The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies

Scagliotti, Giorgio; Hanna, Nasser; Fossella, Frank; Sugarman, Katherine; Blatter, Johannes; Peterson, Patrick; Simms, Lorinda; Shepherd, Frances A.

doi:10.1634/theoncologist.2008-0232

Cited by 690Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies

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Scagliotti, Giorgio, Hanna, Nasser, Fossella, Frank, Sugarman, Katherine, Blatter, Johannes, Peterson, Patrick, Simms, Lorinda, Shepherd, Frances A.·2009·The Oncologist

DOI 10.1634/theoncologist.2008-0232

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Abstract

BACKGROUND: Recent studies of pemetrexed have identified a predictive role for non-small cell lung cancer (NSCLC) histology. We further reviewed the differential efficacy of pemetrexed according to histology in two large, phase III NSCLC trials. METHODS: One study tested pemetrexed versus docetaxel in previously treated patients (n = 571) and the other tested cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients (n = 1,725) with advanced NSCLC. Cox proportional hazard models were used to test for covariate-adjusted treatment-by-histology interactions (THIs) for overall survival (OS) and progression-free survival (PFS). For each histologic subgroup, the Kaplan-Meier method was used to estimate unadjusted within-arm medians, and Cox models were used to estimate covariate-adjusted between-arm hazard ratios (HRs). RESULTS: In both studies, treatment arms were well balanced for histology. THIs were statistically significant (p < .005) for both OS and PFS. Nonsquamous patients treated with pemetrexed-based therapy experienced longer survival than the comparators (HR, 0.78 and 0.84, respectively), whereas squamous patients had shorter survival (HR, 1.56 and 1.23, respectively). Whereas the efficacy of pemetrexed regimens differed according to histology, it did not differ for docetaxel or for cisplatin plus gemcitabine. Pemetrexed was well tolerated across histologic groups. CONCLUSIONS: The consistency of these results across studies confirms the predictive effect of histology for pemetrexed and the survival advantage for pemetrexed in patients with nonsquamous histology. These analyses suggest pemetrexed should not be recommended for the treatment of squamous cell carcinoma, but, because of efficacy and safety advantages, pemetrexed may be preferable to other agents for treatment of patients with nonsquamous NSCLC.

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A retrospective analysis reported a predictive impact of histology on pemetrexed outcome favouring NSCC (median OS 8.0 versus 9.3 months, docetaxel versus pemetrexed, HR 0.78, 95% CI 0.61-1.0, P=0.004).
“In a retrospective analysis, a predictive impact of histology on outcome by pemetrexed was reported favouring those patients with NSCC (median OS: 8.0 versus 9.3 months, docetaxel versus pemetrexed, HR 0.78, 95% CI: 0.61-1.0,P = 0.004) [56].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [56]

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Authors: Scagliotti, G., Hanna, N., Fossella, F., Sugarman, K., Blatter, J., Peterson, P., Simms, L., & Shepherd, F. A.
Affiliations: University of Turin (IT)
Indiana University Indianapolis (US)
The University of Texas MD Anderson Cancer Center (US)
Eli Lilly (United States) (US)
Eli Lilly (Germany) (DE)
Eli Lilly (Canada) (CA)
University of Toronto (CA)
Corresponding author: Scagliotti, Giorgio
ORCID: Scagliotti, Giorgio
Hanna, Nasser
Peterson, Patrick
Shepherd, Frances A.
Venue: The Oncologist
Publisher: Oxford University Press (OUP)
Published: 2009-02-16
Volume: 14
Issue: 3
Pages: 253-263
ISSN: 1083-7159 (ISSN-L)
1549-490X
DOI: 10.1634/theoncologist.2008-0232
OpenAlex: W2139939379
Cited by: 690
References: 51
Citations by year: 2026: 5 · 2025: 8 · 2024: 10 · 2023: 15 · 2022: 21 · 2021: 15 · 2020: 27 · 2019: 29 · 2018: 30 · 2017: 42 · 2016: 46 · 2015: 41 · 2014: 69 · 2013: 72 · 2012: 71
FWCI: 72.97
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: The Oncologist (publishedVersion)
PubMed (publishedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
INFM-OAR (INFN Catania) (submittedVersion, other-oa)
Funders: Eli Lilly and Company
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, non-small cell lung cancer, tumor histology, squamous cell carcinoma, docetaxel, overall survival, progression-free survival, predictive biomarkers
MeSH terms: Pemetrexed, Docetaxel, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Deoxycytidine, Female, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Randomized Controlled Trials as Topic, Taxoids

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The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies

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