A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma
Abstract Objectives The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharm...
Saved in:
| Published in: | Gynecologic oncology Vol. 138; no. 2; pp. 272 - 277 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
Elsevier Inc
01-08-2015
|
| Subjects: | |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | Abstract Objectives The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. Methods This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20 mg/m2 intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). Results 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24 + weeks [clinical benefit rate 23% (95% CI = 9.77%–46.71%)]. Median PFS was 8.4 weeks (95% CI = 6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p = 0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). Conclusions Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. |
|---|---|
| AbstractList | The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics.
This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20mg/m(2) intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks).
26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24+weeks [clinical benefit rate 23% (95% CI=9.77%-46.71%)]. Median PFS was 8.4 weeks (95% CI=6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p=0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3).
Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. OBJECTIVESThe primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics.METHODSThis two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20mg/m(2) intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks).RESULTS26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24+weeks [clinical benefit rate 23% (95% CI=9.77%-46.71%)]. Median PFS was 8.4 weeks (95% CI=6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p=0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3).CONCLUSIONSHu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20mg/m2 intravenously for 8weeks (1cycle) to a maximum of 3cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24weeks). 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24+weeks [clinical benefit rate 23% (95% CI=9.77%–46.71%)]. Median PFS was 8.4weeks (95% CI=6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1weeks (p=0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. •Phase II study of hu3S193 in platinum resistant/refractory ovarian cancer patients.•Didn’t reach the primary endpoint whit mPFS of 8.4 weeks but safe toxicity profile.•mPFS was higher in patients with no ascites/no visceral disease. Abstract Objectives The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. Methods This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20 mg/m2 intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). Results 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24 + weeks [clinical benefit rate 23% (95% CI = 9.77%–46.71%)]. Median PFS was 8.4 weeks (95% CI = 6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p = 0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). Conclusions Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. |
