Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial
Objective: Conversion therapy (surgical resection after chemotherapy) is a promising option for unresectable gastric cancer (GC) patients. Addition of anti-angiogenesis drug improves response to chemotherapy. Hence, this study explored the feasibility and efficacy of preoperative paclitaxel (PTX)/S1...
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Frontiers Media S.A.
2021-03-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2021.642511/full |
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| author | Zhiyuan Xu Can Hu Jianfa Yu Yian Du Ping Hu Guofa Yu Conggang Hu Yu Zhang Wei Mao Shanqi Chen Xiangdong Cheng |
| author_facet | Zhiyuan Xu Can Hu Jianfa Yu Yian Du Ping Hu Guofa Yu Conggang Hu Yu Zhang Wei Mao Shanqi Chen Xiangdong Cheng |
| author_sort | Zhiyuan Xu |
| collection | DOAJ |
| description | Objective: Conversion therapy (surgical resection after chemotherapy) is a promising option for unresectable gastric cancer (GC) patients. Addition of anti-angiogenesis drug improves response to chemotherapy. Hence, this study explored the feasibility and efficacy of preoperative paclitaxel (PTX)/S1 chemotherapy combined with apatinib for unresectable GC.Methods: Thirty-one eligible patients with a single unresectable factor were enrolled in this multi-center, single-arm trial. Apatinib (500 mg qd) was administered continuously, while PTX (130 mg/m2) on day 1 and S1 (80 mg/m2) on day 1–14 were given every 3 weeks. The treatment was given for three cycles preoperatively, but the last cycle did not include apatinib. The primary objective measurements included R0 resection rate, objective response rate (ORR) and morbidity of preoperative treatment.Results: Among the 31 patients, 30 patients were evaluable for tumor response, the ORR to preoperative treatment was 73.3%. Eighteen of 30 patients underwent surgery, and R0 resection was achieved in 17 patients. The patients who underwent the conversion surgery had a superior OS compared with those who did not (3 years OS: 52.9 vs 8.3%, p = 0.001). The surgery was operated after apatinib had stopped for a median duration of 4 weeks. Neither anastomotic leakage nor wound healing complications was observed. No increased bleeding event was observed compared with historical data. During preoperative treatment, grade 3 or 4 toxicities were experienced by 58.1% of the patients.Conclusion: Chemotherapy in combination with apatinib demonstrated higher rates of conversion and R0 resection and a superior survival benefit in initial unresectable GC. It is safe and reasonable to suspend apatinib for 4 weeks before the gastrectomy. |
| first_indexed | 2024-12-19T23:33:59Z |
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| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-19T23:33:59Z |
| publishDate | 2021-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-164b55f948a44e0c9d7f0bb9fff4e64c2022-12-21T20:01:39ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122021-03-011210.3389/fphar.2021.642511642511Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II TrialZhiyuan Xu0Can Hu1Jianfa Yu2Yian Du3Ping Hu4Guofa Yu5Conggang Hu6Yu Zhang7Wei Mao8Shanqi Chen9Xiangdong Cheng10Department of Gastric Surgery, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, ChinaThe 2nd Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Gastric Surgery, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, ChinaDepartment of Gastrointestinal Surgery, the Central Hospital of Lishui City, Lishui, ChinaDepartment of General Surgery, Shengzhou People’s Hospital, Shengzhou, ChinaDepartment of Abdominal Surgery, GuangFu Hospital, Jinhua, ChinaDepartment of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Gastric Surgery, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, ChinaObjective: Conversion therapy (surgical resection after chemotherapy) is a promising option for unresectable gastric cancer (GC) patients. Addition of anti-angiogenesis drug improves response to chemotherapy. Hence, this study explored the feasibility and efficacy of preoperative paclitaxel (PTX)/S1 chemotherapy combined with apatinib for unresectable GC.Methods: Thirty-one eligible patients with a single unresectable factor were enrolled in this multi-center, single-arm trial. Apatinib (500 mg qd) was administered continuously, while PTX (130 mg/m2) on day 1 and S1 (80 mg/m2) on day 1–14 were given every 3 weeks. The treatment was given for three cycles preoperatively, but the last cycle did not include apatinib. The primary objective measurements included R0 resection rate, objective response rate (ORR) and morbidity of preoperative treatment.Results: Among the 31 patients, 30 patients were evaluable for tumor response, the ORR to preoperative treatment was 73.3%. Eighteen of 30 patients underwent surgery, and R0 resection was achieved in 17 patients. The patients who underwent the conversion surgery had a superior OS compared with those who did not (3 years OS: 52.9 vs 8.3%, p = 0.001). The surgery was operated after apatinib had stopped for a median duration of 4 weeks. Neither anastomotic leakage nor wound healing complications was observed. No increased bleeding event was observed compared with historical data. During preoperative treatment, grade 3 or 4 toxicities were experienced by 58.1% of the patients.Conclusion: Chemotherapy in combination with apatinib demonstrated higher rates of conversion and R0 resection and a superior survival benefit in initial unresectable GC. It is safe and reasonable to suspend apatinib for 4 weeks before the gastrectomy.https://www.frontiersin.org/articles/10.3389/fphar.2021.642511/fullgastric cancerconversion surgeryapatinibsafetyunresectable abdominal neoplasms |
| spellingShingle | Zhiyuan Xu Can Hu Jianfa Yu Yian Du Ping Hu Guofa Yu Conggang Hu Yu Zhang Wei Mao Shanqi Chen Xiangdong Cheng Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial Frontiers in Pharmacology gastric cancer conversion surgery apatinib safety unresectable abdominal neoplasms |
| title | Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial |
| title_full | Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial |
| title_fullStr | Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial |
| title_full_unstemmed | Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial |
| title_short | Efficacy of Conversion Surgery Following Apatinib Plus Paclitaxel/S1 for Advanced Gastric Cancer With Unresectable Factors: A Multicenter, Single-Arm, Phase II Trial |
| title_sort | efficacy of conversion surgery following apatinib plus paclitaxel s1 for advanced gastric cancer with unresectable factors a multicenter single arm phase ii trial |
| topic | gastric cancer conversion surgery apatinib safety unresectable abdominal neoplasms |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2021.642511/full |
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