Astrid Oechs

Evaluation of the effect of routine packed red blood cell transfusion in anemic cervix cancer patients treated with radical radiotherapy

PURPOSE It is well established that anemia predicts diminished radiocurability in cervix cancer. However, the therapeutic benefit of measures to correct the anemia remains controversial. The objective of this study was to determine the impact of routine transfusion in patients with hemoglobin level (hb-l) < or =11 g/dl. METHODS AND MATERIALS Since 1985, it has been departmental policy to attempt to correct hb-l < or =11 g/dl before and/or during radiotherapy by red blood cell transfusion (RBCT) in patients undergoing radical radiotherapy for primary cervix cancer. To assess the benefit of RBCT, the charts of 204 patients (FIGO: IB-IV) treated until 1997 were reviewed. Parameters analyzed for their impact on disease-specific survival (DSS), pelvic control (PC), and metastases-free survival (MFS) included pretreatment hb-l, treatment hb-l, stage, tumor size, and lymph node status. To determine any differences in outcome according to type of anemia, a separate analysis was performed, grouping patients by cause of anemia (tumor vs. other medical illness related). RESULTS Each of the parameters tested was significantly correlated with the end points studied in univariate analysis. Patients whose hb-l were corrected (18.5%) had an outcome that did not differ significantly from that of nontransfused patients, whereas DSS, PC, and MFS (all: p < 0.001) were significantly decreased in nonresponders to RBCT. Subgroup analysis showed no impact of hb-l in patients with other medical illness-related anemia (n = 12). In multivariate analysis treatment, but not pretreatment, hb-l remained predictive for DSS, PC, and MFS. Persistent anemia was associated with a significantly increased risk of death (relative risk: 2.1) and pelvic failure (relative risk: 2.4) compared with nontransfused patients. If only patients with tumor anemia were considered, the respective risks increased (2.7; 3.6). None of the patients with other causes of anemia recurred, whether or not their hb-l was maintained. Assessment of the therapeutic gain in patients who responded to RBCT showed improved PC (p = 0.02) and a trend toward increased DSS (p = 0.06), but no effect on MFS after adjustment for tumor size and lymph node status. CONCLUSION Treatment hb-l, in addition to tumor size and lymph node status, independently predicted outcome. Although our final multivariate analysis showed a therapeutic benefit for patients whose hb-l was corrected, the response to RBCT was disappointing. Results of our subgroup analysis suggest that the cause of anemia in patients with cervical cancer warrants in-depth investigation.

Experience with split-course external beam irradiation ± chemotherapy and integrated Ir-192 high-dose-rate brachytherapy in the treatment of primary carcinomas of the anal canal

PURPOSE The effect of the treatment of anal cancer by performing a high-dose-rate (HDR) brachytherapy boost during a short split between the external beam radiotherapy series (EBR) +/- chemotherapy was investigated. METHODS AND MATERIALS Thirty-nine patients with anal canal cancers, stages T1-T4 N0-2 M0, were treated with split-course EBR (50-50.4 Gy) and a Iridium 192 ((192)Ir-) HDR boost (6 Gy) performed during the 1-2-week split. Patients who failed to achieve a complete tumor response received additional brachytherapy. Chemotherapy with 5-fluorouracil and mitomycin C was offered to patients with tumors > 3 cm and employed concomitantly on days 1-5 and day 1, respectively, of each EBR series. RESULTS Follow-up ranged from 3 to 140 months (median 31). Median treatment duration was 56 days. The 3-year (5-year) actuarial rates of locoregional control (LRC) and disease-specific survival (DSS) were 81% (76%) and 80% (76%), respectively. The crude rate of anal preservation was 77% overall, and 97% in patients in whom LRC was achieved. Uncompromised anal function was recorded in 93% of these patients. The actuarial 3-year (5-year) rate of colostomy-free survival (CFS) was 78% (73%). There was a statistically significant difference in LRC and DSS according to stage, tumor size, and nodal status. Complications requiring surgical intervention occurred in 7.6% of patients. CONCLUSION The integration of the HDR boost in a split-course EBR regimen +/- chemotherapy resulted in excellent sphincter function without an increase of severe complications and with rates of LRC, DSS, and CFS, which compare favorably with those reported in the literature.

