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Journal of Clinical Oncology, Vol 18, Issue 10 (May), 2000: 2095-2103
© 2000 American Society for Clinical Oncology

Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

By Frances A. Shepherd, Janet Dancey, Rodryg Ramlau, Karin Mattson, Richard Gralla, Mark O’Rourke, Nathan Levitan, Laurent Gressot, Mark Vincent, Ronald Burkes, Susan Coughlin, Yong Kim, Jocelyne Berille

From the University of Toronto, Toronto, and London Regional Cancer Centre, London, Ontario, Canada; Regional Hospital of Lung Disease and Tuberculosis, Poznan, Poland; Helsinki University, Helsinki, Finland; Alton Ochsner Medical Foundation, New Orleans, LA; Greenville Memorial Medical Center, Greenville, SC; University Hospitals of Cleveland, Cleveland, OH; Veterans Affairs Medical Center, Houston, TX; and Rhône-Poulenc Rorer, Collegeville, PA, and Paris, France.

Address correspondence to Frances A. Shepherd, MD, Princess Margaret Hospital, 610 University Ave, Ste 5-104, Toronto, Ontario M5G 2M9, Canada; email fshepherd{at}torhosp.toronto.on.ca

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/m2 (49 patients) or 75 mg/m2 (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/m2 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/m2, three of whom died, and in one patient treated with docetaxel 75 mg/m2. 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/m2, the benefits of docetaxel therapy outweigh the risks.


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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. C. Talbot, J. von Pawel, E. Cattell, S. M. Yule, C. Johnston, A. S. Zandvliet, A. D.R. Huitema, C. J. Norbury, P. Ellis, L. Bosquee, et al.
A Randomized Phase II Pharmacokinetic and Pharmacodynamic Study of Indisulam as Second-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer
Clin. Cancer Res., March 15, 2007; 13(6): 1816 - 1822.
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 Ann OncolHome page
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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 JCOHome page
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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 Ann OncolHome page
P Bidoli, N Zilembo, D Cortinovis, L Mariani, L Isa, E Aitini, D Cullura, F Pari, P Nova, M Mancin, et al.
Randomized phase II three-arm trial with three platinum-based doublets in metastatic non-small-cell lung cancer. An Italian Trials in Medical Oncology study
Ann. Onc., March 1, 2007; 18(3): 461 - 467.
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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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 Ann OncolHome page
Y Ohe, Y Ohashi, K Kubota, T Tamura, K Nakagawa, S Negoro, Y Nishiwaki, N Saijo, Y Ariyoshi, M Fukuoka, et al.
Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan
Ann. Onc., February 1, 2007; 18(2): 317 - 323.
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 Ann OncolHome page
J Alexandre, E Rey, V Girre, S Grabar, A Tran, V Montheil, F Rabillon, V Dieras, V Jullien, P Herait, et al.
Relationship between cytochrome 3A activity, inflammatory status and the risk of docetaxel-induced febrile neutropenia: a prospective study
Ann. Onc., January 1, 2007; 18(1): 168 - 172.
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 Jpn J Clin OncolHome page
J. J. Lee, J.-Y. Han, D. H. Lee, H. Y. Kim, J. H. Chun, H. G. Lee, S. M. Yoon, S. Y. Lee, and J. S. Lee
A Phase II Trial of Docetaxel Plus Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer
Jpn. J. Clin. Oncol., December 1, 2006; 36(12): 761 - 767.
[Abstract] [Full Text] [PDF]

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 JCOHome page
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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 JCOHome page
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.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
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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 JCOHome page
R. Lilenbaum, M. A. Socinski, N. K. Altorki, L. L. Hart, R. S. Keresztes, S. Hariharan, M. E. Morrison, R. Fayyad, and P. Bonomi
Randomized Phase II Trial of Docetaxel/Irinotecan and Gemcitabine/Irinotecan With or Without Celecoxib in the Second-Line Treatment of Non-Small-Cell Lung Cancer
J. Clin. Oncol., October 20, 2006; 24(30): 4825 - 4832.
[Abstract] [Full Text] [PDF]

