JCOG1007 / iPACS

In asymptomatic patients with unresectable stage IV colorectal cancer, does primary tumour resection before chemotherapy improve survival?

Population and treatment

165 patients with asymptomatic primary colorectal cancer and synchronous unresectable metastases.

Intervention vs comparator: Primary tumour resection followed by chemotherapy vs chemotherapy alone.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=JCOG1007+iPACS+primary+tumor+resection

Results

Median OS 25.9 months with resection vs 26.7 months with chemotherapy alone; HR 1.10 (95% CI 0.76–1.59); p=0.69. The trial stopped early for futility. Postoperative morbidity and three postoperative deaths occurred in the resection arm.

Overall survival · Median (not fixed-time)

NNT: jRCTs031180096

NNH not calculated without defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

26.7

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

Routine primary-tumour resection did not improve OS in asymptomatic patients with unresectable metastases. This does not apply to obstruction, perforation or uncontrolled bleeding. No NNT from median OS.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.