Gemcitabine and carboplatin treatment in patients with relapsing ovarian cancer
Despite progress in primary treatment of patients with advanced ovarian cancer, the majority develop recurrence of the disease. A platinum salt treatment, either as monotherapy or in combination with another cytostatic agent, is indicated for patients who have relapsed 6 or more months after primary...
Saved in:
Published in | Neoplasma Vol. 56; no. 4; p. 291 |
---|---|
Main Authors | , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Slovakia
2009
|
Subjects | |
Online Access | Get more information |
Cover
Loading…
Abstract | Despite progress in primary treatment of patients with advanced ovarian cancer, the majority develop recurrence of the disease. A platinum salt treatment, either as monotherapy or in combination with another cytostatic agent, is indicated for patients who have relapsed 6 or more months after primary treatment and thus have platinum-sensitive relapse. Because repeated use of paclitaxel treatment may lead to substantial neurotoxicity, the combination of gemcitabine with carboplatin represents a suitable treatment option, which is widely used in common clinical practice in the Czech Republic and Slovakia. This non-interventional, prospective study observed the effectiveness and tolerability of second-line treatment with gemcitabine and carboplatin in patients with platinum-sensitive relapse of ovarian cancer in routine clinical practice. The primary endpoint was to evaluate the survival and secondary endpoints were to evaluate time to disease progression, objective tumor response rate, and treatment toxicity. Patients were enrolled to planned second-line treatment with gemcitabine and carboplatin (gemcitabine 1000 mg/m2 and carboplatin AUC 5 on Day 1, and gemcitabine 1000 mg/m2 on Day 8 of a 21-day cycle) for platinum-sensitive relapse of ovarian cancer as a part of routine clinical practice and followed for 12 months. The events (death, tumor progression), tumor response, and maximal grades of toxicity were recorded according to common clinical practice. Survival time (using Kaplan-Meier analysis) and objective tumor response rate were calculated using data forms, and a subgroup analysis was performed using log rank tests for time-to-event endpoints; p-values were also calculated. Response rates were calculated for the whole population; for the subgroups, the Fisher's exact test was performed and only p-values were calculated. Between January 2004 and June 2005, 53 patients were enrolled in the study. The median age was 57 years and 96% of patients had an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 and 1 at baseline. Approximately 91% of patients were originally diagnosed with stage III or IV; 60% of patients had disease free intervals (DFIs) of 12 or more months from previous therapy, and the additional 40% less than 12 months. The 1-year survival rate was 83%. Median survival time was not determined within the 12-month period following the start of the treatment study due to the limited duration of follow-up. Objective tumour response rate was 67.3%. Most common reasons for discontinuation of therapy were "Planned treatment completed" (53%) and "Tumor progression" (11%). Most common toxicities were leukopenia, anaemia, neutropenia, and thrombocytopenia; grades 3 and 4 of these toxicity types did not exceed 30%. Febrile neutropenia was recorded in two patients. Most common non-haematological toxicities were nausea and vomiting, fatigue, and neuropathy; grades 3 and 4 of these were below 6%. Results on time to disease progression are not published due to inconsistent statistical analysis of reported data. Based on this observation from routine clinical practice, which corresponds with previously published results from controlled clinical trials, the gemcitabine and carboplatin combination seems to be a suitable therapeutic option for patients with platinum-sensitive relapse of ovarian cancer. |
---|---|
AbstractList | Despite progress in primary treatment of patients with advanced ovarian cancer, the majority develop recurrence of the disease. A platinum salt treatment, either as monotherapy or in combination with another cytostatic agent, is indicated for patients who have relapsed 6 or more months after primary treatment and thus have platinum-sensitive relapse. Because repeated use of paclitaxel treatment may lead to substantial neurotoxicity, the combination of gemcitabine with carboplatin represents a suitable treatment option, which is widely used in common clinical practice in the Czech Republic and Slovakia. This non-interventional, prospective study observed the effectiveness and tolerability