Stephan Mose

Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial

BACKGROUND Anaemia is associated with poor cancer control, particularly in patients undergoing radiotherapy. We investigated whether anaemia correction with epoetin beta could improve outcome of curative radiotherapy among patients with head and neck cancer. METHODS We did a multicentre, double-blind, randomised, placebo-controlled trial in 351 patients (haemoglobin <120 g/L in women or <130 g/L in men) with carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received curative radiotherapy at 60 Gy for completely (R0) and histologically incomplete (R1) resected disease, or 70 Gy for macroscopically incompletely resected (R2) advanced disease (T3, T4, or nodal involvement) or for primary definitive treatment. All patients were assigned to subcutaneous placebo (n=171) or epoetin beta 300 IU/kg (n=180) three times weekly, from 10-14 days before and continuing throughout radiotherapy. The primary endpoint was locoregional progression-free survival. We assessed also time to locoregional progression and survival. Analysis was by intention to treat. FINDINGS 148 (82%) patients given epoetin beta achieved haemoglobin concentrations higher than 140 g/L (women) or 150 g/L (men) compared with 26 (15%) given placebo. However, locoregional progression-free survival was poorer with epoetin beta than with placebo (adjusted relative risk 1.62 [95% CI 1.22-2.14]; p=0.0008). For locoregional progression the relative risk was 1.69 (1.16-2.47, p=0.007) and for survival was 1.39 (1.05-1.84, p=0.02). INTERPRETATION Epoetin beta corrects anaemia but does not improve cancer control or survival. Disease control might even be impaired. Patients receiving curative cancer treatment and given erythropoietin should be studied in carefully controlled trials.

Influence of CT contrast agents on dose calculations in a 3D treatment planning system

In treatment planning for conformal radiotherapy, it is possible to attain high accuracy in contouring the outline of the target volume and organs at risk by giving contrast agents (CAs) during the CT scan. In order to calculate the dose from the CT scans, Hounsfield units (HUs) are converted into the parameters of a standard set of tissues with given atomic composition and density. Due to the high atomic number of contrast media, high HU values are obtained during CT scanning. The Helax treatment planning system, for instance, erroneously takes them for high density tissue. This misinterpretation results in high absorption of high-energy photon beams and thus affects the dose calculation significantly. A typical bolus diameter of 3 cm and HU values of 1,400 cause an overdose of up to 7.4% and 5.4% for 6 MV and 25 MV photon beams, respectively. However, since the CA concentration and its expansion are rather low the effect on dose calculation in treatment planning is negligible.

Stellenwert der18F-Fluordeoxyglucose-Positronen-emissionstomographie in der Radiotherapieplanung von Kopf-Hals-Tumoren

