Studies on neoadjuvant chemotherapy regimens for Triple Negative Breast Cancer (TNBC)

Study 1: NeoSTOP: Paclitaxel + Carboplatin + Doxorubicin + Cyclophosphamide (Arm A) v/s Paclitaxel + Carboplatin (Arm B)

Dosage: Arm A — Carboplatin AUC 6 every 3 weeks x 4 + Paclitaxel 80 mg/m² every week x 12, followed by Doxorubicin 60 mg/m² + Cyclophosphamide 600 mg/m² every 2 weeks x 4
Arm B — Carboplatin (AUC 6) + Docetaxel (75 mg/m²) given every 21 days × 6 cycles

Cohort: 100 TNBC Stage I–III patients — 48 in Arm A, 52 in Arm B

Result: pCR 54% in Arm A and Arm B
RCB 0+1 67% in Arm A and Arm B
“event-free and overall survival were similar in two arms”

Toxicity: Grade 3/4 adverse events — 73% in Arm A, 21% in Arm B
One patient in Arm A developed secondary acute myeloid leukemia 23 months after completion of neoadjuvant chemotherapy and succumbed to the leukemia at age 53. No treatment-related deaths occurred in Arm B.
In Arm A, 44% (21/48) of patients received filgrastim support during the CbP phase and 17% (8/48) of patients received red blood cell transfusion (all during the dose-dense AC phase). No such therapy was needed in Arm B.

Discontinuation:

Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887017/

Date: Feb 2021

Study 2: Paclitaxel + Carboplatin

Dosage: Carboplatin (AUC 2) + Paclitaxel (80 mg/m²) weekly (doses unknown)

Cohort: 24 locally advanced TNBC patients

Result: pCR 83%
“Taxane/carboplatin-based/anthracycline-free NCT is the best treatment for inoperable TNBC in terms of efficacy and toxicity, because this approach avoids cardiotoxicity and obtains an optimal rate (83%) of pCR, with an important impact on survival.”

Toxicity: No Grade 4; 8% Grade 3

Discontinuation: Unknown

Paper: https://pubmed.ncbi.nlm.nih.gov/27435626/

Date: Feb 2017

Study 3: Docetaxel + Carboplatin

Dosage: Carboplatin (AUC 6) + Docetaxel (75 mg/m²) given every 21 days × 6 cycles

Cohort: 190 patients with stage I–III TNBC, median tumor size was 35 mm, 52% were lymph node positive, and 16% had germline BRCA1/2 mutation.

Result: Overall pCR 55%; RCB 0+1 68%
BRCA mutant pCR 59%; BRCA wild pCR 56%
“results are comparable with pCR achieved with the addition of carboplatin to anthracycline–taxane chemotherapy”

Toxicity: Grade 3 21%; Grade 4 7%
“well tolerated”

Discontinuation: Total 12%
Progressive disease 4.4%
Toxicity 6%
Other 1.6%

Paper: https://clincancerres.aacrjournals.org/content/23/3/649

Date: Feb 2017

Study 4: Docetaxel + Carboplatin

Dosage: Carboplatin (AUC 6) + Docetaxel (75 mg/m²) given every 21 days × 6 cycles

Cohort: 30 TNBC patients (15 T1, 13 T2, 2 T4; 19 N0, 11 N+)

Result: pCR 50%; near pCR 20%

Toxicity: “Grade 3 and 4 toxicities were rare events”
No febrile neutropenia

Discontinuation: 28 of 30 (93%) patients completed all 6 cycles
No toxicity-related treatment discontinuation

Paper: https://europepmc.org/article/MED/24852315

Date: Jan 2013

Study 5: GeparSixto: Paclitaxel + Doxorubicin + Bevacizumab (Arm A) v/s Paclitaxel + Doxorubicin + Bevacizumab + Carboplatin (Arm B)

Dosage: Arm A — 18 weeks with Paclitaxel (80 mg/m² once a week) + non-pegylated liposomal Doxorubicin (20 mg/m² once a week) + simultaneous Bevacizumab (15 mg/kg intravenously every 3 weeks)+ Carboplatin (AUC 2.0 once a week)
Arm B — 18 weeks with Paclitaxel (80 mg/m² once a week) + non-pegylated liposomal Doxorubicin (20 mg/m² once a week) + simultaneous Bevacizumab (15 mg/kg intravenously every 3 weeks)

Cohort: Arm A — 158 TNBC patients
Arm B — 157 TNBC patients

Result: Arm A — pCR 53.2%
Arm B — pCR 36.9%

Toxicity: Grade 3/4 neutropenia — Arm A 65%, Arm B 27%
Grade 3/4 anaemia — Arm A 15%, Arm B <1%
Grade 3/4 thrombocytopenia — Arm A 14%, Arm B <1%
Grade 3/4 thrombocytopenia — Arm A 17%, Arm B 11%

Discontinuation: Arm A — 48%
Arm B — 39%

Paper: https://pubmed.ncbi.nlm.nih.gov/24794243/

Date: Jun 2014