Development of a new tool to monitor and identify inadequate oral intake in hospital

119 Background: Oral fluoropyrimidine plus cisplatin is widely used as a standard treatment for advanced gastric cancer, but patients (pts) with severe peritoneal metastasis often cannot tolerate this regimen. The aim of this study was to assess the feasibility of fluorouracil (5-FU), leucovorin (LV), plus paclitaxel (PTX) for peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake. Methods: Peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake were enrolled in Part I (Level 1 (n=6): 5-FU bolus/l- LV div 2hr/PTX div 1hr = 500/250/60, Level 2 (n=6): 600/250/80 mg/m2 (day1, 8, 15, q4w) to determine dose-limiting toxicity (DLT) and recommended dose (RD). In Part II (n=19), primary endpoint was completion rate of 2 cycles to evaluate the feasibility of this regimen at RD level. Results: One of Level 1 pts had DLT with grade 4 gastrointestinal perforation. Two of Level 2 pts had DLT (grade 3 febrile neutropenia and grade 3 infection with normal neutrophils) and treatment-related death (TRD) was observed in one patient due to pneumonia with grade 4 neutropenia. The RD was determined to be Level 1. Twenty-five patients were enrolled at RD level: first-line/second-line=18/7, performance status 0/1/2=1/19/5. The completion rate of 2 cycles was 92% and objective response rate of ascites was 45%. Grade 3 or 4 neutropenia was observed in 12% (febrile neutropenia in 8%). Five patients out of 7 second-line patients died within 30 days after last administration of FLTAX (TRD: 1 and disease progression: 4). Conclusions: RD of FLTAX regimen was 5-FU/l-LV/PTX=500/250/60 mg/m2. This regimen was feasible as the first-line treatment against peritoneal disseminated gastric cancer patients with massive ascites or inadequate oral intake. [Table: see text]

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Fluoropyrimidine (F) alone versus F plus platinum (P) as first-line chemotherapy in patients (pts) with advanced gastric cancer (AGC) and severe peritoneal metastasis (SPM): A multicenter observational study.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.121 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 121-121

Author(s):

Hiroyuki Arai ◽

Satoru Iwasa ◽

Narikazu Boku ◽

Masahiro Kawahira ◽

Hirofumi Yasui ◽

...

Keyword(s):

Response Rate ◽

Oral Intake ◽

Progression Free Survival ◽

Albumin Level ◽

Nutrition Support ◽

Massive Ascites ◽

Improvement Rate ◽

Multicenter Observational Study ◽

Inadequate Oral Intake ◽

Line Chemotherapy

121 Background: The standard 1st-line chemotherapy for AGC pts with SPM has not been established. F alone is generally used for their treatment because of difficulty of hydration for dosing of cisplatin (CDDP) in pts with massive ascites, and has shown limited efficacy. It is unclear whether a combination of F and P (CDDP or oxaliplatin): FP improves their clinical outcome. We therefore investigated the efficacy and safety of FP in comparison with F alone. Methods: This retrospective study comprised of AGC pts with SPM and HER2 negative or unknown tumors who received FP or F as 1st-line chemotherapy between Jul 2010 and Sep 2016 at 6 institutions in Japan. SPM was defined as having massive ascites and/or inadequate oral intake requiring intravenous nutrition support. Overall survival (OS), progression-free survival (PFS), response rate of ascites, improvement rate of oral intake, and safety were compared between two treatment groups. Results: A total of 129 pts (64 in FP group, 65 in F group) were included. Patient characteristics (FP vs F) were as follows: median age, 62 vs 67; PS 0/1/2/3/4 (%), 6/64/25/3/2 vs 8/42/42/8/0; massive ascites/inadequate oral intake/both (%), 61/25/14 vs 35/29/35; number of metastatic sites 1-2/3-5 (%), 77/23 vs 78/22; median serum albumin level (g/ml), 3.1 vs 3.1. OS was significantly longer in FP group than F group (median, 9.0 vs 5.0 months; HR 0.56, 95%CI 0.39-0.82; log-rank p < 0.01); it remained significant upon multivariate analysis adjusting for prognostic variables (HR 0.48, 95% CI 0.32-0.73, p < 0.01). Pts in FP group had significantly better PFS in both uni- and multivariate analyses (median, 4.3 vs 2.3 months; HR 0.44, p < 0.01 and HR 0.40, p < 0.01, respectively). Response rate of ascites (51% vs 17%) and improvement rate of oral intake (64% vs 43%) also were better in FP group (p < 0.01 and p = 0.09, respectively). Toxicities were tolerable in both groups, but grade ≥3 neutropenia was more frequent in FP group (36% vs 11%). Conclusions: FP showed significantly better efficacy than F alone, and it could be a promising option as 1st-line treatment for AGC pts with SPM.

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Vitamin D Deficiency—A Clinical Spectrum: Is There a Symptomatic Nonosteomalacic State?

International Journal of Endocrinology ◽

10.1155/2010/521457 ◽

2010 ◽

Vol 2010 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Amar Kanekar ◽

Manoj Sharma ◽

V. R. Joshi

Keyword(s):

Vitamin D ◽

Vitamin D Deficiency ◽

Oral Intake ◽

Sun Exposure ◽

Clinical Spectrum ◽

Musculoskeletal Symptoms ◽

Vitamin D Levels ◽

Subclinical Vitamin ◽

Inadequate Oral Intake

Vitamin D deficiency is not uncommon even in the sunny land of India. Lack of sun exposure and inadequate oral intake are both responsible for vitamin D deficiency. This article provides a retrospective, examining the effects of Vitamin D deficiency in 71 patients. The study's inclusion criterion was low vitamin D level combined with musculoskeletal symptoms but without the presence of osteomalacia. All patients in this study were suspected to have vitamin D deficiency. The data were retrieved from the case-charts of patients seen between 1996 and 2001 at the rheumatology services of Hinduja Hospital, Mumbai, India. This study found no correlation between Vitamin D levels and symptoms, or between the severity of Vitamin D deficiency and the number of symptoms displayed. Subclinical vitamin D deficiency or preosteomalacic state was the term coined for individuals with vitamin D deficiency producing nonspecific musculoskeletal symptoms in the absence of clinical osteomalacia.

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