First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study
Open accessAbstract
BACKGROUND: Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). TREATMENT: gefitinib 250 mg day(-1) until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples. RESULTS: Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14%), 106 with EGFR sensitising mutations were enrolled (female 70.8%; adenocarcinoma 97.2%; never-smoker 64.2%). At data cutoff: ORR 69.8% (95% confidence interval (CI) 60.5-77.7), DCR 90.6% (95% CI 83.5-94.8), median PFS 9.7 months (95% CI 8.5-11.0), median OS 19.2 months (95% CI 17.0-NC; 27% maturity). Most common adverse events (AEs; any grade): rash (44.9%), diarrhoea (30.8%); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15%; SAEs: 19%. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10%). Plasma 1 EGFR mutation test sensitivity: 65.7% (95% CI 55.8-74.7). CONCLUSION: First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Liquid biopsy is a validated alternative to tissue rebiopsy, provides a surrogate source of DNA, and is a new strategy for tumour genotyping mainly at progression in EGFR-mutated patients.
“A valid alternative to tissue rebiopsy is represented by liquid biopsy, which has been validated [126], represents a surrogate source of DNA and is a new strategy for tumour genotyping, mainly at the time of progression for EGFR-mutated patients [III, A] [127-129].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [126]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534 · see citing works
Lynch, T. J., Bell, D. W., Sordella, R., Gurubhagavatula, S., Okimoto, R. A., Brannigan, B. W., Harris, P. L., Haserlat, S. M., Supko, J. G., Haluska, F. G., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040938 · Cited by 11,486 · see citing works
<i>EGFR</i> Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy
Paez, J. G., Jänne, P. A., Lee, J. C., Tracy, S., Greulich, H., Gabriel, S., Herman, P., Kaye, F. J., Lindeman, N., Boggon, T. J., et al. (2004) · Science · doi:10.1126/science.1099314 · Cited by 9,368 · see citing works
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Mok, T. S., Wu, Y.-L., Thongprasert, S., Yang, C.-H., Chu, D.-T., Saijo, N., Sunpaweravong, P., Han, B., Margono, B., Ichinose, Y., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0810699 · Cited by 8,261 · see citing works
Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR
Maemondo, M., Inoue, A., Kobayashi, K., Sugawara, S., Oizumi, S., Isobe, H., Gemma, A., Harada, M., Yoshizawa, H., Kinoshita, I., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0909530 · Cited by 5,525 · see citing works
Rosell, R., Carcereny, E., Gervais, R., Vergnenegre, A., Massuti, B., Felip, E., Palmero, R., Garcia-Gomez, R., Pallares, C., Sanchez, J. M., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70393-x · Cited by 5,489 · see citing works
Self-citationMitsudomi, T., Morita, S., Yatabe, Y., Negoro, S., Okamoto, I., Tsurutani, J., Seto, T., Satouchi, M., Tada, H., Hirashima, T., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70364-x · Cited by 4,090 · see citing works
Zhou, C., Wu, Y.-L., Chen, G., Feng, J., Liu, X.-Q., Wang, C., Zhang, S., Wang, J., Zhou, S., Ren, S., et al. (2011) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70184-x · Cited by 4,081 · see citing works
Fukuoka, M., Yano, S., Giaccone, G., Tamura, T., Nakagawa, K., Douillard, J., Nishiwaki, Y., Vansteenkiste, J., Kudoh, S., Rischin, D., et al. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2003.10.038 · Cited by 2,871 · see citing works
Self-citationKris, M. G., Natale, R. B., Herbst, R. S., Lynch, Jr., Prager, D., Belani, C. P., Schiller, J. H., Kelly, K., Spiridonidis, H., Sandler, A., et al. (2003) · JAMA · doi:10.1001/jama.290.16.2149 · Cited by 2,517 · see citing works
Kim, E. S., Hirsh, V., Mok, T. S. K., Socinski, M. A., Gervais, R., Wu, Y.-L. L. C., Li, L.-Y., Watkins, C. L., Sellers, M. V., Lowe, E., et al. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61758-4 · Cited by 1,241 · see citing works
Self-citationSequist, L. V., Martins, R. G., Spigel, D., Grunberg, S. M., Spira, A., Jänne, P. A., Joshi, V. A., McCollum, D., Evans, T. L., Muzikansky, A., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.14.8494 · Cited by 820 · see citing works
Han, J.-Y., Park, K., Kim, S.-W., Lee, D. H., Kim, H. Y., Kim, H. T., Ahn, M. J., Yun, T., Ahn, J. S., Suh, C., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.36.8456 · Cited by 736 · see citing works
Inoue, A., Kobayashi, K., Maemondo, M., Sugawara, S., Oizumi, S., Isobe, H., Gemma, A., Harada, M., Yoshizawa, H., Kinoshita, I., et al. (2013) · Annals of Oncology · doi:10.1093/annonc/mds214 · Cited by 540 · see citing works
Goto, K., Ichinose, Y., Ohe, Y., Yamamoto, N., Negoro, S., Nishio, K., Itoh, Y., Jiang, H., Duffield, E. L., McCormack, R., et al. (2011) · Journal of Thoracic Oncology · doi:10.1097/jto.0b013e3182307f98 · Cited by 209 · see citing works
