Article ; Online: Phase II study of S-1 in patients with previously-treated invasive thymoma and thymic carcinoma: North Japan lung cancer study group trial 1203.
Lung cancer (Amsterdam, Netherlands)
2019 Volume 139, Page(s) 89–93
Abstract: ... thus far. Because promising efficacy of S-1 (tegafur, gimeracil and oteracil combination) has been reported ... regimen of systemic chemotherapy received S-1 orally at a dose based on body surface area for 2 weeks ... Conclusion: Although the primary endpoint was not met, S-1 monotherapy did have effects similar to recently ...
Abstract | Objectives: Invasive thymoma (IT) and thymic carcinoma (TC) are rare epithelial neoplasms arising in the anterior mediastinum. Platinum-based chemotherapies are widely used for first-line treatment of unresectable IT and TC, but no standard treatment has been established for previously-treated IT and TC thus far. Because promising efficacy of S-1 (tegafur, gimeracil and oteracil combination) has been reported in some retrospective studies, we conducted the first prospective phase II trial to evaluate its efficacy in previously-treated patients with advanced IT and TC. Materials and methods: Patients progressing after at least one regimen of systemic chemotherapy received S-1 orally at a dose based on body surface area for 2 weeks followed by one week of rest until tumor progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profile. We defined an ORR of 25% as indicating potential usefulness while ORR of 10% was the lower limit of interest. Results: Forty patients were enrolled (IT, n = 20; TC, n = 20). ORR was 17.5% (95% CI 7.3-32.8; IT, 10%; TC, 25%), disease control rate was 85% (IT, 95%; TC, 75%). Median PFS was 7.0 months (IT, 11.3 months; TC, 5.4 months), and median OS was 40.3 months (IT, 58.5 months; TC, 22.7 months) with a median follow-up of 51.9 months. Major toxicities (grade 3-4) were anorexia (10%), neutropenia (7.5%) and pneumonitis (5%). No treatment-related death was observed. Conclusion: Although the primary endpoint was not met, S-1 monotherapy did have effects similar to recently reported immunotherapies for TC but at much lower cost. S-1 could represent a treatment option for previously-treated advanced TC. This trial was registered as UMIN 000008174. |
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MeSH term(s) | Adenocarcinoma of Lung ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinoma, Non-Small-Cell Lung ; Female ; Follow-Up Studies ; Humans ; Japan ; Lung Neoplasms ; Male ; Middle Aged ; Oxonic Acid/administration & dosage ; Prognosis ; Prospective Studies ; Pyridines/administration & dosage ; Survival Rate ; Tegafur/administration & dosage ; Thymoma/drug therapy ; Thymoma/pathology ; Thymus Neoplasms/drug therapy ; Thymus Neoplasms/pathology |
Chemical Substances | Pyridines ; Tegafur (1548R74NSZ) ; Oxonic Acid (5VT6420TIG) ; gimeracil (UA8SE1325T) |
Language | English |
Publishing date | 2019-10-18 |
Publishing country | Ireland |
Document type | Clinical Trial, Phase II ; Journal Article ; Multicenter Study |
ZDB-ID | 632771-0 |
ISSN | 1872-8332 ; 0169-5002 |
ISSN (online) | 1872-8332 |
ISSN | 0169-5002 |
DOI | 10.1016/j.lungcan.2019.10.016 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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