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Editor, – We are writing to express our concern regarding several aspects of the recent 'New drugs' comment on vinorelbine tartrate ('Newdrugs' Aust Prescr 1998;21:54).
Firstly, the TGA-approved indications were not accurately stated. Vinorelbine has been approved for advanced breast cancer after failure of standard therapy (not 'failure of other treatments') and for first-line treatment of advanced non-small cell lung cancer (and not for small cell lung cancer, as erroneously mentioned in the last paragraph).
Secondly, the statement 'the drug is diluted and given by slow injection or infusion once a week' is an oversimplification. The product information gives specific recommendations for the preparation and administration of vinorelbine that have been found to reduce the occurrence of injection site reactions, and the readers' attention should be drawn to these. Further, dosage regimens can vary from weekly administration to a day 1 and day 5/8 schedule every 3 weeks when given in combination chemotherapy.
Thirdly, the clinically relevant features of the haematological toxicity of vinorelbine, i.e. that neutropenia is rapidly reversible and non-cumulative, and that the incidences of neutropenic sepsis, severe anaemia and thrombocytopenia are relatively low, were not mentioned.
Finally, the concluding two sentences in the comment, concerning survival, appear to reflect a value judgement on the part of the author. Any increase in survival in a disease with a poor prognosis may be relevant to the individual patient, and the questions of quality of life, improvement in performance status and relief of disease-related symptoms should also not be overlooked.
Manager, Regulatory Affairs
and Barry Dale
Medical Adviser, Oncology
The Editor comments:
The intention of the 'New drugs' section of Australian Prescriber is to provide a brief description of the product and its role in therapy. This section always carries the preface that the product information should be obtained before prescribing a new drug. It is not possible, in a short comment, to give detailed instructions about complicated regimens. However, the comment about vinorelbine did state that the dose needs to be modified when there is haematological toxicity. ASTA Medica is correct to point out that the 'non' was missing from one of the 4 mentions of non-small cell lung cancer.
While it is correct that vinorelbine can be given to women with breast cancer after the failure of standard therapy, is it the best option? There has been a study to compare vinorelbine with melphalan in anthracycline-resistant breast cancer. The time to progression of the disease was 12 weeks for vinorelbine and 8 weeks for melphalan.1 Questions remain as to the effect on quality of life and whether melphalan is the most appropriate comparison. Unless there has been a recent change, the Food and Drug Administration in the U.S.A. has not reversed its decision not to approve vinorelbine for breast cancer.
Vinorelbine is approved in the U.S.A. for advanced non-small cell lung cancer. It can be helpful to some patients with inoperable cancers. The decision to prescribe vinorelbine in this situation does indeed require a value judgement. The patients have to judge if their quality of life will be improved by a toxic treatment which, if they are in the minority who respond, will extend their lives for, at best, a few months. As our sister journal Prescribe International concluded, 'Vinorelbine does not appear to influence the grim prognosis of this cancer.'
- Jones S, Winer E, Vogel C, Laufman L, Barlogic B, O'Rourke M, et al. for the Navelbine Breast Cancer Working Group. A multi center, randomized trial of i.v. Navelbine vs. i.v. Alkeran in patients with anthracycline-refractory advanced breast cancer (ABC). American Society of Clinical Oncology (ASCO) proceedings 1994;13:103 (abstr. 216).