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Lauretta A, Montori G, Guerrini GP. Surveillance strategies following curative resection and non-operative approach of rectal cancer: How and how long? Review of current recommendations. World J Gastrointest Surg 2023; 15:177-192. [PMID: 36896297 PMCID: PMC9988648 DOI: 10.4240/wjgs.v15.i2.177] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/23/2022] [Revised: 12/30/2022] [Accepted: 01/18/2023] [Indexed: 02/27/2023] Open
Abstract
Different follow-up strategies are available for patients with rectal cancer following curative treatment. A combination of biochemical testing and imaging investigation, associated with physical examination are commonly used. However, there is currently no consensus about the types of tests to perform, the timing of the testing, and even the need for follow-up at all has been questioned. The aim of this study was to review the evidence of the impact of different follow-up tests and programs in patients with non-metastatic disease after definitive treatment of the primary. A literature review was performed of studies published on MEDLINE, EMBASE, the Cochrane Library and Web of Science up to November 2022. Current published guidelines from the most authoritative specialty societies were also reviewed. According to the follow-up strategies available, the office visit is not efficient but represents the only way to maintain direct contact with the patient and is recommended by all authoritative specialty societies. In colorectal cancer surveillance, carcinoembryonic antigen represents the only established tumor marker. Abdominal and chest computed tomography scan is recommended considering that the liver and lungs are the most common sites of recurrence. Since local relapse in rectal cancer is higher than in colon cancer, endoscopic surveillance is mandatory. Different follow-up regimens have been published but randomized comparisons and meta-analyses do not allow to determine whether intensive or less intensive follow-up had any significant influence on survival and recurrence detection rate. The available data do not allow the drawing of final conclusions on the ideal surveillance methods and the frequency with which they should be applied. It is very useful and urgent for clinicians to identify a cost-effective strategy that allows early identification of recurrence with a special focus for high-risk patients and patients undergoing a “watch and wait” approach.
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Affiliation(s)
- Andrea Lauretta
- Department of Surgical Oncology, Centro di Riferimento Oncologico di Aviano IRCCS, Aviano 33081, Italy
| | - Giulia Montori
- Department of General Surgery, Vittorio Veneto Hospital, ULSS 2 Marca Trevigiana, Vittorio Veneto 31029, Italy
| | - Gian Piero Guerrini
- Hepato-Pancreato-Biliary Surgical Oncology and Liver Transplantation Unit, Policlinico-AUO Modena, Modena 41124, Italy
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Ngu JCY, Kuo LJ, Kung CH, Chen CL, Kuo CC, Chang SW, Chen CC. Robotic transanal minimally invasive surgery for rectal cancer after clinical complete response to neoadjuvant chemoradiation. Int J Med Robot 2018; 14:e1948. [PMID: 30073747 DOI: 10.1002/rcs.1948] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2017] [Revised: 07/08/2018] [Accepted: 07/10/2018] [Indexed: 12/29/2022]
Abstract
BACKGROUND Full-thickness local excision (FTLE) for rectal cancer showing clinical complete remission (cCR) after neoadjuvant chemoradiation therapy (NCRT) is associated with good oncological results. The purpose of this study was to report the results of robotic transanal minimally invasive surgery for such patients. METHODS Patients were treated with a 5-fluorouracil-based NCRT regimen. The determination of cCR was based on digital rectal examination, colonoscopy, and magnetic resonance imaging. RESULTS Six patients underwent transanal FTLE using the da Vinci Xi surgical system. The median operative time was 106.5 minutes, and the estimated blood loss was minimal. The mean length of hospital stay was 4.2 days. After 18.2 months of follow-up, none of the patients developed local recurrences or distant disease. CONCLUSIONS With the use of robotic technology, FTLE can be performed with relative ease and can be considered as a viable alternative to radical resection or a "Watch and Wait" strategy.
