Worse Performance Status Research Articles

Clinical outcomes for radiographic node-positive prostate cancer following definitive radiotherapy.

352 Background: The incidence of regional lymph node metastases at diagnosis is approximately 15%. Androgen deprivation therapy (ADT) with radiotherapy (RT) remains a standard treatment option, but long-term effects and outcomes are understudied. Methods: Data was retrospectively collected from 304 subjects with radiographic node-positive prostate cancer treated with RT from 2014-2024. Covariates include use of androgen receptor signaling inhibitors (ARSI), use of brachytherapy boost to primary disease in prostate, pre-RT PSA, and Gleason Score (GS). Endpoints included biochemical progression (bPFS), distant metastases free survival (DMFS) and overall survival (OS). Kaplan-Meier method, log rank test, univariate (UVA) and multivariate regression analyses (MVA) were used for time to event endpoints. Results: Patient features are summarized in table. 48% of patients had ECOG 0. On MVA, GS 9-10 was significantly associated with worse OS (HR 2.26, 95%CI 1.15 – 4.43, p=0.02), DMFS (HR 2.37, 95%CI 1.32 – 4.24, p<0.01) and bPFS (HR 2.10, 95%CI 1.23 – 3.59, p<0.01). Worse performance status was associated with significantly worse OS (HR 3.14, 95%CI 1.35 – 7.29, p<0.01), DMFS (HR 2.03, 95%CI 0.95 – 4.35, p=0.07) and bPFS (HR 2.01, 95%CI 0.99 – 4.07, p=0.05). Radiation boost dose to involved lymph nodes was significantly associated with OS (p=0.03) and DMFS (p=0.03) but not bPFS. There were no other statistically significant associations on MVA. There was no significant association on UVA between pre-radiation maximum PSA and OS, DMFS, or bPFS. Conclusions: In this cohort of patients treated with ADT and definitive RT, 5-year DMFS was 67%. Gleason score and age were the strongest prognostic features. There was no significant association, but there was numerically higher survival seen with use of ARSI or brachytherapy boost. Future work includes characterizing patterns of care and failure to help optimize management. Characteristics and univariable regression results for OS, DMFS, and bPFS using age and pre-RT PSA as continuous variables. N (%) 5yr OS HR (95%CI) p-value 5yr DMFS HR (95%CI) p-value 5yr bPFS HR (95%CI) p-value Age (continuous) Median age (IQR) 69 (64 – 75) 74% 1.04 (1.00 – 1.09) p=0.07 67% 1.02 (0.99 – 1.06) p=0.2 65% 1.02 (0.99 – 1.05) p=0.3 Gleason 8 156 (54%) 83% 74% 71% 9-10 135 (46%) 69% 2.05 (1.06 – 3.95) p=0.03 62% 2.17 (1.25 – 3.77) p<0.01 60% 2.06 (1.22 – 3.49) p<0.01 Brachytherapy Use Yes 86 (28%) 80% 0.60 (0.27 – 1.35) p=0.2 79% 0.62 (0.31 – 1.22) p=0.2 79% 0.61 (0.32 – 1.16) p=0.13 ARSI Use Yes 182 (60%) 78% 0.91 (0.50 – 1.64) p=0.7 67% 0.90 (0.54 – 1.50) p=0.7 67% 0.79 (0.48 – 1.29) p=0.3 Volume Nodal Boost – Below median Median (IQR) 16.1 cc (7.3 – 33.9) 76% 0.99 (0.54 – 1.80) p>0.9 72% 0.93 (0.55 – 1.56) p=0.8 68% 1.05 (0.64 – 1.73) p=0.8 Volume of radiographically involved lymph nodes assessed as binary variable.

Perioperative versus adjuvant therapy in resectable pancreas cancer.

