trialsTrialNegative

PETACC-3

Irinotecan works in advanced bowel cancer and does nothing after surgery. The trial's tumour bank turned out to be worth more than its result.

PETACC-3 tested whether irinotecan added to biweekly infusional fluorouracil and leucovorin improves adjuvant treatment of colon cancer. In the principal analysis of 2,094 treated stage III patients, five-year disease-free survival was 56.7 percent with irinotecan against 54.3 percent without (log-rank p=0.106) and five-year overall survival 73.6 against 71.3 percent (p=0.094); irinotecan increased grade 3 to 4 gastrointestinal events and neutropenia. With CALGB 89803 reaching the same conclusion, irinotecan was abandoned in the adjuvant setting, and the pattern, that a drug active in metastatic disease can add nothing to surgery, repeated itself later with cetuximab and with bevacizumab. The trial's large annotated tumour bank became one of the main sources for the prognostic work on microsatellite instability, BRAF and the gene-expression subtypes that became the consensus molecular subtypes.

Setting

Stage II and III colon cancer after resection: biweekly infusional fluorouracil and leucovorin with or without irinotecan

Phase

Phase 3

Sponsor

Pan-European Trials in Alimentary Tract Cancer / Pfizer

Registry

Headline result

Five-year disease-free survival 56.7 against 54.3 percent (p=0.106); no overall survival gain.

Reported

2009

Enrolled

2,094 analysed3,278 patients were enrolled; the principal efficacy analysis was of the 2,094 treated patients with stage III disease randomised in the LV5FU2 strata.

Replication

CALGB 89803 also found no benefit from adjuvant irinotecan.

Outcomes

In plain words

What these results mean for people, not percentages

2,094 analysed

Disease-free survival at 5 years (stage III)primarysurrogate endpoint

56.7 vs 54.3 out of 100 alive without the cancer coming back at 5 years with Irinotecan with LV5FU2 compared with LV5FU2; 2.4 more per 100.
Roughly one extra person helped for every 42 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

The p-value (0.106) means the difference could plausibly be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
These results apply to the people the trial enrolled: Stage II and III colon cancer after resection: biweekly infusional fluorouracil and leucovorin with or without irinotecan. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

2,094 analysed.

Disease-free survival at 5 years (stage III)primary

· p = 0.106

Download

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Disease-free survival at 5 years (stage III)primary	Irinotecan with LV5FU2	-	56.7 percent	-	0.106	link
Disease-free survival at 5 years (stage III)primary	LV5FU2	-	54.3 percent	-	0.106	link

Replication

CALGB 89803 also found no benefit from adjuvant irinotecan.

Connected

Similar pages

not linked directly; found by shared links

cancers

2

Colon cancer (adenocarcinoma of the colon)Colorectal cancer

technologies

2

Cytotoxic chemotherapy Topoisomerase-I inhibitors (and ADC payloads)

drugs

3

ApprovedFluoropyrimidine antimetabolite

Fluorouracil (5-FU) · Adrucil / Efudex

ApprovedTopoisomerase I inhibitor (camptothecin prodrug)

Irinotecan (and liposomal irinotecan) · Camptosar / Onivyde

EstablishedReduced folate (rescue agent and chemotherapy modulator)

Leucovorin (folinic acid) · Wellcovorin / generic

terms

3

Consensus molecular subtypes (CMS1-4)Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)Neoadjuvant / adjuvant / perioperative

trials

2

Alliance N0147 MOSAIC