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Nishikawa K.,Osaka National Hospital | Fujitani K.,Osaka General Medical Center | Inagaki H.,Gifu Central Hospital | Akamaru Y.,Osaka Kose Nenkin Hospital | And 13 more authors.
European Journal of Cancer | Year: 2015

Aim The optimal second-line regimen for treating advanced gastric cancer (AGC) remains unclear. While irinotecan (CPT-11) plus cisplatin (CDDP) combination therapy and CPT-11 monotherapy have been explored in the second-line setting, the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated; therefore, we aimed to examine the survival benefit of CPT-11/CDDP combination over CPT-11 monotherapy. Methods AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11/CDDP (CPT-11, 60 mg/m2; CDDP, 30 mg/m2, q2w) or CPT-11 (150 mg/m2, q2w). Results Sixty-eight advanced and 95 recurrent cases were evaluated. The median overall survivals were 13.9 (95% confidence interval [CI]: 10.8-17.6) and 12.7 (95% CI: 10.3-17.2) months for CPT-11/CDDP and CPT-11, respectively (hazard ratio: 0.834; 95% CI: 0.596-1.167, P = 0.288). No significant differences were observed in the secondary end-points, including progression-free survival (4.6 [95% CI: 3.4-5.9] versus 4.1 [95% CI: 3.3-4.9] months) and response rate (16.9% [95% CI: 8.8-28.3] versus 15.4% [95% CI: 7.6-26.5]). The incidences of grade 3-4 anaemia (16% versus 4%) and elevated serum lactate dehydrogenase levels (5% versus 0%) were higher for CPT-11/CDDP than for CPT-11. Exploratory subgroup analysis revealed that CPT-11/CDDP was significantly more effective for intestinal-type AGC, compared with CPT-11 (overall survival: 15.8 versus 14.0 months; P = 0.019). Conclusion No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure. © 2015 The Authors. Published by Elsevier Ltd.


PubMed | Osaka National Hospital, Saitama Medical Center, Kanagawa Cancer Center, Osaka General Medical Center and 13 more.
Type: Clinical Trial, Phase III | Journal: European journal of cancer (Oxford, England : 1990) | Year: 2015

The optimal second-line regimen for treating advanced gastric cancer (AGC) remains unclear. While irinotecan (CPT-11) plus cisplatin (CDDP) combination therapy and CPT-11 monotherapy have been explored in the second-line setting, the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated; therefore, we aimed to examine the survival benefit of CPT-11/CDDP combination over CPT-11 monotherapy.AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11/CDDP (CPT-11, 60 mg/m(2); CDDP, 30 mg/m(2), q2w) or CPT-11 (150 mg/m(2), q2w).Sixty-eight advanced and 95 recurrent cases were evaluated. The median overall survivals were 13.9 (95% confidence interval [CI]: 10.8-17.6) and 12.7 (95% CI: 10.3-17.2) months for CPT-11/CDDP and CPT-11, respectively (hazard ratio: 0.834; 95% CI: 0.596-1.167, P = 0.288). No significant differences were observed in the secondary end-points, including progression-free survival (4.6 [95% CI: 3.4-5.9] versus 4.1 [95% CI: 3.3-4.9]months) and response rate (16.9% [95% CI: 8.8-28.3] versus 15.4% [95% CI: 7.6-26.5]). The incidences of grade 3-4 anaemia (16% versus 4%) and elevated serum lactate dehydrogenase levels (5% versus 0%) were higher for CPT-11/CDDP than for CPT-11. Exploratory subgroup analysis revealed that CPT-11/CDDP was significantly more effective for intestinal-type AGC, compared with CPT-11 (overall survival: 15.8 versus 14.0 months; P = 0.019).No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure.


Shigematsu T.,Saiseikai Shiga Prefectural Hospital | Murai K.,Saiseikai Shiga Prefectural Hospital | Furuta M.,Saiseikai Shiga Prefectural Hospital | Matsumoto H.,Saiseikai Shiga Prefectural Hospital | And 4 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2015

A 77-year-old man presented with epigastralgia. Gastrointestinal endoscopic examination showed advanced gastric cancer, type 3, in the distal antrum. The patient refused surgery and preferred chemotherapy. The regimen consisted of 80 mg/body/day of S-1, continuously administered from day 1-14, followed by discontinuation for 2 weeks. After 2 courses, the patient experienced fatigue and recurrent vomiting. Laboratory studies revealed severe anemia; the hemoglobin level was 5.5 g/dL. An upper gastrointestinal endoscopy revealed pyloric stenosis and significant tumor reduction. Therefore, distal gastrectomy was performed. Histological examination did not reveal any viable cancer cells in the stomach and lymph nodes. Thus, a Grade 3 postchemotherapeutic effect was revealed.

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