Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations
Open accessAbstract
BACKGROUND: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. METHODS: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. RESULTS: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of ORR (20% vs 17%, P = 0.39) and DCR (47% vs 41%, P = 0.23). The median PFS and OS were 4 vs 3 months (P = 0.5) and 11.2 vs 10 months (P = 0.8) in the KRAS-positive vs the KRAS-negative group. The 3-months PFS rate was significantly higher in the KRAS-positive group as compared to the KRAS-negative group (53% vs 42%, P = 0.01). The percentage of any grade and grade 3-4 AEs were 45% vs 33% (P = 0.003) and 11% vs 6% (P = 0.03) in KRAS-positive and KRAS-negative groups, respectively. CONCLUSIONS: Nivolumab is an effective and safe treatment option for patients with previously treated, advanced non-squamous NSCLC regardless of KRAS mutations.
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Two other studies with advanced non-squamous NSCLC reported that the efficacy of immune checkpoint inhibitors is independent of KRAS-mutant status.
“However, two other studies with advanced non-squamous NSCLC reported that the efficacy of immune checkpoint inhibitors is independent of KRAS-mutant status (100, 101).”
From New Horizons in KRAS-Mutant Lung Cancer: Dawn After Darkness (2019) · cites this paper as [101]
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References 31 · Cited by 81
Research works printed but not linked: 1
- [10]Borghaei H Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer N. Engl. J. Med. 2015 373 1627 1639 10.1056/NEJMoa1507643 26412456 PMC5705936 · DOI · Paper page
- Authors
- Passiglia, F., Cappuzzo, F., Alabiso, O., Bettini, A. C., Bidoli, P., Chiari, R., Defferrari, C., Delmonte, A., Finocchiaro, G., Francini, G., Gelsomino, F., Giannarelli, D., Giordano, M., Illiano, A., Livi, L., Martelli, O., Natoli, C., Puppo, G., Ricevuto, E., Roca, E., Turci, D., & Galetta, D.
- Affiliations
- University of Palermo (IT)
- Azienda Unità Sanitaria Locale Della Romagna (IT)
- Azienda Ospedaliero Universitaria Maggiore della Carita (IT)
- Ospedale Papa Giovanni XXIII (IT)
- Azienda Ospedaliera San Gerardo (IT)
- University of Perugia (IT)
- Ente Ospedaliero Ospedali Galliera (IT)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Ospedale Santa Maria alle Scotte (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Instituto Nazionale Tumori Regina Elena (IT)
- Ospedale Sant'Anna (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- Azienda Ospedaliera San Giovanni Addolorata (IT)
- University of Chieti-Pescara (IT)
- University of Pisa (IT)
- University of L'Aquila (IT)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- Ospedale "Santa Maria delle Croci" di Ravenna (IT)
- Istituto Tumori Bari (IT)
- Corresponding author
- Cappuzzo, Federico
- ORCID
- Venue
- British Journal of Cancer
- Published
- 2018-10-31
- Volume
- 120
- Issue
- 1
- Pages
- 57-62
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC6325128
- OpenAlex
- W2898735291
- Cited by
- 81
- References
- 31
- Citations by year
- 2026: 1 · 2025: 8 · 2024: 11 · 2023: 10 · 2022: 16 · 2021: 21 · 2020: 7 · 2019: 7
- FWCI
- 6.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- British Journal of Cancer (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion, cc-by)
- Archivio Istituzionale della Ricerca - Università degli Studi dell Aquila (submittedVersion, public-domain)
- Use Siena air (University of Siena) (submittedVersion, cc-by)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, cc-by)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nivolumab, non-small cell lung cancer, KRAS mutation, previously treated patients, immune checkpoint inhibitors, progression-free survival, objective response rate, adverse events, expanded access program, non-squamous non-small cell lung cancer
- MeSH terms
- Nivolumab, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Immunotherapy, Male, Middle Aged, Mutation, Proto-Oncogene Proteins p21(ras)
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