Self-citationTang, P. A., Pond, G. R., & Chen, E. X. (2009) · Annals of Oncology · doi:10.1093/annonc/mdp478 · Cited by 49 · see citing works
Therapeutic advances in non-small cell lung cancer
Vallières, E., Peters, S., Houtte, P. V., Dalal, P., & Lim, E. K. S. (2011) · Thorax · doi:10.1136/thoraxjnl-2011-201043 · Cited by 29 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Novello, S., Barlesi, F., Califano, R., Cufer, T., Ekman, S., Levra, M. G., Kerr, K., Popat, S., Reck, M., Senan, S., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw326 · Cited by 2,631 · see citing works
Clinical Applications of Circulating Tumor Cells and Circulating Tumor DNA as Liquid Biopsy
Alix-Panabières, C., & Pantel, K. (2016) · Cancer Discovery · doi:10.1158/2159-8290.cd-15-1483 · Cited by 1,394 · see citing works
Park, K., Tan, E.-H., O'Byrne, K., Zhang, L., Boyer, M., Mok, T., Hirsh, V., Yang, J. C.-H., Lee, K. H., Lu, S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30033-x · Cited by 1,183 · see citing works
Liquid biopsy and minimal residual disease - latest advances and implications for cure
Pantel, K., & Alix-Panabières, C. (2019) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-019-0187-3 · Cited by 1,110 · see citing works
Targeting TGF-β Signaling in Cancer
Colak, S., & ten Dijke, P. (2017) · Trends in cancer · doi:10.1016/j.trecan.2016.11.008 · Cited by 1,003 · see citing works
The emerging role of cell-free DNA as a molecular marker for cancer management
Bronkhorst, A. J., Ungerer, V., & Holdenrieder, S. (2019) · Biomolecular Detection and Quantification · doi:10.1016/j.bdq.2019.100087 · Cited by 566 · see citing works
Douillard, J.-Y., Ostoros, G., Cobo, M., Ciuleanu, T., Cole, R., McWalter, G., Walker, J., Dearden, S., Webster, A., Milenkova, T., et al. (2014) · Journal of Thoracic Oncology · doi:10.1097/jto.0000000000000263 · Cited by 448 · see citing works
Self-citationSoria, J.-C., Wu, Y.-L., Nakagawa, K., Kim, S.-W., Yang, J.-J., Ahn, M.-J., Wang, J., Yang, J. C.-H., Lu, Y., Atagi, S., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00121-7 · Cited by 413 · see citing works
Self-citationCouraud, S., Vaca-Paniagua, F., Villar, S., Oliver, J., Schuster, T., Blanché, H., Girard, N., Trédaniel, J., Guilleminault, L., Gervais, R., et al. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-13-3063 · Cited by 215 · see citing works
Targeting EGFR in Lung Cancer: Current Standards and Developments
Díaz-Serrano, A., Gella, P., Jiménez, E., Zugazagoitia, J., & Paz-Ares Rodríguez, L. (2018) · Drugs · doi:10.1007/s40265-018-0916-4 · Cited by 108 · see citing works
Hofheinz, R.-D., Deplanque, G., Komatsu, Y., Kobayashi, Y., Ocvirk, J., Racca, P., Guenther, S., Zhang, J., Lacouture, M. E., & Jatoi, A. (2016) · The Oncologist · doi:10.1634/theoncologist.2016-0051 · Cited by 88 · see citing works
Development of Dual Inhibitors Targeting Epidermal Growth Factor Receptor in Cancer Therapy
Tan, L., Zhang, J., Wang, Y., Wang, X., Wang, Y., Zhang, Z., Shuai, W., Wang, G., Chen, J., Wang, C., et al. (2022) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.1c01714 · Cited by 88 · see citing works
Pilotto, S., Rossi, A., Vavalà, T., Follador, A., Tiseo, M., Galetta, D., Morabito, A., Di Maio, M., Martelli, O., Caffo, O., et al. (2018) · Clinical Lung Cancer · doi:10.1016/j.cllc.2017.05.016 · Cited by 46 · see citing works
- Authors
- Douillard, J.-Y., Ostoros, G., Cobo, M., Ciuleanu, T., McCormack, R., Webster, A., & Milenkova, T.
- Affiliations
- Institut de Cancérologie de l'Ouest (FR)
- Országos Korányi Tbc és Pulmonológiai Intézet (HU)
- Hospital Regional Universitario de Málaga (ES)
- Iuliu Hațieganu University of Medicine and Pharmacy (RO)
- AstraZeneca (United Kingdom) (GB)
- Corresponding author
- Douillard, J-Y
- Venue
- British Journal of Cancer
- Published
- 2013-11-21
- Volume
- 110
- Issue
- 1
- Pages
- 55-62
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC3887309
- OpenAlex
- W1988827171
- Cited by
- 412
- References
- 17
- Citations by year
- 2026: 13 · 2025: 13 · 2024: 26 · 2023: 23 · 2022: 31 · 2021: 34 · 2020: 34 · 2019: 44 · 2018: 50 · 2017: 64 · 2016: 48 · 2015: 26 · 2014: 6
- FWCI
- 21.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- www.springer.com/tdm (unspecified)
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- gefitinib, EGFR-mutant non-small cell lung cancer, first-line therapy, EGFR tyrosine kinase inhibitors, objective response rate, progression-free survival, overall survival, adverse events, Caucasian patients
- MeSH terms
- Gefitinib, Adolescent, Adult, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Prospective Studies, Quinazolines, Disease Progression, Disease-Free Survival, Genes, erbB-1, White People, Protein Kinase Inhibitors, Young Adult, ErbB Receptors
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
