Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer

Dong, Ningning; Wang, Mingyu; Li, Huiqing; Cui, Yongchun; Guo, Qisen

doi:10.1007/s00280-012-1830-1

Cited by 9 publications

(9 citation statements)

References 30 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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“…In fact, response rates in phase II studies 22-39 ranged from 22.0% to 55.5%, depending on patient characteristics, drug doses and schedules, and the type of previously administered chemotherapy. TTP ranged from 3.5 to 10.8 months, and the overall survival duration ranged from 9.2 to 20 months.…”

Section: Discussionmentioning

confidence: 99%

Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature

Abdayem¹,

Ghosn²,

Valero³

et al. 2014

J. Cancer

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Background: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pretreated with anthracyclines and taxanes. Methods: A phase I study was conducted first to establish the maximum tolerated dose (MTD) of the G and V combination in MBC patients. Then, a phase II study evaluated the response rates, the median time to progression (TTP), the overall survival (OS) as well as the toxicities resulting from this combination at the MTD. Results: Nine patients were enrolled in the phase I study. The MTD was identified as 700mg/m2 of G on days 1 and 8 in combination with 15 mg/m2 of V on days 2 and 9, every 21 days. Twenty-one of 25 patients involved in the phase II study were evaluable for response. No complete or partial responses were achieved; 6 patients (24.0%) had stable disease and 15 (60.0%) progressed. The median TTP was 2 months and the median OS 10 months. Grade 3/4 Neutropenia was the major hematologic toxicity, occurring in 52% of the cycles. The most common non-hematologic grade 3/4 toxicities were fatigue (18%), myalgias (17%) and arthralgias (13%). Conclusion: In heavily pretreated patients with MBC, the combination of G and V at the doses stated above was ineffective as it did not induce partial or complete responses. Other chemotherapy agents or combinations should be evaluated in future studies.

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Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review

Mourey

Balardy

Kanoun

et al. 2017

Breast Cancer Res Treat

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Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

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Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer

Abstract: Gemcitabine in combination with vinorelbine is active and safe in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.

Cited by 9 publications

References 30 publications

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

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

Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review

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