Oncology (all articles)
RCT: More Extensive Lymph Node Removal Does Not Improve Outcomes in Right-Sided Colon Cancer Surgery
7 Sep, 2024 | 09:56h | UTCStudy Design and Population: This multicenter, open-label, randomized controlled trial (RELARC) evaluated the efficacy of complete mesocolic excision (CME) versus D2 lymphadenectomy for right-sided colon cancer. Conducted across 17 hospitals in China, the study enrolled 1,072 patients with stage T2-T4aNanyM0 or TanyN+M0 disease. Participants were randomized (1:1) to undergo either CME or D2 dissection, and the primary outcome was 3-year disease-free survival (DFS), with 3-year overall survival (OS) as the main secondary outcome.
Main Findings: Among 995 analyzed patients, no significant differences were observed between CME and D2 groups in 3-year DFS (86.1% vs. 81.9%, HR 0.74, P = 0.06) or 3-year OS (94.7% vs. 92.6%, HR 0.70, P = 0.17). While CME trended toward better DFS, the results were not statistically significant.
Implications for Practice: Given the lack of significant survival benefit, the trial supports D2 dissection as the standard surgical approach for right-sided colon cancer. CME may be reserved for cases with evident mesocolic lymph node involvement.
Cohort Study: Short-Course Radiotherapy with CAPOX Shows Favorable Outcomes in High-Risk Locally Advanced Rectal Cancer
7 Sep, 2024 | 09:38h | UTCStudy Design and Population: This Swedish nationwide cohort study examined total neoadjuvant treatment (TNT) for 273 patients with high-risk locally advanced rectal cancer (LARC) using short-course radiotherapy (5×5 Gy) followed by four cycles of CAPOX chemotherapy. Patients were treated between July 2016 and June 2020 across 16 hospitals, with 189 additional patients treated off-study. The study aimed to evaluate the complete response (CR) rate, comparing outcomes with the RAPIDO trial.
Main Findings: The CR rate, including both pathological complete response (pCR) and clinical complete response (cCR), was 24% (LARCT-US group) and 23% (AdmL group), comparable to the RAPIDO trial’s results. Locoregional recurrences were low (6% and 5%, respectively) after 3 years. Neurotoxicity was lower than in RAPIDO, and overall, the treatment was well tolerated. Notably, two fewer chemotherapy cycles did not compromise the CR rate.
Implications for Practice: While the study demonstrates promising outcomes using short-course radiotherapy and four CAPOX cycles for locally advanced rectal cancer (LARC), these findings are based on an observational study, which inherently limits the ability to draw definitive causal conclusions. Despite this, the real-world data suggests that a shorter chemotherapy regimen may be both feasible and effective. Further randomized trials are needed to confirm these results and assess long-term outcomes. Clinicians should cautiously apply this regimen, considering both the evidence and individual patient factors.
Clinical Trial Follow-Up: Continued Imatinib Significantly Extends Survival and Delays Resistance in Advanced GIST – The Lancet Oncology
25 Aug, 2024 | 11:55h | UTCStudy Design and Population: This exploratory long-term follow-up of the BFR14 open-label, multicenter, randomized phase 3 trial involved patients with advanced gastrointestinal stromal tumors (GIST) across 17 cancer centers in France. The trial included patients aged 18 years or older with stable disease after 1, 3, or 5 years of treatment with imatinib. Participants were randomized to either continue or discontinue imatinib until disease progression, with primary endpoint analysis focused on progression-free survival (PFS).
Main Findings: Imatinib continuation significantly extended PFS compared to discontinuation, with median PFS ranging from 27.8 to over 67.0 months in the continuation group versus 6.1 to 12.0 months in the interruption group, depending on the duration of prior treatment (p-values <0.002). Additionally, continuing imatinib delayed resistance and improved overall survival, particularly notable after 3 years of treatment, with a median overall survival of 134.0 months compared to 104.0 months in the discontinuation group (HR 0.40, p=0.0096).
Implications for Practice: These findings strongly discourage the interruption of imatinib in GIST patients who are stable or responding to treatment, as it leads to worse long-term outcomes, including quicker disease progression and increased resistance to the therapy.
