Pegfilgrastim for the management of neutropenia during neoadjuvant chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in esophageal cancer patients.

BACKGROUND: Neoadjuvant docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy is a new standard for locally advanced esophageal squamous cell carcinoma. The optimal timing of pegfilgrastim with the DCF regimen to prevent febrile neutropenia (FN) remains controversial. The effectiveness of concomitant pegfilgrastim administration with continuous 5-fluorouracil (5-FU) infusion in the DCF regimen was therefore assessed. METHODS: All patients who received neoadjuvant DCF for esophageal cancer were retrospectively assessed. Patients who had been scheduled to receive pegfilgrastim on days 3-5 (early group) or days 7-9 (regular group) of the DCF regimen were included. Uni- and multivariate analyses were used to assess risk factors for FN. RESULTS: Eighty-eight patients were included in the analysis. The 26 patients in the early group received pegfilgrastim as scheduled. In the 62 patients of the regular group, 51 received pegfilgrastim at a median of 7 days after starting DCF chemotherapy. However, 11 patients in the regular group could not receive pegfilgrastim. Twenty-two patients of the regular group and 2 patients of the early group developed FN after the first session of DCF. Early administration of pegfilgrastim and grade 4 neutropenia were significantly associated with onset of FN, with multivariate analysis identifying early administration of pegfilgrastim as an independent preventive factor and grade 4 neutropenia as a risk factor, after adjusting for sex and age. CONCLUSION: Early pegfilgrastim administration is a safe approach that reduces the incidence of FN in DCF therapy. Using pegfilgrastim with continuous 5-FU infusion in the DCF regimen represents a reasonable option to prevent FN.

Effect of Bifidobacterium bifidum G9-1 on the Intestinal Environment and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)-like Symptoms in Patients with Quiescent Crohn's Disease: A Prospective Pilot Study.

Diarrhea-predominant irritable bowel syndrome (IBS-D)-like symptoms are distressing for patients with quiescent Crohn's disease (qCD) and worsen their quality of life. In the present study, we assessed the effect of the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) on the intestinal environment and clinical features in patients with qCD. Eleven patients with qCD, who met the Rome III diagnostic criteria for IBS-D, received BBG9-1 (24 mg) orally three times daily for 4 weeks. Indices of the intestinal environment (fecal calprotectin level and gut microbiome) and clinical features (CD/IBS-related symptoms, quality of life and stool irregularities) were evaluated before and after treatment. Treatment with BBG9-1 tended to reduce the IBS severity index in the studied patients (p = 0.07). Among gastrointestinal symptoms, abdominal pain and dyspepsia tended to be improved by the BBG9-1 treatment (p = 0.07 and p = 0.07, respectively), and IBD-related QOL showed a significant improvement (p = 0.007). With regard to mental status, the patient anxiety score was significantly lower at the endpoint of BBG9-1 treatment than at the baseline (p = 0.03). Although BBG9-1 treatment did not affect the fecal calprotectin level, it suppressed the serum MCP-1 level significantly and increased the abundance of intestinal Bacteroides in the study patients. The probiotic BBG9-1 is able to improve IBD-related QOL with a reduction of anxiety score in patients with quiescent CD and IBS-D-like symptoms.

Evaluation of QOL in Patients with Dyspeptic Symptoms Who Meet or Do Not Meet Rome IV Criteria.

Health related quality of life (HR-QOL) of functional dyspepsia (FD) patients is impaired. However, the QOL of such patients has not been fully examined. Accordingly, we examined the QOL of Rome IV defined FD, endoscopic negative dyspeptic patients who do not meet the criteria, (non-FD patients) and healthy subjects, and investigated the factors that influence HR-QOL. This was a multicenter, prospective, observational study. Two hundred thirty-five patients (126 FD, 87 non-FD) and 111 healthy subjects were investigated, and non-FD patients were subdivided into three groups: 17 patients failing to meet only the disease duration criterion (Group A), 53 patients failing to meet only disease frequency criterion (Group B) and 17 patients failing to meet both the disease duration and frequency criteria (Group C). They completed a questionnaire survey regarding gastrointestinal symptoms (GSRS), QOL and psychological factors, which were compared among three groups. The total GSRS score was significantly higher in FD patients than non-FD patients (p = 0.012), which was higher than the healthy subjects (p < 0.0001). Furthermore, the total GSRS score of FD patients was comparable to that of Group A (p = 0.885), which was significantly higher than that of the Group B and C (p = 0.028, p = 0.014, respectively). HR-QOL is more impaired in FD patients than non-FD patients, which was significantly lower than the healthy subjects. That GSRS score in FD and Group A was comparable suggesting that an increased frequency of symptoms may have impact on the impairment of patient's QOL.