Clinical colorectal cancer最新文献

{"title":"Explanatory Role of Conversion Surgery as a Mediator of the Mortality Risk Difference Between Patients With Unresectable Metastatic Colorectal Cancer Treated With First-Line Anti-EGFR Agents Versus Bevacizumab","authors":"Chien-Chou Su ,&nbsp;Yi-Chia Su ,&nbsp;Chih-Chien Wu ,&nbsp;Pei-Ting Lee","doi":"10.1016/j.clcc.2024.05.008","DOIUrl":"10.1016/j.clcc.2024.05.008","url":null,"abstract":"<div><h3>Introduction</h3><div>Bevacizumab<span> and antiepidermal growth factor receptor-blocking (anti-EGFR) agents plus chemotherapy are first-line therapies for metastatic colorectal cancer<span> (mCRC). Conversion surgery may improve outcomes; however, the extent to which it explains the difference in mortality rates among treatments is unclear. Herein, we aimed to assess the effects of conversion surgery on survival outcomes of patients with unresectable mCRC treated with bevacizumab and anti-EGFR agents.</span></span></div></div><div><h3>Materials and methods</h3><div>This retrospective cohort study<span> included patients with mCRC treated with bevacizumab and anti-EGFR agents as first-line therapy. We estimated the direct and indirect effects of treatments by comparing the mortality risk associated with targeted therapy type. Hazard ratios (HR) and the corresponding confidence intervals (CI) were estimated. Mediation analysis was used to estimate hazard ratio differences, and the proportion mediated.</span></div></div><div><h3>Results</h3><div>A total of 5,106 patients were included. The natural indirect effect of conversion surgery reduced mortality risk (HR: 0.95; 95% CI, 0.93-0.97), with a mediated proportion of 42% after propensity score adjustment. In subgroup analyses, <span><span>KRAS</span></span><span> wild-type (HR: 0.94; 95% CI: 0.91-0.97), left tumor sidedness (HR: 0.94; 95% CI, 0.91-0.96), and liver resection (HR: 0.95; 95% CI, 0.93-0.98) were associated with reduced risks of mortality. The controlled and total direct effects of targeted therapy were associated with reduced mortality risk in the anti-EGFR-treated group compared to those in the bevacizumab-treated group; however, this effect was not statistically significant.</span></div></div><div><h3>Conclusion</h3><div>Conversion surgery may account for the difference in survival outcomes between users of the anti-EGFR agents and bevacizumab.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 4","pages":"Pages 364-371"},"PeriodicalIF":3.3,"publicationDate":"2024-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141328232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survival Outcomes in Patients with Monobloc-Resected Stage IIC (pT4bN0) Colon Cancer: A Retrospective Observational Cohort Study","authors":"Juliette Logeart ,&nbsp;Thomas Samaille ,&nbsp;Antoine Falcoz ,&nbsp;Magali Svrcek ,&nbsp;Olivier Dubreuil ,&nbsp;Dewi Vernerey ,&nbsp;Romain Cohen ,&nbsp;Pascale Cervera ,&nbsp;Alain Valverde ,&nbsp;Yann Parc ,&nbsp;Thierry André","doi":"10.1016/j.clcc.2024.05.005","DOIUrl":"10.1016/j.clcc.2024.05.005","url":null,"abstract":"<div><h3>Background</h3><div>Stage II colon cancer<span> (CC) exhibits considerable prognostic heterogeneous. Our objective was to assess survival but also the prognosis impact of microsatellite instability (MSI) in patients with stage IIC (T4bN0M0) CC.</span></div></div><div><h3>Patients and Methods</h3><div>We conducted a retrospective observational study including all patients who had primary stage IIC CC resection between 2010 and 2020 in 2 expert centers. The primary endpoint was overall survival (OS) and disease-free survival (DFS) and time-to-relapse (TTR) were secondary endpoints.</div></div><div><h3>Results</h3><div><span><span>Sixty-six patients, median age of 74 years [30-95], were included, with 37.9% presenting MSI (n = 25). Organ invasion involved the last ileal loop (n = 17), another colonic segment (n = 15), omentum (n = 13), visceral </span>peritoneum<span> (n = 13), and the bladder (n = 4). Surgical quality criteria showed complete monobloc resection in all patients and 93.9% R0 resection. After a median follow-up of 5 years [3.5-6.6], the entire population showed a 5-year OS of 65.2% [53.0-80.3] and 5-year DFS of 53.5% [41.1-69.6], with 18.9% [6.8-29.4] experiencing relapses at 5 years. The MSI phenotype correlated with improved 5-year OS (75.5% [56.5-100] vs. 59.5% [44.9-79.0], HR 0.41 [0.17-0.99]; </span></span><em>P</em><span><span> = .04), but DFS and TTR did not differ. Adjuvant chemotherapy was administered to 34.9% of patients. </span>Univariate analysis identified age &gt; 65 years, MSI status, and the number of nodes as factors associated with OS.