Phase II trial of single-agent oral vinorelbine in elderly (> or =70 years) patients with advanced non-small-cell lung cancer and poor performance status.
BACKGROUND
Elderly patients with advanced non-small-cell lung cancer (NSCLC) with poor performance status (PS) are a special population requiring particular attention. Single-agent oral vinorelbine could be an attractive option.


METHODS
A total of 43 patients with stage IIIB-IV NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of two or more with good functional status were prospectively recruited. Oral vinorelbine was administered at the dose of 60 mg/m(2) on days 1-8 every 3 weeks. Primary end points were response rate and safety.


RESULTS
Overall response rate was 18.6% with 8 partial responses; 18 of 43 (41.8%) experienced stable disease lasting >12 weeks and 17 of 43 (39.6%) disease progression for an overall clinical benefit of 60.4%. Median time to progression was 4.0 (range 2-22) months and median overall survival 8.0 (range 3-35) months. Treatment was well tolerated. Of 187 cycles, we did not observe any grade 3/4 toxicity with the exception of a single not-febrile G3 neutropenia. Regardless of severity, main toxic effects observed were nausea in 48.1% and vomiting in 22.9% of patients, anemia in 43.2%, fatigue in 32.6% and leukopenia in 23.2%.


CONCLUSIONS
Single-agent oral vinorelbine is extremely safe in elderly patients with advanced NSCLC and ECOG PS of two or more and may represent a valid option in this very special population.
Camerini
A
A
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca. Electronic address: andreacamerini@katamail.com.
Valsuani
C
C
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Mazzoni
F
F
Department of Medical Oncology, Careggi Hospital and Istituto Toscano Tumori, Firenze, Italy.
Siclari
O
O
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Puccetti
C
C
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Donati
S
S
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Rondini
M
M
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Tartarelli
G
G
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Puccinelli
P
P
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
Di Costanzo
F
F
Department of Medical Oncology, Careggi Hospital and Istituto Toscano Tumori, Firenze, Italy.
Amoroso
D
D
Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca.
D000203:Activities of Daily Living; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D018450:Disease Progression; D005260:Female; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D008297:Male; D010166:Palliative Care; D016019:Survival Analysis; D013647:Task Performance and Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine