Gemcitabine/Vinorelbine in Metastatic Breast Cancer Patients Previously Treated with Anthracyclines: Results of a Phase II Trial

Lobo, Francisco; Virizuela, Juan Antonio; Dorta, F.J.; Florián, Jesús; Lomas, M.; Jiménez, Eleanor; López, Pedro Juan Tárraga; Casado, Victoria; León, Ana; Estévez, Laura G.; Dómine, Manuel

doi:10.3816/cbc.2003.n.011

Cited by 15 publications

(10 citation statements)

References 14 publications

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“…Grade 3 and 4 neutropenia was observed in 22 patients (52%), consistent with previous reports [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. Although the incidence of neutropenia in the combination therapy was higher than in capecitabine or vinorelbine monotherapy [34,37], the incidence of febrile neutropenia was considerably low, ranging from 0 to 11% [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27], and it would not be associated with infective complications. The compliance with the protocol observed in our trial was favorable, due to the reasonable dose intensity and moderate toxicity.…”

Section: Discussionsupporting

confidence: 81%

“…In addition, most of the patients experienced grade 1 or 2 nonhematologic adverse events, and no severe event was reported. The toxicological profiles and findings in our results were tolerable and similar to those reported previously [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. …”

Section: Discussionsupporting

confidence: 79%

“…Phase II studies demonstrated that the combination chemotherapy has favorable activity, but most of these were nonrandomized, single-arm studies [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. Several randomized phase II and III studies have been conducted for MBC patients evaluating the combination therapy versus monotherapy or sequential therapy, and they reported conflicting results [34,35,36,37].…”

Section: Discussionmentioning

confidence: 99%

“…These characteristics can make the combination regimen effective for MBC patients pretreated with taxanes or anthracyclines. Several phase II studies have investigated using the combination regimen for various lines of treatment of MBC patients [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. The ORR in these studies ranged from 20 to 55%, PFS ranged from 3.5 to 10.8 months, and OS ranged from 9.2 to 20 months.…”

Section: Discussionmentioning

confidence: 99%

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Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015

Yamamura

Masuda²,

Yamamoto³

et al. 2017

Chemotherapy

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Background: This phase II study was conducted to evaluate the efficacy and safety of the chemotherapy combination of gemcitabine and vinorelbine in taxane-pretreated Japanese metastatic breast cancer patients. Methods: In this multicenter, phase II, single-arm study, patients with recurrent or metastatic HER2-negative breast cancer were administered gemcitabine (1,200 mg/m²) and vinorelbine (25 mg/m²) intravenously on days 1 and 8 every 3 weeks. The primary endpoint was the objective response rate, and other endpoints included progression-free survival, overall survival, and safety. Results: A total of 42 patients were enrolled in this study. The objective response rate and clinical benefit rate were 24 and 43%, respectively. The median progression-free survival was 4.0 months. The median overall survival was 11.1 months. Grade 3/4 neutropenia was the most common hematologic toxicity, occurring in 22 patients (54%). Nonhematologic toxicity was moderate and transient, with fatigue (48%) being the most common condition and no severe adverse event reported. Conclusion: The combination of gemcitabine and vinorelbine is an effective and tolerable regimen for HER2-negative, taxane-pretreated, metastatic breast cancer patients in Japan.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015

Yamamura

Masuda²,

Yamamoto³

et al. 2017

Chemotherapy

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“…Gemcitabine is approved for use in human beings for inoperable, locally advanced, or metastatic non-small-cell lung cancer [5][6][7] and locally advanced or metastatic adenocarcinoma of the pancreas. [8][9][10] Other reports indicate it may have value for relapsed B cell chronic lymphocytic leukemia, 11-13 nonHodgkin's lymphoma, [14][15][16] advanced hepatocellular carcinoma, 17 bladder cancer, 18 advanced stage ovarian cancer, 19 breast cancer, [20][21][22] and as a radiosensitizer. 23 The value of gemcitabine in veterinary oncology has yet to be determined.…”

mentioning

confidence: 99%