Background: The 5-year analysis of adjuvant chemotherapy with intense dose-dense (IDD) ETC had shown a significant improved DFS (HR 0.72; p < 0.001) and OS (HR 0.76; p = 0.29) in comparison with conventional dosed chemotherapy (J Clin Oncol 28: 2874–2880, 2010). In contrast to other dose-dense trials the ETC regimen is dose-dense and dose-intensified. Long-term results are essential to evaluate the impact of dose-dense chemotherapy in the adjuvant treatment of breast cancer patients (pts). We now report the final analysis of DFS, OS, and long-term safety including the application of epoetin alfa after 10 years of follow-up. Patients and Methods: A multi-center phase-III trial of the German AGO Breast Study Group recruited 1284 pts from 12/98 until 4/03. Pts below 65 years of age were eligible if at least 4 axillary lymph nodes were infiltrated. In the experimental arm, pts were assigned to receive three courses each of epirubicin (150 mg/m2), paclitaxel (225 mg/m2) and cyclophosphamide (2500 mg/m2) at 2-week intervals (q2w) (ETC) with G-CSF support (5µg/kg/SC day 3–10). In the standard arm 4 courses of conventional dosed epirubicin/cyclophosphamide (90/600 mg/m2) followed by 4 courses of paclitaxel (175 mg/m2) were given (EC→T). All cycles were administered in 3-week intervals without growth factor support. A second randomization ± epoetin alfa was performed in the IDD-ETC arm only (150IU/kg/sc three times weekly) to reduce the number of red blood cells (RBC's) transfusion and to evaluate the impact of epoetin alfa on DFS and OS in the adjuvant setting. Results: 58% and 42% of the pts presented with 4–9 and ≥ 10 positive nodes with a median number of 8 involved nodes. The median age was 51 years and median follow-up was 122 months. We observed 604 DFS events (282 with IDD ETC; 322 with EC→T) (p = 0.00014, one-sided; HR 0.74; 95% CI, 0.63 to 0.87). IDD ETC improved DFS irrespective of nodal status, HER2 and ER status. 446 pts. have died (201 events in the IDD ETC arm vs. 245 events in the standard arm). 10 year OS rates were 69% with IDD ETC and 59% with EC→ T (p = 0.0007; two-sided; HR, 0.72; 95% CI, 0.60–0.87). Nine cases of acute myeloid leukemia or myelodysplastic syndrome occurred in the IDD ETC arm vs. two cases in the standard arm. 28% of pts in the IDD ETC arm vs. 13% in the IDD ETC arm plus epoetin alfa (p < 0.0001) received RBC's transfusions. There was no difference between the IDD ETC arm alone and the IDD ETC + epoetin alfa arm regarding 10-year DFS and OS ((57% vs. 55% (p = 0.69) and 70% vs. 68% (p = 0.45)). Conclusion: Intense dose-dense ETC remains significantly superior compared to standard chemotherapy after 10 years of follow-up. The risk of secondary leukemia/MDS in the IDD ETC arm (1.3% of pts) is comparable to that of the Cancadian CEF regimen. The prevention of RBC's transfusions and anemia by the application of epoetin alfa in the IDD ETC-arm had no impact on DFS and OS. IDD ETC is a highly effective and safe regimen in the adjuvant treatment of high-risk breast cancer pts. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S3-4.
premenopausal and postmenopausal, 66. 7% and 33.3% had MRM and BCS, respectively. Stage II and III represented 73.3% and 33.3%, respectively. In the post chemotherapy evaluation there was a statistically significant difference between hypothermic and control arms as regards ulnar and superficial radial SNAP amplitude, ulnar CMAP amplitude and ulnar motor DL (p value 0.005, 0.043, 0.001, and 0.008, respectively) but no difference regarding SCV in ulnar and radial nerves. In contrast, the pre chemotherapy evaluation showed no statistically significant difference between both arms in any of the studied parameters.Conclusions: Limb hypothermia had a potential protective effect against paclitaxel induced peripheral neuropathy in both sensory and motor fibers, indicating that it could be a promising solution in decreasing CIPN.
