The Role of Primary Tumor Resection in Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis: A Multicenter Randomized Controlled Trial

Park, Eun Jung; Baek, Jeong‐Heum; Choi, Gyu Seog; Park, Won Cheol; Yu, Chang Sik; Kang, Sung Bum; Min, Byung Soh; Kim, Jae Hwang; Kim, Hyeong Rok; Lee, Bong Hwa; Oh, Jae Hwan; Jeong, Seung Yong; Jung, Minkyu; Ahn, Joong Bae; Baik, Seung Hyuk

doi:10.3390/cancers12082306

Cited by 49 publications

(44 citation statements)

References 30 publications

(37 reference statements)

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“…While PTR followed by chemotherapy resulted in better two-year cancer-specific survival than upfront chemotherapy, the improvement in the two-year OS was not significant. 37 Our multidisciplinary team discussed the two randomized trials with opposite opinions (JCOG1007 and PTR Trial) and believed that although the sample size was small, it was very influential. In the light of previous retrospective studies and the experience of our center (the median overall survival: PTR vs CTX, 18.0 months vs 15.0 months, P=0.006), we believed that at present we should be more cautious about whether to recommend PTR, but at the same time, we have more expectations for randomized controlled trials of patients with stage IV incurable colorectal cancer, such as CAIRO-4 (NCT01606098), SYNCHRONOUS (ISRCTN30964555), CLIMAT (NCT02363049), CCRe-IV (NCT02015923), China multicenter (NCT0214978424), GRECCAR 8 (NCT02314182) and hope that when the comprehensive results of these trials are reported in the near future, the role of PTR will be better defined.…”

Section: Discussionmentioning

confidence: 99%

Role of Surgical Approach to Synchronous Colorectal Liver Metastases: A Retrospective Analysis

Zhai¹,

Sun

Du³

et al. 2021

CMAR

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Purpose This study is a retrospective analysis of exploring the efficiency of surgical management on patients with synchronous colorectal liver metastasis (SCLM). Patients and Methods Nine hundred fifty-three consecutive patients with SCLM from Weifang People’s Hospital of Shandong Province between January 2006 and December 2015 were reviewed. The values of different factors were analyzed, such as different surgical indications of liver metastases, simultaneous or staged resection of primary colorectal cancer and liver metastases, and primary tumor resection (PTR) of asymptomatic patients with unresectable liver metastases. Results Median survival time (47.3 months) and 5-year survival rate (31%) for patients with resected liver metastases were significantly superior to that of with nonoperative treatment (17.2 months, 4%, P<0.001); enlarging the standard of liver metastases resection can improve the resection rates (31.0% vs 13.6%, P<0.001); for patients with resectable liver metastases, the in-hospital cost for simultaneous resection group was lower than that in the staged resection group (36,698 vs 45,134 RMB, P<0.001); for patients of the asymptomatic primary tumor with unresectable liver metastases, PTR was associated with improved median survival (18.0 vs 15.0 months, P=0.006). Conclusion For patients with SCLM, liver resection is considered the best treatment; expanding indications of liver resection can improve the resection rates. Simultaneous resection of the primary tumor and liver metastases were indicated in patients with resectable SCLM; PTR was recommended for asymptomatic patients with unresectable hepatic metastases.

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Section: Discussionmentioning

confidence: 99%

Role of Surgical Approach to Synchronous Colorectal Liver Metastases: A Retrospective Analysis

Zhai¹,

Sun

Du³

et al. 2021

CMAR

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“…Most recently, a prospective randomized trial with a very small sample size (48) of participants was reported, and the results showed that, compared with chemotherapy alone, PTR followed by chemotherapy improved the 2-year cancer-specific survival of patients with asymptomatic stage IV CRC, although no statistical difference was obtained, which might due to the limited patients (14). However, different results were reported in another prospective randomized trial (JCOG1007 study) with a larger sample size of participants which enrolled 165 patients (15).…”

Section: Discussionmentioning

confidence: 99%

“…Most recently, there were 2 reports of prospective randomized clinical trials to compare the effects of PTR followed by chemotherapy with chemotherapy alone, but the results in these 2 studies are also different and controversial (14,15). We also performed this randomized phase II trial from 2015 in colon cancer patients with unresectable metastases, but the design of our study was different with the two reported studies, as we enrolled patients and gave them induction chemotherapy for 3 months, excluded patients with chemotherapy failure whose prognosis was always poor, and then randomly divided them into PTR group and chemotherapy group to compare the effects of induction chemotherapy followed by PTR and chemotherapy alone and determine the value of PTR after induction chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases

Huang

Yang

et al. 2022

Front. Oncol.

