XELOX (capecitabine and oxaliplatin) as 1st line treatment for elderly patients (pts) with advanced/metastatic colorectal cancer (MCRC)

Capecitabine use in geriatric oncology: An analysis of current safety, efficacy, and quality of life data

“…In a randomized controlled study comparing single-agent oral capecitabine with the Mayo Clinic regimen (bolus 5-FU/LV) in patients >60 years aged [43], the ORR was significantly greater with capecitabine (26% versus 16%, P = 0.018). As well, the ORR among patients treated with single-agent capecitabine did not significantly differ between those >60 years of age and those ≤60 years of age (26% versus 24%, [57]: lethargy 3%, dehydration 2%, stomatitis 1%; Twelves et al [47]: hyperbilirubinemia 5% (in patients ≥65 years of age vs. 4% in patients <65 years); Vincent et al [46]: stomatitis 2%; Lopez-Gomez et al [51]: asthenia 13%, stomatitis 3%, fever 3%, anorexia 3%, abdominal pain 3%, paresthesia 3%; Escudero et al [52]: epigastric pain 4%, asthenia 4%, anorexia 1%. Hoff et al [43] did not report AEs for the >60 years subpopulation.…”

“…Other non-hematologic grade 3 or 4 AEs infrequently reported included fever, anorexia, and abdominal pain [51,52]. Neither mucositis nor alopecia was reported in any study.…”

“…Only two treatment-related deaths were reported: one in a patient treated with capecitabine/oxaliplatin, from pulmonary fibrosis, a known adverse effect of oxaliplatin [50], and another in patient treated with capecitabine/irinotecan, from grade 4 diarrhea [51].…”

“…For the treatment of older patients with metastatic colorectal cancer, first-line, singleagent capecitabine was typically dosed at 1250 mg/m 2 BID, but more recently lowered to 1000 mg/m 2 BID [24,43,45,52] or 950 mg/m 2 to adjust for renal impairment [44], all given on a 2 weeks on/1 week off schedule. When used in combination with oxaliplatin or irinotecan, the dose and schedule is typically capecitabine 1000 mg/m 2 BID for 2 weeks on/1 week off and oxaliplatin 85-130 mg/m 2 on day 1) [48,50,51] or irinotecan 60 mg/m 2 on days 1, 8, and 15 [37]. In the adjuvant setting, a recent post hoc analysis was performed on elderly patients in the X-ACT study [53], an important RCT comparing single-agent oral capecitabine (1250 mg/m 2 BID for 2 weeks on/1 week off) with the Mayo Clinic regimen (bolus 5-FU 425 mg/m 2 days with leucovorin 20 mg/m 2 days 1-5 every 4 weeks) in the adjuvant setting among 1987 patients with Dukes' C colon cancer following resection [23].…”

“…More recently, studies have examined its use in the adjuvant setting. Efficacy and safety data for clinical studies of metastatic colorectal cancer in elderly populations are presented in Tables 3 and 4 [24,[43][44][45][46][47][48][49][50][51][52][53]. For the treatment of older patients with metastatic colorectal cancer, first-line, singleagent capecitabine was typically dosed at 1250 mg/m 2 BID, but more recently lowered to 1000 mg/m 2 BID [24,43,45,52] or 950 mg/m 2 to adjust for renal impairment [44], all given on a 2 weeks on/1 week off schedule.…”