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ABSTRACT: We reviewed our seven year single institution experience with pulsed dose rate brachytherapy dose escalation study in patients with intermediate and high risk prostate cancer.
We treated a total of 130 patients for intermediate and high risk prostate cancer at our institution between 2000 and 2007 using PDR-brachytherapy as a boost after conformal external beam radiation therapy to 50.4 Gy. The majority of patients had T2 disease (T1c 6%, T2 75%, T3 19%). Seventy three patients had intermediate-risk and 53 patients had high-risk disease according to the D'Amico classification. The dose of the brachytherapy boost was escalated from 25 to 35 Gy - 33 pts. received 25 Gy (total dose 75 Gy), 63 pts. 30 Gy (total dose 80 Gy) and 34 pts. 35 Gy, (total dose 85 Gy) given in one session (dose per pulse was 0.60 Gy or 0.70 Gy/h, 24h per day, night and day, with a time interval of 1h between two pulses). PSA-recurrence-free survival according to Kaplan-Meier using the Phoenix definition of biochemical failure was calculated and also late toxicities according to Common Toxicity Criteria scale were assessed.
At the time of analysis with a median follow-up of 60 months biochemical control was achieved by 88% of patients - only 16/130 patients (12.3%) developed a biochemical relapse. Biochemical relapse free survival calculated according to Kaplan-Meier for all patients at 5 years was 85.6% (83.9% for intermediate-risk patients and 84.2% for high-risk patients) and at 9 years' follow up it was 79.0%. Analysing biochemical relapse free survival separately for different boost dose levels, at 5 years it was 97% for the 35 Gy boost dose and 82% for the 25 and 30 Gy dose levels. The side effects of therapy were negligible: There were 18 cases (15%) of grade 1/2 rectal proctitis, one case (0.8%) of grade 3 proctitis, 18 cases (15%) of grade 1/2 cystitis, and no cases (0%) with dysuria grade 3. No patient had a bulbourethral stricture requiring dilation or new onset incontinence.
Image-guided conformal PDR-brachytherapy using up to 35 Gy as boost dose after 50 Gy of external beam radiation therapy (total dose up to 85 Gy) is a very effective treatment option with very low morbidity in patients with intermediate or high risk prostate cancer. Further dose escalation seems possible.
Radiotherapy and Oncology 07/2012; 104(2):181-6. · 5.58 Impact Factor
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[show abstract]
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ABSTRACT: Purpose:To describe relative skin dose estimations and their impact on cosmetic outcome in interstitial multicatheter accelerated
partial-breast irradiation (APBI).
Patients and Methods:Between April 2001 and January 2005, 105 consecutive patients with early breast cancer were recruited in Erlangen, Germany,
for this substudy of the German-Austrian APBI phase II trial. 51% (54/105) received pulsed-dose-rate (PDR), and 49% (51/105)
high-dose-rate (HDR) brachytherapy. Prescribed reference dose for HDR brachytherapy was 32 Gy in eight fractions of 4 Gy,
twice daily. Prescribed reference dose in PDR brachytherapy was 49.8 Gy in 83 consecutive fractions of 0.6 Gy every hour.
Total treatment time was 3–4 days. With a wire cross on the skin surface during the brachytherapy-planning procedure the minimal,
mean and maximal relative skin doses (SDmin%, SDmax%, SDmean%) were recorded. Endpoint of this evaluation was the cosmetic outcome in relation to the relative skin doses.
Results:Median follow-up time was 38 months (range, 19–65 months). Cosmetic results for all patients were excellent in 57% (60/105),
good in 36% (38/105), and fair in 7% (7/105). The SDmin% (27.0% vs. 31.7%; p = 0.032), SDmean% (34.2% vs. 38.1%; p = 0.008), and SDmax% (38.2% vs. 46.4%; p = 0.003) were significantly lower for patients with excellent cosmetic outcome compared to patients with
a suboptimal outcome. SDmean% (37.6% vs. 34.2%; p = 0.026) and SDmax% (45.4% vs. 38.2%; p = 0.008) were significantly higher for patients with good cosmetic outcome compared with the patients
with excellent results.
Conclusion:The appraisal of skin doses has been shown to be relevant to the achievement of excellent cosmetic outcome. Further investigations
are necessary, especially on the basis of CT-based brachytherapy planning, to further improve the treatment results of multicatheter
APBI.
Ziel:Entwicklung einer Methode zur Abschätzung von relativen Hautdosen bei der akzelerierten Teilbrustbestrahlung (APBI) in interstitieller
Multikathetertechnik und Untersuchung des Einflusses der ermittelten Hautdosen auf das kosmetische Ergebnis.
Patienten und Methodik:Zwischen 04/2001 und 01/2005 wurden 105 Patientinnen mit einem brusterhaltend operierten, prognostisch günstigen Mammakarzinom
in diese Substudie der Deutsch-Österreichischen Teilbrustbestrahlungsstudie (Phase II) eingebracht. 51% (54/105) erhielten
eine Pulsed-Dose-Rate-(PDR-) und 49% (51/105) eine High-Dose-Rate-(HDR-)Brachytherapie. Die HDR-Brachytherapie erfolgte mit
acht Fraktionen à 4 Gy bis 32 Gy, zwei Fraktionen pro Tag. Die PDR-Brachytherapie-Dosis betrug 49,8 Gy mit 83 stündlichen
Pulsen à 0,6 Gy. Die Gesamtbehandlungszeit betrug 3–4 Tage. Mit Hilfe eines auf die Hautoberfläche aufgeklebten Drahtkreuzes
wurden die relativen minimalen, mittleren und maximalen Hautdosen (SDmin%, SDmean%, SDmax%) beschrieben. Endpunkt der Analyse war das kosmetische Ergebnis in Abhängigkeit von den relativen Hautdosen.
