ABSTRACT
Introduction: Patients presenting for radiation therapy (RT) at a single institution were analysed regarding treatment delays and disparities during the coronavirus disease 2019 (COVID-19) pandemic. Methods: The study was conducted at an urban multidisciplinary cancer centre. In April 2020, the institution's radiation oncology department implemented universal COVID-19 screening protocols prior to RT initiation. COVID-19 testing information on cancer patients planned for RT from 04/2020 to 01/2021 was reviewed. Trends of other lifetime COVID-19 testing and overall care delays were also studied. Results: Two hundred and fifty-four consecutive cancer patients received RT. Median age was 63 years (range 24-94) and 57·9% (n = 147) were Black. Most (n = 107, 42·1%) patients were insured through Medicare. 42·9% (n = 109) presented with stage IV disease. One (0·4%) asymptomatic patient tested positive for COVID-19 pre-RT. The cohort received 975 lifetime COVID-19 tests (median 3 per patient, range 1-18) resulting in 29 positive test results across 21 patients. Sixteen patients had RT delays. Identifying as Hispanic/Latino was associated with testing positive for COVID-19 (p = 0·015) and RT delay (p = 0·029). Conclusion: Most patients with cancer planned for RT tested negative for COVID-19 and proceeded to RT without delay. However, increased testing burden, delays in diagnostic workup and testing positive for COVID-19 may intensify disparities affecting this urban patient population. © The Author(s), 2022. Published by Cambridge University Press.
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BACKGROUND: A novel therapeutic approach using molecularly targeted radiation is currently in development for patients with recurrent GBM. Many tumor types, including GBM, overexpress the L-type amino transporter 1 (LAT-1)4, which is able to internalize the small-molecule amino acid derivative, 4-L-[131I] iodo-phenylalanine (131I-IPA). In preclinical research, combining 131I-IPA with external radiation therapy (XRT) yielded addi- tive cytotoxic effects. Tumoral accumulation of 131I-IPA was confirmed in a proof-of-principle study using single doses of 2-7 GBq 131I-IPA as a monotherapy or in combination with XRT in patients with recurrent GBM. The objective of the IPAX-1 study was to evaluate the safety, tolerability, dosing schedule, and preliminary efficacy of 131I-IPA in combination with secondline radiotherapy in patients with recurrent GBM. METHOD(S): IPAX-1 is a multi-center, open-label, single-arm, dose-finding phase 1/2 study. Key inclusion criteria: 1. Confirmed histological diagnosis of GBM with evidence of first recurrence 2. History of GBM standard therapy 3. >= 6 months since end of first-line XRT 4. Pathologically increased amino acid tumor uptake shown by molecular imaging 5. Current indication for repeat radiation 6. Gross tumour volume of up to 4.8 cm diameter. Treatment: In phase 1 of the study patients received intravenous 131I-IPA at a dose level of 2 GBq administered in one of three different dosing regimens: single dose group with 2 GBq before radiation, 3 (f)-fractionated-parallel group: 3 x 0.67 GBq during XRT and 3 (f)-fractionated-sequential group: 0.67 GBq x 1 -> XRT -> 0.67 GBq x 2. XRT is delivered in 18 fractions of 2 Gy each. RESULT(S): 10 patients were randomized;one patient with Covid related death was withdrawn from analysis. Survival from start of TLX101 therapy showed mPFS2 of 4.33 M (95% -CI 4.18 - 4.48), PFS-6: 18 % and mOS2 of 15.97 M (95% -CI 2.9 - 29.1) at data lock 09/2021. Updated results will be presented at the meeting. CONCLUSION(S): There were no clinically relevant laboratory changes over time. Urinalysis, vital signs, and ECG did not show any clinically relevant changes from baseline. There were no notable differences in safety and tolerability between groups. Injections of single or fractionated doses of 131I-IPA containing a total activity of 2 GBq in combination with XRT in patients with recurrent GBM were safe and well tolerated. Survival data look promising;extension cohort will be treated in a phase II study in Linz;phase 1/2 study in first line setting is planned.
