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Journal of Clinical Oncology, Vol 22, No 16 (August 15), 2004: pp. 3238-3247
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.11.057
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Determinants of Tumor Response and Survival With Erlotinib in Patients With Non—Small-Cell Lung Cancer

Román Pérez-Soler, Abraham Chachoua, Lisa A. Hammond, Eric K. Rowinsky, Mark Huberman, Daniel Karp, James Rigas, Gary M. Clark, Pedro Santabárbara, Philip Bonomi

From the Montefiore Medical Center/Albert Einstein College of Medicine, Bronx; New York University School of Medicine, New York, NY; Institute for Drug Development, San Antonio, TX; Beth Israel Deaconess Medical Center and Deaconess Medical Center, Boston, MA; Dartmouth-Hitchcock Medical Center, Lebanon, NH; OSI Pharmaceuticals Inc, Boulder, CO; and Rush Cancer Institute, Chicago, IL

Address reprint requests to Román Pérez-Soler, MD, Department of Oncology, Hofheimer 100, Montefiore Medical Center/Albert Einstein College of Medicine, 111 E 210th St, Bronx, NY 10467; e-mail: rperezso{at}montefiore.org

PURPOSE: Erlotinib is a highly specific epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor. This phase II study of erlotinib in patients with HER1/EGFR-expressing non–small-cell lung cancer previously treated with platinum-based chemotherapy evaluated tumor response, survival, and symptom improvement.

PATIENTS AND METHODS: Fifty-seven patients received an oral, continuous daily dose of 150 mg of erlotinib. Assessments of objective response used WHO and Response Evaluation Criteria in Solid Tumors criteria. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, supplemented with a lung cancer module, Quality of Life Questionnaire LC13, was used to measure health-related quality of life. Additional analyses were performed to identify predictors of response and survival.

RESULTS: The objective response rate was 12.3% (95% CI, 5.1% to 23.7%). Responses were observed regardless of type or number of prior chemotherapy regimens. Median survival time was 8.4 months (95% CI, 4.8 to 13.9 months), and the 1-year survival rate was 40% (95% CI, 28% to 54%). Erlotinib therapy was associated with tumor-related symptom improvement. The drug was well tolerated; drug-related cutaneous rash and diarrhea were observed in 75% and 56% of patients, respectively. One patient experienced toxicity consisting of severe grade 3 rash and diarrhea. Time since diagnosis and good performance status were significant predictors of survival in a multivariate Cox proportional hazards model, whereas HER1/EGFR staining intensity was not. Additionally, survival correlated with the occurrence and severity of rash.

CONCLUSION: Erlotinib was active and well tolerated in this patient population, and further clinical development is clearly warranted. Cutaneous rash seems to be a surrogate marker of clinical benefit, but this finding should be confirmed in ongoing and future studies.

Supported by OSI Pharmaceuticals, Inc, Melville, NY.

Data was previously presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12–15, 2001; and at the 10th World Congress on Lung Cancer, Vancouver, Canada, 2003.

