Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy: trial

Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy

N = 316

Population

Patients with resectable T3-4 rectal carcinoma without sphincter infiltration

Design

Randomised trial in 19 institutions (1999 to 2002) in patients with resectable T3-4 rectal carcinoma without sphincter infiltration and a lesion accessible to digital rectal examination. Short-course arm: 25 Gy in five fractions of 5 Gy, then total mesorectal excision within 7 days. Chemoradiation arm: 50.4 Gy in 28 fractions of 1.8 Gy with two courses of bolus fluorouracil and leucovorin, then total mesorectal excision after 4 to 6 weeks. 316 patients were enrolled according to the 2004 report; the 2006 long-term report states 312 randomised patients with a median follow-up of living patients of 48 months. Surgeons chose the type of operation according to the tumour status at surgery.

Arms

Short-course radiotherapy (control): 25 Gy in five fractions of 5 Gy, then total mesorectal excision within 7 days
Conventionally fractionated chemoradiation (experimental): 50.4 Gy in 28 fractions of 1.8 Gy with two courses of bolus fluorouracil and leucovorin, then total mesorectal excision after 4 to 6 weeks

People

Bujko K

Δ Sphincter preservation rate−3 pointsΔ 48-month OS−1 pointsΔ DFS−2.8 pointsΔ Local recurrence+5.2 pointsΔ Early radiation toxicity+15 points

Show the numbers

Results reported for Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy
Endpoint	Analysis	Conventionally fractionated chemoradiation	Short-course radiotherapy	Effect
Sphincter preservation rateEnrolled patients (316 in the 2004 abstract); analysis population not stated in the abstractProportion of patients with a sphincter-preserving operation; the 2004 report states this as its aim	primaryBujko 2004	58%	61%	P=0.57The tumour was on average 1.9 cm smaller in patients treated with chemoradiation (P<0.001). Five patients in the chemoradiation group had an abdominoperineal resection despite a clinical complete response.
OSRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractActuarial 4-year overall survival	long term-updatemedian follow-up 48 monthsBujko 2006	66.2% at 4 y	67.2% at 4 y	P=0.960
DFSRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractDisease-free survival; the abstract does not state a time point for this rate	long term-updatemedian follow-up 48 monthsBujko 2006	55.6%	58.4%	P=0.820
Local recurrenceRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractCrude incidence of local recurrence	long term-updatemedian follow-up 48 monthsBujko 2006	14.2%	9%	P=0.170
Early radiation toxicityRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstract	long term-updateBujko 2006	18.2%	3.2%	P<0.001Severe late toxicity was 10.1% with short-course radiotherapy and 7.1% with chemoradiation (P=0.360).

Results reported for Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy
Endpoint	Analysis	Conventionally fractionated chemoradiation	Short-course radiotherapy	Effect
Sphincter preservation rateEnrolled patients (316 in the 2004 abstract); analysis population not stated in the abstractProportion of patients with a sphincter-preserving operation; the 2004 report states this as its aim	primaryBujko 2004	58%	61%	P=0.57The tumour was on average 1.9 cm smaller in patients treated with chemoradiation (P<0.001). Five patients in the chemoradiation group had an abdominoperineal resection despite a clinical complete response.
OSRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractActuarial 4-year overall survival	long term-updatemedian follow-up 48 monthsBujko 2006	66.2% at 4 y	67.2% at 4 y	P=0.960
DFSRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractDisease-free survival; the abstract does not state a time point for this rate	long term-updatemedian follow-up 48 monthsBujko 2006	55.6%	58.4%	P=0.820
Local recurrenceRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstractCrude incidence of local recurrence	long term-updatemedian follow-up 48 monthsBujko 2006	14.2%	9%	P=0.170
Early radiation toxicityRandomised patients (312 in the 2006 abstract); analysis population not stated in the abstract	long term-updateBujko 2006	18.2%	3.2%	P<0.001Severe late toxicity was 10.1% with short-course radiotherapy and 7.1% with chemoradiation (P=0.360).

Appears in

2004 Short-course radiotherapy vs long-course chemoradiation trials

Sources

Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Pudełko M, et al. Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy. Radiother Oncol. 2004;72(1):15-24.
PubMed DOI
Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Kryj M. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Br J Surg. 2006;93(10):1215-23.
PubMed DOI