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Phase II trial of weekly docetaxel and gemcitabine as first-line therapy for patients with advanced non-small cell lung cancer

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Abstract

Background

A platinum doublet has been the standard treatment for patients with advanced non-small cell lung cancer (NSCLC) and good performance status. This treatment results in almost a doubling of 1-yr survival, along with an improvement in quality of life despite treatment-related toxicities. However, platinum-based treatment may be associated with significant toxicity.

Materials and Methods

In this trial, we prospectively evaluated a weekly regimen of docetaxel and gemcitabine for advanced NSCLC. The endpoints of this study included objective response rate, survival, and toxicity. Forty-two patients with previously untreated, advanced NSCLC with PS 0-1 were included. Patients received docetaxel (36 mg/m2) and gemcitabine (600 mg/m2) on d 1, 8, and 15 of a 28-d cycle. Responses were assessed every two cycles. The median age was 63 yr; with 22 males and 20 females; 67% were ≥60 years old; and 38 patients had stage IV disease.

Results

In the intent-to-treat (ITT) analysis of response, 16 patients had a partial response (38%) and 15 patients had stable disease (36%). The 1-yr survival was 48%; median survival for all patients was 11.3 mo and the median progression-free survival was 5.1 mo. Toxicities (≥grade 3) included neutropenia (29%), asthenia (26%), diarrhea (14%), thrombocytopenia (10%), pneumonitis (7%), peripheral neuropathy (5%), peripheral edema (5%), nail changes (2%), and myositis (2%).

Conclusions

This study demonstrated that this non-platinum doublet (docetaxel+gemcitabine) given on a weekly schedule for advanced NSCLC was well tolerated with efficacy comparable to that reported with platinum-based chemotherapy regimens.

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References

  1. Jemal A., et al. Cancer statistics, 2005. CA Cancer J Clin 2005;55(1):10–30.

    Article  PubMed  Google Scholar 

  2. Grilli R, Oxman AD, Julian JA. Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough? J Clin Oncol 1993;11(10):1866–1872.

    PubMed  CAS  Google Scholar 

  3. Marino P, Pampallona S, Preatoni A, Cantoni A, Invernizzi F. Chemotherapy vs supportive care in advanced non-small-cell lung cancer Results of a meta-analysis of the literature. Chest 1994;106(3):861–865.

    PubMed  CAS  Google Scholar 

  4. Non-small Cell Lung Cancer Collaborative Group. Chemotherapy for non-small cell lung cancer. Cochrane Database Syst Rev 2000(2):CD002139.

    Google Scholar 

  5. Souquet PJ, Chauvin F, Boissel JP, Bernard JP. Meta-analysis of randomised trials of systemic chemotherapy versus supportive treatment in non-resectable non-small cell lung cancer. Lung Cancer 1995;12(Suppl 1):S147–154.

    Article  Google Scholar 

  6. Vansteenkiste JF, et al. Clinical-benefit response in advanced non-small-cell lung cancer: a multicentre prospective randomised phase III study of single agent gemcitabine versus cisplatin-vindesine. Ann Oncol 2001;12(9): 1221–1230.

    Article  PubMed  CAS  Google Scholar 

  7. Shepherd FA, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000;18(10): 2095–2103.

    PubMed  CAS  Google Scholar 

  8. Lynch TJ, Jr. Review of two phase III randomized trials of single-agent docetaxel in previously treated advanced non—small cell lung cancer. Semin Oncol 2001;28(3 Suppl 9):5–9.

    Article  PubMed  CAS  Google Scholar 

  9. Roszkowski K, et al. 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). Lung Cancer 2000;27(3):145–157.

    Article  PubMed  CAS  Google Scholar 

  10. Fossella FV, et al. 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 Group. J Clin Oncol 2000;18(12):2354–2362.

    PubMed  CAS  Google Scholar 

  11. Hainsworth JD, et al. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial. J Clin Oncol 2001;19(15):3500–3505.

    PubMed  CAS  Google Scholar 

  12. Lilenbaum RC, et al. Phase II trial of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma. Cancer 2001;92(8):2158–2163.

    Article  PubMed  CAS  Google Scholar 

  13. Petrioli R, et al. Weekly low-dose docetaxel in advanced non-small cell lung cancer previously treated with two chemotherapy regimens. Lung Cancer 2003;39(1):85–89.

    Article  PubMed  Google Scholar 

  14. Tsunoda T, et al. Phase II study of weekly docetaxel combined with cisplatin in patients with advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 2004;54(2):173–177.

    Article  PubMed  CAS  Google Scholar 

  15. Ohe Y, et al. A phase II study of cisplatin and docetaxel administered as three consecutive weekly infusions for advanced non-small-cell lung cancer in elderly patients. Ann Oncol 2004;15(1):45–50.

    Article  PubMed  CAS  Google Scholar 

  16. Mekhail T, et al. Phase I trial of weekly docetaxel and gemcitabine in patients with refractory malignancies. Cancer 2003;97(1):170–178.