Ergebnisse:Die mediane Nachbeobachtungszeit betrug 38 Monate (19–65 Monate). Das kosmetische Ergebnis war sehr gut in 57% (60/105), gut
in 36% (38/105) und mäßig in 7% (7/105) der Fälle. Die relativen Hautdosen SDmin% (27,0% vs. 31,7%; p = 0,032), SDmean% (34,2% vs. 38,1%; p = 0,008) und SDmax% (38,2% vs. 46,4%; p = 0,003) waren in der Gruppe der Patientinnen mit sehr gutem kosmetischen Ergebnis signifikant niedriger
als bei den übrigen Patientinnen mit suboptimalem Ergebnis. SDmean% (37,6% vs. 34,2%; p = 0,026) und SDmax% (45,4% vs. 38,2%; p = 0,008) waren bei Patientinnen mit guter Kosmetik signifikant höher als bei sehr gutem Ergebnis.
Schlussfolgerung:Es konnte erstmals für die interstitielle Multikatheter-APBI gezeigt werden, dass die an der Hautoberfläche deponierte Strahlendosis
die Wahrscheinlichkeit für das Erreichen eines sehr guten kosmetischen Ergebnisses mit beeinflusst. Weiterführende Untersuchungen
sind erforderlich, insbesondere auf der Basis der CT-gestützten Brachytherapieplanung, um das kosmetische Ergebnis nach interstitieller
Multikatheter-APBI noch weiter zu optimieren.
Strahlentherapie und Onkologie 04/2012; 183(8):426-431. · 3.56 Impact Factor
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[show abstract]
[hide abstract]
ABSTRACT: Purpose:
To analyze patient-, disease-, and treatment-related factors for their impact on cosmetic outcome (CO) after interstitial
multicatheter accelerated partial-breast irradiation (APBI).
Patients and Methods:
Between April 2001 and January 2005, 171 patients with early breast cancer were recruited in Erlangen for this subanalysis
of the German-Austrian APBI phase II-trial. 58% (99/171) of the patients received pulsed-dose-rate (PDR), and 42% (72/171)
high-dose-rate (HDR) brachytherapy. Prescribed reference dose for HDR brachytherapy was 32 Gy in eight fractions of 4 Gy,
twice daily. Prescribed reference dose in PDR brachytherapy was 49.8 Gy in 83 consecutive fractions of 0.6 Gy each hour. Total
treatment time was 3–4 days. Endpoint of this evaluation was the CO, graded as excellent, good, fair, or poor. Patients were
divided in two groups with an excellent (n = 102) or nonexcellent (n = 69) cosmetic result. Various factors were analyzed
for their impact on excellent CO.
Results:
The median follow-up time was 52 months (range: 21–91 months). Cosmetic results were rated as excellent in 59.6% (102/171),
good in 29.8% (51/171), fair in 9.9% (17/171), and poor in 0.6% (1/171). The initial cosmetic status was significantly worse
for the nonexcellent CO group (p = 0.000). The percentage of patients who received PDR brachytherapy APBI was higher in the
nonexcellent CO group (68.1% vs. 51%; p = 0.026). Acute toxicity was higher in the nonexcellent CO group (24.6% vs. 12.7%;
p = 0.045). Furthermore, the presence of any late toxicity was found to be associated with a worse cosmetic result (65.2%
vs. 18.6%; p = 0.000). In detail, the appearance of skin hyperpigmentation (p = 0.034), breast tissue fibrosis (p = 0.000),
and telangiectasia (p = 0.000) had a negative impact on CO.
Conclusion:
The initial, surgery-associated cosmetic status, brachytherapy modality, and the presence of acute and late toxicities were
found to have an impact on overall CO. Our data have proven that further treatment optimization is possible. Investigations
are necessary, especially on the basis of CT-based brachytherapy planning, to further improve the treatment results of multicatheter
APBI.
Ziel:
Analyse von patienten-, krankheits- und behandlungsbezogenen Faktoren auf deren Einfluss auf das kosmetische Ergebnis (CO)
nach interstitieller Multikatheter-Teilbrustbestrahlung (APBI).
Patienten und Methodik:
Zwischen 04/2001 und 01/2005 wurden in Erlangen 171 Patientinnen mit einem brusterhaltend operierten, prognostisch günstigen
Mammakarzinom in die Deutsch-Österreichischen Teilbrustbestrahlungsstudie eingebracht und für die vorliegende Analyse berücksichtigt.
58% (99/171) erhielten eine Pulsed-Dose-Rate-(PDR-) und 42% (72/171) eine High-Dose-Rate-(HDR-)Brachytherapie. Die HDR-Brachytherapie
erfolgte mit acht Fraktionen à 4 Gy bis 32 Gy, zwei Fraktionen pro Tag. Die PDR-Brachytherapiedosis betrug 49,8 Gy mit 83
stündlichen Pulsen à 0,6 Gy. Die Gesamtbehandlungszeit betrug 3–4 Tage. Endpunkt der Analyse war das CO. Die Patientinnen
wurden in zwei Gruppen mit exzellentem (n = 102) und nichtexzellentem (n = 69) CO aufgeteilt. Zahlreiche Faktoren wurden auf
ihren Einfluss auf das CO untersucht.
Ergebnisse:
Die mediane Nachbeobachtungszeit betrug 52 Monate (21–91 Monate). Das kosmetische Ergebnis war in 59,6% der Fälle (102/171)
sehr gut, in 29,8% (51/171) gut, in 9,9% (17/171) mäßig und in 0,6% (1/171) schlecht. Der initiale kosmetische Status vor
APBI war für Patientinnen mit einem nichtexzellenten CO signifikant schlechter (p = 0,000). Der Anteil von Patientinnen mit
PDR-Brachytherapie war in der nichtexzellenten CO-Gruppe höher (68,1% vs. 51%; p = 0,026). Die Akuttoxizität war in der nichtexzellenten
CO-Gruppe ebenfalls erhöht (24,6% vs. 12,7%; p = 0,045). Des Weiteren war der globale Nachweis von Spättoxizität mit einem
schlechteren CO assoziiert (65,2% vs. 18,6%; p = 0.000). Im Einzelnen konnte dies für die Endpunkte Hyperpigmentierung (p
= 0,034), Brustgewebsfibrose (p = 0,000) und Teleangiektasie (p = 0,000) nachgewiesen werden.