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




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H. H. Schiffer, E. C. Reding, S. R. Fuhs, Q. Lu, F. Piu, S. Wong, P.-L. H. Littler, D. M. Weiner, W. Keefe, P. K. Tan, et al.
Pharmacology and Signaling Properties of Epidermal Growth Factor Receptor Isoforms Studied by Bioluminescence Resonance Energy Transfer
Mol. Pharmacol., February 1, 2007; 71(2): 508 - 518.
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 The OncologistHome page
A. Araujo, R. Ribeiro, I. Azevedo, A. Coelho, M. Soares, B. Sousa, D. Pinto, C. Lopes, R. Medeiros, and G. V. Scagliotti
Genetic Polymorphisms of the Epidermal Growth Factor and Related Receptor in Non-Small Cell Lung Cancer--A Review of the Literature
Oncologist, February 1, 2007; 12(2): 201 - 210.
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 Cancer Res.Home page
A. Rajput, A. P. Koterba, J. I. Kreisberg, J. M. Foster, J. K.V. Willson, and M. G. Brattain
A Novel Mechanism of Resistance to Epidermal Growth Factor Receptor Antagonism In vivo
Cancer Res., January 15, 2007; 67(2): 665 - 673.
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A.-R. Hanauske, J. Cassidy, J. Sastre, C. Bolling, R. J. Jones, A. Rakhit, S. Fettner, U. Brennscheidt, A. Feyereislova, and E. Diaz-Rubio
Phase 1b Dose Escalation Study of Erlotinib in Combination with Infusional 5-Fluorouracil, Leucovorin, and Oxaliplatin in Patients with Advanced Solid Tumors
Clin. Cancer Res., January 15, 2007; 13(2): 523 - 531.
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B. Brandt, S. Meyer-Staeckling, H. Schmidt, K. Agelopoulos, and H. Buerger
Mechanisms of egfr Gene Transcription Modulation: Relationship to Cancer Risk and Therapy Response
Clin. Cancer Res., December 15, 2006; 12(24): 7252 - 7260.
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B. A. Helfrich, D. Raben, M. Varella-Garcia, D. Gustafson, D. C. Chan, L. Bemis, C. Coldren, A. Baron, C. Zeng, W. A. Franklin, et al.
Antitumor Activity of the Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Gefitinib (ZD1839, Iressa) in Non-Small Cell Lung Cancer Cell Lines Correlates with Gene Copy Number and EGFR Mutations but not EGFR Protein Levels
Clin. Cancer Res., December 1, 2006; 12(23): 7117 - 7125.
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A. R. Tan, D. F. Moore, M. Hidalgo, J. H. Doroshow, E. A. Poplin, S. Goodin, D. Mauro, and E. H. Rubin
Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors
Clin. Cancer Res., November 1, 2006; 12(21): 6517 - 6522.
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 JCOHome page
H.-J. Lenz, E. Van Cutsem, S. Khambata-Ford, R. J. Mayer, P. Gold, P. Stella, B. Mirtsching, A. L. Cohn, A. W. Pippas, N. Azarnia, et al.
Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines
J. Clin. Oncol., October 20, 2006; 24(30): 4914 - 4921.
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 JCOHome page
D. T. Milton, G. J. Riely, W. Pao, V. A. Miller, M. G. Kris, and R. T. Heelan
Molecular On/Off Switch
J. Clin. Oncol., October 20, 2006; 24(30): 4940 - 4942.
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G. Giaccone, M. Gallegos Ruiz, T. Le Chevalier, N. Thatcher, E. Smit, J. A. Rodriguez, P. Janne, D. Oulid-Aissa, and J.-C. Soria
Erlotinib for Frontline Treatment of Advanced Non-Small Cell Lung Cancer: a Phase II Study.
Clin. Cancer Res., October 15, 2006; 12(20): 6049 - 6055.
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 ChestHome page
J. R. Molina, A. A. Adjei, and J. R. Jett
Advances in Chemotherapy of Non-small Cell Lung Cancer.
Chest, October 1, 2006; 130(4): 1211 - 1219.
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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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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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J. A. Engelman and L. C. Cantley
The Role of the ErbB Family Members in Non-Small Cell "Lung Cancers Sensitive to Epidermal Growth Factor Receptor Kinase Inhibitors".
Clin. Cancer Res., July 15, 2006; 12(14): 4372s - 4376s.
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R. K. Thomas, B. Weir, and M. Meyerson
Genomic approaches to lung cancer.
Clin. Cancer Res., July 15, 2006; 12(14): 4384s - 4391s.
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B. E. Johnson and P. A. Janne
Rationale for a Phase II Trial of Pertuzumab, a HER-2 Dimerization Inhibitor, in Patients with Non-Small Cell Lung Cancer.
