A patterns of care analysis of hyperthermia in combination with radio(chemo)therapy or chemotherapy in European clinical centers.

PURPOSE: The combination of hyperthermia (HT) with radio(chemo)therapy or chemotherapy (CT) is an established treatment strategy for specific indications. Its application in routine clinical practice in Europe depends on regulatory and local conditions. We conducted a survey among European clinical centers to determine current practice of HT. METHODS: A questionnaire with 22 questions was sent to 24 European HT centers. The questions were divided into two main categories. The first category assessed how many patients are treated with HT in combination with radio(chemo)therapy or CT for specific indications per year. The second category addressed which hyperthermia parameters are recorded. Analysis was performed using descriptive methods. RESULTS: The response rate was 71% (17/24) and 16 centers were included in this evaluation. Annually, these 16 centers treat approximately 637 patients using HT in combination with radio(chemo)therapy or CT. On average, 34% (range: 3-100%) of patients are treated in clinical study protocols. Temperature readings and the time interval between HT and radio(chemo)therapy or CT are recorded in 13 (81%) and 9 (56%) centers, respectively. The thermal dose quality parameter "cumulative equivalent minutes at 43 °C" (CEM43°C) is only evaluated in five (31%) centers for each HT session. With regard to treatment sequence, 8 (50%) centers administer HT before radio(chemo)therapy and the other 8 in the reverse order. CONCLUSION: There is a significant heterogeneity among European HT centers as to the indications treated and the recording of thermometric parameters. More evidence from clinical studies is necessary to achieve standardization of HT practice.

Role of Hyperthermia in Breast Cancer Locoregional Recurrence: A Review.

In patients with locoregional recurrences of breast cancer not suitable for resection, subsequent local control is difficult to maintain in previously irradiated areas when reirradiation alone or reirradiation with chemotherapy is used. Due to the limited number of treatment options there is a high risk of subsequent failure and uncontrollable local disease. In this group of patients, local hyperthermia combined with radiotherapy increases the clinical response and local control, adding limited acute and late toxicity, as has been shown in randomized trials. Hyperthermia is an artificial elevation of tissue temperature (range 40-44°C for 30-60 min). If hyperthermia is applied shortly before or after radiation, the effect of radiation is enhanced by influencing intratumoral hypoxia and by inhibiting sublethal damage repair in the tumor. Moreover, hyperthermia combined with radiation reduces the total dose of radiation needed compared to radiation alone, of which a higher dose is needed to obtain the same effect. Few data are available on the combination of radiotherapy and hyperthermia with chemotherapy, although the results of trimodality treatment consisting of reirradiation and hyperthermia together with liposomal doxorubicin are promising. Therefore, this literature review was performed to provide more comprehensive data on the mechanism and use of hyperthermia in locoregional recurrence of breast cancer.

Intraoperative radiation therapy: a critical analysis of the ELIOT and TARGIT trials. Part 1--ELIOT.

INTRODUCTION: Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published. The ELIOT Trial used electrons (IOERT), and the TARGIT-A Trial Update used 50-kV X-rays (IORT). These studies were compared for similarities and differences. The results were analyzed and used to determine which patients might be suitable for single-dose treatment. METHOD: The primary sources of data were the ELIOT Trial and TARGIT-A Trial, as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation (APBI) using 50-kV X-rays or electrons. Studies published or presented prior to March 2014 were analyzed for efficacy, patient restrictions, complications, and outcome. RESULTS: With a median follow-up of 5.8 years, the 5-year recurrence rates for ELIOT versus external beam radiation therapy (EBRT) patients were 4.4 % and 0.4 %, respectively, p = .0001. A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 %. With a median follow-up of 29 months, the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 % and 1.3 %, respectively, p = .042. CONCLUSION: With 5.8 years of median follow-up, IOERT appears to have a subset of low-risk women for whom IOERT is acceptable. With 29 months of median follow-up the results of IORT with 50-kV devices are promising, but longer follow-up data are required. At the current time, single-fraction IOERT or IORT patients should be treated under strict institutional protocols.

Intraoperative radiation therapy: a critical analysis of the ELIOT and TARGIT trials. Part 2--TARGIT.

