Previous adjuvant chemotherapy, if given, must have been completed at least 6 months before inclusion. Patients who received earlier adjuvant treatment with oxaliplatin or capecitabine were not eligible. The protocol was approved by the ethics committee and carried out according to the principles of the Declaration of Helsinki and good clinical CHK Inhibitors practice guidelines, and all patients gave their written informed consent to participate in the trial.Physical examinations, a biochemical profile and an electrocardiogram were performed every cycle. Complete blood counts were tested every week.
Tumor markers and computed tomography scans or magnetic resonance images of measurable lesions were assessed at baseline and repeated every two cycles of treatment. Responses were assessed by at least two observers and were confirmed by an expert independent radiologist. Tumor assessment was performed for every 2 cycles of chemotherapy, or earlier when indicated clinically. Responses were to be confirmed by art of warfare subsequent CT scans 4 weeks after the initial response documentation. The Response Evaluation Criteria in Solid Tumors were used to evaluate clinical response. Assessment of time to progression (TTP) was determined by measuring the time interval from the beginning of treatment until the first documentation of progression regardless of the patient’s treatment status. OS was determined by measuring the time interval from the beginning of the treatment to the date of death or last contact.
Toxicity was assessed in each treatment cycle of therapy using the National Cancer Institute Common Toxicity Criteria.From March 2008 to December 2010, 46 elderly patients with metastatic cancer or AGC were enrolled in this trial from 3 centers. The median age was 74 years. All 46 patients were evaluable for toxicity and 45 patients for efficacy. One patient was excluded from the response analysis because he refused AP23573 continuation of treatment due to personal aspects after the first cycle and did not show early progression. The pretreatment characteristics of patients are listed in table 1 . Of the 7 patients who had received adjuvant chemotherapy, 3 received paclitaxel/5-FU regimen, 2 received cisplatin/5- FU, and 2 received 5-FU/leucovorin. At the closing date of 10 March 2011, the median follow-up time from the commencement of treatment was 12.5 months.Systemic chemotherapy has been shown to prolong survival and to relieve symptoms in AGC. However, few studies were conducted to offer an appropriate chemotherapy regimen to elderly patients.
Factors that influence the reluctance to use chemotherapy in the elderly include: declining organ function, decreasing cognitive abilities, socioeconomic precariousness and comorbidities. Therefore, the search for a safe and effective chemotherapy regimen for elderly patients with AGC remains an urgent task. In previously published trials, a cisplatin/ capecitabine regimen and oxaliplatin/5-FU/leucovorin combinations were found to be active in the elderly. However, in these schedules, cisplatin needs venous hydration, and continuous infusion of 5-FU requires external infusion pumps, vascular access, and additional medical care.