Table 3.
Surgery Procedures and Tumor Downstaging
| Surgery and Stage | Good Risk |
Poor Risk |
||
|---|---|---|---|---|
| No. | % | No. | % | |
| No. of patients | 98 | 37 | ||
| Type of surgery | ||||
| Lower anterior resection | 71* | 72.5 | 22† | 59.5 |
| Abdominoperineal resection | 15 | 15.3 | 9 | 24.3 |
| Total proctocolectomy | 4 | 4.1 | 1 | 2.7 |
| Pelvic exenteration | 1 | 1.0 | 0 | |
| Treated but no surgery | 5‡ | 5.1 | 3§ | 8.1 |
| Consent withdrawal or insurance denial | 2 | 2.0 | 2 | 5.4 |
| No. of patients with positive margins | 4 of 91 | 4.4 | 4 of 32 | 12.5 |
| Evaluable patients for downstaging | 90 | 31 | ||
| Nonevaluable patients for downstaging | 8 | 6 | ||
| Death prior to surgery | 1 | 1 | ||
| Clinical CR, no surgery | 1 | 1 | ||
| Refused surgery | 1 | 1 | ||
| Not resectable | 2 | 0 | ||
| Consent withdrawal or insurance denial | 2 | 2 | ||
| Delayed surgery and given FOLFOX before surgery | 1 (pCR) | 0 | ||
| Not given irinotecan by treating physician | NA | 1 | ||
| Post-treatment stage for evaluable patients | 90 | 31 | ||
| Stage 0 | 16 | 18.7 | 9 | 29.0 |
| Stage I (T1-T2 N0 M0) | 27 | 30.0 | 7 | 22.6 |
| Stage II (T3-T4 N0M0) | 12 | 13.3 | 5 | 16.1 |
| Stage III (T-any N1-2 M0) | 22 | 24.4 | 6 | 19.4 |
| Stage IV (T-any N-any M1) | 13 | 14.4 | 4 | 12.9 |
| T stage | ||||
| T0 | 18 | 20.0 | 13 | 41.9 |
| T1-2 | 34 | 37.8 | 7 | 22.6 |
| T3-4 | 38 | 42.2 | 11 | 35.5 |
| N stage | ||||
| N0 | 61 | 67.8 | 24 | 77.4 |
| N1 | 20 | 22.2 | 5 | 16.1 |
| N2 | 9 | 10.0 | 2 | 6.5 |
| T-stage downstaging | 58 | 64.4 | 20 | 64.5 |
| ypT0 | 18 | 20.0 | 13 | 41.9 |
| Pathologic complete response (ypT0N0) | 17 | 18.9 | 11 | 35.5 |
Abbreviations: CR, complete response; FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; pCR, pathologic complete response; NA, not applicable.
One patient had delayed surgery as a result of morbid obesity and received FOLFOX and had a complete pathologic response.
One patient who underwent lower anterior resection was not evaluable as a result of not receiving irinotecan.
One patient died as a result of myocardial infarction before surgery, one patient had a clinical complete response and did not undergo surgery, one patient refused surgery, and two patients were found to have unresectable disease during exploratory laparotomy.
One patient died before surgery, one patient had clinical complete response and did not undergo surgery, and one patient refused surgery.