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Affiliation(s)
| | - Li-Jen Kuo
- Division of Colorectal Surgery, Department of Surgery, Taipei Medical University Hospital, Taipei, Taiwan.,Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
| | - Ching-Huei Kung
- Department of Diagnostic Radiology, Taipei Medical University Hospital, Taipei, Taiwan
| | - Chi-Long Chen
- Department of Pathology, Taipei Medical University Hospital, Taipei, Taiwan
| | - Chia-Chun Kuo
- Department of Radiation Oncology, Taipei Medical University Hospital, Taipei, Taiwan
| | - Sheng-Wei Chang
- Division of Acute Care Surgery and Traumatology, Department of Surgery, Taipei Medical University Hospital, Taipei, Taiwan
| | - Chia-Che Chen
- Division of Colorectal Surgery, Department of Surgery, Taipei Medical University Hospital, Taipei, Taiwan
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Endoscopic criteria to evaluate tumor response of rectal cancer to neoadjuvant chemoradiotherapy using magnifying chromoendoscopy. Eur J Surg Oncol 2018; 44:1247-1253. [DOI: 10.1016/j.ejso.2018.04.013] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2017] [Revised: 10/15/2017] [Accepted: 04/16/2018] [Indexed: 11/21/2022] Open
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Li J, Li L, Yang L, Yuan J, Lv B, Yao Y, Xing S. Wait-and-see treatment strategies for rectal cancer patients with clinical complete response after neoadjuvant chemoradiotherapy: a systematic review and meta-analysis. Oncotarget 2018; 7:44857-44870. [PMID: 27070085 PMCID: PMC5190140 DOI: 10.18632/oncotarget.8622] [Citation(s) in RCA: 38] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2015] [Accepted: 03/28/2016] [Indexed: 12/16/2022] Open
Abstract
Wait-and-see treatment strategies may benefit rectal cancer patients who achieve a clinical complete response (cCR) after neoadjuvant chemoradiotherapy (NCRT). In this study, we analyzed data from 9 eligible trials to compare the oncologic outcomes of 251 rectal cancer patients achieving a cCR through nonsurgical management approaches with the outcomes of 344 patients achieving a pathologic complete response (pCR) through radical surgery. The two patient groups did not differ in distant metastasis rates or disease-free and overall survival, but the nonsurgical group had a higher risk of 1, 2, 3, and 5-year local recurrence. Hence, we concluded that for rectal cancer patients achieving a cCR after NCRT, a wait-and-see strategy with strict selection criteria, an appropriate follow-up schedule, and salvage treatments achieved outcomes at least as good as radical surgery. Long-term randomized and controlled trials with more uniform inclusion criteria and standardized follow-up schedules will help clarify the risks and benefits of wait-and-see treatment strategies for these patients.
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Affiliation(s)
- Jun Li
- General Surgery Department and Central Laboratory, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China
| | - Lunjin Li
- Pharmacy Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China
| | - Lin Yang
- Department of Pathology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
| | - Jiatian Yuan
- General Surgery Department and Central Laboratory, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China
| | - Bo Lv
- General Surgery Department and Central Laboratory, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China
| | - Yanan Yao
- Department of General Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
| | - Shasha Xing
- Central Laboratory, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China
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Glynne-Jones R, Hughes R. Current Status of the Watch-and-Wait Policy for Patients with Complete Clinical Response Following Neoadjuvant Chemoradiation in Rectal Cancer. CURRENT COLORECTAL CANCER REPORTS 2017. [DOI: 10.1007/s11888-017-0344-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
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Xynos E, Tekkis P, Gouvas N, Vini L, Chrysou E, Tzardi M, Vassiliou V, Boukovinas I, Agalianos C, Androulakis N, Athanasiadis A, Christodoulou C, Dervenis C, Emmanouilidis C, Georgiou P, Katopodi O, Kountourakis P, Makatsoris T, Papakostas P, Papamichael D, Pechlivanides G, Pentheroudakis G, Pilpilidis I, Sgouros J, Triantopoulou C, Xynogalos S, Karachaliou N, Ziras N, Zoras O, Souglakos J. Clinical practice guidelines for the surgical treatment of rectal cancer: a consensus statement of the Hellenic Society of Medical Oncologists (HeSMO). Ann Gastroenterol 2016; 29:103-26. [PMID: 27064746 PMCID: PMC4805730 DOI: 10.20524/aog.2016.0003] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
In rectal cancer management, accurate staging by magnetic resonance imaging, neo-adjuvant treatment with the use of radiotherapy, and total mesorectal excision have resulted in remarkable improvement in the oncological outcomes. However, there is substantial discrepancy in the therapeutic approach and failure to adhere to international guidelines among different Greek-Cypriot hospitals. The present guidelines aim to aid the multidisciplinary management of rectal cancer, considering both the local special characteristics of our healthcare system and the international relevant agreements (ESMO, EURECCA). Following background discussion and online communication sessions for feedback among the members of an executive team, a consensus rectal cancer management was obtained. Statements were subjected to the Delphi methodology voting system on two rounds to achieve further consensus by invited multidisciplinary international experts on colorectal cancer. Statements were considered of high, moderate or low consensus if they were voted by ≥80%, 60-80%, or <60%, respectively; those obtaining a low consensus level after both voting rounds were rejected. One hundred and two statements were developed and voted by 100 experts. The mean rate of abstention per statement was 12.5% (range: 2-45%). In the end of the process, all statements achieved a high consensus. Guidelines and algorithms of diagnosis and treatment were proposed. The importance of centralization, care by a multidisciplinary team, adherence to guidelines, and personalization is emphasized.
