Background and purpose Breast cancer can be a major challenge for affected women. Knowledge of the physical function, symptoms of cancer-related fatigue, anxiety, and depression based on the cancer treatment may help to guide adequate support. Methods For this prospective observational study, we collected data from seventy-nine women with a mean age 54.6 ± 9.5 years prior to the onset of breast cancer treatment (T0) and after (T1/T2). Handgrip strength test (HGS), six-minute walk test (6MWT), the phase angle (PhA), the hospital anxiety and depression scale (HADS), and functional assessment of chronic illness therapy-fatigue (FACIT-F) were used to collect data from four treatment subgroups SC, surgery + chemotherapy; SCR, surgery + chemotherapy + radiation therapy; SR, surgery + radiation therapy; and S, surgery. Results A mixed ANOVA revealed a significant interaction between time and group for PhA, F = 8.55, p < 0.01; HGS, F = 3.59, p < 0.01; 6MWT, F = 4.47, p < 0.01; and FACIT-F, F = 2.77, p < 0.05 with most pronounced deterioration seen in group SCR (PhA 4.8°; HGS 27.5 kg, 6MWT 453.4 m, FACIT-F 33.8 points). HADS data displayed moderate anxiety and depression predominantly after treatment. Conclusion Our study showed that the extent of change in physical function, symptoms of fatigue, anxiety, and depression depends on the treatment conditions. The potentially higher risk of impaired function due to the prevalence of values below a critical threshold requires early initiated multidisciplinary support.
Background Dose dense chemotherapy (DDT) has shown improvements of disease-free survival (DFS) and overall survival for primary breast cancer patients with a high risk of relapse. There are much less data about the effect of DDT in patients with intermediate risk of recurrence (1-3 positive axillary lymph nodes). Aim of this prospectively randomized trial was to investigate the superiority of a DDT schedule over a standard chemotherapy (ST) in primary breast cancer patients with 1-3 positive axillary lymph nodes. Methods The ASG1-3 study is a prospectively randomized, open label phase III study of the Adjuvant Study Group of the NOGGO association. Patients were eligible for the trial, if they had a primary invasive breast cancer (pT1-3) with 1-3 positive axillary lymph nodes and no evidence of distant metastases. Patients were randomized to an adjuvant therapy with either 4 cycles epirubicin (90mg/m2 body surface area, BSA) and cyclophosphamide (600mg/m2 BSA) q3w, followed by 4 cycles of paclitaxel (175mg/m2 BSA) referred to as ST or to a therapy with 4 cycles of epicubicin (120 mg/m2 BSA) q2w and primary G-CSF support followed by 4 cycles of paclitaxel (175mg/m2 BSA) q2w and primary G-CSF support referred to as DDT. Trastuzumab was not given in this study. The study was designed to show an increase of 70% DFS (ST) to 80% DFS (DDT) 5 years after randomization. Comparisons were conducted using Kaplan Meier estimates, log rank tests and Cox regression analyses. In an exploratory way, subgroup analyses were performed for HER2, hormone receptor status and grading using Cox regression models with interaction terms. Results A total of 936 patients were eligible for survival analysis, of which 465 were randomized to ST and 471 to DDT from 2001 to 2004. Patient characteristics were mainly well balanced, with patients being 52.5/52.1 years old, 71.9/78.1% being hormone receptor positive, 24.4/24.6% being HER2 positive and 38.6/38.8% having a tumor grade of 3 in the ST arm and DDT arm respectively. 53 events occurred after ST and 46 after DDT. Adjusted hazard ratio (HR) was 0.87 (95%CI: 0.57-1.35; p=0.54). 5 year DFS rates were 85% (ST) vs. 87% (DDT). Hematological toxicities were the most common grade 3 or 4 adverse events. Grade 3/4 neutropenia occurred in 57.2 vs. 28.0%, grade 3/4 anemia in 15.3% vs. 17.1% and grade 3 /4 pain symptoms were seen in 13.2 vs. 12.4% of the patients in the ST arm vs. DDT arm respectively. Other grade 3/4 toxicities were less frequent than 10%. Subgroup analysis showed a significant interaction (p<0.001) between HER2 status and randomization arm with regard to DFS. In HER2 negative patients the HR was 1.53 (95%CI: 0.91-2.59), whereas in HER2 positive patients the HR was 0.22 (95%CI: 0.09-0.55). Patients with HER2 positive disease and DDT had a similar prognosis like HER2 negative patients. Conclusion In the overall population a statistically significant improvement of DFS could not be shown for the DDT arm. In patients with HER2 positive breast cancer DDT chemotherapy improved the disease-free survival to a prognosis which was similar to patients with HER2 negative disease. Citation Format: Fasching PA, Eggemann H, Krocker J, Häberle L, Volz B, Kleine-Tebbe A, Blohmer J-U, Kittel K, Hufnagel M, Janni W, Emons G, Simon E, Köhler U, Thomssen C, Kohls A, Beckmann MW, Hielscher C, Krabisch P, Zeiser T, Brodkorb T, Baier F, Nabieva N, Kellner S, Untch M, Stadie S, Budner M, Breitbach G-P, Keller M, Stickeler E, Kühn T, Tolkmitt M, Belau AK, Schmidt M, Ulm K, Kümmel S. Final results of the ASG1-3 study, a randomized phase III study comparing a standard dose chemotherapy with epirubicin/cyclophosphamide and paclitaxel with a dose dense regimen with epirubicin and paclitaxel [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-13-01.
<b><i>Introduction:</i></b> Breast cancer can be a major challenge for those affected. Knowledge of changes in fine motor dexterity in affected women due to routine cancer therapies can help guide effective support. <b><i>Methods:</i></b> For this prospective observational study, we collected data of 79 women with a mean age 54.6 ± 9.5 years prior to, after breast cancer therapy (T1), and at 3-month follow-up. The fine motor dexterity was assessed for 4 treatment subgroups: SC = Surgery + Chemotherapy, SCR = Surgery + Chemotherapy + Radiotherapy Therapy, SR = Surgery + Radiotherapy, and S = Surgery. <b><i>Results:</i></b> Over time, women with breast cancer showed significant decreases in fine motor dexterity across all treatment groups (<i>p</i> < 0.001). The strongest negative effect was seen in the treatment groups receiving additional chemotherapy. SCR group showed pronounced limitations for dominant hand (DH) −12%; non-dominant hand (NDH) −15%; both hands (BH) −17%; assembly (ASSY) −11% at T1. Significant interaction was noticeable in DH (<i>F</i> = 5.59, <i>p</i> < 0.001), NDH (<i>F</i> = 6.61, <i>p</i> < 0.001), BH (<i>F</i> = 13.11 <i>p</i> < 0.001), and ASSY (<i>F</i> = 5.84 <i>p</i> < 0.001). <b><i>Discussion/Conclusion:</i></b> Our study showed that the extent of change in fine motor dexterity depends on the treatment regimen. The detection of unmet care needs could help to personalize and optimize clinical and survivorship care. Based on our findings, multidisciplinary support initiated early in breast cancer therapy is required.
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