| Author | Smaletz, Oren Wainstein, Alberto J Cunha-Junior, Geraldo F Azevedo, Sergio J Yeda, Fernanda P Hoffman, Eric W Diz, Maria D.P.E Fontana, Ana G do Carmo, Claudio C Sabbaga, Jorge Costa, Ronaldo L Barrios, Carlos H Scott, Andrew M Maluf, Fernando C Alves, Venâncio A Moro, Ana M Blasbalg, Roberto Madrigal, Vivian |
| Author_xml | – sequence: 1 fullname: Smaletz, Oren – sequence: 2 fullname: Diz, Maria D.P.E – sequence: 3 fullname: do Carmo, Claudio C – sequence: 4 fullname: Sabbaga, Jorge – sequence: 5 fullname: Cunha-Junior, Geraldo F – sequence: 6 fullname: Azevedo, Sergio J – sequence: 7 fullname: Maluf, Fernando C – sequence: 8 fullname: Barrios, Carlos H – sequence: 9 fullname: Costa, Ronaldo L – sequence: 10 fullname: Fontana, Ana G – sequence: 11 fullname: Madrigal, Vivian – sequence: 12 fullname: Wainstein, Alberto J – sequence: 13 fullname: Yeda, Fernanda P – sequence: 14 fullname: Alves, Venâncio A – sequence: 15 fullname: Moro, Ana M – sequence: 16 fullname: Blasbalg, Roberto – sequence: 17 fullname: Scott, Andrew M – sequence: 18 fullname: Hoffman, Eric W |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26026738$$D View this record in MEDLINE/PubMed |
| BookMark | eNqFUk1v1DAQtVAR3RZ-ARLysUhk648kmxyoVFV8rLQSh8KBk-W1J6yXxA6202r_Ez-SCbtw4II0ki37vXl68-aCnPnggZCXnC054_X1fnn4dvBhKRivlgxLyCdkwVlbFXVTtWdkwVjLikZUzTm5SGnPGJOMi2fkXNRM1CvZLMjPWzrudAK6XtMcne7po8s7qn12xQYeXSq-0iH4YPrg8XN-3wZ7oFe7Sd7zVr6mXYg07wDZoPMAPtPQ0bHX2flpoBGSSxlp1xG6qE0O8UDDg0Yp_4Z2uu_DiFeapy1gd0vH6AaNmBGiy2gYRY2Oxvkw6OfkKTISvDidl-TL-3ef7z4Wm08f1ne3m8KUTZmLhtvtqrSgZa35iukOOG9bg4NYlWxrDM6hrKGz2upVa5HChNa26WTJu0pwIS_J1bHvGMOPCVJWg0sG-l57CFNS2JRLWTWVRKg8Qk0MKaFHdTKgOFNzTGqvfsek5pgUwxIz69VJYNoOYP9y_uSCgLdHAKDNBwdRJePAG7AugsnKBvcfgZt_-KZ33hndf4cDpH2YIsaJTlQSiqn7eVPmReGVxOlUtfwFNdu-SQ |
| CitedBy_id | crossref_primary_10_1042_BCJ20200610 crossref_primary_10_1007_s00253_016_7841_9 crossref_primary_10_6061_clinics_2021_e3146 crossref_primary_10_1136_jitc_2020_001222 crossref_primary_10_3390_cancers14030645 crossref_primary_10_3389_fimmu_2022_1104625 crossref_primary_10_1007_s13277_016_5080_4 crossref_primary_10_1093_glycob_cwy023 crossref_primary_10_3390_ijms221910577 crossref_primary_10_3389_fonc_2018_00124 crossref_primary_10_1089_mab_2021_0024 crossref_primary_10_1136_ijgc_2020_002239 crossref_primary_10_1111_tme_12820 crossref_primary_10_3390_biomedicines9081059 crossref_primary_10_1021_acs_joc_9b00537 crossref_primary_10_18632_oncotarget_21959 crossref_primary_10_1016_j_pharmthera_2022_108158 crossref_primary_10_1002_jmr_2690 crossref_primary_10_1080_19420862_2016_1156285 |
| Cites_doi | 10.1073/pnas.91.26.12957 10.1002/1097-0142(19871001)60:7<1561::AID-CNCR2820600725>3.0.CO;2-V 10.1016/0197-2456(89)90015-9 10.1093/jnci/92.3.205 10.1200/JCO.1997.15.4.1309 10.1002/(SICI)1097-0215(19960208)65:4<406::AID-IJC2>3.0.CO;2-0 10.1097/JTO.0b013e3181560dcc 10.3322/caac.20107 10.1089/153685903322328947 10.2165/11591720-000000000-00000 10.1158/1078-0432.CCR-07-0284 10.1200/JCO.2001.19.14.3312 10.1634/theoncologist.5-1-26 10.1200/JCO.2013.51.4489 10.1093/jnci/djh081 |
| ContentType | Journal Article |
| Copyright | Elsevier Inc. 2015 Elsevier Inc. Copyright © 2015 Elsevier Inc. All rights reserved. |
| Copyright_xml | – notice: Elsevier Inc. – notice: 2015 Elsevier Inc. – notice: Copyright © 2015 Elsevier Inc. All rights reserved. |
| DBID | CGR CUY CVF ECM EIF NPM AAYXX CITATION 7X8 |
