A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial
Backgrounds In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemother...
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| Veröffentlicht in: | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association 2018-09, Vol.21 (5), p.811-818 |
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| container_title | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association |
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| creator | Nishikawa, Kazuhiro Tsuburaya, Akira Yoshikawa, Takaki Takahashi, Masazumi Tanabe, Kazuaki Yamaguchi, Kensei Yoshino, Shigefumi Namikawa, Tsutomu Aoyama, Toru Rino, Yasushi Kawada, Junji Tsuji, Akihito Taira, Koichi Kimura, Yutaka Kodera, Yasuhiro Hirashima, Yoshinori Yabusaki, Hiroshi Hirabayashi, Naoki Fujitani, Kazumasa Miyashita, Yumi Morita, Satoshi Sakamoto, Junichi |
| description | Backgrounds
In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294).
Methods
HER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m
2
bid for 14 days plus cisplatin 80 mg/m
2
on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety.
Results
Forty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold (
p
|
| doi_str_mv | 10.1007/s10120-018-0815-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2009213281</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2009213281</sourcerecordid><originalsourceid>FETCH-LOGICAL-c439t-d373026411ec285e89fe74bd9dca391c370878d4b5f144df31cf2279829533f23</originalsourceid><addsrcrecordid>eNp1kVFrFDEUhYMotq7-AF8k4Et9iN6bzOwkvpVidaFgoRX6FrKZpDvL7ExMMpX9L_2xZpmtguBTcjnfOffCIeQtwkcEaD4lBOTAACUDiTWDZ-QUK7FkQkD9_OnPFZ6QVyltAbBWuHxJTriqpETOT8njOQ0bkxxdrWiOnenp6Kk1wdkum3U3OBr6KVHbpdCb3A307O76A_VjpKGMbsiJ_uryhpr2wQzWtfTepJJjS0YZ4yw6E_s9ja43oWwyPhfhhmExbadiyzRvXDRh_5neXZt4e8OOt7wmL7zpk3tzfBfkx-WX24tv7Or719XF-RWzlVCZtaIRwJcVorNc1k4q75pq3arWGqHQigZkI9tqXXusqtYLtJ7zRkmuaiE8FwtyNueGOP6cXMp61yXr-t4MbpyS5gCKo-ASC_r-H3Q7TnEo1x0o2UDDyzULgjNl45hSdF6H2O1M3GsEfahOz9XpUp0-VKeheN4dk6f1zrV_HE9dFYDPQCrScO_i39X_T_0NWRyizw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2008707237</pqid></control><display><type>article</type><title>A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><creator>Nishikawa, Kazuhiro ; Tsuburaya, Akira ; Yoshikawa, Takaki ; Takahashi, Masazumi ; Tanabe, Kazuaki ; Yamaguchi, Kensei ; Yoshino, Shigefumi ; Namikawa, Tsutomu ; Aoyama, Toru ; Rino, Yasushi ; Kawada, Junji ; Tsuji, Akihito ; Taira, Koichi ; Kimura, Yutaka ; Kodera, Yasuhiro ; Hirashima, Yoshinori ; Yabusaki, Hiroshi ; Hirabayashi, Naoki ; Fujitani, Kazumasa ; Miyashita, Yumi ; Morita, Satoshi ; Sakamoto, Junichi</creator><creatorcontrib>Nishikawa, Kazuhiro ; Tsuburaya, Akira ; Yoshikawa, Takaki ; Takahashi, Masazumi ; Tanabe, Kazuaki ; Yamaguchi, Kensei ; Yoshino, Shigefumi ; Namikawa, Tsutomu ; Aoyama, Toru ; Rino, Yasushi ; Kawada, Junji ; Tsuji, Akihito ; Taira, Koichi ; Kimura, Yutaka ; Kodera, Yasuhiro ; Hirashima, Yoshinori ; Yabusaki, Hiroshi ; Hirabayashi, Naoki ; Fujitani, Kazumasa ; Miyashita, Yumi ; Morita, Satoshi ; Sakamoto, Junichi</creatorcontrib><description>Backgrounds
In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294).
Methods
HER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m
2
bid for 14 days plus cisplatin 80 mg/m
2
on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety.
Results
Forty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold (
p
< 0.001). Median OS was 13.7 months (95% CI 9.0–17.7) and ORR was 8/30 (26.7%) (95% CI 14.2–44.4). Most common grade ≥ 3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%).
Conclusions
XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers. XP may be a good option for the treatment of patients after early failure after adjuvant S-1.
