Objective and Subjective Assessment of Edema during Adjuvant Chemotherapy Using Taxane-Containing Regimens in a Randomized Controlled Trial: National Surgical Adjuvant Study of Breast Cancer (NSAS-BC) 02.

Abstract

Abstract Background: Taxanes are frequently used in treatment of breast cancer (BC) patients. However, some patients treated with taxanes, especially docetaxel (DTX), experience severe edema during and following the treatment. We prospectively assessed body weight and health-related quality of life (HRQOL) related to edema in a randomized controlled trial (RCT) comparing four taxane-containing regimens in an adjuvant setting.Patients and Method: We conducted NSAS BC02 trial in which postoperative patients with node positive BC were randomly assigned to receive one of the following four adjuvant chemotherapeutic regimens; (1) ACP regimen: 4 cycles of doxorubicin 60mg/m2 plus cyclophosphamide 600mg/m2 q3weeks (AC) followed by 4 cycles of paclitaxel (PTX) 175 mg/m2 q3weeks, (2) ACD regimen: 4 cycles of AC followed by 4 cycles of DTX 75mg/m2 q3weeks, (3) PTX regimen: 8 cycles of PTX, (4) DTX regimen: 8 cycles of DTX. During the study we recorded body weight at baseline (at study entry), on day 1 of each cycle and at 8 months, and every 6 months thereafter. And we asked the patients to answer FACT-B, and -Taxane at baseline, on day 1 of cycle 3, 5, and 7, and at 8 and 12 months. We compared the change of weight and the scores of 4 items regarding edema in FACT-B (B8) (change in weight) and FACT-Taxane (Tax1 [anasarca], Tax2 [edema of hands], and Tax3 [edema of legs]) among the four regimens. Data were analyzed on an intent-to-treat basis. The statistical significance of the differences among the regimens was examined with analysis of covariance and t-test.Results: Of 1060 patients who entered N-SAS BC 02 trial, first 300 patients participated in this HRQOL study (ACP 74 patients, ACD 75, PTX 76, and DTX 75). The weight increased markedly and recovered by 8 months in the patients of DTX regimen, increased slightly in those of ACD regimen, and was almost stable in those of ACP and PTX regimens. The difference in the change of weight from the baseline to the 8th cycle between the patients of DTX plus ACD regimens and those of ACP plus PTX regimens was statistically significant (P< .0001). The compliance of FACT-B, and -Taxane was high throughout the study period (> 85 % at each point). The scores of B8, Tax1, Tax2, or Tax3 were relatively stable in ACP, ACD, and PTX regimens over the study period, but those of DTX regimen became lower (indicating worse HRQOL) up to 8 months, then recovered to the baseline except the scores of Tax2 which were still lower than those of other 3 regimens at 12 months. When the scores of the patients of DTX regimen were compared with those of other 3 regimens combined, the differences were statistically significant in all items of B8 (P= .0450), Tax1 (P= .0016), Tax2 (P< .0001), and Tax3 (P< .0001).Discussion: The patients who received 8 cycles of DTX were agonized by chemotherapy (CT)-related edema. However, the agony seemed to disappear by 6 months after the completion of CT except for that of edema of hands. The reason why only the scores of Tax2 did not recover at 12 months in the patients of DTX regimen is suspected to be the ipsilateral hand and arm edema affected by axillary dissection which might have lasted for a long time. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 2090.