Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer

Jones, Stephen E.; Erban, John K.; Overmoyer, Beth; Budd, G. Thomas; Hutchins, Laura F.; Ee, Lower; Laufman, Leslie Rodgers; Sundaram, Srinand; Urba, W J; Pritchard, Kathleen I.; Mennel, Robert G.; Richards, Donald A.; Olsen, Steven R.; Meyers, Marlene; Ravdin, Peter M.

doi:10.1200/jco.2005.02.027

Cited by 500 publications

(368 citation statements)

References 34 publications

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“…As far as the first point is concerned, Jones et al [24] in a Phase III trial of standard schedule of paclitaxel versus docetaxel showed superiority for docetaxel in all clinical endpoints.…”

Section: Discussionmentioning

confidence: 99%

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Gasparini

Gion²,

Mariani³

et al. 2006

Breast Cancer Res Treat

129

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Background A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2. Patients and methods Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m 2 ) or combined with trastuzumab (4 mg/kg loading dose, then weekly 2 mg/kg). HER-2 overexpression was determined by immunohistochemistry (IHC). Patients with 2+/3+ IHC scores were eligible. IHC was compared with HER-2 serum extracellular domain (ECD). Results Patient characteristics were similar in the two arms. Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity. No patient developed cardiac toxicity. The combined treatment was statistically significant superior for overall response rate (ORR) (75% vs. 56.9%; P = 0.037), particularly in the subset of IHC 3+ patients (84.5% vs. 47.5%; P = 0.00050). A statistically significant better median time to progression was seen in the subgroup with IHC 3+ (369 vs. 272 days; P = 0.030) and visceral disease (301 vs. 183 days; P = 0.0080) treated with combination. Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR (P = 0.0035). Conclusion Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

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Section: Discussionmentioning

confidence: 99%

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Gasparini

Gion²,

Mariani³

et al. 2006

Breast Cancer Res Treat

129

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“…For the treatment of palindromic and metastatc patients with late breast cancer, chemotherapy occupies an extreme important position. With the applications of the third generation chemotherapy drugs such as docetaxel (TXT) and the improvement of chemotherapy program, the effects of chemotherapy have been furtherly improved (Biganzoli et al, 2004;Jones et al, 2005). However, the choice of the patients, especially who failed to adjuvant chemotherapy with the application of taxane and anthracycline, on current clinical chemotherapy was still blind.…”

Section: Introductionmentioning

confidence: 99%

Expression of β-tubulin III and Survivin in Advance Stage Breast Cancer Correlates with Chemotheraputic Effects of Docetaxel

Yuan¹,

Zhu²,

Zheng³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Aims: To investigate the relationship between the expression of β-tubulinⅢ and survivin in advanced breast cancers and chemotherapeutic effects of docetaxel. Methods: Clinical pathological data of 74 patients with advanced breast cancer were retrospectively analyzed after docetaxel chemotherapy. Expression of β-tubulinⅢ and survivin was assessed by immunohistochemistry and analyzed with reference to therapeutical and adverse effects of docetaxel. Results: The positive expression rate of β-tubulinⅢ was 38.1% (32/84), while that of survivin was 76.2% (64/84). The effective rate (complete response + partial response) was 52.4%. That for patients with the positive expression of β-tubulinⅢ or/and survivin was significantly lower than for those with negative expression (P<0.05). There were significant differences in the non-progression of median diseases, 1-year and 2-year survival rates of between the patients with positive and negative expression (P<0.05). The main side effects were myelosuppression, alimentary canal response and alopecie, no differences being observed between groups. Conclusions: The combined detection of β-tubulinⅢ and survivin is a predictive index for chemotherapy effects of docetaxel in metastatic breast cancer.

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“…Moreover, the Programme Adjuvant Cancer du Sein (PACS) 01 study, comparing FEC with FEC-Docetaxel (Doc), and Breast Cancer International Research Group (BCIRG) 001 study, comparing FAC with DocAC, have shown significant and relevant survival benefits for Doc [2]. In addition, Doc has been shown to increase OS in metastatic breast cancer compared with paclitaxel [16], while high-dose adjuvant FEC 100 improved OS compared with a conventionally dosed anthracycline regimen [17].…”

Section: Introductionmentioning

confidence: 99%

Delivery of adjuvant sequential dose-dense FEC–Doc to patients with breast cancer is feasible, but dose reductions and toxicity are dependent on treatment sequence

Wildiers

Dirix

Neven

et al. 2008

Breast Cancer Res Treat

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International audienceThis study prospectively investigates the impact of dose densification and altering sequence of fluorouracil, epirubicin and cyclophosphamide [FEC] and docetaxel [Doc] on dose delivery and tolerability of adjuvant chemotherapy in breast cancer patients. 117 patients with high-risk primary operable breast cancer were randomized (1:1:2:2) to conventional (three cycles of 3-weekly FEC then three cycles of 3-weekly Doc 100 mg/m or reverse sequence) or dose-dense (dd) treatment (four 10- to 11-day cycles of FEC then four 2-weekly cycles of Doc 75 mg/m, or the reverse). In the dd arms, pegfilgrastim was given on day 2 of each cycle, but only as secondary prophylaxis in conventional arms. The primary endpoint was the proportion of patients completing intended cycles at relative dose intensity ≥85% and this was achieved by 95% of patients in each group except for the ddDoc→FEC group (90%). Dose intensity in the dd arms increased by 48% for FEC and 11% for docetaxel, compared with the conventional arms (both < 0.001). Doc dose reductions were more frequent with dd treatment and when Doc was given after FEC. Grade 3–4 neutropenia was significantly more frequent with conventional treatment, while fatigue and hand–foot syndrome were numerically more common with dd treatment, particularly when Doc was given after FEC. Delivery of adjuvant sequential ddFEC and Doc is feasible with growth factor support, and chemotherapy sequence appeared to affect delivery of target doses and toxicity

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Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer

Abstract: Docetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time.

Cited by 500 publications

References 34 publications

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Expression of β-tubulin III and Survivin in Advance Stage Breast Cancer Correlates with Chemotheraputic Effects of Docetaxel

Delivery of adjuvant sequential dose-dense FEC–Doc to patients with breast cancer is feasible, but dose reductions and toxicity are dependent on treatment sequence

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