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

Abstract

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.

A Phase II Study of 3′-Deoxy-3′-18F-Fluorothymidine PET in the Assessment of Early Response of Breast Cancer to Neoadjuvant Chemotherapy: Results from ACRIN 6688

“…Variability in scan timing and timing relative to treatment may also have contributed to variable performance. In our cohort, only 18% of patients had a pCR, a result that is consistent with other trials in locally advanced breast cancer, using standard anthracycline–taxane combination chemotherapy in patients with heterogeneous tumor subtypes (30–32). It is also important to realize the unbalanced number of patients between the pCR and no-pCR groups (9 vs. 42).…”

Residual Cancer Burden in Locally Advanced Breast Cancer: A Superior Tool

“…In our study, clinical response following neoadjuvant chemotherapy did not well predict pathologic response. Of all patients, 22% achieved p cr , a result that is essentially consistent with other trials in labc (mostly using standard anthracycline–taxane combination chemotherapy) 11–14. None of the patients in the present study with ibc achieved p cr , indicating the aggressive—and probably distinct—nature of this disease entity that begs for novel treatment strategies.…”

HER2/neu in systemic therapy for women with breast cancer: a systematic review

“…One trial [59] analysed the efficacy of different taxane doses of single-agent paclitaxel in the metastatic setting, and another [60,61] compared cisplatin, epirubicin, and paclitaxel to epirubicin and paclitaxel. Neither trial reported a test of interaction.…”