| DOI | 10.1016/j.ygyno.2015.05.023 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed CrossRef MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) CrossRef MEDLINE - Academic |
| DatabaseTitleList | MEDLINE MEDLINE - Academic |
| Database_xml | – sequence: 1 dbid: ECM name: MEDLINE url: https://search.ebscohost.com/login.aspx?direct=true&db=cmedm&site=ehost-live sourceTypes: Index Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 1095-6859 |
| EndPage | 277 |
| ExternalDocumentID | 10_1016_j_ygyno_2015_05_023 26026738 S0090825815300056 1_s2_0_S0090825815300056 |
| Genre | Multicenter Study Clinical Trial, Phase II Research Support, Non-U.S. Gov't Journal Article |
| GrantInformation_xml | – fundername: (FINEP) grantid: 01.06.0759.00; 01.07.0096.00 |
| GroupedDBID | --- --K --M .1- .55 .FO .GJ .~1 0R~ 1B1 1P~ 1RT 1~. 1~5 29I 3O- 4.4 457 4G. 53G 5GY 5RE 5VS 7-5 71M 8P~ 9JM AABNK AACTN AAEDT AAEDW AAIKJ AAKOC AALRI AAOAW AAQFI AAQQT AAQXK AAXKI AAXUO ABBQC ABFNM ABFRF ABJNI ABMAC ABMZM ABXDB ACDAQ ACGFO ACGFS ACRLP ADBBV ADEZE ADFGL ADMUD AEBSH AEFWE AEKER AENEX AEVXI AFCTW AFFNX AFJKZ AFKWA AFRHN AFTJW AFXIZ AGHFR AGUBO AGYEJ AHHHB AIEXJ AIKHN AITUG AJOXV AJRQY AJUYK AKRWK ALMA_UNASSIGNED_HOLDINGS AMFUW AMRAJ ANZVX ASPBG AVWKF AXJTR AZFZN BKOJK BLXMC BNPGV CAG COF CS3 DM4 DU5 EBS EFBJH EJD EO8 EO9 EP2 EP3 F5P FDB FEDTE FGOYB FIRID FNPLU FYGXN G-2 G-Q GBLVA HED HMK HMO HVGLF HZ~ IH2 IHE J1W K-O KOM L7B LG5 M29 M41 MO0 N9A O-L O9- OAUVE OQ. OZT P-8 P-9 P2P PC. PH~ Q38 R2- RIG ROL RPZ SAE SCC SDF SDG SDP SES SEW SPCBC SSH SSZ T5K UDS UHS UV1 WUQ X7M XPP Z5R ZGI ZMT ZU3 ZXP ~G- AAIAV ABLVK ABYKQ AHPSJ AJBFU EFLBG LCYCR CGR CUY CVF ECM EIF NPM AAYXX CITATION 7X8 |
| ID | FETCH-LOGICAL-c484t-81db74dea36a170afe1199c825740bcc00046efdada79d48402aad8f341f52123 |
| ISSN | 0090-8258 |
| IngestDate | Fri Oct 25 01:58:26 EDT 2024 Thu Sep 26 17:59:38 EDT 2024 Sat Sep 28 08:35:22 EDT 2024 Fri Feb 23 02:31:07 EST 2024 Tue Oct 15 22:55:33 EDT 2024 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 2 |
| Keywords | Anti Lewis-Y monoclonal antibody (hu3S193) platinum resistant/refractory ovarian cancer |
| Language | English |
| License | Copyright © 2015 Elsevier Inc. All rights reserved. |
| LinkModel | OpenURL |
| MergedId | FETCHMERGED-LOGICAL-c484t-81db74dea36a170afe1199c825740bcc00046efdada79d48402aad8f341f52123 |
| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 |
| PMID | 26026738 |
| PQID | 1701335853 |
| PQPubID | 23479 |
| PageCount | 6 |
| ParticipantIDs | proquest_miscellaneous_1701335853 crossref_primary_10_1016_j_ygyno_2015_05_023 pubmed_primary_26026738 elsevier_sciencedirect_doi_10_1016_j_ygyno_2015_05_023 elsevier_clinicalkeyesjournals_1_s2_0_S0090825815300056 |
| PublicationCentury | 2000 |
| PublicationDate | 2015-08-01 |
| PublicationDateYYYYMMDD | 2015-08-01 |
| PublicationDate_xml | – month: 08 year: 2015 text: 2015-08-01 day: 01 |
| PublicationDecade | 2010 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Gynecologic oncology |
| PublicationTitleAlternate | Gynecol Oncol |
| PublicationYear | 2015 |
| Publisher | Elsevier Inc |
| Publisher_xml | – name: Elsevier Inc |