703 Background: Pancreatic ductal adenocarcinoma (PDAC) is the third-leading cause of cancer death in the United States with a 5-year survival rate of 13%. Recurrence rates are high following resection and optimization of neoadjuvant and adjuvant therapy remains under investigation, with the hypothesis that neoadjuvant/perioperative therapy may convert borderline resectable tumors to resectable and prevent progression of micro-metastases in the postoperative setting. Our study evaluates patient outcomes and models predictive and prognostic markers to assist with clinical decision-making in consideration of neoadjuvant therapy for resectable and borderline resectable pancreatic cancers. Methods: We performed a single-institution retrospective analysis of patients who underwent pancreatic resection between January 1, 2016 and December 31, 2020 (n=532). We excluded patients with unresectable disease or a non-PDAC diagnosis. Analysis of the remaining patients (n=175) was performed using automated and manual chart review, basic statistical comparisons with T-tests or Chi-squared tests, Kaplan-Meier Survival analyses, and Cox Proportional Hazard Testing using intention to treat analysis. Results: There were no significant differences (p>0.05) the presenting demographics between the adjuvant (AJ, n=97) and neoadjuvant/perioperative (NP, n=76) groups. Patients were more likely to have a history of pancreatitis, a risk factor for PDAC development, in the NP group (p=0.0153). Patients in the AJ group included patients who ultimately did not receive the recommended adjuvant therapy for various reasons (n=25) and had overall worse performance status (p=0.004) and received less chemotherapy overall compared to the NP cohort (p=0.0003). Adjuvant therapy was more likely to be gemcitabine with capecitabine (n=37, p=0.0007) in the AJ group and gemcitabine with nab-paclitaxel (n=11, p=0.0018) in the NP group. In the neoadjuvant setting, 62% of patients received FOLFIRINOX and 28% received gemcitabine with nab-paclitaxel. Patients in the NP group were more likely to receive radiation (p=0016), including 6 patients who received neoadjuvant radiation. Median overall survival (33.9 [28.8-43.8] versus 38.2 [28.2-47.8] months) and progression free survival (21.1 [18.1-34.2] versus 16.6 [11.7-23.6] months) were not significantly different between the AJ and NP groups, respectively. Conclusions: These results demonstrate similar presenting characteristics between patients with resectable PDAC treated in a period when general practice shifted from adjuvant therapy to a neoadjuvant/perioperative approach. Although patients treated neoadjuvantly received more chemotherapy overall and the chemotherapy regimens differed between the groups, patients had similar outcomes in the two groups.

Real-world evidence of nanoliposomal irinotecan and fluorouracil with folinic acid in patients with unresectable or recurrent pancreatic cancer: Final results of a multicenter observational study.

721 Background: Nanoliposomal irinotecan (NAL-IRI) and fluorouracil with folinic acid (NFF) is the standard regimen after gemcitabine-based therapy for unresectable or recurrent pancreatic cancer (urPC). However, we have almost no prospective data on its efficacy and safety in the real-world, so we conducted this study to investigate them both retrospectively and prospectively (NAPOLEON-2 study). We previously reported the retrospective data in ASCO-GI 2023, and here we report the final results of the prospective part. Methods: We prospectively collected data of urPC patients treated with NFF who had received at least one previous chemotherapy line in 17 hospitals in Japan from June 2021 to October 2023. The primary endpoint was overall survival (OS). Secondary endpoints were overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), dose intensity (DI) and adverse events (AEs). In addition, OS and PFS among the therapeutic lines of NFF were also analyzed. Results: A total of 150 urPC patients were prospectively enrolled. The median follow-up period was 7.2 months (95% confidence interval [CI], 6.3–8.8); median age, 72 years (range, 45–85), with 81 female patients (54%). The Eastern Cooperative Oncology Group performance status was 0/1/2/3 in 46/93/10/1 patients, respectively. Sixteen patients (11%) had locally advanced disease; 134 (89%) had metastatic disease; 77 (51%) had liver metastasis; and 47 (31%) had peritoneal metastasis. All patients previously received gemcitabine-based therapy. NFF was administered as 2nd/3rd/4th-or-later-line therapy to 87/53/10 patients, respectively. The median OS was 7.8 months (95% CI, 6.6–9.2); median PFS, 3.7 months (95% CI, 2.8–4.9); overall response rate, 11%; and disease control rate, 56%. The relative dose intensity was 72.7% with NAL-IRI and 79.4% with fluorouracil. The initial dose of NAL-IRI was reduced in 84 patients (56%), mainly owing to decreased organ function (17%), followed by age (12%), worsened performance status (10%), or UGT1A1 examination status (5%). Dosage reduction of NAL-IRI during treatment (independent of the initial dose reduction) was performed in 74 patients (49%), mainly owing to neutropenia (22%) and anorexia (11%). Frequent Grade 3/4 adverse events were neutropenia (27%), anorexia (19%), and leukopenia (16%). Grade 5 peritoneal infection was observed in only one patient. The median OS and PFS for NFF in the 2nd-line group, compared with the 3rd-or-later-line group, were 7.4 vs 7.8 months (hazard ratio [HR], 0.97; 95% CI, 0.68–1.39; p=0.88) and 3.3 vs 4.2 months (HR, 1.04; 95% CI, 0.74–1.45; p=0.84), respectively. Conclusions: NFF had appropriate efficacy and manageable toxicity profiles, consistent with our previous report. NFF can be a candidate for 2nd-or-later-line regimens in the real-world. Clinical trial information: UMIN000043939 .

