ABSTRACT
Background: The COVID-19 pandemic had a significant impact on the healthcare system globally, including oncology. Which, in turn, led to significant delays in diagnostic and therapeutic procedures. This work aims to evaluate COVID-19 impact on the treatment of bone sarcoma in adult patients based on experience in a single, high-volume institution. Method(s): We have analyzed the early local outcomes (i.e., the possibility of limb-sparing surgery) in all patients with primary bone tumours treated between 2016-01-28 and 2022-11-07 in Polish main sarcoma reference center. Patients treated in the 2016-2019 period were labelled as a "pre-pandemic" group, and patients treated in the 2020-2022 - "pandemic". Mann-Whitney U and Chi-square tests were used in the statistical analysis. Result(s): There were 302 eligible patients identified. The group characteristics are presented in the table. There were no differences in patient-related variables and histological subtypes of tumours between the two groups. The tumour size did not differ (p = 0.053), when all tumour grades were considered, but high-grade tumours were larger in the "pandemic" group (p = 0.034). This was reflected in the percentage of limb-sparing surgeries which dropped from 83.3% to 68.2% ("pre-pandemic" vs "pandemic", p = 0.004). This difference was even more evident in the case of high-grade tumors - 78% vs. 54%, respectively (p = 0.001). [Formula presented] Conclusion(s): To our knowledge, this is the first report of the long-lasting detrimental impact of the COVID-19 pandemic on oncologic treatment outcomes in adult patients with primary malignant bone tumors. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2023 European Society for Medical Oncology
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Background: Durable clinical benefit has been achieved with nivolumab (NIVO) + ipilimumab (IPI), including an overall survival (OS) of 49% and a melanoma-specific survival (MSS) of 56%, with median MSS not reached (NR) at 6.5-y minimum follow-up. Here we report sustained efficacy outcomes at 7.5 y. Methods: Patients (pts) with previously untreated, unresectable stage III/IV melanoma were randomly assigned 1:1:1 and stratified by PD-L1 status, BRAF mutation status, and metastasis stage to receive NIVO 1 mg/kg + IPI 3 mg/kg for 4 doses Q3W, followed by NIVO 3 mg/kg Q2W (n = 314);NIVO 3 mg/kg Q2W + placebo (n = 316);or IPI 3 mg/kg Q3W for 4 doses + placebo (n = 315) until progression or unacceptable toxicity. Co-primary endpoints were progression-free survival (PFS) and OS with NIVO + IPI or NIVO alone versus IPI. Results: With a minimum follow-up of 7.5 y, median OS remained stable at 72.1 mo (NIVO + IPI), 36.9 mo (NIVO), and 19.9 mo (IPI);median MSS was NR, 49.4 mo, and 21.9 mo, respectively (Table). While the objective response rate remained stable at 58% (NIVO + IPI), 45% (NIVO), and 19% (IPI), median duration of response had now been reached for NIVO at 90.8 mo and remains NR and 19.2 mo for NIVO + IPI and IPI, respectively. Subsequent systemic therapy was received by 36%, 49%, and 66% of NIVO + IPI-, NIVO-, and IPI-treated patients, respectively, and median time to that therapy was NR (95% CI, 45.9-NR), 24.7 mo (16.0-38.7), and 8.0 mo (6.5-8.7). Of patients alive at 7.5 y, 106/138 (77%, NIVO + IPI), 80/115 (70%, NIVO), and 27/60 (45%, IPI) were off treatment and had never received subsequent systemic therapy. No change to the safety summary was observed with additional follow-up;updated health-related quality of life data will be reported. Of the 10 new deaths since the 6.5-y follow-up (ie, 5 NIVO + IPI;3 NIVO;2 IPI), none were treatment-related;4 were due to melanoma progression;1 was due to an unknown cause;and 5 were due to other causes, but not associated with a COVID diagnosis. Conclusions: The 7.5-y follow-up continues to demonstrate the durability of responses with NIVO + IPI and an ongoing survival plateau. A substantial difference in median OS and MSS between patients treated with NIVO + IPI or NIVO was observed in descriptive analyses.