RCT: Cold Snare EMR Reduces Major Adverse Events but Increases Residual Adenoma in Large Nonpedunculated Colorectal Polyps – Gastroenterology
25 Aug, 2024 | 11:45h | UTCStudy Design and Population: This multicentric randomized controlled trial (RCT) involved 19 centers in Germany and included 363 patients with 396 large nonpedunculated colorectal polyps (≥20 mm). Participants were randomly assigned to undergo either cold snare endoscopic mucosal resection (EMR) or the traditional hot snare EMR. The study aimed to compare the safety and effectiveness of cold versus hot snare EMR.
Main Findings: Cold snare EMR significantly reduced the incidence of major adverse events (AEs), with a major AE rate of 1.0% compared to 7.9% in the hot snare group. This included significant reductions in perforation and postendoscopic bleeding rates. However, cold snare EMR was associated with a higher rate of residual adenoma at follow-up, with 23.7% of cases compared to 13.8% in the hot snare group. The increased rate of residual adenoma was particularly noted in larger lesions (≥4 cm) and those with high-grade dysplasia.
Implications for Practice: Cold snare EMR offers a safer alternative to hot snare EMR for resecting large nonpedunculated colorectal polyps, particularly in terms of reducing major AEs. However, the higher rate of residual adenoma indicates that cold snare EMR should be used selectively, especially for smaller polyps or less likely to have advanced histology. Further research is needed to refine lesion selection criteria and to explore technical modifications that could improve the efficacy of cold snare EMR.
RCT: : Belzutifan Improves Progression-Free Survival and Objective Response Compared to Everolimus in Advanced Renal-Cell Carcinoma – N Engl J Med
24 Aug, 2024 | 16:48h | UTCStudy Design and Population: This phase 3, multicenter, open-label trial included 746 participants with advanced clear-cell renal-cell carcinoma who had previously undergone immune checkpoint and antiangiogenic therapies. Participants were randomly assigned to receive either belzutifan (120 mg daily) or everolimus (10 mg daily) until disease progression or intolerable toxicity occurred.
Main Findings: The median progression-free survival was identical at 5.6 months for both groups. However, at 18 months, a significantly higher percentage of participants in the belzutifan group (24.0%) remained progression-free compared to the everolimus group (8.3%, P=0.002). Belzutifan also led to a significantly higher objective response rate (21.9% vs. 3.5%, P<0.001). Median overall survival was similar between the groups, with no significant difference (21.4 months vs. 18.1 months, P=0.20).
Implications for Practice: Belzutifan offers a substantial benefit in progression-free survival and objective response rate over everolimus in patients with advanced renal-cell carcinoma post previous therapies. It was well-tolerated, with safety comparable to everolimus, suggesting its potential as a preferred treatment option in this patient population.
RCT: Belantamab Mafodotin Combination Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma Compared to Daratumumab-Based Therapy – N Engl J Med
18 Aug, 2024 | 19:03h | UTCStudy Design and Population: This phase 3, open-label, randomized controlled trial compared the efficacy and safety of belantamab mafodotin, bortezomib, and dexamethasone (BVd) versus daratumumab, bortezomib, and dexamethasone (DVd) in 494 patients with relapsed or refractory multiple myeloma after at least one prior therapy. Patients were randomly assigned to the BVd group (243) or the DVd group (251) and were followed for a median of 28.2 months.
Main Findings: The BVd regimen significantly improved median progression-free survival (36.6 months vs. 13.4 months; HR, 0.41; P<0.001) compared to the DVd regimen. Overall survival at 18 months was also higher in the BVd group (84% vs. 73%). The BVd group showed a higher rate of complete response or better plus MRD-negative status (25% vs. 10%). However, the BVd regimen was associated with a higher incidence of grade 3 or higher adverse events (95% vs. 78%), particularly ocular events.
Implications for Practice: BVd therapy offers a significant progression-free survival advantage over DVd in patients with relapsed or refractory multiple myeloma, though it is associated with a higher rate of serious adverse events, particularly ocular toxicity. These findings suggest BVd as a potent treatment option but highlight the need for careful monitoring and management of side effects, particularly eye-related complications.
