GEICAM/2003-11_CIBOMA/2004-01 trial

Background

GEICAM/2003-11_CIBOMA/2004-01. Phase III RCT of 876 patients with operable TNBC who had completed standard (neo)adjuvant chemotherapy and had node-positive disease (pN1a/pN2a/pN3a, excluding metastatic infraclavicular nodes) or node-negative disease with tumor >1cm. Tested extended adjuvant capecitabine.

Interventions and follow up

Arm A: Capecitabine 1,000mg/m² po BID days 1–14 of a 21-day cycle × 8 cycles after standard adjuvant chemotherapy
Arm B: Observation
Primary endpoint: DFS
mFollow up: 7.3yr

Results

DFS (overall): Not significantly prolonged; HR 0.82, 95%CI 0.63–1.06; P=.136
DFS, non-basal vs basal subtype: HR 0.53 vs 0.94; interaction P=.0694
OS, non-basal vs basal subtype: HR 0.42 vs 1.23; interaction P=.0052

Adverse events

Dermatologic: Grade 3–4 hand-foot syndrome (~19%)
Gastrointestinal: Grade 3–4 diarrhea
Hematologic: Grade 3–4 neutropenia
Overall: Discontinuation for AEs in ~24%

Conclusions

Extended adjuvant capecitabine after standard chemotherapy did not significantly improve DFS in early TNBC overall. An exploratory benefit in the non-basal phenotype subgroup requires prospective validation. Standard chemotherapy: anthracycline- and/or taxane-based × 6–8 cycles in the (neo)adjuvant setting followed by RT; AC × 4 allowed if node-negative.

Key Limitations

Negative for its primary DFS endpoint. The non-basal subgroup signal is exploratory and biologically uncertain. Enrolled patients who had not received neoadjuvant chemotherapy (no residual-disease selection as in CREATE-X). Heterogeneous prior regimens; basal/non-basal classification not standard in practice.

Clinical Context

Contrasts with CREATE-X, which showed a capecitabine benefit in patients with residual disease after neoadjuvant chemotherapy. ASCO/ESMO reserve adjuvant capecitabine for TNBC with residual disease after neoadjuvant therapy; GEICAM/CIBOMA does not support routine extended capecitabine in the broader adjuvant TNBC population.

References