tbuckley/cabot-search huggingface dataset:
Efficacy of treatment with traditional Chinese patent medicine (<i>Fufang E'jiao Syrup</i>) for cancer-related fatigue in patients with advanced cancer: A randomized, double-blinded, placebo-controlled, multicenter trial.
Authors: Shan Shan Gu, Yun Xu, Jun J. Mao, Lingyun Sun, Ning Cui, Feiye Wang, Jing Dong, Xingyu Guo, Li Fu, Jinghui Wang, Jiyan Shi, Yumei Zeng, Yidan Hu, Zipei Zhang
Journal: Journal of Clinical Oncology (2024)

12053 Background: There is ongoing interest in finding effective drugs for cancer-related fatigue (CRF) in advanced cancer patients, although studies have had mixed results. Fufang E'jiao Syrup (FFEJS), a traditional Chinese patent medicine, has shown promise in alleviating CRF. This trial aims to investigate whether FFEJS could reduce fatigue and improve quality of life in advanced cancer patients. Methods: This prospective, multicenter, double-blinded, placebo-controlled trial was implemented at 29 hospitals in China, enrolling 611 advanced non-small cell lung cancer, colorectal cancer, and gastric cancer patients with Visual Analogue Scale for Fatigue ≥ 4 points. The study was conducted between September 23, 2019 and April 7, 2022, with a final follow-up on May 25, 2022. Participants were randomized to receive FFEJS (20 ml, 3 times per day) or a matching placebo orally for six weeks. The safety assessments were extended until the fourth week after the trial ended. The primary outcome was the change in total mean score (range: 0 [no fatigue] to 10 [extreme fatigue] points) on the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV) from baseline to week 6. Secondary outcomes include quality of life (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F) and adverse events. FFEJS were compared with the placebo group using a linear mixed model. Results: Among 611 patients randomized (FFEJS: 303 and placebo: 308; 210 non-small cell lung cancer [34.4%], 201 colorectal cancer [32.9%], 200 gastric cancer [32.7%]; mean [SD] age, 62.8 [9.3] years; 413 [68.3%] man; mean [SD] baseline RPFS-CV total mean score, 4.86 [1.30] points), 503 (82.3%) completed the primary end point. By the end of week 6, the FFEJS group achieved normal fatigue levels (RPFS-CV &lt; 4) compared to the placebo group (FFEJS: 3.78 vs Placebo: 4.39, adjusted mean difference 0.59 points [95% CI, 0.45 to 0.76 points]; P &lt; .001). The adjusted mean difference for a favorable shift to a higher FACIT-F total score at week 6 comparing FFEJS with placebo was 2.77 points (97.36 vs 94.23 points; [95% CI, 0.56-4.96 points]; P = .02). There was no difference in adverse events occurrence between FFEJS and the placebo groups (110 [20%] vs 122 [18%], P = .38). Conclusions: In this randomized clinical trial among advanced cancer patients with CRF, FFEJS reducedfatigue severity and improved quality of life compared to placebo. Research is needed to assess the mechanism, clinical effect, and long-term safety of FFEJS for CRF in advanced cancer patients. Clinical trial information: NCT04147312 .
Fragility index analysis of systemic therapy clinical trials in soft tissue sarcoma (STS).
