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; Falcone, Alfredo; Crinò, Lucio; Rinaldi, Massimo; Nardi, Mario; De Marinis, Filippo; Tonato, Maurizio; Tibaldi, Carmelo; Tinazzi, Angelo; Russo, Francesca; Grassivaro, Nicoletta; Scagliotti, Giorgio Vittorio

doi:10.1016/j.lungcan.2009.02.009

« Previous Next »Lung Cancer
Volume 66, Issue 3 , Pages 327-332, December 2009

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

Silvia Novello
- Department of Clinical & Biological Sciences, Thoracic Oncology Unit, University of Turin, Italy
- Corresponding author at: University of Torino, Department of Clinical & Biological Sciences, Thoracic Oncology Unit, S. Luigi Hospital - Regione Gonzole 10, 10043 Orbassano (Torino), Italy. Tel.: +39 011 9026978; fax: +39 011 9038616.
Alfredo Falcone
- Medical Oncology, Livorno, Italy
Lucio Crinò
- Medical Oncology, Monteluce Hospital, Perugia, Italy
Massimo Rinaldi
- Medical Oncology Division B, IRCCS Regina Hospital, Rome, Italy
Mario Nardi
- Medical Oncology “Bianchi-Melacrino Morelli” Hospital, Reggio, Calabria, Italy
Filippo De Marinis
- Thoracic Oncology Unit, San Camillo Forlanini Hospital, Rome, Italy
Maurizio Tonato
- Medical Oncology, Monteluce Hospital, Perugia, Italy
Carmelo Tibaldi
- Medical Oncology, Livorno, Italy
Angelo Tinazzi
- SENDO Foundation, Milano, Italy
Francesca Russo
- Medical Department, Eli Lilly Italy, Florence, Italy
Nicoletta Grassivaro
- Medical Department, Sanofi Aventis, Milano, Italy
Giorgio Vittorio Scagliotti
- Department of Clinical & Biological Sciences, Thoracic Oncology Unit, University of Turin, Italy

Received 7 October 2008; received in revised form 22 January 2009; accepted 15 February 2009. published online 31 March 2009.

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/m² days 1 and 8 plus gemcitabine 1200mg/m² days 1 and 8 every 21 days (arm A, N=54) or docetaxel 50mg/m² days 1 and 15 plus gemcitabine 1600mg/m² days 1 and 15 every 28 days (arm B, N=57) or gemcitabine 1200mg/m² days 1 and 8 plus cisplatin 100mg/m² day 2 every 21 days for 3 cycles followed by docetaxel 75mg/m² 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.

Keywords: Chemotherapy, Non-small cell lung cancer, Cisplatin, Gemcitabine, Docetaxel