Evaluation of transrectal ultrasound-guided tru-cut biopsy as a complementary method for predicting pathological complete response in rectal cancer after neoadjuvant treatment: a phase II prospective and diagnostic trial.
Uloženo v:
| Název: | Evaluation of transrectal ultrasound-guided tru-cut biopsy as a complementary method for predicting pathological complete response in rectal cancer after neoadjuvant treatment: a phase II prospective and diagnostic trial. |
|---|---|
| Autoři: | Huang Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Xie Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Wang P; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Chen Y; Medical Ultrasonics., Qin S; Medical Ultrasonics., Li F; Radiology., Wu Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Huang M; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Hou Z; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Cai Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., He X; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Lin H; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Hu B; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Qin Q; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Ma T; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Tan S; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Liao Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Ke J; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Zhang D; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Lai S; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Jiang Z; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Wang H; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Xiang J; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Cai Z; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Wang H; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., He X; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Yang Z; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Ren D; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Wu X; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Hong Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Huang M; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Luo Y; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University., Liu G; Medical Ultrasonics.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University., Lin J; Department of General Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou, China.; Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University.; Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University. |
| Zdroj: | International journal of surgery (London, England) [Int J Surg] 2024 Jun 01; Vol. 110 (6), pp. 3230-3236. Date of Electronic Publication: 2024 Jun 01. |
| Způsob vydávání: | Journal Article; Clinical Trial, Phase II |
| Jazyk: | English |
| Informace o časopise: | Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 101228232 Publication Model: Electronic Cited Medium: Internet ISSN: 1743-9159 (Electronic) Linking ISSN: 17439159 NLM ISO Abbreviation: Int J Surg Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2023- : [Philadelphia] : Wolters Kluwer Health, Inc. Original Publication: London : Surgical Associates Ltd., c2004- |
| Výrazy ze slovníku MeSH: | Rectal Neoplasms*/pathology , Rectal Neoplasms*/diagnostic imaging , Rectal Neoplasms*/therapy , Neoadjuvant Therapy*, Humans ; Male ; Female ; Middle Aged ; Prospective Studies ; Aged ; Image-Guided Biopsy/methods ; Adult ; Ultrasonography, Interventional ; Rectum/pathology ; Rectum/surgery ; Rectum/diagnostic imaging ; Predictive Value of Tests ; Treatment Outcome |
| Abstrakt: | Importance: Patients with pathological complete response (pCR) of rectal cancer following neoadjuvant treatment had better oncological outcomes. However, reliable methods for accurately predicting pCR remain limited. Objective: To evaluate whether transrectal ultrasound-guided tru-cut biopsy (TRUS-TCB) adds diagnostic value to conventional modalities for predicting pathological complete response in patients with rectal cancer after neoadjuvant treatment. Design, Setting, and Participants: This study evaluated data of patients with rectal cancer who were treated with neoadjuvant treatment and reassessed using TRUS-TCB and conventional modalities before surgery. This study is registered with ClinicalTrials.gov. Main Outcomes and Measures: The primary outcome was accuracy, along with secondary outcomes including sensitivity, specificity, negative predictive value, and positive predictive value in predicting tumour residues. Final surgical pathology was used as reference standard. Results: Between June 2021 and June 2022, a total of 74 patients were enroled, with 63 patients ultimately evaluated. Among them, 17 patients (28%) exhibited a complete pathological response. TRUS-TCB demonstrated an accuracy of 0.71 (95% CI, 0.58-0.82) in predicting tumour residues. The combined use of TRUS-TCB and conventional modalities significantly improved diagnostic accuracy compared to conventional modalities alone (0.75 vs. 0.59, P =0.02). Furthermore, TRUS-TCB correctly reclassified 52% of patients erroneously classified as having a complete clinical response by conventional methods. The occurrence of only one mild adverse event was observed. Conclusions and Relevance: TRUS-TCB proves to be a safe and accessible tool for reevaluation with minimal complications. The incorporation of TRUS-TCB alongside conventional methods leads to enhanced diagnostic performance. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.) |
