Oncology (all articles)
FDA grants approval for Colosense, a noninvasive stool RNA-based test for colorectal cancer screening
11 May, 2024 | 17:48h | UTCGeneoscopy, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense™, a noninvasive stool RNA-based test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for CRC.
Test Performance and Specifications:
– Sensitivity and Specificity: In the CRC-PREVENT trial, ColoSense demonstrated a sensitivity of 93% for detecting colorectal cancer and 45% sensitivity for detecting advanced adenomas (AA).
– Technology: ColoSense employs a multi-target stool RNA (mt-sRNA) approach, detecting colorectal neoplasia-associated RNA markers and occult hemoglobin. This method is designed to overcome variability in test performance that can occur with age-related changes in other biomarkers.
– Breakthrough Device Designation: The test has been designated as a Breakthrough Device by the FDA, acknowledging its potential to offer more effective diagnosis compared to existing methods.
– Accessibility: ColoSense is intended to facilitate increased screening uptake by providing a noninvasive alternative to traditional colonoscopy, particularly among populations reticent about invasive procedures.
Clinical Application:
– Screening Recommendations: Approved for individuals at typical average risk for CRC, ColoSense aligns with updated screening guidelines that recommend starting CRC screening at age 45.
– Role in Screening Strategy: ColoSense is indicated for use as a screening tool but is not intended to replace diagnostic or surveillance colonoscopy in individuals at high risk for CRC.
Geneoscopy is working towards a commercial launch of ColoSense in collaboration with Labcorp (NYSE: LH), aiming to make the test available by late 2024 or early 2025. (link to news release)
Cohort Study: Extending colonoscopy intervals to 15 years seems feasible in after a negative initial test in individuals without family history of CRC – JAMA Oncol
6 May, 2024 | 06:25h | UTCThis cohort study analyzed Swedish register-based data, examining colorectal cancer (CRC) diagnoses and CRC-specific mortality. The study included 110,074 individuals with a negative first colonoscopy (exposed group) and 1,981,332 matched controls, from 1990 to 2018. Participants were aged 45 to 69 at initial screening and were followed for up to 29 years.
During the follow-up, 484 new CRC cases and 112 CRC-specific deaths occurred in the exposed group. The study found significantly lower risks of CRC and CRC-specific death in the exposed group compared to controls over 15 years. The data suggest extending the screening interval from 10 to 15 years could miss only 2 CRC cases and prevent 1 CRC-specific death per 1,000 individuals while potentially reducing unnecessary colonoscopies.
The findings suggest that for individuals with no family history of CRC and a negative initial screening, the standard 10-year colonoscopy interval could safely be extended to 15 years. This adjustment could decrease the number of invasive procedures without significantly impacting cancer incidence and mortality, optimizing resource allocation and reducing patient burden.
Reference (link to abstract – $ for full-text):
RCT: Adding Ibrutinib to immunochemotherapy and autologous stem-cell transplantation improves PFS in young mantle cell lymphoma patients but increases toxicity – The Lancet
5 May, 2024 | 15:02h | UTCStudy Design and Population:
This study is a three-arm, randomized, open-label, phase 3 superiority trial named TRIANGLE, conducted across 165 centers in Europe and Israel. It aimed to compare the effectiveness of adding ibrutinib to standard immunochemotherapy, both with and without autologous stem-cell transplantation (ASCT), in 870 previously untreated mantle cell lymphoma patients aged 18-65 years, suitable for ASCT.
Main Findings:
After a median follow-up of 31 months, the arm with ibrutinib added to immunochemotherapy followed by ASCT (group A+I) demonstrated a 3-year failure-free survival rate of 88% compared to 72% in the standard immunochemotherapy plus ASCT group (group A). This indicates a significant improvement (hazard ratio 0.52; p=0.0008). Conversely, the efficacy of ASCT in the presence of ibrutinib (group A+I vs. group I, ibrutinib without ASCT) remains under analysis. Adverse events were more frequent and severe post-ASCT, particularly concerning hematological complications and infections.