Authors: Dina Braik, Brooke Wilson, Albiruni Ryan Abdul Razak, Abdulazeez Salawu
Journal: Journal of Clinical Oncology (2024)

11581 Background: The fragility index (FI) measures the robustness of randomized clinical trials (RCT) that have positive results based on statistical p-values. It estimates the minimum number of events that are needed to reverse the trial results from positive to negative. Here, we perform FI analysis on RCTs evaluating systemic treatments for STS. Methods: A systematic search of the Medline and Embase databases for RCTs in adults with advanced STS (Jan 1998 to Dec 2023) was conducted. Gastrointestinal stromal tumor trials were excluded. The FI framework was adapted to allow the use of time-to-event (TTE) outcomes – progression-free survival (PFS) or overall survival (OS) as previously described (Desnoyers et al 2021). Survival tables were reconstructed from published data on positive TTE outcomes, using the Parmar Toolkit. Positive secondary endpoints were used only if the primary endpoint was negative. The number of additional events that would result in a non-significant effect for the hazard ratio (HR) of the positive endpoint of each trial (FI) was calculated and expressed as a proportion of the size of the experimental arm (fragility quotient; FQ). The number of censored patients – those who withdrew consent or were lost to follow-up (C n ) was noted. Results: Among 47 RCTs, 16 (8 phase II; 8 phase III) trials had positive outcomes. The primary endpoint was positive and used for FI analysis in 11/16 trials (68.8%). PFS was the most common positive outcome, evaluated in 13 trials (81.3%). The median FI was 6 (range 2 – 52), with FI &lt; 10 observed in 11 trials (68.8%). Median FQ was 7% (range 1 – 59%) and 10 trials (62.5%) had FQ &lt; 10%. Among 14 trials that reported data, C n was ≥ FI in 7 trials (50%). Only 2 of 4 trials (50%) that led to regulatory approval had FI &gt; 10 or FQ &gt; 10%. Of the other 2, one drug approval was subsequently withdrawn (Table). Conclusions: Most positive clinical trials in STS were fragile and their outcomes may be confounded by the level of censoring. Real-world evaluation of approved systemic therapies and value scales such as ESMO Magnitude of Clinical Benefit scale or ASCO value framework are needed to confirm clinical benefit of systemic treatments in STS.[Table: see text]
Disparities by sex in Hispanic patients with cutaneous melanoma: A national database analysis.
Authors: Anjali Mishra, Mitchell Taylor, Bianca Ituarte, Michaela Clausen, Erin Barett
Journal: Journal of Clinical Oncology (2024)

e23045 Background: Melanoma is the fifth most common form of malignancy in the United States. 1 Studies have established that Hispanic patients have worse melanoma-specific survival compared to non-Hispanic White individuals. 2 However, there is a paucity of literature investigating sex differences in patient characteristics and outcomes within Hispanic melanoma patients. Thus, the aim of this study is to further examine sex differences in melanoma characteristics and disease-specific survival within Hispanic patients. Methods: Individuals of Hispanic descent diagnosed with microscopically confirmed cases of cutaneous melanoma (ICD-O-3 codes 8720/3-8780/3; Primary Site codes C44.0-C44.9) between 2000 and 2020 were identified through the Surveillance, Epidemiology, and End Results (SEER) database. Statistical analyses involved Chi-squared tests, Kaplan-Meier and log-rank methods, and multivariate Cox regression, with significance set at a p-value &lt; 0.05. Results: In a cohort of 12,328 Hispanic melanoma patients (43.3% male, 56.7% female), a significant association between sex and age was found (p &lt; 0.001). The greatest proportion of males were in the 60-79 age group (39.7%), while females were predominantly in the 40-59 age group (39.0%). Greater number of males had truncal melanomas (31.4%) compared to females having lower extremity melanomas (35.2%) (p &lt; 0.001). Females exhibited higher rates of localized disease (80.3% vs 70.2%) while males were more frequently diagnosed with regional (18.5% vs 13.8%) and distant disease (11.3% vs 5.9%) (p &lt; 0.001). Males demonstrated greater mean Breslow thickness (1.80 vs 1.44; p &lt; 0.001), elevated rates of lymph node positivity (37.2% vs 27.2%; p &lt; 0.001), and metastatic disease (2.8% vs 1.6%; p &lt; 0.001). On univariate Kaplan-Meier analysis, males demonstrated significantly reduced disease-specific survival (182.9 months) compared to females (214.2 months) (p &lt; 0.001). After adjusting for age, disease stage, annual income, rural vs urban residence, and primary tumor site, male sex independently increased disease-specific mortality compared to females (HR = 1.31; 95% CI 1.16-1.48; p &lt; 0.001). Conclusions: Our investigation reveals that Hispanic males tend to receive melanoma diagnoses at older ages, advanced-stage disease, and primarily on the trunk. 3 Furthermore, our study is the first to highlight a significantly reduced disease-specific survival in males compared to females. The observed sex differences may arise from a complex interplay of behavioral factors and immunological, hormonal, or genetic influences. 4 Men exhibit a lower likelihood of engaging in skin self-examinations and seeking medical assistance. Limitations to this study include use of data reported through a national database. Nonetheless, this study underscores the significance of sex-specific variations in presentation and disease-specific survival among Hispanic patients.
Comparison of drug treatment intent in stage IV solid tumors in EU4+UK.