BACKGROUND: Two randomized intraoperative radiation therapy trials for early-stage breast cancer were recently published. The ELIOT Trial used electrons (IOERT), and the TARGIT-A Trial Update used 50-kV X-rays (IORT). These studies were compared for similarities and differences. The results were analyzed and used to determine which patients might be suitable for single-dose treatment. METHODS: The primary sources of data were the ELIOT Trial and TARGIT-A Trial, as well as a comprehensive analysis of the peer-reviewed literature of accelerated partial breast irradiation (APBI) using 50-kV X-rays or electrons. Studies published or presented prior to March 2014 were analyzed for efficacy, patient restrictions, complications, and outcome. RESULTS: With a median follow-up of 5.8 years, the 5-year recurrence rates for ELIOT versus EBRT patients were 4.4 and 0.4 %, respectively, p = 0.0001. A low-risk ELIOT group was identified with a 5-year recurrence rate of 1.5 %. With a median follow-up of 29 months, the 5-year recurrence rates for the TARGIT-A versus EBRT patients were 3.3 and 1.3 %, respectively, p = 0.042. CONCLUSIONS: With 5.8 years of median follow-up, IOERT appears to have a subset of low risk women for whom IOERT is acceptable. With 29 months of median follow-up the results of IORT with 50-kV devices are promising, but longer follow-up data are required. At the current time, single-fraction IOERT or IORT patients should be treated under strict institutional protocols.

Intraoperative Electron Radiotherapy (IOERT) as an Alternative to Standard Whole Breast Irradiation: Only for Low-Risk Subgroups?

BACKGROUND: Intraoperative radiotherapy during breast-conserving surgery is being studied as an alternative to 6 weeks of external beam radiotherapy (EBRT) for low-risk women; it can be delivered using electrons (intraoperative electron radiotherapy, IOERT) or 50-kV X-rays. MATERIALS AND METHODS: We analyzed both single institutional and randomized studies involving single-fraction IOERT treatments. Rates for ipsilateral breast tumor recurrences, disease-specific survival, and overall survival were obtained. RESULTS: IOERT had true 5-year recurrence rates of > 1.5% for ASTRO (American Society for Radiation Oncology) and ESTRO (European Society for Therapeutic Radiology and Oncology) suitable women, or for low-risk women as defined by the ELIOT trial. Women with ductal carcinoma in situ eligible for breast-conserving therapy, older women that currently receive no EBRT, and younger women with favorable biology are additional potential candidates. CONCLUSION: ASTRO suitable and ESTRO good women for accelerated partial breast irradiation are low-risk groups. Higher-risk women with favorable biology might also be suitable candidates for IOERT, providing the tumor biology can be determined prior to surgery. For intraoperative radiotherapy using 50-kV X-rays, follow-up was too short to assess the effectiveness of the treatment.

Accelerated partial breast irradiation using only intraoperative electron radiation therapy in early stage breast cancer.

BACKGROUND: We report the results of a single-institution, phase II trial of accelerated partial breast irradiation (APBI) using a single dose of intraoperative electron radiation therapy (IOERT) in patients with low-risk early stage breast cancer. METHODS AND MATERIALS: A cohort of 226 patients with low-risk, early stage breast cancer were treated with local excision and axillary management (sentinel node biopsy with or without axillary node dissection). After the surgeon temporarily reapproximated the excision cavity, a dose of 21 Gy using IOERT was delivered to the tumor bed, with a margin of 2 cm laterally. RESULTS: With a mean follow-up of 46 months (range, 28-63 months), only 1 case of local recurrence was reported. The observed toxicity was considered acceptable. CONCLUSIONS: APBI using a single dose of IOERT can be delivered safely in women with early, low-risk breast cancer in carefully selected patients. A longer follow-up is needed to ascertain its efficacy compared to that of the current standard treatment of whole-breast irradiation.

Regional hyperthermia combined with chemoradiotherapy in primary or recurrent locally advanced pancreatic cancer : an open-label comparative cohort trial.

PURPOSE: To evaluate the therapeutic effect of delivering regional hyperthermia (HT) plus chemoradiotherapy (CRT) in patients suffering from locally advanced unresectable pancreatic cancer (LAPC). METHODS: Between January 2000 and December 2008, 68 patients affected by primary (56/68) or recurrent (12/68) LAPC were treated either with CRT alone or CRT plus HT. Radiotherapy (RT) consisted of 3D conformal irradiation of tumor and regional lymph nodes (dose ranged from 30 Gy/10 fractions to 66 Gy/33 fractions). Chemotherapy (CT) consisted of gemcitabine (GEM) alone or in association with either oxaliplatin, cisplatin, or 5-FU. HT was delivered twice a week, concomitant with RT. RESULTS: In the current study, 60 of the original 68 patients were included. Median overall survival (OS) was 15 months in the HT group versus 11 months in the control group (log-rank test: p = 0.025). HT did not increase CRT toxicity. CONCLUSION: HT can be added safely to CRT in LAPC, thus, resulting in slightly prolonged survival in certain cases.

