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Cancers
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Non Operative Management of Patients with Rectal Cancer
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Non Operative Management of Patients with Rectal Cancer

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Cancer Therapy".

Deadline for manuscript submissions: closed (15 April 2022) | Viewed by 22515

Special Issue Editors

Dr. Te Vuong

E-Mail Website
Guest Editor
Department of Radiation Oncology, McGill University, Jewish General Hospital, Montreal, QC H3T1E2, Canada
Interests: radiation targeted modalities for rectal cancer; colorectal cancer screening; early rectal cancer
Dr. Krzysztof Bujko

E-Mail Website
Guest Editor
Maria Sklodowska-Curie National Research Institute of Oncology Warsaw, Warsaw, Poland
Interests: rectal cancer; anal cancer

Special Issue Information

Dear Colleagues,

For patients with rectal cancer, cure has been improved in recent decades with the introduction of total mesorectal excision (TME) combined with neoadjuvant radiation therapy, either short or long-course chemoradiotherapy using external beam radiation (n-CTRT). However, for survivors who undergo rectal removal with a permanent colostomy, long-term functional sequelae, including sexual and urinary dysfunction, are documented. In addition, 40% of patients with bowel continuity preservation report a significant reduction in their quality of life (QoL). They also have altered bowel habits in the form of frequency, unpredictability, and fecal incontinence [1–4] for up to 14 years after completion of treatment. More than 20 years ago, in an effort to improve patient quality of life, Habr-Gama pioneered the "watch and wait" (W&W) strategy [5] after n-CTRT for patients with a complete clinical response (cCR) in a cohort of patients bound to have a permanent stoma. This study demonstrated the safety of this method through long-term follow-up data [6], as well as local relapses that can be saved by subsequent surgery, with no apparent negative impact on survival. This treatment paradigm is of growing interest among colorectal cancer specialists worldwide. Validation of its results has since been ongoing.

Two strategies for NOM can be distinguished: one opportunistic, when radio (chemo)therapy is needed as preoperative treatment anyway; the other for small cancers, when preoperative radio (chemo)therapy is not routinely indicated, and the goal of radiation therapy is NOM [7]. While the former strategy is increasingly accepted worldwide, the latter is considered experimental due to lack of data. 

Promising new approaches for improving the rate of patients treated with NMW are emerging—namely, adding a brachytherapy boost (either contact x-ray or HDR) to external beam radiation therapy [8,9,10] or using total neoadjuvant therapy (i.e., adding 3–4 months of sequential neoadjuvant chemotherapy to neoadjuvant radio(chemo)therapy) [11]. Mature data displaying the results of these new approaches are awaited as they will be of utmost importance to patients, especially the elderly with co-morbidities, but also any patient who does not wish to undergo major surgery that could result in a permanent colostomy and/or bowel and sexual dysfunction. These alternative treatment strategies could offer a safe cure with fewer complications.

This Special Issue is dedicated to the most recent strategies with modern chemotherapy regimens and innovative technologies that have explored the NOM avenue, in a joint multidisciplinary effort to improve patient quality of life for a specific patient population using quality imaging.