Authors: Federico Gallo, Elsa Ng
Journal: Journal of Clinical Oncology (2024)

e23323 Background: The goal of cancer treatment may vary based on multiple factors. This study uses real-world data to compare treatment intent, and its evolution over time among patients with solid tumors; whilst we focus on stage IV cohorts, a comparison vs. stage I-III patients is also made, for context. Methods: Ipsos’ Global Oncology Monitor is a multi-stakeholder, physician-reported syndicated patient record database. 3,308 solid tumor-treating physicians (France = 834, Germany = 709, Italy = 578, Spain = 626, UK = 561) were screened for seniority and caseload and submitted data on 329,154 patients (France = 64,985, Germany = 77,709, Italy = 64,507, Spain = 65,427, UK = 56,526). Data were collected online from January 2020 to September 2023. Sample data were projected to the wider clinical population using market sizing extrapolations. Results: Of all solid tumor patients reported, regardless of stage, control cancer spread and/or growth (extend life) is the most common cited goal by sampled physicians when choosing drug therapy for the patient in question (average ~50% reported patients). This is followed by intent of eliminating cancer cells to undetectable levels (curative), while the intent to ease cancer symptoms (palliative) is typically less likely to be selected. Treatment intent at stage I-III showed similar trends, with curative being the most common goal (average ~70% of reported patients). When focusing on Stage IV solid tumors we observe life extension generally emerging as the main intention; a more nuanced analysis reveals similarity between Germany and Spain, where palliative intent is cited more often by sampled physicians compare to other regional counterparts. These differences are shown in Table 1. Little change seen in curative intent from 2020 to 2023 across all regions, except UK, where a downward trend is reflected from Q3 2022 onwards with a concurrent increase in extend life. Conclusions: This study indicates that treating to cure is a common aim for EU4+UK sampled physicians when giving drug therapy to stage I-III solid tumor patients, whilst extending life is the notable goal when considering stage IV patients. Additional analysis of tumor- and region-specific changes over time may help establish any potential influences on drug treatment choice due to factors such as reimbursement and treatment type availability. Further investigation using comparator cohort is warranted. [Table: see text]
Assessing the impact of unmeasured confounding in external control arms via tipping point analyses.
Authors: Xiang Yin, Elizabeth Stuart, Mehmet Burcu, Mark Stewart, Elizabeth B. Lamont, Ruthanna Davi
Journal: Journal of Clinical Oncology (2024)

e23065 Background: Estimates of the comparative efficacy of new therapies from single-arm settings can be obtained in advance of RCTs through use of external control arms (ECAs).[1] ECAs are collections of patients with the index disease who were treated outside of the single-arm trial, whose measured baseline attributes are matched to the single-arm trial patients and whose outcomes are compared to trial patients’ to estimate comparative efficacy. Without randomization, observed treatment-outcome associations may be confounded by unmeasured patient attributes. Applying established statistical methods, we estimate the magnitude and prevalence of unmeasured confounding required to move an apparently favorable hazard ratio (HR) to the “tipping point” where the new drug is no longer associated with a favorable survival statistically or clinically. Methods: Studying previously reported patients with multiple myeloma treated with an experimental therapy in a clinical trial (N = 290) and patients treated with standard of care therapy from a rigorously matched ECA (N = 290), we applied the method of Lin et al. to adjust the observed treatment effect (HR and 95% CIs) for overall survival to reflect the impact of a (set of) unmeasured confounder(s).[1,2] Lin’s formula incorporates both the unmeasured confounder’s theoretical association with mortality and its prevalence according to treatment group (i.e., single-arm trial vs. ECA). Results: The observed treatment effect for the single-arm trial treated vs. ECA patients was HR 0.76 (95% CI 0.63-0.91). We estimated the impact of an unmeasured confounder (where HR for overall survival of those patients with and without the confounder is set to 1.5) by its prevalence in each group. When the prevalence of the unmeasured confounder is balanced across groups there is no change in the observed treatment effect. When the presence of the confounder is 70% for ECA patients and absent in the trial patients, the clinical tipping point occurs with loss of the favorable HR (i.e., HR 1.02, 95% CI: 0.85-1.23). Conclusions: While novel analytic methods like ECAs have the potential to accelerate drug development, the lack of randomization raises concern for potential unmeasured confounding. Applying Lin’s method, we illustrate that the impact of unmeasured confounding on HR estimates from a single-arm trial vs.an ECA is a function of both the association with mortality and asymmetries in prevalence. Consistency in the efficacy conclusion for all clinically tenable assumptions indicates a qualitatively reliable conclusion. Friends of Cancer Research whitepaper (2019): available online at https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf. Lin D, Psaty B, Kronmal R. Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics.1998; 54:948–963.