| References: | Tulchinsky H, Rabau M, Shacham-Shemueli E, et al. Can rectal cancers with pathologic T0 after neoadjuvant chemoradiation (ypT0) be treated by transanal excision alone. Ann Surg Oncol 2006;13:347–352. Maas M, Nelemans PJ, Valentini V, et al. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol 2010;11:835–844. Zhang JW, Cai Y, Xie XY, et al. Nomogram for predicting pathological complete response and tumor downstaging in patients with locally advanced rectal cancer on the basis of a randomized clinical trial. Gastroenterol Rep (Oxf) 2020;8:234–241. Habr-Gama A, Perez RO, Nadalin W, et al. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg 2004;240:711–717; discussion 717-8. Smith JJ, Strombom P, Chow OS, et al. Assessment of a watch-and-wait strategy for rectal cancer in patients with a complete response after neoadjuvant therapy. JAMA Oncol 2019;5:e185896. de Jong EA, ten Berge JC, Dwarkasing RS, et al. The accuracy of MRI, endorectal ultrasonography, and computed tomography in predicting the response of locally advanced rectal cancer after preoperative therapy: a metaanalysis. Surgery 2016;159:688–699. Kuo LJ, Chiou JF, Tai CJ, et al. Can we predict pathologic complete response before surgery for locally advanced rectal cancer treated with preoperative chemoradiation therapy. Int J Colorectal Dis 2012;27:613–621. Guillem JG, Ruby JA, Leibold T, et al. Neither FDG-PET Nor CT can distinguish between a pathological complete response and an incomplete response after neoadjuvant chemoradiation in locally advanced rectal cancer: a prospective study. Ann Surg 2013;258:289–295. Patel UB, Taylor F, Blomqvist L, et al. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol 2011;29:3753–3760. Duldulao MP, Lee W, Streja L, et al. Distribution of residual cancer cells in the bowel wall after neoadjuvant chemoradiation in patients with rectal cancer. Dis Colon Rectum 2013;56:142–149. Presti JC Jr, O’Dowd GJ, Miller MC, et al. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol 2003;169:125–129. Ukimura O, Coleman JA, de la Taille A, et al. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol 2013;63:214–230. Zikan M, Fischerova D, Pinkavova I, et al. Ultrasound-guided tru-cut biopsy of abdominal and pelvic tumors in gynecology. Ultrasound Obstet Gynecol 2010;36:767–772. Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open 2016;6:e012799. Amin MBES. AJCC cancer staging manual, 8th ed. Springer; 2016:2017. Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics 2000;56:345–351. Bhoday J, Smith F, Siddiqui MR, et al. Magnetic resonance tumor regression grade and residual mucosal abnormality as predictors for pathological complete response in rectal cancer postneoadjuvant chemoradiotherapy. Dis Colon Rectum 2016;59:925–933. Jang JK, Choi SH, Park SH, et al. MR tumor regression grade for pathological complete response in rectal cancer post neoadjuvant chemoradiotherapy: a systematic review and meta-analysis for accuracy. Eur Radiol 2020;30:2312–2323. Kuo LJ, Chern MC, Tsou MH, et al. Interpretation of magnetic resonance imaging for locally advanced rectal carcinoma after preoperative chemoradiation therapy. Dis Colon Rectum 2005;48:23–28. Hiotis SP, Weber SM, Cohen AM, et al. Assessing the predictive value of clinical complete response to neoadjuvant therapy for rectal cancer: an analysis of 488 patients. J Am Coll Surg 2002;194:131–135; discussion 135-6. Semelka RC, Hussain SM, Marcos HB, et al. Perilesional enhancement of hepatic metastases: correlation between MR imaging and histopathologic findings-initial observations. Radiology 2000;215:89–94. Sasaki Y, Niwa Y, Hirooka Y, et al. The use of endoscopic ultrasound-guided fine-needle aspiration for investigation of submucosal and extrinsic masses of the colon and rectum. Endoscopy 2005;37:154–160. Hu H, Kang L, Zhang J, et al. Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trial. Lancet Gastroenterol Hepatol 2022;7:38–48. Cercek A, Lumish M, Sinopoli J, et al. PD-1 blockade in mismatch repair-deficient, locally advanced rectal cancer. N Engl J Med 2022;386:2363–2376. Chen G, Jin Y, Guan WL, et al. Neoadjuvant PD-1 blockade with sintilimab in mismatch-repair deficient, locally advanced rectal cancer: an open-label, single-centre phase 2 study. Lancet Gastroenterol Hepatol 2023;8:422–431. Ludford K, Ho WJ, Thomas JV, et al. Neoadjuvant pembrolizumab in localized microsatellite instability high/deficient mismatch repair solid tumors. J Clin Oncol 2023;41:2181–2190. André T, Cohen R. Designing trials for neoadjuvant immune checkpoint inhibition in microsatellite instability-high localized colorectal cancer. JCO Oncol Pract 2023;19:261–262. Xie Y, Lin J, Zhang N, et al. Prevalent pseudoprogression and pseudoresidue in patients with rectal cancer treated with neoadjuvant immune checkpoint inhibitors. J Natl Compr Canc Netw 2023;21:133–142.e3. |
| Entry Date(s): | Date Created: 20240213 Date Completed: 20240627 Latest Revision: 20250826 |
| Update Code: | 20250826 |
| PubMed Central ID: | PMC11175734 |
| DOI: | 10.1097/JS9.0000000000001152 |
| PMID: | 38348893 |
| Databáze: | MEDLINE |
Nájsť tento článok vo Web of Science Buďte první, kdo okomentuje tento záznam!