Table 10.
Studies of neoadjuvant chemotherapy without radiation.
| No of ptsa | Eligibility | NACT | Acute Toxicity | PCRb | Ro resection | Outcomes | |
|---|---|---|---|---|---|---|---|
| Ishii 2010 [12] | 26 | T3/T4 N0-2 | Irinotecan (80 mg/m2), FUFA days 1, 8, and 15 for 4 weeks | Not stated | 1/15 (7%) | Not stated | 5 year RFS 74% OS 84% |
| Fernandez-Martos 2014 [13] | 46 | T3 middle third tumors ≥2 mm from the mesorectal fascia | Capox + bev | 2 acute toxic deaths 13% rate of anastomotic leak higher than expected (1 death) | 9/46 (19·5%) | 96·4% | No data |
| Uehara 2011, 2013 [14,15] | 32 | T3 >5 mm, T4, N2, CRM involved/at risk | Capox + bev | Postop complication in 43% | 8/32 (12.5%) | 84·3% | No data |
| Schrag 2014 [16] | 32 | T2N1, T3 any N (not N2 bulky) Not T4 5–12 cm from anal verge | FOLFOX + bev (6 cycles bev 1–4) | 2 pts withdrew (angina arrhythmia) | 8/32 (25%) | 100% | RFS 92% OS 91% |
| AlGizawy 2015 [17] | 45 | C Stage II and III | 6 cycles of FOLFOX 6 | 3 pelvic collections 2 delayed wound healing | 8/45 (17·8% | No data | 3 year DFS 68% 3 year OS 81% |
| Hasegawa 2017 [18] (UMIN000005654) | 60 | C Stage II and III | mFOLFOX6) + bev or cetuximab, depending on KRAS status | Postop complication rate (≥grade 2) 21·7% |
10/60 (16·7%) | 98·3% | No data |
| Matsumoto 2015 [19] retro-spective | 15 | cT3/cT4a, cN+ | FOLFOX (60%) IRIS FOLFIRI | 3/15 (20%) grade 3/4 adverse events | 2/15 (13·3%) | 100% | 5-year RFS rate 66·7% and 62·6% in NAC non-NAC groups |
| Ueki 2016 [20] | 31 | Clinical stage II/III lower rectal cancer | XELOX | Grade 3–4 adverse events in 9/31 (31%). | 3/29 (10·3%) | 96·5% | No data |
| Kamiya 2016 [21] CORONA 1 trial phase II | 41 | cT3/T4 cN+ | XELOX | Major complication in 6/40 patients (15·0%). | 5/41 (12·2%) | 37/41 90·3% |
No data |
| FOWARC trial Deng 2016 [22] | 163 | MRI or CT + EUS stage II (T3-4/N0) or stage III (T1-4/N1-2), M0, <12 cm above anal verge | modified FOLFOX6 alone | Low | 10/152 (6·6%) | 136/152 (89%) | No data |
| FACT trial Koike 2017 [23] | 52 | T3 or T4 stage II/III rectal cancer | FOLFOX | Safe | 5/42 resected (11·9%) 5/52 overall | 91% | No data |
| GRECCAR 4 Rouanet 2017 [24] | 10 | Mri defined cT3 ≥ c, cT4 or predicted CRM ≤ 1 mm | FOLFIRINOX | Grade 3–4 toxicity in 7/11 (63·6%) | 1/10 (10%) | 10/10 (100%) | No data |
| BACCHUS present study | 20 | Mri defined high risk > T3b | Modified FOLFOX6 alone FOLFOXIRI plus Bevacizumab | 1 pelvic sepsis 2 wound infections no leaks |
2/20 10% |
17/18 (94%) resected | 2 year OS 80% |
a
Number entering study.
b
Number having had surgery.