Schlussfolgerung:
Das kosmetische Ergebnis direkt nach der brusterhaltenden Operation, die Brachytherapiemodalität sowie das Auftreten von Akut-
und Spättoxizitäten hatten einen signifikanten Einfluss auf das kosmetische Gesamtergebnis. Unsere Daten belegen, dass eine
weitere Optimierung der interstitiellen APBI möglich ist. Weiterführende Untersuchungen sind erforderlich, insbesondere auf
der Basis der CT-gestützten Brachytherapieplanung, um das CO nach interstitieller Multikatheter-APBI noch weiter zu verbessern.
Strahlentherapie und Onkologie 04/2012; 185(3):170-176. · 3.56 Impact Factor
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ABSTRACT: Accelerated partial breast irradiation by means of multicatheter brachytherapy shows great promise in the modern treatment of early breast cancer combining high efficacy in preventing tumour recurrence with low levels of toxicity. The present work attempts a dosimetric comparison between this treatment modality and conventional whole breast external beam radiotherapy by looking at differences in risk organ exposure to radiation.
The planning CT data sets of 16 consecutive patients with left-sided breast cancer who received external beam radiotherapy to the whole breast followed by a boost to the tumour bed using multicatheter interstitial brachytherapy after breast conserving surgery were used to create two independent physical treatment plans - one for an external radiotherapy, one for sole partial breast brachytherapy in each case assuming a total reference dose of 50Gy for each patient. Dose-volume parameters D(0.1cc), D(0.5cc), D(1cc,)D(2cc), D(5cc,)D(10cc), D(25cc), D(50cc), V(100), V(90), V(50), V(10), V(5) for the ipsilateral lung, the heart and the adjacent skin were calculated and compared between the two treatment modalities.
All organs at risk showed a substantially lower radiation exposure in the brachytherapy plan. This was most pronounced for the heart with values differing by a factor of four. Although somewhat less marked this was also true for the ipsilateral lung and the adjacent skin with exposure ratios of three and two, respectively.
With the use of multicatheter interstitial brachytherapy substantial reductions in the radiation exposure of risk organs can be achieved in comparison to whole breast external beam radiotherapy. These are likely to translate into profound clinical benefits.
Radiotherapy and Oncology 08/2011; 100(2):189-94. · 5.58 Impact Factor
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Oliver J Ott,
Guido Hildebrandt,
Richard Pötter,
Josef Hammer,
Marion Hindemith,
Alexandra Resch,
Kurt Spiegl, Michael Lotter,
Wolfgang Uter,
Rolf-Dieter Kortmann,
Michael Schrauder,
Matthias W Beckmann,
Rainer Fietkau,
Vratislav Strnad
[show abstract]
[hide abstract]
ABSTRACT: To analyze patient, disease, and treatment-related factors regarding their impact on local control after interstitial multicatheter accelerated partial breast irradiation (APBI).
Between November 2000 and April 2005, 274 patients with early breast cancer were recruited for the German-Austrian APBI Phase II trial (ClinicalTrials.gov identifier: NCT00392184). In all, 64% (175/274) of the patients received pulsed-dose-rate (PDR) brachytherapy and 36% (99/274) received high-dose-rate (HDR) brachytherapy. Prescribed reference dose for HDR brachytherapy was 32 Gy in eight fractions of 4 Gy, twice daily. Prescribed reference dose in PDR brachytherapy was 49.8 Gy in 83 consecutive fractions of 0.6 Gy each hour. Total treatment time was 3 to 4 days.
The median follow-up time was 64 months (range, 9-110). The actuarial 5-year local recurrence free survival rate (5-year LRFS) was 97.7%. Comparing patients with an age <50 years (49/274) vs. ≥50 years (225/274), the 5-year LRFS resulted in 92.5% and 98.9% (exact p = 0.030; 99% confidence interval, 0.029-0.032), respectively. Antihormonal treatment (AHT) was not applied in 9% (24/274) of the study population. The 5-year LRFS was 99% and 84.9% (exact p = 0.0087; 99% confidence interval, 0.0079-0.0094) in favor of the patients who received AHT. Lobular histology (45/274) was not associated with worse local control compared with all other histologies (229/274). The 5-year LRFS rates were 97.6% and 97.8%, respectively.
Local control at 5 years is excellent and comparable to therapeutic successes reported from corresponding whole-breast irradiation trials. Our data indicate that patients <50 years of age ought to be excluded from APBI protocols, and that patients with hormone-sensitive breast cancer should definitely receive adjuvant AHT when interstitial multicatheter APBI is performed. Lobular histology need not be an exclusion criterion for future APBI trials.
International journal of radiation oncology, biology, physics 08/2011; 80(5):1458-63. · 4.59 Impact Factor
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Vratislav Strnad,
Guido Hildebrandt,
Richard Pötter,
Josef Hammer,
Marion Hindemith,
Alexandra Resch,
Kurt Spiegl, Michael Lotter,
Wolfgang Uter,
Mayada Bani,
Rolf-Dieter Kortmann,
Matthias W Beckmann,
Rainer Fietkau,
Oliver J Ott
[show abstract]
[hide abstract]
ABSTRACT: To evaluate the impact of accelerated partial breast irradiation on local control, side effects, and cosmesis using multicatheter interstitial brachytherapy as the sole method for the adjuvant local treatment of patients with low-risk breast cancer.
274 patients with low-risk breast cancer were treated on protocol. Patients were eligible for the study if the tumor size was < 3 cm, resection margins were clear by at least 2 mm, no lymph node metastases existed, age was >35 years, hormone receptors were positive, and histologic grades were 1 or 2. Of the 274 patients, 175 (64%) received pulse-dose-rate brachytherapy (D(ref) = 50 Gy). and 99 (36%) received high-dose-rate brachytherapy (D(ref) = 32.0 Gy).
Median follow-up was 63 months (range, 9-103). Only 8 of 274 (2.9%) patients developed an ipsilateral in-breast tumor recurrence at the time of analysis. The 5-year actuarial local recurrence-free survival probability was 98%. The 5- year overall and disease-free survival probabilities of all patients were 97% and 96%, respectively. Contralateral in-breast malignancies were detected in 2 of 274 (0.7%) patients, and distant metastases occurred in 6 of 274 (2.2%). Late side effects ≥ Grade 3 (i.e., breast tissue fibrosis and telangiectasia) occurred in 1 patient (0.4%, 95%CI:0.0-2.0%) and 6 patients (2.2%, 95%CI:0.8-4.7%), respectively. Cosmetic results were good to excellent in 245 of 274 patients (90%).
