- Email: [email protected]
Cardiotocography with ST-waveform analysis for fetal monitoring
1349
the results were equally as good in the CTG group. Because of the size of the trial and the small number of perinatal deaths it is difficult to know whether the deaths in the CTG group would have been prevented if the women had been assigned to the doppler subset. Furthermore, we are becoming increasingly aware that much of the long-term morbidity of infants is attributable not to intrapartum but to antenatal problems. Antenatal CTG monitoring seems not to have had too great an influence in this respect and long-term studies are therefore necessary to establish whether doppler monitoring has any impact. On the basis of this small trial I have difficulty in concluding that
be substituted for CTG monitoring in cases where intrauterine growth retardation is the only complicating factor. A larger and better controlled series with the same protocol should be done and may provide better guidance about the efficiency of the technique in identifying the at-risk fetus, but until then doppler velocimetry should only be used for research.
doppler velocimetry may
Department of Obstetrics and Gynaecology, Western General Hospital, Edinburgh EH4 2XU, UK
M. R. GAUDOIN
Snijders RMJ, Gosden CM, Berry C, Campbell S. Ultrasonographically detectable markers of fetal chromosomal abnormalities.
1.Nicolaides KH,
Lancet 1992; 340: 704-07.
Cardiotocography with ST-waveform analysis for fetal monitoring SIR,-Dr Westgate and colleagues (July 25,
p
194) report
a
randomised controlled study of intrapartum fetal
monitoring comparing fetal heart rate cardiotocography (CTG) monitoring with the new STAN system combining CTG with ST-waveform analysis of the fetal electrocardiogram. Our clinical experience with the STAN monitor started in January, 1990, after an initial period of staff training. About 1500 deliveries took place per year over the 5 years from 1987 to 1991. The figure shows the frequency of acute operative deliveries, with caesarian sections and forceps/vacuum extractions shown separately. The data for the first 6 months of 1992 are also included. We have followed a similar protocol to that used by Westgate et al, but without fetal scalp blood sampling. The number of acute operative deliveries was reduced from 6-2% in 1989 to 2-7% and 2-3% in 1990 and 1991, respectively, without any increase in perinatal morbidity or mortality. Thus our CTG
practice has been strengthened by the addition of ST-waveform analysis to decide if labour should be expedited or allowed to continue without intervention. We believe that these data show that CTG plus ST-waveform analysis during labour is clinically valuable and provides safe assessment of fetal wellbeing. B. C. ERIKSEN
Department of Gynaecology and Obstetrics, Haugesund General Hospital, 5500 Haugesund, Norway
J. HAUSKEN T. EIKELAND
Adjuvant treatment with 5-fluorouracil for colorectal
cancer
SIR,-Prof Fielding and colleagues’ study (Aug 29, p 506) does the question: what is the effect of systemic intravenous 5-fluorouracil (5-FU) as adjuvant therapy for colorectal cancer? Instead, it is a randomised trial of intraportal 5-FU plus heparin
not answer
after surgery
versus surgery alone. Did they believe that conventionally administered intravenous 5-FU was not beneficial? In one of the first large reviews of the type now called meta-analysis, Buyse et aP concluded that 5-FU had a "small benefit of therapy in terms of overall survival" when used as adjuvant therapy. Stage III (Dukes’ C) patients received substantial benefit from adjuvant 5-FU given intravenously in the randomised clinical trial reported by the Central Oncology Group.2 Disease-free survival for all Dukes’ C patients was improved by 5-FU (p = 0-026); both disease-free survival and survival were significantly improved in patients with rectal cancer who were treated with 5-FU after resection (p=0’04 and p = 0005, respectively). The clinical trial of 5-FU and levamisole3 that has led to the widespread use of levamisole with 5-FU in adjuvant therapy
failed to include a control arm of 5-FU alone. For this reason-and like the study by Fielding et al-it was flawed. University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Medical Sciences Building G595, University Heights, Newark, New Jersey 07103, USA
GEORGE J. HILL
Buyse M, Zeelenuich-Jacquette A, Chalmers TC. Adjuvant therapy of colorectal cancer: why we still don’t know. JAMA 1988; 259: 3571-78. 2. Grage TB, Moss SE. Adjuvant chermotherapy in cancer of the colon and rectum: demonstration of effectiveness of prolonged 5-FU chemotherapy in a prospectively controlled, randomised clinical trial. Surg Clin N Am 1981; 61: 1447-56. 3. Laurie JA, Moertel CG, Fleming TR, et al. Surgical adjuvant therapy of large bowel 1.
