Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study
C. ChouaïdSarah DansonStefan AndreasObukohwo SiakpereL. BenjaminRainer EhneßMarie-Hélène Dramard-GoasdoueJanina BarthHans HoffmannVanessa PotterFabrice BarlésiMark PriceCostel ChirilaKelly HollisCarolyn SweeneySorrel WolowaczJames A. KayeIlias Kontoudis
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To inform health-technology assessments of new adjuvant treatments, we describe treatment patterns in patients with complete resection of stage IB-IIIA non-small cell lung cancer (NSCLC) in France, Germany, and the United Kingdom (UK).Data were collected via medical record abstraction. Patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC, diagnosed between 01 January 2009 and 31 December 2011. Median follow-up was 26 months. Adjuvant treatment patterns and clinical outcomes were summarized descriptively.Among the 831 patients studied, 239 (29%) had stage IB disease, 179 (22%) had stage IIA disease, 165 (20%) had stage IIB disease, and 248 (30%) had stage IIIA disease. Adjuvant systemic therapy was received by 402 patients (48.4%), (France, 61.8%; Germany, 51.9%; UK, 33.4%). Use of adjuvant therapy increased with increasing stage of disease. Cisplatin/vinorelbine and carboplatin/vinorelbine were the most frequently prescribed adjuvant regimens. Median disease-free survival was 48.0 months (95% confidence interval [CI] 42.3-not estimable); the 25th percentile was 13.2 months (95% CI, 11.0-15.3). 204 patients (24%) died during the follow-up period. The median overall survival was not reached, the 25th percentile was 31.2 months (95% CI 26.8-36.0 months). 272 patients (33%) had disease recurrence during the follow-up period. For 86 of those patients, the first recurrence was local or regional with no distant metastasis and 14 had further progression to metastatic disease during the follow-up time. For the other 186 patients, the first recurrence involved distant metastases. A total of 200 patients had metastatic disease at any time during study follow-up.Less than half the patients with stage IB-IIIA NSCLC in this observational study received adjuvant systemic therapy. A high rate of first recurrence with distant metastatic disease was observed, emphasising the need for more effective systemic adjuvant therapies in this population.Keywords:
Vinorelbine
Adjuvant Therapy
Carboplatin
现在的学习试图在在老非小的房间肺癌症(NSCLC ) 的生活(QOL ) 的质量的提升上加 vinorelbine 调查 Shenfu 注射的功效的目的病人。一个使随机化的单个盲目选拔赛方法被使用的方法。有 NSCLC 的阶段 IIIB-IV 的 46 个病人随机被划分成试验性的组和控制组。在试验性的组，病人从白天 1 ～ 14 与 50 mL Shenfu 注射被对待，加 vinorelbine (NVB ) 白天 1 和 8 上的 25 mg/m2。在控制组，病人仅仅在白天 1 和 8 上与 NVB 25 mg/m2 被对待。在治疗， QOL，功效和毒性的二周期鈥檚 被观察以后。结果 QOL 在试验性的组和控制组被提高。然而，在在试验性的组的治疗以后的 KPS 的差别比在控制组显著地高( 14 卤 10 对 8 卤 10 ， t = 2.116 ， P = 0.04 )， QOL 的改进率比在控制组好(76.2%对45.0%， 蠂2 = 4.188 ， P = 0.041 )，在试验性的组的相关毒性也是的治疗显著地比在控制组降低( 蠂2 = 3.866 ， P = 0.049 )，但是在二个组之间的功效的差别不是重要的(14.3%对15.0%， 蠂2 = 0.161 ， P = 0.68 加 vinorelbine 的结论 Shenfu 注射能在老 NSCLC 病人提高 QOL。关键词非小的房间肺癌症 - 生活的质量 - 毒性 - shenfu 注射 - vinorelbine
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Vinorelbine is a new semisynthetic vinca alkaloid with significantly less neurotoxicity than other vinca alkaloids. It was recently approved by the Ministry of Health and Welfare in Japan for the treatment of non-small-cell lung cancer. Vinorelbine is active in metastatic breast cancer with a first time response rate of 40% to 52%. High response rates were observed with combination chemotherapies of vinorelbine and other active agents for breast cancer. In non-small-cell lung cancer, four randomized phase III trials of vinorelbine demonstrated that vinorelbine alone, or combination chemotherapy of vinorelbine with cisplatin, improved survival more than best supportive care or cisplatin plus vindesine, respectively. There is a high level of evidence that vinorelbine is an effective agent for the treatment of non-small-cell lung cancer.
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The purpose of this study was to investigate the efficacy and safety profile of vinorelbine-based chemotherapy in different settings for the treatment of breast cancer. We performed a computerized search using combinations of the following keywords: "breast cancer", "breast neoplasms", "trial", "vinorelbine" and "navelbine". A total of 20 trials were included in this analysis, with a total of 5,080 patients accrued. Taxane was associated with enhanced overall survival (OS; p = 0.027) and response rate (RR; p = 0.037) as compared with vinorelbine in monotherapy, but did not show significantly favored progression-free survival (PFS; p = 0.136). Vinorelbine alone was equivalent to fluoropyrimidine treatment in RR (p = 0.79) for the treatment of metastatic breast cancer. For vinorelbine-combined regimens, the analysis showed that the vinorelbine group gave similar results as other regimens for OS (p = 0.849) and PFS (p = 0.143). The RR of vinorelbine-combined regimens was slightly better than that of the other regimens (OR, 1.17), but the difference was not statistically significant. In neoadjuvant setting, vinorelbine treatment was as active as AC (doxorubicin, cyclophosphamide) or DAC (doxorubicin, cyclophosphamide, docetaxel) regimens with respect to RR (p = 0.76) and pathologic complete response (pCR; p = 0.77), but showed lower occurrence of grade 3/4 adverse effects. The analysis also demonstrated that vinorelbine-containing therapy is effective as adjuvant, front-line or salvage therapy of metastatic breast cancer, even for patients who were previously treated with anthracyclines or taxanes.