The long-term results of this prospective Phase II trial confirm that the efficacy of accelerated partial breast irradiation using multicatheter brachytherapy is comparable with that of whole breast irradiation and that late side effects are negligible.
International journal of radiation oncology, biology, physics 05/2011; 80(1):17-24. · 4.59 Impact Factor
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[show abstract]
[hide abstract]
ABSTRACT: To analyze patient-, disease-, and treatment-related factors for their impact on cosmetic outcome (CO) after interstitial multicatheter accelerated partial-breast irradiation (APBI).
Between April 2001 and January 2005, 171 patients with early breast cancer were recruited in Erlangen for this subanalysis of the German-Austrian APBI phase II-trial. 58% (99/171) of the patients received pulsed-dose-rate (PDR), and 42% (72/171) high-dose-rate (HDR) brachytherapy. Prescribed reference dose for HDR brachytherapy was 32 Gy in eight fractions of 4 Gy, twice daily. Prescribed reference dose in PDR brachytherapy was 49.8 Gy in 83 consecutive fractions of 0.6 Gy each hour. Total treatment time was 3-4 days. Endpoint of this evaluation was the CO, graded as excellent, good, fair, or poor. Patients were divided in two groups with an excellent (n = 102) or nonexcellent (n = 69) cosmetic result. Various factors were analyzed for their impact on excellent CO.
The median follow-up time was 52 months (range: 21-91 months). Cosmetic results were rated as excellent in 59.6% (102/171), good in 29.8% (51/171), fair in 9.9% (17/171), and poor in 0.6% (1/171). The initial cosmetic status was significantly worse for the nonexcellent CO group (p = 0.000). The percentage of patients who received PDR brachytherapy APBI was higher in the nonexcellent CO group (68.1% vs. 51%; p = 0.026). Acute toxicity was higher in the nonexcellent CO group (24.6% vs. 12.7%; p = 0.045). Furthermore, the presence of any late toxicity was found to be associated with a worse cosmetic result (65.2% vs. 18.6%; p = 0.000). In detail, the appearance of skin hyperpigmentation (p = 0.034), breast tissue fibrosis (p = 0.000), and telangiectasia (p = 0.000) had a negative impact on CO.
The initial, surgery-associated cosmetic status, brachytherapy modality, and the presence of acute and late toxicities were found to have an impact on overall CO. Our data have proven that further treatment optimization is possible. Investigations are necessary, especially on the basis of CT-based brachytherapy planning, to further improve the treatment results of multicatheter APBI.
Strahlentherapie und Onkologie 04/2009; 185(3):170-6. · 3.56 Impact Factor
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[hide abstract]
ABSTRACT: The aim of this study was to investigate the effect of gamma irradiation with 30 Gy on the coagulation system in leukoreduced fresh-frozen plasma (FFP).
In 74 FFP units that had been stored for 352 +/- 103 days below -30 degrees C, the following variables were determined in parallel in an irradiated and not irradiated half: prothrombin time (PT); activated partial thromboplastin time (APTT); thrombin time; antithrombin III; protein C; protein S; von Willebrand factor antigen; ristocetin cofactor; plasminogen-alpha(2)-antiplasmin; the coagulation factors fibrinogen, factor (F)II, FV, FVII, VIII, F IX, FX, FXI, FXII, FXIII, and activated factor XII (FXIIa); D-dimer; fibrin monomer; thrombin-antithrombin complex; prothrombin fragment 1 + 2 (F1+2); plasmin-alpha(2)-antiplasmin complexes (PAPs); and platelet factor 4. The FVII activity ratio was assayed to quantify activation of FVII.
Irradiation with 30 Gy resulted in a reduction of APTT (35.0 +/- 4.1 sec vs. 34.4 +/- 4.1 sec; p = 0.00000006) and PT (89.8 +/- 8.2% vs. 90.7 +/- 8.0%; p = 0.002) and a significant increase of the activities of the coagulation factors FII, FV, FVII, F IX, FX, and FXII. FVIII activity decreased from 118 +/- 31 to 116 +/- 32 percent (p = 0.02). Activation of the coagulation system was shown by an increase in the FVII activity ratio (1.19 +/- 0.29 vs. 1.31 +/- 0.34; p = 0.0000001), FXIIa (0.81 +/- 0.50 ng/mL vs. 0.90 +/- 0.51 ng/mL; p = 0.006), and F1+2 (1.19 +/- 0.20 nmol/L vs. 1.24 +/- 0.20 nmol/L; p = 0.000005) after irradiation with 30 Gy, whereas an increase of PAP (16.2 +/- 11.5 ng/mL vs. 20.2 +/- 12.0 ng/mL; p = 0.0004) demonstrated activation of the fibrinolytic system. No negative influence of irradiation with 30 Gy on inhibitors of coagulation was observed.
Gamma irradiation of leukoreduced FFPs with 30 Gy results in a significant but very weak activation of the coagulation and fibrinolytic system in FFPs.
Transfusion 10/2007; 47(9):1658-65. · 3.22 Impact Factor
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[hide abstract]
ABSTRACT: To describe relative skin dose estimations and their impact on cosmetic outcome in interstitial multicatheter accelerated partial-breast irradiation (APBI).
Between April 2001 and January 2005, 105 consecutive patients with early breast cancer were recruited in Erlangen, Germany, for this substudy of the German-Austrian APBI phase II trial. 51% (54/105) received pulsed-dose-rate (PDR), and 49% (51/105) high-dose-rate (HDR) brachytherapy. Prescribed reference dose for HDR brachytherapy was 32 Gy in eight fractions of 4 Gy, twice daily. Prescribed reference dose in PDR brachytherapy was 49.8 Gy in 83 consecutive fractions of 0.6 Gy every hour. Total treatment time was 3-4 days. With a wire cross on the skin surface during the brachytherapy-planning procedure the minimal, mean and maximal relative skin doses (SD(min%), SD(max%), SD(mean%)) were recorded. Endpoint of this evaluation was the cosmetic outcome in relation to the relative skin doses.