Treatment for intermediate and high-risk prostate cancer: controversial issues and the role of hyperthermia.

For patients affected by intermediate- and high-risk prostate cancer, a single local therapy is not enough, and a more aggressive treatment, such as androgen suppression therapy (AST) and pelvic irradiation, is indicated. Biochemical disease-free survival (bDFS) and overall survival (OS) improve in intermediate- and high-risk prostate cancer using radiotherapy (RT) combined with AST as compared with the RT alone. Hyperthermia (HT), combined with RT for the treatment of prostate cancer with intermediate- and high-risk, has been defined as "promising". In the development of new strategies, the reduction of short and long-term treatment related toxicity is of primary importance. Quality of Life (QoL) has been previously investigated and the authors concluded that HT does not negatively impact QoL in patients treated with radiation and HT. The use of HT in treating advanced prostate cancer has been reported by many centres; several studies suggest the feasibility of HT added to conventional RT. In intermediate- and high-risk prostate cancer, the combination of RT plus a long-term androgen suppression provides good results in terms of OS and QoL. HT, improving the anti-cancer effects of irradiation, as demonstrated by experimental in vitro and in vivo studies, could increase the outcome in the treatment of locally advanced prostate tumours without adding toxicity. A randomised phase III trial comparing RT-AST combined treatment plus/minus HT is needed to demonstrate the efficacy of HT.

Patterns of care and survival in a retrospective analysis of 1059 patients with glioblastoma multiforme treated between 2002 and 2007: a multicenter study by the Central Nervous System Study Group of Airo (italian Association of Radiation Oncology).

OBJECTIVE: To investigate the pattern of care and outcomes for newly diagnosed glioblastoma in Italy and compare our results with the previous Italian Patterns of Care study to determine whether significant changes occurred in clinical practice during the past 10 years. METHODS: Clinical, pathological, therapeutic, and survival data regarding 1059 patients treated in 18 radiotherapy centers between 2002 and 2007 were collected and retrospectively reviewed. RESULTS: Most patients underwent both computed tomography and magnetic resonance imaging either preoperatively (62.7%) or postoperatively (35.5%). Only 123 patients (11.6%) underwent a biopsy. Radiochemotherapy with temozolomide was the most frequent adjuvant treatment (70.7%). Most patients (88.2%) received 3-dimensional conformal radiotherapy. Median survival was 9.5 months. Two- and 5-year survival rates were 24.8% and 3.9%, respectively. Multivariate analysis showed the statistical significance of age, postoperative Karnofsky Performance Status scale score, surgical extent, use of 3-dimensional conformal radiotherapy, and use of chemotherapy. Use of a more aggressive approach was associated with longer survival in elderly patients. Comparing our results with those of the subgroup of patients included in our previous study who were treated between 1997 and 2001, relevant differences were found: more frequent use of magnetic resonance imaging, surgical removal more common than biopsy, and widespread use of 3-dimensional conformal radiotherapy + temozolomide. Furthermore, a significant improvement in terms of survival was noted (P < .001). CONCLUSION: Changes in the care of glioblastoma over the past few years are documented. Prognosis of glioblastoma patients has slightly but significantly improved with a small but noteworthy number of relatively long-term survivors.

A case of relapsed medulloblastoma treated with intensity-modulated radiotherapy and temozolomide.

We report a case of relapsed high-risk non-metastatic medulloblastoma in a 14-year-old boy, which was treated with intensity-modulated radiotherapy (IMRT) and temozolomide (TMZ). At the age of 11, the patient underwent an MRI-confirmed incomplete resection of a fourth-ventricle medulloblastoma, followed by conventional chemotherapy, craniospinal irradiation (55.8 Gy, 1.8 Gy/fraction) and then myeloablative chemotherapy followed by peripheral blood progenitor cell rescue. After 18 months of complete remission following the completion of chemotherapy, MRI showed a 2.5-cm mass in the olfactory notch. The patient underwent IMRT (45 Gy, 1.8 Gy/fraction) with concomitant administration of TMZ (180 mg/m2, 5 days every 21 days), which was well tolerated. After 5 cycles of TMZ, MRI showed complete remission with no evidence of the mass. TMZ was continued for another 5 cycles and then stopped. At 14 months from the completion of IMRT, a new MRI scan showed multiple nodular relapses around the fourth ventricle and the patient is currently treated with oral etoposide.