Malignant Hematologic Oncology Referrals to an Outpatient Palliative Care Clinic at a Tertiary Cancer Center.

Malignant Hematologic Oncology Referrals to an Outpatient Palliative Care Clinic at a Tertiary Cancer Center.

Pharmacokinetic exposure and treatment outcomes of lenvatinib in patients with renal cell carcinoma and differentiated thyroid carcinoma.

After initial approval of lenvatinib for radioiodine-refractory differentiated thyroid cancer (DTC), it has also shown promising outcomes in among others metastatic renal cell carcinoma (mRCC). Given that trial populations typically do not represent routine clinical care populations, questions arise about how applicable trial outcomes are in clinical practice. This study aims to compare the pharmacokinetics (PK), toxicity patterns, and survival data of lenvatinib in a real-world cohort with DTC and mRCC to those observed in pivotal clinical trials. Patients were included when diagnosed with DTC or mRCC, had received current or prior treatment with lenvatinib, and had at least one available lenvatinib plasma concentration measurement. A descriptive comparison was made between the baseline characteristics, PK data, toxicity and survival data in this real-world cohort and those described in the phase III trials. Overall, 29 patients with mRCC and 35 patients with DTC were included. For mRCC, median time to treatment discontinuation (mTTD) was shorter than observed in the phase III trial (7.5 versus 11.0 months) with fewer dose-limiting toxicities, likely because 66% of the patients started with a reduced dose. mRCC patients were more pretreated and had a worse performance status than trial participants. This was resembled in overall lower PK exposure in mRCC patients. For DTC, mTTD was longer in our cohort (17.1 versus 13.8 months), with similar toxicity patterns and PK exposure as in the phase III trial. Our data suggests that patient characteristics and outcomes in routine clinical care deviate from clinical trials and show the need for alternative treatment strategies to manage tolerability to lenvatinib.

Considerations to forgo systemic treatment in patients with advanced esophageal or gastric cancer: A real-world evidence study.

The majority of patients with advanced esophageal or gastric cancer do not start palliative systemic treatment. To gain insight into the considerations underlying the decision not to start systemic treatment, we analyzed characteristics of patients starting and not starting systemic treatment, reasons for not starting systemic treatment, and receipt of local palliative treatments on a nationwide scale. Patients diagnosed with advanced esophageal or gastric cancer between 2015 and 2021 were included (n = 10,948). Survival was compared using propensity score matching on patient and disease characteristics. Most patients did not start systemic treatment (esophageal cancer 59%; gastric cancer 64%). These patients were generally older, more often female, had more comorbidities and a worse performance status. The main reason for not starting systemic treatment was patient or family preference (35%). Among patients who did not start systemic treatment, 47% (esophageal) and 19% (gastric), received local palliative treatment, most commonly radiotherapy. Patients who did not start systemic treatment had worse median overall survival compared to patients who did start (esophageal cancer 2.9 months vs. 8.9 months; gastric cancer 2.2 vs. 8.2 months). These findings indicate that patient condition and disease burden are important aspects in systemic treatment decisions. However, patient or family preference was the main reason for not starting systemic treatment, highlighting that their priorities also strongly influence the decision. Systemic treatment did show to be associated with improved overall survival in matched patients, and therefore adequately weighing treatment risks and benefits based on real world data against patient preferences is of utmost importance.

Radiation Segmentectomy or Ablative External Beam Radiation Therapy as Initial Treatment for Solitary Hepatocellular Carcinoma: A Multicenter Experience.

