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Cisplatin and vinorelbine combination chemotherapy in inoperable non small cell lung cancer (NSCLC) : a multicenter phase II trial

Quimioterapia de combinación cisplatino y vinorelbina en carcinoma no microcítico pulmonar (NSCLC) inoperable: un ensayo fase II multicéntrico

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Abstract

Purpose

The present article reports the results of a multicentre phase II study analysing both activity and tolerance of the cisplatin vinorelbine combination in patients with inoperable NSCLC.

Materials and methods

87 consecutive patients from 6 Institutions were treated with vinorelbine 25 mg/m2 on days 1 and 8, plus cisplatin 100 mg/m2 on day 1, both intravenously, every 21 days. All patients were younger 75 years old, with unresectable non small cell lung cancer stages IIIA, IIIB and IV, who had a measurable or assessable disease, performance status ECOG 0–2 and had more than 12 weeks life expectancy. Response was assessed after 3 courses. Toxicity was assessed after every cycle.

Results

87 patients treated, all them were evaluable for response. Five patients (5.7%) had a complete response and twenty-two (25.3%) a partial one. The median overall survival was 8.03 months. The toxicity, evaluated on 262 cycles administered, was mainly haematological: 11,3% of courses grade 3–4 neutropenias and 3,8% grade 3 thrombocytopenias. There were 4 deaths due to toxicity (4.5%).

Discussion

The vinorelbine-cisplatin is active with manageable toxicity and response rates are in the range of results usually reported in the previous studies evaluating this combination. It suggest that this combination should be considered as a reference regimen in patients with advanced NSCLC.

Resumen

Objetivo

Este artículo presenta los resultados de un ensayo fase II multicéntrico que analiza la eficacia y tolerancia de una combinación de cisplatino y vinorelbina en pacientes con NSCLC inoperables.

Materiales y métodos

Ochenta y siete enfermos consecutivos en 6 instituciones fueron tratados con vinorelbina, 25 mg/m2 los días 1 y 8, más cisplatino, 100 mg/m2 día 1, am bos intravenosos, cada 21 días. Todos los pacientes eran menores de 75 años, con carcinoma no microcítico pulmonar irresecable en estadios IIIA, IIIB y IV, con enfermedad medible o evaluable, con Performance Status ECOG 0–2 y con expectativa de vida superior a 12 semanas. La respuesta fue evaluada cada 3 ciclos. La toxicidad se evaluó después de cada ciclo.

Resultados

Ochenta y siete enfermos tratados, todos evaluables para respuesta. Cinco pacientes (5,7%) tuvieron una respuesta completa y 22 (25,3%) una respuesta parcial. La supervivencia mediana fue de 8,03 meses. La toxicidad, evaluados en 262 ciclos administrados, fue principalmente hematológica: 11,3% de los cursos con neutropenia grado 3–4 y 3,8% trombocitopenias de grado 3. Hubo 4 muertes debidas a toxicidad (4,5%).

Discusión

La combinación vinorelbina-cisplatino es activa con toxicidad manejable y las tasas de respuestas están en el rango de lo usualmente publicado en estudios previos con esta combinación. Esto sugiere que esta combinación podría ser considerada como un buen régimen en pacientes con NSCLC avanzado.

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Authors and Affiliations

  1. Servicio de Oncología Médica, Hospital General de Valencia, Avda. Tres Cruces, s/n., 46014, Valencia

    Carlos Camps, Alfonso Berrocal & Esther Noguerón

  2. Hospital del Mar, Spain

    Catalina Vadell & Javier Fabregat

  3. Hospital Gregorio Marañón, Spain

    Ramón García Gómez

  4. Hospital General de Elche, Spain

    Alfredo Carrato

  5. Hospital Miguel Servet, Spain

    Antonio Antón

  6. Departamento de Estadística de la Universidad Autónoma de Madrid. GECP, Members of Spanish Lung Cancer Group, Spain

    J. J. Sánchez

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  1. Carlos Camps
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Camps, C., Vadell, C., Gómez, R.G. et al. Cisplatin and vinorelbine combination chemotherapy in inoperable non small cell lung cancer (NSCLC) : a multicenter phase II trial. Rev Oncología 2, 84–90 (2000). https://doi.org/10.1007/BF02979471

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