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Affiliation(s)
- Evaghelos Xynos
- General Surgery, InterClinic Hospital of Heraklion, Greece (Evangelos Xynos)
| | - Paris Tekkis
- Colorectal Surgery, Chelsea and Westminster NHS Foundation Trust, London, UK (Paris Tekkis, Panagiotis Georgiou)
| | - Nikolaos Gouvas
- General Surgery, Metropolitan Hospital of Piraeus, Greece (Nikolaos Gouvas)
| | - Louiza Vini
- Radiation Oncology, Iatriko Center of Athens, Greece (Louza Vini)
| | - Evangelia Chrysou
- Radiology, University Hospital of Heraklion, Greece (Evangelia Chrysou)
| | - Maria Tzardi
- Pathology, University Hospital of Heraklion, Greece (Maria Tzardi)
| | - Vassilis Vassiliou
- Radiation Oncology, Oncology Center of Bank of Cyprus, Nicosia, Cyprus (Vassilis Vassiliou)
| | - Ioannis Boukovinas
- Medical Oncology, Bioclinic of Thessaloniki, Greece (Ioannis Boukovinas)
| | - Christos Agalianos
- General Surgery, Athens Naval & Veterans Hospital, Greece (Christos Agalianos, George Pechlivanides)
| | - Nikolaos Androulakis
- Medical Oncology, Venizeleion Hospital of Heraklion, Greece (Nikolaos Androulakis)
| | | | | | - Christos Dervenis
- General Surgery, Konstantopouleio Hospital of Athens, Greece (Christos Dervenis)
| | - Christos Emmanouilidis
- Medical Oncology, Interbalkan Medical Center, Thessaloniki, Greece (Christos Emmanouilidis)
| | - Panagiotis Georgiou
- Colorectal Surgery, Chelsea and Westminster NHS Foundation Trust, London, UK (Paris Tekkis, Panagiotis Georgiou)
| | - Ourania Katopodi
- Medical Oncology, Iaso General Hospital, Athens, Greece (Ourania Katopodi)
| | - Panteleimon Kountourakis
- Medical Oncology, Oncology Center of Bank of Cyprus, Nicosia, Cyprus (Panteleimon Kountourakis, Demetris Papamichael)
| | - Thomas Makatsoris
- Medical Oncology, University Hospital of Patras, Greece (Thomas Makatsoris)
| | - Pavlos Papakostas
- Medical Oncology, Ippokrateion Hospital of Athens, Greece (Pavlos Papakostas)
| | - Demetris Papamichael
- Medical Oncology, Oncology Center of Bank of Cyprus, Nicosia, Cyprus (Panteleimon Kountourakis, Demetris Papamichael)
| | - George Pechlivanides
- General Surgery, Athens Naval & Veterans Hospital, Greece (Christos Agalianos, George Pechlivanides)
| | | | - Ioannis Pilpilidis
- Gastroenterology, Theageneion Cancer Hospital, Thessaloniki, Greece (Ioannis Pilpilidis)
| | - Joseph Sgouros
- Medical Oncology, Agioi Anargyroi Hospital of Athens, Greece (Joseph Sgouros)
| | | | - Spyridon Xynogalos
- Medical Oncology, George Gennimatas General Hospital, Athens, Greece (Spyridon Xynogalos)
| | - Niki Karachaliou
- Medical Oncology, Dexeus University Institute, Barcelona, Spain (Niki Karachaliou)
| | - Nikolaos Ziras
- Medical Oncology, Metaxas Cancer Hospital, Piraeus, Greece (Nikolaos Ziras)
| | - Odysseas Zoras
- General Surgery, University Hospital of Heraklion, Greece (Odysseas Zoras)
| | - John Souglakos
- Medical Oncology, University Hospital of Heraklion, Greece (John Souglakos)
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Pathologic Complete Response in Rectal Cancer: Can We Detect It? Lessons Learned From a Proposed Randomized Trial of Watch-and-Wait Treatment of Rectal Cancer. Dis Colon Rectum 2016; 59:255-63. [PMID: 26953983 DOI: 10.1097/dcr.0000000000000558] [Citation(s) in RCA: 83] [Impact Index Per Article: 9.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND Chemoradiotherapy has the potential to downsize and downstage tumors before surgery, decrease locoregional recurrence, and induce a complete sterilization of tumor cells for middle and low locally advanced rectal cancer. A watch-and-wait tactic has been proposed for patients with clinical complete response. OBJECTIVE The purpose of this study was to verify our ability to identify complete clinical response in patients with rectal cancer based on clinical and radiologic criteria. DESIGN This was a prospective study. SETTINGS The study was conducted at a single institution, in the setting of a watch-and-wait randomized trial. PATIENTS Consecutive patients with stage T3 to T4N0M0 or T(any)N+M0 cancer located within 10 cm from anal verge or T2N0 within 7 cm from anal verge were included in the study. Patients were staged and restaged 8 weeks after completion of chemoradiation (5-fluorouracil, 5040 cGy) by digital examination, colonoscopy, pelvic MRI, and thorax and abdominal CT scans. MAIN OUTCOME MEASURES Clinical and radiologic judgments of tumor response were compared with pathologic response of patients treated by total mesorectal excision or clinical follow-up of patients selected for nonoperative treatment. RESULTS A total of 118 patients were treated. Six patients were considered clinic complete responders (2 randomly assigned for surgery (1 ypT0N0 and 1 ypT2N0) and 4 patients randomly assigned for observation (3 sustained clinic complete response and 1 had tumor regrowth)). The 112 clinic incomplete responders underwent total mesorectal excision, and 18 revealed pathologic complete response. These 18 patients were not considered complete responders at restaging because they presented at least 1 of the following conditions: mucosal ulceration and/or deformity and/or substenosis of rectal lumen at digital rectal examination and colonoscopy (n = 16), ymrT1 to T4 (n = 16), ymrN+ (n = 2), involvement of circumferential resection margin on MRI (n = 3), extramural vascular invasion on MRI (n = 4), MRI tumor response grade 2 to 4 (n = 15), and pelvic side wall lymph node involvement on MRI (n = 1). Sensitivity for identification of ypT0N0 or sustained clinic complete response was 18.2%. LIMITATIONS This study has a short follow-up and small sample size. Radiologists who reviewed the restaging examination were not blinded to the pretreatment stage. Only 1 radiologist read the images of each patient. CONCLUSIONS Evaluation of clinic complete response according to current adopted criteria has low sensitivity because pathologic complete response more frequently presented as clinic incomplete response (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A221).
