Table 1.
Characteristics of Patients With Clinical Stage II/III and Locally Advanced Rectal Cancer and Received Neoadjuvant Therapy
| Characteristic | Adjuvant Therapy |
All Patients (N = 1,193) |
||||
|---|---|---|---|---|---|---|
| Yes (n = 990) |
No (n = 203) |
|||||
| No. | % | No. | % | No. | % | |
| Age at diagnosis, years | ||||||
| Median | 55 | 65 | 57 | |||
| Range | 22-93 | 21-89 | 21-93 | |||
| < 50 | 300 | 30 | 29 | 14 | 329 | 27 |
| 50-64 | 451 | 46 | 69 | 34 | 520 | 44 |
| 65-74 | 197 | 20 | 53 | 26 | 250 | 21 |
| 75+ | 42 | 4 | 52 | 26 | 94 | 8 |
| Sex | ||||||
| Male | 602 | 61 | 114 | 56 | 716 | 60 |
| Female | 388 | 39 | 89 | 44 | 477 | 40 |
| Racial/ethnic background | ||||||
| White Non-Hispanic | 789 | 80 | 166 | 82 | 955 | 80 |
| African American Non-Hispanic | 57 | 6 | 14 | 7 | 71 | 6 |
| Asian Non-Hispanic | 63 | 6 | 4 | 2 | 67 | 6 |
| Other Non-Hispanic | 7 | < 1 | 1 | < 1 | 8 | < 1 |
| Hispanic | 71 | 7 | 17 | 8 | 88 | 7 |
| Unknown | 3 | < 1 | 1 | < 1 | 4 | < 1 |
| Charlson comorbidity index | ||||||
| 0 | 760 | 77 | 123 | 61 | 883 | 74 |
| 1 | 154 | 15 | 50 | 25 | 204 | 17 |
| 2 | 55 | 6 | 16 | 8 | 71 | 6 |
| 3+ | 21 | 2 | 14 | 7 | 35 | 3 |
| ECOG performance status | ||||||
| 0 | 843 | 85 | 141 | 69 | 984 | 82 |
| 1 | 71 | 7 | 34 | 17 | 105 | 9 |
| 2+ | 15 | 2 | 7 | 3 | 22 | 2 |
| Unknown | 61 | 6 | 21 | 10 | 82 | 7 |
| Center | ||||||
| A | 45 | 5 | 17 | 8 | 62 | 5 |
| B | 85 | 9 | 12 | 6 | 97 | 8 |
| C | 48 | 5 | 9 | 4 | 57 | 5 |
| D | 298 | 30 | 30 | 15 | 328 | 27 |
| E | 43 | 4 | 17 | 8 | 60 | 5 |
| F | 69 | 7 | 50 | 25 | 119 | 10 |
| G | 338 | 34 | 56 | 28 | 394 | 33 |
| H | 64 | 6 | 12 | 6 | 76 | 6 |
| Insurance | ||||||
| Private | 652 | 66 | 74 | 36 | 726 | 61 |
| Medicare | 236 | 24 | 92 | 45 | 328 | 27 |
| Medicaid/Indigent | 59 | 6 | 27 | 13 | 86 | 7 |
| Other | 31 | 3 | 5 | 2 | 36 | 3 |
| Unknown | 12 | 1 | 5 | 2 | 17 | 1 |
| Household income | ||||||
| < 40K | 355 | 36 | 84 | 41 | 439 | 37 |
| 40 to < 60K | 304 | 31 | 63 | 31 | 367 | 31 |
| 60 to < 80K | 187 | 19 | 30 | 15 | 217 | 18 |
| ≥ 80K | 102 | 10 | 16 | 8 | 118 | 10 |
| Unknown | 42 | 4 | 10 | 5 | 52 | 4 |
| Primary site | ||||||
| Rectosigmoid junction* | 72 | 7 | 12 | 6 | 84 | 7 |
| Rectum, NOS | 918 | 93 | 191 | 94 | 1109 | 93 |
| Clinical TNM stage | ||||||
| Locally advanced† | 37 | 4 | 11 | 5 | 48 | 4 |
| II | 290 | 29 | 76 | 37 | 366 | 31 |
| III | 663 | 67 | 116 | 57 | 779 | 65 |
| Pathologic TNM stage | ||||||
| Locally advanced‡ | 12 | 1 | 8 | 4 | 20 | 2 |
| 0 | 190 | 19 | 51 | 25 | 241 | 20 |
| I | 254 | 26 | 52 | 26 | 306 | 26 |
| II | 232 | 23 | 47 | 23 | 279 | 23 |
| III | 302 | 31 | 45 | 22 | 347 | 29 |
| Clinical to pathologic stage: Was patient downstaged/upstaged?‡ | ||||||
| Complete responders (stage 0) | 190 | 19 | 51 | 25 | 241 | 20 |
| Downstaged (from stage II to I or from stage III to II) | 211 | 21 | 56 | 28 | 267 | 22 |
| Downstaged (from stage III to I) | 175 | 18 | 21 | 10 | 196 | 16 |
| Upstaged (from stage II to III) | 64 | 6 | 7 | 3 | 71 | 6 |
| No change in stage | 303 | 31 | 52 | 26 | 355 | 30 |
| Grade at diagnosis | ||||||
| 1 | 44 | 4 | 15 | 7 | 59 | 5 |
| 2 | 745 | 75 | 142 | 70 | 887 | 74 |