Regional hyperthermia added to intensified preoperative chemo-radiation in locally advanced adenocarcinoma of middle and lower rectum.

PURPOSE: To evaluate the safety of delivering pre-operative regional hyperthermia (HT) plus an intensified chemo-radiotherapy (CRT) regimen in patients suffering from locally advanced rectal cancer. METHODS: Between June 2000 and April 2006, 76 patients with locally advanced (cT3-4 N0/+) rectal adenocarcinoma were treated with HT plus CRT. HT was given once a week, to a total of five treatments, 1 to 4 h after radiotherapy (50 Gy with 2-Gy fractions for 5 weeks, plus a 10-Gy boost on the tumour bed, with the same fractionation schedule). Chemotherapy consisted in 5FU 200 mg/m(2) continuous infusion throughout the 6 weeks of irradiation and OXA 45 mg/m(2) in a weekly bolus. Surgery followed 4 to 6 weeks after the completion of HT plus CRT. RESULTS: HT plus CRT was generally well tolerated. At pathologic examination, there was a pathologic complete response (pCR) (ypT0 ypN0) in 18 out of 76 patients (23.6%), a partial response (PR) in 34/76 ones (44.7%) and a stable disease (SD) in 20/76 (26.3%) ones; 4/76 patients (5.2%) had a progression disease (PD) (distant metastases) at the time of surgery. Good predictors of a longer disease-free survival (DFS) were in order ypN status (log-rank test: p = 0.0008), ypT status (p = 0.002) and pCR (p = 0.03). CONCLUSION: Preoperative CRT combined with regional HT yielded acceptable toxicity. The rate of pCR was encouraging, although further studies are needed to prove the long-term efficacy of adding HT to CRT.

The role of hyperthermia in the battle against cancer.

AIMS AND BACKGROUND: Hyperthermia, the heating of tumors to 41.5-43 degrees C, could be today considered the fourth pillar of the treatment of cancer. Employed for 20 years in Europe, the U.S.A. and Asia, hyperthermia, used in addition to radiotherapy, chemotherapy and surgery, increases both local control and overall survival, restores the chance of the surgery for inoperable tumors and allows a new low-dosage treatment of relapsed cancers previously treated with high radiotherapy dosage without increasing toxicity. METHODS: Hyperthermia can be either superficial, produced by a microwave generator, or regional, produced by a radiofrequency applicator with multiple antennas, which emanate a deep focalized or interstitial heating. RESULTS: The results are confirmed by phase III randomized trials, with level 1 evidence. A review of the international literature on hyperthermia, the experience of the University Hospital of Verona Radiotherapy Department (Italy) and a summary of the Symposium regarding the Evolution of Clinical Hyperthermia plus Radiotherapy during the Twentieth Congress of the French Society of Radiation Oncology (SFRO) are presented. CONCLUSIONS: Hyperthermia is an important treatment modality in cancer treatment and its results are strongly supported by criteria of evidence-based medicine. Fifteen years of experience of the Radiation Oncology Department in Verona confirms the positive results obtained with international prospective trials, with level 1 evidence. Hyperthermia appears to be the fourth pillar beside surgery, radiotherapy and chemotherapy.

Plasmacytoid dendritic cell leukemia: a rapidly evolving disease presenting with skin lesions sensitive to radiotherapy plus hyperthermia.

Plasmacytoid dendritic cell leukemia (pDCL) is a rapidly evolving disease, which frequently presents with skin lesions, particularly nodules and plaques with a typical reddish-brown or brown color. Treatment of pDCL is based on multiagent chemotherapy followed by allogeneic hematopoietic stem cell transplant, but skin lesions may be refractory to therapy. Here, we report on a 61-year-old patient affected by pDCL who first presented with multiple cutaneous nodules and plaques on the trunk. Lesions showed an excellent response to radiotherapy plus hyperthermia. Although this treatment did not avoid the systemic evolution of disease, it resolved skin lesions and prevented their relapse, thus representing a therapeutic option to be used in combination with chemotherapy regimens. The case presentation is followed by a general discussion with an emphasis on the diagnosis and treatment of this rare malignancy.

