Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma

Fennell, Dean A.; Steele, Jeremy; Shamash, Jonathan; Sheaff, Michael; Evans, Marie T.; Goonewardene, T.I.; Nyström, Maria; Gower, Nicole H.; Rudd, Robin

doi:10.1016/j.lungcan.2004.08.005

Cited by 43 publications

(17 citation statements)

References 18 publications

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“…[24][25][26] The safety and efficacy of oxaliplatin and vinorelbine combination chemotherapy have been tested in breast cancer, 27 lung cancer, [28][29][30] and malignant pleural mesothelioma. 31 Recently, a phase I/II study selected 4 different dose levels of vinorelbine and oxaliplatin (NVBOX) for phase I study in MBC and no doselimiting toxicities occurred even at the highest level (vinorelbine 30 mg/m 2 and oxaliplatin 90 mg/m 2 every 2 weeks). Then this dosage and schedule of NVBOX as first-line treatment was recommended to the phase II study including 44 MBC patients and was found well tolerated and highly active with ORR of 59%, PFS of 9.2 months and overall survival (OS) of 18.6 months.…”

Section: Introductionmentioning

confidence: 99%

A phase II trial of biweekly vinorelbine and oxaliplatin in second- or third-line metastatic triple-negative breast cancer

Zhang

Wang

et al. 2015

Cancer Biology & Therapy

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These authors contributed equally to this work.Keywords: chemotherapy, metastatic breast cancer, oxaliplatin, triple-negative, vinorelbineAbbreviations: TNBC, triple-negative breast cancer; mTNBC, metastatic triple-negative breast cancer; ER, estrogen receptor; PgR, progesterone receptor; HER2, human epidermal growth factor receptor 2; ORR, overall response rate; MBC, metastatic breast cancer; ECOG, Eastern Cooperative Oncology Group; TTP, time to progression; SD, stable disease; CBR, rate of clinical benefit; CR, complete response; PR, partial response; CI, confidence interval; HR, hazard ratio; AE, adverse events; IHC, immunohistochemistry; FISH, fluorescence in situ hybridization; ANC, absolute neutrophil count; ULN, upper limit of normal; IV, intravenously.Patients with metastatic triple-negative breast cancer (mTNBC) typically have a poor prognosis. The purpose of this study was to prospectively evaluate the efficacy and toxicity of biweekly combination of vinorelbine and oxaliplatin (NVBOX) in second-or third-line setting for mTNBC. Eligible patients were female with 18-70 y old, and had mTNBC that had progressed after 1or 2 prior chemotherapy regimens in the metastatic setting. NVBOX was given biweekly every 4 week for a maximum of 6 cycles. The primary endpoint was progression-free survival (PFS). Forty-4 patients were recruited. All patients had been exposed to anthracyclines and/or taxanes; 56.8% of patients were cis/carbo-platin pretreated. Among the 38 evaluable patients, overall response rate was 31.6% and 7 lasted 6 months. The median PFS and overall survival (OS) were 4.3 (95% CI, 3.6-5.0) months and 12.6 (95% CI, 8.1-17.0) months, respectively. PFS and OS was significantly shorter in patients with interval from diagnosis to recurrence 1 y and time to progression (TTP) of 1-2 previous regimens before recruitment 3 months. For 34 patients who were treated in second line setting, prior platinum was a factor significantly compromising the PFS of NVBOX. Grade 3/4 hematologic toxicities included neutropenia (70.5%), thrombocytopenia (27.3%) and anemia (15.9%). The most frequent grade 3/4 non-hematologic toxicities were constipation/abdominal distension (20.5%) and nausea/vomiting (13.6%). We conclude that biweekly NVBOX regimen is effective with a good safety profile in the second-or third-line mTNBC, which warrants further investigation in a phase III study. This trial was registered with www.clinicaltrials.gov (no. NCT01528826).

