E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer
Purpose Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer (SCLC). Methods Patients with previously untreated extensive-stage SCLC with measurable disease, ECOG performan...
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| Veröffentlicht in: | Cancer chemotherapy and pharmacology 2014-01, Vol.73 (1), p.171-180 |
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| creator | Owonikoko, Taofeek K. Aisner, Joseph Wang, Xin Victoria Dahlberg, Suzanne E. Rubin, Eric H. Ramalingam, Suresh S. Gounder, Murugesan Rausch, Paul Gregory Axelrod, Rita S. Schiller, Joan H. |
| description | Purpose
Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer (SCLC).
Methods
Patients with previously untreated extensive-stage SCLC with measurable disease, ECOG performance status of 0–3 and stable brain metastases were eligible. Arm A consisted of topotecan (0.75 mg/m
2
) on days 1, 2 and 3, etoposide (70 mg/m
2
) and cisplatin (20 mg/m
2
) (PET) on days 8, 9 and 10 in a 3-week cycle. Arm B consisted of irinotecan (50 mg/m
2
) and cisplatin (20 mg/m
2
) on days 1 and 8 followed by etoposide (85 mg/m
2
PO bid) on days 3 and 10 (PIE) in a 3-week cycle.
Results
We enrolled 140 patients and randomized 66 eligible patients to each arm. Only 54.5 % of all patients completed the planned maximum 6 cycles. There were grade ≥3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events. The overall response rates (CR + PR) were 69.7 % (90 % CI 59.1–78.9, 95 % CI 57.1–80.4 %) for arm A and 57.6 % (90 % CI 46.7–67.9, 95 % CI 44.8–69.7 %) for arm B. The median progression-free survival and overall survival were 6.4 months (95 % CI 5.4–7.5 months) and 11.9 months (95 % CI 9.6–13.7 months) for arm A and 6.0 months (95 % CI 5.4–7.0 months) and 11.0 months (95 % CI 8.6–13.1 months) for arm B.
Conclusion
Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC. |
| doi_str_mv | 10.1007/s00280-013-2338-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4705842</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3171676661</sourcerecordid><originalsourceid>FETCH-LOGICAL-c500t-5ca5dad4662b9bfbc3f8248251de28694ff7c7a121355b63ce7fc711a39c34c63</originalsourceid><addsrcrecordid>eNp1Uctu1DAUtRCIDgMfwAZZQuwI9TNxWFRCVYGRKrGBteU41zOuMk6wnUL7O_woHmVoy6KruziPe-49CL2m5AMlpDlNhDBFKkJ5xThX1e0TtKKCs4oowZ-iFeFCVLIh4gS9SOmKECIo58_RCRNMKcroCv25kJLQj3jamQR4s8Epz_0NHh3O4zRmsCbgBD9nCBZ6_MvnHYYDknwPp9anaTDZh_fYhB776MMiuUceFWM3Rgy_M4Tkr6FK2WwBp70ZhsrCMOBhDltcrCzEl-iZM0OCV8e5Rj8-X3w__1pdfvuyOf90WVlJSK6kNbI3vahr1rWd6yx3ignFJO2BqboVzjW2MeVsLmVXcwuNsw2lhreWC1vzNTpbfKe520NvIeRoBj1FvzfxRo_G6_-R4Hd6O15r0RCpBCsGb48GcSxXp6yvxjmGkllT0fASQZWxRnRh2TimFMHdbaBEH3rVS6-69KoPverbonnzMNqd4l-RhfDuSDDJmsHF8jmf7nlKtm0rSOGxhZcKFLYQH0R8dPtfNGW_hA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1473694847</pqid></control><display><type>article</type><title>E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Owonikoko, Taofeek K. ; Aisner, Joseph ; Wang, Xin Victoria ; Dahlberg, Suzanne E. ; Rubin, Eric H. ; Ramalingam, Suresh S. ; Gounder, Murugesan ; Rausch, Paul Gregory ; Axelrod, Rita S. ; Schiller, Joan H.</creator><creatorcontrib>Owonikoko, Taofeek K. ; Aisner, Joseph ; Wang, Xin Victoria ; Dahlberg, Suzanne E. ; Rubin, Eric H. ; Ramalingam, Suresh S. ; Gounder, Murugesan ; Rausch, Paul Gregory ; Axelrod, Rita S. ; Schiller, Joan H.</creatorcontrib><description>Purpose
Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer (SCLC).
