Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin

Background We investigated early tumor shrinkage (ETS) and depth of response (DpR) using data from the G-SOX study comparing S-1 plus oxaliplatin with S-1 plus cisplatin as the first-line treatment for advanced gastric cancer (AGC). Methods ETS was determined as % decrease in the sum of the longest...

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Veröffentlicht in:Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association 2019-01, Vol.22 (1), p.138-146
Hauptverfasser: Nishina, Tomohiro, Azuma, Mizutomo, Nishikawa, Kazuhiro, Gotoh, Masahiro, Bando, Hideaki, Sugimoto, Naotoshi, Amagai, Kenji, Chin, Keisho, Niwa, Yasumasa, Tsuji, Akihito, Imamura, Hiroshi, Tsuda, Masahiro, Yasui, Hirofumi, Fujii, Hirofumi, Yamaguchi, Kensei, Yasui, Hisateru, Hironaka, Shuichi, Shimada, Ken, Miwa, Hiroto, Mitome, Terukazu, Kageyama, Hiroki, Hyodo, Ichinosuke
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container_title Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
container_volume 22
creator Nishina, Tomohiro
Azuma, Mizutomo
Nishikawa, Kazuhiro
Gotoh, Masahiro
Bando, Hideaki
Sugimoto, Naotoshi
Amagai, Kenji
Chin, Keisho
Niwa, Yasumasa
Tsuji, Akihito
Imamura, Hiroshi
Tsuda, Masahiro
Yasui, Hirofumi
Fujii, Hirofumi
Yamaguchi, Kensei
Yasui, Hisateru
Hironaka, Shuichi
Shimada, Ken
Miwa, Hiroto
Mitome, Terukazu
Kageyama, Hiroki
Hyodo, Ichinosuke
description Background We investigated early tumor shrinkage (ETS) and depth of response (DpR) using data from the G-SOX study comparing S-1 plus oxaliplatin with S-1 plus cisplatin as the first-line treatment for advanced gastric cancer (AGC). Methods ETS was determined as % decrease in the sum of the longest diameters of the target lesions at the first evaluation of week 6 compared to baseline. DpR was the maximum % shrinkage during the study treatment. The impact of ETS (cutoff value 20%) and DpR (continuous value) on progression-free survival (PFS) and overall survival (OS) were assessed by the log-rank test and Cox regression analysis including prognostic factors obtained in the G-SOX study; ECOG performance status, baseline sum of tumor diameters, disease status (recurrent/unresectable), and histology (diffuse/intestinal). Results Among 685 patients enrolled in the G-SOX study, 632 patients who had the first tumor evaluation were analyzed. Patients with ETS ≥ 20% had longer PFS (median 4.5 vs. 2.8 months, p  
doi_str_mv 10.1007/s10120-018-0845-7
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Methods ETS was determined as % decrease in the sum of the longest diameters of the target lesions at the first evaluation of week 6 compared to baseline. DpR was the maximum % shrinkage during the study treatment. The impact of ETS (cutoff value 20%) and DpR (continuous value) on progression-free survival (PFS) and overall survival (OS) were assessed by the log-rank test and Cox regression analysis including prognostic factors obtained in the G-SOX study; ECOG performance status, baseline sum of tumor diameters, disease status (recurrent/unresectable), and histology (diffuse/intestinal). Results Among 685 patients enrolled in the G-SOX study, 632 patients who had the first tumor evaluation were analyzed. Patients with ETS ≥ 20% had longer PFS (median 4.5 vs. 2.8 months, p  &lt; 0.0001) and OS (median 14.8 vs. 10.5 months, p  &lt; 0.0001) than those with ETS &lt; 20%. Adjusted hazard ratios of ETS &lt; 20 vs. ≥ 20% were 0.606 (95% confidence interval (CI) 0.506–0.725) for PFS and 0.589 (95% CI 0.492–0.704) for OS. DpR was also significantly associated with PFS and OS (both p  &lt; 0.0001). These results were similar between the SOX and CS groups. Conclusions In AGC patients receiving the first-line therapy, ETS and DpR might be predictors for PFS and OS.