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Section: Introductionmentioning

confidence: 99%

A phase II trial of biweekly vinorelbine and oxaliplatin in second- or third-line metastatic triple-negative breast cancer

Zhang

Wang

et al. 2015

Cancer Biology & Therapy

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“…To date, only multimodality regimens employing extrapleural pneumonectomy (EPP) followed by adjuvant chemoradiation have demonstrated prolonged survival [2,4,5]. The prognosis of disease depends on performance status, age, histology, and hematological parameters [6,7]. However, the mode of treatment and clinical classification are independent prognostic factors for patients with MPM [8].…”

Section: Introductionmentioning

confidence: 99%

Multimodality approach in management of malignant pleural mesothelioma

Neragi-Miandoab

2006

European Journal of Cardio-Thoracic Surgery

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Malignant pleural mesothelioma (MPM) is a solid, locally aggressive tumor, which has been closely linked to asbestos exposure. The survival rate without treatment ranges from 4 to 12 months. Response to chemotherapy and radiation is poor, and surgery is the most effective therapy. There are currently 3000 new MPM cases per year in the United States, with the peak incidence in the United States and Europe expected to occur in the year 2020. The prognosis depends on the stage of the tumor at the time of diagnosis, its histological type, lymph node status, and resection margins. While the diagnosis is often delayed, earlier intervention may improve life expectancy. Single-modality therapy has not been effective in changing the natural history of MPM. As a result, multimodality regimens involving surgery with radiation, chemotherapy, or immunotherapy have been initiated. Multiple modality approach has demonstrated favorable outcome, particularly in patients with epithelial histology, negative resection margins and presence of no metastases to extrapleural lymph nodes. Cisplatin and mitomycin have demonstrated modest efficacy in management of distant tumor recurrence. Cisplatin and gemcitabine regimen as well as cisplatin/pemetrexed followed by 54 Gy of adjuvant hemithorax radiation have been reported to improve the outcome.

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“…The high-dose regimen of gemcitabine and epirubicin had a confirmed response rate, median duration of response, median overall survival, and median time to disease progression that were comparable to other combination regimens, 10,12,22,23,26,27 but was found to have significant hematologic toxicity. Although the low-dose regimen had better hematologic toxicity, it was not found to have significant clinical activity against MPM.…”

Section: Discussionmentioning

confidence: 77%

A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma

Okuno

Delaune

Sloan

et al. 2008

Cancer

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BACKGROUND.The North Central Cancer Treatment Group (NCCTG) conducted a phase 2 study to evaluate the antitumor activity of the combination of gemcitabine and epirubicin in patients with pleural mesothelioma who received no more than 1 prior chemotherapy regimen.METHODS.A total of 23 patients were accrued between August 2001 and April 2002 and received gemcitabine at a dose of 1000 mg/m2 intravenously over 30 minutes weekly every 2 weeks and epirubicin at a dose of 90 mg/m2 intravenously on Day 1 on an every‐21‐days cycle (high‐dose patient group). Between August 2002 and April 2004, an additional 45 patients were treated at a reduced dose of gemcitabine of 750 mg/m2 and epirubicin at a dose of 70 mg/m2 with the same schedule (low‐dose patient group).RESULTS.In the high‐dose patient group, the confirmed response rate was 13% (95% confidence interval [95% CI], 3–34%). The median survival was 9.3 months (95% CI, 7.4–10.7 months) and the median time to disease progression was 6.3 months (95% CI, 3.0–7.6 months). In the low‐dose patient group, the confirmed response rate was 7% (95% CI, 0–28%). The median survival was 5.7 months (95% CI, 4.7–8.7 months) and the median time to disease progression was 4.2 months (95% CI, 2.7–5.6 months). Toxicity was moderate to severe. In the high‐doseand low‐dose groups, 87% and 60% of patients, respectively, experienced at least 1 adverse event of grade 4 or higher (according to National Cancer Institute Common Toxicity Criteria [version 2.0]). The quality of life remained similar from baseline to the end of the 2 cycles of treatment in the high‐dose group but worsened in the low‐dose group.CONCLUSIONS.In the current study, the combination regimen of gemcitabine and epirubicin was found to demonstrate minimal antitumor activity against pleural mesothelioma. Cancer 2008. © 2008 American Cancer Society.

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Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma

Cited by 43 publications

References 18 publications

A phase II trial of biweekly vinorelbine and oxaliplatin in second- or third-line metastatic triple-negative breast cancer

A phase II trial of biweekly vinorelbine and oxaliplatin in second- or third-line metastatic triple-negative breast cancer

Multimodality approach in management of malignant pleural mesothelioma

A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma

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