First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer: A quality of life directed phase II randomized trial of Gruppo Oncologico Italia Meridionale
Received 24 March 2009; received in revised form 6 October 2009; accepted 9 October 2009. published online 12 November 2009. Corrected Proof
Abstract
Background
Quality of life (QoL) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment. Docetaxel (DCT) and cisplatin (CDDP) doublet has been reported to be associated to a better QoL than the weekly vinorelbine (VNR) and CDDP regimen. Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice. The impact of these regimens on patients’ QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically.
Methods
Patients received CDDP 75mg/m2 plus DCT 75mg/m2 on day 1 every weeks (arm A) or CDDP 80mg/m2 on day 1 plus VNR 30mg/m2 day 1 and 8 every 3 weeks (arm B). G-CSF and/or EPO were employed as needed. Health-related QoL was assessed at entry and after every cycle by the EORTC-QLQ-C30 and LC13 questionnaires, toxicity by the NCI-NCCN CTC vs 2, and intent-to-treat objective response by the Recist criteria.
Results
The QoL questionnaires were completed by 37 pts (88%) in the DCT/CDDP arm and 39 pts (87%) in the VNR/CDDP one. Baseline mean scores and rates at which pts failed to complete QoL assessment were similar in the two arms. Global health status of the EORTC QLQ-C30 scale and specific symptoms control (LC13 module) improved during treatment without any statistically significant difference between the two arms. Emotional functioning remained stable in both groups during treatment, whereas physical and role improved slightly. In the DCT/CDDP arm 14 pts (33%; 95%CL 24–40%) had PR, and 10 (24%) SD for a 57% TGCR. In the VNR/CDDP arm 12 pts (27%) achieved PR, 18 (41%) SD a 68% TGCR. Differences were not statistically significant. Median time-to-progression was 4.2 months in the DCT/CDDP arm and 4.5 months in the VNR/CDDP one, and median overall survival was 12.1 (range 1–26+ months) and 12.5 months (range 1–28+ months) for DCT/CDDP and VNR/CDDP arms, respectively. Febrile neutropenia rate was higher in the VNR/CDDP arm (p=0.02) as well as G3-4 anemia (p=0.005) and G-CSF/EPO use (p=0.019).
Conclusions
Global and specific health-related QoL data similar in both treatment groups with no statistically significant difference. Efficacy measures, overall response rate, time-to-progression and overall survival were equivalent in both arms. However, severe anemia and febrile neutropenia are statistically more frequent in the VNR/CDDP arm than in the DCT/CDDP one. These data should be considered in treatment decision-making for pts with advanced non-small-cell lung cancer and for the design of future trials with chemotherapy plus biologics.
aMedical Oncology Unit, University of Palermo, La Maddalena Clinic for Cancer, Palermo, Italy
bMedical Oncology Unit, Ospedale V. Fazzi, Lecce, Italy
cExperimental Oncology Unit, Istituto Oncologico, Bari, Italy
dMedical Oncology Unit, Centro Oncologico Catanese, Humanitas, Catania, Italy
eMedical Oncology Unit, Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy
fMedical Oncology Unit, Ospedale Cardarelli, Napoli, Italy
gMedical Oncology Unit, Ospedale Buccheri-LaFerla, Palermo, Italy
hMedical Oncology Unit, Ospedale Cardarelli, Campobasso, Italy
iMedical Oncology Unit, Ospedale S. Vincenzo, Taormina, Italy
jMedical Oncology Unit, Ospedale Civile Perrino, Brindisi, Italy
kMedical Oncology Unit, Ospedale Civile, Galatina, Lecce, Italy
Corresponding author at: University of Palermo c/o La Maddalena, Via San Lorenzo Colli n. 312d, 90100 Palermo, Italy. Tel.: +39 091 6806710; fax: +39 091 6806906.
ABSTRACT
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