</description><identifier>ISSN: 1436-3291</identifier><identifier>EISSN: 1436-3305</identifier><identifier>DOI: 10.1007/s10120-018-0845-7</identifier><identifier>PMID: 29948386</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Abdominal Surgery ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer Research ; Chemotherapy ; Cisplatin ; Cisplatin - administration &amp; dosage ; Cisplatin - adverse effects ; Clinical Trials, Phase III as Topic ; Drug Combinations ; Female ; Gastric cancer ; Gastroenterology ; Histology ; Humans ; Intestine ; Kaplan-Meier Estimate ; Male ; Medical prognosis ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Multicenter Studies as Topic ; Oncology ; Original Article ; Oxaliplatin ; Oxaliplatin - administration &amp; dosage ; Oxaliplatin - adverse effects ; Oxonic Acid - administration &amp; dosage ; Oxonic Acid - adverse effects ; Patients ; Progression-Free Survival ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Retrospective Studies ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - mortality ; Surgical Oncology ; Survival ; Tegafur - administration &amp; dosage ; Tegafur - adverse effects ; Young Adult</subject><ispartof>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019-01, Vol.22 (1), p.138-146</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-c415t-8779af953743df3ab287c17f4f125b11e6df4c4a5c541a3adcd9c4338e6557933</citedby><cites>FETCH-LOGICAL-c415t-8779af953743df3ab287c17f4f125b11e6df4c4a5c541a3adcd9c4338e6557933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10120-018-0845-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10120-018-0845-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29948386$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nishina, Tomohiro</creatorcontrib><creatorcontrib>Azuma, Mizutomo</creatorcontrib><creatorcontrib>Nishikawa, Kazuhiro</creatorcontrib><creatorcontrib>Gotoh, Masahiro</creatorcontrib><creatorcontrib>Bando, Hideaki</creatorcontrib><creatorcontrib>Sugimoto, Naotoshi</creatorcontrib><creatorcontrib>Amagai, Kenji</creatorcontrib><creatorcontrib>Chin, Keisho</creatorcontrib><creatorcontrib>Niwa, Yasumasa</creatorcontrib><creatorcontrib>Tsuji, Akihito</creatorcontrib><creatorcontrib>Imamura, Hiroshi</creatorcontrib><creatorcontrib>Tsuda, Masahiro</creatorcontrib><creatorcontrib>Yasui, Hirofumi</creatorcontrib><creatorcontrib>Fujii, Hirofumi</creatorcontrib><creatorcontrib>Yamaguchi, Kensei</creatorcontrib><creatorcontrib>Yasui, Hisateru</creatorcontrib><creatorcontrib>Hironaka, Shuichi</creatorcontrib><creatorcontrib>Shimada, Ken</creatorcontrib><creatorcontrib>Miwa, Hiroto</creatorcontrib><creatorcontrib>Mitome, Terukazu</creatorcontrib><creatorcontrib>Kageyama, Hiroki</creatorcontrib><creatorcontrib>Hyodo, Ichinosuke</creatorcontrib><title>Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin</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>Background We investigated early tumor shrinkage (ETS) and depth of response (DpR) using data from the G-SOX study comparing S-1 plus oxaliplatin with S-1 plus cisplatin as the first-line treatment for advanced gastric cancer (AGC). Methods ETS was determined as % decrease in the sum of the longest diameters of the target lesions at the first evaluation of week 6 compared to baseline. DpR was the maximum % shrinkage during the study treatment. The impact of ETS (cutoff value 20%) and DpR (continuous value) on progression-free survival (PFS) and overall