دورية أكاديمية

Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer: The CARTS Study.

التفاصيل البيبلوغرافية
العنوان: Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer: The CARTS Study.
المؤلفون: Stijns RCH; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands., de Graaf EJR; Department of Surgery, IJsselland Hospital, Capelle aan de Ijssel, the Netherlands., Punt CJA; Department of Medical Oncology, Academic Medical Centre, Amsterdam, the Netherlands., Nagtegaal ID; Department of Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands., Nuyttens JJME; Department of Radiation Oncology, Erasmus Medical Centre, Rotterdam, the Netherlands., van Meerten E; Department of Oncology, Erasmus Medical Centre Cancer Institute, Rotterdam, the Netherlands., Tanis PJ; Department of Surgery, Academic Medical Centre, Amsterdam, the Netherlands., de Hingh IHJT; Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands., van der Schelling GP; Department of Surgery, Amphia Hospital, Breda, the Netherlands., Acherman Y; Department of Surgery, Medical Centre Slotervaart, Amsterdam, the Netherlands., Leijtens JWA; Department of Surgery, Laurentius Hospital, Roermond, the Netherlands., Bremers AJA; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands., Beets GL; Department of Surgery, Netherlands Cancer Institute, Amsterdam, the Netherlands., Hoff C; Department of Surgery, Medical Centre Leeuwarden, Leeuwarden, the Netherlands., Verhoef C; Department of Surgical Oncology, Erasmus Medical Centre, Rotterdam, the Netherlands., Marijnen CAM; Department of Radiotherapy, Leiden University Medical Centre, Leiden, the Netherlands., de Wilt JHW; Department of Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
مؤلفون مشاركون: CARTS Study Group
المصدر: JAMA surgery [JAMA Surg] 2019 Jan 01; Vol. 154 (1), pp. 47-54.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Medical Association Country of Publication: United States NLM ID: 101589553 Publication Model: Print Cited Medium: Internet ISSN: 2168-6262 (Electronic) Linking ISSN: 21686254 NLM ISO Abbreviation: JAMA Surg Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Chicago, IL : American Medical Association, [2013]-
مواضيع طبية MeSH: Chemoradiotherapy, Adjuvant/*methods , Organ Sparing Treatments/*methods , Rectal Neoplasms/*therapy , Transanal Endoscopic Microsurgery/*methods, Adult ; Aged ; Aged, 80 and over ; Chemoradiotherapy, Adjuvant/mortality ; Combined Modality Therapy ; Disease-Free Survival ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Recurrence, Local/mortality ; Netherlands/epidemiology ; Rectal Neoplasms/mortality ; Transanal Endoscopic Microsurgery/mortality ; Treatment Outcome
مستخلص: Importance: Treatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature.
Objective: To explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3N0M0 rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM).
Design, Setting, and Participants: In this multicenter phase II feasibility study, patients with cT1-3N0M0 rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017.
Main Outcomes and Measures: The primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL.
Results: Of the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P = .001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation.
Conclusions and Relevance: In early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.
التعليقات: Comment in: JAMA Surg. 2019 Jan 1;154(1):54-55. (PMID: 30304376)
Comment in: Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):1-10. (PMID: 31422802)
References: Br J Surg. 2017 Jan;104(1):138-147. (PMID: 27706805)
Lancet Oncol. 2015 Nov;16(15):1537-1546. (PMID: 26474521)
Dis Colon Rectum. 2013 Dec;56(12):1349-56. (PMID: 24201388)
Eur J Cancer. 1999 Feb;35(2):238-47. (PMID: 10448266)
Eur J Surg Oncol. 2018 Feb;44(2):209-219. (PMID: 29275912)
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. (PMID: 8433390)
Ann Surg. 2011 Jan;253(1):71-7. (PMID: 21135694)
Colorectal Dis. 2012 Jul;14(7):797-803. (PMID: 21689340)
Dis Colon Rectum. 2014 Nov;57(11):1253-9. (PMID: 25285691)
Lancet Oncol. 2010 Sep;11(9):835-44. (PMID: 20692872)
Dis Colon Rectum. 2007 Oct;50(10):1520-5. (PMID: 17674104)
BMC Surg. 2011 Dec 15;11:34. (PMID: 22171697)
Colorectal Dis. 2015 Nov;17(11):1011-7. (PMID: 26112651)
Dis Colon Rectum. 2016 Apr;59(4):270-80. (PMID: 26953985)
N Engl J Med. 2001 Aug 30;345(9):638-46. (PMID: 11547717)
Br J Surg. 2016 Jul;103(8):1069-75. (PMID: 27146472)
Dis Colon Rectum. 2011 Dec;54(12):1589-97. (PMID: 22067190)
Lancet. 2017 Jul 29;390(10093):469-479. (PMID: 28601342)
N Engl J Med. 2004 Oct 21;351(17):1731-40. (PMID: 15496622)
Ann Surg. 2007 May;245(5):726-33. (PMID: 17457165)
Dis Colon Rectum. 2014 May;57(5):585-91. (PMID: 24819098)
Biometrics. 2000 Dec;56(4):971-83. (PMID: 11129494)
Ann Surg. 2007 Nov;246(5):693-701. (PMID: 17968156)
Dis Colon Rectum. 2013 Jan;56(1):6-13. (PMID: 23222274)
BMC Cancer. 2015 Oct 23;15:767. (PMID: 26497495)
Cancer Radiother. 2004 Oct;8(5):297-304. (PMID: 15561595)
Surg Endosc. 2008 Feb;22(2):352-8. (PMID: 17943364)
Br J Surg. 2013 Sep;100(10):1377-87. (PMID: 23939851)
Br J Surg. 1982 Oct;69(10):613-6. (PMID: 6751457)
Dis Colon Rectum. 2017 Oct;60(10):1032-1040. (PMID: 28891846)
Ann Surg. 2012 May;255(5):922-8. (PMID: 22504191)
PLoS One. 2015 Oct 27;10(10):e0141427. (PMID: 26505895)
Br J Surg. 2015 Jun;102(7):853-60. (PMID: 25847025)
J Natl Cancer Inst. 2016 Aug 10;108(12):. (PMID: 27509881)
Lancet Oncol. 2015 Aug;16(8):919-27. (PMID: 26156652)
Colorectal Dis. 2014 Jul;16(7):O223-33. (PMID: 24373460)
J Clin Oncol. 2012 Jun 1;30(16):1926-33. (PMID: 22529255)
Br J Cancer. 2017 Jan 17;116(2):169-174. (PMID: 27997526)
Endoscopy. 2013 Oct;45(10):827-34. (PMID: 23884793)
Radiother Oncol. 2005 Sep;76(3):234-40. (PMID: 16273666)
Colorectal Dis. 2007 Jul;9(6):553-8. (PMID: 17573752)
تواريخ الأحداث: Date Created: 20181011 Date Completed: 20191125 Latest Revision: 20200309
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6439861
DOI: 10.1001/jamasurg.2018.3752
PMID: 30304338
قاعدة البيانات: MEDLINE
الوصف
تدمد:2168-6262
DOI:10.1001/jamasurg.2018.3752