The outcome of COVID-19 infection among Saudi oncology patients.
Authors: Ahmed Ali Badran, Tarek Arabi, Ahmed Ba Theeb, Abdulmalik Ba Wazir, Heba Aly Ateya, Amgad Shaheen, Belal Nedal Sabbah, Mohamed Tlayjeh, Ziyad Aldabbagh, Marwan Alaswad, Mahmoud Abdelsatar Elshenawy, Marwa Nofal, Judy Badran, Shouki Bazarbashi
Journal: Journal of Clinical Oncology (2024)

e23085 Background: Little data are available surrounding the outcomes and risk factors of COVID-19 in Saudi oncological patients. This study aims to elucidate the outcomes of COVID-19 infection among Saudi oncology patients and associated risk factors. Methods: We retrospectively reviewed the medical files of oncology patients who were diagnosed with COVID-19 at the King Faisal Specialist Hospital and Research Centre. The time from a positive PCR until death or last follow-up was calculated as COVID-specific survival. A p-value less than 0.05 was selected as the threshold for statistical significance. Results: 161 oncological patients were included in our analysis. The mean age was 53.83±15.81. 85 (52.8%) patients were female, 17 (10.6%) had a positive history of smoking, and 57 (35.4%) were obese. 70 (43.5%) patients had diabetes mellitus, 64 (39.8%) had hypertension, and 25 (15.5%) had dyslipidemia. The most common cancer in the group was breast cancer, which was present in 24 (14.9%), followed by non-Hodgkin lymphoma, colon cancer, and acute leukemia, respectively. 57 (35.4%) patients had no evidence of disease (NED) at presentation. Furthermore, 65 (40.4%) patients had received antineoplastic therapy within 30 days before infection. 25 (15.5%) patients had stage A COVID-19, 59 (36.6%) had stage B, 48 (29.8%) had stage C, and 29 (18%) had stage D. There was no difference between active and no NED patients in remission in regard to the stages of COVID-19 infection at presentation (p = 0.05). However, the stages of COVID were less severe in patients who received antineoplastic therapy (p = 0.02). 32 (19.9%) patients received tocilizumab during the acute phase of infection. Only 5 (3.1%) patients suffered COVID-specific death. Therefore, the median COVID-specific survival was not reached. Tocilizumab (p = 0.34), corticosteroids (p = 0.77), ACE inhibitors (p = 0.45) had no impact on COVID-specific death in our patient population. In patients who received steroid treatment, the duration of corticosteroid had no impact on survival (HR: 0.76, p = 0.39). Ventilation also had no impact on survival (p = 0.55). There was no difference between patients who received antineoplastic therapy within 30 days from infection and those who did not (p = 0.99). Finally, we noted no difference in survival between patients with active disease and NED patients (p = 0.17). Conclusions: COVID-related mortality is lower in Saudi oncology patients compared to other countries. Early management and admission of oncological patients may result in overall improved outcome. In line with some studies, antineoplastic therapy can reduce COVID-19 severity, possibly due to reduced ACE receptor expression.
Clinicopathological analysis and management of primary cardiac sarcomas: A retrospective study from two cancer centers in China.
