First-Line Treatment of Advanced Breast Cancer With Sunitinib in Combination With Docetaxel Versus Docetaxel Alone: Results of a Prospective, Randomized Phase III Study

2012 ◽  
Vol 30 (9) ◽  
pp. 921-929 ◽  
Author(s):  
Jonas Bergh ◽  
Igor M. Bondarenko ◽  
Mikhail R. Lichinitser ◽  
Annelie Liljegren ◽  
Richard Greil ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Therapy ◽  
Advanced Breast Cancer ◽  
Objective Response ◽  
Advanced Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Study ◽  
First Line Treatment

Purpose To investigate whether sunitinib plus docetaxel improves clinical outcomes for patients with human epidermal growth factor receptor 2 (HER2)/neu–negative advanced breast cancer (ABC) versus docetaxel alone. Patients and Methods In this phase III study, patients were randomly assigned to open-label combination therapy (sunitinib 37.5 mg/d, days 2 to 15 every 3 weeks; and docetaxel 75 mg/m2, day 1 every 3 weeks) or monotherapy (docetaxel 100 mg/m2 every 3 weeks). Progression-free survival (PFS) was the primary end point. Results Two hundred ninety-six patients were randomly assigned to combination therapy, and 297 patients were assigned to monotherapy. Median PFS times were 8.6 and 8.3 months with combination therapy and monotherapy, respectively (hazard ratio, 0.92; one-sided P = .265). The objective response rate (ORR) was significantly higher with the combination (55%) than with monotherapy (42%; one-sided P = .001). Duration of response was similar in both arms (7.5 months with the combination v 7.2 months with monotherapy). Median overall survival (OS) times were 24.8 and 25.5 months with combination therapy and monotherapy, respectively (one-sided P = .904). There were 107 deaths with the combination and 91 deaths with monotherapy. The frequency of common adverse events (AEs) was higher with the combination, as were treatment discontinuations caused by AEs. Conclusion The combination of sunitinib plus docetaxel improved ORR but did not prolong either PFS or OS compared with docetaxel alone when given to an unselected HER2/neu-negative cohort as first-line treatment for ABC. Sunitinib combination therapy may also have resulted in AEs that yield an unfavorable risk-benefit ratio. The sunitinib-docetaxel regimen evaluated in this study is not recommended for further use in ABC.

scholarly journals RANDOMIZED PHASE III TRIAL COMPARING EPIRUBICIN/ DOXORUBICIN PLUS DOCETAXEL AND EPIRUBICIN/ DOXORUBICIN PLUS PACLITAXEL AS FIRST LINE TREATMENT IN WOMEN WITH ADVANCED BREAST CANCER

2021 ◽  
Vol 5 (2) ◽  
Author(s):  
Seema Devi ◽  
Yogesh Kumar Sharma ◽  
Dilip Shah
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Intravenous Infusion ◽  
Advanced Breast ◽  
Phase Iii ◽  
Severe Toxicity ◽  
Line Treatment ◽  
Women Patients ◽  
First Line ◽  
First Line Treatment

Background: The purpose of this study was to compare Epirubicin/ doxorubicin plus docetaxel and Epirubicin/ doxorubicin plus paclitaxel as first line treatment in women with advanced breast cancer. Patients and methods: previously untreated patients with advanced breast cancer randomly assigned to recieve Epirubicin 75mg/m2 and docetaxel 75 mg/m2 (ED) 1-hour intravenous (IV) infusion every 21 days, Epirubicin 75 mg/m2 and paclitaxel 175 mg/m2 (EP) 3-hour IV infusion every 21 days, Intravenous bolus injections of doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 (DD) administered as a 1-hour intravenous infusion every 21 days and doxorubicin 50 mg/m2 and paclitaxel 175 mg/m2 (DP) administered as a 1-hour intravenous infusion every 21 days. Previous anthracycline-based neo-adjuvant chemotherapy was allowed if completed ? 1 year before entering the study. Results: Ten women patients were treated on arm ED &EP and median TTP was 10 versus 11 months, 50 women patients were trated on DD & DP cand median TTP was  8.5 versus 9 months respectively. Severe toxicity include grade 3-4 leukopenia (4% versus 2%), neutropenia (20% versus 22%) , anemia (38% versus 34%), thrombocytopenia (18% versus 24%), neurotoxicity (2% versus 6%) with DD and DP, respectively. Conclusion: The DD and DP regimens have similar efficacy but different toxicity. Either regimen can be used as front- line treatment of ABC. But in case of ED and EP regimen was difficult to compare the result due to very small sample size. Keywords: Epirubicin, doxorubicin, docetaxel, paclitaxel, advanced breast cancer, chemotherapy, neurotoxicity.

Phase III Trial Evaluating the Addition of Bevacizumab to Endocrine Therapy As First-Line Treatment for Advanced Breast Cancer: The Letrozole/Fulvestrant and Avastin (LEA) Study

2015 ◽  
Vol 33 (9) ◽  
pp. 1045-1052 ◽  
Author(s):  
Miguel Martín ◽  
Sibylle Loibl ◽  
Gunter von Minckwitz ◽  
Serafín Morales ◽  
Noelia Martinez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Growth Factor ◽  
Advanced Breast Cancer ◽  
Hormone Receptor ◽  
Advanced Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Hormone Receptor Positive ◽  
First Line Treatment

Purpose To test whether combining bevacizumab, an anti–vascular endothelial growth factor treatment, with endocrine therapy (ET) could potentially delay the emergence of resistance to ET. Patients and Methods A multicenter, randomized, open-label, phase III, binational (Spain and Germany) study added bevacizumab (15 mg/kg every 3 weeks) to ET (ET-B; letrozole or fulvestrant) as first-line therapy in postmenopausal patients with human epidermal growth factor receptor 2 (HER2) –negative and hormone receptor–positive advanced breast cancer. We compared progression-free survival (PFS), overall survival (OS), overall response rate (ORR), response duration (RD), time to treatment failure (TTF), clinical benefit rate (CBR), and safety. Results From 380 patients recruited (2007 to 2011), 374 were analyzed by intent to-treat (184 patients on ET and 190 patients on ET-B). Median age was 65 years, 270 patients (72%) had Eastern Cooperative Oncology Group performance status of 0, 178 patients (48%) had visceral metastases, and 171 patients (46%) and 195 patients (52%) had received prior chemotherapy or ET, respectively. Median PFS was 14.4 months in the ET arm and 19.3 months in the ET-B arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.06; P = .126). ORR, CBR, and RD with ET versus ET-B were 22% versus 41% (P < .001), 67% versus 77% (P = .041), and 13.3 months versus 17.6 months (P = .434), respectively. TTF and OS were comparable in both arms. Grade 3 to 4 hypertension, aminotransferase elevation, and proteinuria were significantly higher in the ET-B arm. Eight patients (4.2%) receiving ET-B died during study or within 30 days of end of treatment. Conclusion The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS in women with HER2-negative/hormone receptor–positive advanced breast cancer.

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