survival (OS) were assessed by the log-rank test and Cox regression analysis including prognostic factors obtained in the G-SOX study; ECOG performance status, baseline sum of tumor diameters, disease status (recurrent/unresectable), and histology (diffuse/intestinal). Results Among 685 patients enrolled in the G-SOX study, 632 patients who had the first tumor evaluation were analyzed. Patients with ETS ≥ 20% had longer PFS (median 4.5 vs. 2.8 months, p  &lt; 0.0001) and OS (median 14.8 vs. 10.5 months, p  &lt; 0.0001) than those with ETS &lt; 20%. Adjusted hazard ratios of ETS &lt; 20 vs. ≥ 20% were 0.606 (95% confidence interval (CI) 0.506–0.725) for PFS and 0.589 (95% CI 0.492–0.704) for OS. DpR was also significantly associated with PFS and OS (both p  &lt; 0.0001). These results were similar between the SOX and CS groups. Conclusions In AGC patients receiving the first-line therapy, ETS and DpR might be predictors for PFS and OS.</description><subject>Abdominal Surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer Research</subject><subject>Chemotherapy</subject><subject>Cisplatin</subject><subject>Cisplatin - administration &amp; dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Gastric cancer</subject><subject>Gastroenterology</subject><subject>Histology</subject><subject>Humans</subject><subject>Intestine</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Oxaliplatin</subject><subject>Oxaliplatin - administration &amp; dosage</subject><subject>Oxaliplatin - adverse effects</subject><subject>Oxonic Acid - administration &amp; dosage</subject><subject>Oxonic Acid - adverse effects</subject><subject>Patients</subject><subject>Progression-Free Survival</subject><subject>Proportional Hazards Models</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Retrospective Studies</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - mortality</subject><subject>Surgical Oncology</subject><subject>Survival</subject><subject>Tegafur - administration &amp; dosage</subject><subject>Tegafur - adverse effects</subject><subject>Young Adult</subject><issn>1436-3291</issn><issn>1436-3305</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kc1u1DAUhSMEoqXwAGyQJTZsUuz4L2GHqhZGqsQCWEd3bGfGJXGCrzMwPGEfC4e0VEJi5Z9zznele4riJaPnjFL9FhllFS0pq0taC1nqR8UpE1yVnFP5-P5eNeykeIZ4QymTDVNPi5OqaUTNa3Va3F5C7I8kzcMYCe6jD99g5wgES6yb0p6MHYkOpzGgIz6QCZJ3ISH54bMI9gDBOEt2gCl6Q8zyjO8I5FCKI07OJH9YeNAf0eOCy1rGj4P_lYPTHjJ4s9kQTLM9LnrnI6ay98GRzyUjUz_n2E_o_dTn4YEc8PxBMB7X7-fFkw56dC_uzrPi69Xll4uP5fWnD5uL99elEUymsta6ga6RXAtuOw7bqtaG6U50rJJbxpyynTACpJGCAQdrbGME57VTUuqG87Pizcqd4vh9dpjawaNxfQ_BjTO2FVW0Vqr5Y339j_VmnGPexOKSlRKCC5VdbHWZvC-Mrmun6AeIx5bRdqm5XWtuc83tUnOrc-bVHXneDs7-Tdz3mg3VasAshZ2LD6P_T_0Nmze1Dw</recordid><startdate>20190101</startdate><enddate>20190101</enddate><creator>Nishina, Tomohiro</creator><creator>Azuma, Mizutomo</creator><creator>Nishikawa, Kazuhiro</creator><creator>Gotoh, Masahiro</creator><creator>Bando, Hideaki</creator><creator>Sugimoto, Naotoshi</creator><creator>Amagai, Kenji</creator><creator>Chin, Keisho</creator><creator>Niwa, Yasumasa</creator><creator>Tsuji, Akihito</creator><creator>Imamura, Hiroshi</creator><creator>Tsuda, Masahiro</creator><creator>Yasui, Hirofumi</creator><creator>Fujii, Hirofumi</creator><creator>Yamaguchi, Kensei</creator><creator>Yasui, Hisateru</creator><creator>Hironaka, Shuichi</creator><creator>Shimada, Ken</creator><creator>Miwa, Hiroto</creator><creator>Mitome, Terukazu</creator><creator>Kageyama, Hiroki</creator><creator>Hyodo, Ichinosuke</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></search><sort><creationdate>20190101</creationdate><title>Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin</title><author>Nishina, Tomohiro ; Azuma, Mizutomo ; Nishikawa, Kazuhiro ; Gotoh, Masahiro ; Bando, Hideaki ; Sugimoto, Naotoshi ; Amagai, Kenji ; Chin, Keisho ; Niwa, Yasumasa ; Tsuji, Akihito ; Imamura, Hiroshi ; Tsuda, Masahiro ; Yasui, Hirofumi ; Fujii, Hirofumi ; Yamaguchi, Kensei ; Yasui, Hisateru ; Hironaka, Shuichi ; Shimada, Ken ; Miwa, Hiroto ; Mitome, Terukazu ; Kageyama, Hiroki ; Hyodo, Ichinosuke</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-8779af953743df3ab287c17f4f125b11e6df4c4a5c541a3adcd9c4338e6557933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Abdominal Surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer Research</topic><topic>Chemotherapy</topic><topic>Cisplatin</topic><topic>Cisplatin - administration &amp; dosage</topic><topic>Cisplatin - adverse effects</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Gastric cancer</topic><topic>Gastroenterology</topic><topic>Histology</topic><topic>Humans</topic><topic>Intestine</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Medicine</topic><topic>Medicine &amp; 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Methods ETS was determined as % decrease in the sum of the longest diameters of the target lesions at the first evaluation of week 6 compared to baseline. DpR was the maximum % shrinkage during the study treatment. The impact of ETS (cutoff value 20%) and DpR (continuous value) on progression-free survival (PFS) and overall survival (OS) were assessed by the log-rank test and Cox regression analysis including prognostic factors obtained in the G-SOX study; ECOG performance status, baseline sum of tumor diameters, disease status (recurrent/unresectable), and histology (diffuse/intestinal). Results Among 685 patients enrolled in the G-SOX study, 632 patients who had the first tumor evaluation were analyzed. Patients with ETS ≥ 20% had longer PFS (median 4.5 vs. 2.8 months, p  &lt; 0.0001) and OS (median 14.8 vs. 10.5 months, p  &lt; 0.0001) than those with ETS &lt; 20%. Adjusted hazard ratios of ETS &lt; 20 vs. ≥ 20% were 0.606 (95% confidence interval (CI) 0.506–0.725) for PFS and 0.589 (95% CI 0.492–0.704) for OS. DpR was also significantly associated with PFS and OS (both p  &lt; 0.0001). These results were similar between the SOX and CS groups. Conclusions In AGC patients receiving the first-line therapy, ETS and DpR might be predictors for PFS and OS.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>29948386</pmid><doi>10.1007/s10120-018-0845-7</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; SpringerLink Journals - AutoHoldings
subjects Abdominal Surgery
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer Research
Chemotherapy
Cisplatin
Cisplatin - administration & dosage
Cisplatin - adverse effects
Clinical Trials, Phase III as Topic
Drug Combinations
Female
Gastric cancer
Gastroenterology
Histology
Humans
Intestine
Kaplan-Meier Estimate
Male
Medical prognosis
Medicine
Medicine & Public Health
Middle Aged
Multicenter Studies as Topic
Oncology
Original Article
Oxaliplatin
Oxaliplatin - administration & dosage
Oxaliplatin - adverse effects
Oxonic Acid - administration & dosage
Oxonic Acid - adverse effects
Patients
Progression-Free Survival
Proportional Hazards Models
Randomized Controlled Trials as Topic
Retrospective Studies
Stomach Neoplasms - drug therapy
Stomach Neoplasms - mortality
Surgical Oncology
Survival
Tegafur - administration & dosage
Tegafur - adverse effects
Young Adult
title Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin
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