Abstract
9070 Background: High-dose chemotherapy (HD) with ICE for 1 up to 4 cycles represents a frequently used salvage regimen for solid tumors refractory to standard dose (SD) chemotherapy. However, the activity of HD-ICE is only moderate particularly in sarcoma or in germ cell tumors unresponsive to SD -ICE. Bevacizumab (B) has some activity in sarcoma and another antiangiogenetic agent, thalidomide in refractory germ cell tumor. Furthermore B has been shown to increase the antitumor efficacy of chemotherapy in colorectal cancer, an effect which might not only be limited to 5 FU based chemotherapy. Therefore the combination of bevacizumab with sequential/intermediate/high-dose chemotherapy might be of interest. To evaluate the potential risk of the combination of HD-ICE + B we are currently performing a feasibility study in pts with progressive sarcoma and germ cell cancer. Methods: To date 5 pts (4 sarcomas, 1 germ cell tumor, including 1 pt with brain metastasis) progressive after SD-ICE (ifosfamid 1,5 g/m2 d1–3, carboplatin 150mg/m2 d1–3, etoposide 150 mg/m2 d1–3) received HD-ICE (ifosfamid 3 g/m2 d1–3, carboplatin 300mg/m2 d1–3, etoposide 300 mg/m2 d1–3) in combination with B (7,5 mg/kg - 10mg/kg) d1 with stem cell support, q 3 weeks. 5 pts were evaluable for toxicity and 4 for response. A total of 5 pts and 12 cycles (c) of chemotherapy (range 1–5) are evaluated to date. Median age was 29y (range 22–38y); female:male 2:3, ECOG 0/1 (5 pts). Results: NCI-CTC grade 3/4 toxicities: Thrombocytopenia 12/12 c, Neutropenia 12/12, nausea/vomiting 1/12, acute ifosfamide encephalopathy 1/12. In one cycle G1 epistaxis occured. There was no hypertension, mucositis over G1, no severe sustained bleeding and no thromboembolic event or severe infection. Efficacy: 1 CR, 1 PR and 2 SD were seen. Conclusions: The addition of B to HD-ICE in pts with refractory solid malignancy has interesting activity without significant increase of toxicity in particular thrombopenic bleeding and acute encephalopathy, even in the pts with brain metastasis. The study is ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Hoffmann-La Roche Hoffmann-La Roche
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