Phase II study of S-1 monotherapy in paclitaxel- and cisplatin-refractory gastric cancer

Lee, Sung-Ji; Cho, Sang‐Hee; Yoon, Juyoung; Hwang, Jun‐Eul; Bae, Woo-Kyun; Shim, Hyungbo; Chung, Ik‐Joo

doi:10.1007/s00280-009-1019-4

Cited by 6 publications

(3 citation statements)

References 37 publications

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“…Despite paclitaxel, docetaxel, irinotecan, and S-1 being used as single agents [13][14][15][16], most studies tried combination regimens. Taxanes were commonly used in one of the second-line combination regimens, followed by irinotecan, a platinum agent, and 5-FU agents, including S-1 and capecitabine.…”

Section: Resultsmentioning

confidence: 99%

“…Shin et al assessed the activity and safety profile of a combination of capecitabine and doxorubicin, which was used as second-line therapy to treat 26 patients and showed an RR of 6.7% and a median OS of 29.1 weeks [34]. Single-agent S-1 in the second-line setting produced an overall RR of 9.4% with a median OS of 10.4 months [16]. An S-1 plus mitomycin combination as second-line therapy showed a 21% overall RR with a median OS of 8.0 months [35].…”

Section: Platinum Agentsmentioning

confidence: 99%

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Second-line chemotherapy for advanced gastric cancer in Korea

et al. 2012

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Stomach cancer is still one of the most prevalent malignancies and is the main cause of cancer deaths worldwide. The outcome for patients with metastasis, as well as for those with tumor recurrence, is dismal, with median survival time not greater than a year. Patients with unresectable locally advanced or metastatic lesions have been treated with systemic chemotherapy, and several randomized studies have demonstrated the benefit of chemotherapy compared with best supportive care. Recently, randomized phase III trials have presented a benefit of second-line chemotherapy compared with supportive care alone. However, it is not known at present which drug is the most effective in this setting. In Korea, the practice of offering second-line treatment to patients with advanced gastric cancer (AGC) is common, and many prospective clinical trials investigating clinical outcomes of second-line chemotherapy have been reported. Therefore, to define the potential role of second-line chemotherapy and to help to select an effective regimen, we review the published Korean prospective data concerning the use of chemotherapy in the second-line setting for the treatment of AGC. No phase III trials but 20 phase II trials were identified. The benefit of second-line chemotherapy in AGC has indirect evidence considering prolongation of progression-free survival (PFS) and improvement of the response rate. Taxanes, irinotecan, and oxaliplatin have been studied much and might be promising drugs considering crossresistance to a 5-fluorouracil and cisplatin combination (FP). A large, prospective, multicenter, randomized phase III study is warranted to select the most effective second-line chemotherapeutic agents.

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Section: Resultsmentioning

confidence: 99%

Section: Platinum Agentsmentioning

confidence: 99%

Second-line chemotherapy for advanced gastric cancer in Korea

et al. 2012

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“…In this study design, an irinotecan dosage of 150mg/m 2 was used-less than the 180mg/m 2 generally utilized in FOLFIRI [22], and S-1 40mg/m 2 twice daily for 2 weeks and 1 week rest was the usual dosage of S-1 single treatment in cases of gastric cancer or CRC [23,24]. However, in a recent phase I/II trial involving a combination of S-1 and irinotecan in first-line CRC chemotherapy, S-1 was administered orally at 80 mg/m 2 per day for 14 consecutive days, followed by 2 weeks of rest, and the recommend dosage of irinotecan was set at 80∼120 mg/m 2 biweekly or 150 mg/m 2 every three weeks [25][26][27].…”

Section: Discussionmentioning

confidence: 99%

Phase II study of irinotecan/S-1 combination chemotherapy for patients with oxaliplatin-refractory colorectal cancer

Choi

et al. 2010

Invest New Drugs

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To determine the efficacy and tolerance of irinotecan in combination with S-1 (IRIS) for patients whose disease progressed after treatment with an oxaliplatin-based therapy for colorectal cancer (CRC). Each patient's disease had progressed after the administration of a regimen containing oxaliplatin and 5-FU. S-1 was administered orally at a fixed dose of 40 mg/m(2) twice daily on days 1-14 and 21-35. Irinotecan (150 mg/m(2)) was administered via intravenous infusion on days 1, 15, and 29. Courses were repeated every 6 weeks. 20 patients were enrolled in this study between April 2006 and March 2008. The median age was 63 years (range: 34-74), and the dominant metastasis sites were the liver, lung, and lymph nodes. The objective response rate was 20%; 1 patient registered complete response and 3 patients registered partial responses; 7 patients were stabilized (35%); and 9 evidenced progression of disease (45%). Median progression-free survival was 3.0 months (95% CI, 2.1-3.9 months) and median overall survival was 9.8 months (95% CI, 6.3-13.3 months). For the 41 cycles analyzed, the most commonly detected hematologic toxicity was grade I-II anemia (63.4%). Leukopenia occurred in 18 cycles (41.5%), including eight cycles (19.5%) of grade 3-4 leukopenia. Frequently observed non-hematologic toxicities included the following: grade I vomiting was reported in 4 patients (20%), grade 2 neuropathy occurred in 3 patients (15%), and grade 2 mucositis was noted in 2 patients (10%). Two patients died from sepsis and hematemesis during treatment. Although the response rate in stage I reached the target (≥ 3/18, p0 = 10%) established for movement to stage II, this study had to be discontinued because two patients died during treatment. Additionally, the follow-up loss rate was higher (16.6%) than we had anticipated (<10%). Even though a regime consisting of irinotecan combined with S-1 (IRIS) has proven effective in oxaliplatin-pretreated patients with advanced CRC, treatment-related mortalities and the high follow-up loss rate suggested that this IRIS protocol should result in early closure and modification.

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Phase II study of biweekly docetaxel and S-1 combination chemotherapy as first-line treatment for advanced gastric cancer

Kunisaki

Takahashi

Makino

et al. 2010

Cancer Chemother Pharmacol

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Phase II study of S-1 monotherapy in paclitaxel- and cisplatin-refractory gastric cancer

Abstract: S-1 monotherapy provides active and safe salvage chemotherapy for patients with advanced gastric cancer who have been previously treated with paclitaxel and cisplatin.

Cited by 6 publications

References 37 publications

Second-line chemotherapy for advanced gastric cancer in Korea

Second-line chemotherapy for advanced gastric cancer in Korea

Phase II study of irinotecan/S-1 combination chemotherapy for patients with oxaliplatin-refractory colorectal cancer

Phase II study of biweekly docetaxel and S-1 combination chemotherapy as first-line treatment for advanced gastric cancer

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