Abstract | BACKGROUND: 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).
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Authors | Andrea Camerini, Cheti Puccetti, Sara Donati, Chiara Valsuani, Maria Cristina Petrella, Gianna Tartarelli, Paolo Puccinelli, Domenico Amoroso |
Journal | BMC cancer
(BMC Cancer)
Vol. 15
Pg. 359
(May 06 2015)
ISSN: 1471-2407 [Electronic] England |
PMID | 25943747
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Biomarkers, Tumor
- VEGFA protein, human
- Vascular Endothelial Growth Factor A
- Vinblastine
- Vinorelbine
|
Topics |
- Administration, Metronomic
- Administration, Oral
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Phytogenic
(administration & dosage)
- Biomarkers, Tumor
(blood)
- Carcinoma, Non-Small-Cell Lung
(blood, drug therapy, pathology)
- Female
- Humans
- Lung Neoplasms
(blood, drug therapy, pathology)
- Male
- Neoplasm Staging
- Treatment Outcome
- Vascular Endothelial Growth Factor A
(blood)
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
|