A Phase II Study of Neoadjuvant Gemcitabine Plus Doxorubicin in Stage IIIB Breast Cancer: A Preliminary Report

A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling

“…Patients who received Gem d1, d8 and Dox d2 during cycle 1 showed higher rates of toxicity during cycle 1 (Supplementary Table 1), with febrile neutropenia, neutropenia with infection, and vomiting being the most prevalent toxicities. Toxicity profiles for the other two cohorts were more manageable (Table 3), and the incidence and types of adverse events were similar to those in previous phase II studies of gemcitabine plus doxorubicin in patients with breast cancer (Pérez-Manga et al, 2000;Gomez et al, 2001;El Serafy et al, 2003;Bensalem and Bouzid, 2006).…”

“…The details of each case were evaluated thoroughly, and we were unable to identify unifying characteristics that indicated why these individuals were more vulnerable to the serious side effects of chemotherapy. Notably, while the standard Gem þ Dox dose schedule produced a toxicity profile that was similar to previous studies with Gem þ Dox, the toxic death rate was higher than that in previous trials (Pérez-Manga et al, 2000;Gomez et al, 2001;El Serafy et al, 2003;Bensalem and Bouzid, 2006). These events highlight the need for appropriate patient education, careful screening, and the use of additional supportive services in developing countries like India, especially in areas where healthcare access may be limited.…”

“…Although several different dosing regimens of Gem þ Dox were applied in previous studies, they were all similar in that gemcitabine and doxorubicin were both given on day 1 and, in some cases, were given together again on day 8 (Pérez-Manga et al, 2000; Gomez et al, 2001;El Serafy et al, 2003;Bensalem and Bouzid, 2006). In these previous studies, haematologic toxicities were the most common, but alopecia and mucositis were also prevalent.…”

“…Gemcitabine has demonstrated singleagent activity in breast cancer (Heinemann, 2003), and is indicated as first-line therapy in combination with paclitaxel for patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (Albain et al, 2004). In the neoadjuvant setting, gemcitabine has been combined with anthracyclines and/or taxanes in several phase II studies of locally advanced breast cancer, with clinical response rates and pCR rates ranging from 71 -95% and 3 -26%, respectively (Gomez et al, 2001;Silva et al, 2002;Schneeweiss et al, 2004).…”

“…Given the tumour shrinking capability of the combination of gemcitabine and doxorubicin (Gem þ Dox) (Pérez-Manga et al, 2000;Gomez et al, 2001), we hypothesised that additional cycles of combination chemotherapy may improve pCR rates. In this phase II study, we evaluated two combination regimens administered sequentially as neoadjuvant chemotherapy in Indian women with operable breast cancer: four cycles of Gem þ Dox followed by four cycles of Gem þ Cis.…”