Table 3 Radiotherapy/Radiochemotherapy for Rectal Cancer

Maas, JCO, 2011

Patients with a cCR after CRT were prospectively selected for the wait-and-see policy with magnetic resonance imaging (MRI) and endoscopy plus biopsies

prospective cohort study

21 patients

control group: FU 35 Mo, 2-J-DFS 93%, 2-J-OS 91%

control group consisted of 20 patients with a pCR after surgery who had a mean follow-up of 35 ± 23 months. For these patients with a pCR, cumulative probabilities of 2-year disease-free survival and overall survival were 93 and 91%, respectively.

Habr-Gama, IJROBP 2014

183 Pat., cT2–4 or N+, CRT (50–54 Gy + 5-FU), Response after 8 weeks, patients with cCR were enrolled in a strict follow-up program with no immediate surgery (Watch and Wait).

Local recurrence may develop in 31% of patients with initial cCR when early regrowths (≤ 12 months) and late recurrences are grouped together. More than half of these recurrences develop within 12 months of follow-up. Salvage therapy is possible in ≥90% of recurrences, leading to 94% local disease control, with 78% organ preservation.

OnCoRe

Renehan, Lancet Oncol 2016

129 Pat.,

RChT, if cCR no surgery

38% 3 J LR, 88% Salvage-OP, better colostomy-free survival (74% vs 47%) in R T group

A substantial proportion of patients with rectal cancer managed by watch and wait avoided major surgery and averted permanent colostomy without loss of oncological safety at 3 years.

Appelt et al. Lancet Oncol 2015

prospective cohort study (2009–2013, 51 Pat.), Follow up 29 months

CRT with 50 Gy incl. SIB 60 Gy + HDR-Brachy 1 × 5 Gy + Tegafur-Uracil 300 mg/m2

40 Pat. With cCR (78%)

Local recurrence in the observation group at 1 year was 15·5% (95% CI 3·3–26·3). The most common acute grade 3 adverse event during treatment was diarrhoea, which affected four (8%) of 51 patients. Sphincter function in the observation group was excellent, with 18 (72%) of 25 patients at 1 year High-dose chemoradiotherapy and watchful waiting might be a safe alternative to abdominoperineal resection for patients with distal rectal cancer.

Garcia-Aguilar et al. Lancet Oncol 2015 ACOSOG Z6041 29

Phase II-study (77 Pat.), FU 52 Mo.

cT2 N0 < 4 cm (EUS oder MRT) neoadj. CRT 50–54 Gy + Oxaliplatin/Capecitabine

after 4–8 weeks local excision for patients with stage T2N0 rectal cancer.

3-year DFS 88%

49% ypT0/is, 14% ypT1, 31% ypT2, 4% ypT3