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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.

This Article Full Text (PDF) eLetters: Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article link to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Einhorn, L. H. Search for Related Content PubMed Articles by Einhorn, L. H.