Radiation segmentectomy (RS) and ablative external beam radiation therapy (EBRT) are now accepted, definitive, local therapies for hepatocellular carcinoma (HCC). This report aimed to describe the clinical outcomes of RS and EBRT for treatment-naïve, solitary, HCC. A multicenter retrospective review was performed of all patients treated with RS or EBRT from March 2016 through September 2023. Inclusion criteria were initial treatment for solitary HCC ≤8 cm and absence of macrovascular invasion or extrahepatic disease. Outcomes were censored for liver transplantation (LT). Eighty-six patients (RS: 58; EBRT: 28) met inclusion criteria. The EBRT cohort had older patients (median 76 vs 66 years, p < 0.001), larger tumors (median 3.7 vs 2.4 cm, p < 0.001), and worse performance status (p = 0.02). The RS cohort had more patients with ≥ grade 3 liver fibrosis (p < 0.001). Radiologic complete response (rCR) was achieved in 97% of RS and 82% of EBRT patients (p = 0.02). Median time to rCR was 1 month (95% CI: 0.9-1.1) after RS and 7 months (95% CI: 6-7) after EBRT (p < 0.001). The 1-year local control was 97% vs 93% for RS and EBRT, respectively (p = 0.80). Subsequent LT was performed in 48% of RS and 11% of EBRT patients with tumor complete pathologic response rates of 76% (n=22/28) and 33% (n=1/3), respectively. Progression free survival at 1-year was 87% after RS vs 80% after EBRT (p = 0.26). 1- and 2-year overall survival was 88% and 85% after RS vs 84% and 59% after EBRT (p = 0.34). RS and EBRT are effective therapies for solitary HCC. Treatment should be determined via multidisciplinary discussion based on individual patient characteristics.

Risk factors for post-endoscopic retrograde cholangiopancreatography complications in very elderly patients aged 90 years or older-No additional risk.

In recent years, the majority of patients eligible for endoscopic retrograde cholangiopancreatography (ERCP) have been aged ≥75 years. We investigated ERCP safety in very elderly patients (aged ≥90 years). We included patients aged ≥75 years who underwent ERCP between January 2015 and December 2020. We compared background factors, comorbidities, ERCP indications, complications, and outcomes and identified risk factors for complications using binary logistic regression and inverse probability of treatment weighting with propensity scores. The study included 1344 patients aged ≥75 years (137 and 1207 very elderly and elderly patients, respectively). The very elderly group had more women, less frequent diabetes, fewer antithrombotic medications, more frequent parapapillary diverticulum, less frequent post-cholecystectomy, and worse performance status. No significant differences were observed in the ERCP indications. Experienced endoscopists were likely to perform the procedure, and the procedure time was shorter for the very elderly. Complications occurred in 21 (15%) very elderly patients and 120 (10%) elderly patients, with no significant differences. The very elderly did not have an increased risk of complications but were less likely to be discharged home and had a significantly worse performance status at discharge. ERCP could be safely performed in the very elderly, and age did not increase the risk of complications. Geriatr Gerontol Int 2025; 25: 54-60.

Characteristics and survival of patients with viral versus nonviral associated hepatocellular carcinoma: a multicenter cohort study.

Viral hepatitis B and C are the leading causes of hepatocellular carcinoma (HCC). With obesity, metabolic-related disorders are increasingly associated with a higher incidence of nonviral HCC. This study aimed to investigate the characteristics, tumor features, treatment outcomes, and survival of patients with viral versus nonviral HCC. This multicenter cohort study was conducted at six tertiary care centers. Patients were recruited between February 2007 and June 2022 and follow-up was recorded until death or the study end (July 2023). The patients were divided into viral-related and nonviral HCC groups. We studied baseline patient characteristics, tumor characteristics, treatment, and overall survival (OS). This study included 2233 patients, 1913 patients with viral and 320 patients with nonviral HCC. Patients with nonviral HCC presented with more advanced Barcelona Clinic Liver Cancer (BCLC) stages (BCLC stage C or D were present in 26.3% and 53.8% of patients with viral and nonviral HCC, respectively) that affected the median OS (19.167 vs. 13.830 months, P-value <0.001 for viral and nonviral HCC, respectively). The OS did not differ between patients with viral and nonviral HCC treated with resection, percutaneous ablation, trans-arterial chemoembolization, or Sorafinib. The independent factors affecting the survival of nonviral HCC were albumin-bilirubin score (hazard ratio = 2.323, 95% confidence interval (CI): 1.696-3.181, P-value <0.001), tumor size (hazard ratio = 1.085, 95% CI: 1.019-1.156, P-value 0.011), and alpha-fetoprotein (hazard ratio = 1.000, 95% CI: 1.000-1.000, P-value 0.042). Patients with nonviral HCC had higher BMI, worse performance status, BCLC stage, and tumor response than those with viral HCC.

