Skip to content
Bending the Curve Trial by Trial
?

Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data

Phase meta-analysisN = 1,196

Population
Four randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal verge
Design
Published systematic review and individual-patient-data meta-analysis (PubMed, Medline, Embase, Web of Science, Cochrane Library, CENTRAL and conference abstracts searched) of European randomised phase 3 trials comparing observation with adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery in patients with non-metastatic rectal cancer. Four trials were eligible, with data from 1196 patients with (y)pTNM stage II or III disease who had an R0 resection, a low anterior or abdominoperineal resection and a tumour within 15 cm of the anal verge. The primary endpoint was overall survival.
Primary endpoint
OS
Arms
  • Observation (control): No adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery
  • Adjuvant chemotherapy (experimental): Adjuvant fluorouracil-based chemotherapy after preoperative (chemo)radiotherapy and surgery (as pooled in the meta-analysis)
People
Breugom AJ
OSHR 0.97 (95% CI 0.81–1.17)DFSHR 0.91 (95% CI 0.77–1.07)Distant recurrenceHR 0.94 (95% CI 0.78–1.14)DFSHR 0.59 (95% CI 0.40–0.85)Distant recurrenceHR 0.61 (95% CI 0.40–0.94)
Show the numbers
Results reported for Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data
EndpointAnalysisAdjuvant chemotherapyObservationEffect
OSFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeOverall survival (primary endpoint of the meta-analysis); adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.97 (95% CI 0.81–1.17)P=0.775
DFSFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeDisease-free survival; adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.91 (95% CI 0.77–1.07)P=0.230
Distant recurrenceFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeDistant recurrences; adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.94 (95% CI 0.78–1.14)P=0.523
DFSSubgroup: tumour 10-15 cm from the anal vergeDisease-free survival in the subgroup with a tumour 10-15 cm from the anal vergeexploratoryBreugom 2015——HR 0.59 (95% CI 0.40–0.85)P=0.005P(interaction) 0.107; subgroup analysis.
Distant recurrenceSubgroup: tumour 10-15 cm from the anal vergeDistant recurrence in the subgroup with a tumour 10-15 cm from the anal vergeexploratoryBreugom 2015——HR 0.61 (95% CI 0.40–0.94)P=0.025P(interaction) 0.126; subgroup analysis.
Results reported for Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data
EndpointAnalysisAdjuvant chemotherapyObservationEffect
OSFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeOverall survival (primary endpoint of the meta-analysis); adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.97 (95% CI 0.81–1.17)P=0.775
DFSFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeDisease-free survival; adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.91 (95% CI 0.77–1.07)P=0.230
Distant recurrenceFour randomised trials, 1196 patients with (y)pTNM stage II or III disease, R0 resection and tumour within 15 cm of the anal vergeDistant recurrences; adjuvant chemotherapy versus observationexploratoryBreugom 2015——HR 0.94 (95% CI 0.78–1.14)P=0.523
DFSSubgroup: tumour 10-15 cm from the anal vergeDisease-free survival in the subgroup with a tumour 10-15 cm from the anal vergeexploratoryBreugom 2015——HR 0.59 (95% CI 0.40–0.85)P=0.005P(interaction) 0.107; subgroup analysis.
Distant recurrenceSubgroup: tumour 10-15 cm from the anal vergeDistant recurrence in the subgroup with a tumour 10-15 cm from the anal vergeexploratoryBreugom 2015——HR 0.61 (95% CI 0.40–0.94)P=0.025P(interaction) 0.126; subgroup analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSDFSDistant recurrenceDFSDistant recurrence0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.970.81–1.17
DFS0.910.77–1.07
Distant recurrence0.940.78–1.14
DFS0.590.4–0.85
Distant recurrence0.610.4–0.94
Primary publication: Breugom AJ, Swets M, Bosset JF, Collette L, Sainato A, Cionini L, et al. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol. 2015;16(2):200-7. PubMedDOI

Appears in

Sources

  1. Breugom AJ, Swets M, Bosset JF, Collette L, Sainato A, Cionini L, et al. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol. 2015;16(2):200-7.

    PubMedDOI