scholarly journals Weekly Paclitaxel plus Capecitabine versus Docetaxel Every 3 Weeks plus Capecitabine in Metastatic Breast Cancer

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
E. A. Wist ◽  
I. Mjaaland ◽  
E. Løkkevik ◽  
H. H. Sommer
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Weekly Paclitaxel ◽  
Weekly Docetaxel ◽  
Randomized Phase Ii ◽  
Grade Ii ◽  
High Level

Background. We performed a randomized phase II study comparing efficacy and toxicity of weekly paclitaxel 80 mg/m2(Weetax) with three weekly docetaxel 75 mg/m2(Threetax), both in combination with oral capecitabine 1000 mg/m2twice daily for 2 weeks followed by a 1-week break.Patients. Thirty-seven women with confirmed metastatic breast cancer were randomized.Results. Median TTF was 174 (Weetax) versus 147 days (Threetax) (). Median OS was 933 (Weetax) versus 464 days (Threetax) (). Reasons for TTF were PD 8/18 (Weetax), 9/19 (Threetax); and toxicity: 8/18 (Weetax), 8/19 (Threetax). ORR was 72% (Weetax) versus 26% (Threetax) (). The Threetax-combination resulted in a higher incidence of leuco-/neutropenia compared to Weetax. Grade II anemia was more pronounced in the Weetax group. No difference was found in quality of life.Conclusion. Taxanes in combination with capecitabine resulted in a high level of toxicity. Taxanes and capecitabine should be considered given sequentially and not in combination.

scholarly journals Quality of Life in a Randomized Phase II Study to Determine the Optimal Dose of 3-Week Cycle Nab-Paclitaxel in Patients with Metastatic Breast Cancer

2021 ◽  
Author(s):  
Naruto Taira ◽  
Kosuke Kashiwabara ◽  
Junji Tsurutani ◽  
Masahiro Kitada ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Optimal Dose ◽  
Randomized Phase Ii ◽  
The Difference

Abstract Purpose: To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).Materials and Methods: Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD: 260 mg/m2 vs. MD: 220 mg/m2 vs. LD: 180 mg/m2). QoL was assessed at baseline and during the 2nd, 4th and 6th courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated-measures (MMRM).Results: A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD p<0.001, LD vs. SD p<0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (p=0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD p=0.011, LD vs. SD p<0.001). Conclusion: QoL of patients treated with 220 or 180 mg/m2 of q3w nab-PTX was significantly better than that of patients treated with 260mg/m2.

scholarly journals Quality of life in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer

2021 ◽  
Author(s):  
Naruto Taira ◽  
Kosuke Kashiwabara ◽  
Junji Tsurutani ◽  
Masahiro Kitada ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Optimal Dose ◽  
Randomized Phase Ii ◽  
The Difference

Abstract Background To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC). Methods Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD: 260 mg/m2 vs. MD: 220 mg/m2 vs. LD: 180 mg/m2). QoL was assessed at baseline and during the 2nd, 4th and 6th courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated-measures (MMRM). Results A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD P < 0.001, LD vs. SD P < 0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (P = 0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD P = 0.011, LD vs. SD P < 0.001). Conclusion QoL of patients treated with 220 or 180 mg/m2 of q3w nab-PTX was significantly better than that of patients treated with 260mg/m2. Trial registration: The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN000015516), on 01/11/2014. Details are available at the following address:

scholarly journals A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer

2004 ◽  
Vol 15 (9) ◽  
pp. 1358-1365 ◽  
Author(s):  
J. Tabernero ◽  
M.A. Climent ◽  
A. Lluch ◽  
J. Albanell ◽  
J.B. Vermorken ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Weekly Docetaxel

scholarly journals Gastrointestinal adverse effects of cyclin-dependent kinase 4 and 6 inhibitors in breast cancer patients: a systematic review and meta-analysis

2017 ◽  
Vol 8 (11) ◽  
pp. 337-347 ◽  
Author(s):  
Kyrillus S. Shohdy ◽  
Shaimaa Lasheen ◽  
Loay Kassem ◽  
Omar Abdel-Rahman
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Safety Profile ◽  
Meta Analysis ◽  
Metastatic Breast ◽  
High Grade ◽  
Cyclin Dependent Kinase ◽  
Breast Cancer Patients ◽  
Randomized Phase Ii

Background: Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors show promising results in metastatic breast cancer. However, an increased incidence of adverse events is remarkable. Among others, gastrointestinal (GI) involvement is of momentous impact on patients and their quality of life. Methods: Our search included PubMed, ASCO, ESMO and SABCS databases. Randomized phase II/III trials in metastatic breast cancer receiving CDK4/6 inhibitors were identified and considered relevant based on providing a sufficient safety profile on the incidence of adverse GI effects. Results: Of the 999 records initially screened for relevance, 33 articles were found relevant and 4 studies were finally eligible for meta-analysis with a total of 2007 patients. The relative risk (RR) for all-grade nausea was 1.48 [95% confidence interval (CI): 1.12–1.93, p = 0.005], vomiting was 1.74 (95% CI: 1.09–2.76, p = 0.02), decreased appetite was 1.42 (95% CI: 1.07–1.88, p = 0.02), and for diarrhea it was 1.44 (95% CI: 1.19–1.74, p = 0.0002). Meanwhile, the RR for high-grade nausea was 1.10 (95% CI: 0.29–4.13, p = 0.89), vomiting was 1.38 (95% CI: 0.25–7.75, p = 0.72), decreased appetite was 4.00 (95% CI: 0.87–18.37, p = 0.07), and high-grade diarrhea was 1.19 (95% CI: 0.44–3.21, p = 0.73). Conclusion: Selective CDK4/6 inhibitors were not associated with higher-grade GI toxicities reflecting a well-tolerated safety profile. Regarding the increase in all-grade GI toxicities, it needs further caution with addition of cytotoxic chemotherapy.

Sign in / Sign up

Export Citation Format

Share Document