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A phase II single institution single arm prospective study with paclitaxel, ifosfamide and cisplatin (TIP) as first-line chemotherapy in high-risk germ cell tumor patients with more than ten years follow-up and retrospective correlation with ERCC1, Topoisomerase 1, 2A, p53 and HER-2 expression.
- Source :
-
Journal of B.U.ON. : official journal of the Balkan Union of Oncology [J BUON] 2016 May-Jun; Vol. 21 (3), pp. 698-708. - Publication Year :
- 2016
-
Abstract
- Purpose: One half of high-risk germ cell tumor (HRGCT) patients relapse after standard chemotherapy. This phase II study evaluated prospectively the toxicity and efficacy in first-line of the paclitaxel-ifosfamide-cisplatin combination (TIP) in HRGCT patients and tried to identify biomarkers that may allow patient-tailored treatments.<br />Methods: Between October 1997- September 2000, 28 chemo-naive HRGCT patients were enrolled. Patients received 4 cycles of TIP (paclitaxel 175 mg/m(2) day 1/; ifosfamide 1.2 g/m(2)/day, days 1-5; Mesna 1.2 g/m(2)/day, days 1-5; and cisplatin 20 mg/m(2)/day, days 1-5 every 3 weeks). A non-randomized comparison was made between HRGCT patients treated in the same period with first-line TIP and bleomycin-etoposide-cisplatin (BEP) (28 patients vs 20). In 17 HRGCT patients treated between 1998-2006, ERCC1, Topoisomerase 1 and 2A, p53 and HER-2 expression was retrospectively analysed by immunohistochemistry (IHC) (7 patients with TIP, 10 with BEP), and correlations were made with response to chemotherapy and survival.<br />Results: With a median follow-up of 72 months [range 48+...89+], 5-year disease free survival (DFS) was 55%, with 95% CI 36-72, and the overall survival (OS) was 63%, with 95% CI 44-78. In June 2015, with a median follow-up of 196.47 months (range 177.30-209.27) (>15 years), 12 [%?] patients were alive and disease-free, and 16 [%?] had died (12 specific causes). There was no significant correlation between the expression of ERCC1, Topoisomerase 1 and 2A, HER-2 and p53 and response to treatment.<br />Conclusion: Long-term follow-up showed no difference in OS between TIP vs BEP as first-line therapy. Both regimens had mild toxicity.
- Subjects :
- Adult
Aged
Follow-Up Studies
Humans
Male
Middle Aged
Neoplasms, Germ Cell and Embryonal chemistry
Neoplasms, Germ Cell and Embryonal mortality
Prospective Studies
Retrospective Studies
Testicular Neoplasms chemistry
Testicular Neoplasms mortality
Antigens, Neoplasm analysis
Antineoplastic Combined Chemotherapy Protocols therapeutic use
DNA Topoisomerases, Type I analysis
DNA Topoisomerases, Type II analysis
DNA-Binding Proteins analysis
Endonucleases analysis
Neoplasms, Germ Cell and Embryonal drug therapy
Receptor, ErbB-2 analysis
Testicular Neoplasms drug therapy
Tumor Suppressor Protein p53 analysis
Subjects
Details
- Language :
- English
- ISSN :
- 1107-0625
- Volume :
- 21
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of B.U.ON. : official journal of the Balkan Union of Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 27569093