Implications for Practice:
The results suggest that adding ibrutinib to first-line immunochemotherapy regimens significantly enhances clinical outcomes in younger patients with mantle cell lymphoma. However, the increased toxicity observed warrants careful patient monitoring, especially following ASCT. Further research is needed to evaluate the necessity and timing of ASCT in regimens containing ibrutinib.
Reference (link to free full-text):
USPSTF Guideline: Biennial screening mammography recommended for women aged 40-74 to reduce breast cancer morbidity and mortality
1 May, 2024 | 21:45h | UTCStudy Design and Population:
The US Preventive Services Task Force (USPSTF) performed a systematic review and collaborated on modeling studies to evaluate the effectiveness of various mammography-based breast cancer screening strategies. This assessment included factors such as age of initiation and cessation of screening, screening intervals, modalities, and the use of supplemental imaging. The population studied consisted of cisgender women and all other persons assigned female at birth who are 40 years or older and at average risk of breast cancer.
Main Findings:
The USPSTF concludes with moderate certainty that biennial screening mammography for women aged 40 to 74 years provides a moderate net benefit in reducing the incidence of and progression to advanced breast cancer, as well as in decreasing breast cancer morbidity and mortality. However, the evidence is insufficient to assess the benefits and harms of mammography screening in women aged 75 and older, as well as the use of supplemental screening with ultrasound or MRI in women with dense breasts.
Implications for Practice:
Based on these findings, the USPSTF recommends biennial screening mammography for women aged 40 to 74 years. This recommendation aims to optimize breast cancer outcomes while considering the balance of benefits and harms of screening. There is a need for further research to clarify the benefits and risks associated with mammography in women older than 75 and for those with dense breasts considering supplemental screening.
Commentary on X (thread – click for more)
🧵 Just published: USPSTF recommends all women undergo routine #breastcancer screening every other year beginning at age 40, an update from the 2016 recommendation to start at age 50.
https://t.co/xDPK4qu7JH pic.twitter.com/3zVBMWeuKb— JAMA (@JAMA_current) April 30, 2024
Reference (link to free full-text):
RCT: Radiation therapy alone superior to chemoradiation in low-grade localized endometrial cancer recurrences
1 May, 2024 | 21:41h | UTCThis randomized clinical trial assessed the effectiveness of radiation therapy alone versus concurrent chemoradiation in treating localized recurrences of endometrial cancer. Conducted from February 2008 to August 2020, the study involved 165 patients who were randomized to receive either radiation therapy alone or chemoradiation with weekly cisplatin. Findings indicate that radiation therapy alone resulted in longer progression-free survival (PFS) compared to chemoradiation, with a median PFS not reached for radiation alone versus 73 months for chemoradiation. Additionally, radiation therapy demonstrated lower rates of acute toxicity. The study concluded that for patients with low-grade and primarily vaginal recurrences, radiation therapy alone is the preferable treatment option, offering excellent outcomes without the added toxicity of chemotherapy.
Reference (link to abstract – $ for full-text):
AUA/ASCO/SUO Updated guidelines for muscle-invasive urothelial bladder cancer
1 May, 2024 | 21:40h | UTCThe 2024 update to the muscle-invasive bladder cancer (MIBC) guidelines provides a risk-assessed framework for the treatment of this high-risk patient group, which constitutes about 25% of all bladder cancer diagnoses. These guidelines, revised through the AUA amendment process, integrate new research findings from May 2020 to November 2023, involving a rigorous review of 3739 abstracts and 46 full-text articles. Key updates include refined protocols for neoadjuvant and adjuvant chemotherapy, radical cystectomy, and multi-modal bladder-preserving therapies. Recommendations are categorized based on evidence strength, ranging from high to low, and are supplemented by clinical principles and expert opinions in areas lacking robust data. This structured approach aims to enhance clinical outcomes by updating practitioners on optimal management strategies and emphasizing the need for ongoing research to refine these recommendations.