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Glynne-Jones R, Hughes R. Complete Response after Chemoradiotherapy in Rectal Cancer (Watch-and-Wait): Have we Cracked the Code? Clin Oncol (R Coll Radiol) 2016; 28:152-160. [DOI: 10.1016/j.clon.2015.10.011] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2015] [Revised: 10/15/2015] [Accepted: 10/19/2015] [Indexed: 12/23/2022]
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9
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Follow-Up Strategy After Primary and Early Diagnosis. Updates Surg 2016. [DOI: 10.1007/978-88-470-5767-8_1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
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10
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How Should a Multi-disciplinary Team (MDT) Approach the Issue of Non-Operative Management in Rectal Cancer? CURRENT COLORECTAL CANCER REPORTS 2015. [DOI: 10.1007/s11888-015-0291-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
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Gaertner WB, Kwaan MR, Madoff RD, Melton GB. Rectal cancer: An evidence-based update for primary care providers. World J Gastroenterol 2015; 21:7659-7671. [PMID: 26167068 PMCID: PMC4491955 DOI: 10.3748/wjg.v21.i25.7659] [Citation(s) in RCA: 46] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2015] [Revised: 04/04/2015] [Accepted: 05/21/2015] [Indexed: 02/07/2023] Open
Abstract
Rectal adenocarcinoma is an important cause of cancer-related deaths worldwide, and key anatomic differences between the rectum and the colon have significant implications for management of rectal cancer. Many advances have been made in the diagnosis and management of rectal cancer. These include clinical staging with imaging studies such as endorectal ultrasound and pelvic magnetic resonance imaging, operative approaches such as transanal endoscopic microsurgery and laparoscopic and robotic assisted proctectomy, as well as refined neoadjuvant and adjuvant therapies. For stage II and III rectal cancers, combined chemoradiotherapy offers the lowest rates of local and distant relapse, and is delivered neoadjuvantly to improve tolerability and optimize surgical outcomes, particularly when sphincter-sparing surgery is an endpoint. The goal in rectal cancer treatment is to optimize disease-free and overall survival while minimizing the risk of local recurrence and toxicity from both radiation and systemic therapy. Optimal patient outcomes depend on multidisciplinary involvement for tailored therapy. The successful management of rectal cancer requires a multidisciplinary approach, with the involvement of enterostomal nurses, gastroenterologists, medical and radiation oncologists, radiologists, pathologists and surgeons. The identification of patients who are candidates for combined modality treatment is particularly useful to optimize outcomes. This article provides an overview of the diagnosis, staging and multimodal therapy of patients with rectal cancer for primary care providers.
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Milgrom SA, Goodman KA. Non-operative management of locally advanced rectal cancer. SEMINARS IN COLON AND RECTAL SURGERY 2014. [DOI: 10.1053/j.scrs.2013.09.006] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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Weiser MR, Beets-Tan R, Beets G. Management of Complete Response After Chemoradiation in Rectal Cancer. Surg Oncol Clin N Am 2014; 23:113-25. [DOI: 10.1016/j.soc.2013.09.012] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
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Sclafani F, Cunningham D. Non-operative management for locally advanced rectal cancer: critical review and future perspective. COLORECTAL CANCER 2013. [DOI: 10.2217/crc.13.33] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
Abstract
SUMMARY Over the last few decades we have observed important advances in diagnostic imaging, surgery, pathology and multimodal treatments for rectal cancer, as well as increased efforts to reduce treatment-related toxicities and preserve quality of life for curatively treated patients. Neoadjuvant short-course radiotherapy and long-course chemoradiotherapy followed by total mesorectal excision remain widely accepted as the standard of care for patients with locally advanced rectal cancer. However, a carefully selected group of patients achieving a complete response to neoadjuvant chemoradiotherapy may be spared the effects of surgery and achieve satisfactory oncologic outcomes with a ‘wait-and-see’ strategy. Although supported by the results of previous studies, this intriguing paradigm shift needs prospective evaluation within a clinical trial setting and a more accurate prediction and assessment of response by means of tumor biomarkers and diagnostic imaging.
