Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy fornon-small-cell lung cancer

Quoix, Élisabeth; Lebeau, B.; Depierre, A; Ducoloné, A; Moro‐Sibilot, D.; Milleron, B.; Breton, Jean-Luc; Lemarié, É.; Pujol, Jean-Louis; Bréchot, J.-M.; Zalcman, Gérard; Debieuvre, D.; Vaylet, F.; Vergnenègre, A.; Clouet, P.

doi:10.1093/annonc/mdh005

Cited by 35 publications

(12 citation statements)

References 11 publications

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“…Response rates with paclitaxel of the range of 0 -38% in previously published studies (Socinski et al, 1999(Socinski et al, , 2002Juan et al, 2002;Sculier et al, 2002a;Buccheri and Ferrigno, 2004;Ceresoli et al, 2004;Yasuda et al, 2004), and of the order of 7.7 and 11.6% in PF and SF patients, respectively, observed in the present study are similar to those with docetaxel, ranging from 2.7 to 12.6% (Fossella et al, 2000;Shepherd et al, 2000;Gridelli et al, 2004;Hanna et al, 2004;Quoix et al, 2004;Gervais et al, 2005;Schuette et al, 2005;Camps et al, 2006).…”

Section: Discussionsupporting

confidence: 87%

“…Paclitaxel for progressing NSCLC T Berghmans et al 2000; Shepherd et al, 2000;Gridelli et al, 2004;Hanna et al, 2004;Quoix et al, 2004;Gervais et al, 2005;Schuette et al, 2005;Camps et al, 2006). Similar were MST with paclitaxel in previous studies, ranging from 4.5 to 14 months (Socinski et al, 1999(Socinski et al, , 2002Juan et al, 2002;Sculier et al, 2002a;Buccheri and Ferrigno, 2004;Ceresoli et al, 2004;Yasuda et al, 2004).…”

Section: Discussionmentioning

confidence: 65%

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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: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 65%

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 these trials, docetaxelrelated toxicity was relevant, despite the significantly better quality of life scores concerning pain control, weight loss, and PS obtained with docetaxel in comparison with the control groups [4]. A phase II randomized trial [5] confirmed that docetaxel at a dose of 75 mg/m 2 has a more favorable toxicity profile than, and a similar efficacy to, docetaxel at 100 mg/m 2 . The current problem of this treatment remains hematologic toxicity, which, in the registration trials [2,3], represented the dose-limiting toxicity: neutropenia occurred in 54%-67% of patients and febrile neutropenia occurred in 1.8%-8.0%.…”

Section: Single-agent Docetaxel Every 3 Weeksmentioning

confidence: 99%

Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer

Marinis

Grossi²

2008

The Oncologist

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In the U.S. and Europe, the current options for the second-and third-line treatment of advanced non-small cell lung cancer (NSCLC) are cytotoxic drugs and targeted agents. Docetaxel was the first drug approved for second-line treatment after two phase III trials demonstrated its superiority over best supportive care (BSC) alone and single-agent chemotherapy. Pemetrexed was also registered for use as second-line therapy after it was demonstrated to have activity comparable with, and a more favorable toxicity profile than, docetaxel. Erlotinib, an epidermal growth factor receptor inhibitor, is the only biological agent to have been approved in the U.S. and Europe for lung cancer treatment after a study showed its superiority over BSC in recurrent (second-/third-line) NSCLC patients. This review focuses on these drugs, dealing with the results supporting the choice among docetaxel, pemetrexed, and erlotinib in second-and/or third-line treatment. The Oncologist 2008;13(suppl 1):14-20

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“…Data from 17 randomised clinical trials, 34,37,41,42,49,64,74,85,[106][107][108][109][110][111][112][113][114][115] which included 3-weekly high-dose docetaxel monotherapy as one treatment arm, were combined to provide a weighted average incidence rate. It was not possible to carry out a formal meta-analysis because of the diversity of comparators, populations and settings of these trials.…”