    Article  PubMed  CAS  Google Scholar 

  17. Dunsford ML, Mead GM, Bateman AC, Cook T, Tung K. Severe pulmonary toxicity in patients treated with a combination of docetaxel and gemcitabine for metastatic transitional cell carcinoma. Ann Oncol 1999;10(8):943–947.

    Article  PubMed  CAS  Google Scholar 

  18. WHO handbook for reporting results of cancer treatment. Geneva (Switzerland) 1979.

  19. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958(53):457–481.

    Article  Google Scholar 

  20. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 1995;311(7010):899–909.

  21. Georgoulias V, et al. Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial. Lancet 2001;357(9267): 1478–1484.

    Article  PubMed  CAS  Google Scholar 

  22. Kosmidis P., et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 2002;20(17): 3578–3585.

    Article  PubMed  CAS  Google Scholar 

  23. Van Meerbeeck JP, et al. A EORTC randomized phase III trial of three chemotherapy regimens in advanced NSCLC. In: ASCO 2001.

  24. Pfister DG, et al. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin. Oncol 2004;22(2):330–353.

    Article  PubMed  Google Scholar 

  25. Rizvi NA, et al. Docetaxel and gemcitabine combinations in non-small cell lung cancer. Semin Oncol 1999;26(5 Suppl 16):27–31; discussion 41–42.

    PubMed  CAS  Google Scholar 

  26. Rizvi NA. Docetaxel (Taxotere) and gemcitabine in combination therapy. Semin Oncol 1999;26(3 Suppl 11):19–22.

    PubMed  CAS  Google Scholar 

  27. Neubauer MA, et al. Results of a phase II multicenter trial of weekly docetaxel and gemcitabine as first-line therapy for patients with advanced non-small cell lung cancer. Lung Cancer 2005;47(1):121–127.

    Article  PubMed  Google Scholar 

  28. Spiridonidis CH, et al. Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. Ann Oncol 2001;12(1):89–94.

    Article  PubMed  CAS  Google Scholar 

  29. van Oosterom AT. Docetaxel (Taxotere) and gemcitabine phase I and early phase II studies: results to date and an overview of ongoing studies. Semin Oncol 1999;26(3 Suppl 10):8–11.

    PubMed  Google Scholar 

  30. J. R. Rigas MC, B. Cole, A. Evans, R. Page, F. Yunus, M. Ruben, H. Ghazal, K. Dragnev. The Dartmouth Non-Platinum Based Chemotherapy Trial Investigators; Dartmouth Medical School, Hanover, NH; Norris Cotton Cancer Center, Lebanon, NH; PPD Development, Wilmington, NC; Texas Cancer Care, Fort Worth, TX; University of Tennessee, Memphis, TN; Florida Cancer Specialist, Bonita Springs, FL; Appalachian Clinical Research, Pikeville, KY; Dartmouth Hitchcock Medical Center, Lebanon, NH. Multicenter Web-based phase III study to test the survival equivalence of non-platinum-based (NPB) vs platinum-based (PB) therapy for advanced non-small cell lung cancer (NSCLC): The Dartmouth NPB Chemotherapy Trial (D0112). In: 2004 ASCO annual meeting 2004.

  31. Hainsworth JD, Burris HA, 3rd, Greco FA. Weekly docetaxel as a single agent and in combination with gemcitabine in elderly and poor performance status patients with advanced non-small cell lung cancer. Semin Oncol 2001;28(3 Suppl 9):21–25.

    Article  PubMed  CAS  Google Scholar 

  32. Kakolyris S, et al. Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study. Lung Cancer 2001;32(2):179–187.

    Article  PubMed  CAS  Google Scholar 

  33. Hejna M, et al. Treatment of patients with advanced nonsmall cell lung carcinoma using docetaxel and gemcitabine plus granulocyte-colony stimulating factor. Cancer 2000;89(3):516–522.

    Article  PubMed  CAS  Google Scholar 

  34. Schiller JH, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002;346(2):92–98.

    Article  PubMed  CAS  Google Scholar 

  35. Rosell Rea. ERCC1 mRNA based randomized phase III trial of docetaxel doublets with cisplatin or gemcitabine in stage IV non-small-cell lung cancer. In: ASCO 40th annual meeting 2005.

  36. Sandler Aea. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): an Eastern Cooperative Oncology Group (ECOG) Trial—E4599. In: ASCO annual meeting: 2005; 2005.

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Authors and Affiliations

  1. Thoracic and Gastrointestinal oncology, Taussig Cancer Center, Cleveland Clinic, Cleveland, Ohio, USA

    Sujith Kalmadi, Giles McNeill, Mellar Davis, David Peereboom, David Adelstein & Tarek Mekhail

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  1. Sujith Kalmadi
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  2. Giles McNeill
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  3. Mellar Davis
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  4. David Peereboom
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  5. David Adelstein
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  6. Tarek Mekhail
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Correspondence to Sujith Kalmadi.

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Kalmadi, S., McNeill, G., Davis, M. et al. Phase II trial of weekly docetaxel and gemcitabine as first-line therapy for patients with advanced non-small cell lung cancer. Med Oncol 23, 507–513 (2006). https://doi.org/10.1385/MO:23:4:507

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  • DOI: https://doi.org/10.1385/MO:23:4:507

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