Metronomic oral vinorelbine for the treatment of advanced non-small cell lung cancer: a multicenter international retrospective analysis
Metronomic oral vinorelbine (MOV) could be a treatment option for unfit patients with advanced non-small cell lung cancer (NSCLC) based on its safety profile and high patient compliance.
We retrospectively collected data on 270 patients [median age 76 (range 48–92) years, M/F 204/66, PS 0 (27)/1 (110)/≥ 2 (133), median of 3 serious comorbidities] with stage IIIB-IV NSCLC treated with MOV as first (T1) (67%), second (T2) (19%) or subsequent (T3) (14%) line. Schedules consisted of vinorelbine 50 mg (138), 40 mg (68) or 30 mg (64) three times a week continuously.
Patients received an overall median of 6 (range 1–25) cycles with a total of 1253 cycles delivered. The overall response rate was 17.8% with 46 partial and 2 complete responses and 119 patients (44.1%) experienced stable disease > 12 weeks with an overall disease control rate of 61.9%. Median overall time to progression was 5 (range 1–21) months [T1 7 (1–21), T2 5.5 (1–19) and T3 4 (1–19) months] and median overall survival 9 (range 1–36) months [T1 10 (1–31), T2 8 (1–36) and T3 6.5 (2–29) months]. Treatment was extremely well tolerated with 2% (25/1253) G3/4 toxicity (mainly G3 fatigue and anemia) and no toxic deaths. We observed the longer OS 14 (range 7–36) months in a subset of squamous NSCLC patients receiving immunotherapy after metronomic oral vinorelbine.
We confirmed MOV as an extremely safe treatment in a large real world population of advanced NSCLC with an interesting activity mainly consisting of long-term disease stabilization. We speculate the possibility of a synergistic effect with subsequent immunotherapy.
KeywordsNon-small cell lung cancer Metronomic Oral vinorelbine Elderly Unfit patients
This study was funded by an unrestricted grant from Lega Italiana per la Lotta contro i Tumori (L.I.L.T.) Sezione Provinciale Lucchese to AC. The authors are grateful to Miss Lara Camerini for editorial assistance and language revision.
This study was funded by an unrestricted grant from Lega Italiana per la Lotta contro i Tumori (L.I.L.T.) Sezione Provinciale Lucchese to AC.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 10.Ferlay J, Soerjomataram I, Ervik M, et al. [homepage on the Internet]. GLOBOCAN 2012-lung cancer incidence and mortality worldwide. http://globocan.iarc.fr. Accessed 15 Sept 2015.
- 11.Gironès Sarriò R, Antonio Rebollo M, Molina Garrido MJ, et al. On the behalf of the Spanish Working Group on Geriatric Oncology of the Spanish Society of Medical Oncology (SEOM). General recommendations paper on the management of older patients with cancer: the SEOM geriatric oncology task force’s position statement. Clin Transl Oncol. 2018. https://doi.org/10.1007/s12094-018-1856-x.CrossRefPubMedPubMedCentralGoogle Scholar
- 15.Lilenbaum R, Villaflor VM, Langer C, et al. Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2: prognostic factors and treatment selection based on two large randomized clinical trials. J Thor Oncol. 2009;4:869–74.CrossRefGoogle Scholar
- 22.Stewart BW, Wild CP. World cancer report 2014. Lyon: International Agency for Research on Cancer (IARC)-World Health Organization; 2014.Google Scholar
- 23.The Elderly Lung Cancer Vinorelbine Italian Study group. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small cell lung cancer. J Natl Cancer Inst. 1999;85:365–76.Google Scholar
- 24.U.S. Department of Health and Human Services (2010). Common terminology criteria for adverse events (CTCAE) version 4.0. National Institutes of Health National Cancer Institute. May 28 2009 (v4.03: June 14, 2010).Google Scholar