Retrospective Cohort Study: Rheumatoid Arthritis Linked to Over 50% Increased Lung Cancer Risk, with a Three-Fold Risk in RA-Associated Interstitial Lung Disease – Arthritis Rheumatol
18 Aug, 2024 | 18:58h | UTCStudy Design and Population: This retrospective matched cohort study examined the risk of lung cancer in 72,795 patients with rheumatoid arthritis (RA) and 757 patients with RA-associated interstitial lung disease (RA-ILD) from the Veterans Health Administration database, compared with 633,937 non-RA controls. The study spanned from 2000 to 2019, with patients matched on age, gender, and enrollment year.
Main Findings: The study found that RA was associated with a 58% increase in lung cancer risk (adjusted hazard ratio [aHR] 1.58). The risk was significantly higher in RA-ILD patients, with a more than three-fold increase (aHR 3.25) compared to non-RA controls. Even among never smokers, RA patients showed a 65% increased lung cancer risk, indicating that factors beyond smoking contribute to the elevated risk.
Implications for Practice: The study underscores the significant increase in lung cancer risk among patients with RA, particularly those with RA-ILD. While this elevated risk is notable, further research is necessary to determine the most effective strategies for monitoring and managing this risk. Clinicians should be aware of these findings and consider them when evaluating the overall health and risk factors of patients with RA, especially those with additional pulmonary complications like ILD. Enhanced awareness and individualized risk assessments may help in early detection and management of lung cancer in this high-risk population.
RCT: Atezolizumab with Chemotherapy Extends Progression-Free Survival in dMMR Advanced Endometrial Cancer – Lancet Oncol
18 Aug, 2024 | 18:27h | UTCStudy Design and Population: The AtTEnd trial is a randomized, double-blind, placebo-controlled phase 3 study conducted in 89 hospitals across 11 countries. It enrolled 551 patients with advanced or recurrent endometrial carcinoma or carcinosarcoma, all of whom had not received prior systemic chemotherapy for recurrence.
Main Findings: The addition of atezolizumab to chemotherapy was associated with an improvement in progression-free survival, particularly in patients with mismatch repair-deficient (dMMR) tumors. In the overall population, progression-free survival and overall survival also showed positive trends.
Implications for Practice: The study suggests that atezolizumab may offer benefits when added to standard chemotherapy in patients with dMMR advanced or recurrent endometrial carcinoma, warranting further investigation as a potential first-line treatment option.
RCT: Isatuximab Plus VRd Significantly Improves Progression-Free Survival in Newly Diagnosed Multiple Myeloma – N Engl J Med
18 Aug, 2024 | 18:11h | UTCStudy Design and Population: This international, open-label, phase 3 trial assessed the efficacy of adding isatuximab to the bortezomib, lenalidomide, and dexamethasone (VRd) regimen in 446 patients aged 18 to 80 years with newly diagnosed multiple myeloma who were ineligible for transplantation. Participants were randomized in a 3:2 ratio to receive either the isatuximab-VRd combination or VRd alone.
Main Findings: At a median follow-up of 59.7 months, the isatuximab-VRd group showed a significantly higher estimated progression-free survival at 60 months (63.2% vs. 45.2%; HR, 0.60; P<0.001) compared to the VRd group. Additionally, the isatuximab-VRd group had higher rates of complete response or better (74.7% vs. 64.1%; P=0.01) and MRD-negative status with a complete response (55.5% vs. 40.9%; P=0.003). Safety profiles were comparable between the two groups.
Implications for Practice: The addition of isatuximab to the standard VRd regimen significantly improves progression-free survival and response rates in newly diagnosed multiple myeloma patients who are ineligible for transplantation, without increasing serious adverse events. This suggests that isatuximab-VRd may be considered a new standard of care in this patient population.
Systematic Review: Immune Checkpoint Inhibitors Plus Chemotherapy Improves Survival in NSCLC for Patients Aged 65-75 – Cochrane Database Syst Rev
18 Aug, 2024 | 15:24h | UTCStudy Design and Population: This Cochrane systematic review evaluated the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with platinum-based chemotherapy versus platinum-based chemotherapy alone (with or without bevacizumab) in treatment-naïve older adults with advanced non-small cell lung cancer (NSCLC). The review included 17 randomized controlled trials (RCTs) with a total of 4,276 participants, focusing on three age groups: 65 years and older, 65-75 years, and 75 years and older.
