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Preoperative irradiation for adenocarcinoma endometrium
1430
(136)
Radiation Oncology ??Biology ??Physics
October 1960, Volume 6, Number 10
PRELIMINARY EXPERIENCE IN A PROSPECTIVE RANDOMIZED TRIAL TO ASSESS THE VALUE OF HYDROXYUREA IN ADDITION TO CONVENTIONAL RADIOTHERAPY IN THE MANAGEMENT OF ADVANCED STAGES OF CARCINOMA OF THE UTERINE CERVIX Hywel Madoc-Jones, M.D. Carlos Perez, M.D. Marvin Camel, M.D. Faye Jennings, R.N. Washington University School of Medicine St. Louis, Missouri 63110 Two prospective randomized trials of the use of Hydroxyurea with radiation in the management of advanced carcinoma of the cervix have been reported, one from Roswell Park (Piver et al.,1977), the other from the GOG (Hreshchyshyn et al., 1979). Both studies have reported an apparent improvement in the survival in the Hydroxyurea-treated patients. However, a large proportion of patients had to have modification of the drug regimen because of bone marrow or gastrointestinal toxicity. In 1975, a prospective randomized trial of radiation alone versus radiation plus Hydroxyurea was begun at the Mallinckrodt Institute of Radiology for carcinoma of the cervix Stages IIB through IVA. The two arms are weighted 2:l in favor of the To date, 41 patients have been entered into the study. Hydroxyurea group. The numbers are too few and the follow-up too short to see any significance in the finding that there is, as yet, no improvement seen in the HydroxyureaThe dose regimen is 80 mg per kg, which is the same as in treated patients. the two studies cited, given every third day (or twice a week) during the treatment and for a period of time after treatment. However, it is already Of the 28 clear that the drug is not well tolerated on this regimen. patients in the Hydroxyurea group, only one patient has completed Hydroxyurea Twelve patients had the drug discontinued permanently as per protocol. during the course of radiation because of gastrointestinal or bone marrow Ten patients had the dose decreased during the course of radiotoxicity. Three patients exercised their therapy for the same reasons of toxicity. Four patients had the dose right to refuse to take any more of the drug. reduced after radiation was completed because of bone marrow toxicity. Because of this experience, we believe that any claim that Hydroxyurea improves the result of conventional radiotherapy for advanced carcinoma of the cervix should be treated with caution.
(137)
PREOPERATIVE
IRRADIATION
FOR ADENOCARCINOMA
ENDOMETRIUM
James M. Slater, M.D. - Alan King, M.D. Department of Radiation Sciences - Obstetrics Loma Linda University Loma Linda, California
and Gynecology
The effectiveness of combined surgical and radiation treatment for Stage I adenocarcinoma of the endometrium, using both external beam and intracavitary radium within tandum and ovoids (omitting Heyman's capsules), was evaluated in a retrospective study of 179 patients treated between 1970 and 1977 at Loma Linda University Medical Center. Fifty-five patients with no unfavorable prognostic factors were treated by surgery alone. For the other 124 patients, preoperative and pbstoperative radiation treatments were designed to compensate for one or more unfavorable prognostic factors--grade, depth of endometrial cavity, and depth of myometrial invasion. Each subgroup was evaluated for survival probability, time and site of recurrence,
1431
Proceedings of the 22nd Annual ASTR Meeting Additional prognostic factors, including age and treatment complications. and status of lymph nodes, were evaluated to determine their significance and Overall adjusted survival rate was 94%. There were no interdependence. Of the 15 rerecurrences in the favorable group receiving surgery alone. currences in the group with unfavorable prognostic factors, only one reGrade and patient age were found to be the most curred in the pelvis alone. Depth of uterine cavity and significant prognostic factors in this program. This of myometrial invasion were not found to be predictive of survival. study indicates appropriately designed irradiation can compensate for unfaThese results can be accomplished without use of vorable prognostic factors. Heyman's capsules, thus avoiding the problems associated with their use.
