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Spindle cell carcinomas are uncommon
Mailbox Spindle cell carcinomas are uncommon We are intrigued by the statement by Borislav Dimitrov that most cancers of the tongue are spindle-cell carcinomas.1 We do not have access to the reference given by the author to his own article in the Encyclopaedia of Human Nutrition.2 However, in our own experience and from the literature, it is clear that conventional squamous carcinoma is the most common cancer of the tongue. At the Tata Memorial Hospital, Mumbai, India, in 1995, there were four spindle cell carcinomas of the tongue compared
with 354 conventional squamous carcinomas. There are few papers on spindlecell carcinomas of the tongue in the literature, which is line with the fact that they are uncommon. To our knowledge, the biggest series on spindle cell carcinomas of the oral cavity was studied by Ellis and Corio.3 They analysed 59 cases, 12 of which were in the tongue. Spindle-cell carcinomas are just an uncommon histological variant of squamous carcinoma with no special prognostic or therapeutic implications. However,
they do need to be distinguished from sarcomas and malignant melanomas. Sanjay A Pai*, Anita M Borges† *Manipal Hospital, Bangalore 560 017, India. †Tata Memorial Hospital, Mumbai 400012, India. 1 Dimitrov BD. Epidemiology of oral cancers. Lancet Oncol 2000; 1: 135. 2 Dimitrov BD. Epidemiology of gastrointestinal cancers other than colorectal. In: Sadler M, Strain S, Caballero B, Eds. Encyclopaedia of Human Nutrition. Academic Press, London, 1998, 248–255. 3 Ellis GL, Corio RL. Spindle cell carcinoma of the oral cavity. Oral Surg 1980; 50: 523–534.
Clinical testing of Ukrain Some remarks in the letter about Ukrain in The Lancet Oncology (Dec 2000) by Farrugia and Slevin1 are based upon a misunderstanding, especially the assertion that we, as the producers of Ukrain, are “unable or unwilling” to take the opportunity for “a sober assessment” of the drug. We agreed immediately to the proposal for a clinical study at St Bartholomew’s Hospital and agreed to supply the drug free of charge. However, we assumed that a clinical study at a major European teaching hospital would be carried out according to Good Clinical Practice (GCP) with independent monitoring, which is a requirement of GCP. Our previous experience has shown that studies
which are not carried out according to GCP are not recognised in Europe. Most of the clinical studies carried out on Ukrain so far have taken place outside the European Union and while investigators have followed the guidelines of GCP the studies have been criticised because not all the formalities were observed. Seen from this point of view, a new clinical study would be of value only if carried out in accordance with GCP. Both the hospital and our company would otherwise bear high costs for a study which would not be recognised. We were therefore unable to understand why Farrugia and Slevin were unwilling to carry out the study according to GCP with independent
monitoring, a precondition which we took for granted would be met at a major European teaching hospital. This is the real reason why the study has not been set up. We would like to emphasise that we are most willing for an objective, independently monitored study in accordance with GCP to be carried out on Ukrain, that we are prepared to supply the drug free of charge for such a study and that we hope that the study proposed by Farrugia and Slevin can in fact take place.
as he rightly says, is lacking in all the clinical papers reported by Nowicky and his colleagues), which prompted us to suggest this study. We intended to subject Ukrain to the same assessment that any other anti-cancer agent would receive within the context of a phase II study. If Ukrain showed objective evidence of activity there would be no difficulty obtaining pharmaceutical funds for further studies to the level of GCP. Clearly this level of
monitoring is outside that which is affordable by a single hospital funded study. It seems to us that the issue of GCP is a red herring designed to prevent the study taking place and it remains unclear to us why Nowicky decided to withdraw his support.
Wassil Nowicky Nowicky Pharma, Margaretenstrasse 7, A1040 Vienna, Austria. 1 Alternative cancer cures. Lancet Oncol 2000; 1: 204.
Authors’ reply The proposed study, which we outlined in our letter, was in keeping with standard practice for phase II studies and had the approval of our institution’s Ethics committee. The issue of an independent monitoring committee was never raised by Nowicky and we would have no objection to this, if the company would bear the cost, although it is not a routine part of phase II studies. It was the need for an objective assessment of this compound (which
David Farrugia*, Maurice L Slevin† *Cheltenham Hospital, Cheltenham, Gloustershire GL53 7AN, UK. †St Bartholomew’s Hospital, West Smithfield, London EC1A 7BE, UK.
