Medical Oncology 1, Veneto Institute of Oncology IOV–IRCCS, Padua, Italy
Giulia Maddalena , Alessandra Prete , Federica Buggin , Fable Zustovich , Jessica Cadau , Giuseppe Azzarello , Letizia Procaccio , Caterina Soldà , Mario Domenico Rizzato , Cosimo Rasola , Claudia Galante , Eleonora Bergo , Silvia Montelatici , Ciro Longobardi , Giorgia Boscolo , Filomena Graziani , Luca Boni , Sara Lonardi , Vittorina Zagonel , Francesca Bergamo
Background: Colorectal cancer (CRC) is the second most frequent malignancy in patients (pts) aged 70. Elderly patients are often excluded by clinical trials; however, improvements in quality of life and comorbidities management led to expand the access to anticancer treatments irrespectively of age per se. Finding new tools to stratify vulnerability in elderly pts is crucial to guide clinicians in therapeutic decisions. G8 and timed up and go test (TUG) have been related to prognosis and functional decline in patients affected by several solid tumors. However, no studies focused on TUG and G8 prognostic value in CRC pts are available. In this study, we assessed the prognostic value of G8 and TUG in a cohort of real-life elderly pts with metastatic CRC (mCRC). Methods: GOLD was a multicentre, observational, prospective study in which pts aged 70 with mCRC and eligible to 1st line therapy were enrolled. G8 and TUG were performed at screening and at the first documented disease progression (PD). G8 cutoff was 14, as reported in literature; TUG8,5 sec (cutoff set with ROC curve using MedCalc software v 20.027). PFS and OS were described with Kaplan-Meyer curve. All analyzed variables were then compared with multivariate models. Primary endpoint of the study was to assess prognostic value of G8 in OS and PFS. Secondary endpoints were to assess prognostic value of TUG in OS and PFS. Results: Since Oct 2017 to Apr 2019, 109 pts were evaluated in 4 different Oncology Units in Veneto (IT); 4 were not eligible to anticancer treatments and where thus excluded. 105 pts were finally enrolled. Clinical, histological and molecular characteristics were well balanced between pts with G814 vs > 14, with the exception of RASmut, more represented in the G8 > 14 group (p = 0,0195). 39 (37%) pts were aged80; 46 (44%) had ECOG PS1; 55 (53%) had RASmut; 15 (15%) had BRAFmut. 81 (77%) had G814; 78 (75%) had TUG8,5. At a median follow up time of 41,2 months, median OS was 19,41 months (95%CI 15,46-23,19) and median PFS 8,78 months (95% CI 7,53-10,07). OS was longer in patients with G814 (HR 0,61; 95%CI 0,39-0,97; p= 0,0584) and TUG8,5 (HR 0,55; 95%CI 0,35- 0,86; p= 0,0201). PFS was not influenced by G8 (HR 0,86; 95%CI 0,55-1,34; p= 0,5125) nor by TUG (HR 0,71; 95%CI 0,47-1,08). G814 and TUG8,5 conferred better OS also in the subgroup of RASmut (respectively p= 0,0133 and p= 0,0088). Worse OS was observed in presence of > 1 metastatic site (HR = 1,71; 95%CI 1,11 to 2,64; p= 0,0161). At the multivariate analysis, G814 (p= 0,0202) and single metastatic site (p= 0,0200) were related to better OS; none of the analysed variables had effect on PFS. Conclusions: In our study G814 and TUG8,5 had prognostic value in OS, but not in PFS, in a real-life population of elderly pts affected by mCRC. G8 and single metastatic site involvement were related to better OS, irrespectively of other clinical, histological and molecular variables.
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