Main Findings: The addition of ICIs to chemotherapy likely improves overall survival (HR 0.78, 95% CI 0.70 to 0.88) and progression-free survival (HR 0.61, 95% CI 0.54 to 0.68) in patients aged 65 years and older. For those aged 65-75, the benefits are more pronounced (HR 0.75 for overall survival; HR 0.64 for progression-free survival), although there may be an increase in treatment-related adverse events (RR 1.47). However, in patients over 75, the benefits in overall survival and progression-free survival are unclear, with a low-certainty evidence suggesting no significant improvement (HR 0.90 and HR 0.83, respectively).
Implications for Practice: The findings support the use of ICIs combined with chemotherapy in older adults aged 65-75 with advanced NSCLC, but caution is advised for those over 75 due to the lack of clear survival benefit and the potential for increased toxicity. Further research is needed to better understand the risks and benefits in the oldest patients.
Network Meta-Analysis: Preoperative Chemoradiotherapy and Chemotherapy Equally Improve Survival in Esophagogastric Adenocarcinoma – JAMA Netw Open
17 Aug, 2024 | 19:21h | UTCStudy Design and Population: This network meta-analysis included 17 randomized clinical trials (RCTs) with a total of 2,549 patients, predominantly male (86.5%), with a mean age of 61 years. The study compared the effects of preoperative chemoradiotherapy (CRT) versus preoperative and/or perioperative chemotherapy, and surgery alone on overall survival and disease-free survival in patients with adenocarcinoma of the esophagus and esophagogastric junction (AEG).
Main Findings: Both preoperative CRT plus surgery (HR, 0.75) and preoperative/perioperative chemotherapy plus surgery (HR, 0.78) significantly improved overall survival compared to surgery alone. Disease-free survival was similarly prolonged with both treatments. No significant difference was observed between CRT and chemotherapy in overall survival, though CRT was associated with higher postoperative morbidity.
Implications for Practice: The findings suggest that both preoperative CRT and preoperative/perioperative chemotherapy are effective in extending survival in AEG patients, with no clear superiority of one approach over the other. Clinicians can consider either modality based on patient-specific factors, although the increased morbidity associated with CRT warrants careful consideration.
RCT: Osimertinib Significantly Extends Progression-Free Survival in Unresectable Stage III EGFR-Mutated NSCLC After Chemoradiotherapy – N Engl J Med
17 Aug, 2024 | 16:30h | UTCStudy Design and Population: This phase 3, double-blind, placebo-controlled trial enrolled 216 patients with unresectable stage III EGFR-mutated non-small-cell lung cancer (NSCLC) who showed no disease progression during or after chemoradiotherapy. Patients were randomly assigned to receive either osimertinib (143 patients) or a placebo (73 patients) until disease progression.
Main Findings: The study found that osimertinib significantly prolonged progression-free survival (PFS) compared to placebo, with a median PFS of 39.1 months versus 5.6 months, respectively. The hazard ratio for disease progression or death was 0.16, indicating a substantial reduction in risk with osimertinib. At 12 months, 74% of patients in the osimertinib group were alive and progression-free, compared to 22% in the placebo group. Interim overall survival data suggested a modest difference favoring osimertinib, though it was not statistically significant.
Implications for Practice: Osimertinib offers a significant survival benefit as a consolidation therapy following chemoradiotherapy in patients with unresectable stage III EGFR-mutated NSCLC. The findings support the use of osimertinib in this setting, despite an increased incidence of adverse events, highlighting its role in improving long-term outcomes.
Study Shows High Prevalence of Solid Lung Nodules in Nonsmoking Adults – Radiology
14 Aug, 2024 | 13:14h | UTCStudy Design and Population: This cohort study examined the prevalence and size distribution of solid lung nodules in a nonsmoking population from the Northern Netherlands. A total of 10,431 participants aged 45 years and older, predominantly nonsmokers, were included in the Imaging in Lifelines (ImaLife) study. The study utilized low-dose chest CT scans to detect and measure lung nodules.