Reference (link to free full-text):
RCT: Aspirin fails to improve invasive disease-free survival in breast cancer patients
1 May, 2024 | 21:37h | UTCThis randomized clinical trial assessed the efficacy of daily aspirin (300 mg) as adjuvant therapy in reducing breast cancer recurrence among 3020 participants with high-risk nonmetastatic breast cancer across the United States and Canada. The study, which followed participants for a median of 33.8 months, found no significant benefit of aspirin on invasive disease-free survival or overall survival, with the hazard ratio for disease-free survival being 1.27 (95% CI, 0.99-1.63; P = .06) and for overall survival 1.19 (95% CI, 0.82-1.72). Given these findings, aspirin is not recommended as an adjuvant treatment for breast cancer, challenging earlier observational data that suggested a potential survival benefit in breast cancer survivors. The trial was concluded early due to the lack of observed benefits, with adverse event rates being similar in both the aspirin and placebo groups.
Commentary on X:
Among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. https://t.co/uPWTeaqXdJ pic.twitter.com/x6Qb4bRlqF
— JAMA (@JAMA_current) April 29, 2024
Reference (link to abstract – $ for full-text):
M-A: Neoadjuvant chemoimmunotherapy enhances event-free survival in resectable NSCLC with low PD-L1 expression
28 Apr, 2024 | 20:20h | UTCThis meta-analysis evaluated the impact of neoadjuvant chemoimmunotherapy versus chemotherapy on resectable non-small cell lung cancer (NSCLC) patients, particularly focusing on those with tumor PD-L1 levels below 1%. The study synthesized data from 43 trials, encompassing 5431 patients, to assess clinical outcomes such as overall and event-free survival, alongside major and complete pathological responses. Findings highlighted that neoadjuvant chemoimmunotherapy significantly improved event-free survival (hazard ratio, 0.74; 95% CI, 0.62-0.89) compared to chemotherapy alone, particularly in patients with low PD-L1 expression, though overall survival benefits were not observed. The pooled analysis from randomized clinical trials showed favorable outcomes across all examined endpoints, supporting the superiority of neoadjuvant chemoimmunotherapy in these settings.
Reference (link to free full-text):
RCT: No improvement in OS with atezolizumab plus cabozantinib vs. docetaxel in metastatic NSCLC post Anti-PD-L1/PD-1 therapy
28 Apr, 2024 | 20:15h | UTCIn a phase III trial, 366 patients with metastatic non-small cell lung cancer (NSCLC) were evaluated to determine the efficacy of atezolizumab combined with cabozantinib versus docetaxel following progression after anti–PD-L1/PD-1 and platinum-based chemotherapy. The study randomly assigned patients to receive either atezolizumab 1,200 mg every 3 weeks plus cabozantinib 40 mg daily or docetaxel 75 mg/m2 every 3 weeks. The results showed no significant difference in median overall survival (OS) between the two groups, with 10.7 months for the combination therapy and 10.5 months for docetaxel (HR 0.88, 95% CI, 0.68-1.16; P = .3668). The safety profiles were consistent with the known risks associated with these treatments.
Reference (link to free full-text):
Meta-Analysis: Efficacy of MRI in prostate cancer screening for reducing unnecessary biopsies
28 Apr, 2024 | 20:13h | UTCThis meta-analysis evaluated the effectiveness of incorporating magnetic resonance imaging (MRI) into prostate cancer screening pathways, compared to prostate-specific antigen (PSA)–only screening strategies. Analyzing data from 80,114 men across 12 studies, the findings demonstrate that MRI-based screening, particularly when using a sequential approach and a PI-RADS score ≥3 cutoff for biopsy, significantly increases the odds of detecting clinically significant prostate cancers (OR, 4.15) while reducing unnecessary biopsies (OR, 0.28) and detection of clinically insignificant cancers (OR, 0.34). Implementing a higher PI-RADS score of ≥4 further decreased the detection of insignificant cancers and biopsies performed, without impacting the detection rate of significant cancers. These results support the integration of MRI into screening programs to enhance diagnostic precision and reduce patient harm.