Photonentherapie der subfovealen choroidalen Neovaskularisation bei altersabhängiger Makuladegeneration

AIM To determine the effect of external beam radiotherapy on subfoveal choroidal neovascularization in age-related macular degeneration. PATIENTS AND METHODS Between September 1995 and July 1996, 40 patients (9 males and 31 females; mean age 74 years, range 61 to 83 years) were included in a prospective study. Eight patients had classic, well-defined neovascularisations, 32 patients had occult lesions. Complete ophthalmic investigations included visual acuity contrast sensitivity as well as fluorescein and indocyanine green angiographic examinations prior to treatment and 1, 3, 6, and 12 months after radiotherapy. External beam radiotherapy (8-MV photons) was delivered with a total dose of 14.4 Gy in 8 fractions of 1.8 Gy per day (Figures 1 and 2). The field size averaged 5.5 x 4.5 cm. RESULTS No treatment related morbidity during or after treatment was obtained. After 6 months follow-up the visual acuity was improved in 2 (5%) patients and maintained at pretreatment level in 17 (42%) patients. However, 12 months post treatment a stable situation was found in 6 (15%) patients and a decrease in visual acuity in 34 (85%) patients (Table 1). The central visual fields deteriorated significantly from 16.5 decibel (dB) to 12.4 dB. The enlargement of exudates and neovascular membranes increased 5- to 7-fold. At 12 months after treatment, 3 (7.5%) patients stated that they had improved vision subjectively, 12 (30%) patients had no change and 25 (62.5%) patients suffered from subjective decrease in visual acuity. CONCLUSIONS Using a total dose of 14.4 Gy/1.8 Gy no difference concerning visual acuity and exudative changes in comparison to the natural history on age-related macular degeneration was obtained after 12 months. However, the results of multicenter studies are to be awaited.ZusammenfassungZielÜberprüfung der Effektivität der Strahlentherapie als Therapieansatz in der Behandlung subfovealer choroidaler Neovaskularisation bei altersabhängiger Makuladegeneration.Patienten und MethodenZwischen September 1995 und Juli 1996 wurden 40 Patienten (neum Männer, 31 Frauen; mittleres Alter 74 Jahre; 61 bis 83 Jahre) im Rahmen einer prospektiven Studie an unserer Abteilung bestrahlt. Acht Patienten hatten die klassische Form, 32 die okkulte Form der Makuladegeneration. Vor der Behandlung sowie ein, drei, sechs und zwölf Monate nach der Bestrahlung wurden ein kompletter ophthalmologischer status mit Visus- und Gesichtsfeldbestimmung sowie eine Fluoreszein- und Indozyaningrün-Angiographie durchgeführt. Die Bestrahlung erfolgte generell von einem 5,5 × 4,5 cm großen lateralen, nicht gekippten Feld in Half-beam-Block-Technik mit 8-MV-Photonen mit einer Einzeldosis von 1,8 Gy bis zu einer Gesamtdosis von 14,4 Gy.ErgebnisseBestrahlungsspezifische Nebenwirkungen wurden weder während der Bestrahlung noch in der Nachsorgephase beobachtet. Sechs Monate nach Bestrahlung kam es bei zwei Patienten (5%) zu einer Visusverbesserung, bei 17 (42,5%) patienten zu einer Stabilisierung und bei 21 (52,5%) Patienten zu einer Verschlechterung. Nach einem Jahr hatte sich bei sechs (15%) Patienten der Visus stabilisiert, bei 34 (85%) patienten verschlechterte sich die Sehkraft vergleichbar dem Spontanverlauf. Die mittlere Empfindlichkeit des zentralen Gesichtsfeldes verringerte sich von 16.5 auf 12,4 Dezibel (dB). Das Ausmaß der Neovaskularisationen, Exsudationen und Membranbildungen nahm bei beiden Formen um ein Fünf- bis Siebenfaches zu. Subjecktiv hatte sich nach zwölf Monaten das Sehvermögen bei drei (7,5%) Patienten verbessert, bei zwölf (30%) Patienten stabilisiert und bei 25 (62,5%) Patienten verschlechtert.SchlußfolgerungMit einer Gesamtdosis von 14,4 Gy konnte nach zwölf Monaten kein befriedigender Einfluß auf den Spontanverlauf der Erkrankung beobachtet werden. Ehe definitive Rückschlüsse gezogen werden können, sollten die Ergebnisse bereits laufender bzw. abgeschlossener Multicenterstudien abgewartet werden.AbstractAimTo determine the effect of external beam radiotherapy on subfoveal choroidal neovascularization in age-related macular degeneration.Patients and MethodsBetween September 1995 and July 1996, 40 patients (9 males and 31 females; mean age 74 years, range 61 to 83 years) were included in a prospective study. Eight patients had classic, well defined neovascularisations, 32 patients had occult lesions. Complete ophthalmic investigations included visual acuity contrast sensitivity as well as fluorescein and indocyanine green angiographic examinations prior to treatment and 1, 3, 6, and 12 months after radiotherapy. External beam radiotherapy (8-MV photons) was delivered with a total dose of 14.4 Gy in 8 fractions of 1.8 Gy per day (Figures 1 and 2). The field size averaged 5.5 ×4.5 cm.ResultsNo treatment related morbidity during or after treatment was obtained. After 6 months follow-up the visual acuity was improved in 2 (5%) patients and maintained at pretreatment level in 17 (42%) patients. However, 12 months post treatment a stable situation was found in 6 (15%) patients and a decrease in visual acuity in 34 (85%) patients (Table 1). The central visual fields deteriorated significantly from 16.5 decibel (dB) to 12.4 dB. The enlargement of exsudats and neovascular membranes increased 5- to 7-fold. At 12 months after treatment, 3 (7.5%) patients stated that they had improved vision subjectively, 12 (30%) patients had no change and 25 (62.5%) patients suffered from subjective decrease in visual acuity.ConclusionsUsing a total dose of 14.4 Gy/1.8 Gy no difference concerning visual acuity and exsudative changes in comparison to the natural history on age-related macular degeneration was obtained after 12 months. However, the results of multicenter studies are to be awaited.

