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Oncology (all articles)

Cohort Study: GLP1 receptor agonist use not associated with significant increase in thyroid cancer risk – The BMJ

25 May, 2024 | 19:51h | UTC

A large Scandinavian cohort study investigated the association between glucagon-like peptide 1 (GLP1) receptor agonist use and thyroid cancer risk in Denmark, Norway, and Sweden from 2007 to 2021. The study compared 145,410 patients treated with GLP1 receptor agonists to 291,667 patients treated with dipeptidyl peptidase 4 (DPP4) inhibitors and included an additional analysis with sodium-glucose cotransporter 2 (SGLT2) inhibitors. Results showed no significant increase in thyroid cancer risk among GLP1 users over a mean follow-up of 3.9 years, with a hazard ratio of 0.93 (95% CI, 0.66 to 1.31) compared to DPP4 inhibitor users. The study utilized nationwide cancer registers and employed an active-comparator, new user design to minimize confounding, using Cox regression models adjusted by propensity score weighting. The findings suggest that while small risk increases cannot be definitively ruled out, the use of GLP1 receptor agonists does not substantially elevate thyroid cancer risk.

 

Reference (link to free full-text):

Björn Pasternak et al. (2024). Glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer: Scandinavian cohort study. BMJ, 385. DOI: https://doi.org/10.1136/bmj-2023-078225

 

RCT: Ponatinib shows superior MRD-negative complete remission rates compared to Imatinib in newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia – JAMA

25 May, 2024 | 19:03h | UTC

This global phase 3 randomized clinical trial investigated the efficacy and safety of ponatinib versus imatinib in adults with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL). The study, conducted across 77 sites, enrolled 245 patients who were randomized in a 2:1 ratio to receive either ponatinib (30 mg/d) or imatinib (600 mg/d) alongside reduced-intensity chemotherapy. The primary endpoint of the trial was minimal residual disease–negative (MRD-negative) complete remission, assessed at the end of cycle 3. Results showed that ponatinib achieved a significantly higher MRD-negative complete remission rate of 34.4% compared to 16.7% with imatinib. Additionally, the safety profile between the two drugs was comparable, with arterial occlusive events being rare and similar across groups. These findings suggest ponatinib as a potentially preferable frontline therapy in this patient population due to its superior efficacy in achieving MRD-negative status without compromising safety.

 

Reference (link to abstract – $ for full-text):

Jabbour E, Kantarjian HM, Aldoss I, et al. (2024). Ponatinib vs Imatinib in Frontline Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. Published online May 9, 2024. doi:10.1001/jama.2024.4783

 

RCT: Impact of single PSA screening invitation on 15-year prostate cancer mortality – JAMA

25 May, 2024 | 19:01h | UTC

Study Design and Population: This study is a secondary analysis of the Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP), which focused on the long-term effects of prostate-specific antigen (PSA) screening on prostate cancer mortality. It involved 415,357 men aged 50 to 69 years from 573 primary care practices across England and Wales. Participants were randomized to either receive a single invitation for a PSA screening or to a control group receiving standard practice without invitation. The follow-up period concluded on March 31, 2021, after a median duration of 15 years.

Main Findings: The intervention group, which received one PSA screening invitation, showed a prostate cancer mortality rate of 0.69% compared to 0.78% in the control group, translating to a rate ratio of 0.92 and demonstrating a statistically significant but modest reduction in death from prostate cancer. Additionally, the screening led to increased detection rates of low-grade and localized prostate cancer. However, there were no significant differences in detection of more advanced cancer stages between the two groups. All-cause mortality rates were similar across both groups.

Implications for Practice: While the introduction of a single PSA screening invitation was associated with a slight decrease in prostate cancer mortality over 15 years, the absolute reduction was small. These findings suggest that while PSA screening can detect cancer earlier, its impact on long-term survival is limited and should be weighed against the potential for overdiagnosis and overtreatment. Future strategies in prostate cancer screening might need to focus more on risk stratification and personalized screening approaches to maximize benefits and minimize unnecessary interventions.