Median follow-up time was 38 months (range, 19-65 months). Cosmetic results for all patients were excellent in 57% (60/105), good in 36% (38/105), and fair in 7% (7/105). The SD(min%) (27.0% vs. 31.7%; p = 0.032), SD(mean%) (34.2% vs. 38.1%; p = 0.008), and SD(max%) (38.2% vs. 46.4%; p = 0.003) were significantly lower for patients with excellent cosmetic outcome compared to patients with a suboptimal outcome. SD(mean%) (37.6% vs. 34.2%; p = 0.026) and SD(max%) (45.4% vs. 38.2%; p = 0.008) were significantly higher for patients with good cosmetic outcome compared with the patients with excellent results.
The appraisal of skin doses has been shown to be relevant to the achievement of excellent cosmetic outcome. Further investigations are necessary, especially on the basis of CT-based brachytherapy planning, to further improve the treatment results of multicatheter APBI.
Strahlentherapie und Onkologie 09/2007; 183(8):426-31. · 3.56 Impact Factor
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[hide abstract]
ABSTRACT: To evaluate the safety and effectiveness of accelerated partial breast irradiation (APBI) with multi-catheter brachytherapy.
Between 11/2000 and 04/2005, 274 patients participated. Patients were eligible for APBI if they had histologically confirmed breast cancer, a tumour diameter 3cm, complete resection with clear margins 2mm, negative axillary lymph nodes or singular nodal micro-metastasis, no distant metastases, hormone receptor-positive tumours, and were >/= 35 years. Patients were excluded if mammographically they showed a multicentric invasive growth pattern, poorly differentiated tumours, residual diffuse micro-calcifications, extensive intraductal component, or vessel invasion. Median follow-up was 32 months (range; 8-68).
The local control rate was 99.3% (272/274), the 3 year-local-recurrence-free survival probability, 99.6%. Peri-operative complications occurred in 5.5% (15/274): 9 (3.3%) experienced implant infection and 6 (2.2%) hematoma. Acute toxicity (Grade 1/2 radio-dermatitis) was seen in 6.6% (18/274). Late side effects >/= Grade 3 (fibrosis, telangiectasia) occurred in 1.8% (4/274). Cosmetic results were excellent/good in 94% (253/274).
This analysis underlined the safety and effectiveness of APBI in a carefully selected subgroup with favourable disease characteristics. Of course, longer follow-up and randomised trials are necessary to conclusively assess the potential of APBI.
Radiotherapy and Oncology 04/2007; 82(3):281-6. · 5.58 Impact Factor
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[hide abstract]
ABSTRACT: Parameters and indices related to the implant geometry in use for describing the quality of volume implants in interstitial brachytherapy were developed on the basis of LDR-brachytherapy. The aim of our study was to evaluate their usefulness for predicting late toxicity and local control in the PDR-brachytherapy of head-and-neck-tumors.
Between January 2000 and October 2004, 210 patients were treated with PDR-brachytherapy which was administered either postoperatively or as definitive treatment. Brachytherapy was used as sole treatment in some cases while in others a combination with EBRT was used. For assessment of quality of implants we analyzed the following indices and parameters using the univariate chi2 test and multivariate logistic regression analysis: V85, V120 and V150 (volume enclosed by the surface of the 85%-, 120%- and 150%-isodose), UI (uniformity index), QI (quality index), HI (homogeneity index), VGR (volume gradient ratio), DNR (dose non-uniformity ratio), LD (low dose), HD (high dose), PD (peak dose) and the intersource spacing.
After a median follow-up of 24 months (4-50) the rate of - usually transient - soft tissue necrosis (STN) was 11%, osteoradionecrosis (ORN) was seen in 7.6% of cases and local relapse occurred in 7% of cases. Univariate analysis shows a significant influence on the development of soft tissue necrosis for V85, and on osteoradionecrosis for HD and PD. In the multivariate analysis a correlation between soft tissue necrosis and QI was found. For local control a correlation with QI, VGR and minimal tube distance was found using univariate analysis.
Using interstitial PDR-brachytherapy in head-and-neck-tumors the probability of local control and of the development of soft tissue necrosis or osteoradionecrosis is dependent on dose and volume parameter like the volume of the reference isodose, the high and peak dose values, on the homogeneity of the dose distribution, quantified by the quality index or the volume gradient ratio as well on the minimal tube distance.
Radiotherapy and Oncology 03/2007; 82(2):167-73. · 5.58 Impact Factor
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[show abstract]
[hide abstract]
ABSTRACT: Irradiation has established itself as a treatment for vulvar and vaginal malignancies. Due to the sensitive nature of the vulvar and vaginal tissues, interstitial brachytherapy (iBT) provides an effective, gentle and individualized therapy.
Patients with vulvar (nine of 22) and vaginal (13 of 22) malignancies were treated using interstitial pulsed-dose-rate brachytherapy (PDR-iBT). Twelve out of 22 patients were additionally treated using external-beam therapy to the pelvis and regional lymph nodes. The median total dose of PDR-iBT administered to patients with vulvar carcinoma was 55.0 Gy. The median total PDR dose administered to patients with vaginal malignancies amounted to 20.25 Gy.
The median follow-up time for patients with vulvar cancer was 19 months and for patients with vaginal malignancies 27 months. Acute mucositis or skin reactions during iBT were observed in 15 of 22 patients. Two of 22 patients showed delayed side effects. After 6 months, 77.8% of the patients with vulvar cancer (seven out of nine) and 100% of the patients with vaginal malignancies (13 out of 13) achieved complete local remission. One patient out of nine with vulvar carcinoma developed local recurrence, four out of nine regional recurrence, and two out of nine developed regional recurrence and had local tumor following therapy. In patients with malignancies of the vagina, no cases of local recurrence were observed, but distant metastases were found in five out of 13 patients. At the time of analysis, eleven out of 22 patients with vulvar or vaginal carcinoma were still alive.
IBT achieved good local control without serious delayed side effects in both localizations. However, survival is limited by regional or distant metastases.
