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Oncology – Gastrointestinal

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.

 

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

 

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

 

RCT | Zolbetuximab plus CAPOX as potential first-line treatment for CLDN18.2+, HER2- advanced gastric adenocarcinoma

7 Aug, 2023 | 14:38h | UTC

Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial – Nature Medicine

 

Commentary on Twitter

 

ACP Guidance | Asymptomatic CRC screening advised from age 50 with fecal occult blood test every 2 years or colonoscopy every 10 years

3 Aug, 2023 | 13:48h | UTC

Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians – Annals of Internal Medicine

News Release: ACP issues updated guidance for colorectal cancer screening of asymptomatic adults – American College of Physicians

Commentary: Start screening for colorectal cancer at age 50 years, ACP suggests – ACP Internist

Summary for Patients: Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults – Annals of Internal Medicine

 

RCT | Camrelizumab-rivoceranib outperforms sorafenib as first-line therapy for unresectable HCC

2 Aug, 2023 | 13:53h | UTC

Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter

 

Nonrandomized Controlled Trial | Long-term survival of 80% in selected colorectal cancer patients post liver transplant

1 Aug, 2023 | 14:20h | UTC

Long-Term Survival, Prognostic Factors, and Selection of Patients With Colorectal Cancer for Liver Transplant: A Nonrandomized Controlled Trial – JAMA Surgery (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Efficacy of different treatment regimens in unresectable colorectal cancer liver metastases

14 Jul, 2023 | 12:42h | UTC

First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group – The Lancet Oncology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | FOLFOXIRI-Bevacizumab shows promise as first-line treatment in unresectable colorectal cancer metastases

5 Jul, 2023 | 01:02h | UTC

First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group – The Lancet Oncology (link to abstract – $ for full-tetxt)

 

Consensus Paper | Colorectal neuroendocrine tumors

30 Jun, 2023 | 14:45h | UTC

European Neuroendocrine Tumor Society (ENETS) 2023 guidance paper for colorectal neuroendocrine tumours – Journal of Neuroendocrinology

 

SR | Supportive care interventions for managing gastrointestinal symptoms following treatment for colorectal cancer

22 Jun, 2023 | 14:49h | UTC

Supportive care interventions for managing gastrointestinal symptoms following treatment for colorectal cancer: a systematic review – Journal of Cancer Survivorship

 

RCT | Fruquintinib extends median survival to 7.4 months vs. 4.8 months with placebo in refractory metastatic colorectal cancer

19 Jun, 2023 | 14:02h | UTC

Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter questioning the control group (thread – click for more)

 

Cohort Study | Overweight or obesity in early and middle adulthood linked to higher gastrointestinal cancer risk

5 Jun, 2023 | 13:34h | UTC

Analysis of Body Mass Index in Early and Middle Adulthood and Estimated Risk of Gastrointestinal Cancer – JAMA Network Open

Editorial: Obesity and Gastrointestinal Cancer: A Life Course Perspective – JAMA Network Open

Commentary: Association Between Overweight/Obesity and Risk of Gastrointestinal Cancer – The ASCO Post

 

AASLD practice guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma

30 May, 2023 | 11:51h | UTC

AASLD practice guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma – Hepatology

 

M-A | Prehabilitation may enhance functional capacity in pre- and postoperative colorectal cancer patients

30 May, 2023 | 11:50h | UTC

Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery – Cochrane Library

Summary: Preparing a patient with bowel cancer for surgery with multiple interventions – Cochrane Library

 

Review | Cholangiocarcinoma — novel biological insights and therapeutic strategies

22 May, 2023 | 13:38h | UTC

Cholangiocarcinoma — novel biological insights and therapeutic strategies – Nature Reviews Clinical Oncology

 

Commentary on Twitter

 

Review | Hereditary colorectal, gastric, and pancreatic cancer

18 May, 2023 | 13:43h | UTC

Hereditary colorectal, gastric, and pancreatic cancer: comprehensive review – BJS Open

 

Commentary on Twitter

 

Current perioperative care in pancreatoduodenectomy: a step-by-step surgical roadmap from first visit to discharge

16 May, 2023 | 14:52h | UTC

Current Perioperative Care in Pancreatoduodenectomy: A Step-by-Step Surgical Roadmap from First Visit to Discharge – Cancers

 

Commentary on Twitter

 

An update on the role of immunohistochemistry in the evaluation of pancreatic/liver/gastrointestinal luminal tract disorders

15 May, 2023 | 13:02h | UTC

An Update on the Role of Immunohistochemistry in the Evaluation of Pancreatic/Liver/Gastrointestinal Luminal Tract Disorders – Archives of Pathology & Laboratory Medicine

 

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