A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer
Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy. In this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disea...
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| Veröffentlicht in: | Gynecologic oncology Jg. 150; H. 2; S. 274 - 281 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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United States
Elsevier Inc
01.08.2018
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| ISSN: | 0090-8258, 1095-6859, 1095-6859 |
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| Abstract | Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.
In this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety.
Overall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63–1.02), 1.22 (0.96–1.55) and 0.87 (0.68–1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55–0.91), 0.99 (0.78–1.26), and 0.97 (0.77–1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified.
PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P.
•Paclitaxel + carboplatin is standard initial therapy for advanced endometrial cancer.•We assessed combinations with bevacizumab, temsirolimus or ixabepilone.•PFS was not significantly improved compared to historical control. |
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| AbstractList | Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.
In this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety.
Overall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63–1.02), 1.22 (0.96–1.55) and 0.87 (0.68–1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55–0.91), 0.99 (0.78–1.26), and 0.97 (0.77–1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified.
PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P.
•Paclitaxel + carboplatin is standard initial therapy for advanced endometrial cancer.•We assessed combinations with bevacizumab, temsirolimus or ixabepilone.•PFS was not significantly improved compared to historical control. Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.OBJECTIVEPaclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.In this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety.METHODSIn this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety.Overall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63-1.02), 1.22 (0.96-1.55) and 0.87 (0.68-1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55-0.91), 0.99 (0.78-1.26), and 0.97 (0.77-1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified.RESULTSOverall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63-1.02), 1.22 (0.96-1.55) and 0.87 (0.68-1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55-0.91), 0.99 (0.78-1.26), and 0.97 (0.77-1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified.PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P.CONCLUSIONPFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P. Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy. In this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety. Overall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63-1.02), 1.22 (0.96-1.55) and 0.87 (0.68-1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55-0.91), 0.99 (0.78-1.26), and 0.97 (0.77-1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified. PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P. AbstractObjectivePaclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy. MethodsIn this randomized phase II trial, patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety. ResultsOverall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p > 0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63–1.02), 1.22 (0.96–1.55) and 0.87 (0.68–1.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p < 0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.55–0.91), 0.99 (0.78–1.26), and 0.97 (0.77–1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified. ConclusionPFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P. |
| Author | Soslow, Robert A. Stuckey, Ashley Bender, David P. Carlson, Jay W. Lankes, Heather A. Tewari, Krishnansu S. Moore, Kathleen Dao, Fanny Gao, JianJiong Aghajanian, Carol Secord, Angeles Alvarez Powell, Matthew A. Filiaci, Virginia Dizon, Don S. O'Malley, David M. Levine, Douglas A. |
| AuthorAffiliation | 11 Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 12 Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY 7 University of California Irvine Medical Center, Orange, CA 10 Women and Infants Hospital, Providence, RI 5 Washington University, St. Louis, MO 9 Ohio State University Medical Center, James Cancer Center, Columbus, OH 13 NRG Oncology Biospecimen Bank-Columbus, Biopathology Center, The Reseach Institue at Nationwide Children’s Hospital, Columbus, OH 8 University of Iowa, Iowa City, IA 1 Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY 2 Department of Biostatics and Bioinformatics, Roswell Park Cancer Institute and NRG Oncology Buffalo Statistical and Data Management Center, Buffalo, NY 3 Lifespan Cancer Institute/Rhode Island Hospital, Providence, RI 4 Cancer Research for the Ozarks, Springfield, MO 14 Stephenson Cancer Center and University of Oklahoma, Oklahoma City |
| AuthorAffiliation_xml | – name: 1 Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY – name: 3 Lifespan Cancer Institute/Rhode Island Hospital, Providence, RI – name: 14 Stephenson Cancer Center and University of Oklahoma, Oklahoma City, OK – name: 4 Cancer Research for the Ozarks, Springfield, MO – name: 7 University of California Irvine Medical Center, Orange, CA – name: 6 Duke University, Durham, NC – name: 8 University of Iowa, Iowa City, IA – name: 9 Ohio State University Medical Center, James Cancer Center, Columbus, OH – name: 11 Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY – name: 13 NRG Oncology Biospecimen Bank-Columbus, Biopathology Center, The Reseach Institue at Nationwide Children’s Hospital, Columbus, OH – name: 12 Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY – name: 5 Washington University, St. Louis, MO – name: 10 Women and Infants Hospital, Providence, RI – name: 2 Department of Biostatics and Bioinformatics, Roswell Park Cancer Institute and NRG Oncology Buffalo Statistical and Data Management Center, Buffalo, NY |