Trial registration
NCT01412294.</description><identifier>ISSN: 1436-3291</identifier><identifier>EISSN: 1436-3305</identifier><identifier>DOI: 10.1007/s10120-018-0815-0</identifier><identifier>PMID: 29488122</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Abdominal Surgery ; Adjuvant therapy ; Adult ; Aged ; Anorexia ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer Research ; Cancer therapies ; Capecitabine - administration & dosage ; Chemotherapy ; Chemotherapy, Adjuvant - methods ; Cisplatin ; Cisplatin - administration & dosage ; Creatinine ; Diarrhea ; Drug Combinations ; ErbB-2 protein ; Fatigue ; Female ; Gastric cancer ; Gastroenterology ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neoplasm Recurrence, Local - drug therapy ; Neutropenia ; Oncology ; Original Article ; Oxonic Acid ; Platinum ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - mortality ; Stomach Neoplasms - pathology ; Surgical Oncology ; Survival Analysis ; Tegafur ; Treatment Outcome</subject><ispartof>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2018-09, Vol.21 (5), p.811-818</ispartof><rights>The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2018</rights><rights>Gastric Cancer is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-d373026411ec285e89fe74bd9dca391c370878d4b5f144df31cf2279829533f23</citedby><cites>FETCH-LOGICAL-c439t-d373026411ec285e89fe74bd9dca391c370878d4b5f144df31cf2279829533f23</cites><orcidid>0000-0003-1213-2732</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10120-018-0815-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10120-018-0815-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29488122$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nishikawa, Kazuhiro</creatorcontrib><creatorcontrib>Tsuburaya, Akira</creatorcontrib><creatorcontrib>Yoshikawa, Takaki</creatorcontrib><creatorcontrib>Takahashi, Masazumi</creatorcontrib><creatorcontrib>Tanabe, Kazuaki</creatorcontrib><creatorcontrib>Yamaguchi, Kensei</creatorcontrib><creatorcontrib>Yoshino, Shigefumi</creatorcontrib><creatorcontrib>Namikawa, Tsutomu</creatorcontrib><creatorcontrib>Aoyama, Toru</creatorcontrib><creatorcontrib>Rino, Yasushi</creatorcontrib><creatorcontrib>Kawada, Junji</creatorcontrib><creatorcontrib>Tsuji, Akihito</creatorcontrib><creatorcontrib>Taira, Koichi</creatorcontrib><creatorcontrib>Kimura, Yutaka</creatorcontrib><creatorcontrib>Kodera, Yasuhiro</creatorcontrib><creatorcontrib>Hirashima, Yoshinori</creatorcontrib><creatorcontrib>Yabusaki, Hiroshi</creatorcontrib><creatorcontrib>Hirabayashi, Naoki</creatorcontrib><creatorcontrib>Fujitani, Kazumasa</creatorcontrib><creatorcontrib>Miyashita, Yumi</creatorcontrib><creatorcontrib>Morita, Satoshi</creatorcontrib><creatorcontrib>Sakamoto, Junichi</creatorcontrib><title>A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial</title><title>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association</title><addtitle>Gastric Cancer</addtitle><addtitle>Gastric Cancer</addtitle><description>Backgrounds
In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294).
Methods
HER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m
2
bid for 14 days plus cisplatin 80 mg/m
2
on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety.
Results
Forty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold (
p
< 0.001). Median OS was 13.7 months (95% CI 9.0–17.7) and ORR was 8/30 (26.7%) (95% CI 14.2–44.4). Most common grade ≥ 3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%).
Conclusions
XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers. XP may be a good option for the treatment of patients after early failure after adjuvant S-1.
