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Navelbine: How I Use It

Indiana University, 550 University Boulevard, University Hospital, Room 1730, Indianapolis, IN 46202-5250

Vinorelbine (Navelbine) is a new vinca alkaloid with superior efficacy compared to older drugs such as vincristine, vinblastine, and vindesine. Unlike the older vinca alkaloids, neuromuscular toxicity is not a major problem. However, myelosuppression (especially granulocytopenia) is the major dose-limiting toxicity. Nonmyelosuppressive toxicity is minimal, although venous irritation can be a major problem. This can be mitigated with shorter infusion times of 5 to 10 minutes.

Vinorelbine is the first drug in over 20 years to be FDA-approved for NSCLC. The older approved drugs, nitrogen mustard, methotrexate and doxorubicin, are not felt to have clinical value. The approval was based upon two phase III studies. An industry-sponsored American study compared Navelbine 30 mg/m² weekly versus 5-FU plus leucovorin in 216 patients. MST was 30 versus 22 weeks, with one-year survivals of 25% versus 16% (p = 0.03). Response rates were 12% versus 3%. The second study was a three-arm European study comparing vinorelbine (30 mg/m²) versus cisplatin (120 mg/m²) and either vinorelbine or vindesine. Six hundred twelve patients were entered. Response rates were 14%, 30%, and 19%, with MST. 31, 40, and 32 weeks (p = 0.04 favoring cisplatin + vinorelbine). Post-FDA approval, SWOG reported a phase III study comparing cisplatin (100 mg/m²) every four weeks with or without vinorelbine (25 mg/m²/week). Response rates (in 432 patients) were 10% versus 26% and MST six versus eight months with one-year survivals of 16.4% versus 35.4%.

Two other vinorelbine phase III studies are noteworthy. A Japanese study evaluated weekly vinorelbine (25 mg/m²) versus vindesine (3 mg/m²). Response rates were 29% versus 9% in 150 patients, with MST 12 versus 10 months. Finally, a phase III study of 231 patients compared vinorelbine (30 mg/m²/week) ± cisplatin (80 mg/m² q 3 weeks). Response rates were 16% versus 43%, but no difference in survival (32 versus 33 weeks: p = 0.48).

Current cooperative group studies will compare cisplatin + vinorelbine to carboplatin + paclitaxel (SWOG), evaluate cisplatin + vinorelbine with XRT in stage III disease (CALGB), and evaluate cisplatin + vinorelbine as postoperative adjuvant therapy for stage I (T₂N_O) and stage II NSCLC (NCI-Canada and ECOG).

Vinorelbine also has activity in ovarian and breast cancer, and possibly prostate cancer. A study from Argentina evaluated vinorelbine 30 mg/m²/week as first-line chemotherapy in metastatic breast cancer. There was a 41% response rate in 44 patients. An industry-supported multi-institutional American study had similar results. Vinorelbine has also been evaluated in metastatic breast cancer patients with prior chemotherapy. Most studies demonstrated activity with mild toxicity.

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