Strahlentherapie und Onkologie 04/2006; 182(3):142-8. · 3.56 Impact Factor
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ABSTRACT: To evaluate the role of pulsed-dose-rate interstitial brachytherapy (PDR IBT) in patients with head-and-neck malignancies.
From October 1997 to December 2003, 236 patients underwent PDR IBT for head-and-neck cancer at the authors' department. 192 patients received brachytherapy as part of their curative treatment regimen after minimal non-mutilating surgery, 44 patients were treated with irradiation alone. 144 patients had sole IBT (median D(REF) = 56 Gy), in 92 patients IBT procedures (median D(REF) = 24 Gy) were performed in combination with external irradiation. The pulses (0.4-0.7 Gy/h) were delivered 24 h a day with a time interval of 1 h between two pulses. The analysis of tumor control, survival and treatment-related toxicity was performed after a median follow-up of 26 months (6-75 months).
At the time of analysis permanent local tumor control was registered in 208 of 236 patients (88%). At 5 years overall survival and local recurrence-free survival of the entire group were 82-73% and 93-83% for T1/2, and 56% and 83% for T3/4, respectively. Soft-tissue necrosis was seen in 23/236 patients (9.7%) and bone necrosis in 17/236 patients (7.2%). No other serious side effects were observed.
PDR IBT with 0.4-0.7 Gy/h and 1 h between pulses is safe and effective. These results confirm that PDR IBT of head-and-neck cancer is comparable with low-dose-rate (LDR) brachytherapy - equally effective and less toxic.
Strahlentherapie und Onkologie 01/2006; 181(12):762-7. · 3.56 Impact Factor
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ABSTRACT: Purpose:To evaluate the role of pulsed–dose–rate interstitial brachytherapy (PDR IBT) in patients with head–and–neck malignancies.
Patients and Methods:From October 1997 to December 2003, 236 patients underwent PDR IBT for head–and–neck cancer at the authors' department. 192
patients received brachytherapy as part of their curative treatment regimen after minimal non–mutilating surgery, 44 patients
were treated with irradiation alone. 144 patients had sole IBT (median DREF = 56 Gy), in 92 patients IBT procedures (median DREF = 24 Gy) were performed in combination with external irradiation. The pulses (0.4–0.7 Gy/h) were delivered 24 h a day with
a time interval of 1 h between two pulses. The analysis of tumor control, survival and treatment–related toxicity was performed
after a median follow–up of 26 months (6–75 months).
Results:At the time of analysis permanent local tumor control was registered in 208 of 236 patients (88%). At 5 years overall survival
and local recurrence–free survival of the entire group were 82–73% and 93–83% for T1/2, and 56% and 83% for T3/4, respectively.
Soft–tissue necrosis was seen in 23/236 patients (9.7%) and bone necrosis in 17/236 patients (7.2%). No other serious side
effects were observed.
Conclusion:PDR IBT with 0.4–0.7 Gy/h and 1 h between pulses is safe and effective. These results confirm that PDR IBT of head–and–neck
cancer is comparable with low–dose–rate (LDR) brachytherapy – equally effective and less toxic.
Ziel:Untersuchung des Stellenwerts der interstitiellen Pulsed–Dose–Rate–Brachytherapie (PDR–IBT) bei Patienten mit HNO–Tumoren.
Patienten und Methodik:Zwischen Oktober 1997 und Dezember 2003 wurden insgesamt 236 HNO–Patienten mit PDR–IBT in der eigenen Klinik behandelt. 192
Patienten wurden in kurativer Intention nach einer minimal–invasiven Chirurgie, 44 Patienten mit alleiniger Strahlentherapie
behandelt. 144 Patienten erhielten eine alleinige IBT (Median DREF = 56 Gy), bei 92% wurde die Brachytherapie (Median DREF = 24 Gy) mit perkutaner Strahlentherapie kombiniert. Die Pulsdosis (0,4–0,7 Gy/h) wurde stündlich 24 h am Tag verabreicht.
Die Analyse der Tumorkontrolle, des Überlebens und der Nebenwirkungen wurde nach einem medianen Beobachtungszeitraum von 26
Monaten (6–75 Monate) durchgeführt.
Ergebnisse:Zur Zeit der Analyse wurde bei 208 von 236 Patienten (88%) eine dauerhafte lokale Tumorkontrolle registriert. Das 5–Jahres–Gesamtüberleben
und das rezidivfreie Überleben für alle Patienten betrugen bei T1/2 82–73% und 93–83% und für T3/T4 56% und 83%. Weichteilnekrosen
fanden sich bei 23 von 236 Patienten (9,7%) und Osteoradionekrosen bei 17 von 236 Patienten (7,2%). Es wurden keine weiteren
schwerwiegenden Nebenwirkungen registriert.
Schlussfolgerung:Die PDR–IBT mit 0,4–0,7 Gy/h und einem Intervall zwischen den Pulsen von 1 h ist eine sichere und effektive Behandlung. Diese
Ergebnisse bestätigen, dass die PDR–IBT bei HNO–Tumoren der Low–Dose–Rate–(LDR–)Brachytherapie vergleichbar ist – gleich effektiv
und weniger toxisch.
Strahlentherapie und Onkologie 11/2005; 181(12):762-767. · 3.56 Impact Factor
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ABSTRACT: To evaluate perioperative morbidity, toxicity, and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole irradiation modality after breast-conserving surgery.
From November 1, 2000 to January 31, 2004, 176 women with early-stage breast cancer became partakers in a protocol of tumor bed irradiation alone using pulsed-dose-rate (PDR) or high-dose-rate (HDR) interstitial multicatheter implants. Patients became eligible, if their tumor was an infiltrating carcinoma < or = 3 cm in diameter, the surgical margins were clear by at least 2 mm, the axilla was surgically staged node-negative, the tumor was estrogen and/or progesterone receptor-positive, well or moderately differentiated (G1/2), the tumor did not contain an extensive intraductal component (EIC) and the patient's age was > 35 years. Implants were positioned using a template guide, delivering either 49.8 Gy in 83 consecutive hours (PDR) or 32.0 Gy in two daily fractions over 4 days (HDR). Perioperative morbidity, toxicity, and cosmetic outcome were assessed. Interim findings of the first 69 patients, who were treated in this multicenter trial, after a median follow-up of 24 months (range, 15-39 months) are presented.
