Prospective randomised phase II study of docetaxel versus paclitaxel administered weekly in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

Esteban, Emilio; Sande, L. González de; Fernández, Yolanda; Corral, Norberto; Fra, J.; Muñiz, I.; Vieitez, José María; Palacio, Isabel; Fernández, José Luís; Estrada, Enrique; Lacave, Ángel J.

doi:10.1093/annonc/mdg456

Cited by 46 publications

(31 citation statements)

References 17 publications

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“…The equivalence of both drugs was evaluated in one small randomised phase II study only. No statistically significant difference was found in terms of response rate (14 vs 3%) and median survival (105 vs 184 days) (Esteban et al, 2003).…”

Section: Discussionmentioning

confidence: 73%

“…Paclitaxel, the other available taxane, has also demonstrated potential activity in the same indication in a few phase II studies (Socinski et al, 1999;Juan et al, 2002;Socinski et al, 2002;Sculier et al, 2002a;Buccheri and Ferrigno, 2004;Ceresoli et al, 2004;Yasuda et al, 2004). There is only one randomised phase II study, including 71 patients, which directly compares paclitaxel to docetaxel (Esteban et al, 2003).…”

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confidence: 99%

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Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

et al. 2007

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In the context of a phase III trial comparing in advanced non-small cell lung cancer (NSCLC) sequential to conventional administration of cisplatin-based chemotherapy and paclitaxel, we evaluated the activity of paclitaxel as second-line chemotherapy and investigated any relation of its efficacy with the type of failure after cisplatin. Patients received three courses of induction GIP (gemcitabine, ifosfamide, cisplatin). Non-progressing patients were randomised between three further courses of GIP or three courses of paclitaxel. Second-line paclitaxel was given to patients with primary failure (PF) to GIP and to those progressing after randomisation to further GIP (secondary failure or SF). One hundred sixty patients received second-line paclitaxel. Response rates were 7.7% for PF and 11.6% for SF (P ¼ 0.42). Median survival times (calculated from paclitaxel start) were 4.1 and 7.1 months for PF and SF (P ¼ 0.002). In multivariate analysis, three variables were independently associated with better survival: SF (hazard ratio (HR) ¼ 1.55, 95% confidence interval (CI) 1.08 -2.22; P ¼ 0.02), normal haemoglobin level (HR ¼ 1.56, 95% CI 1.08 -2.26; P ¼ 0.02) and minimal weight loss (HR ¼ 1.79, 95% CI 1.26 -2.55; P ¼ 0.001). Paclitaxel in NSCLC patients, whether given for primary or for SF after cisplatin-based chemotherapy, demonstrates activity similar to other drugs considered active as second-line therapy.

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Section: Discussionmentioning

confidence: 73%

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confidence: 99%

Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

et al. 2007

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“…The dose of Taxol was determined from previous studies (25). Justification for weekly dosing was from ongoing clinical trials of weekly Taxol in a number of disease types, including NSCLC (26). Concurrent dosing of Taxol with CI-1040 was evaluated initially, because our in vitro studies determined this to be the most effective (20).…”

Section: Resultsmentioning

confidence: 99%

Enhancement of the Therapeutic Efficacy of Taxol by the Mitogen-Activated Protein Kinase Kinase Inhibitor CI-1040 in Nude Mice Bearing Human Heterotransplants

et al. 2005

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Taxol may contribute to intrinsic chemoresistance by activating the mitogen-activated protein kinase kinase (MEK)/ extracellular signal-regulated kinase (ERK) cytoprotective pathway in human cancer cell lines and tumors. We have previously shown additivity between Taxol and the MEK inhibitor, U0126 in human cancer cell lines. Here, the combination of Taxol with an orally bioavailable MEK inhibitor, CI-1040, was evaluated in human lung tumors heterotransplanted into nude mice. Unlike xenograft models that are derived from cells with multiple genetic alterations due to prolonged passage, heterotransplanted tumor models are more clinically relevant. Combined treatment with both drugs resulted in inhibition of tumor growth in all models and tumor regressions in three of four models tested, supporting our previous observation that Taxol's efficacy is potentiated by MEK inhibition. Concurrent administration was superior to intermittent dosing. Pharmacodynamic assessments of tumors indicated that suppression of MEK was associated with induction of S473 phosphorylated Akt and reduced proliferation in the combination groups relative to single agents, in addition to suppression of fibroblast growth factor-mediated angiogenesis and reduced expression of vascular endothelial growth factor. These findings are significant and indicate that this combination may have broad therapeutic applications in a diverse range of lung tumors with different intrinsic chemosensitivities. (Cancer Res 2005; 65(7): 2854-60)

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“…According to ECOG 1594 study which was conducted in patients with lung cancer, following a combination therapy using cisplatin and taxane, there were no significant differences in the response rate and survival period between the two drugs. Neutropenia of Grade 3�4 in severity and neurotoxicity occurred at a similar incidence (9,10). By contrast, according to Phase III studies which have been conducted in patients with breast cancer, as compared with paclitaxel, docetaxel had an excellent profile of the response rate and the progression-free survival.…”

Section: Discussionmentioning

confidence: 99%

Docetaxel versus Paclitaxel Combined with 5-FU and Leucovorin in Advanced Gastric Cancer: Combined Analysis of Two Phase II Trials

Chon

Rha

et al. 2009

Cancer Res Treat

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2) on day 1, followed by a bolus of LV (20 mg/m 2 days 1�3) and a 24-hour infusion of 5-FU (1,000 mg/m 2 days 1�3) every 3 weeks. The primary endpoint was overall response rate (ORR) and the secondary endpoint included survival and toxicity. Results Sixty-six patients received DFL (first-line [n=38]; and second-line [n=28]) and 60 patients received PFL (first-line [n=37]; and second-line [n=23]). The ORRs were not significantly different between the 2 groups (DFL, 26%; PFL, 38%). With a median follow-up of 9.5 months, the progression free survival was 5.2 months (95% confidence interval [CI], 4.2�6.5 months) for DFL and 3.3 months (95% CI, 1.3�5.5 months) for PFL (p=0.17). The overall survival was also comparable between the patients who received DFL and PFL (10.0 months [95% CI, 7.2 �12.5 months] and 13.9 months [95% CI, 10.9�19.2 months], respectively; p=0.37). The most frequent grade 3�4 adverse event was neutropenia (DFL, 71%; PFL, 62%). DFL and PFL had different non-hematologic toxicities; specifically, grade ≥3 mucositis (5%) and diarrhea (3%) were common in DFL, while nausea/vomiting (15%) and peripheral neuropathy (5%) were common in PFL. ConclusionThus, the two taxanes had similar efficacy in the treatment of advanced gastric cancer, but different toxicity profiles. Prospective comparative studies are required to further clarify the role of taxanes in the treatment of advanced gastric cancer.

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Prospective randomised phase II study of docetaxel versus paclitaxel administered weekly in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

Cited by 46 publications

References 17 publications

Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

Second-line paclitaxel in non-small cell lung cancer initially treated with cisplatin: a study by the European Lung Cancer Working Party

Enhancement of the Therapeutic Efficacy of Taxol by the Mitogen-Activated Protein Kinase Kinase Inhibitor CI-1040 in Nude Mice Bearing Human Heterotransplants

Docetaxel versus Paclitaxel Combined with 5-FU and Leucovorin in Advanced Gastric Cancer: Combined Analysis of Two Phase II Trials

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