an evaluation of levamisole and the combination of levamisole and 5-fluorouracil: a study of the North Central Treatment Group (NCCTG) and the Mayo Clinic. J Clin Oncol 1989; 7: 1447-56. cancer:
*** This letter has been shown to Professor Fielding and colleagues whose reply follows.-ED. L. SiR,—The aim of our study was to evaluate the concept set out by previous trials, of intraportal adjuvant chemotherapy for colorectal cancer. We wished to study a large population, to look at the effect of heparin alone in this system, and to tackle some technical and logistic issues within randomised trials by studying the "whole population" of patients with the diagnosis. The study was planned in 1979/80 at a time when the meta-analysis referred to by Hill was yet to be published (in 1988), and indeed the study on adjuvant therapy of systemic 5-fluorouracil
Section
1m 93
1987 1991
Q II
1988
.
Vacuum/ forceps
1989
Hi
1990
1992
Frequency of acute operative deliveries, 1987-92.
alone did not appear until 1981. We could not use 5-fluorouracil alone because addition of low-dose heparin into the infusate was done to prevent or reduce the risk of portal-vein thrombosis. Apart from this biological reason, a randomised trial should not need to include all possible combinations of treatment in different arms of the investigation. To suggest that the absence of a particular arm of interest to the reader results in a "flawed study" is illogical. The thrust of Hill’s letter is that perhaps 5-fluorouracil alone given systemically might be a useful treatment in patients after so-called curative resection for large-bowel adenocarcinoma. I agree that we do not yet have data to discard this possibility, and that the national guidelines in North America to support the use of 5-fluorouracil and levamisole can be viewed as premature. Clearly,
the results were equally as good in the CTG group. Because of the size of the trial and the small number of perinatal deaths it is difficult to know whether the deaths in the CTG group would have been prevented if the women had been assigned to the doppler subset. Furthermore, we are becoming increasingly aware that much of the long-term morbidity of infants is attributable not to intrapartum but to antenatal problems. Antenatal CTG monitoring seems not to have had too great an influence in this respect and long-term studies are therefore necessary to establish whether doppler monitoring has any impact. On the basis of this small trial I have difficulty in concluding that
be substituted for CTG monitoring in cases where intrauterine growth retardation is the only complicating factor. A larger and better controlled series with the same protocol should be done and may provide better guidance about the efficiency of the technique in identifying the at-risk fetus, but until then doppler velocimetry should only be used for research.
doppler velocimetry may
Department of Obstetrics and Gynaecology, Western General Hospital, Edinburgh EH4 2XU, UK
M. R. GAUDOIN
Snijders RMJ, Gosden CM, Berry C, Campbell S. Ultrasonographically detectable markers of fetal chromosomal abnormalities.
1.Nicolaides KH,
Lancet 1992; 340: 704-07.