TMIC-14. RAPID EARLY PROGRESSION IN GLIOBLASTOMA: A COMPREHENSIVE REVIEW OF CLINICAL, IMAGING AND HISTOPATHOLOGICAL FEATURES

Abstract BACKGROUND In glioblastoma patients, Rapid Early Progression (REP) refers to tumour growth between the time of surgery and postoperative chemoradiotherapy. Despite its high incidence relatively little is known about it. The aim of this study was to characterise REP using a combination of clinical, imaging and histopathology data. METHODS Ethical approval was obtained. Supratentorial IDH-wildtype glioblastomas undergoing gross-total resection (GTR) between 2015-2021 were included. REP was defined as a nodular increase in enhancement located within or around the surgical cavity, occurring within 6 weeks of surgery, that was not accounted for by initial areas of diffusion-restriction. REP cases were propensity-score matched to controls on baseline characteristics. Imaging was compared using mean apparent diffusion coefficient (ADC) and T1-postcontrast radiomics. Tissue analyses included DNA methylation subtyping and immunohistochemistry for markers of T-cells (CD3), microglia (P2RY12) and proliferation (PHH3). RESULTS REP occurred in 8/60 GTR cases (13%) and these patients were matched to 16 controls. REP cases had a worse preoperative performance status (median Eastern Cooperative Oncology Group [ECOG] 2 vs. 1), overall-survival (p=0.038) and progression-free survival (p = 0.029). REP was more common in patients over 65 years (27%) and significantly fewer REP patients received radical postoperative chemoradiotherapy (p=0.023). REP and control cases were well matched with respect to preoperative T1-postcontrast radiomics and mean ADC in enhancing (p=0.99) and non-enhancing regions (p=0.67). There was no relative excess of any one DNA methylation subtype in REP cases. The two groups had a similar proportion of T-cells (p=0.81), but REP cases had a trend towards a higher proportion of microglia (31% vs. 17%; p=0.22), and a lower proliferation rate (3% vs. 9%; p=0.19). CONCLUSION REP cases had a worse performance status from diagnosis and received less radical postoperative chemoradiotherapy protocols compared to controls, yielding a significantly shorter median OS/PFS. Differences in immune landscape and proliferation rate should be further investigated.

MANAGEMENT OF THE OLDER PATIENT WITH GLIOBLASTOMA IN THE UK: AN INITIAL REPORT FROM THE HISTO-MOL GBM COLLABORATIVE

Abstract AIMS The management of older (&amp;gt;70 years old) patients with glioblastoma is challenging with significant variation in practice. Using the Histo-Mol GBM database we analysed the variation in practice across 11 UK centres. METHOD Biopsy confirmed glioblastoma patients diagnosed between 01/01-31/12/2021 were identified. Descriptive statistics were used to compare demographic, tumour and treatment characteristics, and the Kaplan-Meier method was used to analyse survival, assessed from surgery date. Differences in treatment between centres were assessed using one way ANOVA. RESULTS In 2021, 81/330 (24.5%) patients with glioblastoma were &amp;gt;70. Compared to younger patients, the older cohort had a greater proportion of males (79.0% vs 59.0%, p&amp;lt;0.001), a worse performance status (66.7% vs 79.5% ECOG PS 0-1, p&amp;lt;0.001), and more likely to have MGMT promoter methylation (30.9% vs 22.9%, p=0.027). Most patients received biopsy only (31/81, 38.3%), followed by subtotal resection (85-94% tumour resection) (26/81, 32.1%), whilst 8/81 (9.9%) underwent debulking, 8/81 near-total resection (95-99% tumour resection), and 8/81 gross total resection, with statistically significant variation in resection extent between centres (p=0.031). Adjuvant radiotherapy was used in 56/81 patients (69.1%) with no difference between centres (p=0.220). However, there was a statistically significant difference in radiotherapy regime between centres (p=0.041). 6/81 (7.4%) received conventional chemoradiotherapy, 28/81 (34.6%) hypofractionated chemoradiotherapy, 16/81 (19.8%) hypofractionated radiotherapy alone, 2/81 (2.5%) temozolomide alone both with MGMT promoter methylation, and 21/81 (25.9%) received no oncological treatment. Median progression free survival was 5.9 months and median overall survival (OS) was 7.1 months with no difference between centres (p=0.199 and p=0.083 respectively). Median OS was 8.4 months with conventional fractionation chemoradiotherapy, 11.2 months with hypofractionated chemoradiotherapy, 7.3 months with hypofractionated radiotherapy alone, 1.8 months with temozolomide alone, and 2.5 months with no oncological treatment. CONCLUSION We identify variations in the treatment of elderly glioblastoma patients across the UK, although these do not significantly impact survival.