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Objectives: Financial toxicity (FT) impacts approximately 50% of patients with gynecologic malignancies. Still, little is known about factors that predispose patients receiving radiation therapy to financial distress or what impact the COVID-19 pandemic had on their financial well-being. We evaluated FT in patients with gynecologic cancer treated with radiation before and after the start of the COVID- 19 pandemic. Methods: Patients from an urban, academic gynecologic radiation oncology practice completed a survey one month after completing radiation from August 2019-March 2020 and November 2020-June 2021. The survey included demographic questions, the Comprehensive Score for Financial Toxicity (COST) tool, and the EQ-5D to measure the quality of life (QOL). Pandemic-related questions were added during the second survey period (pandemic cohort). As with our prior work, high FT was defined as a COST score of ≤23. We assessed the correlation of COST scores with QOL. We used logbinomial regression to examine associations between FT and costcoping strategies, adjusting for age and insurance. Results: Of 97 respondents (92% response rate), 49% completed the survey before, and 51% completed it after the pandemic started. Among the participants, 76% identified as White, 11% as Black, and 8% as Asian. Most patients had uterine (64%), followed by cervical (24%) and vaginal (6%) cancer. Two-thirds (60%) received external beam radiation with or without brachytherapy;the remaining 40% had brachytherapy alone. The median COST score was 15 (IQR: 7-19) in the high FT group (n=27) and 33 (IQR: 28-36) in the low FT group (n=70). High FT correlated with worse QOL (r=-0.37, p<0.01) and was associated with younger age and type of insurance (both p <0.03). Patients with high FT were more likely to move from full- to parttime employment (22% vs 1%, p<0.01), six (95% CI: 1.0-36) times more likely to delay/avoid medical care, 14 (95% CI: 3-64) times more likely to borrow money, and seven (95% CI: 2-27) times as likely to reduce spending on basic goods. Patients with high FT were more likely to report that decreased ability to work (48% vs 13%), medical bills (41% vs 13%), and transportation or parking (15% vs 3%) mostly contributed to their financial stress (p<0.05 for all). The pandemic cohort had fewer patients with high FT than the pre-pandemic cohort (20% vs 35%, p=0.10) and a higher median COST score (32 [IQR: 25-35] vs 27 [IQR: 19-34], p=0.07). The use of cost-coping strategies did not differ between cohorts. Conclusions: Privately insured, younger patients who received radiation for gynecologic cancer were at risk for FT. High FT correlated with worse QOL and was associated with delays or avoidance of medical care and other cost-coping strategies. The prevalence of high FT was not statistically different before and during the pandemic, though we observed less FT in the pandemic cohort. More work is needed regarding the impact of the COVID-19 pandemic on the financial well-being of patients with cancer.
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Background: Combined-modality treatments are bladder-preserving alternatives for patients (pts) who are not candidates for radical cystectomy by medical reasons, refusal, or patientś choice. Immune therapies seem to potentiate tumor-specific immune response induced by radiotherapy (RT). Combination of RT with anti-PD-1/PD-L1 therapy appears safe and there are signs of promising activity. The aim of this study is to assess the efficacy and safety of atezolizumab (ATZ) concurrent with external beam radiotherapy (EBRT) for the treatment of muscle-invasive bladder cancer (MIBC) with bladder preservation intent. Here we present an interim analysis. Methods: This is an open, multicenter, and phase II trial, sponsored by SOGUG, in pts with confirmed diagnosis of MIBC in clinical stages cT2-T4a N0 M0 who are not candidates for radical cystectomy. Treatment consists of 6 doses of ATZ 1200 mg IV every 3 weeks, starting on day 1 of EBRT, and 60 Gy of RT in 30 fractions over 6 weeks at 2 Gy/day. The primary endpoint of the study is pathological complete response (pCR) defined as a response of grade 5 according to Miller and Payne criteria, 1 to 2 months after the last dose of ATZ. A planned interim analysis has been performed (data cut-off date: November 2021) on the primary endpoint to avoid exposure to ineffective treatment according to the minimax two-stages Simon's design (stopping rule: 9 out of the first 13 evaluable pts should achieve pCR). Incidence of adverse events (AE) and serious AE (SAE) has been also secondarily assessed. Results: From September 2019 to November 2021, 39 pts were screened, of whom 13 were excluded due to non-compliance with eligibility criteria. Thus, the evaluable population consisted of 26 pts. The safety analysis was performed in 22 pts who had received at least one dose of ATZ. 14 pts were assessed pathologically and, thus, included in interim efficacy analysis (median age: 78.6 years;clinical stage: 71.4% T2a, 14.3% T2b, 7.1% T3a, 7.1% T3b). All 14 pts had achieved pCR at the cut-off date. 20/22 (91%) pts experienced at least one AE, with asthenia (11 pts), diarrhea (9 pts), and urinary tract infection (4 pts) being the most common. 9 SAEs were reported in 7 (32%) pts (bacteriemia, COVID-19 infection, depressed LVEF, unknown origin fever, hepatic toxicity, kidney failure, rectorrhagia, respiratory infection, and urinary sepsis). 6 (27%) pts suffered AEs leading to treatment discontinuation. No AEs leading to death occurred. 17 pts with available data on survival were alive at the cut-off date. Conclusions: Interim results suggest that ATZ combined with EBRT is a feasible and effective treatment in terms of pCR, with a manageable safety profile. The final results from this trial will provide information about its effects on clinical outcome, including survival and updated safety findings.
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BACKGROUND/AIM: Many patients with prostate cancer receive definitive or adjuvant radiotherapy. This study aimed to identify the frequency of sleep disturbances and corresponding risk factors prior to radiation treatment. PATIENTS AND METHODS: Data of 48 patients assigned to local or loco-regional irradiation for prostate cancer were retrospectively analyzed for pre-radiotherapy sleep disturbances. Fifteen characteristics were analyzed including age, performance status, comorbidity, history of previous malignancy, distress score, (emotional, physical or practical) problems, prostate-specific antigen, primary tumor stage, Gleason-score, upfront androgen deprivation therapy (ADT), treatment volume, brachytherapy, and COVID-19 pandemic. RESULTS: Pre-radiotherapy sleep disturbances were reported by 20.8% of patients and significantly associated with distress scores ≥4 (p<0.0001) and ≥3 physical problems (p=0.0001). Trends were found for Karnofsky performance score ≤80 (p=0.095), Gleason score 7b-9 (p=0.079), and ADT (p=0.067). CONCLUSION: Pre-radiotherapy sleep disturbances were less common in prostate cancer patients than in other cancer patients. Risk factors were identified that can help identify patients requiring psychological support prior to radiotherapy.