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Journal of Clinical Oncology, Vol 22, No 9 (May 1), 2004: pp. 1589-1597
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.08.163
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Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy

Nasser Hanna, Frances A. Shepherd, Frank V. Fossella, Jose R. Pereira, Filippo De Marinis, Joachim von Pawel, Ulrich Gatzemeier, Thomas Chang Yao Tsao, Miklos Pless, Thomas Muller, Hong-Liang Lim, Christopher Desch, Klara Szondy, Radj Gervais, Shaharyar, Christian Manegold, Sofia Paul, Paolo Paoletti, Lawrence Einhorn, Paul A. Bunn, Jr.

From Indiana University and the Hoosier Oncology Group; Eli Lilly and Company, Indianapolis, IN; The University of Texas M.D. Anderson Cancer Center, Houston, TX; University of Colorado Cancer Center, Denver, CO; Virginia Cancer Institute, Richmond, VA; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Instituto Arnaldo Vieira de Carvalho, Sao Paolo, Brazil; San Camillo-Forlanini Hospitals, Rome, Italy; Chang Gung Memorial Hospital, Taoyuan, Taiwan; University Hospital Basel, Petersgraben Switzerland; Fachklinik München, Gauting; Hospital Grosshansdorf, Grosshansdorf; Krankenhaus Hofheim Am Taunus, Hofheim; Thoraxklinik-Heidelberg, Heidelberg, Germany; National University Hospital, Singapore; Semmelweis Medical University Diosarok, Budapest, Hungary; Centre Francois Baclesse, Caen, France; Mayo Hospital, Lahore, Pakistan.

Address reprint requests to Nasser Hanna, MD, Indiana University, 535 Barnhill Dr, Room 473, Indianapolis, IN 46202; e-mail: nhanna{at}iupui.edu

PURPOSE: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non—small-cell lung cancer (NSCLC) previously treated with chemotherapy.

PATIENTS AND METHODS: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival.

RESULTS: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed.

CONCLUSION: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.

Supported by Eli Lilly and Company, Indianapolis, IN.

