A phase II study of gemcitabine combined with vinorelbine as first-line chemotherapy for metastatic breast cancer

Shehata, Samir; Saad, Ehab; Goda, Yasser; El-Mesidi, Salah; Koheil, H.; Elzawhri, Heba; Kandeel, Alaa Abdelrahman; Abdelhamid, Thoraya; Zaki, M; Meshref, Mohamed

doi:10.1016/s1658-3876(10)50049-9

Cited by 7 publications

(23 citation statements)

References 31 publications

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“…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: 92%

“…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: 92%

“…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%

“…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%

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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: 92%

Section: Discussionsupporting

confidence: 92%

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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“…For regimens with an incidence of febrile neutropenia less than 10%, routine prophylactic use of CSF is not recommended. 58,59 Because febrile neutropenia was reported in 1% to 14% of patients in the trials of gemcitabine and vinorelbine reviewed, [3][4][5]8,9,25 …”

Section: Indication(s)mentioning

confidence: 99%

Gemcitabine and Vinorelbine (GemVin) Regimen

Shang

Solimando²,

Waddell³

2014

Hosp Pharm

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The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. This column reviews various issues related to preparation, dispensing, and administration of antineoplastic therapy, and the agents, both commercially available and investigational, used to treat malignant diseases. Questions or suggestions for topics should be addressed to Dominic A. Solimando, Jr, President, Oncology Pharmacy Services, Inc., 4201 Wilson Blvd #110-545, Arlington, VA 22203, e-mail: OncRxSvc@comcast.net; or J. Aubrey Waddell, Professor, University of Tennessee College of Pharmacy; Oncology Pharmacist, Pharmacy Department, Blount Memorial Hospital, 907 E. Lamar Alexander Parkway, Maryville, TN 37804, e-mail: waddfour@charter.net.

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Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer

Stemmler

DiGioia

Freier³

et al. 2011

Br J Cancer

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Background:An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory.Methods:Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m−2 plus vinorelbin 25 mg m−2 on days 1+8 (GemVin), or plus cisplatin 30 mg m−2 on days 1+8 (GemCis), or plus capecitabine 650 mg m−2 b.i.d. orally days 1–14 (GemCap), q3w. The primary end point was response rate.Results:A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ⩾grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand–foot syndrome in 2.0% of the GemCap patients (per patient analysis).Conclusions:This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.

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A phase II study of gemcitabine combined with vinorelbine as first-line chemotherapy for metastatic breast cancer

Abstract: With an overall response rate of 42%, the GEM-VRL combination had promising efficacy and good tolerability in metastatic breast cancer patients.

Cited by 7 publications

References 31 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

Gemcitabine and Vinorelbine (GemVin) Regimen

Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer

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