Cisplatin–epirubicin–paclitaxel weekly administration in advanced breast cancer: A phase I study of the Southern Italy Cooperative Oncology Group

Frasci, G.; D’Aiuto, Giuseppe; Comella, Pasquale; Apicella, Anna; Thomas, R.; Capasso, Immacolata; Bonito, Maurizio Di; Cartenì, Giacomo; Biglietto, M.; Lucia, L. De; Maiorino, L.; Piccolo, Sergio; Bianchi, Ugo; D’Aniello, R.; Lapenta, Liliana; Comella, G.

doi:10.1023/a:1006263226099

Cited by 17 publications

(9 citation statements)

References 17 publications

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“…The Southern Italian Cooperative Oncology Group (SICOG) evaluated the triple combination of weekly paclitaxel, epirubicin, and cisplatin (Platinol ® ; Bristol-Myers Squibb) in a series of phase I, phase II, and phase III trials [79,80]. The phase I trial enrolled 63 women with LABC or MBC who had not received prior therapy for metastatic disease [79].…”

Section: Weekly Paclitaxel-anthracycline-platinum Tripletsmentioning

confidence: 99%

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Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

2005

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Section: Weekly Paclitaxel-anthracycline-platinum Tripletsmentioning

confidence: 99%

“…The phase I trial enrolled 63 women with LABC or MBC who had not received prior therapy for metastatic disease [79]. [81].…”

Section: Weekly Paclitaxel-anthracycline-platinum Tripletsmentioning

confidence: 99%

Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

2005

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“…Five of the eight patients without distant metastases had inflammatory breast cancer. In patients with metastatic disease the main site of disease 2 ) weekly administration with G-CSF support in 24 of 34 patients [14]. The remaining 10 patients had received a standard cyclophosphamide-epirubicinfluorouracil regimen (6) or epirubicin at the dose of 120 mg/m 2 (4).…”

Section: Demographicsmentioning

confidence: 99%

Weekly docetaxel plus gemcitabine or vinorelbine in refractory advanced breast cancer patients: A parallel dose-finding study

Frasci¹,

Comella

D’Aiuto

et al. 2000

Annals of Oncology

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SummaryPurpose: The objective of this study was to determine the docetaxel MTD when combined with gemcitabine or vinorelbine in advanced breast cancer patients who had received previous anthracycline-based chemotherapy for advanced disease.Patients and methods: Advanced breast cancer patients aged between 18 and 70 with ECOG PS 0-2 who had not responded to, or had relapsed after, first-line anthracycline-based chemotherapy, were randomized to receive either gemcitabine 1000 mg/m 2 or vinorelbine 25 mg/m 2 in combination with escalating doses of docetaxel (starting from 30 mg/m 2 ), all on days 1 and 8 every three weeks. Escalation was stopped if > 33% of patients treated at a given dose level showed DLTat the first cycle.Results: A total of 34 patients with locally advanced (8) or metastatic disease (26) were treated, for a total of 94 cycles delivered. Nineteen patients received docetaxel in combination with gemcitabine and 15 with vinorelbine. All patients had been pretreated with anthracyclines, and 24 of 34 had also received weekly dose-dense paclitaxel. A docetaxel dose of 40/m 2 proved to be safe when combined on days 1 and 8 with gemcitabine, while a dose of 35 mg/m 2 was tolerated in combination with vinorelbine. Overall, nine episodes of DLT, all of them neutropenia, occurred at the first cycle. Considering all 94 cyles, grades 3 or 4 neutropenia and thrombocytopenia occurred in 15 (44%), and 7 (20%) patients. Non-hematologic toxicity was mild, except for three cases of grade 2 peripheral neuropathy. All patients were assessed for response on an 'intent-to-treat' basis. Overall, five partial responses were recorded (docetaxel + gemcitabine = 3 and docetaxel + vinorelbine = 2), for a 15% (95% CI: 5%-31%) overall response rate. Only 1 of 24 (4%) patients who had received weekly dosedense paclitaxel responded to treatment. Conclusions:The weekly docetaxel administration in combination with either gemcitabine or vinorelbine is a well-tolerated treatment for heavily pretreated advanced breast cancer patients. This approach, although sometimes capable of achieving a major response, does not seem advisable in advanced breast cancer patients refractory to both anthracyclines and paclitaxel.

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“…Several cisplatin-based regimens have been tested in the neo-adjuvant setting, showing high anti tumour activity (Orlando et al, 2001;Ezzat et al, 2004). In the mid-nineties, we started the assessment of a weekly triplet regimen including cisplatin, epirubicin, and paclitaxel (PET regimen) in breast cancer patients (Frasci et al, 1999). This weekly approach was initially tested in a phase II study in women with LABC (Frasci et al, 2000).…”

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confidence: 99%

Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: final analysis of a sicog phase III study

Frasci¹,

D’Aiuto²,

Comella³

et al. 2006

Br J Cancer

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The present study aimed at evaluating whether a weekly cisplatin, epirubicin, and paclitaxel (PET) regimen could increase the pathological complete response (pCR) rate in comparison with a tri-weekly epirubicin and paclitaxel administration in locally advanced breast cancer (LABC) patients. Patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30 mg m À2, epirubicin 50 mg m À2, and paclitaxel 120 mg m À2 (PET) plus granulocyte-colony stimulating factor support, or four cycles of epirubicin 90 mg m À2 þ paclitaxel 175 mg m À2 (ET) every 3 weeks. Overall, 200 patients (PET/ET ¼ 100/100) were included in this study. A pCR in both breast and axilla occurred in 16 (16%) PET patients and in six (6%) ET patients (P ¼ 0.02). The higher activity of PET was evident only in ER negative (27.5 vs 5.4%; P ¼ 0.026), and in HER/neu positive (31 vs 5%; P ¼ 0.037) tumours. The two arms yielded similar pCR rate in ER positive (PET/ET ¼ 7.5/7.1%) and HER/neu negative (PET/ET ¼ 10/6%) patients. At a 39 months median follow-up, 70 patients showed a progression or relapses (PET, 32 vs ET, 38). Anaemia, mucositis, peripheral neuropathy, and gastrointestinal toxicity were substantially more frequent in the PET arm. The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients with ER negative and/or HER2 positive tumours Mature data in terms of disease-free and overall survival are needed to ascertain whether this approach could improve the prognosis of these subsets of LABC patients.

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Cisplatin–epirubicin–paclitaxel weekly administration in advanced breast cancer: A phase I study of the Southern Italy Cooperative Oncology Group

Cited by 17 publications

References 17 publications

Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer

Weekly docetaxel plus gemcitabine or vinorelbine in refractory advanced breast cancer patients: A parallel dose-finding study

Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: final analysis of a sicog phase III study

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