 

Reference (link to abstract – $ for full-text):

Martin RM et al. (2024). Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality: A Secondary Analysis of the CAP Randomized Clinical Trial. JAMA, 331(17), 1460-1470. DOI: 10.1001/jama.2024.4011

 

RCT: Omission of axillary dissection noninferior to complete dissection in clinically node-negative breast cancer with sentinel-node metastases – N Engl J Med

25 May, 2024 | 18:57h | UTC

Study Design and Population: This noninferiority trial explored the effects of omitting completion axillary-lymph-node dissection in patients with clinically node-negative primary T1 to T3 breast cancer who had one or two sentinel-node macrometastases. A total of 2766 patients were enrolled and randomized 1:1 to either undergo sentinel-node biopsy only or completion dissection. Patients received adjuvant treatment and radiation therapy as per national guidelines, focusing on recurrence-free survival as a secondary end point.

Main Findings: The study reported that the 5-year recurrence-free survival rates were 89.7% in the sentinel-node biopsy-only group and 88.7% in the dissection group, with a country-adjusted hazard ratio for recurrence or death at 0.89 (95% CI, 0.66 to 1.19), significantly below the noninferiority margin (P<0.001). This outcome demonstrates the noninferiority of the less invasive sentinel-node biopsy approach compared to the traditional dissection method in managing sentinel-node macrometastases.

Implications for Practice: The findings suggest that for clinically node-negative breast cancer patients with sentinel-node macrometastases, omitting axillary-lymph-node dissection could be considered a viable treatment option, potentially reducing the surgical burden without compromising recurrence-free survival outcomes. This could lead to adjustments in surgical practice and patient care strategies, emphasizing a less invasive approach while maintaining clinical efficacy.

 

Reference (link to abstract – $ for full-text):

Boniface, J. et al. (2024). Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med, 390(13), 1163-1175. DOI: 10.1056/NEJMoa2313487.

 

RCT: Laparoscopic hemihepatectomy for primary or metastatic cancer offers faster recovery and improved quality of life compared to open surgery – J Clin Oncol

25 May, 2024 | 18:52h | UTC

Study Design and Population: This study was a multicenter, randomized controlled, patient-blinded, superiority trial involving adult patients undergoing major liver resection (hemihepatectomy) primarily for cancer. Conducted across 16 European hospitals from November 2013 to December 2018, it included 352 patients who were randomized, with 332 completing the surgery—166 each in the laparoscopic and open surgery groups.

Main Findings: The primary outcome, time to functional recovery, was significantly shorter for the laparoscopic group, averaging 4 days compared to 5 days for the open surgery group (P < .001). Quality of life assessments showed higher scores for global health status and body image in the laparoscopic group. Although major complication rates were similar between the two groups, the laparoscopic approach demonstrated a notable advantage in the secondary cancer-specific outcome of time to adjuvant systemic therapy, which was significantly shorter compared to the open surgery group.

Implications for Practice: The findings suggest that laparoscopic hemihepatectomy not only enhances functional recovery and quality of life but also accelerates the initiation of adjuvant therapy in cancer patients without compromising safety or oncological outcomes. This evidence supports the broader adoption of laparoscopic techniques in major liver resections, particularly for cancer-related surgeries, to improve postoperative recovery and patient well-being.

 

Reference (link to abstract – $ for full-text):

Fichtinger RS et al. (2024). Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial. Journal of Clinical Oncology. DOI: 10.1200/JCO.23.01019.

 

FDA grants approval for Colosense, a noninvasive stool RNA-based test for colorectal cancer screening

11 May, 2024 | 17:48h | UTC

Geneoscopy, 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 | UTC

This 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):

Qunfeng Liang et al. (2024). Longer Interval Between First Colonoscopy With Negative Findings for Colorectal Cancer and Repeat Colonoscopy. JAMA Oncol., Published online May 2, 2024. DOI: 10.1001/jamaoncol.2024.0827.

 

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 | UTC

Study 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):

Dreyling, M., et al. (2024). Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. The Lancet, 404(10184), 1938-1952. DOI: https://doi.org/10.1016/S0140-6736(24)00184-3.