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Affiliation(s)
- Francesco Sclafani
- Department of Medicine, The Royal Marsden NHS Foundation Trust, Sutton, Surrey, SM2 5PT, UK
| | - David Cunningham
- Department of Medicine, The Royal Marsden NHS Foundation Trust, Sutton, Surrey, SM2 5PT, UK
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Sharma K, Iyer A, Sengupta K, Chakrapani H. INDQ/NO, a Bioreductively Activated Nitric Oxide Prodrug. Org Lett 2013; 15:2636-9. [DOI: 10.1021/ol400884v] [Citation(s) in RCA: 57] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/17/2023]
Affiliation(s)
- Kavita Sharma
- Departments of Chemistry and Biology, Indian Institute of Science Education and Research Pune, Pune 411 008, Maharashtra, India
| | - Aishwarya Iyer
- Departments of Chemistry and Biology, Indian Institute of Science Education and Research Pune, Pune 411 008, Maharashtra, India
| | - Kundan Sengupta
- Departments of Chemistry and Biology, Indian Institute of Science Education and Research Pune, Pune 411 008, Maharashtra, India
| | - Harinath Chakrapani
- Departments of Chemistry and Biology, Indian Institute of Science Education and Research Pune, Pune 411 008, Maharashtra, India
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Glynne-Jones R, Hughes R. Critical appraisal of the 'wait and see' approach in rectal cancer for clinical complete responders after chemoradiation. Br J Surg 2012; 99:897-909. [PMID: 22539154 DOI: 10.1002/bjs.8732] [Citation(s) in RCA: 181] [Impact Index Per Article: 13.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/16/2012] [Indexed: 12/16/2022]
Abstract
BACKGROUND Some 10-20 per cent of patients with locally advanced rectal cancer achieve a pathological complete response (pCR) at surgery following preoperative chemoradiation (CRT). Some demonstrate a sustained clinical complete response (cCR), defined as absence of clinically detectable residual tumour after CRT, and do not undergo resection. The aim of this review was to evaluate non-operative treatment of rectal cancer after CRT, and the outcome of patients observed without radical surgery. METHODS A systematic computerized search identified 30 publications (9 series, 650 patients) evaluating a non-operative approach after CRT. Original data were extracted and tabulated, and study quality evaluated. The primary outcome measure was cCR. Secondary outcome measures included locoregional failure rate, disease-free survival and overall survival. RESULTS The most recent Habr-Gama series reported a low locoregional failure rate of 4·6 per cent, with 5-year overall and disease-free survival rates of 96 and 72 per cent respectively. These findings were supported by a small prospective Dutch study. However, other retrospective series have described higher recurrence rates. All studies were heterogeneous in staging, inclusion criteria, study design and rigour of follow-up after CRT, which might explain the different outcomes. The definition of cCR was inconsistent, with only partial concordance with pCR. The results suggested that patients who are observed, but subsequently fail to sustain a cCR, may fare worse than those who undergo immediate tumour resection. CONCLUSION The rationale of a 'wait and see' policy relies mainly on retrospective observations from a single series. Proof of principle in small low rectal cancers, where clinical assessment is easy, should not be extrapolated uncritically to more advanced cancers where nodal involvement is common. Long-term prospective observational studies with more uniform inclusion criteria are required to evaluate the risk versus benefit.
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Affiliation(s)
- R Glynne-Jones
- Centre for Cancer Treatment, Mount Vernon Hospital, Northwood HA6 2RN, UK.