(138) p. RANDOMISED
FOR
TRIAL
ADV/J,NCEDSTAGE
COMPARING
DAILY
3b CARCINOMA
OF
TO THE
k'EEKLY EXTEVW UTERINE
IwMIIATION
CERVIX
Nora G. de yoor, VB.Bch. D.M.P. (Professor) S. Browde, VB.Bch. M.Med (Rad) T M. Nissenbaum, B.Sc. Engineering, YB.Bch. DeDartment of Theraoeutic Qadiologv, University of the Witwatersrand, Johannesburg, Republic of South Africa A randonised trial comoaring 5 week1.y to 29 daily treatments for Stage 3b carcinoma of the cervix has been completed. Patients included were 70 not suitable for years or ynder, beam theranv lntra-cav1tar.v A received 5 weekunit. Grout delivered by a ly fractions of 750 rads using a 36n" rotation technique. Grouo P received 29 daily fractions using a bi-axial 1800 rotation technique. Field size was determined by the anatomical size of the oelvis, extendin? from the lower edge of the obturator foramen to the middle of the 5th lumbar vertebra (minimum), with s maximum vertical length of 16 ems. The iso-effect doses based on the N.S.D. formula 1765 ret (weekly) 1798 ret (dailv)(Ellis 1967) T.D.F.99 (weekly) 102.6 (dailv) (Organ and Ellis, 1973) C.R.E. 1765 reu (weekly) and 1798 reu (dailv) (Kirk, et al, 1971). There is a dose difference of 2-3s between the 2 reoimes. Ninetv eiaht oatients were entered into the trial, the first one in January, 1977 and ihe last in December, 1978. Eightv seven oatients are available for review, 11 patients having been excluded as they died during or before treatment commenced. Vean age of patients in both grouos were equal, (50.5 years), A 95% follow up show survival, local control, incidence of distant metsstases and severe high dose effects were statistically equal in both fractionation grouos. (See tatle). Our fiaures are in aareement with yadhusudan Dvidedi and Pradhan's results (1978). They claimed eaual local control with no severe side effects when using weekly as compared to daily treatment. Unfortunately, their follow-up was incomolete and therefore their results could be inconclusive. Singh (1978) claimed that for 1 fraction oer week doses predicted are not 'iso-effective' as far as normal DelViC tiSSUeS are concerned. He abandoned the weekly fractionation due to severe bowel damace. P possible exalanation between the contradiction of Singh's results and ours are the fact that he used fixed fields and intracavitarv irradiation in addition to external irradiation.
(136)
Radiation Oncology ??Biology ??Physics
October 1960, Volume 6, Number 10
PRELIMINARY EXPERIENCE IN A PROSPECTIVE RANDOMIZED TRIAL TO ASSESS THE VALUE OF HYDROXYUREA IN ADDITION TO CONVENTIONAL RADIOTHERAPY IN THE MANAGEMENT OF ADVANCED STAGES OF CARCINOMA OF THE UTERINE CERVIX Hywel Madoc-Jones, M.D. Carlos Perez, M.D. Marvin Camel, M.D. Faye Jennings, R.N. Washington University School of Medicine St. Louis, Missouri 63110 Two prospective randomized trials of the use of Hydroxyurea with radiation in the management of advanced carcinoma of the cervix have been reported, one from Roswell Park (Piver et al.,1977), the other from the GOG (Hreshchyshyn et al., 1979). Both studies have reported an apparent improvement in the survival in the Hydroxyurea-treated patients. However, a large proportion of patients had to have modification of the drug regimen because of bone marrow or gastrointestinal toxicity. In 1975, a prospective randomized trial of radiation alone versus radiation plus Hydroxyurea was begun at the Mallinckrodt Institute of Radiology for carcinoma of the cervix Stages IIB through IVA. The two arms are weighted 2:l in favor of the To date, 41 patients have been entered into the study. Hydroxyurea group. The numbers are too few and the follow-up too short to see any significance in the finding that there is, as yet, no improvement seen in the HydroxyureaThe dose regimen is 80 mg per kg, which is the same as in treated patients. the two studies cited, given every third day (or twice a week) during the treatment and for a period of time after treatment. However, it is already Of the 28 clear that the drug is not well tolerated on this regimen. patients in the Hydroxyurea group, only one patient has completed Hydroxyurea Twelve patients had the drug discontinued permanently as per protocol. during the course of radiation because of gastrointestinal or bone marrow Ten patients had the dose decreased during the course of radiotoxicity. Three patients exercised their therapy for the same reasons of toxicity. Four patients had the dose right to refuse to take any more of the drug. reduced after radiation was completed because of bone marrow toxicity. Because of this experience, we believe that any claim that Hydroxyurea improves the result of conventional radiotherapy for advanced carcinoma of the cervix should be treated with caution.