Methods
Patients with previously untreated extensive-stage SCLC with measurable disease, ECOG performance status of 0–3 and stable brain metastases were eligible. Arm A consisted of topotecan (0.75 mg/m
2
) on days 1, 2 and 3, etoposide (70 mg/m
2
) and cisplatin (20 mg/m
2
) (PET) on days 8, 9 and 10 in a 3-week cycle. Arm B consisted of irinotecan (50 mg/m
2
) and cisplatin (20 mg/m
2
) on days 1 and 8 followed by etoposide (85 mg/m
2
PO bid) on days 3 and 10 (PIE) in a 3-week cycle.
Results
We enrolled 140 patients and randomized 66 eligible patients to each arm. Only 54.5 % of all patients completed the planned maximum 6 cycles. There were grade ≥3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events. The overall response rates (CR + PR) were 69.7 % (90 % CI 59.1–78.9, 95 % CI 57.1–80.4 %) for arm A and 57.6 % (90 % CI 46.7–67.9, 95 % CI 44.8–69.7 %) for arm B. The median progression-free survival and overall survival were 6.4 months (95 % CI 5.4–7.5 months) and 11.9 months (95 % CI 9.6–13.7 months) for arm A and 6.0 months (95 % CI 5.4–7.0 months) and 11.0 months (95 % CI 8.6–13.1 months) for arm B.
Conclusion
Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-013-2338-z</identifier><identifier>PMID: 24288121</identifier><identifier>CODEN: CCPHDZ</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Adult ; Aged ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Camptothecin - administration & dosage ; Camptothecin - analogs & derivatives ; Cancer Research ; Cisplatin - administration & dosage ; Etoposide - administration & dosage ; Female ; Humans ; Irinotecan ; Lung Neoplasms - drug therapy ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasm Staging ; Oncology ; Original Article ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Pneumology ; Small Cell Lung Carcinoma - drug therapy ; Small Cell Lung Carcinoma - mortality ; Small Cell Lung Carcinoma - pathology ; Topoisomerase I Inhibitors - administration & dosage ; Topoisomerase II Inhibitors - administration & dosage ; Topotecan - administration & dosage ; Tumors ; Tumors of the respiratory system and mediastinum]]></subject><ispartof>Cancer chemotherapy and pharmacology, 2014-01, Vol.73 (1), p.171-180</ispartof><rights>Springer-Verlag Berlin Heidelberg 2013</rights><rights>2015 INIST-CNRS</rights><rights>Springer-Verlag Berlin Heidelberg 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c500t-5ca5dad4662b9bfbc3f8248251de28694ff7c7a121355b63ce7fc711a39c34c63</citedby><cites>FETCH-LOGICAL-c500t-5ca5dad4662b9bfbc3f8248251de28694ff7c7a121355b63ce7fc711a39c34c63</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/s00280-013-2338-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00280-013-2338-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,315,781,785,886,27929,27930,41493,42562,51324</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28599940$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24288121$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Owonikoko, Taofeek K.</creatorcontrib><creatorcontrib>Aisner, Joseph</creatorcontrib><creatorcontrib>Wang, Xin Victoria</creatorcontrib><creatorcontrib>Dahlberg, Suzanne E.</creatorcontrib><creatorcontrib>Rubin, Eric H.</creatorcontrib><creatorcontrib>Ramalingam, Suresh S.</creatorcontrib><creatorcontrib>Gounder, Murugesan</creatorcontrib><creatorcontrib>Rausch, Paul Gregory</creatorcontrib><creatorcontrib>Axelrod, Rita S.</creatorcontrib><creatorcontrib>Schiller, Joan H.</creatorcontrib><title>E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose
Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer (SCLC).
Methods
Patients with previously untreated extensive-stage SCLC with measurable disease, ECOG performance status of 0–3 and stable brain metastases were eligible. Arm A consisted of topotecan (0.75 mg/m
2
) on days 1, 2 and 3, etoposide (70 mg/m
2
) and cisplatin (20 mg/m
2
) (PET) on days 8, 9 and 10 in a 3-week cycle. Arm B consisted of irinotecan (50 mg/m
2
) and cisplatin (20 mg/m
2
) on days 1 and 8 followed by etoposide (85 mg/m
2
PO bid) on days 3 and 10 (PIE) in a 3-week cycle.
