Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxaliplatin-fluoropyrimidine doublet

Abstract

Background. No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. Methods. We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = 99), or inferior to the lowest quartile (n = 100). The relationship between these three groups and the ECOG PS was then analysed. Results. At multivariate analysis, OS was negatively affected by the number of metastatic sites, the serum alkaline phosphatase, and the ECOG PS, while it was positively affected by the previous surgical resection of the primary tumour. Adding the baseline PF score, the number of disease sites (p < 0.0001), the serum alkaline phosphatase (p = 0.0057), and the PF (p = 0.0007) retained an independent significance, while the ECOG PS and the previous surgery were no longer significant. PF did not significantly affect PFS or RR. A good but not totally overlapping correlation was found between PF grouping and ECOG PS score. Conclusions. Baseline self-reported PF independently predicted the OS of patients. Assessment of QoL should be incorporated in randomised trials evaluating the management of patients with MCRC.

Acknowledgements

The following investigators of the Southern Italy Cooperative Oncology Group, who enrolled the patients and collected the EORTC QLC-C30 questionnaires, are acknowledged as contributors to this paper: Bruno Massidda, MD, University of Cagliary; Gianfranco Filippelli, MD, City Hospital, Paola; Carlo Putzu, MD, University of Sassari; Donato Natale, MD, City Hospital, Penne; Giuseppe Barberis, MD, Villa Betania Hospital, Naples; Luigi Maiorino, MD, San Gennaro Hospital, Naples; Sergio Palmeri, MD, University of Palermo; Michele Cannone, MD, City Hospital, Canosa; Giovanni Condemi, MD, City Hospital, Siderno; Silvana Leo, MD, City Hospital, Lecce; Salvatore Tafuto, MD, City Hospital, Pozzuoli; Ettore Greco, MD, City Hospital, Lametia Terme; Mario Roselli, MD, Tor Vergata University, Rome; Valerio Milia, MD, City Hospital, Macomer; Antonio Gambardella, MD, Second University of Naples; Sergio Mancarella, MD, City Hospital, Galatina; Giancarlo Di Pinto, MD, City Hospital, Castrovillari; Lucio De Luca, MD, Pellegrini Hospital, Naples; Giacomo Vessia, MD, City Hospital, Altamura; Italy.

This work was partially supported by Italian Ministry of Health (FSN 2004).

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.