Paclitaxel by 3-H infusion and carboplatin in anthracycline-resistant advanced breast cancer. A phase II study conducted by the hellenic cooperative oncology group

Fountzilas, George; Athanassiadis, A; Kalogera‐Fountzila, Anna; Aravantinos, G.; Bafaloukos, Dimitrios; Briasoulis, Evangelos; Dombros, Nikolaos; Ioannidis, Ioannis; Pavlidis, Nicholas; Kosmidis, P.; Skarlos, D.

doi:10.1016/s0959-8049(97)00217-7

Cited by 30 publications

(15 citation statements)

References 12 publications

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“…[3][4][5][6][7][8][9]11,12 Also, this response rate compares favorably with the 47-52% response rate observed with combination paclitaxel and doxorubicin in patients with metastatic breast carcinoma in the cooperative group setting in the United States. 10,26 Our findings are similar to two recent reports of two separate trials by Fountzilas et al, 27,28 who administered paclitaxel and carboplatin to women with advanced breast carcinoma at similar doses and schedules. Those investigators reported an overall response rate of 53% for first-line combination paclitaxel and carboplatin therapy and a 43% response rate in a separate study of patients with anthracyclineresistant breast carcinoma.…”

Section: Discussionsupporting

confidence: 90%

“…The overall response rate for combination paclitaxel and carboplatin in metastatic breast carcinoma observed in this study and supported by the studies of Fountzilas and colleagues 27,28 provides persuasive evidence for the continued evaluation of this regimen. An intriguing concept is the potential for the addition of the anti-HER2 antibody trastuzumab (Herceptin) to this combination.…”

Section: Discussionsupporting

confidence: 75%

See 1 more Smart Citation

A phase II study of paclitaxel plus carboplatin as first‐line chemotherapy for women with metastatic breast carcinoma

Perez

Hillman

Stella

et al. 2000

Cancer

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 75%

A phase II study of paclitaxel plus carboplatin as first‐line chemotherapy for women with metastatic breast carcinoma

Perez

Hillman

Stella

et al. 2000

Cancer

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“…Moreover, prolongation of chemotherapy is associated with increased toxicity. Based on data from historic studies, the duration of taxane response was estimated to be about 7 months, depending on the type of taxane (paclitaxel or docetaxel) and the clinical setting (first-or second-line treatment of metastatic disease) [4][5][6][7][8][9][10][11][12]. In practice, taxanes are generally continued for a few months after an objective response is achieved, and therefore, we estimated the median PFS after discontinuation of taxane therapy would be 5 months in these patients.…”

Section: Endpointsmentioning

confidence: 99%

Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer

Wildiers

Fontaine²,

Vuylsteke

et al. 2010

Breast Cancer Res Treat

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The aim of this study is to test the hypothesis that antiangiogenic treatment with sunitinib consolidation can prolong remissions induced by taxane-based chemotherapy in women with metastatic breast cancer. The method involves a two-arm open-label (2:1 randomization) multicenter, randomized phase II trial evaluating the efficacy of sunitinib (arm A) versus no therapy (arm B) in patients with HER-2-negative metastatic breast cancer who achieved an objective response to taxane-based chemotherapy. The results of this study indicates that the primary endpoint of progression-free survival (PFS) > or =5 months was achieved in 10 of 36 patients (28%) in arm A and 4 of 19 patients (21%) in arm B. The median PFS was 2.8 and 3.1 months, respectively. A protocol amendment to the sunitinib dosing schedule was made because 53% (17/32) of patients treated at a starting dose of 50 mg (4 weeks on/2 weeks off) required dose reduction. Changing the starting dose to sunitinib 37.5 mg continuously resulted in dose reductions in 44% (7/16) of patients. Grades III-IV toxicity occurred in 69% of patients in arm A (fatigue 31%, musculoskeletal pain 11%, neutropenia and thrombopenia 8%) and 11% in arm B. The proof-of-principle study does not confirm the hypothesis that sunitinib consolidation therapy can lead to a predefined clinically relevant proportion of patients with PFS of > or =5 months after an objective response to taxanes. Furthermore, toxicity was significant.

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“…New compounds appear to be increasingly active and some, such as the taxanes and capecitabine, have demonstrated prolonged survival in randomized trials [1]. The combination of paclitaxel and carboplatin has been tested in this setting by our group and others, yielding an overall objective response rate (ORR) of 45-55% [2,3]. Moreover, in a randomized phase III study, paclitaxel in combination with carboplatin appeared to be as effective as the combination of paclitaxel and epirubicin in terms of survival and ORR in patients with metastatic breast cancer [4].…”

Section: Introductionmentioning

confidence: 99%

Paclitaxel and carboplatin as first-line chemotherapy combined with gefitinib (IRESSA) in patients with advanced breast cancer: a phase I/II study conducted by the Hellenic Cooperative Oncology Group

Fountzilas

Pectasides²,

Kalogera‐Fountzila³

et al. 2005

Breast Cancer Res Treat

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Paclitaxel (Taxol) and carboplatin are an effective combination regimen for treating advanced breast cancer. Gefitinib (IRESSA) is the first epidermal growth factor receptor tyrosine kinase inhibitor to be approved for cancer treatment. This multicenter phase II trial treated 68 patients with advanced breast cancer with paclitaxel (175 mg/m(2) over 3 h) and 3-weekly carboplatin (area under the curve of 6) for six cycles, and 250 mg/day gefitinib orally. Median age was 57 (range 35-77) years, patients had performance status 0 (69.1%), 1 (27.9%) 2 (2.9%), 82.4% of patients had visceral metastases and 63.2% had received adjuvant chemotherapy. Forty-eight (70.6%) patients completed six cycles of chemotherapy and 20 (29.4%) patients discontinued treatment (seven [10.3%] due to disease progression, seven [10.3%] due to toxicity, five [7.4%] withdrew consent and one [1.5%] died after the first cycle). Sixty-three (92.7%) patients were evaluable for response; nine (13.2%) had complete responses, 30 (44.1%) had partial responses, 21 (30.9%) had stable disease and three (4.4%) had disease progression. Grade 3/4 adverse events in > or =5% of patients except of alopecia, included neutropenia (17.7%), anemia (10.3%), diarrhea (7.4%), thrombocytopenia (5.9%) and peripheral neuropathy (5.9%). Of those tumor biopsies available for immunohistochemical analysis (n=60), 5.0% were positive and 35.0% negative for expression of all HER-family receptors. Comparable numbers of tumor biopsies were nuclear p27(kipl) positive and negative (39.7 and 42.7%, respectively), with the majority (72.1%) negative for cytoplasmic p27(kipl). The observed efficacy data in this study were similar to those reported for the combination of paclitaxel and carboplatin alone.

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Paclitaxel by 3-H infusion and carboplatin in anthracycline-resistant advanced breast cancer. A phase II study conducted by the hellenic cooperative oncology group

Cited by 30 publications

References 12 publications

A phase II study of paclitaxel plus carboplatin as first‐line chemotherapy for women with metastatic breast carcinoma

A phase II study of paclitaxel plus carboplatin as first‐line chemotherapy for women with metastatic breast carcinoma

Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer

Paclitaxel and carboplatin as first-line chemotherapy combined with gefitinib (IRESSA) in patients with advanced breast cancer: a phase I/II study conducted by the Hellenic Cooperative Oncology Group

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