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Is Pathologic Near-Total Regression an Appropriate Indicator of a Good Response to Preoperative Chemoradiotherapy Based on Oncologic Outcome of Disease?

ABSTRACT: We evaluated the oncologic outcomes of patients with rectal cancer who demonstrated pathologic near-total regression (NTR) after preoperative chemoradiotherapy (PCRT) and compared with total regression (TR). Pathologic NTR in rectal cancer by tumor regression grade (TRG) is usually considered to indicate a good response, when evaluating tumor response to PCRT. We retrospectively analyzed the outcomes in 263 patients who received PCRT for advanced T3/4 or N+ rectal cancer followed by radical resection. Patients were diagnosed with TR (n = 132) or NTR (n = 131) according to the TRG. Recurrence-free survival (RFS) was evaluated and compared between groups. For evaluating the consistency between the result and previously published data, meta-analysis for summing up survival curve was performed using generalized linear mixed model. ypT status was heterogeneous in the NTR group as follows; 3 Tis (2.3%), 21 T1 (16%), 72 T2 (55%), and 35 T3 (26.7%). Metastatic lymph nodes were more frequently found in the NTR group (6.8% in TR vs 24.4% in NTR patients; P = 0.003). The cumulative recurrence rate was higher in the NTR group (19.8% vs 6.1%; P = 0.003). The 5-year RFS was lower in the NTR group (94% vs 77.8%; P = 0.001). Significant differences in the RFS rate were found in comparison with the published literature. Based on differences in the oncologic outcomes between the TR and NTR groups, it might not be suitable to use NTR as an indicator of good response to PCRT together with TR.

SUBMITTER: Kim JY

PROVIDER: S-EPMC5058917 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Is Pathologic Near-Total Regression an Appropriate Indicator of a Good Response to Preoperative Chemoradiotherapy Based on Oncologic Outcome of Disease?

Kim Jee Yeon JY Park In Ja IJ Hong Seung Mo SM Lee Jong Lyul JL Yoon Yong Sik YS Kim Chan Wook CW Lim Seok-Byung SB Lee Jung Bok JB Yu Chang Sik CS Kim Jin Cheon JC

Medicine 20151201 50

We evaluated the oncologic outcomes of patients with rectal cancer who demonstrated pathologic near-total regression (NTR) after preoperative chemoradiotherapy (PCRT) and compared with total regression (TR). Pathologic NTR in rectal cancer by tumor regression grade (TRG) is usually considered to indicate a good response, when evaluating tumor response to PCRT. We retrospectively analyzed the outcomes in 263 patients who received PCRT for advanced T3/4 or N+ rectal cancer followed by radical rese ...[more]

PMID: 26683945

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Project description:BackgroundCurrent National Comprehensive Cancer Network guidelines recommend postoperative radiation therapy based only on adverse pathologic findings (APFs), irrespective of preoperative risk group. We assessed whether a model incorporating both the preoperative risk group and APFs could predict long-term oncologic outcomes better than a model based on APFs alone.MethodsWe retrospectively reviewed 4,404 men who underwent radical prostatectomy (RP) at our institution between 1992 and 2014. After excluding patients receiving neoadjuvant therapy or with incomplete pathological or follow-up data, 3,092 men were included in the final analysis. APFs were defined as extraprostatic extension (EPE), seminal vesicle invasion (SVI), or a positive surgical margin (PSM). The adequacy of model fit to the data was compared using the likelihood-ratio test between the models with and without risk groups, and model discrimination was compared with the concordance index (c-index) for predicting biochemical recurrence (BCR) and prostate cancer-specific mortality (PCSM). We performed multivariate Cox proportional hazard model and competing risk regression analyses to identify predictors of BCR and PCSM in the total patient group and each of the risk groups.ResultsAdding risk groups to the model containing only APFs significantly improved the fit to the data (likelihood-ratio test, p <0.001) and the c-index increased from 0.693 to 0.732 for BCR and from 0.707 to 0.747 for PCSM. A RP Gleason score (GS) ≥8 and a PSM were independently associated with BCR in the total patient group and also each risk group. However, only a GS ≥8 and SVI were associated with PCSM in the total patient group (GS ≥8: hazard ratio [HR] 5.39 and SVI: HR 3.36) and the high-risk group (GS ≥8: HR 6.31 and SVI: HR 4.05).ConclusionThe postoperative estimation of oncologic outcomes in men with APFs at RP was improved by considering preoperative risk group stratification. Although a PSM was an independent predictor for BCR, only a RP GS ≥8 and SVI were associated with PCSM in the total patient and high-risk groups.