Efficacy and Toxicity of [177Lu]Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: Results from the U.S. Expanded-Access Program and Comparisons with Phase 3 VISION Data.

The phase 3 VISION trial demonstrated that [177Lu]Lu-PSMA-617 prolonged progression-free survival and overall survival (OS) in prostate-specific membrane antigen [PSMA]-positive metastatic castration-resistant prostate cancer (mCRPC) patients who progressed on taxane-based chemotherapy and androgen receptor-signaling inhibitors (ARSIs). The U.S. expanded-access program (EAP; NCT04825652) was opened to provide access to [177Lu]Lu-PSMA-617 for eligible patients until regulatory approval was obtained. This study aimed to evaluate the efficacy and safety profile of [177Lu]Lu-PSMA-617 within the EAP and compare the results with those from the VISION trial. Methods: Patients enrolled in the EAP at 4 institutions in the United States with available toxicity and outcome data were included. Outcome measures included OS, a prostate-specific antigen (PSA) response rate (RR) of at least 50%, and incidences of toxicity according to Common Terminology Criteria for Adverse Events version 5.0. Differences in baseline characteristics, outcome data, and toxicity between the EAP and VISION were evaluated using t testing of proportions and survival analyses. Results: In total, 117 patients with mCRPC who received [177Lu]Lu-PSMA-617 within the EAP between May 2021 and March 2022 were eligible and included in this analysis. Patients enrolled in the EAP were more heavily pretreated with ARSI (≥2 ARSI regimens: 70% vs. 46%; P < 0.001) and had worse performance status at baseline (Eastern Cooperative Oncology Group score ≥ 2: 19% vs. 7%; P < 0.001) than VISION patients. EAP and VISION patients had similar levels of grade 3 or higher anemia (18% vs. 13%; P = 0.15), thrombocytopenia (13% vs. 8%; P = 0.13), and neutropenia (3% vs. 3%; P = 0.85) and similar PSA RRs (42% vs. 46%; P = 0.50) and OS (median: 15.1 vs. 15.3 mo; P > 0.05). Conclusion: Patients with PSMA-positive mCRPC who received [177Lu]Lu-PSMA-617 within the EAP were later in their disease trajectory than VISION patients. Patients enrolled in the EAP achieved similar PSA RRs and OS and had a safety profile similar to that of the VISION trial patients.

Fulvestrant en la práctica clínica: análisis de efectividad en pacientes uruguayas con cáncer de mama HR+/HER2.

Fulvestrant demonstrated benefits in overall survival and progression-free survival in patients with advanced breast cancer, who are hormone receptor-positive and human epidermal growth factor receptor 2 negative. The characteristics, evolution, and survival of patients with hormone receptor-positive, HER2-negative breast cancer treated with fulvestrant were evaluated according to the national treatment coverage protocols of the National Resources Fund, with the aim of understanding the efficacy of fulvestrant in patients treated in usual clinical practice and comparing our results with those from pivotal studies. A database from the National Resources Fund covering the period from 2009 to 2022 was used. Survival curves were assessed using the Kaplan-Meier method, and differences were analyzed using the Log-Rank test. A total of 1085 patients with an average age of 63,66 years were included. Following a follow-up of 14 months, the median overall survival was 16 months, and the median progression-free survival was 6 months. The presence of liver and bone metastases was associated with a shorter overall survival. Patients from the public sector and those with a better performance status experienced longer overall survival. Our findings provide a valuable perspective for treatment management in a context of limited resources. Overall survival and progression-free survival were somewhat lower than those reported in pivotal clinical trials. The presence of liver and bone metastases was associated with worse prognosis and survival; additionally, patients with worse performance status had shorter overall survival. These findings underscore the need for personalized therapies, opening new lines of future research.

A multicenter retrospective study to assess feasibility, safety and efficacy of first-line carboplatin-paclitaxel versus carboplatin monotherapy in a frail, elderly epithelial ovarian cancer population

ObjectiveUnderrepresentation of elderly ovarian cancer patients in clinical trials has led to lack of clarity regarding optimal first-line chemotherapy in this cohort. The Elderly Women with Ovarian Cancer (EWOC)-1 trial...