One of the 69 patients (1.4%) developed a bacterial infection of the implant. No other perioperative complications, for example bleeding or hematoma, were observed. Acute toxicity was low: 2.9% of the patients (2/69) experienced mild radiodermatitis. Late toxicity: hypersensation/mild pain 7.2% (5/69), intermittent but tolerable pain 1.4% (1/69), mild dyspigmentation 10.1% (7/69), mild fibrosis 11.6% (8/69), moderate fibrosis 1.4% (1/69), mild telangiectasia (< 1 cm(2)) 11.6% (8/69), and moderate teleangiectasia (1-4 cm(2)) 1.4% (1/69). Good to excellent cosmetic results were observed in 92.4% of the patients evaluated. All patients (n = 176) remained disease-free to the date of evaluation.
This analysis indicates that accelerated partial breast irradiation with iridium-192 interstitial multicatheter PDR/HDR implants is feasible with low perioperative morbidity, low acute and mild late toxicity, and does not significantly affect cosmetic results at a median follow-up of 24 months.
Strahlentherapie und Onkologie 11/2004; 180(10):642-9. · 3.56 Impact Factor
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ABSTRACT: Purpose:
To evaluate perioperative morbidity, toxicity, and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole irradiation modality after breast-conserving surgery.
Patients and Methods:
From November 1, 2000 to January 31, 2004, 176 women with early-stage breast cancer became partakers in a protocol of tumor bed irradiation alone using pulsed-dose-rate (PDR) or high-dose-rate (HDR) interstitial multicatheter implants. Patients became eligible, if their tumor was an infiltrating carcinoma 3 cm in diameter, the surgical margins were clear by at least 2 mm, the axilla was surgically staged node-negative, the tumor was estrogen and/or progesterone receptor-positive, well or moderately differentiated (G1/2), the tumor did not contain an extensive intraductal component (EIC) and the patients age was > 35 years. Implants were positioned using a template guide, delivering either 49.8 Gy in 83 consecutive hours (PDR) or 32.0 Gy in two daily fractions over 4 days (HDR). Perioperative morbidity, toxicity, and cosmetic outcome were assessed. Interim findings of the first 69 patients, who were treated in this multicenter trial, after a median follow-up of 24 months (range, 15–39 months) are presented.
Results:
One of the 69 patients (1.4%) developed a bacterial infection of the implant. No other perioperative complications, for example bleeding or hematoma, were observed. Acute toxicity was low: 2.9% of the patients (2/69) experienced mild radiodermatitis. Late toxicity: hypersensation/mild pain 7.2% (5/69), intermittent but tolerable pain 1.4% (1/69), mild dyspigmentation 10.1% (7/69), mild fibrosis 11.6% (8/69), moderate fibrosis 1.4% (1/69), mild telangiectasia (< 1 cm2) 11.6% (8/69), and moderate teleangiectasia (1–4 cm2) 1.4% (1/69). Good to excellent cosmetic results were observed in 92.4% of the patients evaluated. All patients (n = 176) remained disease-free to the date of evaluation.
Conclusion:
This analysis indicates that accelerated partial breast irradiation with iridium-192 interstitial multicatheter PDR/HDR implants is feasible with low perioperative morbidity, low acute and mild late toxicity, and does not significantly affect cosmetic results at a median follow-up of 24 months.
Ziel:
Evaluierung von perioperativer Morbiditt, Akut- und Spttoxizitt sowie des kosmetischen Ergebnisses nach alleiniger interstitieller Pulsed-Dose-Rate-(PDR-)/High-Dose-Rate-(HDR-)Multikatheter-Brachytherapie des Tumorbetts mit 192-Iridium nach brusterhaltender Operation.
Patienten und Methodik:
Zwischen 11/2000 und 01/2004 erhielten 176 Frauen nach brusterhaltender Operation eine alleinige PDR-/HDR-Brachytherapie des Tumorbetts. Einschlusskriterien in diesem multizentrischen Protokoll waren u. a. ein maximaler Tumordurchmesser von 3 cm, ein negativer Nodalstatus (pN0), eine R0-Resektion mit mindestens 2 mm Sicherheitssaum, nur gut oder mig differenzierte Karzinome (G1/2), strogen- und/oder progesteronrezeptorpositive Tumoren, kein Nachweis einer EIC (extensive intraductal component) und ein Patientinnenalter von mindestens 35 Jahren. Die PDR-Brachytherapie wurde mit 49,8 Gy in 83 aufeinander folgenden stndlichen Pulsen, die HDR-Brachytherapie bis 32,0 Gy in zwei tglichen Fraktionen ber 4 Tage appliziert. Ergebnisse der ersten 69 Patientinnen bezglich Morbiditt, Toxizitt und Kosmetik werden prsentiert. Die mediane Nachbeobachtungszeit betrug in dieser Analyse 24 Monate (Bereich: 15–39 Monate).
Ergebnisse:
Eine der evaluierten 69 Patientinnen (1,4%) entwickelte eine bakterielle Infektion des Implantats. Weitere perioperative Komplikationen, z. B. Blutungen oder Hmatome, wurden nicht beobachtet. Die Akuttoxizitt war gering: 2,9% der Patientinnen (2/69) zeigten die Symptome einer Grad-1-Radiodermatitis. Spttoxizitt: berempfindlichkeit/gelegentliches Stechen im Narbenareal 7,2% (5/69), intermittierende, aber tolerable Schmerzen 1,4% (1/69), milde Dyspigmentation 10,1% (7/69), milde Fibrosierung 11,6% (8/69), moderate Fibrosierung 1,4% (1/69), milde Teleangiektasiebildung (< 1 cm2) 11,6% (8/69) und moderate Teleangiektasiebildung (1–4 cm2) 1,4% (1/69). Ein exzellentes oder gutes kosmetisches Ergebnis wurde bei 92,4% der Patientinnen gefunden. Zum Zeitpunkt der Auswertung waren alle behandelten Patientinnen (n = 176) krankheitsfrei.
