Paclitaxel and Gemcitabine, As First-Line Chemotherapy, Combined with Trastuzumab in Patients with Advanced Breast Cancer: A Phase II Study Conducted by the Hellenic Cooperative Oncology Group (HeCOG)

Fountzilas, George; Tsavdaridis, D.; Kalogera‐Fountzila, Anna; Aravantinos, G.; Razis, Evangelia; Kalofonos, Haralabos P.; Papakostas, Pavlos; Karina, M.; Gogas, Helen; Skarlos, Dimosthenis

doi:10.1081/cnv-200032980

Cited by 45 publications

(42 citation statements)

References 13 publications

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“…Two additional Phase II studies by Gori et al [15] and Fountzilas et al [16] of trastuzumab with weekly paclitaxel, confirmed the results by Seidman et al [10].…”

Section: Discussionsupporting

confidence: 52%

“…In vitro studies suggested an additive activity of trastuzumab when combined with paclitaxel [13,14] and several Phase I-II clinical studies have assessed the antitumoral activity and the tolerability of such a combination [12][13][14][15][16][17]. The combination of weekly paclitaxel with trastuzumab [10,15,16] produces extended cumulative exposure to the drug and ameliorates the toxicities associated with the standard tri-weekly administration [17], with mild, non-cumulative, hematologic toxicity allowing its administration for prolonged periods of time [18].…”

Section: Introductionmentioning

confidence: 99%

“…The combination of weekly paclitaxel with trastuzumab [10,15,16] produces extended cumulative exposure to the drug and ameliorates the toxicities associated with the standard tri-weekly administration [17], with mild, non-cumulative, hematologic toxicity allowing its administration for prolonged periods of time [18].…”

Section: Introductionmentioning

confidence: 99%

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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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“…Two additional Phase II studies by Gori et al [15] and Fountzilas et al [16] of trastuzumab with weekly paclitaxel, confirmed the results by Seidman et al [10].…”

Section: Discussionsupporting

confidence: 52%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…These patients participated in ten trials designed and run consecutively by HeCOG, exploring different first-line treatment options for patients with MBC [8][9][10][11][12][13][14][15][16][17]. Information was collected prospectively according to the corresponding trial protocol and deposited in the central HeCOG office database.…”

Section: Methodsmentioning

confidence: 99%

“…Exclusion criteria were previous chemotherapy for advanced disease, symptomatic brain metastases, history of other malignancy (except curatively resected non-melanoma skin cancer or in situ cervical cancer), myocardial infarction within the last 6 months, or other serious illness that would impair the ability of the patient to receive protocol treatment. In two of the studies with trastuzumab administration (HE1199 and HE1100) [14,16], eligibility criteria required histologically proven HER-2/neu overexpression [[25% positive cells by immunohistochemistry or fluorescent in situ hybridization (FISH)-positive]. The current analysis is performed both including and excluding the two trastuzumab studies.…”

Section: Methodsmentioning

confidence: 99%

Fifteen-year trends in metastatic breast cancer survival in Greece

Dafni

Grimani

Xyrafas

et al. 2009

Breast Cancer Res Treat

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In the metastatic setting, a detected time trend to improved prognosis could be attributed to the corresponding recent advances in the therapeutic approaches. The aim of the current study was to first assess, in a large cohort of well over a thousand patients, the time trends in survival in MBC for the last 15 years and second to explore its association to prognostic factors affecting outcome including therapeutic regimen. This meta-analysis uses individual patient data collected from all the trials on MBC (6 nonrandomized, 4 randomized) conducted by HeCOG from 1991 through 2006. Four 4-year time periods (1991-1994, 1995-1998, 1999-2002, and 2003-2006) were constructed for exploration of time trends in survival according to the patient's date of metastatic diagnosis. Different first line regimens in the 10 trials include anthracycline monotherapy (epirubicin, in the early 1990s) and taxanecontaining regimens either as monotherapy or in different combinations with anthracyclines or other drugs. In two phase II studies and in the last randomized study, trastuzumab was administered in all the patients with HER2 overexpressing tumors. In this study, information is based on a total of 1361 patients with a median follow up of 3.7 years and median survival of 1.9 years (median survival 1.28, 1.68, 2.20, and 2.57 years for 1991-1994, 1995-1998, 1999-2002, and 2003-2006, respectively). Survival improved significantly across diagnosis time periods, by 25, 44, and 51%, respectively, in each time period (1995)(1996)(1997)(1998) (1991)(1992)(1993)(1994). The effect of metastatic diagnosis time period remains almost unchanged in the presence of the following significant prognostic factors: performance status, hormonal receptor status, previous adjuvant chemotherapy, previous adjuvant hormonal treatment, visceral metastasis at entry, and number of metastatic sites. When exploring the effect of new systemic treatment introduction, taking into account the same significant prognostic factors, the effect of diagnosis time period disappears, and the survival improvement is explained directly by the introduction of new agents (hormonal treatment for metastatic disease: yes vs. no: HR = 0.72, P \ 0.001; taxanes at first line: yes vs. no: HR = 0.69, P = 0.002; trastuzumab at first line: yes vs. no: HR = 0.63, P \ 0.001). The results of this study provide significant evidence of improvement in prognosis of MBC patients within the last 15 years, taking into account all the important significant prognostic factors, and this improvement can be attributed to the use of new systemic treatment agents in the management of the disease.

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Chemotherapy for Metastatic Breast Cancer Patients Who Received Adjuvant Anthracyclines (An Overview)

Morabito

Piccirillo

Bryce

et al. 2008

Methods of Cancer Diagnosis, Therapy and Prognosis

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Paclitaxel and Gemcitabine, As First-Line Chemotherapy, Combined with Trastuzumab in Patients with Advanced Breast Cancer: A Phase II Study Conducted by the Hellenic Cooperative Oncology Group (HeCOG)

Abstract: TGH is a well-tolerated and effective regimen for the first-line treatment of ABC. Randomized comparison between paclitaxel, trastuzumab, and triplets are warranted.

Cited by 45 publications

References 13 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

Fifteen-year trends in metastatic breast cancer survival in Greece

Chemotherapy for Metastatic Breast Cancer Patients Who Received Adjuvant Anthracyclines (An Overview)

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