Trial registration
NCT01412294.</description><subject>Abdominal Surgery</subject><subject>Adjuvant therapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Anorexia</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer Research</subject><subject>Cancer therapies</subject><subject>Capecitabine - administration & dosage</subject><subject>Chemotherapy</subject><subject>Chemotherapy, Adjuvant - methods</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Creatinine</subject><subject>Diarrhea</subject><subject>Drug Combinations</subject><subject>ErbB-2 protein</subject><subject>Fatigue</subject><subject>Female</subject><subject>Gastric cancer</subject><subject>Gastroenterology</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Oxonic Acid</subject><subject>Platinum</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - mortality</subject><subject>Stomach Neoplasms - pathology</subject><subject>Surgical Oncology</subject><subject>Survival Analysis</subject><subject>Tegafur</subject><subject>Treatment Outcome</subject><issn>1436-3291</issn><issn>1436-3305</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kVFrFDEUhYMotq7-AF8k4Et9iN6bzOwkvpVidaFgoRX6FrKZpDvL7ExMMpX9L_2xZpmtguBTcjnfOffCIeQtwkcEaD4lBOTAACUDiTWDZ-QUK7FkQkD9_OnPFZ6QVyltAbBWuHxJTriqpETOT8njOQ0bkxxdrWiOnenp6Kk1wdkum3U3OBr6KVHbpdCb3A307O76A_VjpKGMbsiJ_uryhpr2wQzWtfTepJJjS0YZ4yw6E_s9ja43oWwyPhfhhmExbadiyzRvXDRh_5neXZt4e8OOt7wmL7zpk3tzfBfkx-WX24tv7Or719XF-RWzlVCZtaIRwJcVorNc1k4q75pq3arWGqHQigZkI9tqXXusqtYLtJ7zRkmuaiE8FwtyNueGOP6cXMp61yXr-t4MbpyS5gCKo-ASC_r-H3Q7TnEo1x0o2UDDyzULgjNl45hSdF6H2O1M3GsEfahOz9XpUp0-VKeheN4dk6f1zrV_HE9dFYDPQCrScO_i39X_T_0NWRyizw</recordid><startdate>20180901</startdate><enddate>20180901</enddate><creator>Nishikawa, Kazuhiro</creator><creator>Tsuburaya, Akira</creator><creator>Yoshikawa, Takaki</creator><creator>Takahashi, Masazumi</creator><creator>Tanabe, Kazuaki</creator><creator>Yamaguchi, Kensei</creator><creator>Yoshino, Shigefumi</creator><creator>Namikawa, Tsutomu</creator><creator>Aoyama, Toru</creator><creator>Rino, Yasushi</creator><creator>Kawada, Junji</creator><creator>Tsuji, Akihito</creator><creator>Taira, Koichi</creator><creator>Kimura, Yutaka</creator><creator>Kodera, Yasuhiro</creator><creator>Hirashima, Yoshinori</creator><creator>Yabusaki, Hiroshi</creator><creator>Hirabayashi, Naoki</creator><creator>Fujitani, Kazumasa</creator><creator>Miyashita, Yumi</creator><creator>Morita, Satoshi</creator><creator>Sakamoto, Junichi</creator><general>Springer Japan</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1213-2732</orcidid></search><sort><creationdate>20180901</creationdate><title>A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial</title><author>Nishikawa, Kazuhiro ; Tsuburaya, Akira ; Yoshikawa, Takaki ; Takahashi, Masazumi ; Tanabe, Kazuaki ; Yamaguchi, Kensei ; Yoshino, Shigefumi ; Namikawa, Tsutomu ; Aoyama, Toru ; Rino, Yasushi ; Kawada, Junji ; Tsuji, Akihito ; Taira, Koichi ; Kimura, Yutaka ; Kodera, Yasuhiro ; Hirashima, Yoshinori ; Yabusaki, Hiroshi ; Hirabayashi, Naoki ; Fujitani, Kazumasa ; Miyashita, Yumi ; Morita, Satoshi ; Sakamoto, Junichi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-d373026411ec285e89fe74bd9dca391c370878d4b5f144df31cf2279829533f23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Abdominal Surgery</topic><topic>Adjuvant therapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Anorexia</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer Research</topic><topic>Cancer therapies</topic><topic>Capecitabine - administration & dosage</topic><topic>Chemotherapy</topic><topic>Chemotherapy, Adjuvant - methods</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Creatinine</topic><topic>Diarrhea</topic><topic>Drug Combinations</topic><topic>ErbB-2 protein</topic><topic>Fatigue</topic><topic>Female</topic><topic>Gastric cancer</topic><topic>Gastroenterology</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Oxonic Acid</topic><topic>Platinum</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - mortality</topic><topic>Stomach Neoplasms - pathology</topic><topic>Surgical Oncology</topic><topic>Survival