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Fischkoff KN, Ruby JA, Guillem JG. Nonoperative Approach to Locally Advanced Rectal Cancer After Neoadjuvant Combined Modality Therapy: Challenges and Opportunities From a Surgical Perspective. Clin Colorectal Cancer 2011; 10:291-7. [DOI: 10.1016/j.clcc.2011.06.001] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2010] [Revised: 12/16/2010] [Accepted: 12/21/2010] [Indexed: 12/22/2022]
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Singh-Ranger G. Management of rectal cancer in the era of neoadjuvant chemoradiation. ANZ J Surg 2011; 81:215-6. [DOI: 10.1111/j.1445-2197.2011.05674.x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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Hughes R, Harrison M, Glynne-Jones R. Could a wait and see policy be justified in T3/4 rectal cancers after chemo-radiotherapy? Acta Oncol 2010; 49:378-81. [PMID: 20151936 DOI: 10.3109/02841860903483692] [Citation(s) in RCA: 70] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
UNLABELLED Chemoradiotherapy (CRT) followed by total mesorectal excision is the standard when MRI staging demonstrates threatened surgical margins in locally advanced rectal cancer (LARC). Interest in non-surgical management of LARC as an alternative to a resection has been provoked by published excellent long-term outcomes of patients who achieve clinical complete responses (cCR) after CRT. The present retrospective study aimed to determine whether similar rates of local disease control are seen in a UK cancer centre in patients with T3-4 tumours, who obtained a cCR after preoperative CRT, but did not undergo surgery. METHOD The outcome and treatment details of 266 patients who underwent CRT for clinically staged T3-4 rectal adenocarcinomas between 1993 and 2005 were reviewed. RESULTS Fifty-eight patients did not proceed to surgery, 10 of whom were identified as having a cCR. Six of these 10 patients subsequently developed intrapelvic recurrent disease with a median time to local progression of 20 months. Local relapse preceded the development of metastatic disease or occurred simultaneously. No patients underwent salvage resection. CONCLUSION CRT alone in cT3/T4 rectal cancers has a high rate of local relapse even after cCR. Delaying or avoiding surgery might be appropriate for cT1 or cT2 tumours, or elderly and frail patients with co-morbidity, but these results do not support the current uncritical move to extrapolate this approach to all surgically fit patients with rectal cancer.
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Affiliation(s)
- Robert Hughes
- Mount Vernon Centre for Cancer Treatment, Northwood, Middlesex HA6 2RN, UK.
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Neuman HB, Elkin EB, Guillem JG, Paty PB, Weiser MR, Wong WD, Temple LK. Treatment for patients with rectal cancer and a clinical complete response to neoadjuvant therapy: a decision analysis. Dis Colon Rectum 2009; 52:863-71. [PMID: 19502849 DOI: 10.1007/dcr.0b013e31819eefba] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
PURPOSE A clinical complete response to neoadjuvant therapy occurs in a subset of patients with rectal cancer. Management of these patients is controversial and tension exists between the recurrence risk with observation, and the impact of surgery on quality-of-life. Therefore, the objective was to develop a decision-analytic model to evaluate the relative benefits of surgery vs. observation in rectal cancer patients who achieve clinical complete response after neoadjuvant chemoradiation. METHODS Clinically relevant inputs and events, including the ability to identify complete responders, likelihood of relapse and of salvage surgery after relapse, and utilities for each health state, were simulated by use of a Markov state-transition model. Transition probabilities and health-state utilities were derived from the literature and expert consensus. One-way and two-way sensitivity analyses were performed to assess the robustness of model results to assumptions. The primary outcome was quality-adjusted life expectancy. RESULTS In the base-case analysis, the quality-adjusted life expectancy with surgery exceeded observation (5.63 vs. 5.34 quality-adjusted life-years). Sensitivity analysis demonstrated that observation was preferred to surgery if the ability to correctly identify patients with true complete responses exceeded 58 percent, if quality-of-life after surgery was poor (utility <0.81), or if the relative reduction in recurrence risk with surgery was <43 percent when compared with observation. CONCLUSIONS Our model outlines the issues associated with surgery vs. observation, and suggests that surgery is beneficial for the average patient with rectal cancer with a clinical complete response after neoadjuvant therapy. Current limitations in the clinical assessment of patient response to chemoradiation constitute an important factor influencing our results, and therefore warrant further investigation.
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Affiliation(s)
- Heather B Neuman
- Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10065, USA
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21
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Glynne-Jones R, Wallace M, Livingstone JIL, Meyrick-Thomas J. Complete clinical response after preoperative chemoradiation in rectal cancer: is a "wait and see" policy justified? Dis Colon Rectum 2008; 51:10-9; discussion 19-20. [PMID: 18043968 DOI: 10.1007/s10350-007-9080-8] [Citation(s) in RCA: 115] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2007] [Revised: 05/14/2007] [Accepted: 05/20/2007] [Indexed: 02/06/2023]
Abstract
PURPOSE A proportion of patients, who receive preoperative chemoradiation for locally advanced (T3, T4, NX) rectal cancer achieve a complete clinical response and a pathologic complete response in the region of 15 to 30 percent. Support is growing in the United Kingdom for the concept of "waiting to see" and not proceeding to radical surgery when a complete clinical response is observed. The purpose of this review was to use a literature search to assess how often complete clinical response is achieved after neoadjuvant chemoradiation, the concordance of this finding with pathologic complete response, and to determine whether it is feasible to observe patients who achieve complete clinical response rather than proceed to surgery. RESULTS In total, 218 Phase I/II or retrospective studies and 28 Phase III trials of preoperative radiotherapy or chemoradiation were identified: 96 percent of trials documented the pathologic complete response, but only 38 trials presented data on the achievement of a complete clinical response/partial clinical response. Only five studies were found in which patients with clinically staged T2/T3 tumors were treated with radiotherapy/chemoradiation and did not routinely proceed to surgery and also reported on the long-term outcome of a "wait and see" policy. DISCUSSION It remains uncertain whether the degree of response to chemoradiation in terms of complete clinical response or pathologic complete response is a useful clinical end point. Studies that include T3 rectal cancer are associated with high local recurrence rates after nonsurgical treatment. Few studies report long-term outcome after achievement of a complete clinical response. CONCLUSIONS The end point of complete clinical response is inconsistently defined and seems insufficiently robust with only partial concordance with pathologic complete response. The rationale of a "wait and see" policy when complete clinical response status is achieved relies on retrospective observations, which are currently insufficient to support this policy except in patients who are recognized to be unfit for or refuse radical surgery.
