Non–anthracycline-containing regimens

The ABC trials were three open-label, randomized, phase III trials comparing TC (taxane and cyclophosphamide) with regimens containing an anthracycline/cyclophosphamide plus a taxane (TaxAC) for the adjuvant treatment of patients with HER2-negative early-stage breast cancer.[33] The three trials were analyzed together with a primary end point of invasive disease-free survival (IDFS). The primary aim was to determine if TC (the non-anthracycline arm) was noninferior to the TaxAC arms. Inferiority for TC was predefined as an HR exceeding 1.18 for the TC versus TaxAC arms. Participants were randomly assigned to receive TC (n = 2, 125) or TaxAC (n = 2,127).

The ABC trials were three open-label, randomized, phase III trials comparing TC (taxane and cyclophosphamide) with regimens containing an anthracycline/cyclophosphamide plus a taxane (TaxAC) for the adjuvant treatment of patients with HER2-negative early-stage breast cancer.[33] The three trials were analyzed together with a primary end point of invasive disease-free survival (IDFS). The primary aim was to determine if TC (the non-anthracycline arm) was noninferior to the TaxAC arms. Inferiority for TC was predefined as an HR exceeding 1.18 for the TC versus TaxAC arms. Participants were randomly assigned to receive TC (n = 2, 125) or TaxAC (n = 2,127).

In an interim futility analysis, the HR for IDFS was 1.202 (95% CI, 0.97–1.49) for TC versus TaxAC, which exceeded the predetermined limit to define TC as inferior.

The ABC trials were three open-label, randomized, phase III trials comparing TC (taxane and cyclophosphamide) with regimens containing an anthracycline/cyclophosphamide plus a taxane (TaxAC) for the adjuvant treatment of patients with HER2-negative early-stage breast cancer.[33] The three trials were analyzed together with a primary end point of invasive disease-free survival (IDFS). The primary aim was to determine if TC (the non-anthracycline arm) was noninferior to the TaxAC arms. Inferiority for TC was predefined as an HR exceeding 1.18 for the TC versus TaxAC arms. Participants were randomly assigned to receive TC (n = 2, 125) or TaxAC (n = 2,127).

The 4-year IDFS rate was 88.2% for patients who received TC and 90.7% for patients who received TaxAC (P = .04).

The ABC trials were three open-label, randomized, phase III trials comparing TC (taxane and cyclophosphamide) with regimens containing an anthracycline/cyclophosphamide plus a taxane (TaxAC) for the adjuvant treatment of patients with HER2-negative early-stage breast cancer.[33] The three trials were analyzed together with a primary end point of invasive disease-free survival (IDFS). The primary aim was to determine if TC (the non-anthracycline arm) was noninferior to the TaxAC arms. Inferiority for TC was predefined as an HR exceeding 1.18 for the TC versus TaxAC arms. Participants were randomly assigned to receive TC (n = 2, 125) or TaxAC (n = 2,127).

Although the findings favored treatment with regimens containing an anthracycline/cyclophosphamide plus a taxane, absolute differences between TC and TaxAC were small. Exploratory analyses suggested the greatest benefits from the TaxAC regimens were seen in patients with triple-negative disease and hormone receptor–positive disease with involved axillary lymph nodes, supporting a role for non–anthracycline-containing regimens in patients with lower-risk disease.

The West German Plan B trial (NCT01049425) randomly assigned 2,499 women with node-positive or high-risk node-negative disease to receive either four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel (EC-T) or six cycles of TC.[34] After an early amendment, women with hormone receptor–positive disease and a recurrence score below 12 were excluded.

The West German Plan B trial (NCT01049425) randomly assigned 2,499 women with node-positive or high-risk node-negative disease to receive either four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel (EC-T) or six cycles of TC.[34] After an early amendment, women with hormone receptor–positive disease and a recurrence score below 12 were excluded.

After a median follow-up of 60 months, 5-year outcomes were similar in the EC-T and TC arms for DFS (HR, 1.004; 95% CI, 0.776–1.299) and OS (HR, 0.937; 95% CI, 0.654–1.342).[34][Level of evidence B1]

The West German Plan B trial (NCT01049425) randomly assigned 2,499 women with node-positive or high-risk node-negative disease to receive either four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel (EC-T) or six cycles of TC.[34] After an early amendment, women with hormone receptor–positive disease and a recurrence score below 12 were excluded.

The upper 90% confidence limit for DFS did not exceed the noninferiority boundary of 1.467.

The West German Plan B trial (NCT01049425) randomly assigned 2,499 women with node-positive or high-risk node-negative disease to receive either four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel (EC-T) or six cycles of TC.[34] After an early amendment, women with hormone receptor–positive disease and a recurrence score below 12 were excluded.

There were five treatment-related deaths among patients who received TC and one death among those who received EC-T, but symptomatic adverse events were more frequent in patients who received EC-T.