Adjuvant Capecitabine, Docetaxel, Cyclophosphamide, and Epirubicin for Early Breast Cancer: Final Analysis of the Randomized FinXX Trial

Joensuu, Heikki; Kellokumpu‐Lehtinen, Pirkko‐Liisa; Huovinen, Riikka; Jukkola-Vuorinen, Arja; Tanner, Minna; Kokko, R.; Ahlgren, Johan; Auvinen, Päivi; Paija, Outi; Helle, Leena; Villman, Kenneth; Nyandoto, Paul; Nilsson, Greger; Pajunen, Marjo; Asola, R.; Poikonen, Paula; Leinonen, Mika; Kataja, Vesa; Bono, Petri; Lindman, Henrik

doi:10.1200/jco.2011.35.4639

Cited by 118 publications

(131 citation statements)

References 19 publications

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“…[1][2][3] However, dose and schedule alterations have produced improvements in outcome, 4,5 indicating that optimizing use of available agents is an effective strategy that should not be abandoned as we search for new approaches. S0221 (Phase III Trial of Continuous Schedule AC ϩ G Versus Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer) is a clinical trial investigating adjuvant chemotherapy performed by the North American Breast Intergroup.…”

Section: Introductionmentioning

confidence: 99%

SWOG S0221: A Phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer

Budd

Barlow

Moore

et al. 2015

JCO

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Purpose To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer. Patients and Methods A 2 × 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided α = .05. Overall survival (OS) was a secondary outcome. Results Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens. After a median follow-up of 6 years, a significant interaction developed between the two randomization factors (DFS P = .024; OS P = .010) in the 2,716 patients randomly assigned in the original design, which precluded interpretation of the two factors separately. Comparing all four arms showed a significant difference in OS (P = .040) but not in DFS (P = .11), with all treatments given once every 2 weeks associated with the highest OS. This difference in OS seemed confined to patients with hormone receptor–negative/human epidermal growth factor receptor 2 (HER2) –negative tumors (P = .067), with no differences seen with hormone receptor–positive/HER2-negative (P = .90) or HER2-positive tumors (P = .40). Conclusion Patients achieved a similar DFS with any of these regimens. Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor–negative/HER2-negative tumors.

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Section: Introductionmentioning

confidence: 99%

SWOG S0221: A Phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer

Budd

Barlow

Moore

et al. 2015

JCO

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“…24 In addition, another Finnish adjuvant trial had the dose of docetaxel decreased from 100 mg m À2 to 80 mg m À2 owing to a high rate of neutropenic infections. 25 Thus far, (after 331 patients) no treatment-related deaths have occurred in the SPCG-13 trial, and most of the patients included in this safety analysis have completed all six cycles of chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…20--23 In addition, docetaxel has shown a significant survival benefit in two large studies in patients with early node-positive breast cancer. 24,25 As docetaxel has proven to be effective in late stages of PC with a large tumor burden, it may be effective in treating intermediateand high-risk PC as an adjuvant treatment after radiotherapy to prevent relapses. Therefore, we conducted a randomized phase III trial in which patients will be randomized either to docetaxel or surveillance.…”

