Results of a phase II study of liposomal doxorubicin (Myocet®) in combination with weekly paclitaxel and trastuzumab (Herceptin®) In patients with HER2-positive locally advanced or metastatic breast cancer (LA/MBC)

Baselga, J.; Climent, M. A.; Lluch, Aña; Hornedo, Javier; Gascón, Pere; Sánchez, Angel Martı́nez; Guillém, Vicente; Cortés-Funes, H.; Regueiro, Pilar; Trigo, J.M.

doi:10.1016/s1359-6349(04)90865-8

Cited by 16 publications

(7 citation statements)

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“…In both the studies an interesting response rate was obtained (ORR:79% BCIRG101; ORR:58% UCLA-ORN, respectively). Phase II studies, exploring triplets of trastuzumab, taxanes, and liposomal doxorubicin are ongoing, and Baselga et al [27] reported a high overall response rate, with half of the patients with objective complete response.…”

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

128

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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

128

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“…Clinical studies therefore investigated the efficacy and safety of Trastuzumab in combination with epirubicin (EPI) or liposomal formulations of DOX. The available studies (phase II studies of Trastuzumab with pegylated liposomal DOX, and phase I and II studies of Trastuzumab with uncoated liposomal DOX and PTX) attest to the promising activity and safety of all such schedules [9][10][11].…”

Section: Clinical Readouts Of the Cardiotoxicity Of Trastuzumab As Simentioning

confidence: 99%

Anthracycline cardiotoxicity in breast cancer patients: synergism with trastuzumab and taxanes

2007

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Doxorubicin is known to cause cardiomyopathy and congestive heart failure (CHF) upon chronic administration. A major obstacle to doxorubicin-containing multiagent therapies pertains to the possible development of cardiomyopathy and CHF at lower than expected cumulative doses of doxorubicin. For example, the cardiac toxicity of doxorubicin is aggravated by the anti-HER2 antibody Trastuzumab or by the tubulin-active taxane paclitaxel; however, the mechanisms by which Trastuzumab and paclitaxel aggravate doxorubicin-induced cardiotoxicity are mechanistically distinct: Trastuzumab interferes with cardiac-specific survival factors that help the heart to withstand stressor agents like anthracyclines, while paclitaxel acts by stimulating the formation of anthracycline metabolites that play a key role in the mechanism of cardiac failure. Here, we briefly review the molecular mechanisms of the cardiotoxic synergism of Trastuzumab or paclitaxel with doxorubicin, and we attempt to briefly outline how the mechanistic know-how translates into the clinical strategies for improving the safety of anthracycline-based multiagent therapies.

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“…Other combinations of trastuzumab, for example with vinca alkaloids, capecitabine, gemcitabine, taxanes or carboplatin-based therapy, have resulted in response rates of 50-86% [13][14][15].…”

Section: Systemic Chemotherapymentioning

confidence: 99%

SEOM clinical guidelines for the treatment of metastatic breast cancer

et al. 2010

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Patients with metastatic breast cancer have a wide number of treatment options, including medical, surgical, and supportive care measures. Treatment decisions are based in predictive and prognostic factors and the informed choice of the patients. SEOM has elaborated these guidelines with evidence-based recommendations for the diagnostic work-up, treatment (chemotherapy, endocrine therapy and targeted therapies) and supportive care for the management of these patients.

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Results of a phase II study of liposomal doxorubicin (Myocet®) in combination with weekly paclitaxel and trastuzumab (Herceptin®) In patients with HER2-positive locally advanced or metastatic breast cancer (LA/MBC)

Cited by 16 publications

References 0 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

Anthracycline cardiotoxicity in breast cancer patients: synergism with trastuzumab and taxanes

SEOM clinical guidelines for the treatment of metastatic breast cancer

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