| References | Dauplat, Hacker, Nieberg, Berek, Rose, Sagae (bb0100) 1987; 60 Yin, Finstad, Kitamura, Federici, Welshinger, Kudryashov (bb0020) 1996; 65 Scott, Geleick, Rubira, Clarke, Nice, Smyth (bb0030) 2000; 60 Krug, Milton, Jungbluth, Chen, Quaia, Pandit-Taskar (bb0040) 2007; 2 Pujade-Lauraine, Hilpert, Weber, Reuss, Poveda, Kristensen (bb0085) 2014; 32 Jemal, Bray, Center, Ferlay, Ward, Forman (bb0005) 2011; 61 Liu, Panousis, Smyth, Murphy, Wirth, Cartwright (bb0065) 2003; 22 Ritter, Cohen, Williams, Richards, Old, Welt (bb0060) 2001; 61 Scott, Tebbutt, Lee, Cavicchiolo, Liu, Gill (bb0035) 2007; 13 Gordon, Fleagle, Guthrie, Parkin, Gore, Lacave (bb0080) 2001; 19 Stiff, Bayer, Kerger, Potkul, Malhotra, Peace (bb0090) 1997; 15 Kitamura, Stockert, Garin-Chesa, Welt, Lloyd, Armour (bb0025) 1994; 91 Sabbatini (bb0105) 2005; 3 (bb0055) August 9, 2006 Simon (bb0075) 1989; 10 Naumann, Coleman (bb0010) 2011; 71 Markman, Bookman (bb0045) 2000; 5 Sakamoto, Furukawa, Cordon-Cardo, Yin, Rettig, Oettgen (bb0015) 1986; 46 Therasse, Arbuck, Eisenhauer, Wanders, Kaplan, Rubinstein (bb0050) 2000; 92 Rustin, Quinn, Thigpen, du Bois, Pujade-Lauraine, Jakobsen (bb0070) 2004; 96 Neumann, Fotopoulou, Schmeding, Thelen, Papanikolaou, Braicu (bb0095) 2012; 32 Markman (10.1016/j.ygyno.2015.05.023_bb0045) 2000; 5 Sabbatini (10.1016/j.ygyno.2015.05.023_bb0105) 2005; 3 Pujade-Lauraine (10.1016/j.ygyno.2015.05.023_bb0085) 2014; 32 Yin (10.1016/j.ygyno.2015.05.023_bb0020) 1996; 65 Liu (10.1016/j.ygyno.2015.05.023_bb0065) 2003; 22 Stiff (10.1016/j.ygyno.2015.05.023_bb0090) 1997; 15 Neumann (10.1016/j.ygyno.2015.05.023_bb0095) 2012; 32 Simon (10.1016/j.ygyno.2015.05.023_bb0075) 1989; 10 Scott (10.1016/j.ygyno.2015.05.023_bb0035) 2007; 13 Krug (10.1016/j.ygyno.2015.05.023_bb0040) 2007; 2 Kitamura (10.1016/j.ygyno.2015.05.023_bb0025) 1994; 91 Therasse (10.1016/j.ygyno.2015.05.023_bb0050) 2000; 92 Jemal (10.1016/j.ygyno.2015.05.023_bb0005) 2011; 61 Scott (10.1016/j.ygyno.2015.05.023_bb0030) 2000; 60 Gordon (10.1016/j.ygyno.2015.05.023_bb0080) 2001; 19 Ritter (10.1016/j.ygyno.2015.05.023_bb0060) 2001; 61 Rustin (10.1016/j.ygyno.2015.05.023_bb0070) 2004; 96 Sakamoto (10.1016/j.ygyno.2015.05.023_bb0015) 1986; 46 Dauplat (10.1016/j.ygyno.2015.05.023_bb0100) 1987; 60 (10.1016/j.ygyno.2015.05.023_bb0055) 2006 Naumann (10.1016/j.ygyno.2015.05.023_bb0010) 2011; 71 |
| References_xml | – volume: 5 start-page: 26 year: 2000 end-page: 35 ident: bb0045 article-title: Second-line treatment of ovarian cancer publication-title: Oncologist contributor: fullname: Bookman – volume: 61 start-page: 69 year: 2011 end-page: 90 ident: bb0005 article-title: Global cancer statistics publication-title: CA Cancer J. Clin. contributor: fullname: Forman – volume: 19 start-page: 3312 year: 2001 end-page: 3322 ident: bb0080 article-title: Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan publication-title: J. Clin. Oncol. contributor: fullname: Lacave – volume: 2 start-page: 947 year: 2007 end-page: 952 ident: bb0040 article-title: Targeting Lewis Y (Le(y)) in small cell lung cancer with a humanized monoclonal antibody, hu3S193: a pilot trial testing two dose levels publication-title: J. Thorac. Oncol. contributor: fullname: Pandit-Taskar – volume: 32 start-page: 1302 year: 2014 end-page: 1308 ident: bb0085 article-title: Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial publication-title: J. Clin. Oncol. contributor: fullname: Kristensen – volume: 3 start-page: 840 year: 2005 end-page: 842 ident: bb0105 article-title: New agents and new