Extended safety and efficacy data on S‐1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study

Abstract

Objective: Clinical and epidemiological research suggest that bone mineral density (BMD) in women is shaped by various reproductive factors such as parity and lactation patterns. However, the extent of these effects on BMD remains unclear because of contradictory findings and a focus on industrialized populations. Because fertility patterns in these groups are vastly different than those of women from non‐Western, subsistence populations, our current understanding of the reproductive effects on skeletal health is incomplete. Using a life history perspective, this study examines the relationship between reproductive factors and bone density among women from the Indigenous Shuar population, an Amazonian Ecuadorian forager‐horticulturalist group. Methods: This preliminary, cross‐sectional study included 130 premenopausal and postmenopausal women (14–86 years old) from the Morona‐Santiago region of Ecuador. Anthropometrics were recorded, as was estimated BMD using a calcaneal ultrasonometer. A reproductive history questionnaire was administered that included questions regarding menarche, parity, lactation patterns, and menopause. Results: Among postmenopausal women, early menarche and greater stature were significantly associated with higher bone density values. Among premenopausal women, few significant relationships between bone values and reproductive variables were documented; effects of lactation appeared to be transient and restored following weaning. Conclusions: Although preliminary and not based on longitudinal data, these findings suggest that the effects of reproduction are transient as the system of calcium homeostasis in premenopausal women efficiently restores the bone loss that results from metabolically active reproductive states. Further, this research suggests that the timing of early life history events may canalize bone density phenotype. Am. J. Hum. Biol., 2012. © 2012 Wiley Periodicals, Inc.

A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer

“…The SP regimen in our study was well tolerated, similar to the results in previous studies [4,[6][7][8][9][10].…”

“…A moderate to high dose of cisplatin is usually administered every 3-5 weeks to patients with advanced gastric cancer [4][5][6][7][8][9][10]; however, excessive hydration is vital to prevent renal toxicity at this dose. To reduce the necessity for excessive hydration and decrease renal toxicity, split-or low-dose cisplatin combined with S-1 has been investigated in several phase I and II studies [11][12][13][14][15] using various doses and schedules (S-1 administered at 80 mg/m 2 for 14-28 days and cisplatin infused at 10 mg/m 2 /day twice a week [11], 25 mg/m 2 /day once a week [12,13], or 4 mg/m 2 /day for 5 consecutive days/week [14]).…”

Preliminary trial of surgery after chemotherapy for advanced gastric cancer with peritoneal dissemination

“…In particular, advanced gastric cancer with peritoneal dissemination has a poor prognosis. The actual rate of CR with S-1-based combination chemotherapy has been found to be relatively low (8,15,20,21). Peritoneal dissemination is the greatest barrier to an improved prognosis for advanced gastric cancer.…”

Prospective Study of Triple Combination Chemotherapy Consisting of Paclitaxel, S-1, and 24-Hour Infusion of Cisplatin (PSC) for Inoperable Highly Advanced Gastric Cancer

“…Paclitaxel combined with other drugs reportedly has tolerable toxicity (Kang, et al, 2008). In addition, continuous infusion of cisplatin for 24 hours has been used to minimize side effects including renal and hematological toxicity (Ina, et al, 2008;Iwase, et al, 2005) with anti-tumor effects the same as in previous reports Lenz, et al, 2007). Therefore, with the aim of improving the tumor response to S-1 plus cisplatin therapy, we combined paclitaxel with S-1 plus cisplatin (PSC triple therapy) for the treatment of advanced gastric cancer.…”