Reference (link to abstract – $ for full-text):
The Lancet Commission: Global projections and recommendations for managing the increasing burden of prostate cancer
27 Apr, 2024 | 18:42h | UTCThe Lancet Commission’s report on prostate cancer highlights the expected doubling of annual cases from 1.4 million in 2020 to 2.9 million by 2040, driven by demographic changes and increased life expectancy. This comprehensive analysis divides the issue into epidemiology, diagnostics, management of localized and advanced disease, emphasizing disparities between high-income countries (HICs) and low- and middle-income countries (LMICs). Key findings indicate that late diagnoses are common, particularly in LMICs, leading to worse outcomes. The Commission advocates for significant changes in the diagnostic pathways and increased use of current technologies tailored to available resources to improve outcomes. Education and awareness programs are recommended to facilitate early detection and shift the treatment paradigm from palliative to curative, focusing on surgery and radiotherapy. Without decisive action, the global mortality from prostate cancer is set to rise, highlighting the need for urgent interventions across all countries, with a special focus on underserved populations.
Reference:
Cohort Study: Validation of a risk score for severe acute kidney injury in cisplatin treatment
27 Apr, 2024 | 16:24h | UTCStudy Design and Population:
This multicenter cohort study aimed to develop and validate a risk prediction model for severe cisplatin-associated acute kidney injury (CP-AKI). Conducted across six major academic cancer centers in the U.S., it included 24,717 adult participants (≥18 years) who received their first dose of intravenous cisplatin from 2006 to 2022. The study population was split into a derivation cohort of 11,766 and a validation cohort of 12,951.
Main Findings:
The study reported an incidence of CP-AKI of 5.2% in the derivation cohort and 3.3% in the validation cohort. Factors independently associated with CP-AKI included age, hypertension, diabetes, and baseline serum levels of creatinine, magnesium, and other relevant biomarkers. A novel, simple risk score was developed using nine covariates, demonstrating significant predictive capability for CP-AKI. The highest risk category had up to 24.00-fold increased odds of CP-AKI compared to the lowest risk category, with the primary model showing superior discrimination (C statistic 0.75) over previous models.
Implications for Practice:
The validated risk score offers a practical tool for clinicians to estimate the risk of severe CP-AKI in patients undergoing cisplatin chemotherapy. Its use could enhance monitoring strategies and potentially guide therapeutic decision-making to mitigate the risk of kidney injury and associated mortality.
Reference (free full-text):
Gupta et al. (2024). Derivation and external validation of a simple risk score for predicting severe acute kidney injury after intravenous cisplatin: cohort study. BMJ, 384, e077169. DOI: https://doi.org/10.1136/bmj-2023-077169
Clinical validation of a cell-free DNA test for colorectal cancer screening: sensitivity and specificity analysis
20 Mar, 2024 | 19:16h | UTCStudy Design and Population: This study conducted a clinical validation of a cell-free DNA (cfDNA) blood-based test to screen for colorectal cancer in a cohort of 10,258 individuals, 7,861 of whom met the eligibility criteria and were evaluable. The research aimed to assess the test’s performance by comparing its sensitivity for detecting colorectal cancer and its specificity for identifying advanced neoplasia (including colorectal cancer or advanced precancerous lesions) against the outcomes of screening colonoscopy, a standard procedure.
Main Findings: The cfDNA test demonstrated a sensitivity of 83.1% for detecting colorectal cancer, with stage-specific sensitivities of 87.5% for stages I-III cancers. However, its sensitivity for identifying advanced precancerous lesions was notably lower at 13.2%. On the specificity front, the test showed an 89.6% ability to correctly identify individuals without any advanced colorectal neoplasia and had an overall specificity of 89.9% for those with a negative colonoscopy result, indicating no presence of colorectal cancer, advanced precancerous lesions, or non-advanced precancerous lesions.
Implications for Practice: The cfDNA blood-based test presents a promising tool for colorectal cancer screening, boasting substantial sensitivity for colorectal cancer detection and high specificity for advanced neoplasia. Its non-invasive nature could potentially enhance screening adherence, facilitating earlier cancer detection and possibly reducing colorectal cancer-related mortality. However, the test’s low sensitivity for advanced precancerous lesions suggests a need for further research and development to improve early detection capabilities.