Project description:The incorporation of chemoradiation prior to resection of the tumour has revolutionized the management of locally advanced rectal cancer. However, a large proportion of these patients are resistant to preoperative treatment schedule. We recently reported that c-Myc gene expression correlates negatively with this resistance in patients with rectal cancer. In this study, we carried out integrated analysis of miRNA and mRNA expression profiling in 45 pre-treatment rectal tumour. Further, expression of miRNAs and c-Myc, and their relationship with clinicopathological factors and patient survival was analysed. As a result, we found that 12 miRNAs were differentially expressed between responder and non-responder rectal cancer patients. Functional classification revealed an association between differentially expressed miRNAs and c-Myc. Subsequent quantitative real-time PCR results showed that both, miRNA-148 and miRNA-375 levels were significantly lower in responder compared to non-responder patients. Notably, the higher level of miRNA-375 was significantly negatively correlated with c-Myc. These results suggest that miRNA-375 and its targeted c-Myc play an important role as predictive biomarker of response to neoadjuvant treatment in patients with locally advanced rectal cancer, but still not suitable for prognosis. Pre-treatment biopsies of 22 patients with LARC were prospectively collected and freshly frozen according to an institutional board-approved protocol. Tumour response was assessed in surgical specimens by pathological examination based on the semi-quantitative tumour regression grading (TRG) system described by Mandard in 1994[36]: TRG1 and TRG2 scores were considered responders, whereas TRG3, TRG4, and TRG5 were classified as non-responders. The inclusion criteria were: histologically proven rectal tumour at a clinical stage UICC II-III (cT3-4/and or N positive), following endorectal ultrasound and/or MRI scan. Patients were excluded if they had the tumour located above 13 cm from the anal verge by rigid rectoscopy, synchronic colonic cancer assessed by colonoscopy, distant metastases by 18FDG PET-CT scan, and suspicion of hereditary colorectal cancer. All patients subsequently received a total dose of 50.4Gy of radiation (28 fractions of 1.8Gy) associated with capecitabine (oral form of 5-FU) with or without oxaliplatine, according to our Hospital Clinical Practice Guidelines. Standardized Surgery was performed, including total mesorectal excision, following an interval of 8-10 weeks after completion of CT/RT.

Project description:ObjectiveNeoadjuvant chemoradiotherapy (CCRT) is current standards of care for locally advanced rectal cancer. The precise and thorough investigation of a tumor during the full course of CCRT by means of daily MRI can provide an idea on real-time treatment sensitivity in addition to tumor biology. Tumor volumetry from daily MRI during CCRT may allow patient-driven treatment decisions.Material and methodsPatients diagnosed with cT3-4 and/or cN+ rectal adenocarcinoma undergoing preoperative CCRT with capecitabine on the pelvis up to 50 Gy in 25 daily fractions from November 2018 to June 2019 were consecutively included. Rectal tumor volume was uniformly measured by a single physician (YKK) in daily 0.35T MRI obtained with MR-guided linear accelerator. Primary endpoint was to assess the pattern of tumor volume regression throughout the full course of CCRT using daily registration MRI. Secondary endpoint was to assess the effect of tumor regression velocity on disease-free survival (DFS). Tumor regression velocity (cc) per fraction of each patient was calculated using the simple regression analysis of tumor volumes from fraction 1 to fraction 25.ResultsTwenty patients were included. Daily tumor volumetry demonstrated linear tumor regression during CCRT. The tumor regression velocity of all 20 patients was 2.40 cc per fraction (R2 = 0.93; p < 0.001). The median tumor regression velocity was 1.52 cc per fraction. Patients with tumor regression velocity ≥ 1.52 cc per fraction were grouped as rapid regressors (N = 9), and those with tumor regression velocity < 1.52 cc per fraction were grouped as slow regressors (N = 11). Rapid regressors had greater tumor regression velocity (4.58 cc per fraction) compared to that of slow regressors (0.78 cc per fraction) with statistical significance (p < 0.001). The mean DFS of rapid regressors was 36.8 months, numerically longer than the 31.9 months of slow regressors (p = 0.400) without statistical significance. Rapid regressors had numerically superior DFS rate compared to slow regressors without statistical significance. The 2-year DFS was 88.9% for rapid regressors and 72.7% for slow regressors, respectively (p = 0.400).ConclusionThis study is the first observation of linear tumor regression in daily MRI during the preoperative CCRT of locally advanced rectal cancer. Daily tumor regression velocity discriminated DFS, although without statistical significance. This study with a phenomenal approach is hypothesis-generating. Nevertheless, the potential of CCRT from therapeutics to a newer level, the "theranostics", has been inceptively suggested. Further validation studies for the value of daily tumor volumetry on treatment decisions are warranted.

Dataset Information

Is Pathologic Near-Total Regression an Appropriate Indicator of a Good Response to Preoperative Chemoradiotherapy Based on Oncologic Outcome of Disease?

Publications

Is Pathologic Near-Total Regression an Appropriate Indicator of a Good Response to Preoperative Chemoradiotherapy Based on Oncologic Outcome of Disease?

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