Cancer Research and Treatment

Original Articles

Pilot Study of Heptaplatin, UFT-E and Leucovorin in Advanced Gastric Carcinoma: Sang Cheul Oh, So Young Yoon, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim, Si Young Kim, Hwi Joong Yoon, Kyung Sam Cho, Jun Suk Kim; Cancer Res Treat. 2003;35(2):117-122. Published online April 30, 2003; DOI: https://doi.org/10.4143/crt.2003.35.2.117

PURPOSE
Heptaplatin (SKI-2053R, Sunpla ), a new platinum analogue which has a better toxicity profile than cisplatin, has been used with 5-fluorouracil (5-FU) continuous infusion for the treatment of advanced gastric carcinoma. However, continuous 5-FU infusion had a inconvenience to administration. The aim of this study was to evaluate the efficacy and toxicity of heptaplatin, UFT-E and leucovorin combination chemotherapy in advanced gastric cancer.
MATERIALS AND METHODS
A total of 22 patients was enrolled in this study at Kyung Hee University and Korea University from September 1999 to May 2001. Heptaplatin 400 mg/m2 was given as intravenous infusion for 1 hour at day 1. Oral UFT-E 360 mg/m2 and leucovorin 45 mg/day were administered for 21 consecutive days followed by a 7-day drug free interval. This schedule was repeated every 4 weeks. RESULTS: The 22 enrolled patients received 81 courses of chemotherapy and the median number of course per patient was three with a range of one to six. Five of 21 patients achieved partial responses (23.8%; 95% confidence interval, 5.6% to 42%) without complete response. Out of the 5 responding patients, three had unresectable perigastric lymph-nodes, one patient had a ovarian metastasis, and one patient had a peritoneal metastasis respectively. Main toxicities were neutropenia and nausea/vomiting. Grade 3 and 4 neutropenia were observed in 4 patients (18%) and grade 3 nausea/vomiting were observed in 5 patients (22.7%). The median time to progression was 4 months (range, 0.5 to 13 months), and median survival duration was 7.5 months (range, 2.0 to 14 months). Median response duration was 5.0 months (range, 1.5 to 10 months). CONCLUSION: A combination chemotherapy of heptaplatin, UFT-E and leucovorin has a comparable efficacy with those of previously reported heptaplatin and intravenous regimen of 5-FU and controllable toxicity in advanced gastric carcinoma. Further study with large patient population is warranted to determine the usefulness of this regimen.

Citations

Citations to this article as recorded by

Platinum drugs: from Pt(II) compounds, Pt(IV) prodrugs, to Pt nanocrystals/nanoclusters
Xi Hu, Fangyuan Li, Nabila Noor, Daishun Ling
Science Bulletin.2017; 62(8): 589. CrossRef
The status of platinum anticancer drugs in the clinic and in clinical trials
Nial J. Wheate, Shonagh Walker, Gemma E. Craig, Rabbab Oun
Dalton Transactions.2010; 39(35): 8113. CrossRef
A Phase II Trial of Haptaplatin/5-FU and Leucovorin for Advanced Stomach Cancer
Won Sup Lee, Gyeong-Won Lee, Hwal Woong Kim, Ok-Jae Lee, Young-Joon Lee, Gyung Hyuck Ko, Jong-Seok Lee, Joung Soon Jang, Woo Song Ha
Cancer Research and Treatment.2005; 37(4): 208. CrossRef
Combination Chemotherapy of Heptaplatin, Paclitaxel and 5-Fluorouracil in Patients with Advanced Gastric Cancer: a Pilot Study
Myung-Ju Ahn, Ho-Suck Oh, Jung-Hye Choi, Young-Yeul Lee, In-Soon Kim, Il-Young Choi, Oh Young Lee, Ho-Soon Choi, Sung-Joon Kwon
Cancer Research and Treatment.2004; 36(3): 182. CrossRef

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Phase II Trial of Gemcitabine, UFT-E, Leucovorin Combination Chemotherapy in Advanced Pancreatic Adenocarcinoma: So Young Yoon, Kyong Hwa Park, Sang Chul Oh, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Jae Seon Kim, Chang Duck Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim; Cancer Res Treat. 2002;34(2):111-116. Published online April 30, 2002; DOI: https://doi.org/10.4143/crt.2002.34.2.111

Abstract PDF

PURPOSE
To evaluate the efficacy and toxicity of a Gemcitabine, UFT-E, Leucovorin combination chemotherapy in the treatment of advanced pancreatic adenocarcinoma. PATIENTS AND METHODS: Patients <=70 years, with no prior chemotherapy and with bidimensionally measurable advanced pancreatic adenocarcinoma, ECOG performance status <=2, and adequate bone marrow, kidney, and liver function were eligible for this trial. Eligibility criteria for clinical benefit assessment were pain with at least a daily analgesic consumption of two nonsteroidal anti-inflammatory drugs or a Karnofsky performance status between 50 and 70. Treatment consisted of 1,000 mg/m2 of Gemcitabine on days 1, 8 and 15, repeated every 4 weeks, with UFT-E administered orally 500 mg-700 mg by body surface area (BSA). Leucovorin was administered 45 mg/day orally. Dosages of UFT-E and Leucovorin were divided and administered three times per day from day 1 to day 21. After 7 days of rest, UFT-E and Leucovorin were administered repeatedly.
RESULTS
Twenty-three patients were enrolled between April 1999 to April 2000. Eighty two cycles (median, four cycles) were delivered to all patients. The objective response rate was 15.8% in 19 assessable patients and 13.0% in the intent-to-treat population. Twelve patients (57.9%) displayed stable disease. Grade 3 or 4 neutropenia occurred in 30.4% of patients, nausea/vomiting in 8.3%, diarrhea in 4.3%, and mucositis in 4.3%. The median time to progression was 8 months. The median survival was 8 months in the assessable population and 6 months in the intent-to-treat population Clinical benefit was achieved in 11 (57.9%) of 19 assessable patients.
CONCLUSION
Gemcitabine, UFT-E, Leucovorin combination chemotherapy is a well-tolerated and safe regimen in cases of advanced pancreatic adenocarcinoma. Although the response rate is low, it shows a survival benefit and clinical benefit and deserves further evaluation in a phase III trial.

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Gemcitabine and oxaliplatin combination as first-line treatment for advanced pancreatic cancer: a multicenter phase II study
Kyung Hee Lee, Min Kyoung Kim, Yeol Hong Kim, Baek Yeol Ryoo, Ho Yeong Lim, Hong Suk Song, Hoon Kyo Kim, Myung Ah Lee, Seock Ah Im, Heung Moon Chang, Jae Yong Cho, Dae Young Zang, Bong Seog Kim, Jun Suk Kim
Cancer Chemotherapy and Pharmacology.2009; 64(2): 317. CrossRef

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