Schlussfolgerung:
Diese Analyse zeigt, dass die alleinige interstitielle PDR-/HDR-Multikatheter-Brachytherapie des Tumorbetts nach brusterhaltender Operation mit niedriger perioperativer Komplikationsrate, geringer Akuttoxizitt und milder Spttoxizitt bei einer medianen Nachbeobachtungszeit von 24 Monaten durchfhrbar ist und das kosmetische Ergebnis bislang nicht signifikant beeinflusst.
Strahlentherapie und Onkologie 01/2004; 180(10):642-649. · 3.56 Impact Factor
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ABSTRACT: To evaluate the value of interstitial brachytherapy (iBT) alone in the treatment of low-risk breast cancer patients with regard to local control, side effects, and cosmesis.
From November 2000 to January 2004, 176 patients with low-risk breast cancer were treated with iBT only. Patients were eligible for entering the study if: the tumor size was <3 cm; resection margins were clear by at least 2 mm; there were no lymph node metastases or only one micrometastasis (pNo, pNmi); age was >35 years; steroid hormone receptor was positive; and histologic grade was 1 or 2. Seventy-five percent of patients received pulsed-dose-rate brachytherapy (D(ref) = 50 Gy); 25% of patients received high-dose-rate brachytherapy (D(ref) = 32.0 Gy). An interim analysis is presented for all patients after an interim follow-up of 12 months, and for half the patient population with an interim follow-up of 21 months.
All patients remained disease-free on the date of analysis. A perioperative complication breast infection was recorded for 1/176 (0.6%) patients. Late toxicity i.e., hypersensation, hyperpigmentation, fibrosis, or teleangiectasia was observed in 1-12% of all patients. Grade I Fibrosis was registered in 7.6% (13/172) and grade II in 7.0% (12/172) of evaluable patients. Similarly, grade I teleangiectasia was observed in 4.7% (8/172), grade II in 0.6% (1/172), and grade III also in 0.6% (1/172) of evaluable patients. Excellent or good cosmetic results have been observed in 92-95% of patients.
Brachytherapy as monotherapy in low-risk breast cancer patients after breast-conserving surgery is an effective, precise treatment modality without perioperative morbidity, low acute, mild late toxicity, and yields good to excellent cosmetic results.
Brachytherapy 01/2004; 3(3):115-9. · 1.47 Impact Factor
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ABSTRACT: The purpose of this prospective study was to analyze the value of interstitial pulsed-dose-rate (PDR) brachytherapy (iBT) with regard to local control and the incidence of side effects in patients with head-and-neck cancer in a previously irradiated area.
From October 1997 to September 2001, 43 patients with head-and-neck cancer in a previously irradiated area (31 patients with recurrent cancer) were treated with iBT alone or in combination with external beam radiation. Thirty-four of 43 patients received interstitial PDR brachytherapy (DREF=20-60 Gy) as part of their curative treatment regimen alone or in combination with external radiation. Nine patients were implanted for palliative purposes. The pulses were delivered 24 h/day with a time interval of 1 h between two pulses. The dose per pulse (dp) ranged from 0.4-0.7 Gy. Sixteen of 43 (37%) patients also received cisplatin or carboplatin with 5-fluorouracil during the time of the iBT. Additionally 20/43 (47%) patients were treated with interstitial hyperthermia. Thirteen of 43 (30%) patients received external beam radiation in a dose range from 20-67 Gy. A follow-up of all patients was done to analyze local control and survival, and acute and delayed toxicity. This analysis was performed after a median follow-up of 24 months (6-48 months).
Local tumor control was achieved in 34 of a total of 43 patients (79%) and in 30/34 patients (88%) treated for curative intention. Distant metastases were observed in 5/43 (12%) patients. The 2-year local recurrence-free survival rates, disease-free survival rates, and overall survival rates according to the Kaplan-Meier method for all patients were 68%, 62%, and 49%, respectively, and for patients treated with curative intention they were 80%, 77% and 66%, respectively. There was no statistical difference in the probability of local recurrence in patients subgrouped by recurrent tumor vs. secondary primary, tumor size, grading and lymphangiosis. The application of chemotherapy or hyperthermia did not have significant influence on the therapy results. Soft tissue necrosis was the only serious side effect seen in 2/43 patients (4.7%). No other serious side effects were observed.
Interstitial pulsed-dose-rate brachytherapy for patients with previously irradiated head-and-neck cancer is an effective therapy with minimal toxicity. The role of chemotherapy and hyperthermia in these patients remains unclear. Further randomized studies with larger patient numbers are necessary to draw a definite conclusion.
Brachytherapy 02/2003; 2(3):158-63. · 1.47 Impact Factor
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ABSTRACT: We attempted in our clinic to evaluate the efficacy and feasibility of a simultaneous application of a cis-platinum-based chemotherapy and interstitial hyperthermia to interstitial pulsed-dose rate (PDR) brachytherapy in patients with recurrent head-and-neck cancer.
Between April 1999 and September 2001, 15 patients with recurrent head-and-neck cancer were treated with PDR brachytherapy, chemotherapy, and interstitial hyperthermia. All patients had received prior radiation therapy. A dose per pulse of 0.46 to 0.55 Gy was given up to a median total dose of 55 Gy. Simultaneously to the PDR brachytherapy, chemotherapy was given with cis-platinum 20 mg/m2 as a short i.v. infusion each day and 5-fluorouracil 800 mg/m2 by continuous infusion from Day 1 to Day 5. After the PDR brachytherapy was finished, all patients were treated with a single session of interstitial hyperthermia.
All the patients could receive the whole treatment. After treatment, only mild oral mucositis occurred. One patient developed soft tissue ulceration. None of the patients developed osteoradionecrosis. After a median follow-up of 6 months, the local tumor control rate was 80% (12 of 15), and the 2-year overall survival was 67% (10 of 15).
The intensification of the interstitial PDR brachytherapy with chemotherapy and hyperthermia is feasible and safe, and the preliminary results are encouraging.
Brachytherapy 02/2002; 1(3):149-53. · 1.47 Impact Factor