Clin. Cancer Res., July 15, 2006; 12(14): 4436s - 4440s.
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D. M. Jackman, B. Y. Yeap, L. V. Sequist, N. Lindeman, A. J. Holmes, V. A. Joshi, D. W. Bell, M. S. Huberman, B. Halmos, M. S. Rabin, et al.
Exon 19 Deletion Mutations of Epidermal Growth Factor Receptor Are Associated with Prolonged Survival in Non-Small Cell Lung Cancer Patients Treated with Gefitinib or Erlotinib.
Clin. Cancer Res., July 1, 2006; 12(13): 3908 - 3914.
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 Ann OncolHome page
A. Italiano, F. B. Vandenbos, J. Otto, J. Mouroux, D. Fontaine, P.-Y. Marcy, N. Cardot, A. Thyss, and F. Pedeutour
Comparison of the epidermal growth factor receptor gene and protein in primary non-small-cell-lung cancer and metastatic sites: implications for treatment with EGFR-inhibitors
Ann. Onc., June 1, 2006; 17(6): 981 - 985.
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S. Goodin
Erlotinib: optimizing therapy with predictors of response?
Clin. Cancer Res., May 15, 2006; 12(10): 2961 - 2963.
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 JCOHome page
E. Calvo and J. Baselga
Ethnic Differences in Response to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors
J. Clin. Oncol., May 10, 2006; 24(14): 2158 - 2163.
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 Molecular Cancer TherapeuticsHome page
S. Van Schaeybroeck, J. Kyula, D. M. Kelly, A. Karaiskou-McCaul, S. A. Stokesberry, E. Van Cutsem, D. B. Longley, and P. G. Johnston
Chemotherapy-induced epidermal growth factor receptor activation determines response to combined gefitinib/chemotherapy treatment in non-small cell lung cancer cells
Mol. Cancer Ther., May 1, 2006; 5(5): 1154 - 1165.
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 JCOHome page
H. L. West, W. A. Franklin, J. McCoy, P. H. Gumerlock, R. Vance, D. H.M. Lau, K. Chansky, J. J. Crowley, and D. R. Gandara
Gefitinib Therapy in Advanced Bronchioloalveolar Carcinoma: Southwest Oncology Group Study S0126
J. Clin. Oncol., April 20, 2006; 24(12): 1807 - 1813.
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 J Clin PharmacolHome page
P. Frohna, J. Lu, S. Eppler, M. Hamilton, J. Wolf, A. Rakhit, J. Ling, S. R. Kenkare-Mitra, and B. L. Lum
Evaluation of the absolute oral bioavailability and bioequivalence of erlotinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in a randomized, crossover study in healthy subjects.
J. Clin. Pharmacol., March 1, 2006; 46(3): 282 - 290.
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 Cancer Res.Home page
M. Sato, M. B. Vaughan, L. Girard, M. Peyton, W. Lee, D. S. Shames, R. D. Ramirez, N. Sunaga, A. F. Gazdar, J. W. Shay, et al.
Multiple Oncogenic Changes (K-RASV12, p53 Knockdown, Mutant EGFRs, p16 Bypass, Telomerase) Are Not Sufficient to Confer a Full Malignant Phenotype on Human Bronchial Epithelial Cells
Cancer Res., February 15, 2006; 66(4): 2116 - 2128.
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G. J. Riely, W. Pao, D. Pham, A. R. Li, N. Rizvi, E. S. Venkatraman, M. F. Zakowski, M. G. Kris, M. Ladanyi, and V. A. Miller
Clinical Course of Patients with Non-Small Cell Lung Cancer and Epidermal Growth Factor Receptor Exon 19 and Exon 21 Mutations Treated with Gefitinib or Erlotinib
Clin. Cancer Res., February 1, 2006; 12(3): 839 - 844.
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 ThoraxHome page
H Nakamura, N Kawasaki, M Taguchi, and K Kabasawa
Survival impact of epidermal growth factor receptor overexpression in patients with non-small cell lung cancer: a meta-analysis
Thorax, February 1, 2006; 61(2): 140 - 145.
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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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 JCOHome page
K. H. Dragnev, W. J. Petty, S. Shah, A. Biddle, N. B. Desai, V. Memoli, J. R. Rigas, and E. Dmitrovsky
Bexarotene and Erlotinib for Aerodigestive Tract Cancer
J. Clin. Oncol., December 1, 2005; 23(34): 8757 - 8764.
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 JCOHome page
C. D. Thienelt, P. A. Bunn Jr, N. Hanna, A. Rosenberg, M. N. Needle, M. E. Long, D. L. Gustafson, and K. Kelly
Multicenter Phase I/II Study of Cetuximab With Paclitaxel and Carboplatin in Untreated Patients With Stage IV Non-Small-Cell Lung Cancer
J. Clin. Oncol., December 1, 2005; 23(34): 8786 - 8793.
[Abstract] [Full Text] [PDF]

