TABLE IV.
Pre-operative
| ||||||
Trial Phase First Author |
n | Regimen | pCR (%) | ORR (%) | Median DFS (months) | Median OS (months) |
Phase II expansion - subgroup Frasci68 |
74 | Cis + E + Pac with GCSF support | 62 | 98.3 | 76% (5-year) | 89% (5-year) |
Phase II Ryan69 |
51 | Cis + Bev | 16 | 80 | n/a | n/a |
Phase II Silver70 |
28 | Cis | 21 | 64 | n/a | n/a |
Phase II Gronwald7 |
25a | Cis | 72 | 100 | n/a | n/a |
Phase III subgroup Sirohi41 |
17 | Plt + E + F(ci) | 17b | 100 | 68 | 65% (5-year) |
Phase II Torrisi71 |
30 | Cis + E + F(ci) → Pac | 40 | 86 | 87.5% (2-year) | n/a |
Advanced | ||||||
Trial Phase First Author |
n | Regimen | ORR (%) | Median PFS (months) | Median OS (months) | |
Phase III First-line+O’Shaughnessy64 |
258 | Cb + Gem | 30 | 4.1 | 11.1 | |
Rd Phase II First-line+Baselga BALI-172 |
58 | Cis | 10.3 | 1.5 | 9.4 | |
Phase II First-line+Kim73 |
62 | Plt | 27.6 | 4.1 | 10.8 | |
Phase II First-line Wang74 |
45c | Gem + Cis | 62.2 | 6.2 | n/a |
All patients had BRCA1 mutation, 20 patients (80%) were TN.
pCR rates could not be compared because 65% (11 of 17) of patients within the TN group did not undergo surgery due to CR. One out of six (17%) patients with TN tumors who underwent surgery had a pCR.
Preliminary analysis of 45 patients out of 65 enrolled.
Bev = bevacizumab; Cb = carboplatin; ci = continuous infusion; Cis = cisplatin; CR = complete response; DFS = disease-free survival; E = epirubicin; F = fluorouracil; GCSF = granulocyte colony-stimulating factor; Gem = gemcitabine; n = number of patients; n/a = not available; ORR = overall response rate; OS = overall survival; Pac = paclitaxel; pCR = pathological complete response; PFS = progression-free survival; Plt = platinum-based regimens; Rd = randomized; TN = triple-negative; TTP = time to progression