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R. Govindan, J. Crowley, L. Schwartzberg, P. Kennedy, C. Williams, B. Ekstrand, A. Sandler, D. Jaunakais, V. Bolejack, and R. Ghalie
Phase II Trial of Bexarotene Capsules in Patients With Advanced Non-Small-Cell Lung Cancer After Failure of Two or More Previous Therapies
J. Clin. Oncol., October 20, 2006; 24(30): 4848 - 4854.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Nemunaitis, R. O. Dillman, P. O. Schwarzenberger, N. Senzer, C. Cunningham, J. Cutler, A. Tong, P. Kumar, B. Pappen, C. Hamilton, et al.
Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in Non-Small-Cell Lung Cancer
J. Clin. Oncol., October 10, 2006; 24(29): 4721 - 4730.
[Abstract] [Full Text] [PDF]

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G. Bepler, I. Kusmartseva, S. Sharma, A. Gautam, A. Cantor, A. Sharma, and G. Simon
RRM1 Modulated In Vitro and In Vivo Efficacy of Gemcitabine and Platinum in Non-Small-Cell Lung Cancer
J. Clin. Oncol., October 10, 2006; 24(29): 4731 - 4737.
[Abstract] [Full Text] [PDF]

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G. J. Weiss, C. Langer, R. Rosell, N. Hanna, F. Shepherd, L. H. Einhorn, B. Nguyen, S. Paul, P. McAndrews, P. A. Bunn Jr, et al.
Elderly Patients Benefit From Second-Line Cytotoxic Chemotherapy: A Subset Analysis of a Randomized Phase III Trial of Pemetrexed Compared With Docetaxel in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 20, 2006; 24(27): 4405 - 4411.
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F. Ohyanagi, F. Taguchi, T. Horai, K. Kasahara, Y. Takeda, K. Shibata, H. Shirosaki, and M. Nishio
Phase II Study of Combination Chemotherapy with Gemcitabine and Irinotecan in Patients with Advanced Non-Small-Cell Lung Cancer Previously Treated with Platinum-Containing Chemotherapy Regimens
Jpn. J. Clin. Oncol., September 1, 2006; 36(9): 547 - 551.
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 JCOHome page
A. Bezjak, D. Tu, L. Seymour, G. Clark, A. Trajkovic, M. Zukin, J. Ayoub, S. Lago, R. de Albuquerque Ribeiro, A. Gerogianni, et al.
Symptom Improvement in Lung Cancer Patients Treated With Erlotinib: Quality of Life Analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21
J. Clin. Oncol., August 20, 2006; 24(24): 3831 - 3837.
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 Ann OncolHome page
M. R. Green, G. M. Manikhas, S. Orlov, B. Afanasyev, A. M. Makhson, P. Bhar, and M. J. Hawkins
Abraxane(R), a novel Cremophor(R)-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer
Ann. Onc., August 1, 2006; 17(8): 1263 - 1268.
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L. L. Garland, M. Hidalgo, D. S. Mendelson, D. P. Ryan, B. K. Arun, J. L. Lovalvo, I. A. Eiseman, S. C. Olson, P. F. Lenehan, and J. P. Eder
A Phase I Clinical and Pharmacokinetic Study of Oral CI-1033 in Combination with Docetaxel in Patients with Advanced Solid Tumors.
Clin. Cancer Res., July 15, 2006; 12(14): 4274 - 4282.
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R. Ramlau, R. Gervais, M. Krzakowski, J. von Pawel, E. Kaukel, R. P. Abratt, B. Dharan, K. M. Grotzinger, G. Ross, G. Dane, et al.
Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., June 20, 2006; 24(18): 2800 - 2807.
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D. R. Gandara and A. M. Davies
Oral Second-Line Chemotherapy for Advanced Non-Small-Cell Lung Cancer: The Bottom Line
J. Clin. Oncol., June 20, 2006; 24(18): 2700 - 2701.
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 The OncologistHome page
S. Ramalingam and A. B. Sandler