Cardiotocography with ST-waveform analysis for fetal monitoring SIR,-Dr Westgate and colleagues (July 25,
p
194) report
a
randomised controlled study of intrapartum fetal
monitoring comparing fetal heart rate cardiotocography (CTG) monitoring with the new STAN system combining CTG with ST-waveform analysis of the fetal electrocardiogram. Our clinical experience with the STAN monitor started in January, 1990, after an initial period of staff training. About 1500 deliveries took place per year over the 5 years from 1987 to 1991. The figure shows the frequency of acute operative deliveries, with caesarian sections and forceps/vacuum extractions shown separately. The data for the first 6 months of 1992 are also included. We have followed a similar protocol to that used by Westgate et al, but without fetal scalp blood sampling. The number of acute operative deliveries was reduced from 6-2% in 1989 to 2-7% and 2-3% in 1990 and 1991, respectively, without any increase in perinatal morbidity or mortality. Thus our CTG
practice has been strengthened by the addition of ST-waveform analysis to decide if labour should be expedited or allowed to continue without intervention. We believe that these data show that CTG plus ST-waveform analysis during labour is clinically valuable and provides safe assessment of fetal wellbeing. B. C. ERIKSEN
Department of Gynaecology and Obstetrics, Haugesund General Hospital, 5500 Haugesund, Norway
J. HAUSKEN T. EIKELAND
Adjuvant treatment with 5-fluorouracil for colorectal
cancer
SIR,-Prof Fielding and colleagues’ study (Aug 29, p 506) does the question: what is the effect of systemic intravenous 5-fluorouracil (5-FU) as adjuvant therapy for colorectal cancer? Instead, it is a randomised trial of intraportal 5-FU plus heparin
not answer
after surgery
versus surgery alone. Did they believe that conventionally administered intravenous 5-FU was not beneficial? In one of the first large reviews of the type now called meta-analysis, Buyse et aP concluded that 5-FU had a "small benefit of therapy in terms of overall survival" when used as adjuvant therapy. Stage III (Dukes’ C) patients received substantial benefit from adjuvant 5-FU given intravenously in the randomised clinical trial reported by the Central Oncology Group.2 Disease-free survival for all Dukes’ C patients was improved by 5-FU (p = 0-026); both disease-free survival and survival were significantly improved in patients with rectal cancer who were treated with 5-FU after resection (p=0’04 and p = 0005, respectively). The clinical trial of 5-FU and levamisole3 that has led to the widespread use of levamisole with 5-FU in adjuvant therapy
failed to include a control arm of 5-FU alone. For this reason-and like the study by Fielding et al-it was flawed. University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Medical Sciences Building G595, University Heights, Newark, New Jersey 07103, USA
GEORGE J. HILL
Buyse M, Zeelenuich-Jacquette A, Chalmers TC. Adjuvant therapy of colorectal cancer: why we still don’t know. JAMA 1988; 259: 3571-78. 2. Grage TB, Moss SE. Adjuvant chermotherapy in cancer of the colon and rectum: demonstration of effectiveness of prolonged 5-FU chemotherapy in a prospectively controlled, randomised clinical trial. Surg Clin N Am 1981; 61: 1447-56. 3. Laurie JA, Moertel CG, Fleming TR, et al. Surgical adjuvant therapy of large bowel 1.
an evaluation of levamisole and the combination of levamisole and 5-fluorouracil: a study of the North Central Treatment Group (NCCTG) and the Mayo Clinic. J Clin Oncol 1989; 7: 1447-56. cancer:
*** This letter has been shown to Professor Fielding and colleagues whose reply follows.-ED. L. SiR,—The aim of our study was to evaluate the concept set out by previous trials, of intraportal adjuvant chemotherapy for colorectal cancer. We wished to study a large population, to look at the effect of heparin alone in this system, and to tackle some technical and logistic issues within randomised trials by studying the "whole population" of patients with the diagnosis. The study was planned in 1979/80 at a time when the meta-analysis referred to by Hill was yet to be published (in 1988), and indeed the study on adjuvant therapy of systemic 5-fluorouracil
Section
1m 93
1987 1991
Q II
1988
.
Vacuum/ forceps
1989
Hi
1990
1992
Frequency of acute operative deliveries, 1987-92.
alone did not appear until 1981. We could not use 5-fluorouracil alone because addition of low-dose heparin into the infusate was done to prevent or reduce the risk of portal-vein thrombosis. Apart from this biological reason, a randomised trial should not need to include all possible combinations of treatment in different arms of the investigation. To suggest that the absence of a particular arm of interest to the reader results in a "flawed study" is illogical. The thrust of Hill’s letter is that perhaps 5-fluorouracil alone given systemically might be a useful treatment in patients after so-called curative resection for large-bowel adenocarcinoma. I agree that we do not yet have data to discard this possibility, and that the national guidelines in North America to support the use of 5-fluorouracil and levamisole can be viewed as premature. Clearly,