Reference: Chung, D.C. et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. Journal Name, Volume(Issue), Pages. Access the study here: [Link]
RCT: Effectiveness of mechanical and oral antibiotic bowel preparation in reducing postoperative complications in elective rectal resection
20 Mar, 2024 | 18:18h | UTCStudy Design and Population
This double-blind, placebo-controlled randomized clinical trial was conducted at three university hospitals in Finland, involving 565 patients aged 18 years and older undergoing elective rectal resection with primary anastomosis for tumors 15 cm or less from the anal verge, as determined by magnetic resonance imaging. Participants were allocated in a 1:1 ratio to either the mechanical and oral antibiotic bowel preparation (MOABP) group, receiving neomycin and metronidazole orally, or to the mechanical bowel preparation (MBP) plus placebo group, with all interventions occurring the day before surgery alongside standard preoperative intravenous antibiotics.
Main Findings
The study found that patients in the MOABP group experienced significantly fewer postoperative complications, with a median Comprehensive Complication Index significantly lower than that of the MBP plus placebo group. Additionally, the MOABP group showed reduced rates of surgical site infections (SSIs) and anastomotic dehiscence compared to the control group, demonstrating a clear benefit in postoperative outcomes.
Implications for Practice
The results of this trial suggest that incorporating oral antibiotics with mechanical bowel preparation prior to elective rectal resection significantly reduces postoperative complications, including SSIs and anastomotic dehiscence. Therefore, MOABP should be adopted as the standard regimen for patients undergoing these procedures to improve postoperative outcomes and reduce the burden of complications. This evidence underscores the importance of updating surgical protocols to include this preparation strategy.
Reference
Laura Koskenvuo et al. (2024). Randomized Clinical Trial: Effectiveness of Mechanical and Oral Antibiotic Bowel Preparation in Reducing Postoperative Complications in Elective Rectal Resection. JAMA Surg, Published online March 20, 2024. DOI: 10.1001/jamasurg.2024.0184. Access the study here: [Link]
Prospective Study: Enhanced detection of colorectal cancer and precancerous lesions with next-generation stool DNA testing
20 Mar, 2024 | 17:41h | UTCStudy Design and Population:
This prospective study evaluated the efficacy of a next-generation multitarget stool DNA test for colorectal cancer screening in asymptomatic adults aged 40 and older. The study encompassed 20,176 participants undergoing screening colonoscopy to determine the test’s sensitivity and specificity in detecting colorectal cancer and advanced neoplasia, including advanced precancerous lesions.
Main Findings:
The next-generation stool DNA test demonstrated a sensitivity of 93.9% for detecting colorectal cancer and a specificity of 90.6% for advanced neoplasia, significantly outperforming the fecal immunochemical test (FIT) in sensitivity for both colorectal cancer and advanced precancerous lesions. However, the test showed slightly lower specificity for advanced neoplasia compared to FIT. No adverse events were reported, indicating the test’s safety for screening purposes.
Implications for Practice:
The findings suggest that the next-generation multitarget stool DNA test offers a superior option for colorectal cancer screening, with significantly higher sensitivity for detecting cancer and advanced precancerous lesions than the currently available FIT. This advance in non-invasive screening technology could lead to earlier detection and treatment of colorectal cancer, potentially improving patient outcomes. Further research may focus on optimizing the balance between sensitivity and specificity to enhance the clinical utility of stool DNA testing.
