Gemcitabine Plus Docetaxel Versus Docetaxel in Patients With Predominantly Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer: A Randomized, Phase III Study by the Danish Breast Cancer Cooperative Group

Abstract

GD compared with docetaxel demonstrated increased TTP in metastatic breast cancer. However, RR and OS were similar. Thus, the addition of gemcitabine failed to demonstrate any clinically meaningful benefit when combined with docetaxel.

Indication of metronomic chemotherapy for metastatic breast cancer: Clinical outcomes and responsive subtypes

“…By contrast, there is no standard regimen recommended in the metastatic setting. In cases with life-threatening metastatic lesions or rapidly growing tumors, regimens that are expected to control lesions quickly, such as simultaneous administration of taxanes and anthracyclines, or taxanes in combination with either gemcitabine, capecitabine or bevacizumab, should be applied (4)(5)(6)(7)(8)(9)(20)(21)(22)(23). However, a proportion of the patients exhibit disease progression during or after receiving these cytotoxic regimens, even if favorable combinations are selected.…”

“…Although anthracyclines and taxanes are the representative agents used as standard chemotherapy in the adjuvant setting, these agents have also been used in several cases of MBC (1)(2)(3)(4) and selecting therapeutic regimens in this setting may be difficult for physicians. In cases of hormone-insensitive tumors, or cases of hormone-sensitive tumors that exhibit resistance to endocrine therapy, cytotoxic agents that have not been previously administered, or taxanes in combination with molecular-targeted agents, are potential candidates (4)(5)(6)(7)(8)(9). Recently, taxanes in combination with bevacizumab, which targets the tumor vasculature to reduce blood supply to the tumors (7-9), or eribulin, which is an analogue of halichondrin B targeting tubulin in tumor cells, have demonstrated favorable efficacy in improving the prognosis of patients with MBC (10).…”

Efficacy of gemcitabine-based chemotherapy in metastatic breast cancer: a meta-analysis of randomized controlled trials

“…Overall, seven trials had Jadad scores of 3 and two of 2. The quality was high in seven phase III studies [12][13][14][15][16][17][18] (Jadad score 3). Two trials were of low quality (Jadad score 2) including one phase II trial 19 and one phase III trial 20 .…”

“…Given that different chemotherapeutics are associated with multiple adverse events, we compared only grade 3 and 4 hematologic toxicity adverse effects between gemcitabine-free and Feher 12 Zielinski 13 Martín 14 Albain 15 Chan 16 Joensuu 17 Nielsen 18 Brufsky 19 Pallis 20 Test for overall effect: Z = 1.83 (P = 0.07) Heterogeneity: Chi 2 = 7.14, df = 8 (P = 0.52); I 2 = 0% Zielinski 13 Feher 12 Martín 14 Albain 15 Joensuu 17 Chan 16 Nielsen 18 Brufsky 19 Pallis 20 Test for overall effect: Z = 0.13 (P = 0.90) Heterogeneity: Tau For personal use only.…”

“…Four trials were excluded [8][9][10][11] , namely, a phase III trial using a three-arm design, two phase III trials without a gemcitabine-free control arm and a phase II trial without sufficient data. A total of nine trials met the inclusion criteria in this metaanalysis [12][13][14][15][16][17][18][19][20] , from which 2651 patients were included in the assessment for overall response and toxicity. Eight of these trials were assessed for overall survival, and seven for time to progression.…”