O-091 A randomized phase II trial of docetaxel alone and in combinationwith gefitinib (IRESSA) as second-line therapy for patients with non-small-cell lung cancer

Robinet, G.; Falchero, L.; Pérol, Maurice; Thomas, P; Monnet, I.; Grivaux, M; Créquit, Jacky; Letreut, J.; Paillotin, D.; Chouaïd, C.

doi:10.1016/s0169-5002(05)80225-9

Cited by 6 publications

(10 citation statements)

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“…The evidence of clinical benefit seen in these studies is consistent with data from our study. The combination of gefitinib and docetaxel in our study was feasible and generally well tolerated, in agreement with previous studies of combination therapy [14,15]. The observed adverse events were as expected from the safety profiles of both gefitinib and docetaxel, with the most common drug-related events including diarrhea, rash, and pruritus.…”

Section: Discussionsupporting

confidence: 90%

“…In particular, the hematological toxicity profile of docetaxel does not seem to be affected by the addition of gefitinib. The incidence of grade 3/4 neutropenia was 17% in our study, and 61.5% (16/26 patients) and 67% (4/6 patients) in two of the studies described above [13][14][15]. In comparison, a phase III study of single-agent docetaxel reported a 54% incidence of grade 4 neutropenia alone [3].…”

Section: Discussionsupporting

confidence: 40%

“…Thus, the DCR was higher with docetaxel plus gefitinib (59.1%) than docetaxel alone (34.1%). Similarly, median progression-free survival and OS were higher in the gefitinib plus docetaxel group compared with docetaxel alone (median progression-free survival: 122 days with gefitinib plus docetaxel versus 66 days with docetaxel alone; median OS: 232 days with gefitinib plus docetaxel versus 188 days with docetaxel alone) [14]. More recently, a phase II study (SIGN; Second-line Indication of Gefitinib in NSCLC) that investigated gefitinib versus docetaxel as second-line monotherapy in patients with advanced NSCLC showed ORR of 13.2 and 13.7%, respectively [13].…”

Section: Discussionmentioning

confidence: 94%

“…Combination therapy with gefitinib and docetaxel has also been investigated previously [13][14][15]. A pilot study assessed two doses of gefitinib (250 and 500 mg/day) combined with docetaxel (75 mg/m 2 ) in patients with locally advanced or metastatic NSCLC as first-and second-line therapy.…”

Section: Discussionmentioning

confidence: 99%

“…At the 250 mg/day gefitinib dose, six patients were enrolled and were evaluable for response, of whom two patients had a PR (one in non-measurable disease) [15]. In a phase II trial of 250 mg/day gefitinib plus 75 mg/m 2 docetaxel versus 75 mg/m 2 docetaxel as second-line therapy in advanced NSCLC, interim results reported an objective tumor response rates of 6.8% with gefitinib plus docetaxel versus 9.1% with docetaxel alone [14]. However, the SD rate was higher with gefitinib plus docetaxel versus docetaxel alone; 52.3 v 25.0%, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Phase II combination of gefitinib and docetaxel for advanced or metastatic non-small cell lung cancer: clinical results and biological monitoring

et al. 2006

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The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib and the cytotoxic agent docetaxel are both used for the second-line treatment of advanced non-small cell lung cancer (NSCLC). This study aimed to investigate the efficacy and safety of gefitinib in combination with docetaxel within this disease setting, and to evaluate the predictive value of assessing pre-treatment levels of soluble serum EGFR and HER2. In this open-label, noncomparative, multicenter, phase II trial, patients with nonresectable advanced or metastatic NSCLC were treated with oral gefitinib (250 mg/day) in combination with docetaxel (75 mg/m 2 IV every 3 weeks). Forty-eight patients were enrolled: 30 had progressed during or after platinum-based chemotherapy (Group A) and 18 were unsuitable for platinum-based chemotherapy (Group B). Anti-tumor activity was seen with objective response rates of 23.3% (Group A) and 11.8% (Group B). The most frequent adverse events considered to be gefitinib-related were diarrhea (57.4%) and skin-related events (dry-skin: 31.9%; rash: 29.8%; pruritus: 12.8%), and those considered to be docetaxel-related were alopecia (21.3%), nausea (19.1%), and diarrhea (17.0%). The addition of gefitinib did not seem to affect the hematological toxicity seen with docetaxel. Serum biomarker investigations revealed that patients who responded had lower serum EGFR levels than non-responders, although this association was not significant (p=0.07). In conclusion, the combination of gefitinib with docetaxel was feasible, generally well tolerated, and has activity for the treatment of advanced NSCLC. Soluble serum EGFR (and HER2 levels) did not appear to be predictive for response. Although this study confirms that the combination of gefinitib and docetaxel appears promisingly effective and tolerable, it should not be recommended as a standard option for second-line therapy in non-small cell lung cancer until results from phase III trials showing a significant superiority over docetaxel alone are available.

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Section: Discussionsupporting

confidence: 90%