Presented in part at the 39th annual meeting of the American Society of Clinical Oncology, Chicago, IL, June 2003, and the 10th World Conference on Lung Cancer meeting of the International Association for the Study of Lung Cancer, Vancouver, Canada, August 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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P. A. Bunn Jr. and N. Thatcher
Introduction
Oncologist, January 1, 2008; 13(suppl_1): 1 - 4.
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S. Ramalingam and C. Belani
Systemic Chemotherapy for Advanced Non-Small Cell Lung Cancer: Recent Advances and Future Directions
Oncologist, January 1, 2008; 13(suppl_1): 5 - 13.
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F. de Marinis and F. Grossi
Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer
Oncologist, January 1, 2008; 13(suppl_1): 14 - 20.
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T. E. Stinchcombe and M. A. Socinski
Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer
Oncologist, January 1, 2008; 13(suppl_1): 28 - 36.
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P. A. Bunn Jr. and N. Thatcher
Conclusion
Oncologist, January 1, 2008; 13(suppl_1): 37 - 46.
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M. A. Socinski and T. E. Stinchcombe
Duration of First-Line Chemotherapy in Advanced Non Small-Cell Lung Cancer: Less Is More in the Era of Effective Subsequent Therapies
J. Clin. Oncol., November 20, 2007; 25(33): 5155 - 5157.
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J. O. Park, S.-W. Kim, J. S. Ahn, C. Suh, J. S. Lee, J. S. Jang, E. K. Cho, S. H. Yang, J.-H. Choi, D. S. Heo, et al.
Phase III Trial of Two Versus Four Additional Cycles in Patients Who Are Nonprogressive After Two Cycles of Platinum-Based Chemotherapy in Non Small-Cell Lung Cancer
J. Clin. Oncol., November 20, 2007; 25(33): 5233 - 5239.
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B. Freidlin, E. L. Korn, S. L. George, and R. Gray
Randomized Clinical Trial Design for Assessing Noninferiority When Superiority Is Expected
J. Clin. Oncol., November 1, 2007; 25(31): 5019 - 5023.
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R. S. Herbst, V. J. O'Neill, L. Fehrenbacher, C. P. Belani, P. D. Bonomi, L. Hart, O. Melnyk, D. Ramies, M. Lin, and A. Sandler
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Chemotherapy or Erlotinib Compared With Chemotherapy Alone for Treatment of Recurrent or Refractory Non Small-Cell Lung Cancer
J. Clin. Oncol., October 20, 2007; 25(30): 4743 - 4750.
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R. S. Herbst, A. M. Davies, R. B. Natale, T. P. Dang, J. H. Schiller, L. L. Garland, V. A. Miller, D. Mendelson, A. D. Van den Abbeele, Y. Melenevsky, et al.
Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non Small Cell Lung Cancer
Clin. Cancer Res., October 15, 2007; 13(20): 6175 - 6181.
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D. S. Hsu, B. S. Balakumaran, C. R. Acharya, V. Vlahovic, K. S. Walters, K. Garman, C. Anders, R. F. Riedel, J. Lancaster, D. Harpole, et al.
Pharmacogenomic Strategies Provide a Rational Approach to the Treatment of Cisplatin-Resistant Patients With Advanced Cancer
J. Clin. Oncol., October 1, 2007; 25(28): 4350 - 4357.
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J. V. Heymach, B. E. Johnson, D. Prager, E. Csada, J. Roubec, M. Pesek, I. Spasova, C. P. Belani, I. Bodrogi, S. Gadgeel, et al.
Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non Small-Cell Lung Cancer
J. Clin. Oncol., September 20, 2007; 25(27): 4270 - 4277.
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A. W. Blackstock and R. Govindan
Definitive Chemoradiation for the Treatment of Locally Advanced Non Small-Cell Lung Cancer
J. Clin. Oncol., September 10, 2007; 25(26): 4146 - 4152.
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J. Vansteenkiste, P. N. Lara Jr, T. Le Chevalier, J.-L. Breton, P. Bonomi, A. B. Sandler, M. A. Socinski, C. Delbaldo, B. McHenry, D. Lebwohl, et al.
Phase II Clinical Trial of the Epothilone B Analog, Ixabepilone, in Patients With Non Small-Cell Lung Cancer Whose Tumors Have Failed First-Line Platinum-Based Chemotherapy
J. Clin. Oncol., August 10, 2007; 25(23): 3448 - 3455.
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M. A. Socinski
Antibodies to the Epidermal Growth Factor Receptor in Non Small Cell Lung Cancer: Current Status of Matuzumab and Panitumumab
Clin. Cancer Res., August 1, 2007; 13(15): 4597s - 4601s.
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P. D. Bonomi, L. Buckingham, and J. Coon
Selecting Patients for Treatment with Epidermal Growth Factor Tyrosine Kinase Inhibitors
Clin. Cancer Res., August 1, 2007; 13(15): 4606s - 4612s.
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B. E. Johnson, D. Jackman, and P. A. Janne
Rationale for a Phase I Trial of Erlotinib and the Mammalian Target of Rapamycin Inhibitor Everolimus (RAD001) for Patients with Relapsed Non Small Cell Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4628s - 4631s.
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A. M. Davies, P. N. Lara Jr., P. C. Mack, and D. R. Gandara
Incorporating Bortezomib into the Treatment of Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4647s - 4651s.
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S. Chattopadhyay, R. Tamari, S. H. Min, R. Zhao, E. Tsai, and I. D. Goldman
Commentary: A Case for Minimizing Folate Supplementation in Clinical Regimens with Pemetrexed Based on the Marked Sensitivity of the Drug to Folate Availability
Oncologist, July 1, 2007; 12(7): 808 - 815.
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C. Gridelli, M. A. Bareschino, C. Schettino, A. Rossi, P. Maione, and F. Ciardiello
Erlotinib in Non-Small Cell Lung Cancer Treatment: Current Status and Future Development
Oncologist, July 1, 2007; 12(7): 840 - 849.
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J. S. Temel, V. A. Jackson, J. A. Billings, C. Dahlin, S. D. Block, M. K. Buss, P. Ostler, P. Fidias, A. Muzikansky, J. A. Greer, et al.
