Randomized Phase II Trial of Irinotecan with Paclitaxel or Gemcitabine for Non-small Cell Lung Cancer: Association of UGT1A16 and UGT1A127 with Severe Neutropenia
Irinotecan-containing regimens are known to be active and tolerable in patients with non-small cell lung cancer (NSCLC). A randomized phase II trial was conducted to evaluate the efficacy of irinotecan plus paclitaxel or gemcitabine for previously untreated stage IIIB or stage IV NSCLC. Previously u...
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| Veröffentlicht in: | Journal of thoracic oncology 2011-01, Vol.6 (1), p.121-127 |
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| creator | Nakamura, Yoichi Soda, Hiroshi Oka, Mikio Kinoshita, Akitoshi Fukuda, Minoru Fukuda, Masaaki Takatani, Hiroshi Nagashima, Seiji Soejima, Yoshifumi Kasai, Takashi Nakatomi, Katsumi Masuda, Noriyuki Tsukamoto, Kazuhiro Kohno, Shigeru |
| description | Irinotecan-containing regimens are known to be active and tolerable in patients with non-small cell lung cancer (NSCLC). A randomized phase II trial was conducted to evaluate the efficacy of irinotecan plus paclitaxel or gemcitabine for previously untreated stage IIIB or stage IV NSCLC.
Previously untreated patients with adequate organ function who gave written informed consent were randomly assigned to receive irinotecan (50 mg/m2 on days 1, 8, and 15) plus paclitaxel (180 mg/m2 on day 1) every 4 weeks (IP group) or irinotecan (100 mg/m2 on days 1 and 8) plus gemcitabine (1000 mg/m2 on days 1 and 8) every 3 weeks (IG group). The primary endpoint was the response rate. We also evaluated the relationship of response and toxicity to polymorphisms of the uridine diphosphate glucuronosyltransferase (UGT) gene.
Eighty patients were enrolled, and 78 patients were eligible (38 in the IP group and 40 in the IG group). The response rate was 31.6% (95% confidence interval: 17.5–48.7%) in the IP group and 20.0% (9.1–35.6%) in the IG group. The median progression-free survival time was 86 days and 145 days, respectively. Both regimens were well tolerated. The most common severe adverse event was grade 4 neutropenia (36.8% and 10.0%, respectively), which was associated with UGT1A1*6 and UGT1A1*27. UGT polymorphisms did not correlate with response.
Irinotecan plus paclitaxel may be more active against NSCLC than irinotecan plus gemcitabine. The UGT1A1*6 and UGT1A1*27 genotypes might be useful predictors of grade 4 neutropenia in patients who receive irinotecan-based chemotherapy. |
| doi_str_mv | 10.1097/JTO.0b013e318200e4e8 |
| format | Article |
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Previously untreated patients with adequate organ function who gave written informed consent were randomly assigned to receive irinotecan (50 mg/m2 on days 1, 8, and 15) plus paclitaxel (180 mg/m2 on day 1) every 4 weeks (IP group) or irinotecan (100 mg/m2 on days 1 and 8) plus gemcitabine (1000 mg/m2 on days 1 and 8) every 3 weeks (IG group). The primary endpoint was the response rate. We also evaluated the relationship of response and toxicity to polymorphisms of the uridine diphosphate glucuronosyltransferase (UGT) gene.
Eighty patients were enrolled, and 78 patients were eligible (38 in the IP group and 40 in the IG group). The response rate was 31.6% (95% confidence interval: 17.5–48.7%) in the IP group and 20.0% (9.1–35.6%) in the IG group. The median progression-free survival time was 86 days and 145 days, respectively. Both regimens were well tolerated. The most common severe adverse event was grade 4 neutropenia (36.8% and 10.0%, respectively), which was associated with UGT1A1*6 and UGT1A1*27. UGT polymorphisms did not correlate with response.