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E. B. Haura, Z. Zheng, L. Song, A. Cantor, and G. Bepler
Activated Epidermal Growth Factor Receptor-Stat-3 Signaling Promotes Tumor Survival In vivo in Non-Small Cell Lung Cancer
Clin. Cancer Res., December 1, 2005; 11(23): 8288 - 8294.
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 Clin. Cancer Res.Home page
S. E. Bates and T. Fojo
Epidermal Growth Factor Receptor Inhibitors: A Moving Target?
Clin. Cancer Res., October 15, 2005; 11(20): 7203 - 7205.
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 JCOHome page
F. R. Hirsch, M. Varella-Garcia, J. McCoy, H. West, A. C. Xavier, P. Gumerlock, P. A. Bunn Jr, W. A. Franklin, J. Crowley, and D. R. Gandara
Increased Epidermal Growth Factor Receptor Gene Copy Number Detected by Fluorescence In Situ Hybridization Associates With Increased Sensitivity to Gefitinib in Patients With Bronchioloalveolar Carcinoma Subtypes: A Southwest Oncology Group Study
J. Clin. Oncol., October 1, 2005; 23(28): 6838 - 6845.
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I. Csiki, J. D. Morrow, A. Sandler, Y. Shyr, J. Oates, M. K. Williams, T. Dang, D. P. Carbone, and D. H. Johnson
Targeting Cyclooxygenase-2 in Recurrent Non-Small Cell Lung Cancer: A Phase II Trial of Celecoxib and Docetaxel
Clin. Cancer Res., September 15, 2005; 11(18): 6634 - 6640.
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 Cancer Res.Home page
B. E. Johnson and P. A. Janne
Epidermal Growth Factor Receptor Mutations in Patients with Non-Small Cell Lung Cancer
Cancer Res., September 1, 2005; 65(17): 7525 - 7529.
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 JCOHome page
D. A. Eberhard, B. E. Johnson, L. C. Amler, A. D. Goddard, S. L. Heldens, R. S. Herbst, W. L. Ince, P. A. Janne, T. Januario, D. H. Johnson, et al.
Mutations in the Epidermal Growth Factor Receptor and in KRAS Are Predictive and Prognostic Indicators in Patients With Non-Small-Cell Lung Cancer Treated With Chemotherapy Alone and in Combination With Erlotinib
J. Clin. Oncol., September 1, 2005; 23(25): 5900 - 5909.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. S. Herbst, D. Prager, R. Hermann, L. Fehrenbacher, B. E. Johnson, A. Sandler, M. G. Kris, H. T. Tran, P. Klein, X. Li, et al.
TRIBUTE: A Phase III Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 1, 2005; 23(25): 5892 - 5899.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
S. Segaert and E. Van Cutsem
Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors
Ann. Onc., September 1, 2005; 16(9): 1425 - 1433.
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