Article ; Online: Phase I Clinical Study of Irinotecan Plus S-1 in Patients With Advanced or Recurrent Cervical Cancer Previously Treated With Platinum-Based Chemotherapy.
2016 Volume 26, Issue 7, Page(s) 1281–1287
Abstract: Objectives: This study aimed to determine the maximum tolerated dose and acute dose-limiting toxicities (DLTs) of intravenous irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer.: Methods: Irinotecan was ... ...
Abstract | Objectives: This study aimed to determine the maximum tolerated dose and acute dose-limiting toxicities (DLTs) of intravenous irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer. Methods: Irinotecan was administered intravenously over the course of 90 minutes on day 1, and S-1 was given orally in 2 divided doses from days 1 to 14 of a 21-day cycle. The dose of S-1 was escalated in a stepwise fashion from 40 (level 1) to 60 mg/m (level 2) and then 80 mg/m (level 3), whereas the dosage of irinotecan remained the same (150 mg/m). The primary end point for the escalation study was acute DLT that occurred within 2 cycles of chemotherapy. Results: Twelve patients were enrolled and treated over 3 dose levels. Their median age was 47 years (range, 28-48 years). At level 1, one episode of grade 3 anemia and a grade 3 fatigue were observed, but no DLT developed. At level 2, the first patient experienced febrile neutropenia, which was considered to be a DLT. To evaluate the toxicity of this dose level, 5 more patients were evaluated. However, no DLT developed in these patients. At level 3, although grade 1 to 2 hematological and nonhematological toxicities developed, no DLT occurred. Conclusions: In women with advanced or recurrent cervical cancer previously treated with platinum-based chemotherapy, S-1 plus irinotecan in a triweekly setting is a reasonable treatment regimen with an acceptable toxicity profile. The recommended doses of S-1 and irinotecan for this regimen are 80 and 150 mg/m, respectively. |
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MeSH term(s) | Adult ; Aged ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; Camptothecin/analogs & derivatives ; Camptothecin/therapeutic use ; Carcinoma/drug therapy ; Drug Combinations ; Female ; Humans ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Oxonic Acid/therapeutic use ; Tegafur/therapeutic use ; Uterine Cervical Neoplasms/drug therapy |
Chemical Substances | Antineoplastic Agents ; Drug Combinations ; S 1 (combination) (150863-82-4) ; Tegafur (1548R74NSZ) ; Oxonic Acid (5VT6420TIG) ; irinotecan (7673326042) ; Camptothecin (XT3Z54Z28A) |
Language | English |
Publishing date | 2016-09-14 |
Publishing country | England |
Document type | Clinical Trial, Phase I ; Journal Article |
ZDB-ID | 1070385-8 |
ISSN | 1525-1438 ; 1048-891X |
ISSN (online) | 1525-1438 |
ISSN | 1048-891X |
DOI | 10.1097/IGC.0000000000000769 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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