Pemetrexed versus erlotinib in pretreated patients with advanced non-small cell lung cancer: a Hellenic Oncology Research Group (HORG) randomized phase 3 study
Open accessAbstract
BACKGROUND: In this superiority study, pemetrexed was compared with erlotinib in pre-treated patients with metastatic non-small cell lung cancer (NSCLC). METHODS: Patients with stage IIIB/IV NSCLC who progressed after first-line or second-line treatment were randomized to receive either pemetrexed or erlotinib. In total, 21.7% of patients in the pemetrexed arm and 23.5% of patients in the erlotinib arm had squamous cell histology, and treatment was third line in 39.2% and 46.4% of patients, respectively. The primary study endpoint was time to tumor progression (TTP). Epidermal growth factor receptor/v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (EGFR/KRAS) mutation status also was investigated. RESULTS: There was no difference in terms of the TTP (P = .195), the objective response rate (P = .469), or overall survival (P = .986) between the 2 treatment arms. In patients who had squamous cell histology, erlotinib resulted in a superior TTP compared with pemetrexed (4.1 months vs 2.5 months, respectively; P = .006). The incidence of grade 3 and 4 neutropenia, thrombocytopenia, and asthenia was significantly higher in the pemetrexed arm, whereas the incidence of grade 3 and 4 skin rash was higher in the erlotinib arm. CONCLUSIONS: Both pemetrexed and erlotinib had comparable efficacy in pre-treated patients with metastatic NSCLC, and the current results indicated that genotyping of tumor cells may have an important effect on treatment efficacy.
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A large randomised phase III trial showed comparable outcomes with pemetrexed or erlotinib.
“Finally, a large randomised phase III trial showed comparable outcome with pemetrexed or erlotinib [90].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [90]
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- Authors
- Karampeazis, A., Voutsina, A., Souglakos, J., Kentepozidis, N., Giassas, S., Christofillakis, C., Kotsakis, A., Papakotoulas, P., Rapti, A., Agelidou, M., Agelaki, S., Vamvakas, L., Samonis, G., Mavroudis, D., & Georgoulias, V.
- Affiliations
- NIMTS Hospital (GR)
- University of Crete (GR)
- Hellenic Air Force (GR)
- IASO General Hospital (GR)
- Department of Medical Oncology 401 Military Hospital of Athens Athens Greece
- Theageneio General Hospital (GR)
- Sotiria Chest Diseases Hospital 8th Pulmonary Clinic Athens Greece
- Sismanoglio General Hospital (GR)
- University Hospital of Heraklion (GR)
- Corresponding author
- Georgoulias, Vassilis
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2013-05-09
- Volume
- 119
- Issue
- 15
- Pages
- 2754-2764
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W1523764380
- Cited by
- 113
- References
- 33
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 1 · 2022: 1 · 2021: 4 · 2020: 2 · 2019: 6 · 2018: 9 · 2017: 13 · 2016: 17 · 2015: 25 · 2014: 28 · 2013: 2 · 2012: 1
- FWCI
- 19.50
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- pemetrexed, erlotinib, non-small cell lung cancer, metastatic non-small cell lung cancer, EGFR mutation, KRAS mutation, lung squamous cell carcinoma, time to tumor progression, third-line therapy, neutropenia, rash, EGFR tyrosine kinase inhibitors, antifolate chemotherapy
- MeSH terms
- Pemetrexed, Erlotinib Hydrochloride, Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Carcinoma, Non-Small-Cell Lung, Female, Folic Acid Antagonists, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Quinazolines, Disease Progression, Disease-Free Survival, Protein Kinase Inhibitors
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