Phase III Study of Second-Line Chemotherapy for Advanced Non–Small-Cell Lung Cancer With Weekly Compared With 3-Weekly Docetaxel

Schuette, Wolfgang; Nagel, S.; Blankenburg, Thomas; Lautenschlaeger, Christine; Hans, K.; Schmidt, E. W.; Dittrich, Ina; Schweisfurth, H.; Weikersthal, Ludwig Fischer von; Raghavachar, Aruna; Reißig, Angelika; Serke, Monika

doi:10.1200/jco.2005.02.3739

Cited by 158 publications

(129 citation statements)

References 18 publications

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“…In particular, the present trial confirms our previous observation (Tibaldi et al, 2006) that a modified schedule of docetaxel (37.5 mg m À2 on days 1 and 8 every 3 weeks) is feasible and well tolerated in elderly advanced NSCLC patients. Our tolerability data confirm the previous observations that weekly docetaxel is advantageous in terms of haematological toxicity with respect to 3-weekly schedule (Gridelli et al, 2004;Schuette et al, 2005;Camps et al, 2006).…”

Section: Discussionsupporting

confidence: 81%

“…Three randomised phase III trials (Gridelli et al, 2004;Schuette et al, 2005;Camps et al, 2006) have compared, in second line advanced NSCLC, docetaxel at the dose of 75 mg m À2 every 3 weeks, considered the standard of care, against a weekly schedule, indicating a similar efficacy but a significantly less severe toxicity in terms of leukopenia, neutropenia and febrile neutropenia with weekly docetaxel.…”

mentioning

confidence: 99%

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First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Tibaldi¹,

Vasile²,

Antonuzzo

et al. 2008

Br J Cancer

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This multicenter phase II study evaluated, in chemonaive patients with stage IIIB -IV NSCLC, age X70 and with a performance status 0 -2, the activity, efficacy and tolerability of planned sequential administration of gemcitabine 1200 mg m À2 on days 1 and 8 every 3 weeks for three courses followed by three cycles of docetaxel 37.5 mg m À2 on days 1 and 8 every 3 weeks, provided there was no evidence of disease progression. A total of 56 patients entered the study. According to intention-to-treat analysis, the objective response rate was 16.0% (95% CI 7.6 -28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of gemcitabine obtained a conversion to partial response by docetaxel. Median time to progression was 4.8 months (95% CI 3.6 -6.0 months) and median duration of survival was 8.0 months (95% CI 5.6 -10.5 months). The 1-year survival rate was 34%. No grade 4 haematological toxicity was observed and grade 3 neutropenia and thrombocytopenia were reported in 5.4 and 3.6% of the patients, respectively. Grade 3/4 mucositis and grade 3 diarrhoea, both occurred in 3.6% of the patients and grade 3 asthenia was observed in 9% of patients. One patient reported a grade 4 skin toxicity. No treatment-related deaths occurred. Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.

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Section: Discussionsupporting

confidence: 81%

mentioning

confidence: 99%

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Tibaldi¹,

Vasile²,

Antonuzzo

et al. 2008

Br J Cancer

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“…In conclusion, the results of four randomized trials [13][14][15][16] and two meta-analyses [17,18] demonstrate no difference in survival, although there are some critical issues because of the limited number of patients (about 700) and the different endpoints considered (safety, overall survival, quality of life) that mean that no clear, conclusive definition of the role of a weekly docetaxel schedule can be determined. The use of a weekly docetaxel schedule for relapsed NSCLC patients is not supported by a direct comparison with pemetrexed.…”

Section: Single-agent Weekly Docetaxelmentioning

confidence: 99%

“…In a German study [15], 208 patients were randomized to receive 3-weekly or weekly docetaxel (35 mg/m 2 for 3 weeks every 28 days), and the primary endpoint was overall survival. A significantly lower rate of hematologic toxicity was recorded for the weekly arm (20.6% versus 4.8% patients suffered from neutropenia), with a significant difference observed in the median survival time and 1-year survival rate for the two schedules (6.3 versus 9.2 months and 26.9% versus 39.5% in the 3-weekly and weekly treatment groups, respectively; p = .07).…”

Section: Single-agent Weekly Docetaxelmentioning

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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“…In studies of nonsmall-cell lung cancer patients, weekly use of docetaxel signiWcantly reduced hematologic toxicity without compromising eYcacy [8,9]. Several studies on colorectal cancer reported low incidences of toxicities for weekly 5-FU administration [10,11].…”

Section: Introductionmentioning

confidence: 99%

Phase I dose-escalating study of 24-h continuous infusion of 5-fluorouracil in combination with weekly docetaxel and cisplatin in patients with advanced gastric cancer

Wang

Zhang

Hong

et al. 2008

Cancer Chemother Pharmacol

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Purpose To determine the maximum-tolerated dose (MTD) of a 24-h continuous infusion of 5-Xuorouracil (5-FU) when administered in combination with a Wxed weekly dose of docetaxel and cisplatin in patients with advanced gastric cancer. Methods Patients with advanced gastric adenocarcinoma (n = 21) received a weekly regimen of docetaxel, cisplatin and 5-FU (DCF) for 3 consecutive weeks every 4 weeks. The doses of docetaxel and cisplatin were Wxed at 33.3 and 30 mg/m 2 , respectively. The dose of 5-FU was increased from a starting dose of 1,000 mg/m 2 to the MTD. Results A total of 53 cycles of chemotherapy were administered (median = 3 cycles/patient). The MTD of 5-FU was 1,750 mg/m 2 . All 21 patients were assessed for toxicity and 19 patients (90%) were evaluated for response. Both grade 3-4 hematologic and non-hematologic toxicities occurred in less than 10% of patients and there were no treatment-related deaths. Among the 19 patients, we observed 1 complete and 4 partial responses for an overall response rate of 26% (95% CI: 6-46%). This rate increased to 39% (95% CI: 12-66%) in 13 chemotherapy-naïve patients.Conclusions A consecutive weekly DCF regimen at 4-week intervals appears feasible for advanced gastric cancer with a favorable toxicity proWle. The recommended doses are 33.3 mg/m 2 of docetaxel, 30 mg/m 2 of cisplatin and 1,500 mg/m 2 of a 24-h continuous intravenous infusion of 5-FU. The response of this weekly regimen in our study was favorable and deserved further investigation in a phase II trial.

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Phase III Study of Second-Line Chemotherapy for Advanced Non–Small-Cell Lung Cancer With Weekly Compared With 3-Weekly Docetaxel

Abstract: Weekly docetaxel 35 mg/m2 demonstrated similar efficacy and better tolerability than standard 3-weekly docetaxel 75 mg/m2 and can be recommended as a feasible alternative second-line treatment option for patients with advanced NSCLC.

Cited by 158 publications

References 18 publications

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

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

Phase I dose-escalating study of 24-h continuous infusion of 5-fluorouracil in combination with weekly docetaxel and cisplatin in patients with advanced gastric cancer

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