Decreased Long-Term Survival of Patients With Newly Diagnosed Cancer Discharged Home After Unplanned ICU Admission: A Prospective Observational Study.

To compare the 18-month survival between patients with newly diagnosed cancer discharged home after early unplanned ICU admission and those without early unplanned ICU admission; we also evaluated the frequency and risk factors for early unplanned ICU admission. Observational study with prospectively collected data from September 2019 to June 2021 and 18 months follow-up. Single dedicated cancer center in São Paulo, Brazil. We screened consecutive adults with suspected cancer and included those with histologically proven cancer from among 20 highly prevalent cancers. None. The exposure was early unplanned ICU admission, defined as admission for medical reasons or urgent surgery during the first 6 months after cancer diagnosis. The main outcome was 18-month survival after cancer diagnosis, and the main analysis was Cox's proportional hazards model adjusted for confounders and immortal time bias. Propensity score matching was used in the sensitivity analysis. We screened 4738 consecutive adults with suspected cancer and included 3348 patients. Three hundred twelve (9.3%) had early unplanned ICU admission, which was associated with decreased 18-month survival both in the unadjusted (hazard ratio, 4.03; 95% CI, 2.89-5.62) and adjusted (hazard ratio, 1.84; 95% CI, 1.29-2.64) models. The sensitivity analysis confirmed the results because the groups were balanced after matching, and the 18-month survival of patients with early ICU admission was lower compared with patients without early ICU admission (87.0% vs. 93.9%; p = 0.01 log-rank test). Risk factors for early unplanned ICU admission were advanced age, comorbidities, worse performance status, socioeconomic deprivation, metastatic tumors, and hematologic malignancies. Patients with newly diagnosed cancer discharged home after early unplanned ICU admission have decreased 18-month survival compared with patients without early unplanned ICU admission.

Factors associated with receipt of systemic anticancer treatment for locally advanced or metastatic urothelial carcinoma in England: a population-based study

Factors associated with receipt of systemic anticancer treatment for locally advanced or metastatic urothelial carcinoma in England: a population-based study

Time Toxicity Experienced by Early-Phase Cancer Clinical Trial Participants.

Early-phase clinical trials (EP-CTs) are designed to determine optimal dosing, tolerability, and preliminary activity of novel cancer therapeutics. Little is known about the time that patients spend interacting with the health care system (eg, time toxicity) while participating in these studies. We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 to obtain baseline characteristics and number of health care-associated days, defined as all inpatient and outpatient visits while on trial. We used univariable and multivariable analyses to identify predictors of increased time toxicity, defined as the proportion of health care-associated days among total days on trial. For ease of interpretation, we created a dichotomous variable, with high time toxicity defined as ≥20% health care-associated days during time on trial and used regression models to evaluate relationships between time toxicity and clinical outcomes. Among 408 EP-CT participants (mean age, 60.5 years [standard deviation, SD, 12.6]; 56.5% female; 88.2% White; 96.0% non-Hispanic), patients had an average of 22.5% health care-associated days while on trial (SD, 13.8%). Those with GI (B = 0.07; P = .002), head/neck (B = 0.09; P = .004), and breast (B = 0.06; P = .015) cancers and those with worse performance status (B = 0.04; P = .017) and those receiving targeted therapies (B = 0.04; P = .014) experienced higher time toxicity. High time toxicity was associated with decreased disease response rates (odds ratio, 0.07; P < .001), progression-free survival (hazard ratio [HR], 2.10; P < .001), and overall survival (HR, 2.16; P < .001). In this cohort of EP-CT participants, patients spent more than one-fifth of days on trial with health care contact. We identified characteristics associated with higher time toxicity and found that high toxicity correlated with worse clinical outcomes. These data could help inform patient-clinician discussions about EP-CTs, guide future trial design, and identify at-risk patients.

Effect of palliative radiation dose on symptom response in metastatic sarcomas

Effect of palliative radiation dose on symptom response in metastatic sarcomas

Quantification of treatment-related time toxicity in patients with advanced stage cancer.

