Do clinical criteria reflect pathologic complete response in rectal cancer following neoadjuvant therapy?

Garant, Aurélie; Florianova, Livia; Gologan, Adrian; Spatz, Alan; Faria, Julio; Morin, Nancy; Vasilevsky, Carol Ann; Vuong, T.

doi:10.1007/s00384-018-3033-7

Cited by 5 publications

(10 citation statements)

References 30 publications

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“…The following 3 criteria were required to achieve cCR: no mass remaining upon rectoscopic examination, soft palpation on the digital exam, and absence of residual tumor on MRI [ 23 ]. If there was interval regression on two consecutive endoscopic evaluations, small soft ulcers were considered acceptable “near complete response” [ 16 , 24 , 25 ] and eligible for continued surveillance. However, if the 3 criteria specified above were not fulfilled, patients were characterized as non-complete clinical responders.…”

Section: Methodsmentioning

confidence: 99%

MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results

Garant

Vasilevsky

Boutros

et al. 2022

Cancers

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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.

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Section: Methodsmentioning

confidence: 99%

MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results

Garant

Vasilevsky

Boutros

et al. 2022

Cancers

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“…11 In line with our findings, several studies demonstrated that some patients with residual mucosal abnormalities, therefore regarded as incomplete clinical responders, may have achieved pCR. [13][14][15][16] Accordingly, it is hypothesized that the majority of patients with pCR does not have the mucosal features displaying a cCR. In other words, an incomplete clinical response due to residual mucosal abnormalities may not be a reliable indicator of the absence of pCR.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have also demonstrated that the recommended criteria for cCR is a poorly sensitive indicator of the pCR. [13][14][15][16] In a study, Smith et al determined the performance of cCR criteria. Seventyfour percent of their pCR patients had a residual mucosal abnormality (the most common abnormality being ulcer), precluding the diagnosis of a cCR.…”

Section: Discussionmentioning

confidence: 99%

“…Specifically, some patients with residual mucosal abnormalities, therefore regarded as incomplete clinical responders, may have achieved pCR (ypT0N0). [13][14][15][16] Accordingly, it is hypothesized that an incomplete clinical response due to residual mucosal abnormalities may not be a reliable indicator of the absence of pCR. Therefore, we aimed to review and report the gross findings of pathologically documented pCR in a retrospective, cross-sectional study on rectal cancer patients undergoing surgical resection.…”

Section: Introductionmentioning

confidence: 99%

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Gross morphologic features of surgical specimen in rectal cancer patients with pathological complete response following neoadjuvant chemoradiotherapy: A cross‐sectional study

Fazeli,

Tadbir Vajargah,

Fazeli

et al. 2024

World j. surg.

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Backgroundpathological complete response (pCR) is achieved in 10%–30% of rectal cancer patients following neoadjuvant chemoradiotherapy and surgery. Residual mucosal abnormalities, which make patients ineligible for nonoperative management, may not be an accurate indicator of the pCR. The purpose of this study was to report the gross findings of rectal cancer patients with pathological complete responses.MethodsThis study was conducted at Tehran University of Medical Sciences, Tehran, Iran. A total of 130 patients with rectal adenocarcinoma, treated by neoadjuvant chemoradiotherapy, followed by surgical resection between March 2007, and March 2017, with a surgical pathology report of pCR, were included. Patients' demographics and pretreatment tumor characteristics were collected from the medical records. Data regarding residual mucosal abnormalities were extracted from postoperative surgical pathology reports. Abnormal findings were reported as "ulcer" or " non‐ulcerative lesion".ResultsOne hundred and fifteen patients (88.5%; 95% CI: 81.7%–93.4%) had at least one abnormal finding in the gross examination, including ulcer or non‐ulcerative lesion (any mucosal abnormalities other than ulcers, including polyps, telangiectasia, etc.). Patients with higher‐stage tumors had a higher chance of having an ulcerative lesion (p = 0.05). Younger patients tended to have deeper layers of involvement (p = 0.013). Patients with different gross findings were not significantly different regarding baseline characteristics, except for the pretreatment stage, where patients with a higher stage had higher odds of having ulcerative lesions.ConclusionsMost rectal cancer patients achieving a pCR exhibit abnormalities on gross examination. The higher pretreatment stages were significantly associated with gross abnormalities especially ulcers.

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“…pCR may sometimes present as an incomplete response showed as mucosal ulceration, irregularities, and rectal lumen stenosis. [88][89][90] That necessitates more tools and biomarkers involved to increase the accuracy and reliability of tumor response assessment.…”

Section: Reassessmentmentioning

confidence: 99%

Organ Preservation in MSS Rectal Cancer

Gao

2023

Clin Colon Rectal Surg

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Rectal cancer is a heterogeneous disease with complex genetic and molecular subtypes. Emerging progress of neoadjuvant therapy has led to increased pathological and clinical complete response (cCR) rates for microsatellite stable (MSS) rectal cancer, which responds poorly to immune checkpoint inhibitor alone. As a result, organ preservation of MSS rectal cancer as an alternative to radical surgery has gradually become a feasible option. For patients with cCR or near-cCR after neoadjuvant treatment, organ preservation can be implemented safely with less morbidity. Patient selection can be done either before the neoadjuvant treatment for higher probability or after with careful assessment for a favorable outcome. Those patients who achieved a good clinical response are managed with nonoperative management, organ preservation surgery, or radiation therapy alone followed by strict surveillance. The oncological outcomes of patients with careful selection and organ preservation seem to be noninferior compared with those of radical surgery, with lower postoperative morbidity. However, more studies should be done to seek better regression of tumor and maximize the possibility of organ preservation in MSS rectal cancer.

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Do clinical criteria reflect pathologic complete response in rectal cancer following neoadjuvant therapy?

Abstract: Most patients undergoing neoadjuvant therapy for rectal cancer have residual mucosal abnormalities which preclude to a cCR as per published criteria from Brazil. Further studies are required to optimize clinical evaluation and MRI imaging in selected patients.

Cited by 5 publications

References 30 publications

MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results

MORPHEUS Phase II–III Study: A Pre-Planned Interim Safety Analysis and Preliminary Results

Gross morphologic features of surgical specimen in rectal cancer patients with pathological complete response following neoadjuvant chemoradiotherapy: A cross‐sectional study

Organ Preservation in MSS Rectal Cancer

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