Long-term results after external radiotherapy in age-related macular degeneration: A prospective study

Purpose:To prospectively evaluate the short- and long-term efficacy of external radiotherapy (RT) in patients with age-related macular degeneration (AMD) by comparing two different dose schedules.Patients and Methods:In this prospective, nonrandomized, comparative study including 80 patients, the efficacy of external RT with a total dose of 14.4 Gy (group A, n = 40) and 25.2 Gy (group B, n = 40) was compared. Patients of group A were irradiated between September 1995 and July 1996, patients of group B between August 1996 and November 1997. 67 patients presented with occult choroidal neovascularization (CNV), 13 with classic subfoveal lesions. Complete ophthalmologic investigation was performed before RT, at intervals of 3 months during the 1st year after RT, and of 6 months thereafter.Results:12 months after RT, vision deteriorated in 85% (14.4 Gy) and 65% (25.2 Gy) of patients. Central visual field decreased with both dose schedules. There was no morphological benefit in neovascular changes. After 48 months, complete follow-up was possible in 46 patients who showed a significant loss of vision similar to the natural course of AMD.Conclusion:External RT of AMD with 14.4 Gy as well as with the escalated dose of 25.2 Gy showed a poor beneficial outcome after 6 and 12 months, respectively. After a follow-up of 4 years, visual outcome in irradiated patients was similar to the natural course of the disease. A conspicuous efficacy of RT in prevention of blindness could not be demonstrated.Ziel:Prospektive Evaluierung der Kurz- und Langzeitergebnisse nach externer Strahlentherapie (RT) der altersabhängigen Makuladegeneration (AMD) mit Vergleich zweier Dosierungsschemata.Patienten und Methodik:In dieser prospektiven, nicht randomisierten, vergleichenden Studie, die 80 Patienten einschloss, wurde die Effektivität der externen RT mit einer Gesamtdosis von 14,4 Gy (Gruppe A, n = 40) einer Dosis mit 25,2 Gy (Gruppe B, n = 40) gegenübergestellt. Die Patienten der Gruppe A wurden von September 1995 bis Juli 1996, die Patienten der Gruppe B zwischen August 1996 und November 1997 bestrahlt. 67 Patienten hatten die okkulte, 13 die klassische Form der choroidalen Neovaskularisation (CNV). Ein kompletter ophthalmologischer Status wurde vor der RT sowie in 3-monatigen Intervallen innerhalb des 1. Jahres nach RT und anschließend in 6-monatigen Abständen erhoben.Ergebnisse:Nach 12 Monaten verschlechterte sich die Sehkraft bei 85% der Patienten mit 14,4 Gy und bei 65% in der Gruppe mit 25,2 Gy. Es wurde keine Besserung der morphologischen neovaskulären Veränderungen beobachtet. Bei 46 Patienten war eine Nachsorge von mindestens 48 Monaten möglich. Es zeigte sich kein Unterschied gegenüber dem natürlichen Verlauf der Erkrankung. Die Sehkraft verminderte sich signifikant.Schlussfolgerung:Die externe RT der AMD sowohl mit 14,4 Gy als auch nach Dosiserhöhung mit 25,2 Gy zeigte einen nur geringen positiven Effekt nach 6 bzw. 12 Monaten. Nach 4-jähriger Nachsorge war der Visus bei den bestrahlten Patienten ähnlich dem natürlichen Verlauf dieser Erkrankung. Somit konnte keine überzeugende Wirkung in der Prävention des vollständigen Visusverlusts nachgewiesen werden.

