Reference
LR (%)
DFS(%)
OS (%)
Median FU (months)
Local excision
You et al. [8]
8.2
93
77
60
Bentrem et al. [9]
15.0
93
89
60
Endreseth et al. [17]
12.0
64
70
60
Garcia-Aguilar et al. [16]
18.0
77
82
54
Nash et al. [18]
19.0
83
69
59
Doornebosch et al. [19]
21.0
–
–
36
Standard surgery
You et al. [8]
4.3
97
82
60
Bentrem et al. [9]
3.0
97
93
60
Endreseth et al. [17]
6.0
77
80
60
Nash et al. [18]
–
94
85
77
Table 14.2
Eligibility criteria for transanal excision in early rectal cancer
<30% bowel circumference |
|---|
Clear margin (>3 mm) |
Mobile, nonfixed tumor |
Tumor size <3 cm |
Tumor within 8 cm from anal verge |
T1 only |
Endoscopically removed polyp with cancer or indeterminate pathology |
No lymphovascular or perineural invasion |
Well- to moderately differentiated tumor |
No evidence of lymphadenopathy on pretreatment imaging |
A further consideration is related to the relationship between LR and overall survival (OS). Although an increased rate of LR should translate into worse OS, Bentrem et al. [9] found a 5-year OS of 89% vs. 93% and a 5-year disease-free survival (DFS) of 93% vs. 97%, respectively, in patients who underwent LE excision or radical surgery for T1 RC. These differences were not statistically significant. Similar findings have been published by You et al. [8] and by Endreseth et al. [17]. However, comparing the long-term survival after LE or conventional surgery, Nash et al. [18] found a similar OS in the first 4 years after diagnosis but an increased rate of cancer-related deaths between 4 and 8 years in the LE group. In their review article, Chang et al. [22] found rates of OS at 5 years ranging from 69 to 83.4% in the LE group versus 82–90.4% in the radical surgery group. These findings were confirmed in a recent meta-analysis [23] that showed a higher risk of death in patients who underwent LE compared with those who underwent conventional radical surgery (relative risk [RR] 1.46; 95% confidence interval [CI] 1.19–1.77). Lastly, in a large population-based study of approximately 40,000 patients, Bhangu et al. [24] showed that while LE for T1 RC has equivalent outcomes in terms of OS compared with standard surgery, LE shows worse results for T2 tumors.
14.2.1 Conclusion
Although not fully supported by strong clinical evidence, LE is widely accepted as an adequate oncologic treatment for low-risk T1 RCs.
14.3 Conservative Approach After PCRT
As for LE in early RC, a major concern for using conservative approaches after PCRT relies on the risk of leaving nodal metastases in the mesorectum. It is well known that the most relevant predictor of lymph node metastasis is the ypT stage (pathologic T stage after neoadjuvant therapy). The risk of involved mesorectal lymph nodes ranges between 2 and 9.1% for ypT0 tumors, between 4 and 17.1% for ypT1 tumors, between 17 and 23% for ypT2 tumors, and >30% for ypT3–4 tumors [25–27]. Two conservative approaches have been proposed for RC patients who after PCRT show a major cCR: the wait-and-see policy and LE.
14.3.1 Wait-and-See Policy
The wait-and-see policy was first proposed by Brazilian surgeons [28]. Strict selection criteria, latest imaging techniques, and meticulous follow-up are the cornerstones of this approach. Excellent results have also been achieved using salvage therapy in cases of recurrence. Habr-Gama et al. [28–33] compared operative versus nonoperative treatments after neoadjuvant therapy. Patients with RC located low in the rectum underwent PCRT (50.4–54 Gy of RT combined with 5-fluorouracil-based chemotherapy), and 8–10 weeks after completion of PCRT, tumor response was evaluated using clinical, endoscopic, and radiologic parameters. Although tumor response parameters varied over time, the most recent definition of cCR includes the absence of residual ulceration or mass or significant wall irregularity and no pathologic features at imaging (e.g., absence of restriction to diffusion in diffusion-weighted MRI). Patients with cCR were strictly monitored via monthly visits for tumor response reassessment. Studies on the wait-and-see policy are summarized in Table 14.3. In these studies, the proportion of patients who achieved cCR varied from 10.9 to 38.7%, and of those who showed locoregional failure varied from 3 to 60%. Habr-Gama et al. [31] reported on 360 patients, of whom 122 showed an initial cCR and 99 a sustained cCR at 12 months. The authors found an impressive OS of 93% and DFS of 85% at 5 years. Maas et al. [34] found similar findings in 21 patients with cCR; at a mean follow-up of 25 months, only one recurrence was observed. On the contrary, Hughes et al. [35] showed a cCR rate of 17% and, with a median follow-up of 20 months, a 60% rate of LR. At a median follow-up of 26 months, Dalton et al. [36] described a high cCR rate (24%) but also an unacceptable 50% rate of LR.
Table 14.3
Outcomes after local excision vs. standard surgery for T1 rectal cancer
Reference | Follo-up | N. | N. | N. of local |
|---|---|---|---|---|
months | of patients | of cCR (%) | recurrences (%) | |
Habr-Gama series | ||||
Habr-Gama et al. [28] | 57.3 | 265 | 71 (26.8) | 2/71 (3.0) |
Habr-Gama et al. [29] | 36.0 | 118 | 36 (30.5) | 8/30 (27.0) |
Habr-Gama et al. [30] | 57.0 | 260 | 71 (27.3) | 2/71 (3.0) |
Habr-Gama et al. [31] | 60.0 | 360 | 99 (27.5) | 6/99 (6.0) |
Habr-Gama et al. [32] | 65.0 | 173 | 67 (38.7) | 8/173 (4.6) |
Habr-Gama et al. [33] | 60.0 | 183 | 90 (49.0) | 28/90 (31.0) |
Other series | ||||
Maas et al. [34] | 25.0 | 192 | 21 (10.9) | 1/21 (5.0) |
Hughes et al. [35] | 20.0 | 58 | 10 (17.0) | 6/10 (60.0) |
Dalton et al. [36] | 26.0 | 49 | 12 (24.0) | 6/12 (50.0) |
14.3.2 Local Excision
Compared with the wait-and-see policy, LE is able to provide information on the pathologic T stage. LE is considered primarily a “wide biopsy”, allowing the surgeon to decide whether to proceed to no further treatment if a pCR is found or to radical surgery if a residual tumor is found. Many studies have reported on LE after PCRT for RC; however, most of them are retrospective, single institution, and include heterogeneous patients (i.e., patients who refused or were unfit for major surgery) [37–41].
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