formulations for the treatment of ovarian cancer publication-title: Clin. Adv. Hematol. Oncol. contributor: fullname: Sabbatini – volume: 60 start-page: 3254 year: 2000 end-page: 3261 ident: bb0030 article-title: Construction, production, and characterization of humanized anti-Lewis Y monoclonal antibody 3S193 for targeted immunotherapy of solid tumors publication-title: Cancer Res. contributor: fullname: Smyth – volume: 22 start-page: 219 year: 2003 end-page: 228 ident: bb0065 article-title: Generation of anti-idiotype antibodies for application in clinical immunotherapy laboratory analyses publication-title: Hybrid. Hybridomics contributor: fullname: Cartwright – volume: 15 start-page: 1309 year: 1997 end-page: 1317 ident: bb0090 article-title: High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients publication-title: J. Clin. Oncol. contributor: fullname: Peace – volume: 65 start-page: 406 year: 1996 end-page: 412 ident: bb0020 article-title: Serological and immunochemical analysis of Lewis y (Ley) blood group antigen expression in epithelial ovarian cancer publication-title: Int. J. Cancer contributor: fullname: Kudryashov – volume: 32 start-page: 4517 year: 2012 end-page: 4521 ident: bb0095 article-title: Clinical outcome of patients with advanced ovarian cancer after resection of liver metastases publication-title: Anticancer Res. contributor: fullname: Braicu – volume: 96 start-page: 487 year: 2004 end-page: 488 ident: bb0070 article-title: Re: new guidelines to evaluate the response to treatment in solid tumors (ovarian cancer) publication-title: J. Natl. Cancer Inst. contributor: fullname: Jakobsen – volume: 13 start-page: 3286 year: 2007 end-page: 3292 ident: bb0035 article-title: A phase I biodistribution and pharmacokinetic trial of humanized monoclonal antibody hu3s193 in patients with advanced epithelial cancers that express the Lewis-Y antigen publication-title: Clin. Cancer Res. contributor: fullname: Gill – volume: 61 start-page: 6851 year: 2001 end-page: 6859 ident: bb0060 article-title: Serological analysis of human anti-human antibody responses in colon cancer patients treated with repeated doses of humanized monoclonal antibody A33 publication-title: Cancer Res. contributor: fullname: Welt – year: August 9, 2006 ident: bb0055 publication-title: Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0 – volume: 10 start-page: 1 year: 1989 end-page: 10 ident: bb0075 article-title: Optimal two-stage designs for phase II clinical trials publication-title: Control. Clin. Trials contributor: fullname: Simon – volume: 71 start-page: 1397 year: 2011 end-page: 1412 ident: bb0010 article-title: Management strategies for recurrent platinum-resistant ovarian cancer publication-title: Drugs contributor: fullname: Coleman – volume: 92 start-page: 205 year: 2000 end-page: 216 ident: bb0050 article-title: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada publication-title: J. Natl. Cancer Inst. contributor: fullname: Rubinstein – volume: 46 start-page: 1553 year: 1986 end-page: 1561 ident: bb0015 article-title: Expression of Lewisa, Lewisb, X, and Y blood group antigens in human colonic tumors and normal tissue and in human tumor-derived cell lines publication-title: Cancer Res. contributor: fullname: Oettgen – volume: 60 start-page: 1561 year: 1987 end-page: 