Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx®) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group

Abstract

The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.

Combination of pegylated liposomal doxorubicin (PLD) and paclitaxel in patients with advanced soft tissue sarcoma: a phase II study of the Hellenic Cooperative Oncology Group

“…Similarly, these were the most common nonhaematological toxicities of the combination of PLD with paclitaxel in this group of patients, with 7% of patients experiencing grade 3 PPE and one patient discontinuing treatment due to exfoliative dermatitis. However, the incidence of marked skin toxicity observed in our study, is significantly lower than that usually reported when lower doses of PLD (35 mg m À2 ) are administered in shorter time intervals, every 3 weeks (Gogas et al, 2002). The addition of paclitaxel to the higher dose of PLD used in our study did not seem to affect the incidence of skin toxicity, as this is possibly related to the dose scheduling intervals and exposure to persistent drug levels (Lyass et al, 2000).…”

“…We opted for a higher dose of PLD (45 mg m À2 ) combined with paclitaxel at 150 mg m À2 , and administration every 4 weeks, which has been shown to be the optimal time schedule for such doses with regard to skin toxicity. The above schedule exhibited a similar toxicity profile to reported combinations of paclitaxel -PLD in other tumour types (Briasoulis et al, 1999;Dirix and van Oosterom, 1999;Gogas et al, 2002). There was no grade 3 or 4 gastrointestinal toxicity, while myelosuppression was acceptable, with only one case of febrile neutropenia requiring hospitalisation.…”

“…The doses and schedule of administration of the two drugs in our study were identified from previous phase I/II experience of our group and others (Briasoulis et al, 1999, Gogas et al, 2002. Although there is considerable experience with the combination of doxorubicin and paclitaxel, data regarding the use of PLD and taxanes are limited.…”

“…PLD and paclitaxel in advanced soft tissue sarcoma D Bafaloukos et al 175 mg m À2 combined with 30 -35 mg m À2 PLD, administered every 3 -4 weeks (Briasoulis et al, 1999;Dirix and van Oosterom, 1999;Gogas et al, 2002). We opted for a higher dose of PLD (45 mg m À2 ) combined with paclitaxel at 150 mg m À2 , and administration every 4 weeks, which has been shown to be the optimal time schedule for such doses with regard to skin toxicity.…”

Use of liposomal doxorubicin for adjuvant chemotherapy of breast cancer in clinical practice

“…A phase-II study has suggested that after Smorenburg et al, 2014 6 cycles of treatment in combination with PLD (administered at 30 mg/m 2 every three weeks), gemcitabine, and paclitaxel, better therapeutic efficacy was detected in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy (Artioli et al, 2010). In a phase-II clinical study by Gogas et al (2002) suggested that 71% of patients were remitted after 6 cycles of combined therapy. This research finding further verified the activity of combined PLD and paclitaxel in neoadjuvant chemotherapy of patients with locally advanced breast cancer.…”