A Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation Therapy in Elderly Patients With Rectal Cancer

Abstract

Purpose/Objective(s)To determine the maximum tolerated dose and the dose-limiting toxicity of postoperative capecitabine with concurrent radiation therapy as adjuvant treatment in patients aged over 70 with stage II/III rectal cancer.Materials/MethodsThis is a prospective phase I study. Patients aged over 70 with stage II/III rectal cancer after radical surgery were eligible. Patients received intensify modulated radiation to pelvis at a dose of 50 Gy/25f, with concurrent capecitabine orally twice daily on days 1 to 14, repeated every 3 weeks. Capecitabine doses were escalated from 1000 mg/m2/d as far as no more than 1/3 of the patients in a level developing dose limiting toxicities (DLT). DLT were defined as ≥grade 2 hematologic, hepatic and renal toxicity and other grade 3/4 nonhematologic toxicities.ResultsBetween November 2011 and October 2012, 12 patients were enrolled at the following dose levels: 1,000 (6 patients), 1,200 (3 patients) and 1,400 mg/m2/d (3 patients). The median age was 74.5 (range, 71-83). Eleven patients (91.7%) were male, and 7 patients (58.3%) had a Karnofsky status of 90-100. Nine patients were Stage III (75%), and 9 of them had received low anterior resection (75%). DLT was only observed in 1 patient at 1,000 mg/m2/day (Grade 3 diarrhea). Among 12 patients, 44 adverse events (AEs) were observed, including 1 grade 3 (diarrhea), 6 grade 2(including 4 gastrointestinal, 1 hematologic and 1 dermatologic toxicity), and 37 grade 1. Table shows the observed toxicities at each dose escalation level. Gastrointestinal toxicity was the most common AE (17/44).ConclusionsPoster Viewing Abstract 2354; TableToxicity grade at each dose escalation levelLevelCapecitabine (mg/m2/d)Patients (n)Toxicity grade (n)12311000621412120034003140031220 Open table in a new tab Purpose/Objective(s)To determine the maximum tolerated dose and the dose-limiting toxicity of postoperative capecitabine with concurrent radiation therapy as adjuvant treatment in patients aged over 70 with stage II/III rectal cancer. To determine the maximum tolerated dose and the dose-limiting toxicity of postoperative capecitabine with concurrent radiation therapy as adjuvant treatment in patients aged over 70 with stage II/III rectal cancer. Materials/MethodsThis is a prospective phase I study. Patients aged over 70 with stage II/III rectal cancer after radical surgery were eligible. Patients received intensify modulated radiation to pelvis at a dose of 50 Gy/25f, with concurrent capecitabine orally twice daily on days 1 to 14, repeated every 3 weeks. Capecitabine doses were escalated from 1000 mg/m2/d as far as no more than 1/3 of the patients in a level developing dose limiting toxicities (DLT). DLT were defined as ≥grade 2 hematologic, hepatic and renal toxicity and other grade 3/4 nonhematologic toxicities. This is a prospective phase I study. Patients aged over 70 with stage II/III rectal cancer after radical surgery were eligible. Patients received intensify modulated radiation to pelvis at a dose of 50 Gy/25f, with concurrent capecitabine orally twice daily on days 1 to 14, repeated every 3 weeks. Capecitabine doses were escalated from 1000 mg/m2/d as far as no more than 1/3 of the patients in a level developing dose limiting toxicities (DLT). DLT were defined as ≥grade 2 hematologic, hepatic and renal toxicity and other grade 3/4 nonhematologic toxicities. ResultsBetween November 2011 and October 2012, 12 patients were enrolled at the following dose levels: 1,000 (6 patients), 1,200 (3 patients) and 1,400 mg/m2/d (3 patients). The median age was 74.5 (range, 71-83). Eleven patients (91.7%) were male, and 7 patients (58.3%) had a Karnofsky status of 90-100. Nine patients were Stage III (75%), and 9 of them had received low anterior resection (75%). DLT was only observed in 1 patient at 1,000 mg/m2/day (Grade 3 diarrhea). Among 12 patients, 44 adverse events (AEs) were observed, including 1 grade 3 (diarrhea), 6 grade 2(including 4 gastrointestinal, 1 hematologic and 1 dermatologic toxicity), and 37 grade 1. Table shows the observed toxicities at each dose escalation level. Gastrointestinal toxicity was the most common AE (17/44). Between November 2011 and October 2012, 12 patients were enrolled at the following dose levels: 1,000 (6 patients), 1,200 (3 patients) and 1,400 mg/m2/d (3 patients). The median age was 74.5 (range, 71-83). Eleven patients (91.7%) were male, and 7 patients (58.3%) had a Karnofsky status of 90-100. Nine patients were Stage III (75%), and 9 of them had received low anterior resection (75%). DLT was only observed in 1 patient at 1,000 mg/m2/day (Grade 3 diarrhea). Among 12 patients, 44 adverse events (AEs) were observed, including 1 grade 3 (diarrhea), 6 grade 2(including 4 gastrointestinal, 1 hematologic and 1 dermatologic toxicity), and 37 grade 1. Table shows the observed toxicities at each dose escalation level. Gastrointestinal toxicity was the most common AE (17/44). ConclusionsPoster Viewing Abstract 2354; TableToxicity grade at each dose escalation levelLevelCapecitabine (mg/m2/d)Patients (n)Toxicity grade (n)12311000621412120034003140031220 Open table in a new tab