A Camerini1, G L Banna2, S Cinieri3, A Pezzuto4, M Mencoboni5, F Rosetti6, A Figueiredo7, P Rizzo3, A Ricci8, L Langenhoven9, A Santo10, A Addeo11, D Amoroso12, F Barata7. 1. Medical Oncology, Versilia Hospital - ASL Toscana Nord-Ovest, via Aurelia 335, 55043, Lido di Camaiore, LU, Italy. andrea.camerini@uslnordovest.toscana.it. 2. Division of Medical Oncology, Cannizzaro Hospital, via Messina 829, 95126, Catania, Italy. 3. Medical Oncology, Perrino Hospital, Strada Statale 7 per Mesagne, 72100, Brindisi, Italy. 4. Department of Cardio-Thoracic-Vascular Science, S. Andrea Hospital, Via di Grottarossa, 1035, 00189, Rome, Italy. 5. Medical Oncology, ASL 3 Genovese, Ospedale Villa Scassi, Corso Onofrio Scassi 1, 16121, Genoa, Italy. 6. Medical Oncology, ULSS3 Serenissima, Distretto Mirano-Dolo, Via Pasteur, 30031, Dolo, VE, Italy. 7. Pneumology, Centro Hospitalar e Universitario de Coimbra, Avenida Doutor Bissaya Barreto S/N, Praceta De Mota Pinto, Celas-Coimbra, Portugal. 8. Department of Molecular and Clinical Medicine, S. Andrea Hospital, Via di Grottarossa, 1035, 00189, Rome, Italy. 9. Clinical Oncology, Panorama Oncology Centre, 43 Hennie Winterbach St, Panorama, Cape Town, 7500, South Africa. 10. Medical Oncology, University Hospital of Verona, Piazzale Aristide Stefani 1, 37126, Verona, Italy. 11. Oncology Department, University Hospital Geneva, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland. 12. Medical Oncology, Versilia Hospital - ASL Toscana Nord-Ovest, via Aurelia 335, 55043, Lido di Camaiore, LU, Italy.
Abstract
PURPOSE: Metronomic oral vinorelbine (MOV) could be a treatment option for unfit patients with advanced non-small cell lung cancer (NSCLC) based on its safety profile and high patient compliance. METHODS: We retrospectively collected data on 270 patients [median age 76 (range 48-92) years, M/F 204/66, PS 0 (27)/1 (110)/≥ 2 (133), median of 3 serious comorbidities] with stage IIIB-IV NSCLC treated with MOV as first (T1) (67%), second (T2) (19%) or subsequent (T3) (14%) line. Schedules consisted of vinorelbine 50 mg (138), 40 mg (68) or 30 mg (64) three times a week continuously. RESULTS: Patients received an overall median of 6 (range 1-25) cycles with a total of 1253 cycles delivered. The overall response rate was 17.8% with 46 partial and 2 complete responses and 119 patients (44.1%) experienced stable disease > 12 weeks with an overall disease control rate of 61.9%. Median overall time to progression was 5 (range 1-21) months [T1 7 (1-21), T2 5.5 (1-19) and T3 4 (1-19) months] and median overall survival 9 (range 1-36) months [T1 10 (1-31), T2 8 (1-36) and T3 6.5 (2-29) months]. Treatment was extremely well tolerated with 2% (25/1253) G3/4 toxicity (mainly G3 fatigue and anemia) and no toxic deaths. We observed the longer OS 14 (range 7-36) months in a subset of squamous NSCLC patients receiving immunotherapy after metronomic oral vinorelbine. CONCLUSION: We confirmed MOV as an extremely safe treatment in a large real world population of advanced NSCLC with an interesting activity mainly consisting of long-term disease stabilization. We speculate the possibility of a synergistic effect with subsequent immunotherapy.
PURPOSE: Metronomic oral vinorelbine (MOV) could be a treatment option for unfit patients with advanced non-small cell lung cancer (NSCLC) based on its safety profile and high patient compliance. METHODS: We retrospectively collected data on 270 patients [median age 76 (range 48-92) years, M/F 204/66, PS 0 (27)/1 (110)/≥ 2 (133), median of 3 serious comorbidities] with stage IIIB-IV NSCLC treated with MOV as first (T1) (67%), second (T2) (19%) or subsequent (T3) (14%) line. Schedules consisted of vinorelbine 50 mg (138), 40 mg (68) or 30 mg (64) three times a week continuously. RESULTS:Patients received an overall median of 6 (range 1-25) cycles with a total of 1253 cycles delivered. The overall response rate was 17.8% with 46 partial and 2 complete responses and 119 patients (44.1%) experienced stable disease > 12 weeks with an overall disease control rate of 61.9%. Median overall time to progression was 5 (range 1-21) months [T1 7 (1-21), T2 5.5 (1-19) and T3 4 (1-19) months] and median overall survival 9 (range 1-36) months [T1 10 (1-31), T2 8 (1-36) and T3 6.5 (2-29) months]. Treatment was extremely well tolerated with 2% (25/1253) G3/4 toxicity (mainly G3 fatigue and anemia) and no toxic deaths. We observed the longer OS 14 (range 7-36) months in a subset of squamous NSCLCpatients receiving immunotherapy after metronomic oral vinorelbine. CONCLUSION: We confirmed MOV as an extremely safe treatment in a large real world population of advanced NSCLC with an interesting activity mainly consisting of long-term disease stabilization. We speculate the possibility of a synergistic effect with subsequent immunotherapy.
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