Irinotecan plus paclitaxel may be more active against NSCLC than irinotecan plus gemcitabine. The UGT1A1*6 and UGT1A1*27 genotypes might be useful predictors of grade 4 neutropenia in patients who receive irinotecan-based chemotherapy.</description><identifier>ISSN: 1556-0864</identifier><identifier>EISSN: 1556-1380</identifier><identifier>DOI: 10.1097/JTO.0b013e318200e4e8</identifier><identifier>PMID: 21150467</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - genetics ; Adenocarcinoma - pathology ; Aged ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Camptothecin - administration & dosage ; Camptothecin - analogs & derivatives ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - genetics ; Carcinoma, Squamous Cell - pathology ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Female ; Follow-Up Studies ; Gemcitabine ; Glucuronosyltransferase - genetics ; Humans ; Irinotecan ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Lung Neoplasms - pathology ; Male ; Neoplasm Staging ; Neutropenia - etiology ; NSCLC ; Paclitaxel ; Paclitaxel - administration & dosage ; Polymorphism, Genetic - genetics ; Risk Factors ; Survival Rate ; Treatment Outcome ; UGT1A127 ; UGT1A16</subject><ispartof>Journal of thoracic oncology, 2011-01, Vol.6 (1), p.121-127</ispartof><rights>2011 International Association for the Study of Lung Cancer</rights><rights>2011International Association for the Study of Lung Cancer</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5008-35e225bb0b82d6f385faac6373cd79b1d6b94e8cdd006208326b4aca3decedd63</citedby><cites>FETCH-LOGICAL-c5008-35e225bb0b82d6f385faac6373cd79b1d6b94e8cdd006208326b4aca3decedd63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21150467$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakamura, Yoichi</creatorcontrib><creatorcontrib>Soda, Hiroshi</creatorcontrib><creatorcontrib>Oka, Mikio</creatorcontrib><creatorcontrib>Kinoshita, Akitoshi</creatorcontrib><creatorcontrib>Fukuda, Minoru</creatorcontrib><creatorcontrib>Fukuda, Masaaki</creatorcontrib><creatorcontrib>Takatani, Hiroshi</creatorcontrib><creatorcontrib>Nagashima, Seiji</creatorcontrib><creatorcontrib>Soejima, Yoshifumi</creatorcontrib><creatorcontrib>Kasai, Takashi</creatorcontrib><creatorcontrib>Nakatomi, Katsumi</creatorcontrib><creatorcontrib>Masuda, Noriyuki</creatorcontrib><creatorcontrib>Tsukamoto, Kazuhiro</creatorcontrib><creatorcontrib>Kohno, Shigeru</creatorcontrib><title>Randomized Phase II Trial of Irinotecan with Paclitaxel or Gemcitabine for Non-small Cell Lung Cancer: Association of UGT1A16 and UGT1A127 with Severe Neutropenia</title><title>Journal of thoracic oncology</title><addtitle>J Thorac Oncol</addtitle><description>Irinotecan-containing regimens are known to be active and tolerable in patients with non-small cell lung cancer (NSCLC). A randomized phase II trial was conducted to evaluate the efficacy of irinotecan plus paclitaxel or gemcitabine for previously untreated stage IIIB or stage IV NSCLC.
Previously untreated patients with adequate organ function who gave written informed consent were randomly assigned to receive irinotecan (50 mg/m2 on days 1, 8, and 15) plus paclitaxel (180 mg/m2 on day 1) every 4 weeks (IP group) or irinotecan (100 mg/m2 on days 1 and 8) plus gemcitabine (1000 mg/m2 on days 1 and 8) every 3 weeks (IG group). The primary endpoint was the response rate. We also evaluated the relationship of response and toxicity to polymorphisms of the uridine diphosphate glucuronosyltransferase (UGT) gene.
Eighty patients were enrolled, and 78 patients were eligible (38 in the IP group and 40 in the IG group). The response rate was 31.6% (95% confidence interval: 17.5–48.7%) in the IP group and 20.0% (9.1–35.6%) in the IG group. The median progression-free survival time was 86 days and 145 days, respectively. Both regimens were well tolerated. The most common severe adverse event was grade 4 neutropenia (36.8% and 10.0%, respectively), which was associated with UGT1A1*6 and UGT1A1*27. UGT polymorphisms did not correlate with response.