Phase II Study: Integrated Palliative Care in Newly Diagnosed Advanced Non-Small-Cell Lung Cancer Patients
J. Clin. Oncol., June 10, 2007; 25(17): 2377 - 2382.
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T. Li, Y.-H. Ling, I. D. Goldman, and R. Perez-Soler
Schedule-Dependent Cytotoxic Synergism of Pemetrexed and Erlotinib in Human Non-Small Cell Lung Cancer Cells
Clin. Cancer Res., June 1, 2007; 13(11): 3413 - 3422.
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S. M. Lichtman, H. Wildiers, E. Chatelut, C. Steer, D. Budman, V. A. Morrison, B. Tranchand, I. Shapira, and M. Aapro
International Society of Geriatric Oncology Chemotherapy Taskforce: Evaluation of Chemotherapy in Older Patients--An Analysis of the Medical Literature
J. Clin. Oncol., May 10, 2007; 25(14): 1832 - 1843.
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C. H. Takimoto, L. A. Hammond-Thelin, J. E. Latz, L. Forero, M. Beeram, B. Forouzesh, J. de Bono, A. W. Tolcher, A. Patnaik, P. Monroe, et al.
Phase I and Pharmacokinetic Study of Pemetrexed with High-Dose Folic Acid Supplementation or Multivitamin Supplementation in Patients with Locally Advanced or Metastatic Cancer
Clin. Cancer Res., May 1, 2007; 13(9): 2675 - 2683.
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S. Malempati, H. S. Nicholson, J. M. Reid, S. M. Blaney, A. M. Ingle, M. Krailo, L. C. Stork, A. S. Melemed, R. McGovern, S. Safgren, et al.
Phase I Trial and Pharmacokinetic Study of Pemetrexed in Children With Refractory Solid Tumors: The Children's Oncology Group
J. Clin. Oncol., April 20, 2007; 25(12): 1505 - 1511.
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M. Di Maio, F. Perrone, P. Chiodini, C. Gallo, C. Camps, W. Schuette, E. Quoix, C.-M. Tsai, and C. Gridelli
Individual Patient Data Meta-Analysis of Docetaxel Administered Once Every 3 Weeks Compared With Once Every Week Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., April 10, 2007; 25(11): 1377 - 1382.
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D. M. Mintzer and K. Zagrabbe
On How Increasing Numbers of Newer Cancer Therapies Further Delay Referral to Hospice: The Increasing Palliative Care Imperative
American Journal of Hospice and Palliative Medicine, April 1, 2007; 24(2): 126 - 130.
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S Boeck, K Weigang-Kohler, M Fuchs, E Kettner, D Quietzsch, J Trojan, O Stotzer, S Zeuzem, F Lordick, C-H Kohne, et al.
Second-line chemotherapy with pemetrexed after gemcitabine failure in patients with advanced pancreatic cancer: a multicenter phase II trial
Ann. Onc., April 1, 2007; 18(4): 745 - 751.
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G. Giaccone
The Potential of Antiangiogenic Therapy in Non-Small Cell Lung Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 1961 - 1970.
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F. Grossi, M. Aita, A. Follador, C. Defferrari, A. Brianti, G. Sinaccio, and O. Belvedere
Sequential, Alternating, and Maintenance/Consolidation Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Review of the Literature
Oncologist, April 1, 2007; 12(4): 451 - 464.
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G. Weiss, R Rosell, F Fossella, M Perry, R Stahel, F Barata, B Nguyen, S Paul, P McAndrews, N Hanna, et al.
The impact of induction chemotherapy on the outcome of second-line therapy with pemetrexed or docetaxel in patients with advanced non-small-cell lung cancer
Ann. Onc., March 1, 2007; 18(3): 453 - 460.
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M. Soares, M. Darmon, J. I. F. Salluh, C. G. Ferreira, G. Thiery, B. Schlemmer, N. Spector, and E. Azoulay
Prognosis of Lung Cancer Patients With Life-Threatening Complications
Chest, March 1, 2007; 131(3): 840 - 846.
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C. J. Langer
Mind Your Elders: Therapeutic Implications of Epidermal Growth Factor Receptor Inhibition in Older Patients With Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., March 1, 2007; 25(7): 751 - 753.
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L. V. Sequist, D. W. Bell, T. J. Lynch, and D. A. Haber
Molecular Predictors of Response to Epidermal Growth Factor Receptor Antagonists in Non-Small-Cell Lung Cancer
J. Clin. Oncol., February 10, 2007; 25(5): 587 - 595.
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S. Chattopadhyay, R. G. Moran, and I. D. Goldman
Pemetrexed: biochemical and cellular pharmacology, mechanisms, and clinical applications
Mol. Cancer Ther., February 1, 2007; 6(2): 404 - 417.
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T. Y. Seiwert, P. P. Connell, A. M. Mauer, P. C. Hoffman, C. M. George, L. Szeto, R. Salgia, K. E. Posther, B. Nguyen, D. J. Haraf, et al.
A Phase I Study of Pemetrexed, Carboplatin, and Concurrent Radiotherapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung or Esophageal Cancer
Clin. Cancer Res., January 15, 2007; 13(2): 515 - 522.
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N. Hanna, R. Lilenbaum, R. Ansari, T. Lynch, R. Govindan, P. A. Janne, and P. Bonomi
Phase II Trial of Cetuximab in Patients With Previously Treated Non Small-Cell Lung Cancer
J. Clin. Oncol., November 20, 2006; 24(33): 5253 - 5258.
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M. P. Fanucchi, F. V. Fossella, R. Belt, R. Natale, P. Fidias, D. P. Carbone, R. Govindan, L. E. Raez, F. Robert, M. Ribeiro, et al.
Randomized Phase II Study of Bortezomib Alone and Bortezomib in Combination With Docetaxel in Previously Treated Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., November 1, 2006; 24(31): 5025 - 5033.
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J. R. Murillo Jr. and J. Koeller
Chemotherapy Given Near the End of Life by Community Oncologists for Advanced Non-Small Cell Lung Cancer
Oncologist, November 1, 2006; 11(10): 1095 - 1099.
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