| Author_xml | – sequence: 1 givenname: Carol surname: Aghajanian fullname: Aghajanian, Carol email: aghajanc@mskcc.org organization: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY, United States – sequence: 2 givenname: Virginia surname: Filiaci fullname: Filiaci, Virginia organization: Department of Biostatics and Bioinformatics, Roswell Park Cancer Institute and NRG Oncology Buffalo Statistical and Data Management Center, Buffalo, NY, United States – sequence: 3 givenname: Don S. surname: Dizon fullname: Dizon, Don S. organization: Lifespan Cancer Institute/Rhode Island Hospital, Providence, RI, United States – sequence: 4 givenname: Jay W. surname: Carlson fullname: Carlson, Jay W. organization: Cancer Research for the Ozarks, Springfield, MO, United States – sequence: 5 givenname: Matthew A. surname: Powell fullname: Powell, Matthew A. organization: Washington University, St. Louis, MO, United States – sequence: 6 givenname: Angeles Alvarez surname: Secord fullname: Secord, Angeles Alvarez organization: Duke University, Durham, NC, United States – sequence: 7 givenname: Krishnansu S. surname: Tewari fullname: Tewari, Krishnansu S. organization: University of California Irvine Medical Center, Orange, CA, United States – sequence: 8 givenname: David P. surname: Bender fullname: Bender, David P. organization: University of Iowa, Iowa City, IA, United States – sequence: 9 givenname: David M. surname: O'Malley fullname: O'Malley, David M. organization: Ohio State University Medical Center, James Cancer Center, Columbus, OH, United States – sequence: 10 givenname: Ashley surname: Stuckey fullname: Stuckey, Ashley organization: Women and Infants Hospital, Providence, RI, United States – sequence: 11 givenname: JianJiong surname: Gao fullname: Gao, JianJiong organization: Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, United States – sequence: 12 givenname: Fanny surname: Dao fullname: Dao, Fanny organization: Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, United States – sequence: 13 givenname: Robert A. surname: Soslow fullname: Soslow, Robert A. organization: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY, United States – sequence: 14 givenname: Heather A. surname: Lankes fullname: Lankes, Heather A. organization: NRG Oncology Biospecimen Bank-Columbus, Biopathology Center, The Reseach Institue at Nationwide Children's Hospital, Columbus, OH, United States – sequence: 15 givenname: Kathleen surname: Moore fullname: Moore, Kathleen organization: Stephenson Cancer Center and University of Oklahoma, Oklahoma City, OK, United States – sequence: 16 givenname: Douglas A. surname: Levine fullname: Levine, Douglas A. organization: Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY, United States |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29804638$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2018 Elsevier Inc. Elsevier Inc. Copyright © 2018 Elsevier Inc. All rights reserved. |
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| Keywords | Carboplatin Temsirolimus Ixabepilone Endometrial cancer Paclitaxel Bevacizumab |
| Language | English |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 Study concept and design: Aghajanian C, Filiaci V, Dizon DS, Levine DA Final approval of manuscript: Aghajanian C, Filiaci V, Dizon DS, Carlson JW, Powell MA, Alvarez Secord A, Tewari KS, Bender DP, O’Malley DM, Stuckey A, Gao J, Dao F, Soslow RA, Lankes HA, Moore K, Levine DA Analysis and interpretation of data: Aghajanian C, Filiaci V, Gao J, Dao F, Soslow RA, Lankes HA, Levine DA Manuscript writing: Aghajanian C, Filiaci V, Gao J, Dao F, Lankes HA, Levine DA Critical review of the manuscript: Filiaci V, Dizon DS, Carlson JW, Powell MA, Alvarez Secord A, Tewari KS, Bender DP, O’Malley DM, Stuckey A, Soslow RA, Moore K, Levine DA Acquisition of data: Aghajanian C, Dizon DS, Carlson JW, Powell MA, Alvarez Secord A, Tewari KS, Bender DP, O’Malley DM, Stuckey A, Gao J, Dao F, Soslow RA, Lankes HA, Moore K, Levine DA AUTHOR CONTRIBUTIONS Provision of materials or patients: Aghajanian C, Dizon DS, Carlson JW, Powell MA, Alvarez Secord A, Tewari KS, Bender DP, O’Malley DM, Stuckey A, Moore K |
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| PublicationTitle | Gynecologic oncology |
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| Snippet | Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating... AbstractObjectivePaclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of... |
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| SubjectTerms | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bevacizumab Bevacizumab - administration & dosage Carboplatin Carboplatin - administration & dosage Endometrial cancer Endometrial Neoplasms - drug therapy Epothilones - administration & dosage Female Hematology, Oncology, and Palliative Medicine Humans Ixabepilone Middle Aged Neoplasm Recurrence, Local - drug therapy Obstetrics and Gynecology Paclitaxel Paclitaxel - administration & dosage Sirolimus - administration & dosage Sirolimus - analogs & derivatives Temsirolimus |
| Title | A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer |
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