Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104)

yushu Study Group of Clinical Cancer

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose: Capecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC. Methods: Patients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and an expected value of 50%, with a one-sided α of 0.05 and a beta of approximately 0.2. Results: Forty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9% (95% confidence interval 28.7–59.1%). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5%), anemia (24.4%), anorexia (24.4%), and nausea (12.2%). Conclusions: First-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.

Original languageEnglish
Pages (from-to)147-153
Number of pages7
JournalCancer chemotherapy and pharmacology
Volume79
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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Cisplatin
Stomach Neoplasms
Chemotherapy
Tumors
Therapeutics
Capecitabine
Anorexia
Neutropenia
Sample Size
Nausea
Multicenter Studies
Disease-Free Survival
Anemia
Confidence Intervals
Safety
Drug Therapy
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104). / yushu Study Group of Clinical Cancer.

In: Cancer chemotherapy and pharmacology, Vol. 79, No. 1, 01.01.2017, p. 147-153.

Research output: Contribution to journalArticle

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title = "Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104)",
abstract = "Purpose: Capecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC. Methods: Patients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30{\%} and an expected value of 50{\%}, with a one-sided α of 0.05 and a beta of approximately 0.2. Results: Forty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9{\%} (95{\%} confidence interval 28.7–59.1{\%}). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5{\%}), anemia (24.4{\%}), anorexia (24.4{\%}), and nausea (12.2{\%}). Conclusions: First-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.",
author = "{yushu Study Group of Clinical Cancer} and Hironaga Satake and Masaaki Iwatsuki and Yoshikazu Uenosono and Takeshi Shiraishi and Hiroaki Tanioka and Hiroshi Saeki and Keishi Sugimachi and Hiroshi Saeki and Mototsugu Shimokawa and Eiji Oki and Yasunori Emi and Yoshihiro Kakeji and Akihito Tsuji and Yoshito Akagi and Shoji Natsugoe and Hideo Baba and Yoshihiko Maehara",
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T1 - Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104)

AU - yushu Study Group of Clinical Cancer

AU - Satake, Hironaga

AU - Iwatsuki, Masaaki

AU - Uenosono, Yoshikazu

AU - Shiraishi, Takeshi

AU - Tanioka, Hiroaki

AU - Saeki, Hiroshi

AU - Sugimachi, Keishi

AU - Saeki, Hiroshi

AU - Shimokawa, Mototsugu

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Kakeji, Yoshihiro

AU - Tsuji, Akihito

AU - Akagi, Yoshito

AU - Natsugoe, Shoji

AU - Baba, Hideo

AU - Maehara, Yoshihiko

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Purpose: Capecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC. Methods: Patients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and an expected value of 50%, with a one-sided α of 0.05 and a beta of approximately 0.2. Results: Forty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9% (95% confidence interval 28.7–59.1%). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5%), anemia (24.4%), anorexia (24.4%), and nausea (12.2%). Conclusions: First-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.

AB - Purpose: Capecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC. Methods: Patients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and an expected value of 50%, with a one-sided α of 0.05 and a beta of approximately 0.2. Results: Forty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9% (95% confidence interval 28.7–59.1%). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5%), anemia (24.4%), anorexia (24.4%), and nausea (12.2%). Conclusions: First-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.

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