Results
We enrolled 140 patients and randomized 66 eligible patients to each arm. Only 54.5 % of all patients completed the planned maximum 6 cycles. There were grade ≥3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events. The overall response rates (CR + PR) were 69.7 % (90 % CI 59.1–78.9, 95 % CI 57.1–80.4 %) for arm A and 57.6 % (90 % CI 46.7–67.9, 95 % CI 44.8–69.7 %) for arm B. The median progression-free survival and overall survival were 6.4 months (95 % CI 5.4–7.5 months) and 11.9 months (95 % CI 9.6–13.7 months) for arm A and 6.0 months (95 % CI 5.4–7.0 months) and 11.0 months (95 % CI 8.6–13.1 months) for arm B.
Conclusion
Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Camptothecin - administration & dosage</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Cancer Research</subject><subject>Cisplatin - administration & dosage</subject><subject>Etoposide - administration & dosage</subject><subject>Female</subject><subject>Humans</subject><subject>Irinotecan</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Pneumology</subject><subject>Small Cell Lung Carcinoma - drug therapy</subject><subject>Small Cell Lung Carcinoma - mortality</subject><subject>Small Cell Lung Carcinoma - pathology</subject><subject>Topoisomerase I Inhibitors - administration & dosage</subject><subject>Topoisomerase II Inhibitors - administration & dosage</subject><subject>Topotecan - administration & dosage</subject><subject>Tumors</subject><subject>Tumors of the respiratory system and mediastinum</subject><issn>0344-5704</issn><issn>1432-0843</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1Uctu1DAUtRCIDgMfwAZZQuwI9TNxWFRCVYGRKrGBteU41zOuMk6wnUL7O_woHmVoy6KruziPe-49CL2m5AMlpDlNhDBFKkJ5xThX1e0TtKKCs4oowZ-iFeFCVLIh4gS9SOmKECIo58_RCRNMKcroCv25kJLQj3jamQR4s8Epz_0NHh3O4zRmsCbgBD9nCBZ6_MvnHYYDknwPp9anaTDZh_fYhB776MMiuUceFWM3Rgy_M4Tkr6FK2WwBp70ZhsrCMOBhDltcrCzEl-iZM0OCV8e5Rj8-X3w__1pdfvuyOf90WVlJSK6kNbI3vahr1rWd6yx3ignFJO2BqboVzjW2MeVsLmVXcwuNsw2lhreWC1vzNTpbfKe520NvIeRoBj1FvzfxRo_G6_-R4Hd6O15r0RCpBCsGb48GcSxXp6yvxjmGkllT0fASQZWxRnRh2TimFMHdbaBEH3rVS6-69KoPverbonnzMNqd4l-RhfDuSDDJmsHF8jmf7nlKtm0rSOGxhZcKFLYQH0R8dPtfNGW_hA</recordid><startdate>20140101</startdate><enddate>20140101</enddate><creator>Owonikoko, Taofeek K.</creator><creator>Aisner, Joseph</creator><creator>Wang, Xin Victoria</creator><creator>Dahlberg, Suzanne E.</creator><creator>Rubin, Eric H.</creator><creator>Ramalingam, Suresh S.</creator><creator>Gounder, Murugesan</creator><creator>Rausch, Paul Gregory</creator><creator>Axelrod, Rita S.</creator><creator>Schiller, Joan H.</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><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>7TO</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>5PM</scope></search><sort><creationdate>20140101</creationdate><title>E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer</title><author>Owonikoko, Taofeek K. ; Aisner, Joseph ; Wang, Xin Victoria ; Dahlberg, Suzanne E. ; Rubin, Eric H. ; Ramalingam, Suresh S. ; Gounder, Murugesan ; Rausch, Paul Gregory ; Axelrod, Rita S. ; Schiller, Joan H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c500t-5ca5dad4662b9bfbc3f8248251de28694ff7c7a121355b63ce7fc711a39c34c63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Camptothecin - administration & dosage</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Cancer Research</topic><topic>Cisplatin - administration & dosage</topic><topic>Etoposide - administration & dosage</topic><topic>Female</topic><topic>Humans</topic><topic>Irinotecan</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Pneumology</topic><topic>Small Cell Lung Carcinoma - drug therapy</topic><topic>Small Cell Lung Carcinoma - mortality</topic><topic>Small Cell Lung Carcinoma - pathology</topic><topic>Topoisomerase I Inhibitors - administration & dosage</topic><topic>Topoisomerase II Inhibitors - administration & dosage</topic><topic>Topotecan - administration & dosage</topic><topic>Tumors</topic><topic>Tumors of the respiratory system and mediastinum</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Owonikoko, Taofeek K.