Dose-intensity temozolomide after concurrent chemoradiotherapy in operated high-grade gliomas.

PURPOSE: We performed a new phase II trial enrolling patients with newly diagnosed high-grade glioma (HGG) to test the efficacy of a weekly alternating temozolomide (TMZ) schedule after surgery and concomitant chemoradiotherapy. METHODS: From January 2005 to January 2007, 34 patients (21 men, 13 women; age range 30-70, mean age 53) were enrolled. There were 32 glioblastoma multiforme and two anaplastic astrocytoma. Each patient after surgery received standard concurrent chemoradiotherapy. After a 4-week break, patients were then to receive 12 cycles of 1-week-on/1-week-off TMZ, with 75 mg/m(2) for the first cycle, 100 mg/m(2) for the second, 125 mg/m(2) for the third, and 150 mg/m(2) from the fourth to the 12th. Hematological toxicity was monitored every week during concomitant chemoradiotherapy and then every 4 weeks. RESULTS: After 12 months from the end of radiotherapy, the overall survival (OS) rate was 59% (20/38), distributed as follows: 60% (18/30) for recursive partitioning analysis (RPA) class 4 patients and 33% (1/3) for RPA class 6 patients; the only RPA class 1 patient was alive and disease free at the time of writing. Median OS was 13 months [95% confidence interval (CI) 11.02-14.98 months]. Hematological toxicity was seen in six patients (18%): grade 1 neutropenia in four, grade 2 thrombocytopenia in one, and grade 4 thrombocytopenia plus grade 1 neutropenia in one. There was one case of opportunistic infection (Pneumocystis carinii pneumonitis). CONCLUSION: The toxicity of the TMZ dose-dense regimen was very low. Results seem to be encouraging for RPA lower classes (patients with good prognostic factors).

Gamma knife radiosurgery for cerebral arteriovenous malformations in children/adolescents and adults. Part I: Differences in epidemiologic, morphologic, and clinical characteristics, permanent complications, and bleeding in the latency period.

PURPOSE: To compare the epidemiologic, morphologic, and clinical characteristics of 92 children/adolescents (Group A) and 362 adults (Group B) with cerebral arteriovenous malformations (cAVMs) considered suitable for radiosurgery; to correlate radiosurgery-related permanent complication and post-radiosurgery bleeding rates in the 75 children/adolescents and 297 adults available for follow-up. METHODS AND MATERIALS: Radiosurgery was performed with a model C 201-source Co60 Leksell Gamma Unit (Elekta Instruments, Stockholm, Sweden). Fisher exact two-tailed, Wilcoxon rank-sum, and two-sample binomial exact tests were used for statistical analysis. RESULTS: There were significant differences between the two populations in sex (p = 0.015), clinical presentation (p = 0.001), and location (p = 0.008). The permanent complication rate was lower in younger (1.3%) than in older patients (5.4%), although the difference was not significant (p = 0.213). The postradiosurgery bleeding rate was lower in Group A (1.3%) than in Group B (2.7%) (p = 0.694), with global actuarial bleeding rates of 0.56% per year and 1.15% per year, respectively. CONCLUSIONS: The different characteristics of child/adolescent and adult cAVMs suggest that they should be considered two distinct vascular disorders. The similar rates of radiosurgery-related complications and latency period bleeding in the two populations show that gamma knife radiosurgery does not expose young patients to a higher risk of sequelae than that for older patients.

Physical side effects and quality of life during postoperative radiotherapy for uterine cancer. Prospective evaluation by a diary card.

