▎Clinical Problem: In the treatment of lymph node-positive early breast cancer patients, the effect of adding fluorouracil to chemotherapy regimens of epirubicin, cyclophosphamide and paclitaxel on clinical outcomes is unclear.

▎ Study Protocol:

(1) Recruiting BC patients aged 18-70 years old with surgical, lymph node positive, and ECOG score of 0-1 from 81 hospitals in Italy; from April 24, 2003 to July 3, 2006, a total of 2,091 patients were recruited;

(2) Eligible patients were randomly assigned (1:1:1:1) to the following four study groups: ① EC (epixorubicin 90mg/m² and cyclophosphamide 600mg/m²) was injected intravenously for four cycles, and then paclitaxel (175mg/m²) was injected intravenously for four cycles (q3EC-P group, 545 people); ② FEC (fluorouracil 600mg/m² was injected intravenously for four cycles (q3EC-P group, 545 people); ② FEC (fluorouracil 600mg/m² was intravenously for four cycles every 3 weeks (frourouracil 600mg/m² was intravenously for four cycles (q3EC-P group, 545 people); ② FEC (fluorouracil 600mg/m² was intravenously for four cycles every 3 weeks (frourouracil 600mg/m² was intravenously for four cycles (q3EC-P group, 545 people); 90mg/m², cyclophosphamide 600mg/m²), a total of four cycles, and then intravenously injected paclitaxel (175mg/m²) every 3 weeks on the first day, a total of four cycles (q3FEC-P group, 544 people); ③ Dosage-intensive EC-P regimen, the dosage and drug are the same as those in the q3EC-P group, but the dose is given once every 2 weeks (q2EC-P group, 502 people); ④ Dosage-intensive FEC-P regimen, The dose and drug were the same as the q3FEC-P group, but were given every 2 weeks (q2FEC-P group, 500 people);

(3) used a centralized interactive system based on the Internet for randomization of the exchange block size of 12, and randomized treatment grouping; 88 patients were included in the center that only provided standard interval treatment, and were assigned to only receiving q3FEC-P treatment and q3EC-P treatment; therefore, 2091 patients were included in the comparative EC-P group (1047 patients) vs. Intention-to-treatment analysis in the FEC-P group (1044 patients), 2003 patients were included in the intention-to-treatment analysis in the comparative dose-intensive regimen (1002 patients) vs. the standard regimen (1001 patients).

(4) The primary endpoint was DFS in the intention-to-treat population, comparing different chemotherapy plans (dose-intensive vs standard dosage intervals) and treatment regimens (FEC-P group vs EC-P group);

(5) The safety population included all patients who received at least one dose of any study drug based on the treatment received.

▎ mainly found:

(1) After 15.1 years (IQR 8.4 years-16.3 years), there was no significant difference in median DFS between the FEC-P group and the EC-P group [17.09 years (95%CI, 15.51 years-not reached) vs. not reached (95%CI, 17.54 years-not reached); unadjusted hazard ratio 1.12 (95%CI, 0.98-1.29); log-rank p=0.11].

(2) The median DFS in the dose-intensive regimen group was significantly higher than that in the standard regimen group [not reached (95%CI, 17.45-not reached) vs 16.52 (95%CI, 14.24-17.54); 0.77 (95%CI, 0.67-0.89); p=0.0004].

(3) The most common grade 3-4 adverse events were neutropenia [200 (37%) of 536 patients in the q3EC-P group, 257 (48%) of 533 patients in the q3FEC-P group, 50 (10%) of 496 patients in the q2EC-P group, 97 (20%) of 492 patients in the q2FEC-P group] and hair loss [238 (44%) vs 249 (47%) vs 228 (46%) vs 235 (48%)]. During the extended follow-up period, no more grade 3-4 adverse events or deaths related to toxic effects were reported.In q3EC-P group, 9 (2%) patients reported severe adverse events related to treatment, 7 (1%) were found in the q3FEC-P group, 9 (2%) were found in the q2EC-P group, and 9 (2%) were found in the q2FEC-P group. No treatment-related deaths occurred.

▎ Outlook:

(1) Addition of fluorouracil to chemotherapy for early BC patients with lymph node positive cannot improve clinical outcomes, but also increases the risk of adverse reactions. Therefore, fluorouracil should not be added to the chemotherapy regimens of epirubicin, cyclophosphamide and paclitaxel.

(2) Compared with standard interval chemotherapy regimens, shortening the dosing interval can improve the clinical outcomes of early BC patients.

References:

[1]

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00632-5/fulltextml13

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This article was first published: Medical World Tumor Channel

Author: Dingchao Jingyao Group

Editor: Sweet

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