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EDITORIALS: S O'Reilly and A Forastiere New approaches to treating oesophageal cancer BMJ 1994; 308: 1249-1250 [Full text]

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Oesophageal Cancer Clinical Trials

Abd H Mat Sain   (19 April 2003)

Oesophageal Cancer Clinical Trials 19 April 2003
Abd H Mat Sain, Consultant Surgeon, Advanced Medical and Dental Institute Universiti Sains Malaysia, Penang, Malaysia,11800 Send response to journal: Re: Oesophageal Cancer Clinical Trials	Sir - The call by this editorial has been responded by this ambitious study from the Medical Research Council (MRC) Oesophageal Cancer Working Party and should be applauded in trying to add further knowledge and wisdom in the management of this dismal disease (1). Advances in the management of oesophageal cancers have been hard to come by for so many years now. Apart from the Japanese experience of treating the early discovered cancers through screening programs, most of the cases elsewhere were quite unimpressive with regard to the utility and success of surgical approaches with or without adjuvant therapies (2). One of the problems that has caused such a lull period in getting randomized controlled trials in oesophageal cancers has been the difficulty in getting the interested parties to recruit their patients into such a trial (3). The randomized controlled trials for the treatment of oesophageal cancers illustrates the perennial and universal difficulties in attempting to conduct the experimentation of clinical surgery according to the highest standard of scientific rigour (4). Multicentre trials may be necessary in trying to recruit the appropriate number of patients for a statistically valid experimentation. However, the logistics of organisation of patients and collation of data might be utterly insurmountable. One glaring example is the deviation from the usual norm of any scientific article in that a paper from multi-institutional study is sometimes "authorless". The only sense of associated responsibility is to be found under the Writing committees, Working Part committees and contributors which may amount to more than 100 (1). It is no surprise then to discover so many inconsistencies and questions in the methodology and the results of this kind of study. Epithelial oesophageal cancers consisting mainly of the squamous and adeno-type are essentially heterogeneous and constitute two different types of diseases altogether. Not to differentiate them in most of the analyses, is a futile attempt to homogenise two biologically diverse entities. This can cause a serious and significant confounding factor to affect the overall validity of any analysis. It is also shown that the extent of resection and radiotherapy have contributed to the outcome of oesophageal cancer management and as such require standardization to neutralize confounders (5). This confounding technical consideration appears to be the “Achilles heel” of many trials in surgical therapy as surgeons’ performance differ tremendously from one individual to the other even from the same unit (6). In conclusion, a satisfactory management of oesophageal cancers worldwide remains a clinical enigma and better organisations and research methodology are required in any future endevour. References 1. Medical Research Council Oesophageal Cancer Working Party. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Volume 359, Number 9319 18 May 2002 2. Shimizu Y, Tukagoshi H, Fujita M, Hosokawa M, Kato M, asaka M. Endoscopic screening for early esophageal cancer by iodine staining in patients with other current or prior primary cancers. Gastrointest Endosc 2001 Jan 53:1 1-5 3. Earlam R. An MRC prospective randomised trial of radiotherapy versus surgery for operable squamous cell carcinoma of the oesophagus. Ann R Coll Surg Engl 1991 Jan 73:1 8-12 4. Peter McCulloch, Irving Taylor, Mitsuru Sasako, Bryony Lovett, and Damian Griffin. Randomised trials in surgery: problems and possible solutions. BMJ 2002; 324: 1448-1451. 5. Wobst A, Audisio RA, Colleoni M, Geraghty JG. Oesophageal cancer treatment: studies, strategies and facts. Ann Oncol 1998 Sep 9:951-62 6. David Carter. The surgeon as a risk factor . BMJ 2003; 326: 832- 833. Competing interests:   None declared