A phase II trial of vinorelbine plus gemcitabine in previously untreated inoperable (stage IIIb/IV) non-small-cell lung cancer patients aged 80 or older

Chen, Yuh Min; Perng, Reury Perng; Chen, Mei Chun; Tsai, Chun Ming; Ming-Liu, Jacqueline; Whang‐Peng, Jacqueline

doi:10.1016/s0169-5002(03)00031-x

Cited by 22 publications

(14 citation statements)

References 22 publications

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“…Among the available variates, our results demonstrated that PS, comorbidity, chemotherapy cycle and second-line therapy were correlated with patient prognosis in univariate analysis. The favorable prognosis in patients with good PS is consistent with previous studies [12, 15]. PS is well known to be one of the most powerful prognosticators of survival in patients with advanced NSCLC.…”

Section: Discussionsupporting

confidence: 91%

“…In phase II trials of vinorelbine plus gemcitabine, response rates were between 18 and 35%, with a median survival time from 10 to 11 months. The regimens were generally well tolerated by elderly patients with advanced NSCLC [11, 12, 21]. Phase II studies on a combination of new cytotoxic agents with cisplatin in modified schedules or attenuated doses also revealed good activity and tolerability [22, 23].…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the risks of noncancerous comorbidities and poorer performance status (PS) also have an impact on the ability of the elderly to tolerate combination chemotherapy in this setting. Despite these concerns, several phase II trials have shown that single-agent vinorelbine or gemcitabine treatment and a non-platinum-containing combination of vinorelbine plus gemcitabine was well tolerated and showed activity in elderly patients aged ≥70 years with advanced NSCLC [7,8,9,10,11,12]. Several retrospective subset analyses of randomized trials have shown that main treatment outcome did not differ between adult and elderly patients treated with platinum-based combination chemotherapy [13,14,15].…”

Section: Introductionmentioning

confidence: 99%

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Prognostic Factors in Elderly Patients with Advanced Non-Small Cell Lung Cancer Treated with Chemotherapy

Chen

Dai

et al. 2009

Oncology

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Objective: The prognosis of advanced non-small cell lung cancer (NSCLC) is poor. The aim of this study was to assess the outcome of chemotherapy for elderly patients with advanced NSCLC, focusing on the prognostic factors influencing survival. Methods: We reviewed retrospectively the medical records of 109 elderly patients with advanced NSCLC treated with chemotherapy from January 1999 to December 2006. Collected data included demographic information, clinical assessment before therapy, and information on treatment and outcome. Survival was estimated using the Kaplan-Meier method, and prognostic factors were analyzed by the log-rank test and Cox regression model. Results: The median survival time for the entire group was 10.5 (95% confidence interval: 9.15–11.88) months, with 1- and 2-year survival rates of 31.2 and 9.2%, respectively. Univariate analysis showed that performance status (PS; p = 0.013), comorbidity (p = 0.006), chemotherapy cycle (p = 0.006) and second-line therapy (p = 0.002) significantly influenced overall survival. In multivariate analysis, comorbidity, chemotherapy cycles and second-line therapy were identified as independent prognostic factors. Conclusions: Survival of elderly patients with advanced NSCLC treated with chemotherapy is significantly influenced by the patient’s PS, comorbidity, chemotherapy cycle and second-line therapy. These results may help to choose the appropriate treatment in clinical practice.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prognostic Factors in Elderly Patients with Advanced Non-Small Cell Lung Cancer Treated with Chemotherapy

Chen

Dai

et al. 2009

Oncology

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“…Published literature reports describe apparently similar presentations of gemcitabine-associated lung injury with the terms capillary leak syndrome, 24,26 -30 noncardiogenic pulmonary edema, 16,31,32 interstitial pneumonitis, 16,[33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48] acute pneumonitis, 49 acute respiratory distress syndrome, 8,36,50,51 acute pulmonary toxicity, 52 or acute lung injury. 16,44,45,36,46,[53][54][55][56] In conclusion, our findings highlight the importance of consideration of the risk of lung injury from drug-drug or drug-radiotherapy interactions in designing novel therapeutic regimens for cancer patients, particularly for drugs with additive or synergistic pulmonary toxicity. The MedWatch program is the mechanism by which healthcare professionals …”