</creatorcontrib><creatorcontrib>Aisner, Joseph</creatorcontrib><creatorcontrib>Wang, Xin Victoria</creatorcontrib><creatorcontrib>Dahlberg, Suzanne E.</creatorcontrib><creatorcontrib>Rubin, Eric H.</creatorcontrib><creatorcontrib>Ramalingam, Suresh S.</creatorcontrib><creatorcontrib>Gounder, Murugesan</creatorcontrib><creatorcontrib>Rausch, Paul Gregory</creatorcontrib><creatorcontrib>Axelrod, Rita S.</creatorcontrib><creatorcontrib>Schiller, Joan H.</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>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Owonikoko, Taofeek K.</au><au>Aisner, Joseph</au><au>Wang, Xin Victoria</au><au>Dahlberg, Suzanne E.</au><au>Rubin, Eric H.</au><au>Ramalingam, Suresh S.</au><au>Gounder, Murugesan</au><au>Rausch, Paul Gregory</au><au>Axelrod, Rita S.</au><au>Schiller, Joan H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2014-01-01</date><risdate>2014</risdate><volume>73</volume><issue>1</issue><spage>171</spage><epage>180</epage><pages>171-180</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><coden>CCPHDZ</coden><abstract>Purpose
Sequence-dependent improved efficacy of topoisomerase I followed by topoisomerase 2 inhibitors was assessed in a randomized phase II study in extensive-stage small-cell lung cancer (SCLC).
Methods
Patients with previously untreated extensive-stage SCLC with measurable disease, ECOG performance status of 0–3 and stable brain metastases were eligible. Arm A consisted of topotecan (0.75 mg/m
2
) on days 1, 2 and 3, etoposide (70 mg/m
2
) and cisplatin (20 mg/m
2
) (PET) on days 8, 9 and 10 in a 3-week cycle. Arm B consisted of irinotecan (50 mg/m
2
) and cisplatin (20 mg/m
2
) on days 1 and 8 followed by etoposide (85 mg/m
2
PO bid) on days 3 and 10 (PIE) in a 3-week cycle.
Results
We enrolled 140 patients and randomized 66 eligible patients to each arm. Only 54.5 % of all patients completed the planned maximum 6 cycles. There were grade ≥3 treatment-related adverse events in approximately 70 % of the patients on both arms including 6 treatment-related grade 5 events. The overall response rates (CR + PR) were 69.7 % (90 % CI 59.1–78.9, 95 % CI 57.1–80.4 %) for arm A and 57.6 % (90 % CI 46.7–67.9, 95 % CI 44.8–69.7 %) for arm B. The median progression-free survival and overall survival were 6.4 months (95 % CI 5.4–7.5 months) and 11.9 months (95 % CI 9.6–13.7 months) for arm A and 6.0 months (95 % CI 5.4–7.0 months) and 11.0 months (95 % CI 8.6–13.1 months) for arm B.
Conclusion
Sequential administration of topoisomerase inhibitors did not improve on the historical efficacy of standard platinum-doublet chemotherapy for extensive-stage SCLC.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>24288121</pmid><doi>10.1007/s00280-013-2338-z</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0344-5704 |
| ispartof | Cancer chemotherapy and pharmacology, 2014-01, Vol.73 (1), p.171-180 |
| issn | 0344-5704 1432-0843 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4705842 |
| source | MEDLINE; SpringerNature Journals |
| subjects | Adult Aged Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Camptothecin - administration & dosage Camptothecin - analogs & derivatives Cancer Research Cisplatin - administration & dosage Etoposide - administration & dosage Female Humans Irinotecan Lung Neoplasms - drug therapy Lung Neoplasms - mortality Lung Neoplasms - pathology Male Medical sciences Medicine Medicine & Public Health Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasm Staging Oncology Original Article Pharmacology. Drug treatments Pharmacology/Toxicology Pneumology Small Cell Lung Carcinoma - drug therapy Small Cell Lung Carcinoma - mortality Small Cell Lung Carcinoma - pathology Topoisomerase I Inhibitors - administration & dosage Topoisomerase II Inhibitors - administration & dosage Topotecan - administration & dosage Tumors Tumors of the respiratory system and mediastinum |
| title | E5501: phase II study of topotecan sequenced with etoposide/cisplatin, and irinotecan/cisplatin sequenced with etoposide for extensive-stage small-cell lung cancer |
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