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Cetuximab in preoperative treatment of rectal cancer - term outcome of the XERT trial.

Velenik V, Ocvirk J, Oblak I, Anderluh F - Radiol Oncol (2012)

Bottom Line: There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small.Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and was associated with an impressive three-year local control rate.The use of tumour KRAS mutation status as a biomarker for the efficacy of cetuximab-based regimens in this setting requires further investigation.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.

ABSTRACT

Background: Preoperative capecitabine-based chemoradiotherapy (CRT) is feasible for the treatment of resectable locally advanced rectal cancer (LARC). To try to improve efficacy, we conducted a phase II study in which the epidermal growth factor receptor-targeting monoclonal antibody cetuximab was added to capecitabine-based CRT. The results for long-term survival and for an analysis investigating the relationship between survival and patient and disease characteristics, including tumour KRAS mutation status, and surgery type, are presented. PATIENTS AND METHODS.: Patients with resectable LARC received capecitabine (1250 mg/m(2) twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m(2) for 1 week) and then with CRT (250 mg/m(2)/week) comprising capecitabine (825 mg/m(2) twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m(2) twice daily for 14 days every 21 days) three weeks later.

Results: Forty-seven patients were enrolled and 37 underwent treatment. Twenty-eight of the patients (75.7%) had T3N+ disease. Thirty-six patients were evaluable for efficacy. The median follow-up time was 39.0 months (range 5.0--87.0). The three-year local control, disease-free survival, relapse-free survival and overall survival rates were 96.9% (95% CI 90.0--100), 72.2% (57.5--86.9), 74.3% (95% CI 59.8--88.8) and 68.1% (95% CI 36.7--99.4), respectively. There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small.

Conclusions: Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and was associated with an impressive three-year local control rate. The use of tumour KRAS mutation status as a biomarker for the efficacy of cetuximab-based regimens in this setting requires further investigation.

No MeSH data available.


Related in: MedlinePlus

Disease-free survival of patients treated with preoperative capecitabine-base chemotherapy and cetuximab (n=36).
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Related In: Results  -  Collection

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f2-rado-46-03-252: Disease-free survival of patients treated with preoperative capecitabine-base chemotherapy and cetuximab (n=36).

Mentions: The median follow-up time for all 36 patients was 39.0 months (range 5.0–87.0 months). The median time to disease recurrence was 35.0 months (range 5.0–87.0 months). Local failure occurred in one patient (2.8%), 11.5 months after the end of treatment. The three-year local control rate was 96.9% (95% CI 90.9–100). Disease dissemination was observed in nine patients (25.0%) with the following pattern of distribution: liver (n=3; 8.3%), lung (n=3; 8.3%), suprarenal gland (n=1; 2.8%), bones (n=1; 2.8%) and synchronous lung plus retroperitoneum (n=1; 2.8%). The latest distant failure was observed 26 months after the end of treatment. No secondary malignancies were observed. The three-year relapse-free survival rate was 74.3% (95% CI 59.8–88.8) (Figure 1) and the three-year disease-free survival rate was 72.2% (95% CI 57.5–86.9) (Figure 2). The median survival has not yet been reached. The three-year survival rate was 68.1% (95% CI 36.7–99.4) (Figure 3).


Cetuximab in preoperative treatment of rectal cancer - term outcome of the XERT trial.

Velenik V, Ocvirk J, Oblak I, Anderluh F - Radiol Oncol (2012)

Disease-free survival of patients treated with preoperative capecitabine-base chemotherapy and cetuximab (n=36).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3472951&req=5

f2-rado-46-03-252: Disease-free survival of patients treated with preoperative capecitabine-base chemotherapy and cetuximab (n=36).
Mentions: The median follow-up time for all 36 patients was 39.0 months (range 5.0–87.0 months). The median time to disease recurrence was 35.0 months (range 5.0–87.0 months). Local failure occurred in one patient (2.8%), 11.5 months after the end of treatment. The three-year local control rate was 96.9% (95% CI 90.9–100). Disease dissemination was observed in nine patients (25.0%) with the following pattern of distribution: liver (n=3; 8.3%), lung (n=3; 8.3%), suprarenal gland (n=1; 2.8%), bones (n=1; 2.8%) and synchronous lung plus retroperitoneum (n=1; 2.8%). The latest distant failure was observed 26 months after the end of treatment. No secondary malignancies were observed. The three-year relapse-free survival rate was 74.3% (95% CI 59.8–88.8) (Figure 1) and the three-year disease-free survival rate was 72.2% (95% CI 57.5–86.9) (Figure 2). The median survival has not yet been reached. The three-year survival rate was 68.1% (95% CI 36.7–99.4) (Figure 3).

Bottom Line: There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small.Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and was associated with an impressive three-year local control rate.The use of tumour KRAS mutation status as a biomarker for the efficacy of cetuximab-based regimens in this setting requires further investigation.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.

ABSTRACT

Background: Preoperative capecitabine-based chemoradiotherapy (CRT) is feasible for the treatment of resectable locally advanced rectal cancer (LARC). To try to improve efficacy, we conducted a phase II study in which the epidermal growth factor receptor-targeting monoclonal antibody cetuximab was added to capecitabine-based CRT. The results for long-term survival and for an analysis investigating the relationship between survival and patient and disease characteristics, including tumour KRAS mutation status, and surgery type, are presented. PATIENTS AND METHODS.: Patients with resectable LARC received capecitabine (1250 mg/m(2) twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m(2) for 1 week) and then with CRT (250 mg/m(2)/week) comprising capecitabine (825 mg/m(2) twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m(2) twice daily for 14 days every 21 days) three weeks later.

Results: Forty-seven patients were enrolled and 37 underwent treatment. Twenty-eight of the patients (75.7%) had T3N+ disease. Thirty-six patients were evaluable for efficacy. The median follow-up time was 39.0 months (range 5.0--87.0). The three-year local control, disease-free survival, relapse-free survival and overall survival rates were 96.9% (95% CI 90.0--100), 72.2% (57.5--86.9), 74.3% (95% CI 59.8--88.8) and 68.1% (95% CI 36.7--99.4), respectively. There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small.

Conclusions: Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and was associated with an impressive three-year local control rate. The use of tumour KRAS mutation status as a biomarker for the efficacy of cetuximab-based regimens in this setting requires further investigation.

No MeSH data available.


Related in: MedlinePlus