Main Findings: Lung nodules were present in 42% of participants, with a higher prevalence in males (47.5%) than females (37.7%). The prevalence of clinically relevant nodules (≥100 mm³) was 11.1%, and actionable nodules (≥300 mm³) were found in 2.3% of individuals. Both prevalence and nodule size increased with age, and male participants consistently showed a higher prevalence and larger nodule sizes compared to females.
Implications for Practice: While 42% of nonsmoking adults in this Northern European cohort were found to have solid lung nodules, the incidence of lung cancer within this population is notably low. This suggests that many of the clinically relevant and even actionable nodules identified in nonsmokers are likely benign. These findings highlight the need to refine nodule management strategies for individuals at low risk of lung cancer, potentially reducing unnecessary follow-up and interventions in nonsmoking populations. Future research on lung cancer outcomes in this cohort could further inform and optimize guidelines for nodule management in low-risk groups.
RCT: Blinatumomab Improves Overall Survival in MRD-Negative Acute Lymphoblastic Leukemia Patients – N Engl J Med
11 Aug, 2024 | 12:53h | UTCStudy Design and Population: This phase 3 randomized clinical trial included 488 adults aged 30 to 70 with BCR::ABL1-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who achieved measurable residual disease (MRD)-negative remission after initial chemotherapy. The study compared the outcomes of patients receiving four cycles of blinatumomab alongside consolidation chemotherapy versus those receiving consolidation chemotherapy alone.
Main Findings: At a median follow-up of 43 months, the blinatumomab group demonstrated a significant improvement in overall survival (85% vs. 68% at 3 years) compared to the chemotherapy-only group, with a hazard ratio for death of 0.41 (95% CI, 0.23 to 0.73; P = 0.002). The 3-year relapse-free survival was also higher in the blinatumomab group (80% vs. 64%), with a hazard ratio for relapse or death of 0.53 (95% CI, 0.32 to 0.87). However, a higher incidence of neuropsychiatric events was noted in the blinatumomab group.
Implications for Practice: The addition of blinatumomab to consolidation chemotherapy significantly enhances overall and relapse-free survival in adult patients with MRD-negative BCP-ALL, suggesting its potential as a standard treatment approach for this population. Clinicians should monitor for neuropsychiatric side effects associated with blinatumomab use.
Deep Learning Model Noninferior to Radiologists in Detecting Clinically Significant Prostate Cancer at MRI – Radiology
10 Aug, 2024 | 21:31h | UTCStudy Design and Population: This retrospective study evaluated the performance of a deep learning (DL) model for detecting clinically significant prostate cancer (csPCa) using multiparametric MRI (mpMRI) images from 5215 patients (5735 examinations) with a mean age of 66 years. The study included patients who underwent prostate MRI between January 2017 and December 2019 at a single academic institution. The DL model was trained on T2-weighted, diffusion-weighted, and contrast-enhanced MRI sequences, with pathologic diagnosis as the reference standard.
Main Findings: The DL model achieved an area under the receiver operating characteristic curve (AUC) of 0.89 on the internal test set and 0.86 on an external test set, demonstrating noninferiority to radiologists, who had AUCs of 0.89 and 0.84, respectively. Additionally, the combination of the DL model and radiologists improved diagnostic performance (AUC of 0.89). Gradient-weighted class activation maps (Grad-CAMs) effectively localized csPCa lesions, overlapping with true-positive cases in 92% of internal test set and 97% of external test set cases.
Implications for Practice: The DL model showed comparable performance to experienced radiologists in detecting csPCa at MRI, suggesting its potential to assist radiologists in improving diagnostic accuracy and reducing interobserver variability. Future research should focus on integrating the model into clinical workflows and assessing its impact on biopsy targeting.
Cohort Study: GLP1 receptor agonist use not associated with significant increase in thyroid cancer risk – The BMJ
25 May, 2024 | 19:51h | UTCA 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):
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 | UTCThis 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):
RCT: Impact of single PSA screening invitation on 15-year prostate cancer mortality – JAMA
25 May, 2024 | 19:01h | UTCStudy 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):
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 | UTCStudy 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):
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 | UTCStudy 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):
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):