Prof. Dr. Te Vuong
Dr. Krzysztof Bujko
Guest Editors

References

  1. Pucciarelli, S.; Del Bianco, P.; Efficace, F.; Serpentini, S.; Capirci, C.; De Paoli, A.; Amato, A.; Cuicchi, D.; Nitti, D. Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal ancer: a multicenter prospective observational study. Surg. 2011, 253, 71–77.
  2. Nesbakken, A.; Nygaard, K.; Bull-Njaa, T.; Carlsen, E.; Eri, L.M. Bladder and sexual dysfunction after mesorectal excision for rectal cancer. BJS 2000, 87, 206–210, https://0-doi-org.brum.beds.ac.uk/10.1046/j.1365-2168.2000.01357.x.
  3. Peeters, K.; van de Velde, C.; Leer, J.; Martijn, H.; Junggeburt, J.; Kranenbarg, E.K.; Steup, W.; Wiggers, T.; Rutten, H.; Marijnen, C. Late Side Effects of Short-Course Preoperative Radiotherapy Combined With Total Mesorectal Excision for Rectal Cancer: Increased Bowel Dysfunction in Irradiated Patients—A Dutch Colorectal Cancer Group Study. Clin. Oncol. 2005, 23, 6199–6206, https://0-doi-org.brum.beds.ac.uk/10.1200/jco.2005.14.779.
  4. Wiltink, L.M.; Chen, T.Y.; Nout, R.A.; Kranenbarg, E.M.-K.; Fiocco, M.; Laurberg, S.; van de Velde, C.J.; Marijnen, C.A. Health-related quality of life 14years after preoperative short-term radiotherapy and total mesorectal excision for rectal cancer: Report of a multicenter randomised trial. J. Cancer 2014, 50, 2390–2398, https://0-doi-org.brum.beds.ac.uk/10.1016/j.ejca.2014.06.020.
  5. Habr-Gama, A.; Perez, R.O.; Sabbaga, J.; Nadalin, W.; Julião, G.P.S.; Gama-Rodrigues, J. Increasing the Rates of Complete Response to Neoadjuvant Chemoradiotherapy for Distal Rectal Cancer: Results of a Prospective Study Using Additional Chemotherapy During the Resting Period. Colon Rectum 2009, 52, 1927–1934, https://0-doi-org.brum.beds.ac.uk/10.1007/dcr.0b013e3181ba14ed.
  6. Habr-Gama, A.; Gama-Rodrigues, J.; Julião, G.P.S.; Proscurshim, I.; Sabbagh, C.; Lynn, P.B.; Perez, R.O. Local Recurrence After Complete Clinical Response and Watch and Wait in Rectal Cancer After Neoadjuvant Chemoradiation: Impact of Salvage Therapy on Local Disease Control. J. Radiat. Oncol. 2014, 88, 822–828, https://0-doi-org.brum.beds.ac.uk/10.1016/j.ijrobp.2013.12.012.
  7. Gérard, J.-P.; Barbet, N.; Benezery, K. Organ preservation for T2-T3 rectal cancer: opportunistic or planned strategy. Oncotarget 2019, 10, 3431–3432, https://0-doi-org.brum.beds.ac.uk/10.18632/oncotarget.26916.
  8. Appelt, A.L.; Pløen, J.; Harling, H.; Jensen, F.S.; Jensen, L.H.; Jørgensen, J.C.R.; Lindebjerg, J.; Rafaelsen, S.R.; Jakobsen, A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015, 16, 919–927, https://0-doi-org.brum.beds.ac.uk/10.1016/s1470-2045(15)00120-5.
  9. Benezery, K.; Montagne, L.; Evesque, L.; Schiappa, R.; Hannoun-Levi, J.M.; Francois, E.; Thamphya, B.; Gerard, J.P. Clinical response assessment after contact X-Ray brachytherapy and chemoradiotherapy for organ preservation in rectal cancer T2-T3 M0: The time/dose factor influence. Transl. Radiat. Oncol. 2020, 24, 92–98.
  10. Garant, A.; Magnan, S.; Devic, S.; Martin, A.-G.; Boutros, M.; Vasilevsky, C.-A.; Ferland, S.; Bujold, A.; DesGroseilliers, S.; Sebajang, H.; et al. Image Guided Adaptive Endorectal Brachytherapy in the Nonoperative Management of Patients With Rectal Cancer. J. Radiat. Oncol. 2019, 105, 1005–1011, https://0-doi-org.brum.beds.ac.uk/10.1016/j.ijrobp.2019.08.042.
  11. Garcia-Aguilar, J.; Patil, S.; Kim, J.K.; Yuval, J.B.; Thompson, H.; Verheij, F.; Lee, M.; Saltz, L.B.; on behalf of the OPRA Consortium Preliminary results of the organ preservation of rectal adenocarcinoma (OPRA) trial. Clin. Oncol. 2020, 38, 4008, https://0-doi-org.brum.beds.ac.uk/10.1200/jco.2020.38.15_suppl.4008.

