Phase I trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

Nakamura, Kazuyoshi; Yamaguchi, Taketo; Ishihara, Takeshi; Kobayashi, A; Tadenuma, Hiroshi; Sudo, Kentaro; Kato, Hiroyuki; Saisho, Hiromitsu

doi:10.1038/sj.bjc.6602644

Cited by 61 publications

(27 citation statements)

References 25 publications

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“…As yet, the combination regimen of S-1 and gemcitabine for patients with APC has not been investigated. We previously performed a phase I study to evaluate the safety of treatment combining gemcitabine with S-1 to determine the MTD of each drug in patients with APC (Nakamura et al, 2005). That study indicated that the recommended dose was 30 mg m À2 twice daily of S-1 given orally for 14 consecutive days and 1000 mg m À2 gemcitabine given on day 8 and 15, and that the cycle should be repeated every 21 days.…”

Section: Discussionmentioning

confidence: 99%

“…We anticipated that combination chemotherapy of gemcitabine and S-1 would be effective through the synergistic activity of gemcitabine and 5-FU derived from S-1. Thus, we performed a phase I study to evaluate the safety of treatment combining GEM with S-1 and to determine the MTD of each drug in patients with APC (Nakamura et al, 2005). This combination chemotherapy was well tolerated and showed outstanding antitumour activity.…”

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Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

et al. 2006

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We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients. Patients who had pathologically proven pancreatic cancer with metastatic lesions were eligible candidates for entry into the study. S-1 was given orally (30 mg m À2 ) b.i.d. for 14 consecutive days and gemcitabine (1000 mg m À2 ) was given on days 8 and 15. The cycle was repeated every 21 days. We enrolled 33 MPC patients. The median number of cycles was eight (range 1 -20). Grade 3 -4 toxicities were leucopenia (33%), neutropenia (55%), anaemia (9%), thrombocytopenia (15%), anorexia (6%), fever (9%), and interstitial pneumonia (6%). Objective responses were obtained in 16 patients (one complete response and 15 partial responses; response rate, 48%; 95% confidence interval (CI), 33 -65). Median survival and 1-year survival rate were 12.5 months (95% CI, 5.9 -19.1) and 54% (95% CI, 36 -72), respectively. Combination chemotherapy with GEM and S-1 was well tolerated and yielded a significantly high response rate.

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Section: Discussionmentioning

confidence: 99%

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Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

et al. 2006

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“…Several trials have assessed the combination of gemcitabine and S-1 in patients with advanced/metastatic pancreatic cancer. Based on the results of an earlier Phase I study, we used a combination regimen consisting of 60 mg/ m 2 of S-1 for 14 consecutive days and 1000 mg/m 2 gemcitabine on Days 8 and 15 (8). The response rate of patients to this regimen was 27% and the median TTP was 4.6 months.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, synergy between gemcitabine and 5-FU in tumor cell lines, including pancreatic cancer cells, has been reported. The combination of S-1 and gemcitabine has shown promising clinical activity in Phase I clinical studies in advanced pancreatic cancer patients (8,9).…”

Section: Introductionmentioning

confidence: 99%

S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

Kim¹,

Lee²,

Jang

et al. 2008

Japanese Journal of Clinical Oncology

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Objective: The standard beneficial chemotherapy proved for patients with pancreatic cancer is a regimen containing gemcitabine. Novel oral fluoropyrimidine, S-1, can be added to gemcitabine to improve the efficacy of chemotherapy and to provide better convenience for patients. We aimed to evaluate the efficacy and safety of S-1 plus gemcitabine combination chemotherapy as a first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Methods: Patients with histologically confirmed, bidimensionally measurable advanced/ metastatic pancreatic cancer were eligible for the study. Chemotherapy consisted of S-1 (30 mg/m 2 p.o. bid from Day 1 to 14) and gemcitabine (1000 mg/m 2 on Days 8 and 15) every 3 weeks based on the results of a previously reported Phase I trial. Treatment was repeated until disease progression or unacceptable toxicity occurred. Results: From January 2005 to August 2007, 22 patients were enrolled. Median age was 62 years (range, 50 -73). Nineteen patients (86.3%) had metastases and of these, 11 patients (57.9%) had multiple liver metastases. The overall response rate was 27.3% (95% CI, 8.7 -45.9), with a partial response in six patients, stable disease in nine (40.9%) and progressive disease in seven (31.8%). With a median follow-up of 25.4 months, the median time to progression and overall survival were 4.6 (95% CI, 2 -7.2 months) and 8.5 months (95% CI, 6.8 -10.1 months), respectively, and 1-year survival rate was 27.3%. S-1 plus gemcitabine was well tolerated. Grade 3/4 hematological adverse events were neutropenia (9.1/9.1%) and anemia (4.5/0%). Non-hematological adverse events were mainly gastrointestinal events. Twenty patients (91%) received chemotherapy on an outpatient basis. Conclusions: Combination chemotherapy of S-1 plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.

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“…Combination chemotherapy with S-1 and gemcitabine has also been reported to be well-tolerated and active against advanced pancreatic cancer [6,7,8]. …”

Section: Introductionmentioning

confidence: 99%

A Pilot Study for Combination Chemotherapy Using Gemcitabine and S-1 for Advanced Pancreatic Cancer

Nakai¹,

Isayama²,

Sasaki³

et al. 2009

Oncology

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Objectives: We performed a pilot study of a modified combination chemotherapy regimen with S-1 plus gemcitabine for patients with advanced pancreatic cancer. Methods: Gemcitabine was administered at a dose of 1,000 mg/m² in a 30-min intravenous injection on days 1 and 15. S-1 was administered orally at a dose of 40 mg/m² twice daily for 14 consecutive days followed by a 14-day rest. Each cycle was repeated every 28 days. Results: Sixteen patients were enrolled. No complete response was observed and partial response was observed in 5 patients (31.3%), stable disease in 10 patients (62.5%) and progressive disease in 1 patient (6.3%). The median time to progression was 10.0 months (95% CI 4.4–N.A.) and the median survival time was 20.4 months (95% CI 8.6–24.1 months). The major toxicities were grade 3 neutropenia (25.0%) and grade 3 anemia (6.3%). There were no grade 4 toxicities. Conclusions: Combination therapy with gemcitabine and S-1 using the modified 4-week schedule was well tolerated and efficacious for advanced pancreatic cancer.

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Phase I trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

Cited by 61 publications

References 25 publications

Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

S-1 and Gemcitabine as an Outpatient-based Regimen in Patients with Advanced or Metastatic Pancreatic Cancer

A Pilot Study for Combination Chemotherapy Using Gemcitabine and S-1 for Advanced Pancreatic Cancer

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