scholarly journals Primary Tumor Resection Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastases (JCOG1007; iPACS): A Randomized Clinical Trial

2021 ◽  
Vol 39 (10) ◽  
pp. 1098-1107
Author(s):  
Yukihide Kanemitsu ◽  
Kohei Shitara ◽  
Junki Mizusawa ◽  
Tetsuya Hamaguchi ◽  
Dai Shida ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Stage Iv ◽  
Standard Of Care ◽  
Phase Iii ◽  
Primary Tumor Resection ◽  
Primary Tumors ◽  
Intention To Treat ◽  
Unresectable Metastases

PURPOSE It remains controversial whether primary tumor resection (PTR) before chemotherapy improves survival in patients with colorectal cancer (CRC) with asymptomatic primary tumor and synchronous unresectable metastases. PATIENTS AND METHODS This randomized phase III study investigated the superiority of PTR followed by chemotherapy versus chemotherapy alone in relation to overall survival (OS) in patients with unresectable stage IV asymptomatic CRC and three or fewer unresectable metastatic diseases confined to the liver, lungs, distant lymph nodes, or peritoneum. Chemotherapy regimens of either mFOLFOX6 plus bevacizumab or CapeOX plus bevacizumab were decided before study entry. The primary end point was OS, which was analyzed by intention-to-treat. RESULTS Between June 2012 and September 2019, a total of 165 patients were randomly assigned to either chemotherapy alone (84 patients) or PTR plus chemotherapy (81 patients). When the first interim analysis was performed in September 2019 with 50% (114/227) of the expected events observed among 160 patients at the data cutoff date of June 5, 2019, the Data and Safety Monitoring Committee recommended early termination of the trial because of futility. With a median follow-up of 22.0 months, median OS was 25.9 months (95% CI, 19.9 to 31.5) in the PTR plus chemotherapy arm and 26.7 (95% CI, 21.9 to 32.5) in the chemotherapy-alone arm (hazard ratio, 1.10; 95% CI, 0.76 to 1.59; one-sided P = .69). Three postoperative deaths occurred in the PTR plus chemotherapy arm. CONCLUSION Given that PTR followed by chemotherapy showed no survival benefit over chemotherapy alone, PTR should no longer be considered a standard of care for patients with CRC with asymptomatic primary tumors and synchronous unresectable metastases.

A randomized phase III trial comparing primary tumor resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 study (iPACS).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 7-7 ◽  
Author(s):  
Yukihide Kanemitsu ◽  
Kohei Shitara ◽  
Junki Mizusawa ◽  
Tetsuya Hamaguchi ◽  
Dai Shida ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Controlled Trial ◽  
Tumor Resection ◽  
Rectal Adenocarcinoma ◽  
Stage Iv ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Primary Tumor Resection ◽  
Unresectable Metastases

7 Background: It is still controversial whether primary tumor resection (PTR) before chemotherapy (CTX) improves overall survival (OS) of colorectal cancer (CRC) patients (pts) with synchronous unresectable metastases. There are several retrospective analyses suggesting better outcomes in pts who underwent PTR compared to pts without it, but no prospective studies confirming these results. We conducted a randomized controlled trial to confirm the superiority of PTR plus CTX to CTX alone in asymptomatic unresectable stage IV CRC patients. Methods: Eligibility criteria included histologically proven colon and upper rectal adenocarcinoma, cT1-4 without involvement of other organs, presence of three or less unresectable factors confined to either liver, lungs, distant lymph nodes, or peritoneum, aged 20-74, no symptoms due to primary tumor and PS 0-1. Eligible patients were randomized to either PTR followed by CTX or CTX alone. CTX regimens were declared before study entry; options included mFOLFOX6 plus bevacizumab or CapeOX plus bevacizumab. The primary endpoint was the OS. The planned sample size was 140 pts per arm, with one-sided alpha of 5%, and 70% power detecting a median OS difference of 8 months (24 months vs. 32 months). Results: Between Jun 2012 and Apr 2019, 160 patients were randomized. 78 pts were allocated to PTR plus CTX, and 82 pts to CTX alone. When the first interim analysis was performed in Sep 2019, with 50% (114/227) of the expected events observed, the DSMC recommended the early termination of the trial based on its futility. With a median follow-up period of 22.0 months for 160 patients, median OS was25.9 months (95% CI 19.9 – 31.5) with PTR plus CTX and 26.7(21.9 – 32.5) with CTX alone (hazard ratio 1.10 [0.76 – 1.59], one-sided p = 0.69). Median PFS was 10.4 (8.6-13.4) with PTR plus CTX and 12.1 (9.4 – 13.2) with CTX alone (hazard ratio 1.08 [0.77 – 1.50]). There were three treatment related deaths following PTR due to postoperative complications. Conclusions: PTR followed by CTX has no survival benefit over CTX alone. PTR is not recommended for CRC patients with asymptomatic primary tumor and synchronous unresectable metastases. Clinical trial information: UMIN000008147.