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Published Papers (7 papers)

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Research

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11 pages, 690 KiB  
Article
Image-Guided Brachytherapy for Rectal Cancer: Reviewing the Past Two Decades of Clinical Investigation
by Te Vuong, Aurelie Garant, Veronique Vendrely, Remi Nout, André-Guy Martin, Shirin A. Enger, Ervin Podgorsak, Belal Moftah and Slobodan Devic
Cancers 2022, 14(19), 4846; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14194846 - 04 Oct 2022
Cited by 2 | Viewed by 1747
Abstract
(1) Background: The introduction of total mesorectal excision (TME) for rectal cancer has led to improvement in local recurrence (LR) outcomes. Furthermore, the addition of preoperative external beam radiotherapy to TME reduces LR to less than 6%. As a trade-off to these gradual [...] Read more.
(1) Background: The introduction of total mesorectal excision (TME) for rectal cancer has led to improvement in local recurrence (LR) outcomes. Furthermore, the addition of preoperative external beam radiotherapy to TME reduces LR to less than 6%. As a trade-off to these gradual improvements in local therapies, the oncology community’s work is now focusing on mitigating treatment-related toxicities. In other words, if a small proportion of 4–6% of rectal cancer patients benefit from additional local therapy beyond TME, the burden of acute and long-term side effects must be considered with care. (2) Methods: With the introduction of better-quality imaging for tumor visualization and treatment planning, a new conformed radiation treatment was introduced with high-dose-rate endorectal brachytherapy. The treatment concept was tested in phase I and II studies: first in the pre-operative setting, and then as a boost after external beam radiation therapy, as a dose-escalation study, to achieve higher local tumor control. (3) Results: HDREBT is safe and effective in achieving a high tumor regression rate and was well tolerated in a phase II multicenter and two matched-pair studies. (4) Conclusions: HDREBT is a conformed radiation therapy that is safe and effective, and is presently explored in a phase III dose-escalation study in the NOM of patients with operable rectal cancer. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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12 pages, 879 KiB  
Article
MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results
by Aurelie Garant, Carol-Ann Vasilevsky, Marylise Boutros, Farzin Khosrow-Khavar, Petr Kavan, Hugo Diec, Sylvain Des Groseilliers, Julio Faria, Emery Ferland, Vincent Pelsser, André-Guy Martin, Slobodan Devic and Te Vuong
Cancers 2022, 14(15), 3665; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14153665 - 28 Jul 2022
Cited by 15 | Viewed by 2567
Abstract
Background: We explored image-guided adaptive endorectal brachytherapy patients electing non-operative management for rectal cancer. We present the first pre-planned interim analysis. Methods: In this open-label phase II–III randomized study, patients with operable cT2-3ab N0 M0 rectal cancer received 45 Gy in 25 fractions [...] Read more.
Background: We explored image-guided adaptive endorectal brachytherapy patients electing non-operative management for rectal cancer. We present the first pre-planned interim analysis. Methods: In this open-label phase II–III randomized study, patients with operable cT2-3ab N0 M0 rectal cancer received 45 Gy in 25 fractions of pelvic external beam radiotherapy (EBRT) with 5-FU/Capecitabine. They were randomized 1:1 to receive either an EBRT boost of 9 Gy in 5 fractions (Arm A) or three weekly adaptive brachytherapy (IGAEBT) boosts totaling 30 Gy (Arm B). Patient characteristics and toxicity are presented using descriptive analyses; TME-free survival between arms with the intention to treat the population is explored using the Kaplan–Meier method. Results: A total of 40 patients were in this analysis. Baseline characteristics were balanced; acute toxicities were similar. Complete clinical response (cCR) was 50% (n = 10/20) in Arm A and 90% in Arm B (n = 18/20). Median follow-up was 1.3 years; 2-year TME-free survival was 38.6% (95% CI: 16.5–60.6%) in the EBRT arm and 76.6% (95% CI: 56.1–97.1%) in the IGAEBT arm. Conclusions: Radiation intensification with IGAEBT is feasible. This interim analysis suggests an improvement in TME-free survival when comparing IGAEBT with EBRT, pending confirmation upon completion of this trial. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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10 pages, 651 KiB  
