Biweekly docetaxel and gemcitabine as neoadjuvant chemotherapy followed by adjuvant doxorubicin and cyclophosphamide therapy in stage II and III breast cancer patients: results of a phase II study

Estévez, Laura G.; Sánchez‐Rovira, Pedro; Dómine, Manuel; León, Ana; Calvo, Isabel; Jaén, A.; Casado, Victoria; Rubio, Gustavo; Díaz, M.; Miró, Cristina Martínez; Lobo, Francisco; Carrasco, Eva; Casillas, M.; Antonio, Belén San

doi:10.1007/s12094-007-0059-7

Cited by 5 publications

(5 citation statements)

References 34 publications

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“…This type of complication had been reported with gemcitabine combinations for neoadjuvant treatment in significantly variable rates (10 to 54%), making some authors to advocate for the use of granulocyte stimulating factor during the AG phase, while others do not [9, 13-15, 18, 19] .In our study, the use of weekly paclitaxel seemed not to have potentiated the neutropenic effect, which was more related to the AG combination, as observed in other studies [14,24,25] . Mucositis was much more frequent in our study than reported in other gemcitabine-combination strategies.…”

supporting

confidence: 78%

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Petrarca

Calleari

Morelle

et al. 2012

JST

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Background: Neoadjuvant chemotherapy is a therapeutic strategy for patients with locally advanced breast cancer. To evaluate the toxicity and clinical efficacy of the combination of Gemcitabine plus doxorubicin followed by paclitaxel in neoadjuvancy. Methods:A phase II trial, in which 19 patients, ages 37 to 65, with pathologically proven breast cancer, were included. They received four cycles of doxorubicin 50mg/m 2 on day 1 and Gemcitabine 1000 mg/m 2 on days 1 and 8, every 21 days;followed by four cycles of paclitaxel 80 mg/m 2 on days 1, 8, and 15, every 28 days. The follow-up was performed with mammography and clinical examination. Results:The planned regimen was completed in 17 (89.4%) of the 19 patients. Thirty seven percent of the patients presented mucositis grades 3-4 and 15% had diarrhea grades 3-4. Hematologic toxicities grades 3-4 were seen in 31.5% of the cases (6 patients). Complete clinical response was observed in 9 (47%) patients; of whom four showed complete pathological response after surgery. Conclusion:The response rate (clinical and pathological) in this study was similar to the one observed in the usual regimen of neoadjuvancy using doxorubicin, cyclophosphamide, and paclitaxel. However, the toxicity profile of the combination regimen containing gemcitabine was exceedingly high, causing the interruption of the protocol.

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supporting

confidence: 78%

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Petrarca

Calleari

Morelle

et al. 2012

JST

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“…Furthermore, the combination therapy was advantageous for large or locally advanced breast cancer with respect to breast conservation (76.5%). These results are consistent with the results of a previous neoadjuvant study on patients with stage II–III breast cancer [ 13 16 ].…”

Section: Discussionsupporting

confidence: 92%

“…Although few reports have assessed the efficacy and safety of the combination of docetaxel and gemcitabine as NAC [ 13 14 ], an overall RR of 71.4% (95% CI, 53.7–85.4), with eight complete and 17 partial responses, was found in a previous neoadjuvant study that enrolled 35 patients with stage II–III breast cancer [ 13 ]. Furthermore, breast conservation was possible in 59% of the patients.…”

Section: Discussionmentioning

confidence: 99%

“…Based on these reports, the combination of docetaxel and gemcitabine may offer a new NAC regimen for locally advanced stage II–III breast cancer. However, reports on NAC using the combination treatment of docetaxel and gemcitabine are limited [ 13 14 ]. Therefore, we aimed to assess the efficacy and safety of the combination of docetaxel and gemcitabine as NAC in the current multicenter, single-arm, phase II study in women with locally advanced stage II–III breast cancer.…”

Section: Introductionmentioning

confidence: 99%

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A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

et al. 2017

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PurposeThe current multicenter phase II study was conducted to evaluate the efficacy and safety of the combination of docetaxel and gemcitabine as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer.MethodsA total of 98 patients with stage II–III breast cancer were enrolled. The primary endpoint was pathological complete response (pCR) rate of invasive cancer after the completion of the fourth cycle of NAC. The secondary endpoints included response rate (RR), rate of breast-conserving surgery, toxicity, and disease-free survival (DFS). This study is registered with ClinicalTrials.gov (NCT01352494).ResultspCR in the breast and the axillary lymph node was observed in seven of the 98 enrolled patients (7.1%). The overall clinical RR, including partial responses, was 65.3%. Breast-conserving surgery was performed in 75 of the 98 assessable patients (76.5%). Neutropenia was frequent and was observed in 92 of the 98 patients (93.9%), including grade 3 and 4 in 24 patients (24.5%) and 63 patients (64.3%), respectively. Dose reductions were required for 30 of the 92 patients (32.6%). After a median follow-up of 24 months, the overall DFS of the group was 86.7%.ConclusionThe combination of docetaxel and gemcitabine did not improve pCR. However, this regimen has shown potential as a NAC by producing a reasonable rate of breast-conserving surgery and favorable responses in patients with locally advanced breast cancer. The therapeutic efficacy of this regimen will be determined in additional trials to overcome the limitations of the current study.

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“…Other common grade III/IV toxicities included thrombocytopenia, anemia, and nausea/vomiting, all with less than a 7% incidence of grade III/IV events. When docetaxel was combined with other drugs every 2 weeks, toxicity profile changed accordingly (Table 4) [22,[29][30][31][32][33][34][35]. Vinorelbine-containing and irinotecan-containing regimens had more myelosuppressive and gastrointestinal toxicity, respectively (Table 4).…”

Section: Discussionmentioning

confidence: 99%

Biweekly docetaxel-containing chemotherapy may be the optimal schedule

et al. 2008

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The dosing schedule of docetaxel may affect its clinical activity and toxicity profile. Although triweekly docetaxel has higher antitumor activity but more severe hematological toxicity, weekly docetaxel seems to have less activity or fewer adverse events. To evaluate the efficacy and toxicity of biweekly docetaxel and mitoxantrone in patients with advanced breast cancer, the regimen consisting of docetaxel (60 mg/m), and mitoxantrone (8 mg/m) was administered intravenously to 59 patients every 2 weeks. Most (54.2%) of the patients experienced objective responses. The median time to progression for the whole group was 6.8 months. The median time to progression for patients with complete or partial response was 10.3 months, but only 3.6 months for patients with stable or progressive disease (P<0.001). Grade III/IV adverse events of neutropenia, thrombocytopenia, anemia, febrile neutropenia, and nausea/vomiting were documented in 61.0, 6.8, 3.4, 3.4, and 3.4% of the patients, respectively. The median overall survival was 16.9 months. In conclusion, biweekly use of docetaxel and mitoxantrone is a highly effective and well-tolerated regimen for patients with advanced breast cancer. The optimal dosage of docetaxel in combination with chemotherapeutic regimen may be given every 2 weeks.

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Biweekly docetaxel and gemcitabine as neoadjuvant chemotherapy followed by adjuvant doxorubicin and cyclophosphamide therapy in stage II and III breast cancer patients: results of a phase II study

Abstract: We consider biweekly docetaxel and gemcitabine could be an active and tolerable regimen option in the neoadjuvant setting sequentially with standard adjuvant doxorubicin-cyclophosphamide in patients with stage II or III breast cancer.

Cited by 5 publications

References 34 publications

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Biweekly docetaxel-containing chemotherapy may be the optimal schedule

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