Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer
Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and m...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Kaira, Kyoichi [verfasserIn] Sunaga, Noriaki [verfasserIn] Imai, Hisao [verfasserIn] Kamide, Yosuke [verfasserIn] Koga, Yasuhiko [verfasserIn] Ono, Akihiro [verfasserIn] Kuwako, Tomohito [verfasserIn] Masuda, Tomomi [verfasserIn] Hisada, Takeshi [verfasserIn] Ishizuka, Tamotsu [verfasserIn] Yamada, Masanobu [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2015 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: International journal of clinical oncology - Tokyo : Springer, 1996, 21(2015), 2 vom: 13. Aug., Seite 240-247 |
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| Übergeordnetes Werk: |
volume:21 ; year:2015 ; number:2 ; day:13 ; month:08 ; pages:240-247 |
| Links: |
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| DOI / URN: |
10.1007/s10147-015-0883-7 |
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| Katalog-ID: |
SPR008909717 |
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| 245 | 1 | 0 | |a Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer |
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| 520 | |a Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. | ||
| 650 | 4 | |a Amrubicin |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Paclitaxel |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a NSCLC |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Phase I |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Topoisomerase II |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Class III β-tubulin |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Sunaga, Noriaki |e verfasserin |4 aut | |
| 700 | 1 | |a Imai, Hisao |e verfasserin |4 aut | |
| 700 | 1 | |a Kamide, Yosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Koga, Yasuhiko |e verfasserin |4 aut | |
| 700 | 1 | |a Ono, Akihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kuwako, Tomohito |e verfasserin |4 aut | |
| 700 | 1 | |a Masuda, Tomomi |e verfasserin |4 aut | |
| 700 | 1 | |a Hisada, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ishizuka, Tamotsu |e verfasserin |4 aut | |
| 700 | 1 | |a Yamada, Masanobu |e verfasserin |4 aut | |
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10.1007/s10147-015-0883-7 doi (DE-627)SPR008909717 (SPR)s10147-015-0883-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Kaira, Kyoichi verfasserin aut Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 Sunaga, Noriaki verfasserin aut Imai, Hisao verfasserin aut Kamide, Yosuke verfasserin aut Koga, Yasuhiko verfasserin aut Ono, Akihiro verfasserin aut Kuwako, Tomohito verfasserin aut Masuda, Tomomi verfasserin aut Hisada, Takeshi verfasserin aut Ishizuka, Tamotsu verfasserin aut Yamada, Masanobu verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 21(2015), 2 vom: 13. Aug., Seite 240-247 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:21 year:2015 number:2 day:13 month:08 pages:240-247 https://dx.doi.org/10.1007/s10147-015-0883-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 21 2015 2 13 08 240-247 |
| spelling |
10.1007/s10147-015-0883-7 doi (DE-627)SPR008909717 (SPR)s10147-015-0883-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Kaira, Kyoichi verfasserin aut Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 Sunaga, Noriaki verfasserin aut Imai, Hisao verfasserin aut Kamide, Yosuke verfasserin aut Koga, Yasuhiko verfasserin aut Ono, Akihiro verfasserin aut Kuwako, Tomohito verfasserin aut Masuda, Tomomi verfasserin aut Hisada, Takeshi verfasserin aut Ishizuka, Tamotsu verfasserin aut Yamada, Masanobu verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 21(2015), 2 vom: 13. Aug., Seite 240-247 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:21 year:2015 number:2 day:13 month:08 pages:240-247 https://dx.doi.org/10.1007/s10147-015-0883-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 21 2015 2 13 08 240-247 |
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10.1007/s10147-015-0883-7 doi (DE-627)SPR008909717 (SPR)s10147-015-0883-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Kaira, Kyoichi verfasserin aut Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 Sunaga, Noriaki verfasserin aut Imai, Hisao verfasserin aut Kamide, Yosuke verfasserin aut Koga, Yasuhiko verfasserin aut Ono, Akihiro verfasserin aut Kuwako, Tomohito verfasserin aut Masuda, Tomomi verfasserin aut Hisada, Takeshi verfasserin aut Ishizuka, Tamotsu verfasserin aut Yamada, Masanobu verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 21(2015), 2 vom: 13. Aug., Seite 240-247 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:21 year:2015 number:2 day:13 month:08 pages:240-247 https://dx.doi.org/10.1007/s10147-015-0883-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 21 2015 2 13 08 240-247 |
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10.1007/s10147-015-0883-7 doi (DE-627)SPR008909717 (SPR)s10147-015-0883-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Kaira, Kyoichi verfasserin aut Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 Sunaga, Noriaki verfasserin aut Imai, Hisao verfasserin aut Kamide, Yosuke verfasserin aut Koga, Yasuhiko verfasserin aut Ono, Akihiro verfasserin aut Kuwako, Tomohito verfasserin aut Masuda, Tomomi verfasserin aut Hisada, Takeshi verfasserin aut Ishizuka, Tamotsu verfasserin aut Yamada, Masanobu verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 21(2015), 2 vom: 13. Aug., Seite 240-247 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:21 year:2015 number:2 day:13 month:08 pages:240-247 https://dx.doi.org/10.1007/s10147-015-0883-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 21 2015 2 13 08 240-247 |
