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BMC Cancer. 2015 May 6;15:359. doi: 10.1186/s12885-015-1354-2.

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).

Author information

1
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. andreacamerini@katamail.com.
2
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. c.puccetti@usl12.toscana.it.
3
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. s.donati@usl12.toscana.it.
4
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. chiara.valsuani@libero.it.
5
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. mariacristina.petrella@gmail.com.
6
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. g.tartarelli@usl12.toscana.it.
7
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. p.puccinelli@usl12.toscana.it.
8
Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. d.amoroso@usl12.toscana.it.

Abstract

BACKGROUND:

Metronomic oral vinorelbine could be a safe option for elderly patients with advanced non small cell lung cancer (NSCLC). Metronomic administration of chemotherapy leads to a cytostatic action shifting treatment target from cancer cell to tumor angiogenesis.

METHODS:

43 chemotherapy naive elderly (ā‰„ 70 yrs) PS 0-2 patients with stage IIIB-IV NSCLC were prospectively recruited. Median age was 80 yrs (M/F 36/7) with predominantly squamous histology. PS distribution was 0-1(16)/2(27) with a median of 3 serious co-morbid illnesses. Study treatment consisted of oral vinorelbine 50mg three times weekly (Monday-Wednesday-Friday) continuously until disease progression, unacceptable toxicity or patient refusal. Primary endpoints were overall response rate (ORR), clinical benefit (CB--disease response plus disease stabilization >12 weeks) and safety. Health-related QoL (HRQoL) was also assessed with FACT-L V4 scoring questionnaire. We conducted an exploratory time-course analysis of VEGF and thrombospondin-1 (TSP1) serum levels in a subgroup of patients.

RESULTS:

Patients received a median of 5 (range 1-21) cycles with a total of 272 cycles delivered. ORR was 18.6% with 7 partial and 1 complete responses; 17/43 experienced stable disease lasting more than 12 weeks leading to an overall CB of 58.1%. Median time to progression was 5 (range 2-21) and median overall survival 9 (range 3-29) months. Treatment was well tolerated with rare serious toxicity. Regardless of severity main toxicities observed were anemia in 44%, fatigue in 32.4%, and diarrhoea 10.5%. FACT-L v4 scores did not significantly vary during treatment. Baseline VEGF levels were lower and showed a rapid increase during treatment in non-responders pts only while TSP1 levels did not change.

CONCLUSIONS:

Metronomic oral vinorelbine is safe in elderly patients with advanced NSCLC with an interesting activity mainly consisting in long-term disease stabilization coupled with an optimal patient compliance (Eudra-CT 2010-018762-23, AIFA OSS on 26 February 2010).

PMID:
25943747
PMCID:
PMC4424528
DOI:
10.1186/s12885-015-1354-2
[Indexed for MEDLINE]
Free PMC Article

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