18 years old). Investigators and patients were masked to treatment allocation. Patients in the placebo group, after centrally confirmed progressive disease, could cross over to receive regorafenib. The primary endpoint was the proportion of patients without disease progression at 8 weeks. Analyses were done by modified intention to treat (ie, patients without any major entry criteria violation who initiated masked study drug treatment were included). All participants who received at least one dose of study drug were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT02389244, and the results presented here are the final analysis of the osteosarcoma cohort (others cohorts are ongoing).RESULTS: Between Oct 10, 2014, and April 4, 2017, 43 adult patients were enrolled from 13 French comprehensive cancer centres. All patients received at least one dose of assigned treatment and were evaluable for safety; five patients were excluded for major protocol violations (two in the placebo group and three in the regorafenib group), leaving 38 patients who were evaluable for efficacy (12 in the placebo group and 26 in the regorafenib group). 17 of 26 patients (65%; one-sided 95% CI 47%) in the regorafenib group were non-progressive at 8 weeks compared with no patients in the placebo group. Ten patients in the placebo group crossed over to receive open-label regorafenib after centrally confirmed disease progression. 13 treatment-related serious adverse events occurred in seven (24%) of 29 patients in the regorafenib group versus none of 14 patients in the placebo group. The most common grade 3 or worse treatment-related adverse events during the double-blind period of treatment included hypertension (in seven [24%] of 29 patients in the regorafenib group vs none in the placebo group), hand-foot skin reaction (three [10%] vs none), fatigue (three [10%] vs one [3%]), hypophosphataemia (three [10%] vs none), and chest pain (three [10%] vs none). No treatment-related deaths occurred.CONCLUSIONS: Regorafenib demonstrated clinically meaningful antitumour activity in adult patients with recurrent, progressive, metastatic osteosarcoma after failure of conventional chemotherapy, with a positive effect on delaying disease progression. Regorafenib should be further evaluated in the setting of advanced disease as well as potentially earlier in the disease course for patients at high risk of relapse. Regorafenib might have an important therapeutic role as an agent complementary to standard cytotoxic chemotherapy in the therapeutic armamentarium against osteosarcoma.BACKGROUND: Bayer HealthCare

    Supervised Physical Activity Quickly Improves Social Dimension of Quality of Life in Breast Cancer Patients

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    PurposeThe objectives of the present study was to evaluate the implementation of the program in real life and the evolution of the quality of life (QoL) in breast cancer patients after 3 months of supervised PA in real life and to determine the factors associated with changes in various QoL dimensions.MethodsThis prospective cohort study was carried out in female patients with breast cancer diagnosed within a maximum of 3 yr. QoL and physical exertion intensity during the supervised physical activity (PA) sessions were assessed by the Quality of Life Questionnaire for Cancer and Borg scale, respectively. Statistical analyses comparing QoL scores between the start and the end of supervised PA program were assessed using paired Student's t-tests. Multivariate analysis was performed by linear regression with only variables with a P value ResultsA total of 93 patients were included in the analyses. There was a significant improvement of social functioning at T3 ( increment = 11.5; P < 0.001). The improvement of social functioning was significantly and independently associated with the Borg improvement (beta = 2.66 +/- 1.31, P = 0.046), chemotherapy (beta = 11.03 +/- 5.45, P = 0.046), hormone therapy (beta = -13.91 +/- 5.51, P = 0.013), social isolation (beta = -14.81 +/- 6.55, P = 0.026), and comorbidities (beta = -15.32 +/- 5.59, P = 0.007).ConclusionsWe observed a real enthusiasm and need among patients for practicing PA supervised by a sport trainer near their home. The increase in the intensity of exercise over time contributes to the improvement of the QoL, especially on the social functioning. These results, consistent with previous literature, reinforce the importance of exercise intensity on many dimensions of QoL. In addition, patients expressed great satisfaction with the supervised program, resulting in a strong desire to maintain long-term PA
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