</span></div></div><div><h3>Conclusion</h3><div>These data underline, in relation to a low rate of relapse, the lack of consensus regarding the appropriate indication for adjuvant chemotherapy in this high-risk stage II population.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 4","pages":"Pages 346-353.e1"},"PeriodicalIF":3.3,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141144365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peritoneal Carcinomatosis in Colorectal Cancer: Review and Update of Current Clinical Data","authors":"S. Blaj ,&nbsp;H. Leebmann ,&nbsp;M. Babucke ,&nbsp;M. Acs ,&nbsp;P. Piso","doi":"10.1016/j.clcc.2024.05.007","DOIUrl":"10.1016/j.clcc.2024.05.007","url":null,"abstract":"<div><div><span>The peritoneal metastasized colorectal cancer<span> (pmCRC) represents a serious health problem worldwide with a special emphasis in the developed countries. Several guidelines recognize the role of multimodal therapy consisting of cytoreductive surgery (CRS) and hyperthermic </span></span>intraperitoneal chemotherapy<span> (HIPEC) in the treatment of pmCRC. New data suggests that some other factors, eg, tumor biology, immune profile, neoadjuvant chemotherapy may play a predictive role for the oncological outcome of these patients.</span></div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 4","pages":"Pages 309-317"},"PeriodicalIF":3.3,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141145619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Unresectable or Metastatic Colorectal Cancer in Asian Patients: A Prospective Cohort Study","authors":"Yijiao Chen ,&nbsp;Dexiang Zhu ,&nbsp;Yiyi Yu ,&nbsp;Wenju Chang ,&nbsp;Lechi Ye ,&nbsp;Qingyang Feng ,&nbsp;Pingping Xu ,&nbsp;Miao Chen ,&nbsp;Meiling Ji ,&nbsp;Ye Wei ,&nbsp;Tianshu Liu ,&nbsp;Jianmin Xu","doi":"10.1016/j.clcc.2024.05.006","DOIUrl":"10.1016/j.clcc.2024.05.006","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancers (CRC) with BRAF V600E mutation exhibit limited chemotherapy response and a poor prognosis. Safety and efficacy of the VIC (Vemurafenib/Irinotecan/Cetuximab) regimen in the first-line setting for patients with BRAF V600E-mutated CRC remain undetermined.</div></div><div><h3>Methods</h3><div><span><span>In the prospective cohort study, the untreated, BRAF V600E-mutated, unresectable or </span>metastatic CRC patients were enrolled. The VIC regimen and </span>bevacizumab<span> plus chemotherapy were compared in the first-line setting. The objective response rate (ORR), disease control rate (DCR), conversion resection rate, progression-free survival (PFS), and overall survival (OS) were evaluated.</span></div></div><div><h3>Results</h3><div>In the intent-to-treat analysis, 38 patients received VIC regimen and 40 received bevacizumab plus chemotherapy. The ORR and DCR in the VIC group were significantly higher than in the bevacizumab-therapy group (ORR: 63.2% vs. 37.5%, <em>P</em> = .025; DCR: 94.7% vs. 75.0%, <em>P</em> = .019). The VIC regimen significantly outperformed bevacizumab plus chemotherapy in both PFS (11.9 vs. 7.7 months; hazard ratio [HR] = 0.51, 95% CI, 0.30-0.87; <em>P</em> = .010) and OS (25.3 vs. 14.6 months; HR = 0.43, 95% CI, 0.22-0.82; <em>P</em><span><span> = .011). In the VIC group, the conversion resection rate for liver metastases was 34.8% (8 of 23 patients), and for unresectable local CRC it was 54.5% (6 of 11 patients). The </span>adverse events rates of Grade 3 to 4 were 34.2% and 32.5% for the VIC regimen and bevacizumab plus chemotherapy respectively.</span></div></div><div><h3>Conclusions</h3><div>Among Asian patients with BRAF V600E-mutated CRC, the VIC regimen showed favorable outcomes compared to bevacizumab plus chemotherapy in terms of tumor response and oncological survival, with a tolerable and manageable toxicity profile in the first-line setting.