Section: Discussionmentioning

confidence: 99%

Clinical features and correlates of gemcitabine‐associated lung injury

Belknap

Kuzel

Yarnold

et al. 2006

Cancer

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BACKGROUNDGemcitabine is a commonly used chemotherapeutic agent structurally and pharmacologically similar to cytarabine. Recently, instances of severe gemcitabine‐associated lung injury have been reported. Herein, investigators affiliated with the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program evaluated clinical characteristics of gemcitabine‐associated severe acute lung injury from clinical trial reports, medical literature case reports, and spontaneous reports to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS).METHODSClinical data were obtained by reviewing adverse event case reports for gemcitabine‐associated lung injury as reported in the medical literature and in the FDA AERS database. Upper limit estimates of ADE rate were derived from review of published clinical trials reporting gemcitabine‐associated lung injury rates of 10% or higher.RESULTSA total of 178 reports of gencitabine‐associated lung injury were identified; in AERS, there were 55 cases from clinical trials and 92 spontaneous reports. A comprehensive search revealed 31 medical literature reports. Clinical features of gemcitabine‐associated lung injury included dyspnea, fever, pulmonary infiltrate, and cough with recognition of toxicity occurring after a median duration of 48 (range, 1‐529) days after initiation of gemcitabine. The taxanes, docetaxel and paclitaxel, were frequently reported as coadministered therapies. Eleven Phase II or Phase III clinical trials with 317 patients identified gemcitabine‐associated lung injury rates of greater than 10%, with the highest rates (22% and 42%) being observed in Phase III clinical trials where Hodgkin disease patients were treated with a regimen that included gemcitabine and bleomycin.CONCLUSIONSHigh rates of gemcitabine‐associated severe lung injury were observed when gemcitabine was combined with other therapies known to also cause lung injury. Physicians should have a high index of suspicion for this toxicity and report the relevant clinical findings to the FDA's AERS. Cancer 2006. © 2006 American Cancer Society.

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“…Elderly patients with a good performance status are considered candidates for platinum-based combination therapy [16]. Also, Chen et al [17] found a better prognosis in elderly patients with NSCLC with a good performance status. Our results were consistent with these previous studies.…”

Section: Discussionmentioning

confidence: 99%

Prognostic factors in elderly patients with non-small cell lung cancer: a two-center experience

et al. 2010

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Non-small cell lung cancer (NSCLC) is usually at advanced stage when it is diagnosed. There is no consensus about the standard treatment in elderly patients with advanced NSCLC. Generally, data regarding elderly patients with NSCLC are withdrawn from general NSCLC studies based on subgroup analyses and suggestions. We evaluated prognostic factors in elderly patients with advanced NSCLC. We reviewed retrospectively 338 patients from August 2005 to July 2009 in two centers in Turkey. Medical records of the patients≥65 years with advanced NSCLC were collected. Collected data included demographic informations, clinical assessments and information on treatment, toxicities and outcomes. Survival was estimated by using Kaplan-Meier method and prognostic factors were evaluated with log-rank and Cox regression tests. The median overall survival (OS) for the entire group was 15.4 months (95% CI: 12.7-18.0). In univariate analysis, weight loss, stage, combination therapy, second-line chemotherapy and tumor response (P<0.01) and performance status significantly affected OS (P<0.05). The median progression-free survival (PFS) was 10 months (95% CI: 8.4-11.6). In univariate analysis, there was only a significant association between tumor response and PFS (14.6 vs. 8.5 months; P<0.001). Multivariate analysis showed that only response to therapy was an important prognostic factor for OS (P<0.001). Survival of elderly patients with advanced NSCLC is significantly influenced by performance status, weight loss, stage, combination therapy, second-line chemotherapy and response to therapy. Not only age but also these factors may be kept in mind in the treatment planning of the elderly patients with NSCLC. These results may be of benefit in changing clinical practice in elderly patients with NSCLC who are often undertreated.

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A phase II trial of vinorelbine plus gemcitabine in previously untreated inoperable (stage IIIb/IV) non-small-cell lung cancer patients aged 80 or older

Cited by 22 publications

References 22 publications

Prognostic Factors in Elderly Patients with Advanced Non-Small Cell Lung Cancer Treated with Chemotherapy

Prognostic Factors in Elderly Patients with Advanced Non-Small Cell Lung Cancer Treated with Chemotherapy

Clinical features and correlates of gemcitabine‐associated lung injury

Prognostic factors in elderly patients with non-small cell lung cancer: a two-center experience

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