Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial

Summary Background Paclitaxel and carboplatin given every 3 weeks is standard treatment for advanced ovarian carcinoma. Attempts to improve patient survival by including other drugs have yielded disappointing results. We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense...

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Published in:The Lancet (British edition) 2009-10, Vol.374 (9698), p.1331-1338
Main Authors: Katsumata, Noriyuki, Dr, Yasuda, Makoto, Prof, Takahashi, Fumiaki, PhD, Isonishi, Seiji, MD, Jobo, Toshiko, MD, Aoki, Daisuke, Prof, Tsuda, Hiroshi, MD, Sugiyama, Toru, Prof, Kodama, Shoji, MD, Kimura, Eizo, MD, Ochiai, Kazunori, Prof, Noda, Kiichiro, Prof
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Biological and medical sciences
Cancer therapies
Carboplatin - administration & dosage
Cells
Chemotherapy
Drugs
Female
Female genital diseases
General aspects
Gynecology. Andrology. Obstetrics
Humans
Internal Medicine
Medical sciences
Middle Aged
Neurotoxicity
Ovarian cancer
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - pathology
Ovarian Neoplasms - surgery
Paclitaxel - administration & dosage
Response rates
Survival Analysis
Tumors
Womens health
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cited_by cdi_FETCH-LOGICAL-c559t-f194adbf416002150c4251139edd1b0997b1b5d2e50c907ad96c893689d0aac63
cites cdi_FETCH-LOGICAL-c559t-f194adbf416002150c4251139edd1b0997b1b5d2e50c907ad96c893689d0aac63
container_end_page 1338
container_issue 9698
container_start_page 1331
container_title The Lancet (British edition)
container_volume 374
creator Katsumata, Noriyuki, Dr
Yasuda, Makoto, Prof
Takahashi, Fumiaki, PhD
Isonishi, Seiji, MD
Jobo, Toshiko, MD
Aoki, Daisuke, Prof
Tsuda, Hiroshi, MD
Sugiyama, Toru, Prof
Kodama, Shoji, MD
Kimura, Eizo, MD
Ochiai, Kazunori, Prof
Noda, Kiichiro, Prof
description Summary Background Paclitaxel and carboplatin given every 3 weeks is standard treatment for advanced ovarian carcinoma. Attempts to improve patient survival by including other drugs have yielded disappointing results. We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense weekly regimen in women with advanced ovarian cancer. Methods Patients with stage II to IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible for enrolment in this phase 3, open-label, randomised controlled trial at 85 centres in Japan. Patients were randomly assigned by computer-generated randomisation sequence to receive six cycles of either paclitaxel (180 mg/m2 ; 3-h intravenous infusion) plus carboplatin (area under the curve [AUC] 6 mg/mL per min), given on day 1 of a 21-day cycle (conventional regimen; n=320), or dose-dense paclitaxel (80 mg/m2 ; 1-h intravenous infusion) given on days 1, 8, and 15 plus carboplatin given on day 1 of a 21-day cycle (dose-dense regimen; n=317). The primary endpoint was progression-free survival. Analysis was by intention to treat (ITT). This trial is registered with ClinicalTrials.gov , number NCT00226915. Findings 631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population (dose-dense regimen, n=312; conventional regimen, n=319). Median progression-free survival was longer in the dose-dense treatment group (28·0 months, 95% CI 22·3–35·4) than in the conventional treatment group (17·2 months, 15·7–21·1; hazard ratio [HR] 0·71; 95% CI 0·58–0·88; p=0·0015). Overall survival at 3 years was higher in the dose-dense regimen group (72·1%) than in the conventional treatment group (65·1%; HR 0·75, 0·57–0·98; p=0·03). 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early. Reasons for participant dropout were balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group (n=113 vs n=69). The most common adverse event was neutropenia (dose-dense regimen, 286 [92%] of 312; conventional regimen, 276 [88%] of 314). The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group (214 [69%]) than in the conventional treatment group (137 [44%]; p
doi_str_mv 10.1016/S0140-6736(09)61157-0
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Attempts to improve patient survival by including other drugs have yielded disappointing results. We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense weekly regimen in women with advanced ovarian cancer. Methods Patients with stage II to IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible for enrolment in this phase 3, open-label, randomised controlled trial at 85 centres in Japan. Patients were randomly assigned by computer-generated randomisation sequence to receive six cycles of either paclitaxel (180 mg/m2 ; 3-h intravenous infusion) plus carboplatin (area under the curve [AUC] 6 mg/mL per min), given on day 1 of a 21-day cycle (conventional regimen; n=320), or dose-dense paclitaxel (80 mg/m2 ; 1-h intravenous infusion) given on days 1, 8, and 15 plus carboplatin given on day 1 of a 21-day cycle (dose-dense regimen; n=317). The primary endpoint was progression-free survival. Analysis was by intention to treat (ITT). This trial is registered with ClinicalTrials.gov , number NCT00226915. Findings 631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population (dose-dense regimen, n=312; conventional regimen, n=319). Median progression-free survival was longer in the dose-dense treatment group (28·0 months, 95% CI 22·3–35·4) than in the conventional treatment group (17·2 months, 15·7–21·1; hazard ratio [HR] 0·71; 95% CI 0·58–0·88; p=0·0015). Overall survival at 3 years was higher in the dose-dense regimen group (72·1%) than in the conventional treatment group (65·1%; HR 0·75, 0·57–0·98; p=0·03). 