Purpose: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.
Patients and methods: Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks.
Results: One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors. Of 84 patients with measurable lesions, six (7. 1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P <.001), as was median survival (7.0 v 4.6 months; log-rank test, P =.047). The difference was more significant for docetaxel 75 mg/m(2) patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P =.010; 1-year survival, 37% v 11%; chi(2) test, P =.003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2), three of whom died, and in one patient treated with docetaxel 75 mg/m(2). Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occurred at a similar rate in both the docetaxel and best supportive care groups.
Conclusion: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m(2), the benefits of docetaxel therapy outweigh the risks.
Review of Two Phase III Randomized Trials of Single-Agent Docetaxel in Previously Treated Advanced Non--Small Cell Lung CancerTJ Lynch Jr. Semin Oncol 28 (3 Suppl 9), 5-9. PMID 11444253. - ReviewRandomized phase III studies reported this year prove that docetaxel is superior both to best supportive care (BSC) and to a standard regimen of vinorelbine or ifosfamide …
Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non-Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens. The TAX 320 Non-Small Cell Lung Cancer Study GroupFV Fossella et al. J Clin Oncol 18 (12), 2354-62. PMID 10856094. - Clinical TrialThis first randomized trial in this setting demonstrates that D75 every 3 weeks can offer clinically meaningful benefit to patients with advanced NSCLC whose disease has …
Docetaxel for Previously Treated Non-Small-Cell Lung CancerFV Fossella. Oncology (Williston Park) 16 (6 Suppl 6), 45-51. PMID 12108897. - ReviewTwo phase III trials were conducted using docetaxel (Taxotere), administered every 3 weeks, as second-line treatment of non-small-cell lung cancer (NSCLC) in patients pre …
Combination Second-Line Chemotherapy With Gemcitabine and Docetaxel for Recurrent Non-Small-Cell Lung Cancer After Platinum-Containing Chemotherapy: A Phase I/II TrialS Niho et al. Cancer Chemother Pharmacol 52 (1), 19-24. PMID 12712259. - Clinical TrialThe combination chemotherapy of gemcitabine and docetaxel is active and well tolerated in patients with recurrent NSCLC after platinum-based chemotherapy and with a good …
A Multicenter, Randomized, Phase III Study of Docetaxel Plus Best Supportive Care Versus Best Supportive Care in Chemotherapy-Naive Patients With Metastatic or Non-Resectable Localized Non-Small Cell Lung Cancer (NSCLC)K Roszkowski et al. Lung Cancer 27 (3), 145-57. PMID 10699688. - Clinical TrialThis was an open-label randomized Phase III study of 207 patients with either unresectable or metastatic non-small cell lung cancer (NSCLC) who were treated with docetaxe …
Cited by 327 PubMed Central articles
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30-day Mortality After the Start of Systemic Anticancer Therapy for Lung Cancer: Is It Really a Useful Performance Indicator?JA Burgers et al. ERJ Open Res 4 (4). PMID 30406123.Systemic treatment is the standard treatment for unresectable stage III and IV lung cancer. Nevertheless, a 5-10% death rate has been described within 30 days after the l …
Hunting for Transcription Factors: STAT3 Decoy in Non-Small Cell Lung CancerJ Carmicheal et al. Transl Lung Cancer Res 7 (Suppl 3), S254-S257. PMID 30393616.
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Efficacy and Safety of Nivolumab in Non-Small Cell Lung Cancer Patients in Tel-Aviv Tertiary Medical Center: Facing the RealityS Shamai et al. Mol Clin Oncol 9 (4), 419-422. PMID 30214730.Nivolumab is a human IgG4 programmed death (PD)-1 immune checkpoint inhibitor antibody, which is approved in Israel for the treatment of patients with advanced non-small …
- Antineoplastic Agents, Phytogenic / therapeutic use *
- Carcinoma, Non-Small-Cell Lung / drug therapy *
- Lung Neoplasms / drug therapy *
- Paclitaxel / analogs & derivatives *
- Taxoids *
- Antineoplastic Agents / therapeutic use
- Carboplatin / therapeutic use
- Chi-Square Distribution
- Cisplatin / therapeutic use
- Disease Progression
- Middle Aged
- Paclitaxel / therapeutic use
- Palliative Care
- Proportional Hazards Models
- Prospective Studies
- Quality of Life
- Survival Analysis
- Treatment Outcome