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 4","pages":"Pages 354-363.e4"},"PeriodicalIF":3.3,"publicationDate":"2024-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141130844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Phase 1 Study of Cabozantinib and Trifluridine/Tipiracil in Metastatic Colorectal Adenocarcinoma","authors":"Farshid Dayyani ,&nbsp;Jasmine Balangue ,&nbsp;Jennifer Valerin ,&nbsp;Matthew J. Keating ,&nbsp;Jason A. Zell ,&nbsp;Thomas H. Taylor ,&nbsp;May T. Cho","doi":"10.1016/j.clcc.2023.11.001","DOIUrl":"10.1016/j.clcc.2023.11.001","url":null,"abstract":"<div><h3>Introduction</h3><p><span>This study determined the safety and recommended phase 2 dose (RP2D) of the multikinase inhibitor cabozantinib in combination with trifluridine/tipiracil (FTD/TPI) in refractory metastatic </span>colorectal carcinoma (mCRC).</p></div><div><h3>Patients and Methods</h3><p>Single institution investigator-initiated phase 1 study using 3+3 design. Eligible mCRC patients had received prior standard regimens. Cabozantinib was given orally (p.o.) at 20 mg (dose level [DL] 0) or 40 mg (DL 1) daily on days 1-28, and FTD/TPI p.o. at 35 mg/m² on days 1-5 and 8-12 every 28 days. Prophylactic growth-factor support was allowed.</p></div><div><h3>Results</h3><p>Fifteen patients were enrolled. Median age 56 years (31-80), male (12/15), ECOG<span><span><span> 0/1 = 9/6. Three patients were treated at DL 0 and another nine were treated at DL 1, none exhibiting a DLT. Most common any grade (G) treatment related adverse events (TRAE) were diarrhea (50%), nausea (42%), neutropenia (42%), fatigue (33%), and rash (25%). G3-4 TRAE were neutropenia (25%) and thrombocytopenia, </span>hypokalemia, and weight loss (each 8%). No serious TRAE or G5 were reported. The RP2D was determined to be DL 1. Median </span>PFS was 3.8 months (95% CI 1.9-6.8) and disease control rate was 86.7%.</span></p></div><div><h3>Conclusion</h3><p>The combination of cabozantinib and FTD/TPI is feasible and tolerable at standard doses with the use of growth factors and showed encouraging clinical activity in refractory mCRC.</p></div><div><h3>ClinicalTrials.Gov</h3><p>NCT04868773.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 67-72"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138525565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Fecal Occult Blood Test (FOBT) Colorectal Cancer Screening Using Gut Bacteriome as a Biomarker","authors":"Moumita Roy Chowdhury ,&nbsp;Karina Gisèle Mac Si Hone ,&nbsp;Karine Prévost ,&nbsp;Philippe Balthazar ,&nbsp;Mariano Avino ,&nbsp;Mélina Arguin ,&nbsp;Jude Beaudoin ,&nbsp;Mandy Malick ,&nbsp;Michael Desgagné ,&nbsp;Gabriel Robert ,&nbsp;Michelle Scott ,&nbsp;Jean Dubé ,&nbsp;Isabelle Laforest-Lapointe ,&nbsp;Eric Massé","doi":"10.1016/j.clcc.2023.10.004","DOIUrl":"10.1016/j.clcc.2023.10.004","url":null,"abstract":"<div><h3>Background</h3><p><span>Colorectal cancer (CRC) is a major cause of cancer mortality in the world. One of the most widely used screening tests for CRC is the immunochemical fecal occult blood test (iFOBT), which detects human hemoglobin from patient's stool sample. Although it is highly efficient in detecting blood from patients with gastro-intestinal lesions, such as polyps and cancers, the iFOBT has a high rate of false positive discovery. Recent studies suggested gut bacteria as a promising noninvasive biomarker for improving the diagnosis of CRC. In this study, we examined the composition of gut bacteria using iFOBT leftover from patients undergoing screening test along with a </span>colonoscopy.</p></div><div><h3>Methods</h3><p>After collecting data from more than 800 patients, we considered 4 groups for this study. The first and second groups were respectively “healthy” in which the patients had either no blood in their stool or had blood but no lesions. The third and fourth groups of patients had both blood in their stools with precancerous and cancerous lesions and considered either as low-grade and high-grade lesion groups, respectively. An amplification of 16S rRNA (V4 region) gene was performed, followed by sequencing along with various statistical and bioinformatic analysis.