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early. Reasons for participant dropout were balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group (n=113 vs n=69). The most common adverse event was neutropenia (dose-dense regimen, 286 [92%] of 312; conventional regimen, 276 [88%] of 314). The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group (214 [69%]) than in the conventional treatment group (137 [44%]; p&lt;0·0001). The frequencies of other toxic effects were similar between groups. Interpretation Dose-dense weekly paclitaxel plus carboplatin improved survival compared with the conventional regimen and represents a new treatment option in women with advanced epithelial ovarian cancer. Funding Bristol-Myers Squibb.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(09)61157-0</identifier><identifier>PMID: 19767092</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - administration &amp; dosage ; Biological and medical sciences ; Cancer therapies ; Carboplatin - administration &amp; dosage ; Cells ; Chemotherapy ; Drugs ; Female ; Female genital diseases ; General aspects ; Gynecology. Andrology. 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Attempts to improve patient survival by including other drugs have yielded disappointing results. We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense weekly regimen in women with advanced ovarian cancer. Methods Patients with stage II to IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible for enrolment in this phase 3, open-label, randomised controlled trial at 85 centres in Japan. Patients were randomly assigned by computer-generated randomisation sequence to receive six cycles of either paclitaxel (180 mg/m2 ; 3-h intravenous infusion) plus carboplatin (area under the curve [AUC] 6 mg/mL per min), given on day 1 of a 21-day cycle (conventional regimen; n=320), or dose-dense paclitaxel (80 mg/m2 ; 1-h intravenous infusion) given on days 1, 8, and 15 plus carboplatin given on day 1 of a 21-day cycle (dose-dense regimen; n=317). The primary endpoint was progression-free survival. Analysis was by intention to treat (ITT). This trial is registered with ClinicalTrials.gov , number NCT00226915. Findings 631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population (dose-dense regimen, n=312; conventional regimen, n=319). Median progression-free survival was longer in the dose-dense treatment group (28·0 months, 95% CI 22·3–35·4) than in the conventional treatment group (17·2 months, 15·7–21·1; hazard ratio [HR] 0·71; 95% CI 0·58–0·88; p=0·0015). Overall survival at 3 years was higher in the dose-dense regimen group (72·1%) than in the conventional treatment group (65·1%; HR 0·75, 0·57–0·98; p=0·03). 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early. Reasons for participant dropout were balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group (n=113 vs n=69). The most common adverse event was neutropenia (dose-dense regimen, 286 [92%] of 312; conventional regimen, 276 [88%] of 314). The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group (214 [69%]) than in the conventional treatment group (137 [44%]; p&lt;0·0001). The frequencies of other toxic effects were similar between groups. Interpretation Dose-dense weekly paclitaxel plus carboplatin improved survival compared with the conventional regimen and represents a new treatment option in women with advanced epithelial ovarian cancer. 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Obstetrics</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neurotoxicity</topic><topic>Ovarian cancer</topic><topic>Ovarian Neoplasms - drug therapy</topic><topic>Ovarian Neoplasms - pathology</topic><topic>Ovarian Neoplasms - surgery</topic><topic>Paclitaxel - administration &amp; dosage</topic><topic>Response rates</topic><topic>Survival Analysis</topic><topic>Tumors</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Katsumata, Noriyuki, Dr</creatorcontrib><creatorcontrib>Yasuda, Makoto, Prof</creatorcontrib><creatorcontrib>Takahashi, Fumiaki, PhD</creatorcontrib><creatorcontrib>Isonishi, Seiji, MD</creatorcontrib><creatorcontrib>Jobo, Toshiko, MD</creatorcontrib><creatorcontrib>Aoki, Daisuke, Prof</creatorcontrib><creatorcontrib>Tsuda, Hiroshi, MD</creatorcontrib><creatorcontrib>Sugiyama, Toru, Prof</creatorcontrib><creatorcontrib>Kodama, Shoji, MD</creatorcontrib><creatorcontrib>Kimura, Eizo, MD</creatorcontrib><creatorcontrib>Ochiai, Kazunori, Prof</creatorcontrib><creatorcontrib>Noda, Kiichiro, Prof</creatorcontrib><creatorcontrib>for