Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence: interim analysis from a multicenter prospective clinical trial

Wen hua Zhan, Peng zhi Wang, Yong fu Shao, Xiao ting Wu, Jin Gu, Rong Li, De sen Wan, Ke feng Ding, Yingqiang Shi, Ji ren Yu, Hui shan Lu, Xiao ming Zou, Jian wei Bi, Yi hong Sun, Yun fei Lu, Dao da Chen, Xin hua Zhang

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence. METHODS: A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated. RESULTS: From Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9%, the small intestine in 38.6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4% . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits. CONCLUSION: Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.

Original languageEnglish (US)
Pages (from-to)383-387
Number of pages5
JournalZhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery
Volume9
Issue number5
StatePublished - Jan 1 2006

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Gastrointestinal Stromal Tumors
Clinical Trials
Safety
Recurrence
Therapeutics
Adjuvant Chemotherapy
Disease-Free Survival
Quality of Life
Imatinib Mesylate
Neoplasms
Intention to Treat Analysis
Mitosis
Teaching Hospitals
Small Intestine
China
Stomach
Survival Rate
Neoplasm Metastasis
Incidence

ASJC Scopus subject areas

  • Medicine(all)

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Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence : interim analysis from a multicenter prospective clinical trial. / Zhan, Wen hua; Wang, Peng zhi; Shao, Yong fu; Wu, Xiao ting; Gu, Jin; Li, Rong; Wan, De sen; Ding, Ke feng; Shi, Yingqiang; Yu, Ji ren; Lu, Hui shan; Zou, Xiao ming; Bi, Jian wei; Sun, Yi hong; Lu, Yun fei; Chen, Dao da; Zhang, Xin hua.

In: Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery, Vol. 9, No. 5, 01.01.2006, p. 383-387.

Research output: Contribution to journalArticle

Zhan, Wen hua ; Wang, Peng zhi ; Shao, Yong fu ; Wu, Xiao ting ; Gu, Jin ; Li, Rong ; Wan, De sen ; Ding, Ke feng ; Shi, Yingqiang ; Yu, Ji ren ; Lu, Hui shan ; Zou, Xiao ming ; Bi, Jian wei ; Sun, Yi hong ; Lu, Yun fei ; Chen, Dao da ; Zhang, Xin hua. / Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence : interim analysis from a multicenter prospective clinical trial. In: Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery. 2006 ; Vol. 9, No. 5. pp. 383-387.
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abstract = "OBJECTIVE: To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence. METHODS: A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated. RESULTS: From Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9{\%}, the small intestine in 38.6{\%} and the colorectum in 10.5{\%} of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4{\%} . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits. CONCLUSION: Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.",
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T1 - Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence

T2 - interim analysis from a multicenter prospective clinical trial

AU - Zhan, Wen hua

AU - Wang, Peng zhi

AU - Shao, Yong fu

AU - Wu, Xiao ting

AU - Gu, Jin

AU - Li, Rong

AU - Wan, De sen

AU - Ding, Ke feng

AU - Shi, Yingqiang

AU - Yu, Ji ren

AU - Lu, Hui shan

AU - Zou, Xiao ming

AU - Bi, Jian wei

AU - Sun, Yi hong

AU - Lu, Yun fei

AU - Chen, Dao da

AU - Zhang, Xin hua

PY - 2006/1/1

Y1 - 2006/1/1

N2 - OBJECTIVE: To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence. METHODS: A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated. RESULTS: From Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9%, the small intestine in 38.6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4% . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits. CONCLUSION: Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.

AB - OBJECTIVE: To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence. METHODS: A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated. RESULTS: From Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9%, the small intestine in 38.6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4% . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits. CONCLUSION: Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.

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