ZusammenfassungHintergrundEine exakte Ausbreitungsdiagnostik ist Voraussetzung für die individualisierte Bestrahlungsplanung bei Patienten mit Kopf-Hals-Tumoren. Trotz hoher Zuverlässigkeit der in der Routine eingesetzten Verfahren Computer-und Kernspintomographie ist die sichere Diagnostik eines lymphonodalen Tumorbefalls oft nicht möglich. Wir untersuchten im Rahmen einer Studie, ob die zusätzliche Durchführung einer18F-Fluordeoxyglucose-Positronenemissionstomographie (FDG-PET) hier einen für die Radiotherapieplanung relevanten Informationsgewinn erbringt.Patienten und MethodeUntersucht wurden Daten von 34 Patienten mit Plattenepitheltumoren der HNO-Region, bei denen im Rahmen des Staging vor Radiotherapieplanung zusätzlich zu Sonographie, MRT, CT und Panendoskopie eine FDG-PET durchgeführt wurde. Ausgewertet wurde, wie häufig und in welchem Ausmaß das Ergebnis der PET eine Änderung des geplanten Bestrahlungsfeldes bzw. des Behandlungskonzeptes erforderte.ErgebnisseBei 7/12 der Rezidive und 9/22 der Primärtumoren wurde durch die FDG-PET ein konventionell nicht festgestellter Tumorbefall diagnostiziert. In allen Fällen war eine Änderung des Therapiekonzeptes oder des Bestrahlungsvolumens erforderlich. Überdurchschnittlich häufig waren therapierelevante PET-Befunde bei Rezidivtumoren, großen Primärtumoren (T3 und T4) und bei Primärtumoren mit ausgedehntem Lymphknotenbefall (N2 und N3).SchlußfolgerungBesonders bei Rezidivtumoren und fortgeschrittenen Kopf-Hals-Tumoren erbringt die FDG-PET einen Gewinn an diagnostischer Information für die Radiotherapieplanung. Bei dieser Patientengruppe sowie bei unklarer Befundlage sollte die FDG-PET als zusätzliches diagnostisches Verfahren im prätherapeutischen Staging vor der Entscheidung über Therapiestrategie und Bestrahlungsplanung hinzugezogen werden.AbstractPurposeAn individualized radiation treatment planning in patients with head and neck tumors requires an exact definition of tumorspread. Despite of high reliability of methods like computed tomography, sonography or magnetic resonance imaging used in daily routine, the correct diagnosis of lymphonodal tumor infiltration is often not possible. In a prospective trial, we examined whether an additional FDG-PET gives a relevant gain of information for radiation treatment planning.Patients and MethodsWe studied data of 34 patients with histologically confirmed squamous cell carcinoma of the head and neck who received a FDG-PET prior to treatment planning additionally to conventional staging procedures. The extent of changes of treatment strategy or target volume due to additional FDG-PET finding were analyzed.ResultsIn 9/22 of patients with primary tumors and in 7/12 of patients with recurrent disease, FDG-PET detected additional tumor manifestations. In all cases, changes of treatment strategy or target volume were necessary. Regarding patients with primary tumors, the percentage of treatment modifications was highest in patients with large tumors (T3 and T4) and patients with advanced lymph node involvement (N2 and N3).ConclusionsEspecially in patients with recurrent disease and patients with advanced tumor stages, FDG-PET is able to give clinically relevant information compared to conventional staging procedures. Therefore, in these group of patients a FDG-PET study prior to radiotherapy planning should be considered.PURPOSE An individualized radiation treatment planning in patients with head and neck tumors requires an exact definition of tumorspread. Despite of high reliability of methods like computed tomography, sonography or magnetic resonance imaging used in daily routine, the correct diagnosis of lymphonodal tumor infiltration is often not possible. In a prospective trial, we examined whether an additional FDG-PET gives a relevant gain of information for radiation treatment planning. PATIENTS AND METHODS We studied data of 34 patients with histologically confirmed squamous cell carcinoma of the head and neck who received a FDG-PET prior to treatment planning additionally to conventional staging procedures. The extent of changes of treatment strategy or target volume due to additional FDG-PET findings were analyzed. RESULTS In 9/22 of patients with primary tumors and in 7/12 of patients with recurrent disease, FDG-PET detected additional tumor manifestations. In all cases, changes of treatment strategy or target volume were necessary. Regarding patients with primary tumors, the percentage of treatment modifications was highest in patients with large tumors (T3 and T4) and patients with advanced lymph node involvement (N2 and N3). CONCLUSIONS Especially in patients with recurrent disease and patients with advanced tumor stages, FDG-PET is able to give clinically relevant information compared to conventional staging procedures. Therefore, in these group of patients a FDG-PET study prior to radiotherapy planning should be considered.

Neoadjuvant capecitabine combined with standard radiotherapy in patients with locally advanced rectal cancer: mature results of a phase II trial.