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Purpose or Objective The role of perioperative treatment in radiation-induced and in-field recurrent sarcomas (RIS/IFRS) is unknown. Reirradiation may be associated with a risk of significant toxicity;thus, it is rarely used. We hypothesized that the combination of preoperative or definitive 12x 3 Gy radiotherapy (RT) with or without integrated 3.5 Gy to 42 Gy boost combined with regional hyperthermia twice a week will enable satisfactory local control without significant late toxicity in patients with RIS/IFRS. Materials and Methods A prospective phase II, single-arm clinical trial was conducted. We included patients with locally advanced RIS/IFRS without distant metastases. Treatment combined three weeks of radiotherapy, four fractions per week, 3 or 3.5 Gy per fraction, with regional hyperthermia, followed by surgery or observation. The choice of the boost or no-boost regimen was based on resectability (Figure 1). The intervention would be deemed tolerable if significant RT-related (grade 3+ CTCAE 5.0) late adverse events occur in less than 20% of patients. We planned to enroll 20 patients based on Wilson’s method for calculation of confidence intervals. (Figure Presented) Results We recruited 20 patients. All patients completed the treatment without interruptions. Eight of them had RIS whereas twenty were diagnosed with IFRS. Patients’ characteristics were provided in Table 1. Twelve patients from planned 15 underwent surgery. Two patients with potentially resectable tumors did not undergo surgery due to COVID-related reasons. One patient preferred not to undergo surgery after the preoperative no-boost regimen. The remaining five patients were deemed unresectable at the enrollment and received the simultaneous boost. In five patients who underwent resection, we observed extensive pathological response according to the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group recommendations for pathological examination and reporting, namely grade A in two cases and grade C in three cases. In four patients we observed complete radiological response. The median follow-up was 13 months. In 14 patients we noted mild or moderate radiation dermatitis. One patient experienced grade 2 gastrointestinal toxicities. From the late toxicities, we observed restricted limb mobility (grade 1) in one patient and chronic skin ulceration (grade 2) in one patient. None of the patients who developed grade 3 or higher late toxicity. Two patients who received the no-boost regimen and did not undergo resection developed local progression. One patient experienced borderline local relapse after surgery. None of the patients who received the boost regimen developed local progression. Three patients developed distant metastases. One patient was lost to follow-up. (Figure Presented) Conclusion Preliminary data suggest that the tolerance of the regimen is acceptable;however, data regarding late toxicity may change during the follow-up period. Boost may play a significant role in achieving local control in non-resected tumors.
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Background: The diagnosis and treatment of cancer are associated with anxiety of death and cancer recurrence. The outbreak of SARS-CoV-2 pandemic has caused fear and anxiety among cancer patients. Incidence of severe and even fatal complications during SARS-CoV-2 infection is greater in the cancer patients, therefore recommendations of oncological therapy have changed. The aim of the study was the anxiety level analysis among oncology patients during SARS-CoV-2 pandemic in correlation with mental adjustment to cancer. Methods: 306 patients, ≥18-years of age with histologically confirmed cancer and concurrently receiving systemic treatment were enrolled in 4 Oncological Centeres in Poland. The most common types of cancer were breast cancer (n=84), colorectal cancer (n=55) and melanoma (n=25). The level of cancer- related anxiety (CRA) and SARS-CoV-2-related anxiety (SRA) was measured in numerical (0-10 points) scale and validated Fear of COVID-19 Scale. The degree of adaptation to cancer was evaluated with the Mini-Mental Adjustment to Cancer scale (Mini-MAC). The study was performed on May 11-15th, 2020. Non-parametric tests and Spearman correlations were used for statistical analyses. Descriptive statistics are presented as median and interquartile range. The study was approved by the ethics committee. Results: The median of CRA (6;5-10) was higher than SRA anxiety (5;3-8;p=0.025). The level of CRA significantly correlated with coronavirus anxiety (r=0,531;p=0,01). The numerical and Fear of the COVID-19 scales were highly comparable (r=0.741;p<0.001). Gender (p<0.001) and tumor type (p=0.025) were significantly associated with SRA. The anxiety was higher in women (8;5-10) than in men (5;4-8) Patients with breast cancer had the highest SAR, while those with lung cancer had the lowest. Patients with high destructive attitude in Mini-MAC had higher SAR than with low attitude (p<0.001). Conclusions: The level of CRA was higher than SRA among oncological patients during SARS-CoV-2 pandemic. Women with breast cancer and patients with destructive attitude should be provided with increased psychological care. Despite changes in the functioning of oncological healthcare, continuity of care should be maintained. Legal entity responsible for the study: Local Bioetics committee in Olsztyn, c11/2020/VII. Funding: Department of Oncology, University of Warmia and Mazury in Olsztyn. Disclosure: D.S. Sigorski: Travel/Accommodation/Expenses: Astellas. P. Sobczuk: Travel/Accommodation/Expenses: MSD;Travel/Accommodation/Expenses: Roche;Travel/Accommodation/Expenses: Pierre Fabre. P. Rutkowski: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Speaker Bureau/Expert testimony: Bureau;Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS;Honoraria (self): Roche;Honoraria (self), Speaker Bureau/Expert testimony: Pfizer;Honoraria (self), Speaker Bureau/Expert testimony: Eli Lilly;Advisory/Consultancy: Blueprint Medicines. All other authors have declared no conflicts of interest.