Study
Histology
Treatment
No. of patients
% pCR
Treatment related mortality (%)
Survival
Quality of evidence
Kelsen et al. [2]
SCC 59.7 %
CDDP + 5FU + S
213
2.5
6.4
23 % at 3 years
Moderate
S
227
4
26 % at 3 years
MRC OEO2 [3]
SCC 31 %
CDDP + 5FU + S
434
4
N/A
23 % at 5 years
Moderate
S
437
N/A
17 % at 5 years
ACA 100 %
Perioperative ECF + S
250
36.3 % at 5 years
Low
S
253
23 % at 5 years
Ychou et al. [5]
ACA 100 %
Perioperative CDDP + 5FU + S
113
4.6
38 % at 5 years
Moderate
S
111
4.5
24 % at 5 years
Ancona et al. [6]
SCC 100 %
CDDP + 5FU + S
48
12.8
4.2
22 % at 5 years
Moderate
S
48
4.2
34 % at 5 years
Boonstra et al. [7]
SCC 100 %
CDDP + etoposide + S
85
7
5
26 % at 5 years
Moderate
S
84
4
17 % at 5 years
Table 23.2
Selected meta-analysis of surgery with or without neoadjuvant therapy
Study | Treatment | No. of patients | Treatment related mortality (95%CI)a | Overall survival (95%CI)a |
|---|---|---|---|---|
Neoadjuvant chemotherapy and surgery versus surgery only | ||||
Urschel et al. [8] | CS | NS | 0.94 | 1 year: 1.00 (0.76–1.3; p = 0.98) |
(0.66–1.35, p = 0.76) | 2 year: 0.88 (0.62–1.24; p = 0.45) | |||
3 year: 0.77 (0.37–1.59; p = 0.48) | ||||
S | NS | |||
Kaklamanos et al. [9] | CS | 845 | Difference in mortality 1.7 % (–0.9 to 4.3, p = 0.38)b | ARR for mortality at 2 years by 4.4 % (0.3–8.5; p = 0.07)b |
S | 838 | |||
Neoadjuvant chemoradiation and surgery versus surgery only | ||||
Sjouquist et al. [10] | CS | 1,046 | Not stated | 0.87 (0.79–0.96; p = 0.005) |
S | 1,016 | |||
Urschel et al. [19] | CRS | NS | 1.72 (0.96–3.07; p = 0.07) | 1 year: 0.79 (0.59–1.06; p = 0.12) |
2 year: 0.77 (0.56–1.05; p = 0.1) | ||||
3 year: 0.66 (0.47–0.92 p = 0.016) | ||||
S | NS | |||
Kaklamanos et al. [9] | CRS | 289 | Difference in mortality 3.4 % (95%CI −0.1 to 7.3; p = 0.2)b | ARR for mortality at 2 years by 6.4 % (95%CI 1.2–14.0; p = 0.86)b |
S | 280 | |||
Fiorica et al. [20] | CRS | 385 | 2.10 (1.18–3.73; p = 0.01) | 0.53 (0.32–0.89; p = 0.02) |
S | 379 | |||
Jin et al. [21] | CRS | 659 | 1.68 (1.03–2.73, p = 0.04) | 1 year 1.28 (1.01–1.64, p = .05) |
3 year 1.78 (1.2–2.66 p = 0.02) | ||||
5 year 1.46 (1.07–1.99, p = 0.02) | ||||
S | 649 | |||
Sjouquist et al. [10] | CS | 980 | Not stated | 0.78 (0.70–0.88; p < 0.0001). |
S | 952 | |||
The United Kingdom Medical Research Council (MRC) OEO2 trial was published in 2002 and subsequently was updated in 2009. This trial is the largest single trial addressing neoadjuvant chemotherapy published (802 patients) to date [3]. Patients with esophageal tumors of the upper, middle or lower third of the esophagus, including tumors of the cardia, were enrolled. Almost two thirds of the patients had adenocarcinoma, whereas 31 % has squamous cell carcinoma (SCC) and 3 % had undifferentiated histology. The study group included patients that received two cycles of preoperative cisplatin (CDDP) and 5-fluorouracil (5FU) followed by surgery versus the control group that underwent surgery only. There were 434 patients in the study group versus 437 patients in the control group. Two-year survival was significantly better in the chemotherapy arm at 43 % versus 34 % in the surgery only group. In a later update, this advantage extended to 5- years, with an overall survival rate of 23 % in the chemotherapy group versus 17 % in the surgery group. Progression-free survival was also improved in the chemotherapy arm. One major peculiarity about this trial is the exclusion of 69 patients from one site due to unclear reasons.
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