(137)
PREOPERATIVE
IRRADIATION
FOR ADENOCARCINOMA
ENDOMETRIUM
James M. Slater, M.D. - Alan King, M.D. Department of Radiation Sciences - Obstetrics Loma Linda University Loma Linda, California
and Gynecology
The effectiveness of combined surgical and radiation treatment for Stage I adenocarcinoma of the endometrium, using both external beam and intracavitary radium within tandum and ovoids (omitting Heyman's capsules), was evaluated in a retrospective study of 179 patients treated between 1970 and 1977 at Loma Linda University Medical Center. Fifty-five patients with no unfavorable prognostic factors were treated by surgery alone. For the other 124 patients, preoperative and pbstoperative radiation treatments were designed to compensate for one or more unfavorable prognostic factors--grade, depth of endometrial cavity, and depth of myometrial invasion. Each subgroup was evaluated for survival probability, time and site of recurrence,
1431
Proceedings of the 22nd Annual ASTR Meeting Additional prognostic factors, including age and treatment complications. and status of lymph nodes, were evaluated to determine their significance and Overall adjusted survival rate was 94%. There were no interdependence. Of the 15 rerecurrences in the favorable group receiving surgery alone. currences in the group with unfavorable prognostic factors, only one reGrade and patient age were found to be the most curred in the pelvis alone. Depth of uterine cavity and significant prognostic factors in this program. This of myometrial invasion were not found to be predictive of survival. study indicates appropriately designed irradiation can compensate for unfaThese results can be accomplished without use of vorable prognostic factors. Heyman's capsules, thus avoiding the problems associated with their use.
(138) p. RANDOMISED
FOR
TRIAL
ADV/J,NCEDSTAGE
COMPARING
DAILY
3b CARCINOMA
OF
TO THE
k'EEKLY EXTEVW UTERINE
IwMIIATION
CERVIX
Nora G. de yoor, VB.Bch. D.M.P. (Professor) S. Browde, VB.Bch. M.Med (Rad) T M. Nissenbaum, B.Sc. Engineering, YB.Bch. DeDartment of Theraoeutic Qadiologv, University of the Witwatersrand, Johannesburg, Republic of South Africa A randonised trial comoaring 5 week1.y to 29 daily treatments for Stage 3b carcinoma of the cervix has been completed. Patients included were 70 not suitable for years or ynder, beam theranv lntra-cav1tar.v A received 5 weekunit. Grout delivered by a ly fractions of 750 rads using a 36n" rotation technique. Grouo P received 29 daily fractions using a bi-axial 1800 rotation technique. Field size was determined by the anatomical size of the oelvis, extendin? from the lower edge of the obturator foramen to the middle of the 5th lumbar vertebra (minimum), with s maximum vertical length of 16 ems. The iso-effect doses based on the N.S.D. formula 1765 ret (weekly) 1798 ret (dailv)(Ellis 1967) T.D.F.99 (weekly) 102.6 (dailv) (Organ and Ellis, 1973) C.R.E. 1765 reu (weekly) and 1798 reu (dailv) (Kirk, et al, 1971). There is a dose difference of 2-3s between the 2 reoimes. Ninetv eiaht oatients were entered into the trial, the first one in January, 1977 and ihe last in December, 1978. Eightv seven oatients are available for review, 11 patients having been excluded as they died during or before treatment commenced. Vean age of patients in both grouos were equal, (50.5 years), A 95% follow up show survival, local control, incidence of distant metsstases and severe high dose effects were statistically equal in both fractionation grouos. (See tatle). Our fiaures are in aareement with yadhusudan Dvidedi and Pradhan's results (1978). They claimed eaual local control with no severe side effects when using weekly as compared to daily treatment. Unfortunately, their follow-up was incomolete and therefore their results could be inconclusive. Singh (1978) claimed that for 1 fraction oer week doses predicted are not 'iso-effective' as far as normal DelViC tiSSUeS are concerned. He abandoned the weekly fractionation due to severe bowel damace. P possible exalanation between the contradiction of Singh's results and ours are the fact that he used fixed fields and intracavitarv irradiation in addition to external irradiation.