A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases Journal Article
| Authors: | Iwamoto, F. M.; Omuro, A. M.; Raizer, J. J.; Nolan, C. P.; Hormigo, A. L.; Lassman, A. B.; Gavrilovic, I. T.; Abrey, L. E. |
| Article Title: | A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases |
| Abstract: | Purpose: To investigate the efficacy and safety of the combination of vinorelbine and intensive temozolomide for recurrent or progressive brain metastases from solid tumors. Methods; Patients ≥18 years of age and with Karnofsky performance scale (KPS) ≥60, adequate organ function and progressive or recurrent brain metastases were eligible. This was a phase II trial with 28-day cycles using temozolomide (150 mg/m2, days 1-7 and 15-21) and vinorelbine 25 or 30 mg/m2on days one and eight. The primary endpoint was objective radiographic response. Results: Thirty-eight patients (15 men, 23 women) with a median age of 57 years (range, 39-75) and median KPS of 80 were enrolled. The primary tumor sites were lung (n = 20), breast (n = 11), colorectal (n = 2), kidney (n = 2), bladder (n = 1), endometrium (n = 1), head and neck (n = 1). Prior therapies included chemotherapy (97%), whole-brain radiation therapy (79%), brain metastasis resection (53%) and stereotatic radiosurgery (47%). Objective radiographic response rate was 5% (one complete response and one minor response); five patients had stable disease, 29 progressive disease and two patients were not evaluable. Twenty-nine patients (76%) have died and the median follow-up of survivors was six months. Median progression-free and overall survivals were 1.9 and 5 months, respectively. Grade 3/4 toxicities were mainly hematological and two patients discontinued the study due to myelosuppression. Conclusions: In this heavily pretreated population of patients with brain metastases, adding vinorelbine and increasing the intensity of temozolomide do not improve response rates compared to previous studies with single-agent temozolomide at standard doses. © Springer Science+Business Media, LLC. 2007. |
| Keywords: | adult; cancer chemotherapy; cancer survival; clinical article; treatment response; aged; disease-free survival; middle aged; survival analysis; cancer surgery; survival rate; overall survival; clinical trial; disease course; neutropenia; drug dose comparison; drug dose reduction; drug efficacy; drug safety; drug withdrawal; monotherapy; side effect; temozolomide; nuclear magnetic resonance imaging; outcome assessment; brain neoplasms; antineoplastic agent; endometrium cancer; colorectal cancer; dacarbazine; multiple cycle treatment; phase 2 clinical trial; neoplasm recurrence, local; breast cancer; anemia; bone marrow suppression; leukopenia; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; lung cancer; combination chemotherapy; bladder cancer; vinblastine; lymphocytopenia; kaplan-meiers estimate; disease severity; karnofsky performance status; head and neck cancer; brain metastasis; recurrent disease; kidney cancer; corticosteroid; navelbine; stereotaxic surgery; vinorelbine; whole body ct |
| Journal Title: | Journal of Neuro-Oncology |
| Volume: | 87 |
| Issue: | 1 |
| ISSN: | 0167-594X |
| Publisher: | Springer |
| Date Published: | 2008-01-01 |
| Start Page: | 85 |
| End Page: | 90 |
| Language: | English |
| DOI: | 10.1007/s11060-007-9491-3 |
| PUBMED: | 17987262 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 8" - "Export Date: 17 November 2011" - "CODEN: JNODD" - "Source: Scopus" |
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