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Phase II Study of Preoperative Capecitabine and Oxaliplatin-based Intensified Chemoradiotherapy With or Without Induction Chemotherapy in Patients With Locally Advanced Rectal Cancer and Synchronous Liver-limited Resectable Metastases

View Article: PubMed Central - PubMed

ABSTRACT

Objectives:: Controversy surrounds the management of patients with locally advanced rectal cancer with synchronous resectable liver metastases (LMs). This study was designed to improve both systemic and local control in these patients.

Methods:: Patients with locally advanced rectal cancer (cT3-4N0 or cTanyN1-2) and synchronous resectable liver-limited metastases (cM1a) were randomly assigned to receive either preoperative treatments of induction CapeOx, followed by chemoradiotherapy with CapeOx (CapeOx-RT) (arm A) or CapeOx-RT alone (arm B). Induction CapeOx consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 2 cycles; CapeOx-RT consisted of radiotherapy with 45 Gy/25 daily fractions±5.4 Gy/3 fractions, oxaliplatin 50 mg/m2 weekly for 5 weeks, and capecitabine 825 mg/m2 twice daily on days 1 to 38. Total mesorectal excision and simultaneous liver metastasectomy were planned within 6 weeks after completion of preoperative treatments. The primary endpoint was R0 resection rate of both the primary tumor and LMs.

Results:: Thirty-eight patients were randomly assigned to the present study, 18 to arm A and 20 to arm B. The overall R0 resection rate for both the primary tumor and LMs was 77.8% in arm A and 70.0% in arm B (P=0.72). The median progression-free survival was 14.2 versus 15.1 months (P=0.422) and the 3-year overall survival rate was 75.0% versus 88.8% (P=0.29), respectively.

Conclusions:: Both treatment strategies showed considerable R0 resection rates; however, further study will be warranted to apply these intensified strategies in clinical practice.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curve for overall survival time according to treatment arms in the intention-to-treat population.
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Figure 3: Kaplan-Meier curve for overall survival time according to treatment arms in the intention-to-treat population.

Mentions: In the intention-to-treat population, the synchronous complete R0 resection rates were 77.8% in arm A and 70.0% in arm B (odds ratio 1.500; 95% confidence interval [CI], 0.346-6.501; P=0.72); the R0 resection rates for the primary tumor were 83.3% versus 95.0% (P=0.33), whereas those for the LM were 77.8% versus 70.0% (P=0.72), respectively (Table 2). The radiologic response rates were 61.1% in arm A and 70.0% in arm B (Supplementary Table S2, Supplemental Digital Content 2, http://links.lww.com/AJCO/A132, which shows the radiologic evaluation of the responses to preoperative treatments). In addition, the pCR rates were 11.1% versus 5.0%, and the major pathologic response rates of the primary tumor were 22.2% versus 25.0% (Table 3), respectively. At a median follow-up of 32.7 months (range, 3.0 to 57.9 mo), the median PFSs were 14.2 versus 15.1 months, the 3-year PFSs were 25.1% versus 36.3% (hazards ratio 0.707; 95% CI, 0.304-1.646; P=0.42) (Fig. 2), and the 3-year OSs were 75.0% versus 88.8% (hazards ratio 0.379; 95% CI, 0.063-2.283; P=0.29) (Fig. 3), respectively.


Phase II Study of Preoperative Capecitabine and Oxaliplatin-based Intensified Chemoradiotherapy With or Without Induction Chemotherapy in Patients With Locally Advanced Rectal Cancer and Synchronous Liver-limited Resectable Metastases
Kaplan-Meier curve for overall survival time according to treatment arms in the intention-to-treat population.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5120770&req=5

Figure 3: Kaplan-Meier curve for overall survival time according to treatment arms in the intention-to-treat population.
Mentions: In the intention-to-treat population, the synchronous complete R0 resection rates were 77.8% in arm A and 70.0% in arm B (odds ratio 1.500; 95% confidence interval [CI], 0.346-6.501; P=0.72); the R0 resection rates for the primary tumor were 83.3% versus 95.0% (P=0.33), whereas those for the LM were 77.8% versus 70.0% (P=0.72), respectively (Table 2). The radiologic response rates were 61.1% in arm A and 70.0% in arm B (Supplementary Table S2, Supplemental Digital Content 2, http://links.lww.com/AJCO/A132, which shows the radiologic evaluation of the responses to preoperative treatments). In addition, the pCR rates were 11.1% versus 5.0%, and the major pathologic response rates of the primary tumor were 22.2% versus 25.0% (Table 3), respectively. At a median follow-up of 32.7 months (range, 3.0 to 57.9 mo), the median PFSs were 14.2 versus 15.1 months, the 3-year PFSs were 25.1% versus 36.3% (hazards ratio 0.707; 95% CI, 0.304-1.646; P=0.42) (Fig. 2), and the 3-year OSs were 75.0% versus 88.8% (hazards ratio 0.379; 95% CI, 0.063-2.283; P=0.29) (Fig. 3), respectively.

View Article: PubMed Central - PubMed

ABSTRACT

Objectives:: Controversy surrounds the management of patients with locally advanced rectal cancer with synchronous resectable liver metastases (LMs). This study was designed to improve both systemic and local control in these patients.

Methods:: Patients with locally advanced rectal cancer (cT3-4N0 or cTanyN1-2) and synchronous resectable liver-limited metastases (cM1a) were randomly assigned to receive either preoperative treatments of induction CapeOx, followed by chemoradiotherapy with CapeOx (CapeOx-RT) (arm A) or CapeOx-RT alone (arm B). Induction CapeOx consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 2 cycles; CapeOx-RT consisted of radiotherapy with 45 Gy/25 daily fractions±5.4 Gy/3 fractions, oxaliplatin 50 mg/m2 weekly for 5 weeks, and capecitabine 825 mg/m2 twice daily on days 1 to 38. Total mesorectal excision and simultaneous liver metastasectomy were planned within 6 weeks after completion of preoperative treatments. The primary endpoint was R0 resection rate of both the primary tumor and LMs.

Results:: Thirty-eight patients were randomly assigned to the present study, 18 to arm A and 20 to arm B. The overall R0 resection rate for both the primary tumor and LMs was 77.8% in arm A and 70.0% in arm B (P=0.72). The median progression-free survival was 14.2 versus 15.1 months (P=0.422) and the 3-year overall survival rate was 75.0% versus 88.8% (P=0.29), respectively.

Conclusions:: Both treatment strategies showed considerable R0 resection rates; however, further study will be warranted to apply these intensified strategies in clinical practice.

No MeSH data available.


Related in: MedlinePlus