scholarly journals The Impact of Primary Tumor Resection on Survival in Asymptomatic Colorectal Cancer Patients With Unresectable Metastases

2021 ◽  
Vol 37 (2) ◽  
pp. 94-100
Author(s):  
Ki Yoon Doah ◽  
Ui Sup Shin ◽  
Byong Ho Jeon ◽  
Sang Sik Cho ◽  
Sun Mi Moon
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Cox Regression ◽  
Tumor Resection ◽  
Stage Iv ◽  
Primary Tumor Resection ◽  
Multivariate Logistic Regression Model ◽  
Risk Of Cancer ◽  
The Impact ◽  
Unresectable Metastases

Purpose: This study was conducted to evaluate the effectiveness of primary tumor resection (PTR) in asymptomatic colorectal cancer (CRC) patients with unresectable metastases using the inverse probability of treatment weighting (IPTW) method to minimize selection bias.Methods: We selected 146 patients diagnosed with stage IV CRC with unresectable metastasis between 2001 and 2018 from our institutional database. In a multivariate logistic regression model using the patients’ baseline covariates associated with PTR, we applied the IPTW method based on a propensity score and performed a weighted Cox proportional regression analysis to estimate survival according to PTR.Results: Upfront PTR was performed in 98 patients, and no significant differences in baseline factors were detected. The upweighted median survival of the PTR group was 18 months and that of the non-PTR group was 15 months (P = 0.15). After applying the IPTW, the PTR was still insignificant in the univariate Cox regression (hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.5–1.21). However, in the multivariate weighted Cox regression with adjustment for other covariates, the PTR showed a significantly decreased risk of cancer-related death (HR, 0.61; 95% CI, 0.40–0.94).Conclusion: In this study, we showed that asymptomatic CRC patients with unresectable metastases could gain a survival benefit from upfront PTR by analysis with the IPTW method. However, randomized controlled trials are mandatory.

A Novel Derivation Predicting Survival After Primary Tumor Resection in Stage IV Colorectal Cancer

2017 ◽  
Vol 60 (9) ◽  
pp. 895-904 ◽  
Author(s):  
Winson Jianhong Tan ◽  
Sreemanee Raaj Dorajoo ◽  
Madeline Yen Min Chee ◽  
Wah Siew Tan ◽  
Fung Joon Foo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Stage Iv ◽  
Primary Tumor Resection ◽  
Stage Iv Colorectal Cancer

scholarly journals Role of Primary Tumor Resection Among Chemotherapy-Treated Patients with Synchronous Stage IV Colorectal Cancer: A Survival Analysis

2013 ◽  
Vol 18 (3) ◽  
pp. 592-598 ◽  
Author(s):  
Walter Y Tsang ◽  
Argyrios Ziogas ◽  
Bruce S. Lin ◽  
Tara E. Seery ◽  
William Karnes ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Survival Analysis ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Stage Iv ◽  
Primary Tumor Resection ◽  
Stage Iv Colorectal Cancer

scholarly journals Primary tumor resection in stage IV unresectable colorectal cancer: what has changed?

2017 ◽  
Vol 34 (12) ◽  
Author(s):  
Michał Pędziwiatr ◽  
Magdalena Mizera ◽  
Jan Witowski ◽  
Piotr Major ◽  
Grzegorz Torbicz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Stage Iv ◽  
Primary Tumor Resection

Primary Tumor Resection for Stage IV Colorectal Cancer in the Era of Targeted Chemotherapy

2018 ◽  
Vol 23 (11) ◽  
pp. 2144-2150
Author(s):  
Dai Shida ◽  
Narikazu Boku ◽  
Taro Tanabe ◽  
Takefumi Yoshida ◽  
Shunsuke Tsukamoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Stage Iv ◽  
Primary Tumor Resection ◽  
Targeted Chemotherapy ◽  
Stage Iv Colorectal Cancer
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