Article
Role of Local Excision for Suspected Regrowth in a Watch and Wait Strategy for Rectal Cancer
by Barbara M. Geubels, Vincent M. Meyer, Henderik L. van Westreenen, Geerard L. Beets, Brechtje A. Grotenhuis and on behalf of the Dutch Watch and Wait Consortium
Cancers 2022, 14(13), 3071; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14133071 - 23 Jun 2022
Cited by 5 | Viewed by 1973
Abstract
Rectal cancer patients with a clinical complete response to neoadjuvant (chemo)radiation are eligible for Watch and Wait (W&W). For local regrowth, total mesorectal excision (TME) is considered the standard of care. This study evaluated local excision (LE) for suspected local regrowth. From 591 [...] Read more.
Rectal cancer patients with a clinical complete response to neoadjuvant (chemo)radiation are eligible for Watch and Wait (W&W). For local regrowth, total mesorectal excision (TME) is considered the standard of care. This study evaluated local excision (LE) for suspected local regrowth. From 591 patients prospectively entered into a national W&W registry, 77 patients with LE for regrowth were included. Outcomes analyzed included histopathologic findings, locoregional recurrence, long-term organ preservation, and colostomy-free and overall survival. In total, 27/77 patients underwent early LE (<6 months after neoadjuvant radiotherapy) and 50/77 underwent late LE (≥6 months). Median follow-up was 53 (39–69) months. In 28/77 patients the LE specimen was histopathologically classified as ypT0 (including 9 adenomas); 11/77 were ypT1, and 38/77 were ypT2–3. After LE, 13/77 patients with ypT2–3 and/or irradical resection underwent completion TME. Subsequently, 14/64 patients without completion TME developed locoregional recurrence, and were successfully treated with salvage TME. Another 8/77 patients developed distant metastases. At 5 years, overall organ preservation was 63%, colostomy-free survival was 68%, and overall survival was 96%. There were no differences in outcomes between early or late LE. In W&W for rectal cancer, LE can be considered as an alternative to TME for suspected regrowth in selected patients who wish to preserve their rectum or avoid colostomy in distal rectal cancer. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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12 pages, 32118 KiB  
Article
Targeted Radiotherapy Using Contact X-ray Brachytherapy 50 kV
by Jean-Pierre Gerard, Arthur Sun Myint, Nicolas Barbet, Catherine Dejean, Brice Thamphya, Jocelyn Gal, Lucile Montagne and Te Vuong
Cancers 2022, 14(5), 1313; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14051313 - 03 Mar 2022
Cited by 4 | Viewed by 3109
Abstract
Rectal adenocarcinoma is a quite radioresistant tumor. In order to achieve non-operative management (NOM) radiotherapy plays a major role. Targeted radiotherapy aiming at high precision 3D radiotherapy uses stereotactic image-guided external beam radiotherapy machines. To further safely increase the tumor dose, endocavitary brachytherapy [...] Read more.
Rectal adenocarcinoma is a quite radioresistant tumor. In order to achieve non-operative management (NOM) radiotherapy plays a major role. Targeted radiotherapy aiming at high precision 3D radiotherapy uses stereotactic image-guided external beam radiotherapy machines. To further safely increase the tumor dose, endocavitary brachytherapy (ECB) is an original approach. There are two different ways to perform such an ECB: contact X-ray brachytherapy (CXB) using a 50 kV X-ray generator with an X-ray tube positioned under eye guidance into the rectal cavity and high-dose-rate brachytherapy (HDRB) using iridium-192 sources positioned into the rectal cavity under image guidance. This study focused on CXB. CXB uses a small mobile generator that produces 50 kV X-rays with limited penetration. This technique is well adapted to accessible tumors of limited size and especially needs a high dose rate (≥15 Gy/minutes) for