Page 74 - Demo

Chapter 472neoadjuvant chemotherapy and one patient received prior chemoradiation). Treatment was initiated in 78 patients. Four patients did not receive chemotherapy after randomization. One patient, allocated to the vitamin group, deceased unexpectedly before the first chemotherapy while another patient in the same treatment group was not eligible due to neutropenia. Two patients allocated to the treatment arm without vitamin suppletion were not eligible due to increasing renal impairment. These four patients could not be monitored for response but were included in the intention to treat analysis for TTP and OS. Table 1. Baseline patient and disease characteristics.Supplemented patientsN=41Unsupplemented patientsN=41CharacteristicMean age (range) 61 yr (50-78) 61 (35-82)Gender (female/male) 8 / 33 8 / 33Primary tumor (stomach /esophagus)11 /30 12 / 29Tumortype (SCC/AC) 8/33 8/33Performance status PS 0 14 (34%) 12 (29%)PS 1 23 (56%) 23 (56%)PS 2 2 (5%) 4 (10%)PS unknown 2 (5%) 2 (5%)Prior therapy 4 (10%) 0Safety and tolerabilityThe overall incidence of grade 3-5 AEs was comparable between the two treatment groups and probably caused by the chemotherapy (Table 2). Grade 3 leukopenia was the most common severe toxicity in supplemented patients (22%), while fatigue was the most common severe toxicity (24%) in unsupplemented patients. Three supplemented patients suffered from grade 4 thrombopenia. Grade 4 thrombopenia was reported in one unsupplemented patient. Two supplemented patients were diagnosed with an ischemic cerebrovascular accident (CVA) after two treatment cycles (grade 4 neurologic toxicity) and one patient was diagnosed with a hemorrhagic CVA three days after day 1 of the first chemotherapy cycle (grade 4 hemorrhage) and received no further study treatment. Two unsupplemented patients deceased shortly after the first chemotherapy cycle, in 1 case probably