Purpose:The objective of this expanded phase II trial was to confirm the safety results of the preceding phase I study and establish the efficacy of neoadjuvant radiochemotherapy with capecitabine in rectal cancer in a multicenter setting.Patients and Methods:96 patients (63% male, age 34–81 years) with advanced rectal cancer (cT3–4 or cN+) from seven university centers in Germany were recruited. All were to receive a total irradiation dose of 50.4–55.8 Gy with conventional fractions. Capecitabine was given at an oral dosage of 825 mg/m2bid on each day of the radiotherapy period with the first daily dose applied 2 h before irradiation, followed by surgery 6 weeks later.Results:Most of the patients suffered from an advanced primary tumor (cT3: 57%, cT4: 40%) with lymph node involvement in 60%. After neoadjuvant treatment, with a mean of 99% of the scheduled radiation dose actually delivered, a clinical response rate of 68% (95% confidence interval: 57–78%) was observed. Out of 87 evaluable patients undergoing surgery, a sphincter-preserving procedure could be performed in 51% and R0 resection in 94%. A pathologically complete response was achieved in six patients (7%, 95% confidence interval: 3–14%). The comparison of initial diagnosis and pathologic findings showed a downstaging in 61%. Acute toxicity with > 5% incidence of NCI (National Cancer Institute) grade ≥ 3 included lymphopenia (12%), leukopenia (6%), and diarrhea (7%). Mild to moderate hand-foot syndrome occurred in 12% only. After a median follow-up of 48 months, the 5-year overall survival and tumor control data were, with regard to patient selection, in the expected range with an overall survival of 65%, a relapse-free survival of 47%, and a local recurrence rate after 5 years of 17%.Conclusion:The data clearly confirm that capecitabine is an adequate substitute for 5-fluorouracil in preoperative chemoradiation of rectal cancer with a favorable safety profile.Ziel:Diese multizentrische Phase-II-Studie sollte Effektivität und Toxizität einer neoadjuvanten Radiochemotherapie mit Capecitabine prüfen.Patienten und Methodik:96 Patienten (davon 63% männlich, Alter 34–81 Jahre) mit lokal fortgeschrittenem Rektumkarzinom (cT3–4 oder cN+) aus sieben deutschen Universitätskliniken wurden rekrutiert. Alle erhielten eine präoperative Radiotherapie (50,4–55,8 Gy in konventioneller Fraktionierung mit 5 × 1,8 Gy) und zusätzlich 2 × täglich 825 mg/m2Capecitabin während gesamten Radiotherapie (erste Dosis 2 h vor Radiotherapie, keine Pause am Wochenende). 6 Wochen nach der Radiochemotherapie war die Resektion geplant.Ergebnisse:97% der Patienten hatten T3/T4-Tumoren (T3: 57%; T4: 40%). Lymphknotenbefall (cN+) lag in 60% vor. Die präoperative Therapie war gut durchführbar (mittlere Strahlendosis 99%, mittlere Capecitabindosis 96% der geplanten Dosis). Die klinische Ansprechrate betrug 68% (95%-Konfidenzintervall: 57–78%) und entsprach der Studienhypothese. Von 87 auswertbaren operierten Patienten wurden 94% R0-reseziert; ein Sphinktererhalt war in 51% möglich. Sechs Patienten (7%, 95%-Konfidenzintervall: 3–14%) hatten eine histologisch komplette Remission (ypT0) im Resektat. Ein Downstaging wurde in 61% erreicht. Akute Nebenwirkungen CTC-Grad ≥ 3 (Common Toxicity Criteria) mit einer Frequenz von > 5% wurden für Lymphopenie (12%), Diarrhö (7%) und Leukopenie (6%) beobachtet. Ein Hand-Fuß-Syndrom trat in 12% auf und war jeweils nur mild (Grad 1–2). Die 5-Jahres-Überlebensrate betrug 65%, das rezidivfreie Überleben 47% und die lokale Kontrolle nach 5 Jahren 83%.Schlussfolgerung:Die Daten dieser multizentrischen Phase-II-Studie bestätigen, dass die Kombination von präoperativer Radiotherapie und Capecitabin eine wirksame und nebenwirkungsarme Behandlung beim lokal fortgeschrittenen Rektumkarzinom darstellt. Capecitabin eignet sich als Ersatz für eine kontinuierliche 5-Fluorouracil-Infusion.

Neoadjuvant Capecitabine Combined with Standard Radiotherapy in Patients with Locally Advanced Rectal Cancer

