Phase I–II trial of prolonged gemcitabine infusion plus paclitaxel as a biweekly schedule for advanced breast cancer patients pretreated with anthracyclines

Abstract

Toxicity was mostly mild to moderate, mainly consisting of G3-G4 neutropenia (9.6%) and hypertransaminasemia (9.5%). Conclusions Biweekly FDR GEM in combination with PACL is an active and safe regimen for advanced breast cancer patients pretre ated with anthracyclines. A prolonged infusion regimen of GEM does not seem to improve the efficacy of a standard 30-minute infusion.

RRM1, TUBB3, TOP2A, CYP19A1, CYP2D6: Difference between mRNA and protein expression in predicting prognosis of breast cancer patients

“…However, no definite conclusion can be drawn based on published data. It has been reported that RRM1 expression at the protein level had no statistical association with clinical responsiveness to gemcitabine-based treatment (23). In addition to its role in gemcitabine resistance, RRM1 mRNA expression and genetic variants have been found to be associated with clinical outcomes of patients with cancer by genotyping detection (24)(25)(26).…”

A Multicenter Phase II Randomized Trial of Docetaxel/Gemcitabine versus Docetaxel/Capecitabine as First-Line Treatment for Advanced Breast Cancer: A Gruppo Oncologico Italia Meridionale Study

“…With regard to paclitaxel-based combinations, definite results of the pivotal phase III trial comparing gemcitabine/paclitaxel versus paclitaxel alone in anthracycline-pretreated patients showed advantages for the combination arm in terms of response rate, time to progression and overall survival, with, as expected, slightly higher hematological toxicity [15]. Docetaxel-based regimens have demonstrated very encouraging results in phase II trials [16], and, among them, the docetaxel/gemcitabine regimen is one of the most frequently employed, showing interesting results in many phase II/III studies, with a favorable therapeutic index [8,12,17,18,19,20]. The combination of docetaxel/capecitabine demonstrated efficacy and manageable toxicity in phase II/III trials [21,22,23] and represents one of the reasonable choices of first-line treatment in anthracycline-pretreated patients.…”

“…Our group has previously carried out other phase II trials with taxane-based doublets in advanced disease [6,7,8,11,12], showing good tolerability and high efficacy, both in up-front or salvage treatment for anthracycline-pretreated patients.…”

“…For patients in whom anthracyclines have failed, both paclitaxel and docetaxel have been widely evaluated, and taxane-based treatment is a current standard of care, with docetaxel achieving a response rate of up to 48% and median survival of up to 16 months [2,3,4]. Other active drugs, such as capecitabine or gemcitabine, have been explored in combination with taxanes in pretreated patients, with very encouraging results [5,6,7,8]. The combination of capecitabine/docetaxel was found to be superior to docetaxel alone [9] as first-line treatment, and the preliminary results with a paclitaxel/gemcitabine regimen suggested better results for the combination arm in comparison with paclitaxel alone [10].…”