1566 ident: bb0100 article-title: Distant metastases in epithelial ovarian carcinoma publication-title: Cancer contributor: fullname: Sagae – volume: 91 start-page: 12957 year: 1994 end-page: 12961 ident: bb0025 article-title: Specificity analysis of blood group Lewis-y (Le(y)) antibodies generatedagainst synthetic and natural Le(y) determinants publication-title: Proc. Natl. Acad. Sci. U. S. A. contributor: fullname: Armour – volume: 91 start-page: 12957 issue: 26 year: 1994 ident: 10.1016/j.ygyno.2015.05.023_bb0025 article-title: Specificity analysis of blood group Lewis-y (Le(y)) antibodies generatedagainst synthetic and natural Le(y) determinants publication-title: Proc. Natl. Acad. Sci. U. S. A. doi: 10.1073/pnas.91.26.12957 contributor: fullname: Kitamura – volume: 60 start-page: 3254 issue: 12 year: 2000 ident: 10.1016/j.ygyno.2015.05.023_bb0030 article-title: Construction, production, and characterization of humanized anti-Lewis Y monoclonal antibody 3S193 for targeted immunotherapy of solid tumors publication-title: Cancer Res. contributor: fullname: Scott – volume: 60 start-page: 1561 issue: 7 year: 1987 ident: 10.1016/j.ygyno.2015.05.023_bb0100 article-title: Distant metastases in epithelial ovarian carcinoma publication-title: Cancer doi: 10.1002/1097-0142(19871001)60:7<1561::AID-CNCR2820600725>3.0.CO;2-V contributor: fullname: Dauplat – volume: 10 start-page: 1 issue: 1 year: 1989 ident: 10.1016/j.ygyno.2015.05.023_bb0075 article-title: Optimal two-stage designs for phase II clinical trials publication-title: Control. Clin. Trials doi: 10.1016/0197-2456(89)90015-9 contributor: fullname: Simon – volume: 92 start-page: 205 issue: 3 year: 2000 ident: 10.1016/j.ygyno.2015.05.023_bb0050 article-title: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada publication-title: J. Natl. Cancer Inst. doi: 10.1093/jnci/92.3.205 contributor: fullname: Therasse – volume: 15 start-page: 1309 issue: 4 year: 1997 ident: 10.1016/j.ygyno.2015.05.023_bb0090 article-title: High-dose chemotherapy with autologous transplantation for persistent/relapsed ovarian cancer: a multivariate analysis of survival for 100 consecutively treated patients publication-title: J. Clin. Oncol. doi: 10.1200/JCO.1997.15.4.1309 contributor: fullname: Stiff – volume: 65 start-page: 406 issue: 4 year: 1996 ident: 10.1016/j.ygyno.2015.05.023_bb0020 article-title: Serological and immunochemical analysis of Lewis y (Ley) blood group antigen expression in epithelial ovarian cancer publication-title: Int. J. Cancer doi: 10.1002/(SICI)1097-0215(19960208)65:4<406::AID-IJC2>3.0.CO;2-0 contributor: fullname: Yin – volume: 46 start-page: 1553 issue: 3 year: 1986 ident: 10.1016/j.ygyno.2015.05.023_bb0015 article-title: Expression of Lewisa, Lewisb, X, and Y blood group antigens in human colonic tumors and normal tissue and in human tumor-derived cell lines publication-title: Cancer Res. contributor: fullname: Sakamoto – volume: 2 start-page: 947 issue: 10 year: 2007 ident: 10.1016/j.ygyno.2015.05.023_bb0040 article-title: Targeting Lewis Y (Le(y)) in small cell lung cancer with a humanized monoclonal antibody, hu3S193: a pilot trial testing two dose levels publication-title: J. Thorac. Oncol. doi: 10.1097/JTO.0b013e3181560dcc contributor: fullname: Krug – volume: 32 start-page: 4517 issue: 10 year: 2012 