Introduction: In recent years, patient reported outcomes have become increasingly a focus in clinical investigations. Health related quality of life (HRQoL) is now regularly evaluated in clinical trials, yet data on HRQoL in postmenopausal women receiving adjuvant aromatase inhibitor treatment for early breast cancer (EBC) is limited. Here, we present the 12 months results on HRQoL and patient satisfaction from PACT, a program which aims to increase awareness, motivation and adherence to adjuvant anastrozole therapy in routine clinical practice by adding regular standardized information (brochures and motivational letters) to standard clinical care. Methods: PACT is a prospective, randomised, two-arm parallel-group study with 60 months follow-up (NCT00555867, sponsored by AstraZeneca Germany). Postmenopausal women on anastrozole for hormone-receptor positive (HR+) EBC were randomized to routine clinical care alone or additional regular standardized information (educational arm) for the first year of adjuvant endocrine therapy. Primary endpoint was the compliance rate in the educational vs. routine arm after 12 months. Secondary endpoints include HRQoL and patient satisfaction, evaluated via EORTC IN-PATSAT32, QLQ-C30, and QLQ-BR23. The present analysis focuses on differences in HRQoL and patient satisfaction between the standard and educational arm and between compliant and non-compliant patients at 12 months after treatment initiation. Results: 4,923 patients were enrolled into PACT by Nov. 2008. Of these, 2,707 were evaluable for analysis of the primary endpoint compliance and the secondary endpoints patient satisfaction and HRQoL. Analysis of HRQoL and patient satisfaction scores showed no differences between the standard and the educational arm at 12 months. When comparing compliant vs. non-compliant patients, however, compliant patients reached significantly higher (=better) patient satisfaction scores in all domains. In addition, compliant patients achieved significantly higher (=better) scores in the HRQoL domains of physical functioning (p=0.04), emotional functioning (p=0.018), cognitive functioning (p=0.004), social functioning (p=0.005), and sexual enjoyment (p=0.047), as well as lower (=better) scores in the domains of fatigue (p=0.01), systemic therapy (p=0.003), and arm symptoms (p=0.03). After correction for multiple testing, statistically significant differences favouring compliant patients were retained in the areas of information provision and availability (p=0.0008 and p=0.0005, respectively). Conclusion: In postmenopausal patients with HR+ EBC assigned to adjuvant endocrine treatment with an aromatase inhibitor (anastrozole), HRQoL and patient satisfaction were not affected by the intervention. However, analysis of compliant vs. non-compliant patients revealed improved scores for patient satisfaction in multivariate analysis favouring compliant patients at 12 months after treatment initiation. PACT represents an important project in health outcomes research regarding adjuvant endocrine therapy in postmenopausal patients with HR+ EBC. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-11-12.
Introduction: According to recent retrospective studies, compliance to adjuvant endocrine therapy for early breast cancer (EBC) may drop to below 70% after one year and to as low as 50% by year 4. PACT aimed to increase treatment adherence in postmenopausal women taking an adjuvant aromatase inhibitor via a standardized information service (educational arm). Yet, after 12 months, there was no difference in compliance between the standard and educational arm (reported at this meeting 2010). Methods: PACT is a prospective, randomised, two-arm parallel-group study in Germany, sponsored by AstraZeneca (NCT00555867). Postmenopausal women on anastrozole for hormone-receptor positive (HR+) EBC were randomized to routine clinical care alone or to receive additional standardized information (educational arm) at nine times over the first 12 months of adjuvant therapy. Primary endpoints were compliance and persistence rates in the educational versus routine arm after 12 months. Secondary endpoints included longer follow-up, reasons for non-compliance, influence of baseline characteristics, and clinical outcome parameters (DSF, OS). Compliance was evaluated via patient questionnaires, prescription data and physician recall. Per protocol compliance was analysed only for patients with full documentation both by patients and physicians. Persistence was defined as the duration of time from initiation to discontinuation of therapy (Cramer et al 2007) and measured by prescription data. Results: PACT enrolled 4,923 female patients at 109 breast centres and 1,361 registered specialist practices from all regions in Germany. 4,397 patients were evaluable for baseline characteristics. 2,707 patients were evaluable for the primary endpoint (full documentation on tablet intake both by patients and physicians). No difference in compliance could be shown between the standard (88.2%) and the educational arm (88.3%) at 12 months (p=0.92, Fisher's exact test). Persistence rates were 40.3% for the standard arm and 43.0% for the educational arm, respectively (p=0.17, Fisher's exact test). At 24 months, data from 1539 patients was available for analysis compliance per protocol. Compliance rates were 88.7% (educational arm) and 87% (standard arm; p=0.29). Persistence again much lower at 41.1% and 42.1% (p=0.68). Variables influencing compliance were regular attendance to follow-up visits, participation in a cancer rehabilitation program, number of co-morbidities and current employment status. Persistence was influenced by factors such as tumour stage, joint pain and cancer rehab program participation. Conclusion: The addition of standardized information materials to standard clinical care did not lead to a significant increase in compliance or persistence rates at 12 or 24 months. With 4,923 women included, the PACT study represents the largest prospective study to evaluate the influence of educational material as well as baseline demographic and histopathological characteristics on the compliance and persistence to adjuvant endocrine therapy in postmenopausal patients with HR+ EBC. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-17-05.
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