of second-line treatment with gemcitabine and carboplatin in patients with platinum-sensitive relapse of ovarian cancer in routine clinical practice. The primary endpoint was to evaluate the survival and secondary endpoints were to evaluate time to disease progression, objective tumor response rate, and treatment toxicity. Patients were enrolled to planned second-line treatment with gemcitabine and carboplatin (gemcitabine 1000 mg/m2 and carboplatin AUC 5 on Day 1, and gemcitabine 1000 mg/m2 on Day 8 of a 21-day cycle) for platinum-sensitive relapse of ovarian cancer as a part of routine clinical practice and followed for 12 months. The events (death, tumor progression), tumor response, and maximal grades of toxicity were recorded according to common clinical practice. Survival time (using Kaplan-Meier analysis) and objective tumor response rate were calculated using data forms, and a subgroup analysis was performed using log rank tests for time-to-event endpoints; p-values were also calculated. Response rates were calculated for the whole population; for the subgroups, the Fisher's exact test was performed and only p-values were calculated. Between January 2004 and June 2005, 53 patients were enrolled in the study. The median age was 57 years and 96% of patients had an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 and 1 at baseline. Approximately 91% of patients were originally diagnosed with stage III or IV; 60% of patients had disease free intervals (DFIs) of 12 or more months from previous therapy, and the additional 40% less than 12 months. The 1-year survival rate was 83%. Median survival time was not determined within the 12-month period following the start of the treatment study due to the limited duration of follow-up. Objective tumour response rate was 67.3%. Most common reasons for discontinuation of therapy were "Planned treatment completed" (53%) and "Tumor progression" (11%). Most common toxicities were leukopenia, anaemia, neutropenia, and thrombocytopenia; grades 3 and 4 of these toxicity types did not exceed 30%. Febrile neutropenia was recorded in two patients. Most common non-haematological toxicities were nausea and vomiting, fatigue, and neuropathy; grades 3 and 4 of these were below 6%. Results on time to disease progression are not published due to inconsistent statistical analysis of reported data. Based on this observation from routine clinical practice, which corresponds with previously published results from controlled clinical trials, the gemcitabine and carboplatin combination seems to be a suitable therapeutic option for patients with platinum-sensitive relapse of ovarian cancer. |
Author | Tkacova, V Svetlovska, D Horvathova, D Packan, T Kroslakova, D Laluha, A Rakicka, G Chovanec, J Koza, I Sufliarsky, J Dorr, A Helpianska, L Spacek, J Magdin, D Malec, V Stresko, M Habetinek, V Sevcik, L Jancokova, I Minarik, T Lalabova, R |
Author_xml | – sequence: 1 givenname: J surname: Sufliarsky fullname: Sufliarsky, J email: jozef.sufliarsky@nou.sk organization: National Cancer Institute Bratislava, 833 10 Brtaislava, Slovakia, Czech Republic. jozef.sufliarsky@nou.sk – sequence: 2 givenname: J surname: Chovanec fullname: Chovanec, J – sequence: 3 givenname: D surname: Svetlovska fullname: Svetlovska, D – sequence: 4 givenname: T surname: Minarik fullname: Minarik, T – sequence: 5 givenname: T surname: Packan fullname: Packan, T – sequence: 6 givenname: D surname: Kroslakova fullname: Kroslakova, D – sequence: 7 givenname: R surname: Lalabova fullname: Lalabova, R – sequence: 8 givenname: L surname: Helpianska fullname: Helpianska, L – sequence: 9 givenname: D surname: Horvathova fullname: Horvathova, D – sequence: 10 givenname: L surname: Sevcik fullname: Sevcik, L – sequence: 11 givenname: J surname: Spacek fullname: Spacek, J – sequence: 12 givenname: A surname: Laluha fullname: Laluha, A – sequence: 13 givenname: V surname: Tkacova fullname: Tkacova, V – sequence: 14 givenname: V surname: Malec fullname: Malec, V – sequence: 15 givenname: G surname: Rakicka fullname: Rakicka, G – sequence: 16 givenname: D surname: Magdin fullname: Magdin, D – sequence: 17 givenname: I surname: Jancokova fullname: Jancokova, I – sequence: 18 givenname: A surname: Dorr fullname: Dorr, A – sequence: 19 givenname: M surname: Stresko fullname: Stresko, M – sequence: 20 givenname: V surname: Habetinek fullname: Habetinek, V – sequence: 21 givenname: I surname: Koza fullname: Koza, I |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/19473054$$D View this record in MEDLINE/PubMed |
