Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Lilenbaum, Rogério; Cano, Roberto; Schwartz, Michael; Siegel, Lydia C.; Lutzky, Jose; Lewis, Marion; Krill, Elisa; Barreras, Luis; Davila, Evelyn P.

doi:10.1002/(sici)1097-0142(20000201)88:3<557::aid-cncr10>3.0.co;2-5

Cited by 45 publications

(13 citation statements)

References 11 publications

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“…Indeed, there were no clinically relevant differences between included and excluded patients on any measured variable, except for the frequency of single vs double chemotherapy regimen. During the study period, double regimen was considered advantageous for the higher risk patients (Lilenbaum et al, 2000;Lilenbaum, 2003).…”

Section: Discussionmentioning

confidence: 99%

Flexible modeling improves assessment of prognostic value of C-reactive protein in advanced non-small cell lung cancer

et al. 2010

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BACKGROUND: C-reactive protein (CRP) is gaining credibility as a prognostic factor in different cancers. Cox's proportional hazard (PH) model is usually used to assess prognostic factors. However, this model imposes a priori assumptions, which are rarely tested, that (1) the hazard ratio associated with each prognostic factor remains constant across the follow-up (PH assumption) and (2) the relationship between a continuous predictor and the logarithm of the mortality hazard is linear (linearity assumption). METHODS: We tested these two assumptions of the Cox's PH model for CRP, using a flexible statistical model, while adjusting for other known prognostic factors, in a cohort of 269 patients newly diagnosed with non-small cell lung cancer (NSCLC). RESULTS: In the Cox's PH model, high CRP increased the risk of death (HR ¼ 1.11 per each doubling of CRP value, 95% CI: 1.03 -1.20, P ¼ 0.008). However, both the PH assumption (P ¼ 0.033) and the linearity assumption (P ¼ 0.015) were rejected for CRP, measured at the initiation of chemotherapy, which kept its prognostic value for approximately 18 months. CONCLUSION: Our analysis shows that flexible modeling provides new insights regarding the value of CRP as a prognostic factor in NSCLC and that Cox's PH model underestimates early risks associated with high CRP.

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Section: Discussionmentioning

confidence: 99%

Flexible modeling improves assessment of prognostic value of C-reactive protein in advanced non-small cell lung cancer

et al. 2010

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“…Their PR rate was 54.5% (6 patients), similar to the one observed in the younger population (52.2%, 12 out of 23 patients). The survival analysis, according to PS, confirmed the findings of Lilenbaum et al 14 The 10 patients with a PS of 2 had a median survival of only 3.3 months, in contrast to 17.5 months for the 24 patients with a PS of 0ϩ1. The difference in survival distribution curves was also highly significant (P ϭ 0.003) (Fig.…”

Section: Response and Survivalmentioning

confidence: 99%

Flexible chemotherapy regimen with gemcitabine and vinorelbine for metastatic nonsmall cell lung carcinoma

Hirsh¹,

Langleben²,

Ayoub³

et al. 2001

Cancer

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“…Lilenbaum et al 29 conducted another Phase II study evaluating the combination of gemcitabine and vinorelbine in patients with advanced NSCLC. Thirty two patients with Stage IIIB or IV NSCLC were treated with gemcitabine at 1250 mg/m 2 over 30 minutes (1000 mg/m 2 for the first six patients) and vinorelbine at 25 mg/m 2 over 6 minutes, both administered intravenously on Days 1 and 8 every 21 days.…”

Section: Discussionmentioning

confidence: 99%

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Herbst

Khuri

et al. 2002

Cancer

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BACKGROUNDGemcitabine and vinorelbine are two of the most active third‐generation agents for the treatment of advanced nonsmall cell lung carcinoma (NSCLC). The authors conducted a formal Phase II trial to evaluate the efficacy of this combination in both untreated and previously treated patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC.METHODSA total of 78 patients were treated on the current Phase II trial of front‐line or second/third‐line therapy with gemcitabine and vinorelbine in NSCLC. Eligible patients manifested either untreated disease (n = 42) or had received at least one but not more than two prior chemotherapy regimens (n = 36). The median age was 59 years (range, 33–79) with 57 men (73%) and 21 women (27%). The median performance status was one (range, one to two). The initial eight patients (four untreated and four previously treated) were treated at a previously established maximum tolerated dose of vinorelbine (30 mg/m2) and gemcitabine (1000 mg/m2) on Days 1, 8, and 15, with significant myelosuppression seen in five out of eight patients requiring dose omission in the first cycle. The next 70 patients received a reduced dose of vinorelbine (25 mg/m2) followed by gemcitabine (900 mg/m2) on Days 1, 8, and 15.RESULTSSeventy eight patients were treated. Fifteen (36%) of the 42 evaluable patients who received front‐line therapy had objective responses and 14 (33%) had stable disease. In the patients with prior treatment, 6 (17%) of 36 patients had partial response and 18 patients (50%) had stable disease. Median survival time for the previously untreated patient group was 10.1 months, with a one year survival of 43% and a two year survival rate of 32%. For the previously treated patients, the median survival time was 8.5 months, with a one year survival rate of 30%. Toxic effects were notable for significant myelosuppression, with ≥Grade 3 granulocytopenia seen in 55% of the patients on the untreated arm and 67% of the patients on the previously untreated arm. Additionally, 9.5% and 13.9% (untreated and previously treated), respectively, of these patients experienced Grades 3 and 4 thrombocytopenia at some point in their treatment. A full dose delivery analysis showed that this myelosuppression resulted in Course 1, Day 15 skipped doses (even at the reduced dose level) in 42% of previously untreated patients and 47% of pretreated patients. Other side effects seen at Grades 3 and 4 in previously untreated and treated patients included anemia (9.5% and 2.8%), asthenia (4.8% and 5.5%), infection (14.3% and 5.6%), pain (9.5% and 19.4%), and pulmonary complications (4.8% and 13.8%).CONCLUSIONSGemcitabine/vinorelbine is an active, well‐tolerated combination in both front‐line and second/third‐line therapy for Stage IIIB/IV NSCLC. The response rate, median survival rate, and one year survival rate compare favorably with platinum‐based regimens. The toxicity profile of the gemcitabine/vinorelbine combination was quite favorable, with minimal Grade 3 and 4 toxic effects aside from granulocytopenia, which resulted in numerous Day 15 skipped doses but no significant febrile neutropenia or infection. The combination of gemcitabine and vinorelbine could be a useful regimen in standard clinical practice and has the potential for efficient combination with biologic/targeted therapy. Multiple randomized trials of this combination versus platinum combinations are now ongoing. Cancer 2002;95:340–353. © 2002 American Cancer Society.DOI 10.1002/cncr.10629

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Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Cited by 45 publications

References 11 publications

Flexible modeling improves assessment of prognostic value of C-reactive protein in advanced non-small cell lung cancer

Flexible modeling improves assessment of prognostic value of C-reactive protein in advanced non-small cell lung cancer

Flexible chemotherapy regimen with gemcitabine and vinorelbine for metastatic nonsmall cell lung carcinoma

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

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