OBJECTIVE: Adjuvant pelvic radiotherapy (XRT) after radical surgery for uterine cancer may cause various (mainly gastrointestinal) side effects capable of affecting a patient's lifestyle. This prospective study used a diary card to evaluate toxicity and daily quality of life changes in uterine cancer patients given postoperative pelvic radiotherapy. METHODS: The self-completed diary card listed 12 items concerning lifestyle changes and side effects. The patients were stratified by age (65 years). RESULTS: Twenty-five patients were evaluable, and a total of 848 days were assessed (82.6% of the 1027 days of XRT). The mean number of daily stools progressively increased during treatment (P < 0.01). No statistically significant differences were observed in terms of nausea or pain. There was a significant decrease in appetite (P < 0.01). Vaginal symptom scores did not significantly change during treatment, and no significant differences were found in terms of anxiety, daily activities, or compliance to therapy. The subjective perception of overall well-being and the quality of life score progressively and significantly decreased over time (P < 0.01). The younger patients had significantly more bowel movements, less appetite, more pain and vaginal burning, less vaginal bleeding, more anxiety, a greater reduction in daily activities and therapeutic compliance, a poorer subjective perception of overall well-being, and a lower quality of life score. CONCLUSIONS: The use of a diary card may be an adequate means of detecting the extent of treatment-related changes in the lifestyle of uterine cancer patients receiving postoperative radiotherapy.

The role of Gamma Knife radiosurgery in the management of cavernous sinus meningiomas.

PURPOSE: To evaluate the efficacy of Gamma Knife (GK) radiosurgery in terms of neurologic improvement and tumor growth control (TGC) in a large series of patients with cavernous sinus meningioma (CSM). METHODS AND MATERIALS: One hundred thirty-eight patients with CSM (28 males, 110 females; mean age: 56.2 years) were treated with GK between February 1993 and February 2001. GK was used as a first-choice treatment in 68/138 patients and as postoperative adjuvant therapy in 70/138. In 32 patients, it was possible to compare the size of the planned treatment volume to tumor volume using the conformity index (CI); optimal CI values were taken to be < or =1.5 (range: 0.94-2.24). RESULTS: A follow-up (FU) period of at least 12 months was available for 111 patients (median: 48.2 months, range: 12.1-84.5 months). Clinical conditions were improved or stable in 107/111 patients (96.5%). Neurologic recovery was observed in 76% of cases treated by GK alone and in 56.5% of adjuvant treatments (p < 0.03). Adequate TGC was documented in 108/111 tumors (97%), with shrinkage/disappearance in 70/111 (63%) and no variation in volume in 38/111 (34%); the overall actuarial progression-free survival rate at 5 years was 96%. Tumor size regression was observed in 79.5% of patients with FU >30 months, compared with 47.5% of patients with FU <30 months (p < 0.001). One hundred percent TGC was shown in treated patients with a CI < or =1.5 (20/32), compared with 92% TGC in cases with a CI >1.5 (p < 0.15, NS). Radiosurgical sequelae were transient in 4/111 cases (3.5%) and permanent in one case (1%). CONCLUSIONS: For the FU period of our series (median: >4 years), GK radiosurgery seems to be both safe (permanent morbidity 1%) and effective (96% neurologic improvement/stability, 97% overall TGC, 96% actuarial TGC at 5 years) and might be considered as a first-choice treatment for selected patients with CSM.

Evaluation of toxicity and quality of life using a diary card during postoperative radiotherapy for rectal cancer.

PURPOSE: Adjuvant pelvic radiotherapy after radical surgery for rectal cancer may produce several side-effects (mainly gastrointestinal) capable of affecting patient lifestyle. This prospective study evaluated by means of a diary card the toxicity and daily changes in the quality of life of patients with rectal cancer treated with postoperative pelvic radiotherapy. METHODS: We used a diary card listing ten items about lifestyle changes and side-effects compiled by patients themselves. The patients were stratified by age (< or = 65 vs. > 65 years), the presence or not of a stoma, and the administration or not of concurrent chemotherapy. RESULTS: Twenty-seven patients were evaluable. The mean number of bowel movements increased across time, without statistically significant differences. Nausea and appetite did not significantly change during the treatment period. There was a statistically significant, progressive increase in the perception of pain (P < 0.03). Although not significantly, the anxiety scores were lower during radiotherapy than at baseline. Daily activities and compliance with therapy did not significantly change during the treatment. There was a significant worsening in overall well-being (P < 0.04) and quality of life evaluation (P < 0.03). The patients who received chemoradiotherapy experienced a worsened lifestyle and greater side-effects. Older patients experienced less pain but had statistically significant higher levels of anxiety. Patients with a stoma reported a better quality of life score than those without. CONCLUSIONS: The use of a diary card may be an adequate means of detecting the extent of treatment-related changes in the lifestyle of patients with rectal cancer treated by postoperative radiotherapy.