Phase II Trial of Gemcitabine/Doxorubicin/Paclitaxel Administered Every Other Week in Patients with Metastatic Breast Cancer

Sánchez‐Rovira, Pedro; Jaén, A.; González, Encarnación; Porras, Ignacio; Dueñas, Maria Rosario; Medina, B.; Mohedano, Nicolás Mohedano; Fernández, Margarita; Martos, Maximiliano; Lozano, Álvaro

doi:10.3816/cbc.2000.n.019

Cited by 11 publications

(8 citation statements)

References 18 publications

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“…These adverse events are dose-and schedule-related with stomatitis being more frequent and severe at higher doses, while shorter dosing intervals lead to an increased incidence and severity of skin manifestations. However, in the present study, mucositis, a relatively frequent adverse event of PCX plus anthracycline plus GEM combination (Sanchez-Rovira et al, 2000;Conte et al, 2001;Zielinski et al, 2005), as well as PPE, were mild and uncommon. Moreover, neurotoxicity or cardiac toxicity, which already have been reported to complicate the PCX plus epirubicin plus GEM regimen (Sanchez-Rovira et al, 2000;Zielinski et al, 2005), were not observed in the present study.…”

Section: Discussioncontrasting

confidence: 52%

“…Conversely, in a study by Sanchez-Rovira et al (2000) almost 60% of the cycles required support with granulocyte colony-stimulating factor. In addition, none of the patients in our study developed febrile neutropaenia.…”

Section: Discussionmentioning

confidence: 88%

“…Indeed, the PK studies of doxorubicin in regimens containing PCX have demonstrated that the schedule-dependent increase in C max and AUC and the reduction in doxorubicin clearance were associated with severe neutropaenia and mucositis (Holmes et al, 1996) as well as cardiac toxicity (Gianni et al, 1997). Furthermore, the addition of GEM to the PCX/anthracycline combination was associated with an increased incidence of severe neutropaenia ranging from 62 to 72% of patients (Sanchez-Rovira et al, 2000;Conte et al, 2001;Cappuzzo et al, 2004;Zielinski et al, 2005). In order to improve the toxicity profile of the combination of PCX with anthracyclines, PLD was substituted for doxorubicin or epirubicin and the regimen was administered on a biweekly basis; this phase I study indicated that the regimen was very well tolerated with treatment delay due to grade 2 and 3 neutropaenia to be the dose-limiting event .…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the triplet combination of PCX, epirubicin and GEM was active against MBC, but it was associated with a high (about 60%) incidence of grade 3 and 4 neutropaenia and, to a lesser extent, cardiotoxicity (Sanchez-Rovira et al, 2000;Conte et al, 2001;Cappuzzo et al, 2004;Zielinski et al, 2005). In order to improve the toxicity profile of the triple combination of PCX plus PLD plus GEM by reducing the dose-dependent toxicities and allowing sufficient time to recover between treatments, a biweekly regimen was developed and evaluated in a phase I study.…”

mentioning

confidence: 99%

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A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours

et al. 2007

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To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of pegylated liposomal doxorubicin (PLD), paclitaxel (PCX) and gemcitabine (GEM) combination administered biweekly in patients with advanced solid tumours. Twenty-two patients with advanced-stage solid tumours were treated with escalated doses of PLD on day 1 and PCX plus GEM on day 2 (starting doses: 10, 100 and 800 mg m À2 , respectively) every 2 weeks. DLTs and pharmacokinetic (PK) parameters of all drugs were determined during the first cycle of treatment. All but six (73%) patients had previously received at least one chemotherapy regimen. The DLT dose level was reached at PLD 12 mg m À2 , PCX 110 mg m À2 and GEM 1000 mg m À2 with neutropaenia being the doselimiting event. Of the 86 chemotherapy cycles delivered, grade 3 and 4 neutropaenia occurred in 20% with no cases of febrile neutropaenia. Non-haematological toxicities were mild. The recommended MTDs are PLD 12 mg m À2 , PCX 100 mg m À2 and GEM 1000 mg m À2 administered every 2 weeks. The PK data revealed no obvious drug interactions. Biweekly administration of PLD, PCX and GEM is a well-tolerated chemotherapy regimen, which merits further evaluation in various types of solid tumours.

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Section: Discussioncontrasting

confidence: 52%

Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours

et al. 2007

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“…The overall response rates, including partial and complete responses, ranged from 55.2 to 82.9%, while grades III-IV neutropenia ranged from 41 to 69%. In a phase II trial conducted by Passardi and colleagues, 27% of patients required the use of granulocyte colony-stimulating factor [20][21][22][23] .…”

mentioning

confidence: 99%

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Petrarca

Calleari

Morelle

et al. 2012

JST

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Background: Neoadjuvant chemotherapy is a therapeutic strategy for patients with locally advanced breast cancer. To evaluate the toxicity and clinical efficacy of the combination of Gemcitabine plus doxorubicin followed by paclitaxel in neoadjuvancy. Methods:A phase II trial, in which 19 patients, ages 37 to 65, with pathologically proven breast cancer, were included. They received four cycles of doxorubicin 50mg/m 2 on day 1 and Gemcitabine 1000 mg/m 2 on days 1 and 8, every 21 days;followed by four cycles of paclitaxel 80 mg/m 2 on days 1, 8, and 15, every 28 days. The follow-up was performed with mammography and clinical examination. Results:The planned regimen was completed in 17 (89.4%) of the 19 patients. Thirty seven percent of the patients presented mucositis grades 3-4 and 15% had diarrhea grades 3-4. Hematologic toxicities grades 3-4 were seen in 31.5% of the cases (6 patients). Complete clinical response was observed in 9 (47%) patients; of whom four showed complete pathological response after surgery. Conclusion:The response rate (clinical and pathological) in this study was similar to the one observed in the usual regimen of neoadjuvancy using doxorubicin, cyclophosphamide, and paclitaxel. However, the toxicity profile of the combination regimen containing gemcitabine was exceedingly high, causing the interruption of the protocol.

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A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer

Bozionelou

Kalbakis

Vamvakas

et al. 2009

Cancer Chemother Pharmacol

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Phase II Trial of Gemcitabine/Doxorubicin/Paclitaxel Administered Every Other Week in Patients with Metastatic Breast Cancer

Cited by 11 publications

References 18 publications

A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours

A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

A phase I trial of gemcitabine, docetaxel and carboplatin administered every 2 weeks as first line treatment in patients with advanced breast cancer

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