Long-Term Results after External Radiotherapy in Age-Related Macular Degeneration

Purpose:To prospectively evaluate the short- and long-term efficacy of external radiotherapy (RT) in patients with age-related macular degeneration (AMD) by comparing two different dose schedules.Patients and Methods:In this prospective, nonrandomized, comparative study including 80 patients, the efficacy of external RT with a total dose of 14.4 Gy (group A, n = 40) and 25.2 Gy (group B, n = 40) was compared. Patients of group A were irradiated between September 1995 and July 1996, patients of group B between August 1996 and November 1997. 67 patients presented with occult choroidal neovascularization (CNV), 13 with classic subfoveal lesions. Complete ophthalmologic investigation was performed before RT, at intervals of 3 months during the 1st year after RT, and of 6 months thereafter.Results:12 months after RT, vision deteriorated in 85% (14.4 Gy) and 65% (25.2 Gy) of patients. Central visual field decreased with both dose schedules. There was no morphological benefit in neovascular changes. After 48 months, complete follow-up was possible in 46 patients who showed a significant loss of vision similar to the natural course of AMD.Conclusion:External RT of AMD with 14.4 Gy as well as with the escalated dose of 25.2 Gy showed a poor beneficial outcome after 6 and 12 months, respectively. After a follow-up of 4 years, visual outcome in irradiated patients was similar to the natural course of the disease. A conspicuous efficacy of RT in prevention of blindness could not be demonstrated.Ziel:Prospektive Evaluierung der Kurz- und Langzeitergebnisse nach externer Strahlentherapie (RT) der altersabhängigen Makuladegeneration (AMD) mit Vergleich zweier Dosierungsschemata.Patienten und Methodik:In dieser prospektiven, nicht randomisierten, vergleichenden Studie, die 80 Patienten einschloss, wurde die Effektivität der externen RT mit einer Gesamtdosis von 14,4 Gy (Gruppe A, n = 40) einer Dosis mit 25,2 Gy (Gruppe B, n = 40) gegenübergestellt. Die Patienten der Gruppe A wurden von September 1995 bis Juli 1996, die Patienten der Gruppe B zwischen August 1996 und November 1997 bestrahlt. 67 Patienten hatten die okkulte, 13 die klassische Form der choroidalen Neovaskularisation (CNV). Ein kompletter ophthalmologischer Status wurde vor der RT sowie in 3-monatigen Intervallen innerhalb des 1. Jahres nach RT und anschließend in 6-monatigen Abständen erhoben.Ergebnisse:Nach 12 Monaten verschlechterte sich die Sehkraft bei 85% der Patienten mit 14,4 Gy und bei 65% in der Gruppe mit 25,2 Gy. Es wurde keine Besserung der morphologischen neovaskulären Veränderungen beobachtet. Bei 46 Patienten war eine Nachsorge von mindestens 48 Monaten möglich. Es zeigte sich kein Unterschied gegenüber dem natürlichen Verlauf der Erkrankung. Die Sehkraft verminderte sich signifikant.Schlussfolgerung:Die externe RT der AMD sowohl mit 14,4 Gy als auch nach Dosiserhöhung mit 25,2 Gy zeigte einen nur geringen positiven Effekt nach 6 bzw. 12 Monaten. Nach 4-jähriger Nachsorge war der Visus bei den bestrahlten Patienten ähnlich dem natürlichen Verlauf dieser Erkrankung. Somit konnte keine überzeugende Wirkung in der Prävention des vollständigen Visusverlusts nachgewiesen werden.

Clinical risk management in radiotherapy: Published guidelines and own experience

Background Radiotherapy (RT) is one of the major treatment options in cancer management. The process of RT is complex and incorporates the use of highly specialized technical equipment. Therefore quality assurance (QA) procedures have always been an inclusive part of RT. Due to the rapidly increasing complexity during the last years, comprehensive QA has become even more of an issue, including treatment planning software, information handling and treatment delivery. Obviously methods from clinical risk management (RM) can be well adapted and adopted for use in radiotherapy. In this paper we aim to discuss currently available guidelines on RM in radiotherapy and to present risk assessment and process evaluation activities involved in the RM-implementation process at our department.