title: 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).
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 (≥ 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).
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. andreacamerini@katamail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Camerini
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. c.puccetti@usl12.toscana.it.
authors.forename: Cheti
authors.initials: C
authors.lastname: Puccetti
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. s.donati@usl12.toscana.it.
authors.forename: Sara
authors.initials: S
authors.lastname: Donati
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. chiara.valsuani@libero.it.
authors.forename: Chiara
authors.initials: C
authors.lastname: Valsuani
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. mariacristina.petrella@gmail.com.
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Petrella
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. g.tartarelli@usl12.toscana.it.
authors.forename: Gianna
authors.initials: G
authors.lastname: Tartarelli
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. p.puccinelli@usl12.toscana.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Puccinelli
authors.affiliation: Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. d.amoroso@usl12.toscana.it.
authors.forename: Domenico
authors.initials: D
authors.lastname: Amoroso
mesh_terms: D059250:Administration, Metronomic; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D014408:Biomarkers, Tumor / Q000097:blood; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000097:blood; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014408:Biomarkers, Tumor; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D014747:Vinblastine; D000077235:Vinorelbine