BookMark | eNo1T01LxDAUzGHFXdc9e5P8gerLV9scZdFVWNiLnstr-qqRNi1pVPz3BtS5zAfMwFywVZgCMXYl4EYLbW8DTY0EsA3oRlqxYhsAWReyrM2a7ZblHTJKA1KKc7YWVlcKjN6w04FG5xO2PhDH0HGHsZ3mAZMPPEXCNFJIPJs5R1ku_MunNx5pwHnx4ZVPnxg9hlwMjuIlO-txWGj3x1v28nD_vH8sjqfD0_7uWDhpTSq0E7p2quq0cihdW1l0PRlQFVhQpqSys9Zima-4Dtsaje5bR0qAKAkqlFt2_bs7f7Qjdc0c_Yjxu_l_Jn8AcBlSnQ |
CitedBy_id | crossref_primary_10_1007_s10147_019_01471_5 crossref_primary_10_1177_1078155220929409 crossref_primary_10_1634_theoncologist_2009_0331 |
ContentType | Journal Article |
DBID | CGR CUY CVF ECM EIF NPM |
DOI | 10.4149/neo_2009_04_291 |
DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed |
DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) |
DatabaseTitleList | MEDLINE |
Database_xml | – sequence: 1 dbid: NPM name: PubMed url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: EIF name: MEDLINE url: https://proxy.k.utb.cz/login?url=https://www.webofscience.com/wos/medline/basic-search sourceTypes: Index Database |
DeliveryMethod | no_fulltext_linktorsrc |
ExternalDocumentID | 19473054 |
Genre | Research Support, Non-U.S. Gov't Multicenter Study Journal Article |
GroupedDBID | --- .GJ 123 53G 5RE 6RX ABOCM ADBBV AENEX AFFNX ALMA_UNASSIGNED_HOLDINGS BAWUL CGR CUY CVF DIK ECM EIF EMOBN F5P J5H K-P NPM P2P P6G TR2 UDS UGK ZGI ZXP |
ID | FETCH-LOGICAL-c295t-4c148c37d43ca2cb79acfe5037090356e6d999a6291cdab8a54fbce31016e07a2 |
ISSN | 0028-2685 |
IngestDate | Thu May 23 23:13:33 EDT 2024 |
IsPeerReviewed | true |
IsScholarly | true |
Issue | 4 |
Language | English |
LinkModel | OpenURL |
MergedId | FETCHMERGED-LOGICAL-c295t-4c148c37d43ca2cb79acfe5037090356e6d999a6291cdab8a54fbce31016e07a2 |
PMID | 19473054 |
ParticipantIDs | pubmed_primary_19473054 |
PublicationCentury | 2000 |
PublicationDate | 2009-00-00 |
PublicationDateYYYYMMDD | 2009-01-01 |
PublicationDate_xml | – year: 2009 text: 2009-00-00 |
PublicationDecade | 2000 |
PublicationPlace | Slovakia |
PublicationPlace_xml | – name: Slovakia |
PublicationTitle | Neoplasma |
PublicationTitleAlternate | Neoplasma |
PublicationYear | 2009 |
SSID | ssj0000650221 |
Score | 1.841614 |
Snippet | Despite progress in primary treatment of patients with advanced ovarian cancer, the majority develop recurrence of the disease. A platinum salt treatment,... |
SourceID | pubmed |
SourceType | Index Database |
StartPage | 291 |
SubjectTerms | Adenocarcinoma, Mucinous - drug therapy Adenocarcinoma, Mucinous - secondary Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carboplatin - administration & dosage Carcinoma, Endometrioid - drug therapy Carcinoma, Endometrioid - secondary Cystadenocarcinoma, Serous - drug therapy Cystadenocarcinoma, Serous - secondary Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease Progression Endometrial Neoplasms - drug therapy Endometrial Neoplasms - secondary Female Humans Immunoenzyme Techniques Middle Aged Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - pathology Neoplasm Staging Ovarian Neoplasms - drug therapy Ovarian Neoplasms - pathology Prognosis Prospective Studies Survival Rate Treatment Outcome Young Adult |
Title | Gemcitabine and carboplatin treatment in patients with relapsing ovarian cancer |
URI | https://www.ncbi.nlm.nih.gov/pubmed/19473054 |
Volume | 56 |
hasFullText | |
inHoldings | 1 |
isFullTextHit | |
isPrint | |
link | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV07T8MwELYoLCwIxPslD6yBPJzXiCoeQmoZaKVukX1xREWbRG3pwK_nHCdNGgECFiuNIyvO9_l6d747E3Jl2wG3pckMO1bbjH7iGYGFjRDCB8ZNhxVbMb2-9zhkTyN3VKcQFNklC3ENH1_mlfwHVbyHuKos2T8guxoUb-A14ostIoztrzB-kFNA214oTbHIT-MzkeUqui1tRJDX1VPLVDaVv5IXPoJsiaYyrnBQ2M-aimpfRZbzeS21X96TyRitYO1rXXmXu684RiphfYdpKReTbDl_42sxxT2V-ztuhGZX3oaw4W2oov8RA08fs1NJUF0avGQKa4pDfRJXW0wzNMtU2VeZqVMww8hkUetJ_M75tEDNChkKIV1o-ufeVt3sqqtDOn6gZF-_9OPo_2gXlRerKtGtJqTrPqlXu2m9WFFYVg_WMj4KJWSwS3ZK64HeairskQ2Z7pPnBg0o0oA2aEBXNKD4o6IBVTSgKxrQkgZU0-CADO_vBt1HozwnwwA7dBcGA7RpwfFj5gC3Qfghh0S6puMrJ5zrSS9GM4B7OBWIuQi4yxIB0lGOG2n63D4km2mWymNCJVi4qkPh2LhKRQJB7JpMcFQCwQcrdk_IkZ5_lOtiKFH1ZU6_7Tkj2zWTzslWgqtPXqAqtxCXBSqfR1lJDg |
link.rule.ids | 786 |
linkProvider | National Library of Medicine |
openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Gemcitabine+and+carboplatin+treatment+in+patients+with+relapsing+ovarian+cancer&rft.jtitle=Neoplasma&rft.au=Sufliarsky%2C+J&rft.au=Chovanec%2C+J&rft.au=Svetlovska%2C+D&rft.au=Minarik%2C+T&rft.date=2009-01-01&rft.issn=0028-2685&rft.volume=56&rft.issue=4&rft.spage=291&rft_id=info:doi/10.4149%2Fneo_2009_04_291&rft_id=info%3Apmid%2F19473054&rft_id=info%3Apmid%2F19473054&rft.externalDocID=19473054 |
thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=0028-2685&client=summon |
thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=0028-2685&client=summon |
thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=0028-2685&client=summon |