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Because life is filled with special moments...

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Give your
patients
a survival
advantage

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One Year Survival

As shown in large, randomized, well-controlled, multicenter studies...

35% of patients treated with NAVELBINE plus
cisplatin were alive at one year1,2

One-year survival: Le Chevalier1

*Vindesine, a vinca alkaloid, is widely used in Europe for the treatment of NSCLC.

Granulocytopenia resulting in hospitalization for fever and/or sepsis was reported in 8% of patients in the North American experience.

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The only NSCLC therapy with a survival advantage
confirmed in a second Phase III trial2

One-year survival: Southwest Oncology Group

Study (SWOG 9308 Phase III)2

Concurrent administration of cisplatin with NAVELBINE does not appear to influence the pharmacokinetics of NAVELBINE.5,6

Please consult Full Prescribing Information.


Single-Agent Navelbine

NAVELBINE
offers quality
of time to
NSCLC
patients

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Single-agent NAVELBINE: Survival rates
comparable to platinum-based therapy1

*Vindesine, a vinca alkaloid, is widely used in Europe for the treatment of NSCLC.

NAVELBINE is a moderate vesicant. Proper administration is important to avoid potential injection-site reactions.


Adverse Events

Single-agent NAVELBINE: well tolerated,
with few grade 3-4 adverse events

Nonhematologic Adverse Events* (n=365)

All Grades (% Incidence) Grade 3 (% Incidence) Grade 4 (% Incidence)
All patients NSCLC All patients NSCLC All patients NSCLC
Asthenia 36 27 7 5 0 0
Injection-site reactions 28 38 2 5 0 0
Injection-site pain 16 13 2 1 0 0
Nausea 44 34 2 1 0 0
Vomiting 20 15 2 1 0 0
Constipation 35 29 3 2 0 0
Peripheral neuropathy 25 20 1 1 <1 0
Phlebitis 7 10 <1 1 0 0
Dyspnea 7 3 2 2 1 0
Alopecia 12 12 <1 1 0 0
*Patients with NSCLC had not received prior chemotherapy. The majority of remaining patients had received prior chemotherapy.

Summary of Incidence of Granulocytopenia by Treatment Group10
Treatment No. of Patients All Grades Grade 3 Grade 4
NVB 201 85% 25% 28%
NVB + CDDP 207 95% 20% 58%
NVB=NAVELBINECDDP=cisplatin


NAVELBINE plus cisplatin: nonhematologic adverse
events are usually mild to moderate1

Grade 3- 4 Nonhematologic Adverse Events1,10

Number of Patients (%)
NVB (n=201) VDS§ + CDDP (n=192) NVB + CDDP (n=207)
Nausea/vomiting 2% 25% 30%
Alopecia 2% 14% 7.5%
Neurotoxicity* 9% 17% 7%
Injection-site reactions** 2% 0% 2.5%
Ototoxicity 0% 1% 2.5%
Diarrhea 0.5% 1% 1.5%
Pruritus 0% 0% 0%
Allergy 1% 0% 0%
NVB=NAVELBINECDDP=cisplatinVDS=vindesine§

* Neurotoxicity includes peripheral neuropathy and constipation.9
**NAVELBINE was administered as a 20-minute intravenous infusion.
§ Vindesine, a vinca alkaloid, is widely used in Europe for the treatment of NSCLC.

As with other products that suppress white blood cells, there is an increased susceptibility to infection.

For additional information, please contact your Glaxo Wellcome Oncology/HIV representative.

Please consult Full Prescribing Information.

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Mode Of Action

Not just another vinca...

Chemical
structure of
NAVELBINE
sets it apart

As with other products that suppress white blood cells, there is an increased susceptibility to infection.


The engineered vinca with high relative selectivity

In North American clinical trials, nonhematologic adverse effects were usually mild or moderate and included injection-site reactions (38%), nausea (34%), vomiting (15%), constipation (29%), fatigue (27%), peripheral neuropathy (20%), diarrhea (13%), and alopecia (12%).


First-line
versatility

Aggressive first-line treatment with several indications:

Administration of NAVELBINE is contraindicated in patients with pretreatment granulocyte counts <1,000 cells/mm3.

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NAVELBINE plus cisplatin is favorably priced12

Average Wholesale Price*

Navelbine
1-mL vial $56.55
5-mL vial $282.74
*Average wholesale price based on Red Book®, February 1997. Prices presented may not necessarily reflect the actual prices paid by health care facilities or consumers.

As with other products that suppress white blood cells, there is an increased susceptibility to infection.

For additional information, please contact your Glaxo Wellcome Oncology/HIV representative.

Please consult Full Prescribing Information.

Navelbine Logo


References:

  1. Le Chevalier T, Brisgand D, Douillard J-Y, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non­small-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol. 1994;12:360-367.
  2. Data on file, Glaxo Wellcome Inc. [SWOG 9308 Phase III].
  3. Souquet PJ, Chauvin F, Boissel JP, et al. Polychemotherapy in advanced non small cell lung cancer: a meta-analysis. Lancet. 1993;342:19-21.
  4. Depierre A, Chastang Cl, Quoix E, et al. Vinorelbine versus vinorelbine plus cisplatin in advanced non­small-cell lung cancer: a randomized trial. Ann Oncol. 1994;5:37-42.
  5. Wargin WA, Luca VS. The clinical pharmacokinetics of vinorelbine (Navelbine). Semin Oncol. 1994;21(suppl 10):21-27.
  6. Levêque D, Jehl F, Quoix E, Breillout F. Clinical pharmacokinetics of vinorelbine alone and combined with cisplatin. J Clin Pharmacol. 1992;32:1096-1098.
  7. Lorusso V, Pezzella G, Catino AM, et al. Results of a clinical multicentric randomized phase II study of non­small-cell lung cancer treated with vinorelbine-cisplatin versus vinorelbine alone. Int J Oncol. 1995;6:65-68.
  8. Crawford J, O'Rourke M, Schiller J, et al. Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non­small-cell lung cancer. J Clin Oncol. 1996;14:2774-2784.
  9. Hohneker JA. A summary of vinorelbine (Navelbine) safety data from North American clinical trials. Semin Oncol. 1994;21(suppl 10):42-47.
  10. Data on file, Glaxo Wellcome Inc.
  11. Binet S, Fellous A, Lataste H, Krikorian A, Couzinier JP, Meininger V. In situ analysis of the action of NavelbineJ on various types of microtubules using immunofluorescence. Semin Oncol. 1989;16(suppl 4):5-8.
  12. Red Book® Montvale, NJ: Medical Economics Data Co; February 1997.

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