Purpose:The objective of this expanded phase II trial was to confirm the safety results of the preceding phase I study and establish the efficacy of neoadjuvant radiochemotherapy with capecitabine in rectal cancer in a multicenter setting.Patients and Methods:96 patients (63% male, age 34–81 years) with advanced rectal cancer (cT3–4 or cN+) from seven university centers in Germany were recruited. All were to receive a total irradiation dose of 50.4–55.8 Gy with conventional fractions. Capecitabine was given at an oral dosage of 825 mg/m2bid on each day of the radiotherapy period with the first daily dose applied 2 h before irradiation, followed by surgery 6 weeks later.Results:Most of the patients suffered from an advanced primary tumor (cT3: 57%, cT4: 40%) with lymph node involvement in 60%. After neoadjuvant treatment, with a mean of 99% of the scheduled radiation dose actually delivered, a clinical response rate of 68% (95% confidence interval: 57–78%) was observed. Out of 87 evaluable patients undergoing surgery, a sphincter-preserving procedure could be performed in 51% and R0 resection in 94%. A pathologically complete response was achieved in six patients (7%, 95% confidence interval: 3–14%). The comparison of initial diagnosis and pathologic findings showed a downstaging in 61%. Acute toxicity with > 5% incidence of NCI (National Cancer Institute) grade ≥ 3 included lymphopenia (12%), leukopenia (6%), and diarrhea (7%). Mild to moderate hand-foot syndrome occurred in 12% only. After a median follow-up of 48 months, the 5-year overall survival and tumor control data were, with regard to patient selection, in the expected range with an overall survival of 65%, a relapse-free survival of 47%, and a local recurrence rate after 5 years of 17%.Conclusion:The data clearly confirm that capecitabine is an adequate substitute for 5-fluorouracil in preoperative chemoradiation of rectal cancer with a favorable safety profile.Ziel:Diese multizentrische Phase-II-Studie sollte Effektivität und Toxizität einer neoadjuvanten Radiochemotherapie mit Capecitabine prüfen.Patienten und Methodik:96 Patienten (davon 63% männlich, Alter 34–81 Jahre) mit lokal fortgeschrittenem Rektumkarzinom (cT3–4 oder cN+) aus sieben deutschen Universitätskliniken wurden rekrutiert. Alle erhielten eine präoperative Radiotherapie (50,4–55,8 Gy in konventioneller Fraktionierung mit 5 × 1,8 Gy) und zusätzlich 2 × täglich 825 mg/m2Capecitabin während gesamten Radiotherapie (erste Dosis 2 h vor Radiotherapie, keine Pause am Wochenende). 6 Wochen nach der Radiochemotherapie war die Resektion geplant.Ergebnisse:97% der Patienten hatten T3/T4-Tumoren (T3: 57%; T4: 40%). Lymphknotenbefall (cN+) lag in 60% vor. Die präoperative Therapie war gut durchführbar (mittlere Strahlendosis 99%, mittlere Capecitabindosis 96% der geplanten Dosis). Die klinische Ansprechrate betrug 68% (95%-Konfidenzintervall: 57–78%) und entsprach der Studienhypothese. Von 87 auswertbaren operierten Patienten wurden 94% R0-reseziert; ein Sphinktererhalt war in 51% möglich. Sechs Patienten (7%, 95%-Konfidenzintervall: 3–14%) hatten eine histologisch komplette Remission (ypT0) im Resektat. Ein Downstaging wurde in 61% erreicht. Akute Nebenwirkungen CTC-Grad ≥ 3 (Common Toxicity Criteria) mit einer Frequenz von > 5% wurden für Lymphopenie (12%), Diarrhö (7%) und Leukopenie (6%) beobachtet. Ein Hand-Fuß-Syndrom trat in 12% auf und war jeweils nur mild (Grad 1–2). Die 5-Jahres-Überlebensrate betrug 65%, das rezidivfreie Überleben 47% und die lokale Kontrolle nach 5 Jahren 83%.Schlussfolgerung:Die Daten dieser multizentrischen Phase-II-Studie bestätigen, dass die Kombination von präoperativer Radiotherapie und Capecitabin eine wirksame und nebenwirkungsarme Behandlung beim lokal fortgeschrittenen Rektumkarzinom darstellt. Capecitabin eignet sich als Ersatz für eine kontinuierliche 5-Fluorouracil-Infusion.

Multimodality Treatment Including Postoperative Radiation and Concurrent Chemotherapy with Weekly Docetaxel is Feasible and Effective in Patients with Oral and Oropharyngeal Cancer

