br Patients br Incomplete clinical response br Complete path
7 Incomplete clinical response
3 Complete pathological response
2 Complete clinical response
Fig. 3 – Endoscopic aspect of a patient with complete clinical response.
thus greater local and distance control, as well as better PFS and OS.8 Considering this data, the real need for surgery in this group was questioned; Dr. Angelita Habr-Gama, from Brazil, was the first to conduct a study in order to elucidate this ques-tion and to experimentally adopt the wait-and-see policy (no surgical resection and vigilant follow-up).
Habr-Gama et al. assessed 265 patients with distal rectal cancer (0–7 cm from the anal border) considered resectable. These patients underwent CHT and neoadjuvant RT from 1991 to 2002. Approximately 26.8% of them presented cCR, and were closely followed-up, 8.3% had almost complete clin-ical response (small residual lesion) and underwent lesion resection, and the others underwent conventional surgical treatment.3 The wait-and-see policy group was followed-up for 57 months and the resection group, for 48 months. In the resection group, there were nine definitive colostomies and seven temporary ileostomies. Three systemic recurrences were observed in each group, as well as two endorectal recurrences in the observation group and two deaths in the resection group. Overall five-year survival rate was 88% vs. 83% (p = 0.01) in the resection group and in the observation group, respectively. However, no significant difference in disease-free survival was observed in both groups (100% and 92%, respec-tively; p = 0.09).3
In another study, published in 2009, Harb-Gama et al. showed the results of an extended RT/CHT scheme, in which a sustained cCR rate of 65.5% was observed. In the present study, a slightly lower rate (40%) was observed.9 However, 20% of the patients presented cPR, which indicates that there is
still some difficulty in actually characterizing cCR with the cur-rently available exams, showing a similarity with the results obtained with a different CHT regimen.
The present series has a mean follow-up time of 19 months, ranging from 14 to 27 months, with no relapse to date. This is a preliminary analysis, as the study is still in progress.
From 2004 to 2010, Mass et al. conducted the second study to evaluate the wait-and-see policy. Patients with T3, T4, and Anti-Human TNF-alpha node positive rectal cancer were treated with the standard neoadjuvant RT/CHT regimen. After seven weeks, they were reassessed clinically and through colonoscopy and MRI. Twenty-one patients presented cRC and were followed-up every 3–6 months with similar exams; in the control group, 20 patients presented cPR after TME. In the wait-and-see group, only one local recurrence was observed after 22 months. However, no significant differences were observed in the cumulative PFS rates at two years (89% vs. 93%; p = 0.77), and overall survival (100% vs. 91%) in the cRC and pRC groups, respectively.10
In a review of thirty studies (nine series, 650 patients) on the non-surgical treatment of rectal cancer patients after RT/CHT, despite the low rates of locoregional recurrence reported in the series by Habr-Gama et al. and Mass et al., other retro-spective studies presented recurrence rates of 23–83%.11 These differences in outcome may be explained by heterogeneity in staging, inclusion criteria, study design, and intensity of follow-up after cCR.12
Thus, when considering the different treatment options for a patient, both the oncological results and the morbimortal-ity of the treatment should be considered. The wait-and-see policy should be valued not only for elderly patients with comorbidities, but also for young patients biomass comply with active surveillance. The goal is to spare them from and reduce the incidence of intestinal, genitourinary, and sexual dysfunc-tion, which are relevant to their quality of life.
Advances in RT and CHT protocols led to better complete response rates, as shown in the present study, in which a 40% cCR was observed in the preliminary analysis. It is still diffi-cult to characterize cCR with the available tests; 20% of the patients who underwent surgery presented cPR. The present study is still in progress, aiming to evaluate in the future the
overall survival and disease-free survival, quality of life, and incontinence scores.
Conflicts of interest
The authors declare no conflicts of interest.
1. Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004;351:1731–41.
2. Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, et al. Preoperative versus postoperative chemotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012;30:1926–33.