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Old 07-13-2011, 12:25 PM   #4
Jackie07
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Re: GEMZAR...any tips from those who have had it?

Sheila,

Below are the Gemzar users I gleaned from the 'Calling all Stage IV Sisters' thread and some abstracts I had found before (don't know where I had posted it - the second one is also on Rich's 2nd list). Hopefully these members will see this thread and respond soon.

Trish of Melbourne, Australia had used it briefly in July. 2008

radiant 2010 - went on Gemzar, Navelbine, Herceptin - Navelbine and Herceptin took liver mets down. lymph node slightly progressed.

SoCalGal 3/07 mets - lungs & sternum. Tykerb/Xeloda boo. Tykerb/Carbo/Gemzar boo.

CourtneyL Nov 09- April 10: Lung progression, add Gemzar to Herceptin, Zometa

Pam P 2/09 - gemzar/herceptin/zometa
March 11: Add Gemzar

Am J Clin Oncol. 2011 Jan 26. [Epub ahead of print]
Phase II Trial of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Metastatic Breast Cancer Patients.
Jacquin JP, Chargari C, Thorin J, Mille D, Mélis A, Orfeuvre H, Clavreul G, Chaigneau L, Nourissat A, Dumanoir C, Savary J, Merrouche Y, Magné N.
Departments of*Medical Oncology ‡Public Health, Statistical Unit **Radiotherapy, Institut de Cancérologie de la Loire, St Priest en Jarez †Service of Oncology Radiotherapy, Hôpital d'Instruction des Armées du Val-de-Grâce ¶Department of Oncology Development, Laboratoire Schering Plough ♯Department of Oncology Development, Laboratoire Elli Lilly, Paris §Department of Medical Oncology, Centre Hospitalier de Bourg en Bresse, Bourg en Bresse Department of Medical Oncology, Centre Hospitalier Universitaire Jean Minjoz, Besançon, France.
Abstract
OBJECTIVE: To assess the efficacy and toxicity of pegylated liposomal doxorubicin combined with gemcitabine as first-line chemotherapy in metastatic breast cancer patients in a phase II trial.
PATIENTS AND METHODS: All breast cancer patients with HER2-negative status, hormone refractory tumor, assessable targets, with preserved performance status, and who had not received chemotherapy earlier as treatment for their metastatic disease were eligible. The patients received pegylated liposomal doxorubicin (30 mg/m, venous injection, day 1) concurrently with gemcitabine (1000 mg/m, venous injection, days 1 and 8), 1 cycle every 3 weeks.
RESULTS: Although 38 patients should have been included, this study was prematurely discontinued after recruiting 20 patients because of excessive toxicity: 75% of the patients experienced grade 3 or 4 treatment-related toxicity, including neutropenia, thrombopenia, hand-foot syndrome, and stomatitis, which significantly affected the quality of life. Cardiac toxicity was mild. With regard to efficacy, 50% of the patients (95% confidence interval, 26%-74%) experienced tumor response. The response rate was 40% in patients who had earlier received anthracyclines as adjuvant therapy. Median progression-free survival and median overall survival were 8.8 months and 19 months, respectively.
CONCLUSIONS: This combination was efficient, but not well tolerated. From these results, we could not recommend these doses for further assessment and lower doses should be preferred.

Med Oncol. 2011 Jan 25. [Epub ahead of print]
Safety and efficacy of gemcitabine plus cisplatin combination in pretreated metastatic breast cancer patients.
Brito LG, de Andrade JM, Lins-Almeida T, Zola FE, Pinheiro MN, Marana HR, Tiezzi DG, Peria FM.
Department of Gynecology and Obstetrics, School of Medicine of Ribeirão Preto, São Paulo University, Avenida Bandeirantes, 3900, 8th Floor, Ribeirão Preto, SP, 14048-900, Brazil, lgobrito@gmail.com.
Abstract
Metastatic breast cancers (MBC) previously treated with anthracyclines (A) and taxanes (T) have a complicated management. Gemcitabine (G)-cisplatin (C) combinations have been used as synergistic salvage therapy in MBC and are considered as another option for patients with important symptoms and aggressive visceral disease. We analyzed the safety and efficacy of GC in AT-pretreated MBC, as well as overall survival (OS) and time to progression (TTP). Forty-nine subjects received IV G 750 mg/m(2) and C 30 mg/m(2), both d1 and d8 every 3 weeks. Response evaluation was performed every second cycle and in the end of treatment. GC protocol was the first-line palliative chemotherapy in half of the cases, and median number of cycles/patient were 4(2-12). Lung (75.5%) was the most frequent site of metastasis. Most of the patients related clinical improvement with chemotherapy with minimal/mild tolerable collateral effects in 85.7% of cases. Following 34 months, mean OS/TTP was 13.12/6.6 months. Objective-responded patients (40.3%) were statistically associated with the improvement in symptoms after CT (P < 0.01), and OS was directly correlated with chemotherapy response (P < 0.01). HER-2 overexpression was a prognostic factor with reduced OS (P = 0.01). GC protocol was effective and tolerable in objective-responded patients

Med Oncol. 2010 Dec 31. [Epub ahead of print]
Gemcitabine and cisplatin salvage regimen in heavily pretreated metastatic breast cancer: a Brazilian experience.
de Lima Araújo LH, Moitinho MV, Silva AM, Gomes CA, Noronha Júnior H.
Hospital de Câncer III, Instituto Nacional de Câncer (INCA), Rio de Janeiro, RJ, Brazil, laraujo@inca.gov.br.
Abstract
Gemcitabine and cisplatin combination (Gem-Cis) is a commonly used regimen in metastatic breast cancer (MBC), with proven activity in phase II trials. It is mostly used as a salvage regimen for progressive disease refractory to anthracyclines and taxanes, and when liver dysfunction secondary to liver metastasis precludes these drugs. Retrospective review of medical charts was conducted for patients treated with Gem-Cis for MBC in a single institution in Brazil between January 2004 and July 2007. The purpose of this study was to evaluate the outcomes and toxicity of Gem-Cis in a broad indication, including patients with deteriorated performance status (PS) and liver dysfunction, which were excluded from clinical trials. Fifty-six patients were included. Median age was 52 years, 46.4% were hormone-receptor negative, 57.2% received 3 or more prior chemotherapy lines, and 34 had liver metastasis. The median overall survival (OS) was 7.6 months, the median progression-free survival was 3.3 months, and the response rate was 21.2%. In variable analysis, PS was significantly associated with OS, even after adjusting to other factors. Toxicities included grades 3 or 4 anemia in 19.3%, neutropenia in 21.1%, and thrombocytopenia in 12.3%. Gem-Cis was a relatively active combination in this population that typically carries a poor prognosis. The subgroup of patients with favorable PS experienced longer survival, even when liver metastasis and hepatic dysfunction were a concern. Toxicity was manageable and it was not correlated with PS or liver dysfunction.
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Last edited by Jackie07; 07-13-2011 at 03:22 PM..
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