Background:To examine the feasibility and efficacy of weekly docetaxel with concurrent radiation as postoperative treatment in a multimodality approach to oral and oropharyngeal cancer.Patients and Methods:94 patients (Table 1) with primary resectable squamous cell carcinoma of the oral cavity and oropharynx (UICC stage I 14%, II 15%, III 18%, IV 53%; Table 2) were treated with a multimodality therapy program consisting of neoadjuvant intra-arterial high-dose chemotherapy (cisplatin 150 mg/m2 with parallel systemic sodium thiosulfate 9 g/m2 for neutralization), followed by surgery of the primary and neck, and postoperative concurrent radiation and chemotherapy with weekly docetaxel (20–30 mg/m2; Table 3). Chronic toxicities were followed over a period of 5 years.Results:At a median follow-up of 4 years, the 5-year survival rate for all 94 patients was 80%, and disease-free survival was 73% (Figures 1 and 2). Among patients with advanced disease (stage III and IV), survival was 83 and 59%, respectively (Figure 4). Grade 3 and 4 mucositis was the main acute toxicity necessitating supportive care. Long-term toxicity appears to be moderate (Table 4). The maximum tolerated dose of weekly docetaxel was 25 mg/m2.Conclusions:Concurrent radiation and chemotherapy with weekly docetaxel is a feasible postoperative treatment in a multimodality approach to oral and oropharyngeal cancer, resulting in high overall and disease-free survival. This approach warrants further evaluation in prospective randomized trials.Hintergrund:Untersuchung der Durchführbarkeit und Effektivität einer wöchentlichen Docetaxelapplikation bei konkomitanter Bestrahlung in einem multimodalen Behandlungskonzept von Mundhöhlen- und Oropharynxkarzinomen.Patienten und Methoden:94 Patienten (Tabelle 1) mit primären resektablen Plattenepithelkarzinomen der Mundhöhle und des Oropharynx (UICC-Stadium I 14%, II 15%, III 18%, IV 53%; Tabelle 2) wurden mit einem multimodalen Therapiekonzept behandelt, das aus einer neoadjuvanten intraarteriellen Hochdosischemotherapie (150 mg/m2 Cisplatin mit paralleler systemischer Neutralisierung durch 9 g/m2 Natriumthiosulfat), einer Radikaloperation des Primarius und des Halses sowie einer postoperativen konkomitanten Bestrahlung und Chemotherapie mit wöchentlicher Docetaxelgabe (20–30 mg/m2) bestand (Tabelle 3). Chronische Nebenwirkungen wurden über 5 Jahre hinweg beobachtet.Ergebnisse:Nach einem medianen Follow-up von 4 Jahren lag die 5-Jahres-Überlebensrate aller 94 Patienten bei 80% und das krankheitsfreie Überleben bei 73% (Abbildungen 1 und 2). Bei Patienten mit fortgeschrittener Erkrankung (Stadium III und IV) lag das Überleben bei jeweils 83% und 59% (Abbildung 4). Eine Mukositis der Grade III und IV war die hauptsächliche Akuttoxizität, die eine supportive Therapie nötig machte. Die Langzeittoxizität schien moderat zu sein (Tabelle 4). Die maximal tolerierte wöchentliche Docetaxeldosis war 25 mg/m2.Schlussfolgerungen:Die konkomitante Bestrahlung und Chemotherapie mit wöchentlicher Docetaxelgabe ist eine durchführbare postoperative Behandlung in einem multimodalen Therapiekonzept für Mundhöhlen- und Oropharynxkarzinome, die in einem hohen Gesamt- und krankheitsfreien Überleben resultiert. Dieser Therapieansatz erfordert eine weitere Bewertung in prospektiven randomisierten Studien.

Survival of very young children with medulloblastoma (primitive neuroectodermal tumor of the posterior fossa) treated with craniospinal irradiation

PURPOSE Very young children with medulloblastoma are considered to have a worse prognosis than older children. As radiotherapy remains an important part of the treatment, the adverse prognosis could be due to inadequate radiation treatment rather than biological factors. We analyzed the published literature to examine the impact of radiotherapy on survival in this group. METHODS AND MATERIALS A Medline search was performed and we reviewed studies of treatment of medulloblastoma where radiotherapy was delivered using megavoltage equipment and the minimum follow-up allowed the calculation of 5-year survival rates. RESULTS Thirty-nine studies were published between 1979 and 1996 with a treatment including craniospinal irradiation and boost to the posterior fossa. Eleven studies comprising 1366 patients analyzed survival by age at diagnosis. Eight of 11 studies showed a worse 5-year survival for the younger patient group which reached statistical significance in two. There is also a suggestion of a higher proportion of children with metastatic disease at presentation in the very young age group. The usual policy in younger children was to give a lower dose of radiotherapy to the craniospinal axis (CSA) and posterior fossa (PF) with reduction of dose in the range of 15 to 25% compared to standard treatment. As dose reduction to the posterior fossa is associated with worse survival and local recurrence is the predominant site of failure, the major determinant of worse survival in very young children with medulloblastoma may be suboptimal radiotherapy. Protocols including postoperative chemotherapy with delayed, omitted, or only local tumor irradiation do not reach survival rates of protocols with standard radiotherapy, also suggesting a continued importance for irradiation. CONCLUSION Very young children with medulloblastoma have a worse prognosis than older children. Inadequate radiation dose and technique to the primary tumor region may be a major contributing factor. Current chemotherapeutic regimes alone are not sufficient to compensate for reduced radiation doses and volumes.