Salvage therapy for advanced non-small cell lung cancer: factors influencing treatment selection.
Oncologist, June 1, 2006; 11(6): 655 - 665.
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 JCOHome page
D. Ajzensztejn, V. S. Hegde, and S. M. Lee
Tumor Lysis Syndrome After Treatment With Docetaxel for Non-Small-Cell Lung Cancer
J. Clin. Oncol., May 20, 2006; 24(15): 2389 - 2391.
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 ChestHome page
Y.-M. Chen, J.-F. Shih, R.-P. Perng, C.-M. Tsai, and J. Whang-Peng
A Randomized Trial of Different Docetaxel Schedules in Non-small Cell Lung Cancer Patients Who Failed Previous Platinum-Based Chemotherapy.
Chest, April 1, 2006; 129(4): 1031 - 1038.
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 Ann OncolHome page
C. Camps, B. Massuti, A. Jimenez, I. Maestu, R. G. Gomez, D. Isla, J. L. Gonzalez, D. Almenar, A. Blasco, R. Rosell, et al.
Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial
Ann. Onc., March 1, 2006; 17(3): 467 - 472.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
T. C. Y. Tsao, C.-H. Chen, J. W. C. Chang, and C.-H. Lee
Weekly Short Infusion of Taxotere at a 4 Week Cycle in Chinese Patients with Advanced NSCLC Who Have Failed or Relapsed after the Frontline Platinum-based Non-Taxane Chemotherapy--A Phase II Trial
Jpn. J. Clin. Oncol., February 1, 2006; 36(2): 80 - 84.
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P. A. Janne, A. M. Borras, Y. Kuang, A. M. Rogers, V. A. Joshi, H. Liyanage, N. Lindeman, J. C. Lee, B. Halmos, E. A. Maher, et al.
A Rapid and Sensitive Enzymatic Method for Epidermal Growth Factor Receptor Mutation Screening
Clin. Cancer Res., February 1, 2006; 12(3): 751 - 758.
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 The Annals of PharmacotherapyHome page
D. A Frieze and J. S McCune
Current Status of Cetuximab for the Treatment of Patients with Solid Tumors
Ann. Pharmacother., February 1, 2006; 40(2): 241 - 250.
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 The Annals of PharmacotherapyHome page
M. H Nelson and C. R Dolder
Lapatinib: A Novel Dual Tyrosine Kinase Inhibitor with Activity in Solid Tumors
Ann. Pharmacother., February 1, 2006; 40(2): 261 - 269.
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 Jpn J Clin OncolHome page
K.-H. Cho, Y.-B. Song, I.-S. Choi, E.-H. Cho, J.-W. Choi, Y. M. Ahn, Y. H. Roh, S.-H. Nam, and B.-S. Kim
A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer
Jpn. J. Clin. Oncol., January 1, 2006; 36(1): 50 - 54.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
J. Ikeda, R. Maruyama, T. Okamoto, F. Shoji, H. Wataya, and Y. Ichinose
Phase I Study of Amrubicin Hydrochloride and Cisplatin in Patients Previously Treated for Advanced Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., January 1, 2006; 36(1): 12 - 16.
[Abstract] [Full Text] [PDF]

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 ChestHome page
G. A. Silvestri and M. P. Rivera
Targeted Therapy for the Treatment of Advanced Non-small Cell Lung Cancer: A Review of the Epidermal Growth Factor Receptor Antagonists
Chest, December 1, 2005; 128(6): 3975 - 3984.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
C.-L. Lai, C.-M. Tsai, C.-H. Chiu, G.-S. Wang, W.-J. Su, Y.-M. Chen, and R.-P. Perng
Phase II Randomized Trial of Tri-weekly Versus Days 1 and 8 Weekly Docetaxel as a Second-line Treatment of Advanced Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., December 1, 2005; 35(12): 700 - 706.
[Abstract] [Full Text] [PDF]


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