Analysis</topic><topic>Tegafur</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nishikawa, Kazuhiro</creatorcontrib><creatorcontrib>Tsuburaya, Akira</creatorcontrib><creatorcontrib>Yoshikawa, Takaki</creatorcontrib><creatorcontrib>Takahashi, Masazumi</creatorcontrib><creatorcontrib>Tanabe, Kazuaki</creatorcontrib><creatorcontrib>Yamaguchi, Kensei</creatorcontrib><creatorcontrib>Yoshino, Shigefumi</creatorcontrib><creatorcontrib>Namikawa, Tsutomu</creatorcontrib><creatorcontrib>Aoyama, Toru</creatorcontrib><creatorcontrib>Rino, Yasushi</creatorcontrib><creatorcontrib>Kawada, Junji</creatorcontrib><creatorcontrib>Tsuji, Akihito</creatorcontrib><creatorcontrib>Taira, Koichi</creatorcontrib><creatorcontrib>Kimura, Yutaka</creatorcontrib><creatorcontrib>Kodera, Yasuhiro</creatorcontrib><creatorcontrib>Hirashima, Yoshinori</creatorcontrib><creatorcontrib>Yabusaki, Hiroshi</creatorcontrib><creatorcontrib>Hirabayashi, Naoki</creatorcontrib><creatorcontrib>Fujitani, Kazumasa</creatorcontrib><creatorcontrib>Miyashita, Yumi</creatorcontrib><creatorcontrib>Morita, Satoshi</creatorcontrib><creatorcontrib>Sakamoto, Junichi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nishikawa, Kazuhiro</au><au>Tsuburaya, Akira</au><au>Yoshikawa, Takaki</au><au>Takahashi, Masazumi</au><au>Tanabe, Kazuaki</au><au>Yamaguchi, Kensei</au><au>Yoshino, Shigefumi</au><au>Namikawa, Tsutomu</au><au>Aoyama, Toru</au><au>Rino, Yasushi</au><au>Kawada, Junji</au><au>Tsuji, Akihito</au><au>Taira, Koichi</au><au>Kimura, Yutaka</au><au>Kodera, Yasuhiro</au><au>Hirashima, Yoshinori</au><au>Yabusaki, Hiroshi</au><au>Hirabayashi, Naoki</au><au>Fujitani, Kazumasa</au><au>Miyashita, Yumi</au><au>Morita, Satoshi</au><au>Sakamoto, Junichi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial</atitle><jtitle>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association</jtitle><stitle>Gastric Cancer</stitle><addtitle>Gastric Cancer</addtitle><date>2018-09-01</date><risdate>2018</risdate><volume>21</volume><issue>5</issue><spage>811</spage><epage>818</epage><pages>811-818</pages><issn>1436-3291</issn><eissn>1436-3305</eissn><abstract>Backgrounds
In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294).
Methods
HER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m
2
bid for 14 days plus cisplatin 80 mg/m
2
on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety.
Results
Forty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold (
p
< 0.001). Median OS was 13.7 months (95% CI 9.0–17.7) and ORR was 8/30 (26.7%) (95% CI 14.2–44.4). Most common grade ≥ 3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%).
Conclusions
XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers. XP may be a good option for the treatment of patients after early failure after adjuvant S-1.
Trial registration
NCT01412294.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>29488122</pmid><doi>10.1007/s10120-018-0815-0</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-1213-2732</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1436-3291 |
| ispartof | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2018-09, Vol.21 (5), p.811-818 |
| issn | 1436-3291 1436-3305 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2009213281 |
| source | MEDLINE; Springer Nature - Complete Springer Journals; EZB-FREE-00999 freely available EZB journals |
| subjects | Abdominal Surgery Adjuvant therapy Adult Aged Anorexia Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer Research Cancer therapies Capecitabine - administration & dosage Chemotherapy Chemotherapy, Adjuvant - methods Cisplatin Cisplatin - administration & dosage Creatinine Diarrhea Drug Combinations ErbB-2 protein Fatigue Female Gastric cancer Gastroenterology Humans Male Medicine Medicine & Public Health Middle Aged Neoplasm Recurrence, Local - drug therapy Neutropenia Oncology Original Article Oxonic Acid Platinum Stomach Neoplasms - drug therapy Stomach Neoplasms - mortality Stomach Neoplasms - pathology Surgical Oncology Survival Analysis Tegafur Treatment Outcome |
| title | A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-23T22%3A43%3A15IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20phase%20II%20trial%20of%20capecitabine%20plus%20cisplatin%20(XP)%20for%20patients%20with%20advanced%20gastric%20cancer%20with%20early%20relapse%20after%20S-1%20adjuvant%20therapy:%20XParTS-I%20trial&rft.jtitle=Gastric%20cancer%20:%20official%20journal%20of%20the%20International%20Gastric%20Cancer%20Association%20and%20the%20Japanese%20Gastric%20Cancer%20Association&rft.au=Nishikawa,%20Kazuhiro&rft.date=2018-09-01&rft.volume=21&rft.issue=5&rft.spage=811&rft.epage=818&rft.pages=811-818&rft.issn=1436-3291&rft.eissn=1436-3305&rft_id=info:doi/10.1007/s10120-018-0815-0&rft_dat=%3Cproquest_cross%3E2009213281%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2008707237&rft_id=info:pmid/29488122&rfr_iscdi=true |