ident: 10.1016/j.ygyno.2015.05.023_bb0095 article-title: Clinical outcome of patients with advanced ovarian cancer after resection of liver metastases publication-title: Anticancer Res. contributor: fullname: Neumann – volume: 61 start-page: 6851 issue: 18 year: 2001 ident: 10.1016/j.ygyno.2015.05.023_bb0060 article-title: Serological analysis of human anti-human antibody responses in colon cancer patients treated with repeated doses of humanized monoclonal antibody A33 publication-title: Cancer Res. contributor: fullname: Ritter – volume: 61 start-page: 69 issue: 2 year: 2011 ident: 10.1016/j.ygyno.2015.05.023_bb0005 article-title: Global cancer statistics publication-title: CA Cancer J. Clin. doi: 10.3322/caac.20107 contributor: fullname: Jemal – volume: 22 start-page: 219 issue: 4 year: 2003 ident: 10.1016/j.ygyno.2015.05.023_bb0065 article-title: Generation of anti-idiotype antibodies for application in clinical immunotherapy laboratory analyses publication-title: Hybrid. Hybridomics doi: 10.1089/153685903322328947 contributor: fullname: Liu – volume: 3 start-page: 840 issue: 11 year: 2005 ident: 10.1016/j.ygyno.2015.05.023_bb0105 article-title: New agents and new formulations for the treatment of ovarian cancer publication-title: Clin. Adv. Hematol. Oncol. contributor: fullname: Sabbatini – volume: 71 start-page: 1397 issue: 11 year: 2011 ident: 10.1016/j.ygyno.2015.05.023_bb0010 article-title: Management strategies for recurrent platinum-resistant ovarian cancer publication-title: Drugs doi: 10.2165/11591720-000000000-00000 contributor: fullname: Naumann – volume: 13 start-page: 3286 issue: 11 year: 2007 ident: 10.1016/j.ygyno.2015.05.023_bb0035 article-title: A phase I biodistribution and pharmacokinetic trial of humanized monoclonal antibody hu3s193 in patients with advanced epithelial cancers that express the Lewis-Y antigen publication-title: Clin. Cancer Res. doi: 10.1158/1078-0432.CCR-07-0284 contributor: fullname: Scott – volume: 19 start-page: 3312 issue: 14 year: 2001 ident: 10.1016/j.ygyno.2015.05.023_bb0080 article-title: Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan publication-title: J. Clin. Oncol. doi: 10.1200/JCO.2001.19.14.3312 contributor: fullname: Gordon – volume: 5 start-page: 26 issue: 1 year: 2000 ident: 10.1016/j.ygyno.2015.05.023_bb0045 article-title: Second-line treatment of ovarian cancer publication-title: Oncologist doi: 10.1634/theoncologist.5-1-26 contributor: fullname: Markman – volume: 32 start-page: 1302 year: 2014 ident: 10.1016/j.ygyno.2015.05.023_bb0085 article-title: Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial publication-title: J. Clin. Oncol. doi: 10.1200/JCO.2013.51.4489 contributor: fullname: Pujade-Lauraine – volume: 96 start-page: 487 issue: 6 year: 2004 ident: 10.1016/j.ygyno.2015.05.023_bb0070 article-title: Re: new guidelines to evaluate the response to treatment in solid tumors (ovarian cancer) publication-title: J. Natl. Cancer Inst. doi: 10.1093/jnci/djh081 contributor: fullname: Rustin – year: 2006 ident: 10.1016/j.ygyno.2015.05.023_bb0055 |
| SSID | ssj0003012 |
| Score | 2.3084598 |
| Snippet | Abstract Objectives The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in... The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum... OBJECTIVESThe primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with... |