Section: Introductionmentioning

confidence: 99%

Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial

Kellokumpu-Lehtinen

Hjälm-Eriksson

Thellenberg‐Karlsson

et al. 2012

Prostate Cancer Prostatic Dis

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and for the SPCG-13 BACKGROUND: Radical radiotherapy (RT) combined with androgen deprivation therapy is currently the standard treatment for elderly patients with localized intermediate-or high-risk prostate cancer (PC). To increase the recurrence-free and overall survival, we conducted an adjuvant, randomized trial using docetaxel (T) in PC patients (Scandinavian Prostate Cancer Group trial 13). METHODS:The inclusion criteria are the following: men 418 and p75 years of age, WHO/ECOG performance status 0--1, histologically proven PC within 12 months before randomization and one of the following: T2, Gleason 7 (4 þ 3), PSA 410; T2, Gleason 8--10, any PSA; or any T3 tumors. Neoadjuvant/adjuvant hormone therapy is mandatory for all patients. The patients were randomized to receive six cycles of T (75 mg m À2 d 1. cycle 21 d) or no docetaxel after radical RT (with a minimum tumor dose of 74 Gy). This study identifier number is NTC 006653848 (http://www.clinicaltrials.org). RESULTS: In this preplanned safety analysis of 100 patients, T treatment induced grade (G) 3 adverse events (AEs) in 15 patients (30%) and G4 AEs in 30 patients (60%), mainly due to bone marrow toxicity. Neutropenia G3--4 was observed in 72% of the patients, febrile neutropenia was found in 24% of patients, neutropenic infection in 10% of patients and G3 infection without neutropenia in 4% of patients. Nonhematological G3 AEs were rare: anorexia, diarrhea, mucositis, nausea, pain (1 patient each) and fatigue (5). Other severe serious AEs related to T were pulmonary embolism and renal failure. However, only three patients discontinued T before completing the planned six cycles. No deaths had occurred. No patients in the control arm experienced G3--4 toxicities at 12 weeks after the randomization. CONCLUSIONS: Adjuvant docetaxel chemotherapy after radiotherapy has a higher frequency of neutropenia than previous studies on patients with metastatic disease. Otherwise, the treatment was quite well tolerated.

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“…A meta-analysis by Jiang et al demonstrated that disease-free survival significantly improved following addition of capecitabine to an anthracycline-taxane-based adjuvant chemotherapy in patients with high-risk early breast cancer (19). The final results of the FinXX trial indicated that the addition of capecitabine significantly improved breast cancer-specific survival, although not the recurrence-free survival, in early breast cancer (20). A small retrospective study involving elderly patients with stage IIa breast cancer by Hu et al reported that the patients who underwent adjuvant capecitabine monotherapy had a similar overall survival compared with those who received traditional cyclophosphamide/epirubicin/5-fluorouracil (CAF regimen) chemotherapy, but fewer adverse reactions (21).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the clinical benefits of adjuvant capecitabine monotherapy in elderly women with breast cancer: A retrospective study

2017

Molecular and Clinical Oncology

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Abstract.Capecitabine is orally administered and may be safely and conveniently used in patients with cancer. The antitumor activity of capecitabine in breast cancer was mostly demonstrated in the salvage therapy setting, whereas the effect of adjuvant capecitabine monotherapy in breast cancer remains unclear. The aim of the present study was to evaluate adjuvant capecitabine monotherapy in elderly women with breast cancer. A total of 251 patients were enrolled and survival was compared between elderly breast cancer patients who received adjuvant capecitabine monotherapy and those who received no chemotherapy. Cancer-specific and disease-free survival curves were compared using log-rank tests and survival curves were calculated using the Kaplan-Meier method. Multivariate analyses were conducted using Cox's proportional hazard regression model. There was no significant difference between the clinicopathological characteristics, including age, tumor size, lymph node status, histological grade and hormone status, between patients in the two groups. The breast cancer-specific survival rate was 89.3% in the capecitabine monotherapy group vs. 81.3% in the no chemotherapy group; the difference was not statistically significant (P= 0.128). The disease-free survival rate was 81.7% in the capecitabine monotherapy group vs. 65.3% in the no chemotherapy group. Kaplan-Meier analysis indicated a longer disease-free survival in the capecitabine monotherapy group (P= 0.015). On Cox regression analysis, capecitabine monotherapy was found to be associated with the disease-free survival rate (P= 0.014, hazard ratio= 0.500) but not with the cancer-specific survival rate (P= 0.181). The adverse events of capecitabine monotherapy were recorded and there was no chemotherapy interruption due to severe adverse reactions. Therefore, adjuvant capecitabine monotherapy in elderly women with breast cancer is a safe and effective option, as well as a viable alternative for elderly breast cancer patients who refuse standard adjuvant therapy.

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Adjuvant Capecitabine, Docetaxel, Cyclophosphamide, and Epirubicin for Early Breast Cancer: Final Analysis of the Randomized FinXX Trial

Abstract: Integration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine.

Cited by 118 publications

References 19 publications

SWOG S0221: A Phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer

SWOG S0221: A Phase III Trial Comparing Chemotherapy Schedules in High-Risk Early-Stage Breast Cancer

Toxicity in patients receiving adjuvant docetaxel + hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer: a preplanned safety report of the SPCG-13 trial

Evaluation of the clinical benefits of adjuvant capecitabine monotherapy in elderly women with breast cancer: A retrospective study

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