Irinotecan plus paclitaxel may be more active against NSCLC than irinotecan plus gemcitabine. The UGT1A1*6 and UGT1A1*27 genotypes might be useful predictors of grade 4 neutropenia in patients who receive irinotecan-based chemotherapy.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - genetics</subject><subject>Adenocarcinoma - pathology</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Camptothecin - administration & dosage</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - genetics</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gemcitabine</subject><subject>Glucuronosyltransferase - genetics</subject><subject>Humans</subject><subject>Irinotecan</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - genetics</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Neoplasm Staging</subject><subject>Neutropenia - etiology</subject><subject>NSCLC</subject><subject>Paclitaxel</subject><subject>Paclitaxel - administration & dosage</subject><subject>Polymorphism, Genetic - genetics</subject><subject>Risk Factors</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>UGT1A127</subject><subject>UGT1A16</subject><issn>1556-0864</issn><issn>1556-1380</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkN1uEzEQhS1ERUvhDRDyC2wZr3e9DhdIUVRCUNRWJb1e-WeWGHbtyN40wOPwpLjawAUX7c3MGXnOGfkj5A2DCwaz5t3nzfUFaGAcOZMlAFYon5EzVteiYFzC86MGKapT8jKlbwBVDZV8QU5LxrISzRn5fau8DYP7hZbebFVCulrRTXSqp6Gjq-h8GNEoTw9u3NIbZXo3qh-YXyNd4mDypJ1H2uX5KvgiDarv6QJzWe_9V7pQ3mB8T-cpBePU6IJ_CL5bbticCZqPH3XZTCe-4D1GpFe4H2PYoXfqFTnpVJ_w9bGfk7uPl5vFp2J9vVwt5uvC1ACy4DWWZa01aFla0XFZd0oZwRtubDPTzAo9y4iMtQCiBMlLoStlFLdo0FrBz0k15ZoYUorYtbvoBhV_tgzaB-RtRt7-jzzb3k623V4PaP-Z_jLOC3JaOIR-xJi-9_sDxnaLqh-3T2V_mKyY_33vsisZh5modRHN2NrgHg_4A0xKpNM</recordid><startdate>201101</startdate><enddate>201101</enddate><creator>Nakamura, Yoichi</creator><creator>Soda, Hiroshi</creator><creator>Oka, Mikio</creator><creator>Kinoshita, Akitoshi</creator><creator>Fukuda, Minoru</creator><creator>Fukuda, Masaaki</creator><creator>Takatani, Hiroshi</creator><creator>Nagashima, Seiji</creator><creator>Soejima, Yoshifumi</creator><creator>Kasai, Takashi</creator><creator>Nakatomi, Katsumi</creator><creator>Masuda, Noriyuki</creator><creator>Tsukamoto, Kazuhiro</creator><creator>Kohno, Shigeru</creator><general>Elsevier Inc</general><general>International Association for the Study of Lung Cancer</general><scope>6I.</scope><scope>AAFTH</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></search><sort><creationdate>201101</creationdate><title>Randomized Phase II Trial of Irinotecan with Paclitaxel or Gemcitabine for Non-small Cell Lung Cancer: Association of UGT1A16 and UGT1A127 with Severe Neutropenia</title><author>Nakamura, Yoichi ; Soda, Hiroshi ; Oka, Mikio ; Kinoshita, Akitoshi ; Fukuda, Minoru ; Fukuda, Masaaki ; Takatani, Hiroshi ; Nagashima, Seiji ; Soejima, Yoshifumi ; Kasai, Takashi ; Nakatomi, Katsumi ; Masuda, Noriyuki ; Tsukamoto, Kazuhiro ; Kohno, Shigeru</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5008-35e225bb0b82d6f385faac6373cd79b1d6b94e8cdd006208326b4aca3decedd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - genetics</topic><topic>Adenocarcinoma - pathology</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Camptothecin - administration & dosage</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Carcinoma, Squamous Cell - genetics</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gemcitabine</topic><topic>Glucuronosyltransferase - genetics</topic><topic>Humans</topic><topic>Irinotecan</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - genetics</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Neoplasm Staging</topic><topic>Neutropenia - etiology</topic><topic>NSCLC</topic><topic>Paclitaxel</topic><topic>Paclitaxel - administration & dosage</topic><topic>Polymorphism, Genetic - genetics</topic><topic>Risk