</p></div><div><h3>Results</h3><p>We analyzed the composition of the gut bacteriome at phylum, class, genus, and species levels. Although members of the Firmicute phylum increased in the 3 groups compared to healthy patients, the phylum Actinobacteriota was found to decrease. Moreover, <span><em>Blautia</em><em> obeum</em></span> and <em>Anaerostipes hadrus</em><span> from the phylum Firmicutes were increased and </span><span><em>Collinsella aerofaciens</em></span> from phylum Actinobacteriota was found decreased when healthy group is compared to the patients with high-grade lesions. Finally, among the 5 machine learning algorithms used to perform our analysis, both elastic net (AUC &gt; 0.7) and random forest (AUC &gt; 0.8) performs well in differentiating healthy patients from 3 other patient groups having blood in their stool.</p></div><div><h3>Conclusion</h3><p>Our study integrates the iFOBT screening tool with gut bacterial composition to improve the prediction of CRC lesions.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 22-34.e2"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135761072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Salvage Treatment of Recurrent or Persistent Anal Squamous Cell Carcinoma: The Role of Multi-modality Therapy","authors":"Ethan P. Damron ,&nbsp;Jordan McDonald ,&nbsp;Michael K. Rooney ,&nbsp;Prajnan Das ,&nbsp;Ethan B. Ludmir ,&nbsp;Bruce D. Minsky ,&nbsp;Craig Messick ,&nbsp;George J. Chang ,&nbsp;Van K. Morris ,&nbsp;Emma B. Holliday","doi":"10.1016/j.clcc.2023.12.002","DOIUrl":"10.1016/j.clcc.2023.12.002","url":null,"abstract":"<div><h3>Background</h3><p>The standard treatment for recurrent or persistent anal squamous cell carcinoma is surgical salvage, but disease control and survival are suboptimal.</p></div><div><h3>Patients/Methods</h3><p>Patients treated for recurrent or persistent anal squamous cell carcinoma at our institution from 2002 to 2022 were included. Patients were classified by type of salvage treatment received: surgery alone vs. reirradiation followed by surgery and by whether they received intraoperative radiation at the time of surgery. Clinical and pathologic variables were collected and assessed for association with risk of second local recurrence and death from any cause.</p></div><div><h3>Results</h3><p>Sixty four patients were included; 55(85.9%) were treated with surgery alone and 9 (14.1%) were treated with reirradiation followed by surgery. Median (IQR) follow up from the time of salvage treatment was 40.0 (20.3-68.0) months. The 3-year cumulative incidence of second local recurrence (95% CI) after salvage surgery was 36% (24%-48%); 39% (26%-52%) for patients treated with surgery alone and 15% (0.46%-51%) for patients treated with reirradiation followed by surgery. Factors associated with increased second local recurrence after salvage surgery included a locoregional recurrence, lymphovascular space invasion and positive surgical margins. The 3-year overall survival (95% CI) after salvage surgery was 70% (59%-83%); 68% (7%-56%) after surgery alone and 89% (10.5%-70.6%) after reirradiation followed by surgery. Factors associated with worse overall survival included male sex, a larger recurrent tumor and positive surgical margins.</p></div><div><h3>Conclusions</h3><p>Approximately 60% of patients achieved pelvic control after salvage therapy for recurrent or persistent anal squamous cell carcinoma. Although receipt of reirradiation and intraoperative radiation were not associated with improved second local recurrence or overall survival in our cohort, patients with positive surgical margins and lymphovascular space invasion on surgical pathology had higher rates of pelvic recurrence after salvage surgery and may benefit from escalated salvage therapy.