| SourceID | proquest crossref pubmed elsevier |
| SourceType | Aggregation Database Index Database Publisher |
| StartPage | 272 |
| SubjectTerms | Adult Aged Anti Lewis-Y monoclonal antibody (hu3S193) Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - immunology Antibodies, Monoclonal, Humanized - pharmacokinetics Carcinoma, Ovarian Epithelial Disease-Free Survival Drug Resistance, Neoplasm Fallopian Tube Neoplasms - immunology Fallopian Tube Neoplasms - metabolism Fallopian Tube Neoplasms - therapy Female Hematology, Oncology and Palliative Medicine Humans Lewis Blood-Group System - immunology Middle Aged Neoplasms, Glandular and Epithelial - immunology Neoplasms, Glandular and Epithelial - metabolism Neoplasms, Glandular and Epithelial - therapy Obstetrics and Gynecology Organoplatinum Compounds - pharmacology Ovarian Neoplasms - immunology Ovarian Neoplasms - metabolism Ovarian Neoplasms - therapy Peritoneal Neoplasms - immunology Peritoneal Neoplasms - metabolism Peritoneal Neoplasms - therapy platinum resistant/refractory ovarian cancer Young Adult |
| Title | A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma |
| URI | https://www.clinicalkey.es/playcontent/1-s2.0-S0090825815300056 https://dx.doi.org/10.1016/j.ygyno.2015.05.023 https://www.ncbi.nlm.nih.gov/pubmed/26026738 https://search.proquest.com/docview/1701335853 |
| Volume | 138 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://sdu.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwtV3pi9NAFB-6K4hfxNt6MYIflGy6uY-PxXbdihd2BfXLMMkkbpbdpGwbpf5N_pG-N0fSdVlRQSihTJjMpO_Xd807CHkSuhy0AC-0eZSCgZK7hZ1EaWYHSRbxGKb4str-_jx-8zGZTIPpYGCaX_Zj_5XSMAa0xszZv6B291AYgO9Ac7gC1eH6R3QfW4tDkEzWbGapjhw6e21V2a-Kb9XS_mTBXpr8WLoAcTxrhDzyP2z9uYtVn9Iu9rAPQ29kw-lVhYHzYKGj1okVC_ZAwJ7Klj1rq_kKdrfyp5Z4nL9A3rFqdTDHQpe1wMrKWAAc65JgH6O60ZJBa8gv1nWRK45sNXV-xus_PwFxJhvQWm83ctgm1XeddlRxazJ6N5qOzC3RYEjLifIHH_NWVDDQ3Z3zLOPKs_wSjwY2XSBu2AXgab-cyc05EzoKyiMmyavC8KNCsXdQKO0o0TXIDf_3kw2ge5vcXHUV0oqBp_rNnJM5yv1xNFp_WdeYTuqGshasSqP-pZj3HHeFmwJBg-pytEUuecAikUN_Dt93OgSwXVXnXr-DqZclIxPPLXSRTnWRzSR1p4Nr5Ko2euhYofU6GRT1DXL5tQ7ruEl-jKkELZ3NqAQtRdDSTdDSHrTUgJY-1ZB9RgGwFABLO8DSpqQGsLQD7G4PV6rhukM7sFIEKzxdUA1W2oOVdmC9RT7sTQ-e79u6jYidB0mwssEiy-JAFNyPuBs7vCxcN01z-FnjwMnyXCZQF6XggsepgCmOx7lIStDvSpnZfpts17DUXUIzxwNuhgGabhkETpr5PCtEyjO3dAVY7kOyYwjB9E6ZCaM8YpJuDOnGHPh4_pDEhljMJEKD6C6Wmp8smcuWHnPYOdgMSdTN1KqyUoEZoPL3Sz42oGAgSPB0kNdF08JSMViDfgjq-5DcUWjp3sGTjer85N6_LnufXOn_uA_I9uq0LR6SraVoH0ng_wQ60vmt |
| link.rule.ids | 315,782,786,27933,27934 |
| linkProvider | Elsevier |
| 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=A+phase+II+trial+with+anti-Lewis-Y+monoclonal+antibody+%28hu3S193%29+for+the+treatment+of+platinum+resistant%2Frefractory+ovarian%2C+fallopian+tube+and+primary+peritoneal+carcinoma&rft.jtitle=Gynecologic+oncology&rft.au=Smaletz%2C+Oren&rft.au=Diz%2C+Maria+D.P.E.&rft.au=do+Carmo%2C+Claudio+C.&rft.au=Sabbaga%2C+Jorge&rft.date=2015-08-01&rft.pub=Elsevier+Inc&rft.issn=0090-8258&rft.eissn=1095-6859&rft.volume=138&rft.issue=2&rft.spage=272&rft.epage=277&rft_id=info:doi/10.1016%2Fj.ygyno.2015.05.023&rft.externalDocID=S0090825815300056 |
| thumbnail_m | http://sdu.summon.serialssolutions.com/2.0.0/image/custom?url=https%3A%2F%2Fcdn.clinicalkey.com%2Fck-thumbnails%2F00908258%2FS0090825815X00102%2Fcov150h.gif |