A Clinical Phase II Study of Cisplatinum and Vinorelbine (PVn) in Advanced Breast Carcinoma (ABC)

Shamseddine, Ali; Khalifeh, Mohammed; Chehal, Aref; Saliba, Teddy; Mourad, Yasser Abou; Taher, Ali T.; Jalloul, Rahif; Bitar, Nizar; Dandashi, Azzam; Abbas, Jaber; Geara, Fady

doi:10.1097/01.coc.0000145335.39398.ee

Cited by 4 publications

(3 citation statements)

References 22 publications

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“…It was reported that the vinorelbine-cisplatin combination yielded 46% to 62% RRs for the treatment of advanced breast cancer [ 56 , 57 ]. In metastatic breast cancer patients previously treated with anthracyclines and docetaxel, the vinorelbine-cisplatin combination was reported to achieve a 47.2% ORR, and median TPP of 16 weeks [ 58 ]. In addition, the combination of vinorelbine and cisplatin achieved a 43.9% ORR and median TTP of 6 months in 41 patients with TNBC, and the major chemotherapy-induced toxicity were bone marrow inhibition, gastrointestinal reactions, and phlebitis [ 59 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes

et al. 2017

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BackgroundThis study aimed to compare the efficacy and safety of vinorelbine plus cisplatin (NP regimen) vs. gemcitabine plus cisplatin (GP regimen) for treatment of metastatic TNBC after failure with anthracyclines and taxanes.Material/MethodsA total of 48 patients with metastatic TNBC that failed in anthracyclines and taxanes treatment were enrolled and randomly grouped. Patients in the NP group (n=22) were given 25 mg/m2 vinorelbine on days 1 and 8 and 25 mg/m2 cisplatin on days 2–4 of each 21-day cycle, while subjects in the GP group (n=26) were administered 1000 mg/m2 gemcitabine on days 1 and 8 and 25 mg/m2 cisplatin on days 2–4 of each 21-day cycle. The treatment response and adverse events were compared between the 2 groups every 2 cycles.ResultsThe ORR, DCR, and median TTP were 45.5%, 77.3%, and 5 months in the NP group, and 46.2%, 80.8%, and 5.2 months in the GP group, and no significant differences were observed in ORR, DCR, and median TTP between the 2 groups (P>0.05). The major adverse events included grade I–II bone marrow inhibition, gastrointestinal reactions, and phlebitis, and a lower incidence of thrombocytopenia and rash and a higher incidence of phlebitis was found in the NP group than in the GP group (P<0.05).ConclusionsEither NP or GP regimen is active and tolerated in treatment of metastatic TNBC with anthracyclines and/or taxanes resistance, which may be used as a salvage treatment for metastatic TNBC.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes

et al. 2017

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“…When used as first-line therapy, the RR ranged between 55 and 67% (table 6) [128,129,130,131,132]. Major toxicities resulting from treatment were myelosuppression as grade III/IV neutropenia and grade III thrombocytopenia.…”

Section: Experience With Combination Chemotherapymentioning

confidence: 99%

Platinum-Based Compounds for the Treatment of Metastatic Breast Cancer

Shamseddine¹,

Farhat²

2011

Chemotherapy

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The role of platinum-based compounds (PBCs) in the treatment of metastatic breast cancer (MBC) has been extensively studied. As single agents, high response rates have been observed in first-line therapy, while results in pretreated patients were discouraging. Regimens containing cisplatin/carboplatin together with taxanes showed the highest efficacy and safety as both first-line and second-line therapy. When administered with vinorelbine, the combination was also active and well tolerated in anthracycline- and taxane-pretreated patients. Combining PBCs with etoposide or nucleoside analogues showed moderate activity, yet high toxicity in the case of etoposide. The overall results for the combination with anthracyclines were disappointing. Addition of trastuzumab to PBC combinations showed remarkable activity and good tolerability in patients with HER2/neu overexpression. The use of cisplatin or carboplatin alongside novel targeted therapeutics for patients with triple-negative MBC seems promising and is being further evaluated. The use of PBCs against MBC requires careful patient selection and combination with the right chemotherapeutic agent.

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“…With the above background, and based on our previous encouraging positive experience with the combination of cisplatinum and vinorelbine (PVn) as salvage therapy for patients with MBC [25], and as first-line therapy for advanced disease [26], we designed this phase II study of PVn followed by docetaxel as a first-line sequential treatment in MBC.…”

Section: Introductionmentioning

confidence: 99%

A Clinical Phase II Study of a Non-Anthracycline Sequential Combination of Cisplatin-Vinorelbine Followed by Docetaxel as First-Line Treatment in Metastatic Breast Cancer

Shamseddine

Otrock²,

Khalifeh³

et al. 2006

Oncology

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Background: We tested a sequential combination regimen using cisplatin and vinorelbine (PVn) followed by docetaxel as first-line chemotherapy in a phase II clinical trial in metastatic breast cancer (MBC). Patients and Methods: Thirty-five patients were enrolled. Cisplatin 80 mg/m² was given on day 1 and vinorelbine 30 mg/m² on days 1 and 8 every 3 weeks for 4 cycles. Responding patients received docetaxel 75 mg/m² every 21 days for a maximum of 4 cycles. Three patients were excluded from analysis because of death unrelated to treatment. Results: After a median follow-up of 14 months, 32 patients completed the study. The overall response rate was 53.1%. Complete remission was seen in 5 patients (15.6%), partial response in 12 (37.5%), stable disease in 6 (18.75%), and progressive disease in 9 patients (28.1%). Median time to disease progression was 8 months (range 1–24). At 24 months, 12 (37.5%) patients were alive. A total of 183 cycles were administered. Febrile neutropenia was observed in 4 patients (2.2%). Grade II nephrotoxicity occurred in 12 cycles (6.5%) and grade III vomiting in 31/183 cycles (16.9%). Discussion: PVn is a feasible non-anthracycline option as first-line chemotherapy in patients with metastatic breast cancer and has acceptable toxicity. The sequential addition of 4 cycles of docetaxel following 4 cycles of PVn did not improve the overall response rate and results.

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A Clinical Phase II Study of Cisplatinum and Vinorelbine (PVn) in Advanced Breast Carcinoma (ABC)

Abstract: PVn is effective as first line treatment of advanced breast cancer with overall response rate of 64% in metastatic breast cancer and 92.3% in locally advanced breast cancer, and acceptable toxicity.

Cited by 4 publications

References 22 publications

Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes

Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes

Platinum-Based Compounds for the Treatment of Metastatic Breast Cancer

A Clinical Phase II Study of a Non-Anthracycline Sequential Combination of Cisplatin-Vinorelbine Followed by Docetaxel as First-Line Treatment in Metastatic Breast Cancer

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