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Affiliation(s)
- R Glynne-Jones
- Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom.
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22
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Lim L, Chao M, Shapiro J, Millar JL, Kipp D, Rezo A, Fong A, Jones IT, McLaughlin S, Gibbs P. Long-term outcomes of patients with localized rectal cancer treated with chemoradiation or radiotherapy alone because of medical inoperability or patient refusal. Dis Colon Rectum 2007; 50:2032-9. [PMID: 17896138 DOI: 10.1007/s10350-007-9062-x] [Citation(s) in RCA: 45] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/21/2006] [Revised: 12/31/2006] [Accepted: 02/18/2007] [Indexed: 02/07/2023]
Abstract
PURPOSE The standard management of rectal cancer continues to be defined by the results of randomized, clinical trials exploring the optimal timing and use of adjuvant chemotherapy and radiation therapy in relation to surgery. The patient with rectal cancer who is elderly and/or has significant comorbidities and the patient who refuses surgery are clinical contexts for which there is limited current data to guide decision making. METHODS A retrospective analysis was performed at six Australian centers of patients with rectal cancer treated with radiation therapy or chemoradiation alone because of excessive operative risk or patient refusal of surgery. RESULTS We identified 48 patients treated between August 1998 and June 2005 with a median age of 76 (range, 49-94) years. Twenty-four patients (50 percent) were considered medically inoperable and 24 patients refused surgery. Treatment was with chemoradiation (with 5-fluorouracil) in 36 patients and radiotherapy alone in 12 patients; 93 percent completed the planned therapy. A clinical complete response was seen in 56 percent and a partial response in 30 percent of patients. At a median follow-up of 49 months, 18 patients have disease progression, including 10 of 24 in the medically inoperable group and 8 of 24 in the refused surgery group. Of the 25 deceased patients, 16 died from progressive disease and 9 from noncancer causes. CONCLUSIONS Chemoradiation or radiotherapy alone is a safe alternative that results in significant progression-free and overall survival times in patients who are considered medically inoperable or refuse to undergo surgery. Ultimately, however, many patients will progress.
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Affiliation(s)
- L Lim
- Royal Melbourne Hospital, Parkville, Australia.
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23
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Ferrigno R, Novaes PERDS, Silva MLG, Nishimoto IN, Nakagawa WT, Rossi BM, Ferreira FDO, Lopes A. Neoadjuvant radiochemotherapy in the treatment of fixed and semi-fixed rectal tumors. Analysis of results and prognostic factors. Radiat Oncol 2006; 1:5. [PMID: 16722598 PMCID: PMC1459184 DOI: 10.1186/1748-717x-1-5] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2005] [Accepted: 03/28/2006] [Indexed: 12/21/2022] Open
Abstract
PURPOSE To report the retrospective analysis of patients with locally advanced rectal cancer treated with neodjuvant radiochemotherapy. METHODS AND MATERIALS From January 1994 to December 2003, 101 patients with fixed (25%) or semi-fixed (75%) rectal adenocarcinoma were treated by preoperative radiotherapy with a dose of 45 Gy at the whole pelvis and 50.4 Gy at primary tumor, concomitant to four weekly chemotherapies with 5-Fluorouracil (425 mg/m2) and Leucovorin (20 mg/m2). In 71 patients (70.3%) the primary tumor was located up to 6 cm from the anal verge and in 30 (29.7%) from 6.5 cm to 10 cm. Age, gender, tumor fixation, tumor distance from the anal verge, clinical response, surgical technique, and postoperative TNM stage were the prognostic factors analyzed for overall survival (OS), disease-free survival (DFS), and local control (LC) at five years. RESULTS Median follow-up time was 38 months (range, 2-141). Complete response was observed in eight patients (7.9%), partial in 54 (53.4%) and absence in 39 (38.7%). OS, DFS and LC were 52.6%, 53.8%, and 75.9%, respectively. Distant metastasis occurred in 40 (39.6%) patients, local recurrence in 20 (19.8%) and both in 16 (15.8%). Patients with fixed tumors had lower OS (17% Vs 65.6%; p < 0.001), DFS (31.2% Vs 60.9%; p = 0.005), and LC (58% Vs 82%; p = 0.004). Patients with tumors more than 6 cm above the anal verge had better LC (93% Vs 69%; p = 0.04). The postoperative TNM stage was a significant factor for DFS (I:64.1%, II:69.6%, III:35.2%, IV:11.1%; p < 0.001) and for LC (I:75.7%, II: 92.9%, III:54.1%, IV:100%; p = 0.005). Patients with positive lymph nodes had worse OS (37.9% Vs 70.4%, p = 0.006), DFS (32% Vs 72.7%, p < 0.001) and LC (56.2% Vs 93.4%; p < 0.001). CONCLUSION This study suggests that the neoadjuvant treatment employed was effective for local control. Fixation of the lesion and lymph nodes metastasis were the main adverse prognostic factors. Distant failures were frequent, supporting the need of new drugs for adjuvant chemotherapy.