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10.1007/s10147-015-0883-7 doi (DE-627)SPR008909717 (SPR)s10147-015-0883-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Kaira, Kyoichi verfasserin aut Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 Sunaga, Noriaki verfasserin aut Imai, Hisao verfasserin aut Kamide, Yosuke verfasserin aut Koga, Yasuhiko verfasserin aut Ono, Akihiro verfasserin aut Kuwako, Tomohito verfasserin aut Masuda, Tomomi verfasserin aut Hisada, Takeshi verfasserin aut Ishizuka, Tamotsu verfasserin aut Yamada, Masanobu verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 21(2015), 2 vom: 13. Aug., Seite 240-247 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:21 year:2015 number:2 day:13 month:08 pages:240-247 https://dx.doi.org/10.1007/s10147-015-0883-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 21 2015 2 13 08 240-247 |
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Enthalten in International journal of clinical oncology 21(2015), 2 vom: 13. Aug., Seite 240-247 volume:21 year:2015 number:2 day:13 month:08 pages:240-247 |
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Enthalten in International journal of clinical oncology 21(2015), 2 vom: 13. Aug., Seite 240-247 volume:21 year:2015 number:2 day:13 month:08 pages:240-247 |
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Amrubicin Paclitaxel NSCLC Phase I Topoisomerase II Class III β-tubulin |
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International journal of clinical oncology |
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Kaira, Kyoichi @@aut@@ Sunaga, Noriaki @@aut@@ Imai, Hisao @@aut@@ Kamide, Yosuke @@aut@@ Koga, Yasuhiko @@aut@@ Ono, Akihiro @@aut@@ Kuwako, Tomohito @@aut@@ Masuda, Tomomi @@aut@@ Hisada, Takeshi @@aut@@ Ishizuka, Tamotsu @@aut@@ Yamada, Masanobu @@aut@@ |
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Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. 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Kaira, Kyoichi |
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Kaira, Kyoichi ddc 610 bkl 44.81 misc Amrubicin misc Paclitaxel misc NSCLC misc Phase I misc Topoisomerase II misc Class III β-tubulin Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer |
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610 ASE 44.81 bkl Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer Amrubicin (dpeaa)DE-He213 Paclitaxel (dpeaa)DE-He213 NSCLC (dpeaa)DE-He213 Phase I (dpeaa)DE-He213 Topoisomerase II (dpeaa)DE-He213 Class III β-tubulin (dpeaa)DE-He213 |
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ddc 610 bkl 44.81 misc Amrubicin misc Paclitaxel misc NSCLC misc Phase I misc Topoisomerase II misc Class III β-tubulin |
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ddc 610 bkl 44.81 misc Amrubicin misc Paclitaxel misc NSCLC misc Phase I misc Topoisomerase II misc Class III β-tubulin |
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Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer |
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Kaira, Kyoichi Sunaga, Noriaki Imai, Hisao Kamide, Yosuke Koga, Yasuhiko Ono, Akihiro Kuwako, Tomohito Masuda, Tomomi Hisada, Takeshi Ishizuka, Tamotsu Yamada, Masanobu |
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phase i dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer |
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Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer |
| abstract |
Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. |
| abstractGer |
Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. |
| abstract_unstemmed |
Background We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small cell lung cancer (NSCLC). Patients and methods PTX was administered at a fixed dose of 150 mg/$ m^{2} $/day on day 1 and AMR was intravenously administered at a starting dose of 25 mg/$ m^{2} $/day on days 1–3, and this was repeated every 4 weeks. Doses of each drug were planned as follows—level 0, 20/150; level 1, 25/150; level 2, 30/150; level 3, 30/180 AMR mg/$ m^{2} $ per day/PTX mg/$ m^{2} $ per day. Results Twelve patients were enrolled in this study. The dose-limiting toxicity (DLT) of the regimen was assessed during the first cycle. At level 1, all three patients developed a DLT due to grade 4 neutropenia lasting >4 days, grade 4 thrombocytopenia and grade 3 febrile neutropenia. Therefore, level 1 was considered the MTD and level 0 was selected as the RD. Objective responses were seen in two patients (response rate 16.7 %). Overall disease control rate was 91.7 %. Conclusions The combination of AMR and PTX is a feasible and well-tolerated regimen for the treatment of patients with previously treated advanced NSCLC. Although our study included a small number of patients, encouraging disease control and progression-free survival were achieved at the recommended doses. Further clinical trials are warranted. |
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| score |
7.3987417 |