rectal tumors. It is performed on an ambulatory basis. A total dose between 80–110 Gy is delivered in 3–4 fractions over 3 to 6 weeks into a small volume (5 cm3). CXB was pioneered in the 1970s by Papillon using the Philips RT 50TM. Since 2009, the Papillon P50TM has been used in 11 institutions in Europe. The OPERA Phase III trial tested the hypothesis that a CXB boost (90 Gy/3 fr) compared to an EBRT boost (9 Gy/5 fr) for T2–T3 ab < 5 cm and N0–N1 < 8 mm will increase the 3-year organ preservation (OP) rate when combined with 45 Gy/5 weeks with concomitant capecitabine. Out of more than 300 patients with tumors < 3 cm (1962–1992), Papillon reported a long-term local control close to 85%. Similar results were published in Europe and USA at that time. The Lyon R96-2 Phase III trial (2004) demonstrated that, when combined with preoperative EBRT, a CXB boost (90 Gy/3 fr) significantly increased the rate of clinical complete response (cCR) and sphincter preservation, with some patients having OP at 10 years. With more than 2000 patients treated in Europe (2010–2020) using the Papillon 50TM, organ preservation appears possible in close to 80% of cases in selected early T2–T3. The OPERA trial closed after 141 inclusions (2015–2020) after an independent data monitoring committee recommendation because of promising results. At the 2-year follow-up (blinded data), the rate of cCR and OP were 77% and 72%, respectively, for the 141 tumors, and for T < 3 cm (61 pts), they were 86% and 85%, respectively, with good bowel function. The final results should be available in 2022. Organ preservation using NOM appears to be a promising approach for rectal cancer. A CXB boost with chemoradiotherapy in selected early T2–T3 could become an attractive option to achieve a planned OP. This approach should be proposed to well-informed patients after discussion in an MDT. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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13 pages, 1915 KiB  
Article
Contact X-ray Brachytherapy for Older or Inoperable Rectal Cancer Patients: Short-Term Oncological and Functional Follow-Up
by Petra A. Custers, Barbara M. Geubels, Inge L. Huibregtse, Femke P. Peters, Ellen G. Engelhardt, Geerard L. Beets, Corrie A. M. Marijnen, Monique E. van Leerdam and Baukelien van Triest
Cancers 2021, 13(24), 6333; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers13246333 - 16 Dec 2021
Cited by 8 | Viewed by 2637
Abstract
Total mesorectal excision for rectal cancer is a major operation associated with morbidity and mortality. For older or inoperable patients, alternatives are necessary. This prospective study evaluated the oncological and functional outcome and quality of life of older or inoperable rectal cancer patients [...] Read more.
Total mesorectal excision for rectal cancer is a major operation associated with morbidity and mortality. For older or inoperable patients, alternatives are necessary. This prospective study evaluated the oncological and functional outcome and quality of life of older or inoperable rectal cancer patients treated with a contact X-ray brachytherapy boost to avoid major surgery. During follow-up, tumor response and toxicity on endoscopy were scored. Functional outcome and quality of life were assessed with self-administered questionnaires. Additionally, in-depth interviews regarding patients’ experiences were conducted. Nineteen patients were included with a median age of 80 years (range 72–91); nine patients achieved a clinical complete response and in another four local control of the tumor was established. The 12 month organ-preservation rate, progression-free survival, and overall survival were 88%, 78%, and 100%, respectively. A transient decrease in quality of life and bowel function was observed at 3 months, which was generally restored at 6 months. In-depth interviews revealed that patients’ experience was positive despite the side-effects shortly after treatment. In older or inoperable rectal cancer patients, contact X-ray brachytherapy can be considered an option to avoid total mesorectal excision. Contact X-ray brachytherapy is well-tolerated and can provide good tumor control. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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Review