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Affiliation(s)
- Robson Ferrigno
- Department of Radiation Oncology, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | | | - Maria Letícia Gobo Silva
- Department of Radiation Oncology, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | - Ines Nobuko Nishimoto
- Department of Biostatistics, Fundação Antonio Prudente, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | - Wilson Toshihiko Nakagawa
- Department of Pelvic Surgery, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | - Benedito Mauro Rossi
- Department of Pelvic Surgery, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | - Fábio de Oliveira Ferreira
- Department of Pelvic Surgery, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
| | - Ademar Lopes
- Department of Pelvic Surgery, Hospital do Câncer A. C. Camargo, Rua Prof. Antonio Prudente, 211, São Paulo, SP 01509-900, Brazil
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24
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Nakagawa WT, Rossi BM, de O Ferreira F, Ferrigno R, David Filho WJ, Nishimoto IN, Vieira RAC, Lopes A. Chemoradiation instead of surgery to treat mid and low rectal tumors: is it safe? Ann Surg Oncol 2002; 9:568-73. [PMID: 12095973 DOI: 10.1007/bf02573893] [Citation(s) in RCA: 63] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND The main treatment for rectal carcinoma is surgery. Preoperative chemoradiation (CRT) is advocated to reduce local recurrence and improve resection of mid and low tethered rectal tumors. METHODS Fifty-two patients with mid or low rectal tumors underwent CRT (external beam radiation plus 5-fluorouracil plus folinic acid). Patients who had low rectal tumors with complete response (CR) were not submitted to surgical treatment. All other patients were submitted to surgery, independently of the response. Mean follow-up was 32.1 months. RESULTS Five-year overall survival was 60.5%. Clinical evaluation after CRT showed CR in 10 cases (19.2%), all low tumors; incomplete response (>50%) in 21 (40.4%); and no response (<50%) in 19 (36.6%). Among the 10 cases with CR, 8 presented with local recurrence within 3.7 to 8.8 months. Two patients were not submitted to surgery and are still alive without cancer after 37 and 58 months. Thirty-nine patients had radical surgery. Seven had local recurrences after CRT plus surgery (17.9%). Overall survival was negatively affected by lymph node metastases (P =.017) and perineural invasion (P =.026). CONCLUSIONS Exclusive CRT approach is not safe to treat patients with low infiltrative rectal carcinoma.
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Affiliation(s)
- Wilson T Nakagawa
- Pelvic Surgery Department, A. C. Camargo Cancer Hospital, Antonio Prudente Foundation, São Paulo, Brazil.
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Abstract
The most common neo-adjuvant therapy for rectal cancer is chemotherapy and concurrent radiation therapy. In general, it is delivered pre-operatively for patients with clinical evidence of T(3-4) disease or post-operatively in patients who have undergone surgery and have T(3) and/or N(1-2) disease. This chapter reviews the rationale and results for neo-adjuvant therapy, the selection process for pre-operative versus post-operative treatment, and new approaches and controversies.
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Affiliation(s)
- Bruce D Minsky
- Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, Cornell University, USA
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Gómez Fleitas M. La quimiorradioterapia preoperatoria en el tratamiento del cáncer de recto. Cir Esp 2001. [DOI: 10.1016/s0009-739x(01)71843-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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Abstract
Combined modality therapy is the standard adjuvant therapy for selected patients with adenocarcinoma of the rectum. In the postoperative setting, the primary goal is to decrease local recurrence and improve overall survival. In the preoperative setting, adjuvant therapy has the additional potential benefit of enhancing sphincter preservation and less acute toxicity as compared with postoperative adjuvant therapy. Investigational trials are in progress to examine new systemic chemotherapeutic agents and altered radiation fractionation schemes.
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Affiliation(s)
- B D Minsky
- Memorial Sloan-Kettering Cancer Center and Cornell University Medical College, New York, New York 10021, USA
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Affiliation(s)
- B D Minsky
- Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA.
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