BACKGROUND: In the attempt to optimize the efficacy of chemotherapy in advanced non-small cell lung cancer (NSCLC) several strategies need to be investigated including the use of non-platinum combinations and the sequential use of different agents. PATIENTS AND METHODS: In a phase II randomised study 165 patients with stage IIIB or IV NSCLC were assigned to receive docetaxel 40mg/m(2) days 1 and 8 plus gemcitabine 1200mg/m(2) days 1 and 8 every 21 days (arm A, N=54) or docetaxel 50mg/m(2) days 1 and 15 plus gemcitabine 1600mg/m(2) days 1 and 15 every 28 days (arm B, N=57) or gemcitabine 1200mg/m(2) days 1 and 8 plus cisplatin 100mg/m(2) day 2 every 21 days for 3 cycles followed by docetaxel 75mg/m(2) day 1 every 21 days for 3 cycles (arm C, N=54). The primary endpoint of the trial was overall response rate. Secondary end points included safety, progression-free and overall survival. RESULTS: Response rate was 22.2%, 23.2% and 33.3% after 3 cycles, whereas at the end of treatment was 24.1%, 12.5% and 27.8% in arm A-C, respectively. Median time to progression was similar in all the 3 arms: 6.7 months in arm A (95% CI: 4.8-9.7), 5.6 in arm B (5.0-7.9) and 6.6 in arm C (5.7-9.1). The median survival time was 10.7 months in arm A (95% CI: 6.8-15.6), 8.9 in arm B (7.4-12.5) and 14.6 in arm C (8.0-22.4) and 1-year survival rate was 46.3%, 37.9% and 53.9%, respectively. Grade 3-4 haematological toxicities were more frequent in arm C while non-haematological were more common in the gemcitabine and docetaxel arms. CONCLUSIONS: The results of this phase II randomised clinical trial do not indicate a clear superior efficacy of one of the tested combinations according to the planned statistical design and none of these regimens is sufficiently active or less toxic to warrant further investigation in a phase III study.

Randomised multicenter phase II study of two schedules of docetaxel and gemcitabine or cisplatin/gemcitabine followed by docetaxel as first line treatment for advanced non-small cell lung cancer

NOVELLO, Silvia;RINALDI, Mauro;NARDI, Marzia;SCAGLIOTTI, Giorgio Vittorio
2009-01-01

Abstract

BACKGROUND: In the attempt to optimize the efficacy of chemotherapy in advanced non-small cell lung cancer (NSCLC) several strategies need to be investigated including the use of non-platinum combinations and the sequential use of different agents. PATIENTS AND METHODS: In a phase II randomised study 165 patients with stage IIIB or IV NSCLC were assigned to receive docetaxel 40mg/m(2) days 1 and 8 plus gemcitabine 1200mg/m(2) days 1 and 8 every 21 days (arm A, N=54) or docetaxel 50mg/m(2) days 1 and 15 plus gemcitabine 1600mg/m(2) days 1 and 15 every 28 days (arm B, N=57) or gemcitabine 1200mg/m(2) days 1 and 8 plus cisplatin 100mg/m(2) day 2 every 21 days for 3 cycles followed by docetaxel 75mg/m(2) day 1 every 21 days for 3 cycles (arm C, N=54). The primary endpoint of the trial was overall response rate. Secondary end points included safety, progression-free and overall survival. RESULTS: Response rate was 22.2%, 23.2% and 33.3% after 3 cycles, whereas at the end of treatment was 24.1%, 12.5% and 27.8% in arm A-C, respectively. Median time to progression was similar in all the 3 arms: 6.7 months in arm A (95% CI: 4.8-9.7), 5.6 in arm B (5.0-7.9) and 6.6 in arm C (5.7-9.1). The median survival time was 10.7 months in arm A (95% CI: 6.8-15.6), 8.9 in arm B (7.4-12.5) and 14.6 in arm C (8.0-22.4) and 1-year survival rate was 46.3%, 37.9% and 53.9%, respectively. Grade 3-4 haematological toxicities were more frequent in arm C while non-haematological were more common in the gemcitabine and docetaxel arms. CONCLUSIONS: The results of this phase II randomised clinical trial do not indicate a clear superior efficacy of one of the tested combinations according to the planned statistical design and none of these regimens is sufficiently active or less toxic to warrant further investigation in a phase III study.
2009
66 (3)
327
332
Novello S; Falcone A; Crinò L; Rinaldi M; Nardi M; De Marinis F; Tonato M; Tinazzi A; Russo F; Grassivaro N; Scagliotti GV
File in questo prodotto:
File Dimensione Formato  
doi_10.1016_j.lungcan.2009.02.009.pdf

Accesso riservato

Tipo di file: PDF EDITORIALE
Dimensione 347.92 kB
Formato Adobe PDF
347.92 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/63431
Citazioni
  • ???jsp.display-item.citation.pmc??? 3
  • Scopus 15
  • ???jsp.display-item.citation.isi??? 10
social impact