12137 Background: Treatment-related Time Toxicity (TrTT) in cancer patients is a recently proposed metric to describe the burden of time spent in pursuing medical care, including office/hospital visits, side effect management, lab tests, imaging scans, and travel time. Time toxicity is a valuable concept in patient-centered shared-decision making, especially in the palliative management of end-stage cancer patients with limited life expectancy. Despite tremendous progress in cancer treatment, most of the guideline-recommended treatment options convey short survival benefits of around 3-6 months when compared to supportive care. While medication toxicities are meticulously reviewed with patients, the cumulative burden and impact of time are rarely included in the discussion, partly due to the lack of standardized measurement of TrTT, and the absence of data from clinical trials. Thus, there is a compelling need for the quantification of time toxicity to guide clinical practice and patient preference. Methods: This was an observational analysis of the time toxicity from palliative treatment for patients with incurable solid tumors at a regional safety-net oncology office that focuses on underserved communities. Time toxicity is calculated as the number of days a patient spent with any healthcare-related encounters during a 3-month period from our medical record system. Results: The median age of the total 94 included patients was 57. 54% of the population were Hispanic. The ratios for mild, moderate, and severe time toxicity were 38%, 44%, and 18%, respectively. Immunotherapy was associated with significantly less time toxicity (TrTT = 8.5 days, 95% CI = 6.3-9.7) compared to chemotherapy (26.3 days, 95% CI = 18.3-34.4, P &lt; 0.001), while targeted therapy (13.4, 95% CI = 7.0-19.8, P = 0.01) and hormone therapy (11.9, 95% CI = 4.1-19.7, P &lt; 0.01) also has lower TrTT than chemotherapy. Patients with a worse performance status (ECOG PS 3-4, 30.1 days, 95% CI = 18.3-41.9) experienced higher time toxicity than fitter patients (PS 0-2, 16.7 days, 95% CI = 13.2-20.2, P &lt; 0.05). Among different cancer types, gastrointestinal malignancies were associated with the highest time toxicity with average TrTT of 30.2 days/3 months (95% CI =22.5-37.2). Conclusions: This is the first comprehensive study to quantify real-world Treatment-Related Time Toxicity across multiple cancer and therapy types in an underserved population. We found 18% of patients with incurable solid malignancies experienced severe time toxicity (&gt; 1 in 3 days). Higher TrTT was associated with cytotoxic chemotherapies, GI malignancies, and poor performance status. Time toxicity should be taken into account with other quality-of-life outcomes in treatment pathways and patient-centered oncology care.

Large language models to evaluate racial discrepancies in performance status assignment.

1561 Background: Oncologic treatment eligibility relies heavily on “Performance Status” (PS), a subjective gauge of a patient's overall health. Despite frameworks aimed at quantifying PS, these assessments remain prone to potential bias. A systematic evaluation of discrepancies in language between ECOG PS and race has yet to be conducted. Large language models (LLMs) have the ability to synthesize text and may enable an assessment of the relationship between race, note text, and physician-documented PS. We hypothesize that LLMs can quantify these relationships to understand potential inconsistencies in ECOG PS. Methods: In our single-institution cohort study, we examined patients from medical or radiation oncology clinics between January 2012 to December 2023 with documented ECOG PS. PS was extracted from clinical notes and redacted from downstream analyses. Notes were categorized by patient-reported race (Asian, Black, White, Other). 1,500 matched subjective assessments (from oncologist clinical notes) and PS were randomly sampled for each race, except for Black patients, where only 640 entries were available. We divided training and test sets using an 80-20 ratio across each race. Using the training cohort, we trained race-specific models to assign ECOG PS based on subjective assessment, using two LLMs: UCSFBERT (BERT pretrained on UCSF data) and RoBERTa. In the hold-out test sets, we applied each model across all races to assign ECOG PS based on subjective assessments. These were evaluated by micro-F1 (model accuracy) and Multiway ANOVA to compute model-specific p-values. Results: 13.6% of patients had a documented ECOG 2+, with variation across races (Asian: 16.1%, Black: 17.7%, White: 7.7%, Other: 15.3%). Models tended to assign Black patients with ECOG 0-1 with worse performance status (ECOG 2+). Other than RoBERTa models trained on Asian and White cohorts, all models trained on a specific race showed disparate classification results when applied to other races (out-of-domain), highlighting potential biases in LLM models trained where a specific race predominates (Table; ANOVA). Conclusions: This study demonstrates a novel way to use LLM to assess discordance within physician documentation and performance status assignment. It underscores the need for incorporating diverse demographic data when using LLM in medical contexts. This research has potential to dissect how bias may be propagated within physician practice and provide insight into known disparities in clinical trial enrollment and standard of care implementation.[Table: see text]