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: 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)

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