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BackgroundIt is still controversial whether primary tumor resection (PTR) improves survival in colorectal cancer (CRC) patients with unresectable metastases.MethodsColon cancer patients were enrolled and randomly allocated to with or without PTR after induction chemotherapy with XELOX or mFOLFOX6, and those with chemotherapy failure were excluded. The primary endpoint was TTF (time to strategy failure) on an intent-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT02291744.ResultsBetween April 2015 and July 2020, 140 patients were enrolled, and 54 patients were excluded due to colon obstruction (16), perforation (1), disease progression (22), death (1), radical resection (3), or other reasons (11). After induction chemotherapy, 86 patients were randomized into group A (the resection group, n = 42) or group B (chemotherapy-alone group, n = 44). The median TTF was 143 days (95% CI: 104.9–181.1) in group A and 196 days (95% CI: 96.5–295.5) in group B (HR: 0.930 95% CI: 0.589–1.468, p = 0.755), and there was no significant difference in PFS, OS, and incidence of chemotherapy-related adverse events between two groups. The primary lesion-related events after PTR in group A were significantly fewer than those in group B. Patients with a tumor regression grade (TRG) score of 2 had longer TTF and PFS than those with score of 3.ConclusionPTR after induction chemotherapy could not bring survival benefits for colon cancer patients with unresectable metastases, and it is not recommended routinely. However, it also requires individualized treatment as colon obstruction or perforation occurred in some patients and PTR could reduce primary tumor-related events, and the TRG score might help for selection of beneficial patients.

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“…Besides, age, histological type, CEA and chemotherapy were also determined as important factors for CSS of T1N0M1 patients, which have been linked with considerable importance in predicting survival of CC patients in recent years. [24][25][26] Therefore, a nomogram was built to determine cancer-specific…”

Section: Discussionmentioning

confidence: 99%

Nomogram to Predict the Occurrence and Prognosis of Distant Metastasis in T1N0 Colon Cancer: A SEER Data-Based Study

Liu¹,

Zhang²,

Zheng³

et al. 2021

IJGM

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Purpose: Distant metastasis (DM) is relatively rare in T1 colon cancer (CC) patients, especially in those with negative lymph node metastasis. The aim of this study was to explore the main clinical factors and build nomogram for predicting the occurrence and prognosis of DM in T1N0 colon cancer patients. Methods: Patients with T1N0 stage CC were collected from the Surveillance, Epidemiology, and End Result (SEER) database. All patients were divided into development and validation cohorts with the 3:1 ratio. Logistic regressions were performed to analyze the clinical risk factors for DM. Cox regression model was used to identify potential prognostic factors for patients with DM. The performance of nomogram was evaluated by concordance index (C-index), calibration curves, receiver operating characteristic (ROC) curves and decision curve analyses (DCAs). Based on cancer-specific survival (CSS), Kaplan-Meier curves were generated and analyzed using Log rank tests. Results: A total of 6770 patients were enrolled in this study, including 428 patients (6.3%) with DM. Age, size, grade, CEA were independent risk factors associated with DM. Age, grade, CEA, surgery and chemotherapy were independent prognostic factors for CSS. Nomograms were applied and C-index, calibration curves, ROC curves and DCA curves proved good discrimination, calibration and clinical practicability of the nomogram in predicting the occurrence and prognosis of DM in T1N0 CC patients. In the DM nomogram, the AUCs for development and validation cohort were 0.901 (95% CI = 0.879-0.922) and 0.899 (95% CI=0.865-0.940), respectively. The calibration curves (development cohort: S: p = 0.712; validation cohort: S: p = 0.681) showed the relatively satisfactory prediction accuracy. Similarly, the AUCs of the nomogram at 1-, 2-, and 3-year were 0.763 (95% CI=0.744-0.782), 0.794 (95% CI=0.775-0.813), and 0.822 (95% CI=0.803-0.841) for the development cohort, and 0.785 (95% CI=0.754-0.816), 0.748 (95% CI=0.717-0.779) and 0.896 (95% CI=0.865-0.927) for the validation cohort in the CSS nomogram. The C-indices of the development and validation cohort were 0.718 (95% CI=0.639-0.737) and 0.712 (95% CI=0.681-0.743). Conclusion:The population-based nomogram could help clinicians predict the occurrence and prognosis of DM in T1N0 CC patients and provide a reference to perform appropriate metastatic screening plans and rational therapeutic options for the special population.

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The Role of Primary Tumor Resection in Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis: A Multicenter Randomized Controlled Trial

Cited by 49 publications

References 30 publications

Role of Surgical Approach to Synchronous Colorectal Liver Metastases: A Retrospective Analysis

Role of Surgical Approach to Synchronous Colorectal Liver Metastases: A Retrospective Analysis

Induction Chemotherapy Followed by Primary Tumor Resection Did Not Bring Survival Benefits in Colon Cancer Patients With Asymptomatic Primary Lesion and Synchronous Unresectable Metastases

Nomogram to Predict the Occurrence and Prognosis of Distant Metastasis in T1N0 Colon Cancer: A SEER Data-Based Study

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