Authors: Qing Ji, Zhichao Tan, Jun Cao, Meiyu Fang, Jiayong Liu
Journal: Journal of Clinical Oncology (2024)

e23544 Background: Primary cardiac sarcomas (PCS) are rare malignant tumors associated with a poor prognosis. The clinical and pathological features of PCS remain elusive. Methods: We retrospectively collected records of patients with PCS at Peking University Cancer Hospital and Zhejiang Cancer Hospital from 2016 to 2023. Clinicopathological data, treatments, and outcomes were included and analyzed. Results: Between January 2016 and October 2023, a total of 26 patients with primary cardiac sarcoma were included, with the majority of patients being female (57.7%). The median age of the patients was 38.5 years (range: 15-82). Tumors were most frequently located in the right (42.3%) and left (26.9%) atria. The predominant histological subtype was angiosarcoma (46.1%), followed by myxoid fibrosarcoma (15.4%) and intimal sarcoma (11.5%). At baseline, the LDH level was elevated in 42.3% of patients. Metastases were observed in 21 (80.8%) patients, predominantly in lung (61.9%), bone (42.9%) and liver (28.6%). Nineteen patients (73.1%) underwent surgery for the primary tumor, with 8 (42.1%) achieving a complete (R0) resection and 11 (57.9%) achieving a microscopically (R1) or macroscopically (R2) incomplete resection. Sixteen patients (61.5%) received anthracycline-based chemotherapy as their first-line palliative treatment. The median overall survival (OS) for all patients was 19.2 months (95% CI: 16.7-31.2). Patients with normal baseline LDH levels had a significantly longer median OS (25.4 months) compared to patients with elevated LDH levels (11.6 months, P= 0.001). The median OS was 25.4 months for patients who underwent R0 resection, compared to 18.7 months for those who underwent R1/R2 resection, and 6.03 months for those who did not undergo surgery. Patients who received anthracycline-based chemotherapy had a moderately better survival than those who received paclitaxel-based chemotherapy (mOS 19.2 vs.14.8 months, P= 0.13). Conclusions: In patients with PCS, angiosarcoma is the predominant histological subtype, and the most common sites of metastasis are the lung, bone, and liver. Elevated LDH is associated with a poorer prognosis. Complete surgical resection of the cardiac sarcoma after diagnosis may benefit long-term survival. [Table: see text]
Unveiling the impact: Exploring thrombotic outcomes in hospitalized patients with COVID-19—Comparing those with and without a cancer diagnosis.
Authors: Muhammad Mujtaba Bhinder, Elaine A. Davis, Christine A. Welch, Amir Shahzad Kamran
Journal: Journal of Clinical Oncology (2024)

e23318 Background: There is a shared hypercoagulable association of COVID-19 and cancer, noting an increased risk of thromboembolic events (TEE)in both conditions. The current study focuses on patients with concurrent COVID-19 and underlying cancer and compares incidence of TEE and related outcomes in this complex intersection of acute viral infection and oncological challenges. Methods: In this retrospective cohort study, we examined data from the Charleston Area Medical Center’s (CAMC) COVID-19 Registry, involving 5,479 adult, symptomatic, PCR-positive COVID-19 hospitalized patients (3/1/2020 to 1/20/2024). Demographics, co-morbidities, lab values, treatments, and outcomes were assessed. Propensity score matching (3:1) non-cancer patients vs those with an active cancer diagnosis was undertaken using sex and age. SAS 9.4 was utilized for the analysis. The groups were compared using Chi-square/Fisher’s Exact tests for categorical variables and t-tests for continuous variables and a logistic regression modelling to determine differences in key variables, the incidence of thromboembolic events and other outcomes. Results: After propensity matching, 1,623 non-cancer and 427 active cancer patients were included. The incidence of venous thromboembolism (VTE) was higher in the active cancer group (9.42% vs 4.2%, P &lt; 0.001) with no significant differences in acute stroke. Intensive care unit (ICU) admissions, mechanical or non-invasive ventilation requirement, and mortality were not different although more patients with cancer were discharged to hospice (11.8% vs 3.3%, P &lt; 0.001). However, mean D-dimer results in both groups were &gt; 2.5 mg/L, it was not performed consistently. The active cancer group had greater frequencies of abnormal ferritin levels (59.1% vs 49.1%, P=0.01), and elevated procalcitonin levels &gt; 0.05 ng/mL (72.9% vs 60.6%, p &lt; 0.001). Among key treatments, remdesivir was used more frequently in cancer patients (41.4% vs 35.7%, P &lt; 0.01). In addition to the cancer diagnosis (OR = 1.729 95% CI [1.1-2.8] P =0.02), LOS &gt; / = 7days was also a predictor of TEE (OR= 1.825 95% CI [1.1-2.9] P &lt; 0.01). Conclusions: Symptomatic VTE rates in our COVID-19 and active cancer cohort align with published studies. Diligence in evaluation of D-dimer, early detection of TEE and adherence to published guidelines in prophylaxis and treatment is recommended.