the Japanese Gynecologic Oncology Group</creatorcontrib><creatorcontrib>Japanese Gynecologic Oncology Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>News PRO</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Global News &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>Biological Sciences</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>PML(ProQuest Medical Library)</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</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>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Katsumata, Noriyuki, Dr</au><au>Yasuda, Makoto, Prof</au><au>Takahashi, Fumiaki, PhD</au><au>Isonishi, Seiji, MD</au><au>Jobo, Toshiko, MD</au><au>Aoki, Daisuke, Prof</au><au>Tsuda, Hiroshi, MD</au><au>Sugiyama, Toru, Prof</au><au>Kodama, Shoji, MD</au><au>Kimura, Eizo, MD</au><au>Ochiai, Kazunori, Prof</au><au>Noda, Kiichiro, Prof</au><aucorp>for the Japanese Gynecologic Oncology Group</aucorp><aucorp>Japanese Gynecologic Oncology Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2009-10-17</date><risdate>2009</risdate><volume>374</volume><issue>9698</issue><spage>1331</spage><epage>1338</epage><pages>1331-1338</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>Summary Background Paclitaxel and carboplatin given every 3 weeks is standard treatment for advanced ovarian carcinoma. Attempts to improve patient survival by including other drugs have yielded disappointing results. We compared a conventional regimen of paclitaxel and carboplatin with a dose-dense weekly regimen in women with advanced ovarian cancer. Methods Patients with stage II to IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible for enrolment in this phase 3, open-label, randomised controlled trial at 85 centres in Japan. Patients were randomly assigned by computer-generated randomisation sequence to receive six cycles of either paclitaxel (180 mg/m2 ; 3-h intravenous infusion) plus carboplatin (area under the curve [AUC] 6 mg/mL per min), given on day 1 of a 21-day cycle (conventional regimen; n=320), or dose-dense paclitaxel (80 mg/m2 ; 1-h intravenous infusion) given on days 1, 8, and 15 plus carboplatin given on day 1 of a 21-day cycle (dose-dense regimen; n=317). The primary endpoint was progression-free survival. Analysis was by intention to treat (ITT). This trial is registered with ClinicalTrials.gov , number NCT00226915. Findings 631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population (dose-dense regimen, n=312; conventional regimen, n=319). Median progression-free survival was longer in the dose-dense treatment group (28·0 months, 95% CI 22·3–35·4) than in the conventional treatment group (17·2 months, 15·7–21·1; hazard ratio [HR] 0·71; 95% CI 0·58–0·88; p=0·0015). Overall survival at 3 years was higher in the dose-dense regimen group (72·1%) than in the conventional treatment group (65·1%; HR 0·75, 0·57–0·98; p=0·03). 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early. Reasons for participant dropout were balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group (n=113 vs n=69). The most common adverse event was neutropenia (dose-dense regimen, 286 [92%] of 312; conventional regimen, 276 [88%] of 314). The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group (214 [69%]) than in the conventional treatment group (137 [44%]; p&lt;0·0001). The frequencies of other toxic effects were similar between groups. Interpretation Dose-dense weekly paclitaxel plus carboplatin improved survival compared with the conventional regimen and represents a new treatment option in women with advanced epithelial ovarian cancer. Funding Bristol-Myers Squibb.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19767092</pmid><doi>10.1016/S0140-6736(09)61157-0</doi><tpages>8</tpages></addata></record>
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identifier ISSN: 0140-6736
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issn 0140-6736
1474-547X
language eng
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source Elsevier
subjects Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Biological and medical sciences
Cancer therapies
Carboplatin - administration & dosage
Cells
Chemotherapy
Drugs
Female
Female genital diseases
General aspects
Gynecology. Andrology. Obstetrics
Humans
Internal Medicine
Medical sciences
Middle Aged
Neurotoxicity
Ovarian cancer
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - pathology
Ovarian Neoplasms - surgery
Paclitaxel - administration & dosage
Response rates
Survival Analysis
Tumors
Womens health
title Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial
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