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 85-94"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138687733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness of the New Combination Trifluridine/Tipiracil Plus Bevacizumab for the Third-Line Treatment for Metastatic Colorectal Cancer in Italy","authors":"Jacopo Giuliani ,&nbsp;Beatrice Mantoan ,&nbsp;Daniela Mangiola ,&nbsp;Marco Muraro ,&nbsp;Giuseppe Napoli ,&nbsp;Marina Tommasi ,&nbsp;Francesco Fiorica ,&nbsp;Marta Mandarà","doi":"10.1016/j.clcc.2023.10.005","DOIUrl":"10.1016/j.clcc.2023.10.005","url":null,"abstract":"","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 1-3"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71489981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Propensity-Score Matched Analysis of Survival Outcomes of Adjuvant Therapy in Stage II-III Signet-Ring Cell Carcinoma of the Colon","authors":"Sameh Hany Emile ,&nbsp;Nir Horesh ,&nbsp;Zoe Garoufalia ,&nbsp;Rachel Gefen ,&nbsp;Victor Strassmann ,&nbsp;Steven D. Wexner","doi":"10.1016/j.clcc.2023.10.006","DOIUrl":"10.1016/j.clcc.2023.10.006","url":null,"abstract":"<div><h3>Background</h3><p><span>Colonic signet ring cell carcinoma (SRCC) is a </span>mucinous adenocarcinoma subtype often associated with poor prognosis. This study assessed the survival benefits of adjuvant therapy after curative resection of stage II-III colonic SRCC.</p></div><div><h3>Methods</h3><p>This was a retrospective analysis of outcomes of adjuvant therapy in colonic SRCC using National Cancer Database (2010-2019) data. Patients who received adjuvant therapy were matched to those who did not use the nearest neighbor propensity-score matching. The primary outcome was 5-year overall survival (OS).</p></div><div><h3>Results</h3><p><span>The unmatched cohort included 3530 patients. Patients who received adjuvant therapy were significantly younger, more often male, and more often had Charlson scores 0-1, left-sided cancers, stage III disease, lymphovascular invasion<span>, and perineural invasion. The matched cohort included 958 patients (53.6% female); 479 received adjuvant therapy and 479 did not. Adjuvant therapy was associated with longer mean OS (39.9 vs. 29.2 months; </span></span><em>P</em> &lt; .001)<strong>.</strong> Survival benefit of adjuvant therapy was evident in stage III disease (37.5 vs. 24.7 months; <em>P</em><span> &lt; .001), right-sided colon cancer (40.2 vs. 27.7 months; </span><em>P</em><span> &lt; .001), and transverse colon cancer (40.6 vs. 31.1 months; </span><em>P</em> = .002), but not stage II disease (52.1 vs. 53.1 months; <em>P</em> = .694) or left-sided colon cancer (35.8 vs. 32.6 months; <em>P</em> = .417). Independent predictors of improved OS were adjuvant therapy (HR: 0.539; <em>P</em><span> &lt; .001), laparoscopic surgery (HR: 0.829; </span><em>P</em> = .001), robotic-assisted surgery (HR: 0.63; <em>P</em> = .007), and number of harvested lymph nodes (HR: 0.976; <em>P</em> &lt; .001).</p></div><div><h3>Conclusions</h3><p>Adjuvant therapy was associated with improved OS in stage III, right-sided, and transverse colon SRCC. The survival benefit of adjuvant therapy in stage II and left-sided colon SRCC was limited.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 35-45"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136093804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada","authors":"Winson Y. Cheung ,&nbsp;Setareh Samimi ,&nbsp;Kim Ma ,&nbsp;Gregory John Knight ,&nbsp;Shaqil Kassam ,&nbsp;Bruce Colwell ,&nbsp;Annie Beaudoin ,&nbsp;Mark David Vincent ,&nbsp;Mateya Trinkaus ,&nbsp;Alain Filion ,&nbsp;Katerine Marquis ,&nbsp;Hatim Karachiwala ,&nbsp;Timothy Asmis ,&nbsp;Lucas Sideris ,&nbsp;Rajvi J. Wani ,&nbsp;Elaine Ngan ,&nbsp;Naila Inam ,&nbsp;Yinhao Du ,&nbsp;Leyla Nunez ,&nbsp;Maria Eberg ,&nbsp;Carlye Cirone Morris","doi":"10.1016/j.clcc.2023.10.007","DOIUrl":"10.1016/j.clcc.2023.10.007","url":null,"abstract":"<div><h3>Background</h3><p>ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC.</p></div><div><h3>Materials and Methods</h3><p>Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site.</p></div><div><h3>Results</h3><p>A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2.</p></div><div><h3>Conclusion</h3><p>The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"23 1","pages":"Pages 46-57.e4"},"PeriodicalIF":3.4,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1533002823000944/pdfft?md5=c5b19261efb6c944060160487270dab5&pid=1-s2.0-S1533002823000944-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136160579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}