51
Views
2
CrossRef citations to date
0
Altmetric
Clinical Trials Report

Pemetrexed in small-cell lung cancer: background and review of the ongoing GALES pivotal trial

, &
Pages 635-640 | Published online: 10 Jan 2014

References

  • Kamangar F, Dores M, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J. Clin. Oncol.24(14), 2137–2215 (2006).
  • Govindan R, Page N, Morgensztern D et al. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the Surveillance, Epidemiologic, and End Results database. J. Clin. Oncol.24(28), 4539–4544 (2006).
  • Socinski MA, Weissman C, Hart LL et al. Randomized Phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer. J. Clin. Oncol.24(30), 4840–4847 (2006).
  • Hanauske AR, Chen V, Paoletti P, Niyikiza C. Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors. Oncologist6(4), 363–373 (2001).
  • Schutlz RM, Patel VF, Worzalla JF, Shih C. Role of thymidylate synthase in the antitumor activity of the multitargeted antifolate, LY231514. Anticancer Res.19, 437–443 (1999).
  • Shih C, Thornton DE. Preclinical pharmacology studies and the clinical development of a novel multitargeted antifolate, MTA (LY231514). In: Antifolate Drugs in Cancer Jackman AL (Ed.). Humana Press, Totowa, NJ, USA 183–201 (1999).
  • Britten CD, Izbicka E, Hilsenbeck S et al. Activity of the multitargeted antifolate LY231514 in the human tumor cloning assay. Cancer Chemother. Pharmacol.44, 105–110 (1999).
  • Teicher BA, Chen V, Shih C et al. Treatment regimens including the multitargeted antifolate LY231514 in human tumor xenografts. Clin. Cancer Res.6, 1016–1023 (2000).
  • Niyikiza C, Baker SD, Seitz ED et al. Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol. Cancer Ther.1(7), 545–552 (2002).
  • Vogelzang NJ, Rusthoven JJ, Symanowski J et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J. Clin. Oncol.21(14), 2636–2644 (2003).
  • Hanna N, Shepherd FA, Fossella FV et al. Randomized Phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J. Clin. Oncol.22, 1589–1597 (2004).
  • Demarinis F, Paul S, Hanna N, Chang Yao Tsao T, Lim HL, Adachi S. Survival update for the Phase III study of pemetrexed vs docetaxel in non-small cell lung cancer (NSCLC). Presented at: Proceedings of the 42nd Annual Meeting of the American Society of Clinical Oncology June 2–6, Atlanta, GA, USA (2006) (Abstract 7133).
  • Chute JP, Chen T, Feigal E, Simon R, Johnson BE. Twenty years of Phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress. J. Clin. Oncol.17(6), 1794–1801 (1999).
  • Pujol JL, Carestia L, Daures J. Is there a case for cisplatin in the treatment of small cell lung cancer? A meta analysis of randomised trials of a cisplatin-containing regimen versus a regimen without this alkalylating agent. Br. J. Cancer83(1), 8–15 (2000).
  • Mascaux C, Paesmans M, Berghmans T et al. A systematic review of the role of etoposide and cisplatin in the chemotherapy of small cell lung cancer with methodology assessment and meta-analysis. Lung Cancer30(1), 23–36 (2000).
  • Bunn PA Jr. Review of therapeutic trials of carboplatin in lung cancer. Semin. Oncol.16(2 Suppl. 5), 27–33 (1989).
  • Gatzemeier U, Hossfeld DK, Neuhauss R, Reck M, Achterrath W, Lenaz L. Phase II and III studies with carboplatin in small cell lung cancer. Semin. Oncol.19(1 Suppl. 2), 28–36 (1992).
  • Thatcher N, Lind M. Carboplatin in small cell lung cancer. Semin. Oncol.17(1 Suppl. 2), 40–48 (1990).
  • Brahmer JR, Ettinger DS. Carboplatin in the treatment of small cell lung cancer. Oncologist3(3), 143–154 (1998).
  • Kosmidis PA, Samantas E, Fountzilas G et al. Cisplatin/etoposide versus carboplatin/etoposide chemotherapy and irradiation in small cell lung cancer: a randomized Phase III study. Hellenic Cooperative Oncology Group for Lung Cancer Trials. Semin. Oncol.21(3 Suppl. 6), 23–30 (1994).
  • Lassen U, Kristjansen PE, Osterlind K et al. Superiority of cisplatin or carboplatin in combination with teniposide and vincristine in the induction chemotherapy of small-cell lung cancer. A randomized trial with 5 years follow up. Ann. Oncol.7, 365–371 (1996).
  • Hanna N, Ansari R, Bhatia S et al. Pemetrexed in patients with relapsed small cell lung cancer (SCLC). A Phase II study of the Hoosier Oncology Group. J. Clin. Oncol.24(S18 Suppl. 1), 7063 (2006).
  • Noda K, Nishiwaki Y, Kawahara M et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive stage small-cell lung cancer. New Engl. J. Med.346(2), 85–91 (2002).
  • Hanna N, Bunn PA, Langer C et al. Randomized Phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J. Clin. Oncol.24(13), 2038–2043 (2006).
  • Eckardt JR, von Pawel J, Papai Z et al. Open-label, multicenter, randomized, Phase III study comparing oral topotecan/cisplatin versus etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive-disease small-cell lung cancer. J. Clin. Oncol.24(13), 2044–2051 (2006).
  • Reck M, von Pawel J, Macha HN et al. Efficient palliation in patients with small-cell lung cancer by a combination of paclitaxel, etoposide and carboplatin: quality of life and 6-years’-follow-up results from a randomised Phase III trial. Lung Cancer53(1), 67–75 (2006).
  • Mavroudis D, Papadakis E, Veslemes M et al. A multicenter randomized clinical trial comparing paclitaxel–cisplatin–etoposide versus cisplatin–etoposide as front-line treatment in patients with small cell lung cancer. Ann Oncol.12(4), 463–470 (2001).
  • Niell HB, Herndon JE II, Miller AA et al. Randomized Phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B Trial 9732. J. Clin. Oncol.23(16), 3752–3759 (2005).
  • James LE, Rudd R, Gower NH et al. A Phase III randomised comparison of gemcitabine/carboplatin (GC) with cisplatin/etoposide (PE) in patients with poor prognosis small cell lung cancer (SCLC). Presented at: Proceedings of the 38th Annual Meeting of the American Society of Clinical Oncology. May 18–21, Orlando, FL, USA (2002) (Abstract 1170).
  • Ohe Y, Negoro S, Matsui K et al. Phase I–II study of amrubicin and cisplatin in previously untreated patients with extensive stage small cell lung cancer. Ann. Oncol.16(3), 430–436 (2005).
  • Yana T, Negoro S, Takada M et al. Phase II study of amrubicin in previously untreated patients with extensive-disease small cell lung cancer: West Japan Thoracic Oncology Group (WJTOG) study. Invest. New Drugs (2006) (Epub ahead of print).
  • Pujol JL, Breton JL, Gervais R et al. A prospective randomized Phase III, double-blind, placebo-controlled study of thalidomide in extended-disease (ED) SCLC patients after response to chemotherapy (CT): an intergroup study FNCLCC Cleo04 - IFCT 00-01. Presented at: Proceedings of the 42nd Annual Meeting of the American Society of Clinical Oncology. June 2–6, Atlanta, GA, USA (2006) (Abstract 7057).

Website

  • ALIMTA®: pemetrexed for injection www.fda.gov/cder/foi/label/2004/021677lbl.pdf.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.