Bilateral breast carcinoma versus unilateral disease. Review of 498 patients.

In literature data, an uncertainty exists whether occurrence of bilateral breast cancer decreases the survival probability of affected patients. Therefore, we analyzed the medical records of 498 postoperatively irradiated (1977-1982) female breast cancer patients (T1-4,N0-3,M0). In the follow-up time, in 36 patients a bilateral breast carcinoma treated by surgery with or without radiotherapy was found. The 10-year overall survival rates were 54% in patients who had unilateral disease, compared with 56% in bilateral carcinoma patients, respectively. The incidence of metastasis did not differ between both groups: 24.2% versus 38.8%. Eleven percent of unilateral cancers recurred; in the other group, local failure of the first and second tumor was observed in 19.4% and 11.1%, respectively. We conclude that the occurrence of bilateral breast cancer has no significant impact on survival, although the development of local failures and metastases seems to be more frequent. The therapeutic strategy in bilateral carcinoma should resemble the treatment procedure in unilaterally affected patients.

Can prophylactic application of immunoglobulin decrease radiotherapy-induced oral mucositis?

Therapeutic application of immunoglobulin is reported to be successful in radiation-induced oral and oropharyngeal mucositis. In this study the efficacy of prophylactic application of immunoglobulin was investigated. In 42 patients with head and neck cancer, postoperative radiation treatment or radiation combined with chemotherapy was performed. In 20 consecutive patients, prophylactic mucositis treatment consisted of panthenol (4 x 10 ml/day) and nystatin (4 x 1 ml/day). The 22 following patients received, supplementary to panthenol and nystatin, 800 mg (5 ml) human immunoglobulin intramuscularly once weekly. During the treatment time, the degree of mucositis was examined 3 times a week. The distribution of maximal mucositis degree revealed slightly more severe mucous membrane reaction in the control group compared with the immunoglobulin group (n.s.). The analysis of mean mucositis degrees in both groups demonstrated statistically significant differences (t test, p = 0.031) related to the entire group (n = 42) and to those 16 patients receiving radiation combined with chemotherapy. There was no significant immunoglobulin-induced effect on mucositis in patients treated by radiation alone. The time from the beginning of therapy to the first interruption could be prolonged 5 days in the immunoglobulin group (n.s.). In conclusion, it is demonstrated that the prophylactic application of immunoglobulin seems to lower the degree of radiation-induced mucositis. In comparison to the published data about therapeutically given immunoglobulin, the clinical efficacy of the prophylactic application of immunoglobulin as it is performed in this study is less evident.

Influence of irradiation on therapy-associated psychological distress in breast carcinoma patients

PURPOSE To confirm our assumptions regarding factors that apparently cause psychological distress related to adjuvant radiotherapy in breast cancer patients and to evaluate variables that can predict therapy-associated distress. METHODS AND MATERIALS Between January 1997 and April 1998, 111 women (33-84 years) with early-stage breast cancer were irradiated (56 Gy) after breast-conserving surgery. Patients were given self-assessment questionnaires on the first and last day of radiotherapy. Statistical analysis was performed using the structural equation model LISREL, variance analysis, and regression analysis. RESULTS The internal subject-related factors (coping, radiation-related anxiety, physical distress, psychological distress) reciprocally influenced each other, whereas external radiotherapy-specific factors (environmental influence, confidence in the medical staff) were causally related to coping, anxiety, and distress. Fifty-three percent of the women felt distressed because cancer affected the breast; 48% were initially afraid of radiotherapy. For 36%, anxiety was not reduced during treatment. Highly distressed women were identified by the following parameters: < or =58 years; initial anxiety; they were affected by having breast cancer, were negatively affected by environmental factors, and did not find distraction helpful. CONCLUSION Despite considerable individual variability in breast cancer patients, it seems possible to identify women who run a high risk of therapy-associated distress. In these patients, psychosocial support is necessary to reduce treatment-related anxiety and to stabilize confidence in the medical staff.