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

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

doi:10.3390/cancers12082306

Abstract

We aimed to assess the survival benefits of primary tumor resection (PTR) followed by chemotherapy in patients with asymptomatic stage IV colorectal cancer with asymptomatic, synchronous, unresectable metastases compared to those of upfront chemotherapy alone. This was an open-label, prospective, randomized controlled trial (ClnicalTrials.gov Identifier: NCT01978249). From May 2013 to April 2016, 48 patients (PTR, n = 26; upfront chemotherapy, n = 22) diagnosed with asymptomatic colorectal cancer with unresectable metastases in 12 tertiary hospitals were randomized (1:1). The primary endpoint was two-year overall survival. The secondary endpoints were primary tumor-related complications, PTR-related complications, and rate of conversion to resectable status. The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%; p = 0.049). However, the two-year overall survival rate was not significantly different between the PTR and upfront chemotherapy groups (69.5% vs. 44.8%, p = 0.058). The primary tumor-related complication rate was 22.7%. The PTR-related complication rate was 19.2%, with a major complication rate of 3.8%. The rates of conversion to resectable status were 15.3% and 18.2% in the PTR and upfront chemotherapy groups. While PTR followed by chemotherapy resulted in better two-year cancer-specific survival than upfront chemotherapy, the improvement in the two-year overall survival was not significant.

Highlights

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related death according to the global cancer statistics [1]
Since these complications are associated with increased mortality and morbidity, upfront primary tumor resection (PTR) is preferred to avoid tumor-related complications, which can develop during chemotherapy
PTR followed by systemic chemotherapy showed improved two-year cancer-specific survival in patients with asymptomatic CRC with synchronous unresectable metastases compared with upfront chemotherapy alone

Summary

Introduction

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related death according to the global cancer statistics [1]. In the treatment of stage IV CRC, primary tumor resection (PTR) has been performed to relieve tumor-related complications and to avoid life-threatening conditions such as intractable bleeding, intestinal obstruction, and perforation. PTR in patients with asymptomatic stage IV CRC can prevent impending obstruction and emergent situations caused by the primary cancer. Since these complications are associated with increased mortality and morbidity, upfront PTR is preferred to avoid tumor-related complications, which can develop during chemotherapy. A nationwide study in the Netherlands found that PTR followed by systemic chemotherapy showed survival benefits compared with chemotherapy alone [8]

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