scholarly journals Neo‐adjuvant Capecitabine Chemotherapy in Women with Newly Diagnosed Locally Advanced Breast Cancer in a Resource‐poor Setting (Nigeria): Efficacy and Safety in a Phase II Feasibility Study

2013 ◽  
Vol 19 (5) ◽  
pp. 470-477 ◽  
Author(s):  
Olukayode A. Arowolo ◽  
Uchenna O. Njiaju ◽  
Temidayo O. Ogundiran ◽  
Oyewale Abidoye ◽  
Olukayode O. Lawal ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Feasibility Study ◽  
Phase Ii ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Resource Poor Setting ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Resource Poor

Neoadjuvant capecitabine chemotherapy in women with newly diagnosed locally advanced breast cancer in a resource-poor setting (Nigeria): Efficacy and safety in a phase II feasibility study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11554-e11554
Author(s):  
Olukayode Adeolu Arowolo ◽  
Uchenna O Njiaju ◽  
Temidayo O Ogundiran ◽  
Olukayode O Lawal ◽  
Millicent Obajimi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Examination ◽  
Advanced Breast Cancer ◽  
Clinical Response ◽  
Phase Ii ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Complete Clinical Response ◽  
Resource Poor

e11554 Background: The majority of clinical trials of neoadjuvant therapy for breast cancer have been conducted in resource-rich countries. We chose Nigeria, a resource-poor country, as the major site for a phase II feasibility open label multicenter clinical trial designed to evaluate the efficacy, safety and tolerability of neoadjuvant capecitabine in locally advanced breast cancer. Methods: Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000mg/m2 twice daily (2000mg/m2 total per day). Each cycle consisted of a 14-day period of therapy followed by a 7-day pause, and patients were evaluated after 3 cycles and taken off study if no response was documented. Responding patients were treated for no more than 8 cycles. The primary endpoints were partial, complete clinical response and pathologic complete response. Results: A total of 16 patients were recruited from August 2007 to April 2010. The study was terminated early as a result of slow accrual. After the first 3 cycles of therapy, partial clinical responses were seen in 5 of 16 patients (31%; 95% CI 11% - 59%). Of the remaining 11 patients, 8 had no response or stable disease, and 3 had progressive disease. Seven pateints proceeded with further therapy, two of them with stable disease but exactly in the border line of 25% increase. By physical examination, only 2 of the 6 patients had a documented complete clinical response, while by ultrasonomammography, partial responses were observed in 5 patients. Thus, overall response rate at the end of 8 cycles were 31.1% both by clinical examination and by ultrasonomammography. Clinical response by physical examination and radiologic response by ultrasonomammography were highly concordant (the spearman correlation between the two ratios was 0.70). The most common adverse effect was Grade 1 Hand and Foot Syndrome in 75% of patients. Conclusions: Despite several limitations, we successfully carried out this phase II feasibility study of neoadjuvant capecitabine for locally advanced breast cancer in Nigeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted.

scholarly journals A Phase II Study of Sequential Treatment with Anthracycline and Taxane Followed by Eribulin in Patients with HER2-negative, Locally Advanced Breast Cancer (JBCRG-17)

2021 ◽  
Author(s):  
Ippei Fukada ◽  
Yoshinori Ito ◽  
Naoto Kondo ◽  
Shoichiro Ohtani ◽  
Masaya Hattori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Clinical Response ◽  
Phase Ii ◽  
Response Rate ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Advanced Breast ◽  
Clinical Response Rate ◽  
Sequential Administration

Abstract PurposeThe sequence of taxanes (T) followed by anthracyclines (A) as neoadjuvant chemotherapy (NAC) has been the standard of care for almost 20 years for locally advanced breast cancer (LABC). Sequential administration of eribulin (E) following A/T could provide a greater response rate for women with LABC.MethodsIn this single-arm, multicenter, Phase II prospective study, the patients received 4 cycles of the FEC regimen and 4 cycles of taxane. After the A/T-regimen, 4 cycles of E were administered followed by surgical resection. The primary endpoint was the clinical response rate. Eligible patients were women aged 20 years or older, with histologically confirmed invasive breast cancer, clinical Stage IIIA (T2-3 and N2 only), Stage IIIB, and Stage IIIC, HER2-negative.ResultsA preplanned interim analysis aimed to validate the trial assumptions was conducted after treatment of 20 patients and demonstrated that clinical progressive disease (cPD) rates in the E phase were significantly higher (30%) than assumed. Therefore, the Independent Data Monitoring Committee recommended stopping the study. Finally, 53 patients were enrolled, and 26 patients received the A/T/E-regimen. The overall observed clinical response rate (RR) was 73% (19/26); RRs were 77% (20/26) in the AT phase and 23% (6/26) in the E phase. Thirty percent (8/26) of patients had PD in the E phase, 6 of whom had achieved cCR/PR in the AT phase. Reported grade >3 AEs related to E were neutropenia (42%), white blood cell count decrease (27%), febrile neutropenia (7.6%), weight gain (3.8%), and weight loss (3.8%)ConclusionSequential administration of eribulin after the A/T-regimen provided no additional effect for LABC patients. Future research should continue to focus on identifying specific molecular biomarkers that can improve response rates.

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