Comparison of the effectiveness and toxicity of neoadjuvant chemotherapy regimens, capecitabine/epirubicin/cyclophosphamide vs 5-fluorouracil/epirubicin/cyclophosphamide, followed by adjuvant, capecitabine/docetaxel vs docetaxel, in patients with operable breast cancer

Abstract

The aim of this study was to compare the effectiveness and toxicity of neoadjuvant chemotherapy regimens, xeloda/epirubicin/cyclophosphamide (XEC) vs 5-fluorouracil/epirubicin/cyclophosphamide (FEC), followed by adjuvant chemotherapy regimens, capecitabine/taxotere (XT) vs taxotere (T), in axillary lymph node (LN)-positive early-stage breast cancer. In this randomized, Phase III trial, 137 patients with operable primary breast cancer (T2-0, N0-1) who were tested axillary LN positive through aspiration biopsy of axillary LNs were randomized (1:1) to four 3-weekly cycles of XEC or FEC. Patients underwent surgery within 4–6 weeks after the fourth cycle, followed by four adjuvant cycles of 3-weekly XT or T. The primary end point was tumor pathological complete response. Toxicity profiles were secondary objectives. In total, 131 patients had clinical and radiological evaluation of response and underwent surgery. Treatment with XEC led to an increased rate of pathological complete response in primary tumor (18% vs 6%, respectively, P=0.027) and objective remission rate (87% vs 73%, P=0.048) compared to FEC. Clinical complete response occurred in 20% and 7% for XEC and FEC, respectively. Compared to FEC, XEC was associated with more hand-foot syndrome (57% vs 11%, P<0.001) and 3/4 grade nausea/vomiting/diarrhea (30% vs 14%, P=0.034) but less phlebitis (3% vs 14%, P=0.035). XT and T adjuvant chemotherapy regimens were well tolerated: treatment-related 3/4 grade adverse events occurred in 28% and 17% of patients receiving XT and T, respectively.

GOLPH3: a novel biomarker that correlates with poor survival and resistance to chemotherapy in breast cancer

“…Systemic chemotherapy, including neoadjuvant chemotherapy and adjuvant chemotherapy, is a very important treatment strategy for breast cancer patients [ 31 – 37 ]. To date, no studies have investigated the association between GOLPH3 expression and neoadjuvant chemotherapy in breast cancer.…”

Epirubicin chemotherapy in women with breast cancer: Alternating arms for intravenous administration to reduce chemical phlebitis

“…The chemotherapy drug 5-FU is also known to cause phlebitis and could have potentially influenced the incidence and severity of phlebitis; however, the phlebitis resulting from 5-FU is most commonly seen with prolonged infusions rather than the bolus administration used for this study (Gebbia et al, 1999), and although 5-FU is a venous irritant, it is usually associated with superficial phlebitis symptoms (Berardi et al, 2003) without the more severe venous sclerosis resulting from the vesicant epirubicin. Zhang et al (2016) demonstrated that the incidence of phlebitis was significantly lower when epirubicin and cyclophosphamide were given in combination with capecitabine (an oral pro-drug of 5-FU) instead of intravenous 5-FU. However, the TACT-2 study with over 4,000…”

Chemotherapy‐induced phlebitis via the GBP5/NLRP3 inflammasome axis and the therapeutic effect of aescin

“…Intravenous chemotherapy, which is widely used in clinical treatment of cancer (Gotwals et al, 2017; Meric‐Bernstam et al, 2020; Tsimberidou et al, 2020), causes phlebitis in 35–65% cancer patients (Lennan et al, 2005; Zhang et al, 2016). Venous inflammation and inflammatory reactions to intravenous chemotherapy drugs can last from weeks to months, leading to a variety of forms of pathological changes including vein lesions, pain, fever, redness, swelling, tissue stiffening and thickening (Bolton‐Maggs & Flavin, 2005; Tagalakis et al, 2002).…”