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CALGB 40603 showed that adding carboplatin to pre-operative chemotherapy made more triple-negative tumours disappear, but at nearly eight years of follow-up neither carboplatin nor bevacizumab clearly improved survival, in a trial too small to prove that either way.
CALGB 40603 (NCT00861705) was a randomised 2 by 2 factorial phase 2 trial in 454 registered patients (443 treated) with stage II to III triple-negative breast cancer, testing the addition of carboplatin and of bevacizumab to weekly paclitaxel followed by dose-dense doxorubicin and cyclophosphamide before surgery. Both additions raised the pathological complete response rate in the primary report (JCO 2015). At a median follow-up of 7.9 years (JCO 2022) long-term outcomes were not significantly improved by either drug, overall or in basal-like tumours defined by gene expression, in a trial not powered for those secondary endpoints. Pathological complete response (46.3 percent of patients) carried a five-year event-free survival of 85.5 percent against 56.6 percent without it, and was superior even to minimal residual disease; markers of immune activation in the pretreatment biopsy independently predicted response and survival.
With GeparSixto (disease-free survival gain) and BrighTNess (event-free survival gain) this is the third trial of the platinum debate: the pathological complete response gain is consistent across all three, the survival gain is seen in the two European trials and not in this one, and carboplatin became the platinum of the KEYNOTE-522 backbone on that combined reading.
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.
454 enrolled.
Prognostic comparison, not a randomised arm comparison
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 5 years by pathological response | Pathological complete response | 205 | 85.5% | - | - | link |
| Residual disease | - | 56.6% |
Shares GeparSixto, KEYNOTE-522, Pathologic complete response (pCR), Cyclophosphamide.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Early triple-negative breast cancer.
Shares Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer, Platinum agents.
Shares Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer, Platinum agents.
Shares Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer, Platinum agents.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Cyclophosphamide, Doxorubicin.
Shares BrighTNess, KEYNOTE-522, Pathologic complete response (pCR), Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), KEYNOTE-522, Pathologic complete response (pCR), Early triple-negative breast cancer.