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ISSUE 1 FEBRUARY
Letters to the Editor

Vinflunine

  • Jacqueline du Toit

The Editorial Executive Committee welcomes letters, which should be less than 250 words. Before a decision to publish is made, letters which refer to a published article may be sent to the author for a response. Any letter may be sent to an expert for comment. When letters are published, they are usually accompanied in the same issue by their responses or comments. The Committee screens out discourteous, inaccurate or libellous statements. The letters are sub-edited before publication. Authors are required to declare any conflicts of interest. The Committee's decision on publication is final.

 

Letter to the Editor

Editor, – It was with interest that we read your opinion on vinflunine in the new drugs section ofAustralian Prescriber (2011;34:122). It is important however to also provide the information which formed the basis of the positive assessment of vinflunine's benefit–risk balance by the Therapeutic Goods Administration (TGA).

Vinflunine is the only drug registered for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a platinum-containing regimen. It received marketing approval from the TGA in 2011 and the European Medicines Agency in 2009.

Vinflunine's benefit is described as modest in your article. The TGA's clinical evaluator assessed the benefit of vinflunine as significant and meaningful over a range of efficacy parameters: response rate, disease control rates, progression free survival and overall survival.1 A statistically significant 2.6 month increase in overall survival observed in the eligible population, which most closely reflects the population intended for treatment (6.9 months versus 4.3 months in the control arm),2 is clinically meaningful in a rapidly progressing disease and similar to that of docetaxel, the standard treatment in castration-resistant metastatic prostate cancer (+ 2.4 months).3

The TGA concluded that vinflunine's safety profile was well characterised, acceptable and manageable by appropriate dose modifications leading to a low rate of discontinuation and treatment-related deaths.1Further, that vinflunine is generally well tolerated by patients. The main dose limiting toxicity associated with vinflunine is neutropenia but, as pointed out by the TGA, neutropenia is a familiar adverse event that oncologists are used to managing by a variety of medical measures.1 Your opinion of myelosuppression as being a considerable problem with vinflunine and describing vinflunine's adverse effects as severe is not a fair assessment of the adverse effect profile of this drug.

Your concluding quote that 'it is better to focus on individually tailored palliative care' is taken from a single French drug bulletin4 as opposed to numerous peer-reviewed oncology journals which conclude the contrary.5-9 The conclusion of the TGA's clinical evaluator, that the vinflunine data support a positive benefit–risk balance for its approved indication in patients who have few available therapeutic options, is more reliable.1

Jacqueline du Toit
Regulatory manager
Pierre Fabre Médicament Australia Pty Ltd
Sydney

 

References

  1. Therapeutic Goods Administration. Australian Public Assessment Report for Vinflunine ditartrate. 2011 Apr.www.tga.gov.au/pdf/auspar/auspar-javlor.pdf[cited 2012 Jan 6]
  2. Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009;27:4454-61.
  3. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12.
  4. Vinflunine. No benefit for bladder cancer patients despite statistical manipulation. Prescrire Int 2011;20:11-3.
  5. Di Palma M. Savoir prescrire \u2013 la vinflunine (Javlor). Refl\u00e9xions en M\u00e9decine Oncologique 2010 Mai;7:29-30.
  6. Th\u00e9odore C. Prise en charge du patient m\u00e9tastatique dans le cancer de la vessie (Treatment strategies for metastatic patients in bladder cancer). Bull Cancer, synth\u00e9se 2010;97:27-33.
  7. Morel A, Talbot D. Critical evaluation of vinflunine in the treatment of refractory metastatic urothelial carcinoma. Open Access Journal of Urology 2010;2:99-108.
  8. Frampton JE, Moen MD. Vinflunine. Drugs 2010;70:1283-92.
  9. Gerullis H, Ecke T, Eimer C, Wishahi M, Otto T. Vinflunine as second-line treatment in platin-resistant metastatic urothelial carcinoma: a review. Anticancer Drugs 2011;22:9-17.

Jacqueline du Toit

Regulatory manager, Pierre Fabre Médicament Australia Pty Ltd Sydney