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10 pages, 439 KiB  
Review
Non-Operative Management of Patients with Rectal Cancer: Lessons Learnt from the OPRA Trial
by Paolo Goffredo, Felipe F. Quezada-Diaz, Julio Garcia-Aguilar and J. Joshua Smith
Cancers 2022, 14(13), 3204; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14133204 - 30 Jun 2022
Cited by 11 | Viewed by 7166
Abstract
Over the past decade, the management of locally advanced rectal cancer (LARC) has progressively become more complex. The introduction of total neoadjuvant treatment (TNT) has increased the rates of both clinical and pathological complete response, resulting in excellent long-term oncological outcomes. As a [...] Read more.
Over the past decade, the management of locally advanced rectal cancer (LARC) has progressively become more complex. The introduction of total neoadjuvant treatment (TNT) has increased the rates of both clinical and pathological complete response, resulting in excellent long-term oncological outcomes. As a result, non-operative management (NOM) of LARC patients with a clinical complete response (cCR) after neoadjuvant therapy has gained acceptance as a potential treatment option in selected cases. NOM is based on replacement of surgical resection with safe and active surveillance. However, the identification of appropriate candidates for a NOM strategy without compromising oncologic safety is currently challenging due to the lack of an objective standardization. NOM should be part of the treatment plan discussion with LARC patients, considering the increasing rates of cCR, patient preference, quality of life, expectations, and the potential avoidance of surgical morbidity. The recently published OPRA trial showed that organ preservation is achievable in half of rectal cancer patients treated with TNT, and that chemoradiotherapy followed by consolidation chemotherapy may an appropriate strategy to maximize cCR rates. Ongoing trials are investigating optimal algorithms of TNT delivery to further expand the pool of patients who may benefit from NOM of LARC. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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22 pages, 604 KiB  
Review
A Multidisciplinary Approach for the Personalised Non-Operative Management of Elderly and Frail Rectal Cancer Patients Unable to Undergo TME Surgery
by Stijn H. J. Ketelaers, Anne Jacobs, An-Sofie E. Verrijssen, Jeltsje S. Cnossen, Irene E. G. van Hellemond, Geert-Jan M. Creemers, Ramon-Michel Schreuder, Harm J. Scholten, Jip L. Tolenaar, Johanne G. Bloemen, Harm J. T. Rutten and Jacobus W. A. Burger
Cancers 2022, 14(10), 2368; https://0-doi-org.brum.beds.ac.uk/10.3390/cancers14102368 - 11 May 2022
Cited by 3 | Viewed by 2056
Abstract
Despite it being the optimal curative approach, elderly and frail rectal cancer patients may not be able to undergo a total mesorectal excision. Frequently, no treatment is offered at all and the natural course of the disease is allowed to unfold. These patients [...] Read more.
Despite it being the optimal curative approach, elderly and frail rectal cancer patients may not be able to undergo a total mesorectal excision. Frequently, no treatment is offered at all and the natural course of the disease is allowed to unfold. These patients are at risk for developing debilitating symptoms that impair quality of life and require palliative treatment. Recent advancements in non-operative treatment modalities have enhanced the toolbox of alternative treatment strategies in patients unable to undergo surgery. Therefore, a proposed strategy is to aim for the maximal non-operative treatment, in an effort to avoid the onset of debilitating symptoms, improve quality of life, and prolong survival. The complexity of treating elderly and frail patients requires a patient-centred approach to personalise treatment. The main challenge is to optimise the balance between local control of disease, patient preferences, and the burden of treatment. A comprehensive geriatric assessment is a crucial element within the multidisciplinary dialogue. Since limited knowledge is available on the optimal non-operative treatment strategy, these patients should be treated by dedicated multidisciplinary rectal cancer experts with special interest in the elderly and frail. The aim of this narrative review was to discuss a multidisciplinary patient-centred treatment approach and provide a practical suggestion of a successfully implemented clinical care pathway. Full article
(This article belongs to the Special Issue Non Operative Management of Patients with Rectal Cancer)
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