Low energy contact X-ray brachytherapy (the Papillon technique) for early stage rectal cancer

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a randomised controlled trial of 88 patients treated by both low‑energy contact X‑ray brachytherapy (CXB) and external‑beam radiotherapy (EBRT; n=45) or EBRT alone (n=43), overall actuarial survival rates (Kaplan–Meier estimates) were 55% and 56% respectively, at 10‑year follow‑up (p=0.85). In the same study, disease‑free survival rates were 53% and 54% respectively, at 10‑year follow‑up (p=0.99). In a case series of 101 patients treated by low‑energy CXB with or without interstitial brachytherapy boost, overall actuarial survival rates (Kaplan–Meier estimates) were 83% and 63% at 5 and 8 years respectively. In the same study, disease‑specific survival rates were 94% and 89% at 5 and 8 years respectively. Actuarial survival rates for patients with stage T1 and T2 tumours were 68% and 55% respectively, at 8‑year follow‑up (p=0.73). Disease‑specific survival rates for patients with stage T1 and T2 tumours were 91% and 86% respectively, at 8‑year follow‑up (p=0.82).

4.2 In a case series of 97 patients treated by low‑energy CXB with or without interstitial brachytherapy boost, a complete response (no definition provided) was reported in 85% (82/97) of patients at a median follow‑up of 39 days. In a case series of 63 patients treated by low‑energy CXB followed by EBRT and interstitial brachytherapy boost, a complete clinical response (no definition provided) was reported in 92% (58/63) of patients at 2‑month follow‑up.

4.3 In the randomised controlled trial of 88 patients treated by low‑energy CXB and EBRT (n=45) or EBRT alone (n=43), actuarial local recurrence rates (Kaplan–Meier estimates) were 10% and 15% respectively, at 10‑year follow‑up (p=0.69). Distant recurrence was reported in 27% (12/45) of patients in the low‑energy CXB and EBRT group and 26% (11/43) of patients in the EBRT‑alone group at 10‑year follow‑up (no p value reported).

4.4 In the randomised controlled trial of 88 patients treated by low‑energy CXB and EBRT (n=45) or EBRT alone (n=43) all patients had surgery (either sphincter‑saving procedures or abdominoperineal resections) after initial treatment. Sphincter‑saving procedures were possible in 76% (34/45) of patients in the low‑energy CXB and EBRT group and 44% (19/43) of patients in the EBRT‑alone group (no p values reported). Abdominoperineal resections were needed in 24% (11/45) of patients in the low‑energy CXB and EBRT group and 56% (24/43) of patients in the EBRT‑alone group (no p values reported). In the same study, the actuarial colostomy rates (Kaplan–Meier estimates) were 29% in the low‑energy CXB and EBRT group and 63% in the EBRT‑alone group at 10‑year follow‑up (p<0.001).

4.5 In a case series of 312 patients treated by low‑energy CXB and interstitial brachytherapy boost, a permanent colostomy was needed in 3% (8/312) of patients.

4.6 Specialist advisers listed the following key efficacy outcomes: overall survival, disease‑free survival, clinical response, local control rates, loco‑regional and distant recurrence rates, avoiding a permanent stoma, quality of life, as well as bowel, urinary and sexual function.