PMID- 25943747
OWN - NLM
STAT- MEDLINE
DCOM- 20160216
LR  - 20220321
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 15
DP  - 2015 May 6
TI  - 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).
PG  - 359
LID - 10.1186/s12885-015-1354-2 [doi]
LID - 359
AB  - 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).
FAU - Camerini, Andrea
AU  - Camerini A
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. andreacamerini@katamail.com.
FAU - Puccetti, Cheti
AU  - Puccetti C
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. c.puccetti@usl12.toscana.it.
FAU - Donati, Sara
AU  - Donati S
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. s.donati@usl12.toscana.it.
FAU - Valsuani, Chiara
AU  - Valsuani C
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. chiara.valsuani@libero.it.
FAU - Petrella, Maria Cristina
AU  - Petrella MC
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. mariacristina.petrella@gmail.com.
FAU - Tartarelli, Gianna
AU  - Tartarelli G
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. g.tartarelli@usl12.toscana.it.
FAU - Puccinelli, Paolo
AU  - Puccinelli P
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. p.puccinelli@usl12.toscana.it.
FAU - Amoroso, Domenico
AU  - Amoroso D
AD  - Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di 
      Camaiore, Italy. d.amoroso@usl12.toscana.it.
LA  - eng
SI  - EudraCT/EUDRA-CT2010-018762-23
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20150506
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (VEGFA protein, human)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - Q6C979R91Y (Vinorelbine)
SB  - IM
MH  - Administration, Metronomic
MH  - Administration, Oral
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Phytogenic/*administration & dosage
MH  - Biomarkers, Tumor/blood
MH  - Carcinoma, Non-Small-Cell Lung/blood/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/blood/*drug therapy/pathology
MH  - Male
MH  - Neoplasm Staging
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/blood
MH  - Vinblastine/administration & dosage/*analogs & derivatives
MH  - Vinorelbine
PMC - PMC4424528
EDAT- 2015/05/07 06:00
MHDA- 2016/02/18 06:00
PMCR- 2015/05/06
CRDT- 2015/05/07 06:00
PHST- 2014/03/24 00:00 [received]
PHST- 2015/04/23 00:00 [accepted]
PHST- 2015/05/07 06:00 [entrez]
PHST- 2015/05/07 06:00 [pubmed]
PHST- 2016/02/18 06:00 [medline]
PHST- 2015/05/06 00:00 [pmc-release]
AID - 10.1186/s12885-015-1354-2 [pii]
AID - 1354 [pii]
AID - 10.1186/s12885-015-1354-2 [doi]
PST - epublish
SO  - BMC Cancer. 2015 May 6;15:359. doi: 10.1186/s12885-015-1354-2.