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Background Cisplatin and vinorelbine given intravenously is a well-established adjuvant chemotherapy regimen after surgery for early non-small cell lung cancer. However, few validated alternatives exist when cisplatin is not indicated or tolerated. Carboplatin is frequently used in this setting. We evaluated the 5-year overall survival, progression-free survival and toxicity in patients treated for stage IB to IIIB resected non-small cell lung cancer receiving adjuvant carboplatin-based chemotherapy compared to cisplatin in association with vinorelbine. Methods Single-center retrospective study of patients having received adjuvant chemotherapy between January 2004 and December 2013 at the oncology clinic at Institut Universitaire de Cardiologie et de Pneumologie de Québec (Canada). Three sub-groups, cisplatin/vinorelbine, carboplatin/vinorelbine and the substitution of cisplatin/vinorelbine for carboplatin/vinorelbine (cisplatin/vinorelbine/carboplatin/vinorelbine), were studied during treatment. Results One hundred twenty-seven patients were included in this study. The median PFS was not significantly different, with 50.4 months for cisplatin/vinorelbine, 57.3 months for cisplatin/vinorelbine/carboplatin/vinorelbine and not yet achieved for the carboplatin/vinorelbine group ( p = 0.80). Overall survival also did not differ significantly between the three groups. The 5-year overall survival rates were 66% in cisplatin/vinorelbine group, 55% in carboplatin/vinorelbine group and 70% in cisplatin/vinorelbine/carboplatin/vinorelbine group ( p = 0, 95). No differences were noted between groups concerning high-grade hematologic toxicity. Conclusions Although the effectiveness and hematologic toxicity are comparable between cisplat in and carboplatin in the adjuvant treatment of resected non-small cell lung cancer, the results obtained corroborate the practice used at our oncology clinic. Nevertheless, more prospective studies would be needed to confirm these results.
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Aim: to analyze the results of treatment with vinorelbine in patients with metastatic breast cancer (BC). Patients and methods: There were 5943 of new cases of BC in Moscow and there were 2378 patients with IV stage of the disease. 113 patients were treated with vinorelbine as a monotherapy, 1056 had other options of chemotherapy and 1209 patients had no treatment. As a first-line therapy vinorelbine was used in 13.5% of patients, as a second-line – in 59.7% and as a third-line – in 26.8%. Results: There were no significant difference in 1-year survival between group of treatment with vinorelbine (CI 95%; 0.25–1.0), group of other options of chemotherapy (CI 95%; 0.47–1.0) and group with no treatment (CI 95%; 0.32–0.49). But there were a clear tendency of increasing of difference between vinorelbine group and group without treatment. Conclusion: Vinorelbine is an ef fective and well-tolerated agent in patients with metastatic BC. But randomized multicenter trials are needed to evaluate ef ficacy of vinorelbine as a monotherapy.
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Many patients with metastatic nonsmall cell lung carcinoma (NSCLC) cannot tolerate intravenous chemotherapy. Orally active agents would be more convenient and thus could improve their quality of life.A total of 189 patients were randomized 2:1, 181 patients received treatment, 120 PO and 61 IV vinorelbine, 158 patients had stage IV and 31 stage IIIB disease. Among patients who received PO vinorelbine, the median age was 72 years, 62% were males; the Karnofski Performance Status (KPS) was 80-100 in 71%. These compare with a median age of 70 years, 56% male, and KPS of 80-100 in 65% of patients who received IV vinorelbine. Oral vinorelbine 60 mg/m2 was to be dose-escalated to 70 mg/m2 after the initial 3-weekly doses if there was no unacceptable toxicity. Intravenous vinorelbine was to be given 30 mg/m2 weekly.Five patients (4%) on PO and 8 (13%) on IV vinorelbine had a confirmed partial response, 56 (44%) and 29 (46%) had stable disease, respectively. Median time-to-disease-progression was 16.6 weeks (PO) versus 23.9 weeks (IV), and the median survival was 26 weeks (PO) versus 40.9 weeks IV vinorelbine. Median survival on PO vinorelbine for patients with KPS 60-70 was 8.3 weeks versus 43 weeks (IV). On PO vinorelbine 59 patients (57%) were dose escalated, 9 (7.5%) were dose reduced, and 10 (8.3%) did not receive PO vinorelbine at week 4. Pharmacokinetic studies confirmed PO vinorelbine exposure was significantly less than IV exposure.The inability to escalate the dose of PO vinorelbine above 60 mg/m2 weekly resulted in inferiority to IV vinorelbine at 30 mg/m2 weekly, especially in patients with poor performance status.
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