Section: Appendix 2 Quality Assessment Of Included Studiesmentioning

confidence: 99%

Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation

Greenhalgh

Bagust

Boland

et al. 2015

Health Technol Assess

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BackgroundLung cancer is the second most diagnosed cancer in the UK. Over 70% of lung cancers are non-small cell lung cancers (NSCLCs). Patients with stage III or IV NSCLC may be offered treatment to improve survival, disease control and quality of life. One-third of these patients receive further treatment following disease progression; these treatments are the focus of this systematic review.ObjectivesTo appraise the clinical effectiveness and cost-effectiveness of erlotinib [Tarceva®, Roche (UK) Ltd] and gefitinib (IRESSA®, AstraZeneca) compared with each other, docetaxel or best supportive care (BSC) for the treatment of NSCLC after disease progression following prior chemotherapy. The effectiveness of treatment with gefitinib was considered only for patients with epidermal growth factor mutation-positive (EGFR M+) disease.Data sourcesFour electronic databases (EMBASE, MEDLINE, The Cochrane Library, PubMed) were searched for randomised controlled trials (RCTs) and economic evaluations. Manufacturers’ evidence submissions to the National Institute for Health and Care Excellence were also considered.Review methodsOutcomes for three distinct patient groups based on EGFR mutation status [EGFR M+, epidermal growth factor mutation negative (EGFR M–) and epidermal growth factor mutation status unknown (EGFR unknown)] were considered. Heterogeneity of the data precluded statistical analysis. A de novo economic model was developed to compare treatments (incremental cost per quality-adjusted life-year gained).ResultsTwelve trials were included in the review. The use of gefitinib was compared with chemotherapy (n = 6) or BSC (n = 1), and the use of erlotinib was compared with chemotherapy (n = 3) or BSC (n = 1). One trial compared the use of gefitinib with the use of erlotinib. No trials included solely EGFR M+ patients; all data were derived from retrospective subgroup analyses from six RCTs [Kim ST, Uhm JE, Lee J, Sun JM, Sohn I, Kim SW,et al.Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy.Lung Cancer2012;75:82–8, V-15-32, Tarceva In Treatment of Advanced NSCLC (TITAN), BR.21, IRESSA Survival Evaluation in Lung cancer (ISEL) and IRESSA NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST)]. These limited data precluded conclusions regarding the clinical effectiveness of any treatment for EGFR M+ patients. For EGFR M– patients, data were derived from the TArceva Italian Lung Optimization tRial (TAILOR) trial and Docetaxel and Erlotinib Lung Cancer Trial (DELTA). Retrospective data were also derived from subgroup analyses of BR.21, Kimet al., TITAN, INTEREST and ISEL. The only statistically significant reported results were for progression-free survival (PFS) for TAILOR and DELTA, and favoured docetaxel over erlotinib [TAILOR hazard ratio (HR) 1.39, 95% confidence interval (CI) 1.06 to 1.82; DELTA HR 1.44, 95% CI 1.08 to 1.92]. In EGFR unknown patients, nine trials (INTEREST, IRESSA as Second-line Therapy in Advanced NSCLC – KoreA, Li, Second-line Indication of Gefitinib in NSCLC, V-15-32, ISEL, DELTA, TITAN and BR.21) reported overall survival data and only one (BR.21) reported a statistically significant result favouring the use of erlotinib over BSC (HR 0.7, 95% CI 0.58 to 0.85). For PFS, BR.21 favoured the use of erlotinib when compared with BSC (HR 0.61, 95% CI 0.51 to 0.74) and the use of gefitinib was favoured when compared with BSC (HR 0.82, 95% CI 0.73 to 0.92) in ISEL. Limitations in the clinical data precluded assessment of cost-effectiveness of treatments for an EGFR M+ population by the Assessment Group (AG). The AG’s economic model suggested that for the EGFR M– population, the use of erlotinib was not cost-effective compared with the use of docetaxel and compared with BSC. For EGFR unknown patients, the use of erlotinib was not cost-effective when compared with BSC.Conclusions/future workThe lack of clinical data available for distinct patient populations limited the conclusions of the assessment. Future trials should distinguish between patients with EGFR M+ and EGFR M– disease.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy fornon-small-cell lung cancer

Abstract: The optimal docetaxel dosage in this second-line setting is 75 mg/m(2), as it has a more favourable safety profile and on balance a similar efficacy to the 100 mg/m(2) dose.

Cited by 35 publications

References 11 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

Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer

Erlotinib and gefitinib for treating non-small cell lung cancer that has progressed following prior chemotherapy (review of NICE technology appraisals 162 and 175): a systematic review and economic evaluation

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