Reference:
RCT | Superior PFS with avelumab vs. chemotherapy in second-line treatment for mCRC with microsatellite instability
11 Aug, 2023 | 15:25h | UTCSee also: Visual Abstract
Commentary: Avelumab Outperforms Standard Second-Line Therapy in dMMR/MSI Metastatic CRC – Cancer Therapy Advisor
RCT – 2ry analysis | Aerobic exercise intervention shows potential to reduce chemotherapy-induced peripheral neuropathy
11 Aug, 2023 | 15:17h | UTCSee also: Visual Abstract
Commentary: Aerobic Exercise Cuts Chemotherapy-Induced Peripheral Neuropathy Symptoms – HealthDay
Commentary on Twitter
Aerobic exercise improves chemotherapy-induced peripheral neuropathy (CIPN) in women who were treated for ovarian cancer. Incorporating referral to exercise programs as a part of standard of oncology care is recommended. https://t.co/lp9C9seyM6 @anlan_cao
— JAMA Network Open (@JAMANetworkOpen) August 1, 2023
Phase 2 RCT | Adding stereotactic body radiotherapy to immune checkpoint inhibitors fails to improve outcomes in solid tumor patients
9 Aug, 2023 | 15:28h | UTCCheckpoint Inhibitors in Combination With Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors: The CHEERS Phase 2 Randomized Clinical Trial – JAMA Oncology (link to abstract – $ for full-text)
See also: Visual Abstract
Commentary: Addition of SBRT to Immunotherapy in Advanced Solid Tumors – The ASCO Post
Cohort Study | Moderate to heavy drinking linked to increased risk of early-onset colorectal cancer
9 Aug, 2023 | 15:27h | UTCCommentary: Association of Alcohol Intake With Risk of Early-Onset Colorectal Cancer – The ASCO Post
Commentary on Twitter
🧐 Moderate/heavy alcohol intake linked to increased risk of early-onset #ColorectalCancer, particularly distal colon & rectal cancers ➡️ https://t.co/2akaNsHbLu #CRCSM pic.twitter.com/5DGrrmdX4i
— Journal of Clinical Oncology (@JCO_ASCO) July 18, 2023
Determination of “borderline resectable” pancreatic cancer – A global assessment of 30 shades of grey
8 Aug, 2023 | 13:22h | UTC
Commentary on Twitter
What is BORDERLINE respectable?! 🤔
A global assessment of 30 shades of grey 🌗🌑🌓
🚀 Interobserver variability among radiologists and surgeons globally is high
👩⚖️ Central review of images required for quality control initiativeshttps://t.co/Z2G1cInZ5f pic.twitter.com/mlucwMT5f9
— Giovanni Marchegiani (@Gio_Marchegiani) July 30, 2023
Systematic Review | Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer
8 Aug, 2023 | 13:11h | UTCPegylated liposomal doxorubicin for relapsed epithelial ovarian cancer – Cochrane Library
Cohort Study | Potential negative survival impact of PPI and palbociclib co-administration in breast cancer patients
8 Aug, 2023 | 13:07h | UTC
RCT | Upfront radiosurgery reduces tumor volume vs. a wait-and-scan approach in small- to medium-sized vestibular schwannoma
7 Aug, 2023 | 14:40h | UTCUpfront Radiosurgery vs a Wait-and-Scan Approach for Small- or Medium-Sized Vestibular Schwannoma: The V-REX Randomized Clinical Trial – JAMA (free for a limited period)
See also: Visual Abstract
Commentary on Twitter
Among patients with small or medium vestibular schwannoma, a treatment strategy consisting of upfront radiosurgery was more effective at reducing tumor volume at 4 years than was the initial wait-and-scan approach. https://t.co/Qv3YZVsq2Q pic.twitter.com/aNeu7MJfl0
— JAMA (@JAMA_current) August 2, 2023
RCT | Zolbetuximab plus CAPOX as potential first-line treatment for CLDN18.2+, HER2- advanced gastric adenocarcinoma
7 Aug, 2023 | 14:38h | UTC
Commentary on Twitter
In the phase 3 GLOW trial, CAPOX plus zolbetuximab significantly improved progression free survival and overall survival in patients with CLDN18.2+, HER2- untreated #GastricCancer or gastroesophageal junction adenocarcinoma @AstellasUS @mdmanishshah https://t.co/YYbLHhiyOq
— Nature Medicine (@NatureMedicine) August 1, 2023
RCT | Mammography screening with AI reduces workload by 44.3% without loss in detection efficacy
4 Aug, 2023 | 12:13h | UTCArtificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study – The Lancet Oncology (link to abstract – $ for full-text)
News Release: First randomized trial finds AI-supported mammography screening is safe and almost halves radiologist workload – Lancet
Commentaries:
Large Mammography Study Shows Significant Benefits with AI-Aided Screening – Diagnostic Imaging