Abstract
Purpose
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.
Methods
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.
Results
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.
Conclusion
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.
Similar content being viewed by others
References
André N, Carré M, Pasquier E. Metronomics: towards personalized chemotherapy? Nat Rev Clin Oncol. 2014;11:413–31.
Banna GL, Camerini A, Bronte G, et al. Oral metronomic vinorelbine in advanced non-small cell lung cancer patients unfit for chemotherapy. Anticancer Res. 2018;38:3689–97.
Bilir C, Durak S, Kizilkaya B, et al. Efficacy of metronomic vinorelbine in elderly patients with advanced non-small-cell lung cancer and poor performance status. Curr Oncol. 2017;24:e199–204.
Bocci G, Kerbel RS. Pharamacokinetics of metronomic chemotherapy: a neglected but crucial aspect. Nat Rev Clin Oncol. 2016;13:569–673.
Briasoulis E, Aravantinos G, Kouvatseas G, et al. Dose selection trial of metronomic oral vinorelbine monotherapy in patients with metastatic cancer: a hellenic cooperative oncology group clinical translational study. BMC Cancer. 2013;13:263.
Camerini A, Puccetti C, Donati S, et al. Metronomic oral vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer: results of a phase II trial (MOVE trial). BMC Cancer. 2015;15:359.
Camerini A, Valsuani C, Mazzoni F, et al. Phase II trial of single agent oral vinorelbine in elderly (≥ 70 years) patients with advanced non-small cell lung cancer and poor performance status. Ann Oncol. 2010;21:1290–5.
Cazzaniga ME, Camerini A, Addeo R, et al. Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: current status and future development. Future Oncol. 2016;12:373–87.
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–47.
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.
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.
Gridelli C, Morabito A, Cavanna L, et al. Cisplatin-based first-line treatment of elderly patients with advanced non-small-cell lung cancer: joint analysis of MILES-3 and MILES-4 phase III trials. J Clin Oncol. 2018;36:2585–92.
Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advance non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003;95:362–72.
Griffin AM, Butow PN, Coates AS, et al. On the receiving end V: patient perceptions of the side effects of cancer chemotherapy in. Ann Oncol. 1993;7:189–95.
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.
Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997;15:110–5.
Mencoboni M, Filiberti RA, Taveggia P, et al. Safety of first-line chemotherapy with metronomic single-agent oral vinorelbine in elderly patients with NSCLC. Anticancer Res. 2017;37:3189–94.
Molina JR, Yang P, Cassivi SD, et al. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008;83:584–94.
Planchard D, Popat S, Kerr K, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol Suppl. 2018;4:iv192–iv237.
Quoix E, Zalcman G, Oster JP, et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011;378:1079–88.
Repetto L, Balducci L. A case for geriatric oncology. Lancet Oncol. 2002;3:289–97.
Stewart BW, Wild CP. World cancer report 2014. Lyon: International Agency for Research on Cancer (IARC)-World Health Organization; 2014.
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.
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).
Weir HK, Thun MJ, Hankey BF, et al. Annual report to the nation on the status of cancer, 1975–2000, featuring the use of surveillance data for cancer prevention and control. J Natl Cancer Inst. 2003;95:1276–99.
Acknowledgements
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.
Funding
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical approval
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
Informed consent was obtained from all individual participants included in the study.
Rights and permissions
About this article
Cite this article
Camerini, A., Banna, G.L., Cinieri, S. et al. Metronomic oral vinorelbine for the treatment of advanced non-small cell lung cancer: a multicenter international retrospective analysis. Clin Transl Oncol 21, 790–795 (2019). https://doi.org/10.1007/s12094-018-1989-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12094-018-1989-y