A Multicenter Phase II Randomized Trial of Docetaxel/Gemcitabine versus Docetaxel/Capecitabine as First-Line Treatment for Advanced Breast Cancer: A Gruppo Oncologico Italia Meridionale Study

Abstract

Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m² on day 1, gemcitabine 1,000 mg/m² on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m² on day 1, capecitabine 1,250 mg/m² twice daily on days 1–14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6–57.8]; arm B, 38.9% (95% CI 23–54.8). Median progression-free survival was 10.9 months (95% CI 8.1–13.7) in arm A and 10 months (95% CI 8.8–11.2) in arm B. Overall survival was 26 months (95% CI 22.0–30.0) in arm A and 28 months (95% CI 23.4–32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3–4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.

Capecitabine maintenance therapy following docetaxel/capecitabine combination treatment in patients with metastatic breast cancer

“…Efficacy outcomes of this regimen are in the range of data reported for docetaxel and capecitabine combination. In the first-line setting this combination is reported to provide a PFS duration of 8.5-10 months and an ORR of 39-74% (12,13). Although a control arm was not included in the present study, the TTP following 6 cycles of taxane with combination therapy without maintenance was 3.8 months in a previous study (14).…”

Capecitabine in Combination with Docetaxel in First Line in HER2-Negative Metastatic Breast Cancer: an Observational Study

“…In our study, neutropenia and hand-foot syndrome (HFS) were the most common adverse events, followed by mucositis and diarrhea. These adverse effects are well known from both the previous studies [7][8][9][10][11][12][13][14][15][16][17] and everyday practice. In the pivotal phase III trial gastrointestinal side effects and HFS occurred more frequently in patients receiving combined chemotherapy [9].…”

“…XT combination was significantly superior to docetaxel monotherapy, with significantly superior ORR, TTP, and OS as compared to single-agent docetaxel [9]. The subsequent randomized trials in first-, second-and third-line settings using the same regimen achieved TTP/PFS of 7.9-10 months, median overall survival (OS) of 16.4-28 months and ORR of 38.9-68 % [10][11][12][13]. Despite the differences in patient populations, the regimens and the response criteria applied, our data are comparable with these results.…”

“…A limitation of our study was the small size of the population included. Although the study design did not allow the evaluation of the safety, tolerability and efficacy of XT treatment in comparison with a control arm, since these data are well known from large phase II-III clinical studies [9][10][11][12][13][14][15][16][17][18][19][20], the main goal was the introduction of this new regimen into routine practice. Our findings raise the attention to the importance of appropriate patient selection and toxicity management.…”

Gemcitabine-based chemotherapy as a viable option for treatment of advanced breast cancer patients: a meta-analysis and literature review

“…'s study [ 26 ] and Seidman et al 's study [ 23 ]. For these reasons, we excluded above six studies and enrolled the rest 15 studies [ 12 – 18 , 26 – 33 ] in our systematic review (The Selection flow was is shown in Figure 1 ).…”