Factors</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>UGT1A127</topic><topic>UGT1A16</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakamura, Yoichi</creatorcontrib><creatorcontrib>Soda, Hiroshi</creatorcontrib><creatorcontrib>Oka, Mikio</creatorcontrib><creatorcontrib>Kinoshita, Akitoshi</creatorcontrib><creatorcontrib>Fukuda, Minoru</creatorcontrib><creatorcontrib>Fukuda, Masaaki</creatorcontrib><creatorcontrib>Takatani, Hiroshi</creatorcontrib><creatorcontrib>Nagashima, Seiji</creatorcontrib><creatorcontrib>Soejima, Yoshifumi</creatorcontrib><creatorcontrib>Kasai, Takashi</creatorcontrib><creatorcontrib>Nakatomi, Katsumi</creatorcontrib><creatorcontrib>Masuda, Noriyuki</creatorcontrib><creatorcontrib>Tsukamoto, Kazuhiro</creatorcontrib><creatorcontrib>Kohno, Shigeru</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of thoracic oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nakamura, Yoichi</au><au>Soda, Hiroshi</au><au>Oka, Mikio</au><au>Kinoshita, Akitoshi</au><au>Fukuda, Minoru</au><au>Fukuda, Masaaki</au><au>Takatani, Hiroshi</au><au>Nagashima, Seiji</au><au>Soejima, Yoshifumi</au><au>Kasai, Takashi</au><au>Nakatomi, Katsumi</au><au>Masuda, Noriyuki</au><au>Tsukamoto, Kazuhiro</au><au>Kohno, Shigeru</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Phase II Trial of Irinotecan with Paclitaxel or Gemcitabine for Non-small Cell Lung Cancer: Association of UGT1A16 and UGT1A127 with Severe Neutropenia</atitle><jtitle>Journal of thoracic oncology</jtitle><addtitle>J Thorac Oncol</addtitle><date>2011-01</date><risdate>2011</risdate><volume>6</volume><issue>1</issue><spage>121</spage><epage>127</epage><pages>121-127</pages><issn>1556-0864</issn><eissn>1556-1380</eissn><abstract>Irinotecan-containing regimens are known to be active and tolerable in patients with non-small cell lung cancer (NSCLC). A randomized phase II trial was conducted to evaluate the efficacy of irinotecan plus paclitaxel or gemcitabine for previously untreated stage IIIB or stage IV NSCLC.
Previously untreated patients with adequate organ function who gave written informed consent were randomly assigned to receive irinotecan (50 mg/m2 on days 1, 8, and 15) plus paclitaxel (180 mg/m2 on day 1) every 4 weeks (IP group) or irinotecan (100 mg/m2 on days 1 and 8) plus gemcitabine (1000 mg/m2 on days 1 and 8) every 3 weeks (IG group). The primary endpoint was the response rate. We also evaluated the relationship of response and toxicity to polymorphisms of the uridine diphosphate glucuronosyltransferase (UGT) gene.
Eighty patients were enrolled, and 78 patients were eligible (38 in the IP group and 40 in the IG group). The response rate was 31.6% (95% confidence interval: 17.5–48.7%) in the IP group and 20.0% (9.1–35.6%) in the IG group. The median progression-free survival time was 86 days and 145 days, respectively. Both regimens were well tolerated. The most common severe adverse event was grade 4 neutropenia (36.8% and 10.0%, respectively), which was associated with UGT1A1*6 and UGT1A1*27. UGT polymorphisms did not correlate with response.
Irinotecan plus paclitaxel may be more active against NSCLC than irinotecan plus gemcitabine. The UGT1A1*6 and UGT1A1*27 genotypes might be useful predictors of grade 4 neutropenia in patients who receive irinotecan-based chemotherapy.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>21150467</pmid><doi>10.1097/JTO.0b013e318200e4e8</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of thoracic oncology, 2011-01, Vol.6 (1), p.121-127 |
| issn | 1556-0864 1556-1380 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Journals@Ovid Complete |
| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - genetics Adenocarcinoma - pathology Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Camptothecin - administration & dosage Camptothecin - analogs & derivatives Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - genetics Carcinoma, Squamous Cell - pathology Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Female Follow-Up Studies Gemcitabine Glucuronosyltransferase - genetics Humans Irinotecan Lung Neoplasms - drug therapy Lung Neoplasms - genetics Lung Neoplasms - pathology Male Neoplasm Staging Neutropenia - etiology NSCLC Paclitaxel Paclitaxel - administration & dosage Polymorphism, Genetic - genetics Risk Factors Survival Rate Treatment Outcome UGT1A127 UGT1A16 |
| title | Randomized Phase II Trial of Irinotecan with Paclitaxel or Gemcitabine for Non-small Cell Lung Cancer: Association of UGT1A16 and UGT1A127 with Severe Neutropenia |
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