| 3 | 71 | 7 | 9 | 5 | 80 | 7 |
| Unknown | 110 | 11 | 34 | 17 | 144 | 12 |
| NA | 20 | 2 | 3 | 1 | 23 | 1 |
| Lymphovascular invasion at primary surgery | ||||||
| No | 642 | 65 | 119 | 59 | 761 | 64 |
| Yes | 140 | 14 | 28 | 14 | 168 | 14 |
| Unknown | 130 | 13 | 27 | 13 | 157 | 13 |
| NA | 78 | 8 | 29 | 14 | 107 | 9 |
| Perineural invasion at primary surgery | ||||||
| No | 518 | 52 | 109 | 54 | 627 | 53 |
| Yes | 107 | 11 | 18 | 9 | 125 | 10 |
| Unknown | 286 | 29 | 46 | 23 | 331 | 28 |
| NA | 80 | 8 | 30 | 15 | 110 | 9 |
| Any margins (proximal, distal or radial) | ||||||
| Negative | 714 | 72 | 125 | 62 | 839 | 70 |
| Positive/close | 69 | 7 | 21 | 10 | 90 | 8 |
| NA | 207 | 21 | 57 | 28 | 264 | 22 |
| Distance of tumor from anal verge, cm | ||||||
| < 6 | 356 | 36 | 87 | 43 | 443 | 37 |
| 6-8 | 304 | 31 | 42 | 21 | 346 | 29 |
| >8 | 275 | 28 | 56 | 28 | 331 | 28 |
| Unknown | 55 | 5 | 18 | 8 | 73 | 6 |
| CEA after surgery for patients with abnormal CEA at baseline§ | ||||||
| Normal | 167 | 17 | 31 | 15 | 198 | 17 |
| Abnormal | 32 | 3 | 10 | 5 | 42 | 4 |
| No CEA test after surgery | 24 | 2 | 15 | 7 | 39 | 3 |
| NA | 767 | 77 | 147 | 72 | 914 | 76 |
| Surgical procedure | ||||||
| LAR | 670 | 68 | 116 | 57 | 786 | 66 |
| APR | 209 | 21 | 65 | 32 | 274 | 23 |
| Total proctocolectomy | 24 | 2 | 8 | 4 | 32 | 3 |
| Total pelvic exenteration | 9 | 1 | 3 | 1 | 12 | 1 |
| Partial pelvic exenteration | 2 | < 1 | 1 | < 1 | 3 | < 1 |
| Proctectomy | 61 | 6 | 3 | 1 | 64 | 5 |
| Surgical complications | ||||||
| Anastomosis leak/peritonitis | 4 | < 1 | 6 | 3 | 10 | < 1 |
| Postoperative bleeding | 1 | < 1 | 0 | 0 | 1 | < 1 |
| Re-operation bowel obstruction | 3 | < 3 | 0 | 0 | 3 | < 1 |
| Re-operation wound infection | 35 | 4 | 24 | 12 | 59 | 5 |
| Other surgical procedures‖ | ||||||
| Ileostomy | 32 | 3 | 9 | 4 | 41 | 3 |
| Colostomy | 59 | 6 | 20 | 10 | 79 | 7 |
| Closure of ileostomy/colostomy | 587 | 59 | 76 | 37 | 663 | 56 |
| Endoscopic stenting | 9 | 1 | 6 | 3 | 15 | 1 |
| Surgical drainage of abscess | 9 | 1 | 6 | 3 | 15 | 1 |
NOTE. Patients presented to NCCN institutions between September 2005 and December 2010 and received neoadjuvant chemotherapy and pelvic radiation.
Abbreviations: APR, abdominoperineal resection; CEA, carcinoembryonic antigen; ECOG, Eastern Cooperative Oncology Group; LAR, low anterior resection; NA, not applicable; NOS, not otherwise specified.
Seventy-six (90%) treated as rectal, four (5%) treated as colon, four treated as indeterminate.
Locally advanced means no evidence of metastatic disease, but staging was not available. Patients who were not able to be staged clinically and pathologically were not included in this study.
Sixty-three of the patients were excluded from the downstaged/upstaged analyses, as these patients either had clinical TNM stage or a pathologic TNM stage of locally advanced, but stage of disease not further specified.
Baseline was defined as a CEA test before neoadjuvant therapy. NA (not applicable) represents patients who did not have abnormal CEA at baseline (n = 913 with normal CEA at baseline; n = 1 unknown if CEA test was done).
Represents procedures that were performed after the primary rectal surgery.