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, – The new drug comment (Aust Prescr 2001;24:73-4) does not reflect the Australian trial experience with oxaliplatin. At the American Society of Clinical Oncology meeting in San Francisco we reported a phase II trial of oxaliplatin in conjunction with 5-fluorouracil and folinic acid in 40 patients with previously untreated advanced or metastatic colorectal cancer.1 There was a low rate of severe (grade 3/4) toxicities and these included neuropathy (grade 3-17%), diarrhoea (grade 3-11%), mucositis (grade 3-4%) and neutropenia (grade 3/4-34%). Nausea and vomiting were not a major problem with the use of simple antiemetics. In addition the tumour response rate was 56% (95% CI 38-72%), which is very high for these conditions.
The comment that 'like other platinum-based drugs, oxaliplatin is very toxic' is therefore inaccurate, as is the following suggestion that 'most patients will have vomiting, diarrhoea, anaemia and altered liver function tests'. These comments cannot have been written by anyone who has ever used this compound.
Senior Staff Specialist
Department of Medical Oncology
Royal Prince Alfred Hospital
The Executive Editorial Board prepared the new drug comment before oxaliplatin was marketed in Australia. Prior to marketing there is obviously little information available about the use of any new drug in Australia. To ensure readers are presented with a balanced view of a new drug the Executive Editorial Board considers data from a variety of sources including information provided by the manufacturer. While the Executive Editorial Board is interested in the results of Dr Clarke's phase II study they do not negate the new drug comment.
The comment was based on the pivotal clinical trials which used different regimens from the phase II study. In these trials symptoms of neuropathy developed in 85-95% of patients. Anaemia occurred in more than 80% of patients and neutropenia and thrombocytopenia were very common. The comment that most patients will have vomiting and diarrhoea is also consistent with the manufacturer's product information.
In Dr Clarke's trial 83% of the patients required a dose reduction and toxicity resulted in 25% ceasing treatment. While the frequency of severe adverse effects may be low from an oncology perspective, it is important that patients decide what is acceptable to them. The Executive Editorial Board hopes that the favourable response rate seen in the trial will lead to improved survival for the patients.
- Goldstein D, Michael M, Mitchell P, Smith J, Clarke S. Improving patient convenience: a modification schedule of FOLFOX (oxalipatin combined with 5FU) with high activity and tolerability in untreated metastatic colorectal cancer (CRC). Proceedings of the Annual Meeting of the American Society of Clinical Oncology; 2001 May 12-15; San Francisco. Report No. 578.