Abstract | PURPOSE: PATIENTS AND METHODS: Thirty-two patients with nonseminomatous cisplatin-refractory germ cell cancer or relapsed disease after high-dose chemotherapy (HDCT) plus autologous stem-cell support were treated with single-agent oxaliplatin 60 mg/m(2) on days 1, 8, and 15 repeated every 4 weeks (group 1; n = 16) or oxaliplatin 130 mg/m(2) given on days 1 and 15 of a 4-week cycle (group 2; n = 16). Patients were pretreated with a median of seven (range, three to 13) cisplatin-containing treatment cycles; 78% had received carboplatin/ etoposide-based HDCT before oxaliplatin therapy. Twenty-seven patients (84%) were considered refractory (n = 20; 63%) or absolutely refractory (n = 7; 22%) to cisplatin therapy. RESULTS: Overall, four patients achieved a partial remission (13%; 95% confidence interval, 1% to 24%). Two additional patients achieved disease stabilization. All responses were observed in cisplatin-refractory patients, including three who had not responded to previous HDCT. Patients received a median two cycles of oxaliplatin with a median cumulative dose of 350 mg/m(2). Hematologic toxicity was generally mild, with five patients developing grade 3/4 thrombocytopenia. Nonhematologic side effects consisted mainly of nausea/ vomiting. One patient developed grade 3 neurotoxicity. CONCLUSION: Considering the particularly unfavorable prognostic characteristics of this patient population compared with patients from previous trials for new drugs in germ cell cancer, eg, paclitaxel and gemcitabine, a 13% overall response rate and a 19% response rate in the group treated with oxaliplatin 130 mg/m(2) seems to be of interest. Oxaliplatin may be a palliative treatment option for this patient population, and evaluation in combination regimens is warranted.
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Authors | C Kollmannsberger, O Rick, H-G Derigs, N Schleucher, P Schöffski, J Beyer, R Schoch, H G Sayer, A Gerl, M Kuczyk, C Spott, L Kanz, C Bokemeyer |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 20
Issue 8
Pg. 2031-7
(Apr 15 2002)
ISSN: 0732-183X [Print] United States |
PMID | 11956262
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Organoplatinum Compounds
- Oxaliplatin
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Topics |
- Adult
- Antineoplastic Agents
(therapeutic use)
- Feasibility Studies
- Humans
- Male
- Middle Aged
- Neoplasm Recurrence, Local
- Neoplasms, Germ Cell and Embryonal
(drug therapy, secondary)
- Organoplatinum Compounds
(therapeutic use)
- Oxaliplatin
- Palliative Care
- Remission Induction
- Salvage Therapy
- Survival Analysis
- Testicular Neoplasms
(drug therapy, pathology)
- Treatment Failure
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