 

USPSTF Guideline: Biennial screening mammography recommended for women aged 40-74 to reduce breast cancer morbidity and mortality

1 May, 2024 | 21:45h | UTC

Study 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)

 

Reference (link to free full-text):

Screening for Breast Cancer US Preventive Services Task Force Recommendation Statement. JAMA. Published online April 30, 2024. doi:10.1001/jama.2024.5534

 

RCT: Radiation therapy alone superior to chemoradiation in low-grade localized endometrial cancer recurrences

1 May, 2024 | 21:41h | UTC

This 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):

Ann H. Klopp et al. (Year). Radiation Therapy With or Without Cisplatin for Local Recurrences of Endometrial Cancer: Results From an NRG Oncology/GOG Prospective Randomized Multicenter Clinical Trial. Journal of Clinical Oncology. DOI: 10.1200/JCO.23.01279

 

AUA/ASCO/SUO Updated guidelines for muscle-invasive urothelial bladder cancer

1 May, 2024 | 21:40h | UTC

The 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):

Holzbeierlein et al. (2024). Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO GUIDELINE (2017; Amended 2020, 2024). Journal of Urology. DOI: https://doi.org/10.1097/JU.0000000000003981

 

RCT: Aspirin fails to improve invasive disease-free survival in breast cancer patients

1 May, 2024 | 21:37h | UTC

This 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:

 

Reference (link to abstract – $ for full-text):

Wendy Y. Chen et al. (2024). Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA, Published online April 29, 2024. doi:10.1001/jama.2024.4840

 

M-A: Neoadjuvant chemoimmunotherapy enhances event-free survival in resectable NSCLC with low PD-L1 expression

28 Apr, 2024 | 20:20h | UTC

This 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):

Sorin, M., Prosty, C., Ghaleb, L., et al. (2024). Neoadjuvant Chemoimmunotherapy for NSCLC A Systematic Review and Meta-Analysis. JAMA Oncology. doi:10.1001/jamaoncol.2024.0057.

 

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 | UTC

In 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):

Joel Neal et al. (2024). CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non–Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. Journal of Clinical Oncology. DOI: 10.1200/JCO.23.02166

 

Meta-Analysis: Efficacy of MRI in prostate cancer screening for reducing unnecessary biopsies

28 Apr, 2024 | 20:13h | UTC

This 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):

Tamás Fazekas et al. (2024). Magnetic Resonance Imaging in Prostate Cancer Screening:  A Systematic Review and Meta-Analysis. JAMA Oncol, Published online April 5, 2024. DOI: 10.1001/jamaoncol.2024.0734

 

The Lancet Commission: Global projections and recommendations for managing the increasing burden of prostate cancer

27 Apr, 2024 | 18:42h | UTC

The 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:

James, N.D., Tannock, I., N’Dow, J., Feng, F., Gillessen, S., Ali, S.A., et al. (2024). The Lancet Commission on prostate cancer: planning for the surge in cases. The Lancet, 404(10052), 1-29. DOI: https://doi.org/10.1016/S0140-6736(24)00651-2.

Cohort Study: Validation of a risk score for severe acute kidney injury in cisplatin treatment

27 Apr, 2024 | 16:24h | UTC

Study 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 | UTC

Study 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 | UTC

Study 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 | UTC

Study 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:

Imperiale, T. F.et al, & BLUE-C Study Investigators (2024). Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med, 390(11), 984-993. DOI: 10.1056/NEJMoa2310336.

RCT | Superior PFS with avelumab vs. chemotherapy in second-line treatment for mCRC with microsatellite instability

11 Aug, 2023 | 15:25h | UTC

Avelumab vs Standard Second-Line Chemotherapy in Patients With Metastatic Colorectal Cancer and Microsatellite Instability: A Randomized Clinical Trial – JAMA Oncology

See 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 | UTC

Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer: A Secondary Analysis of a Randomized Clinical Trial – JAMA Network Open

See also: Visual Abstract

Commentary: Aerobic Exercise Cuts Chemotherapy-Induced Peripheral Neuropathy Symptoms – HealthDay

 

Commentary on Twitter

 

Phase 2 RCT | Adding stereotactic body radiotherapy to immune checkpoint inhibitors fails to improve outcomes in solid tumor patients

9 Aug, 2023 | 15:28h | UTC

Checkpoint 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 | UTC

Sex and Tumor-Site Differences in the Association of Alcohol Intake With the Risk of Early-Onset Colorectal Cancer – Journal of Clinical Oncology

Commentary: Association of Alcohol Intake With Risk of Early-Onset Colorectal Cancer – The ASCO Post

 

Commentary on Twitter

 

Determination of “borderline resectable” pancreatic cancer – A global assessment of 30 shades of grey

8 Aug, 2023 | 13:22h | UTC

Determination of “borderline resectable” pancreatic cancer – A global assessment of 30 shades of grey – HPB

 

Commentary on Twitter

 

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