Erratum. Apologies to David Gunnell (University of Bristol, UK), whose name should have appeared as the second author on the letter entitled Trends in prostate cancer mortality in England, Wales, and the USA (Lancet Oncol 2000; 1: 136). 10
THE LANCET Oncology Vol 2 January 2001
For personal use only. Not to be reproduced without permission of The Lancet.
with 354 conventional squamous carcinomas. There are few papers on spindlecell carcinomas of the tongue in the literature, which is line with the fact that they are uncommon. To our knowledge, the biggest series on spindle cell carcinomas of the oral cavity was studied by Ellis and Corio.3 They analysed 59 cases, 12 of which were in the tongue. Spindle-cell carcinomas are just an uncommon histological variant of squamous carcinoma with no special prognostic or therapeutic implications. However,
they do need to be distinguished from sarcomas and malignant melanomas. Sanjay A Pai*, Anita M Borges† *Manipal Hospital, Bangalore 560 017, India. †Tata Memorial Hospital, Mumbai 400012, India. 1 Dimitrov BD. Epidemiology of oral cancers. Lancet Oncol 2000; 1: 135. 2 Dimitrov BD. Epidemiology of gastrointestinal cancers other than colorectal. In: Sadler M, Strain S, Caballero B, Eds. Encyclopaedia of Human Nutrition. Academic Press, London, 1998, 248–255. 3 Ellis GL, Corio RL. Spindle cell carcinoma of the oral cavity. Oral Surg 1980; 50: 523–534.
Clinical testing of Ukrain Some remarks in the letter about Ukrain in The Lancet Oncology (Dec 2000) by Farrugia and Slevin1 are based upon a misunderstanding, especially the assertion that we, as the producers of Ukrain, are “unable or unwilling” to take the opportunity for “a sober assessment” of the drug. We agreed immediately to the proposal for a clinical study at St Bartholomew’s Hospital and agreed to supply the drug free of charge. However, we assumed that a clinical study at a major European teaching hospital would be carried out according to Good Clinical Practice (GCP) with independent monitoring, which is a requirement of GCP. Our previous experience has shown that studies
which are not carried out according to GCP are not recognised in Europe. Most of the clinical studies carried out on Ukrain so far have taken place outside the European Union and while investigators have followed the guidelines of GCP the studies have been criticised because not all the formalities were observed. Seen from this point of view, a new clinical study would be of value only if carried out in accordance with GCP. Both the hospital and our company would otherwise bear high costs for a study which would not be recognised. We were therefore unable to understand why Farrugia and Slevin were unwilling to carry out the study according to GCP with independent
monitoring, a precondition which we took for granted would be met at a major European teaching hospital. This is the real reason why the study has not been set up. We would like to emphasise that we are most willing for an objective, independently monitored study in accordance with GCP to be carried out on Ukrain, that we are prepared to supply the drug free of charge for such a study and that we hope that the study proposed by Farrugia and Slevin can in fact take place.
as he rightly says, is lacking in all the clinical papers reported by Nowicky and his colleagues), which prompted us to suggest this study. We intended to subject Ukrain to the same assessment that any other anti-cancer agent would receive within the context of a phase II study. If Ukrain showed objective evidence of activity there would be no difficulty obtaining pharmaceutical funds for further studies to the level of GCP. Clearly this level of
monitoring is outside that which is affordable by a single hospital funded study. It seems to us that the issue of GCP is a red herring designed to prevent the study taking place and it remains unclear to us why Nowicky decided to withdraw his support.
Wassil Nowicky Nowicky Pharma, Margaretenstrasse 7, A1040 Vienna, Austria. 1 Alternative cancer cures. Lancet Oncol 2000; 1: 204.
Authors’ reply The proposed study, which we outlined in our letter, was in keeping with standard practice for phase II studies and had the approval of our institution’s Ethics committee. The issue of an independent monitoring committee was never raised by Nowicky and we would have no objection to this, if the company would bear the cost, although it is not a routine part of phase II studies. It was the need for an objective assessment of this compound (which
David Farrugia*, Maurice L Slevin† *Cheltenham Hospital, Cheltenham, Gloustershire GL53 7AN, UK. †St Bartholomew’s Hospital, West Smithfield, London EC1A 7BE, UK.
Erratum. Apologies to David Gunnell (University of Bristol, UK), whose name should have appeared as the second author on the letter entitled Trends in prostate cancer mortality in England, Wales, and the USA (Lancet Oncol 2000; 1: 136). 10
THE LANCET Oncology Vol 2 January 2001
For personal use only. Not to be reproduced without permission of The Lancet.