Clinical and technical characteristics of intraoperative radiotherapy. Analysis of the ISIORT-Europe database.

BACKGROUND: A joint analysis of clinical data from centres within the European section of the International Society of Intraoperative Radiation Therapy (ISIORT-Europe) was undertaken in order to define the range of intraoperative radiotherapy (IORT) techniques and indications encompassed by its member institutions. MATERIALS AND METHODS: In 2007, the ISIORT-Europe centres were invited to record demographic, clinical and technical data relating to their IORT procedures in a joint online database. Retrospective data entry was possible. RESULTS: The survey encompassed 21 centres and data from 3754 IORT procedures performed between 1992 and 2011. The average annual number of patients treated per institution was 42, with three centres treating more than 100 patients per year. The most frequent tumour was breast cancer with 2395 cases (63.8 %), followed by rectal cancer (598 cases, 15.9 %), sarcoma (221 cases, 5.9 %), prostate cancer (108 cases, 2.9 %) and pancreatic cancer (80 cases, 2.1 %). Clinical details and IORT technical data from these five tumour types are reported. CONCLUSION: This is the first report on a large cohort of patients treated with IORT in Europe. It gives a picture of patient selection methods and treatment modalities, with emphasis on the main tumour types that are typically treated by this technique and may benefit from it.

[Accelerated partial breast irradiation in 2008: interrogations and perspectives]. / Irradiation partielle et accélérée du sein en 2008 : interrogations et perspectives.

From the beginning of 2000, accelerated and partial breast irradiation (APBI) progressively acquired maturity and used more and more sophisticated technologies. At this time, at least six international phase III trials are ongoing. The statistical design of these studies is elaborated in order to show equivalence between APBI and whole breast irradiation (WBI) in term of local control. What and when we have to wait from these randomized trials? The presented analysis discusses not only the advantages and different interrogations concerning APBI, but also the difficulties for radiation oncologists and patients to assume the long period until the publication of the ongoing phase III trial results. APBI will find its place beside WBI, as well as conservative treatment founded its place beside radical mastectomy 30 years ago. However, clinical investigation conditions appear now different and this is this difference we have to manage rigorously and precisely.

The addition of a boost dose on the primary tumour bed after lumpectomy in breast conserving treatment for breast cancer. A summary of the results of EORTC 22881-10882 "boost versus no boost" trial.

PURPOSE: To investigate the impact of the boost dose to the primary tumour bed in the framework of breast conserving therapy on local control, cosmetic results, fibrosis and overall survival for patients with early stage breast cancer. PATIENTS AND METHODS: Five thousand five hundred and sixty-nine patients after lumpectomy followed by whole breast irradiation of 50 Gy were randomised. After a microscopically complete lumpectomy (5318 patients), the boost doses were either 0 or 16 Gy, while after a microscopically incomplete (251 patients) lumpectomy randomisation was between 10 and 26 Gy. The results at a median follow-up of 10 years are presented. RESULTS: At 10 years, the cumulative incidence of local recurrence was 10.2% versus 6.2% for the 0 Gy and the 16 Gy boost groups (p < 0.0001) and 17.5% versus 10.8% for the 10 and 26 Gy boost groups, respectively (p > 0.1). There was no statistically significant interaction per age group but recurrences tended to occur earlier in younger patients. As younger patients had a higher cumulative risk of local relapse by year 10, the magnitude of the absolute 10-year risk reduction achieved with the boost decreased with increasing age. Development of fibrosis was significantly dependent on the boost dose with a 10-year rate for severe fibrosis of 1.6% after 0 Gy, 3.3% after 10 Gy, 4.4% after 16 Gy and 14.4% after 26 Gy, respectively. CONCLUSION: An increase of the dose with 16 Gy improved local control for patients after a complete lumpectomy only. The development of fibrosis was clearly dose dependent. With 10 years median follow-up, no impact of survival was observed.

[Accelerated partial breast irradiation: a concept to individualize treatment in breast cancer]. / Irradiation partielle et accélérée du sein: un concept pour une individualisation thérapeutique dans le cancer du sein.

Whole breast irradiation delivering an equivalent dose of 50 Gy in 5 weeks, followed by a 10 to 16 Gy-boost to the tumor bed is the standard of care after breast-conserving surgery for early-breast cancer. Accelerated partial breast irradiation (APBI) is currently under investigations in large multi-institutional, prospective, randomized trials to objectively address the critical endpoints of treatment efficacy, toxicity and cosmesis. Patient's selection for this new approach is crucial to individualise treatments and define the subgroups of patients who will really benefit from APBI in terms of quality of life without decreasing long-term results of the disease control and cosmesis. In this review, we will discuss the patients' profiles selection for APBI regarding their general and tumor criteria. The differences between APBI techniques either performed intra or post operatively will be also discussed.

Increased levels of tumor markers in the follow-up of 400 patients with breast cancer without recurrence or metastasis: interpretation of false-positive results.

PURPOSE: To analyze, study and interpret the increased levels of tumor markers in breast cancer patients without recurrence or metastasis. PATIENTS AND METHODS: We studied a series of 400 patients with stage 1 breast cancer during a 3-year follow-up after primary treatment. Follow-up included frequent serum estimation of CEA, CA 15.3, CA 125, CA 27-29, TPA and TPS tumor markers. RESULTS: Of 358 patients being continuously disease-free, 18 (5%) cases showed false-positive levels of tumor markers, associated with benign conditions and not to cancer recurrence or metastasis. These conditions included ovarian cysts, thyroid disorders, hepatitis, renal stone and sarcoidosis. CONCLUSION: The value of increased tumor markers should be interpreted cautiously because it doesn't always imply disease recurrence. Tumor markers may increase in many benign conditions.

Treatment of the mouse Lewis tumor by the association of radiotherapy and immunotherapy with Bacillus Calmette-Guérin.

Three groups of 6 to 8-week-old male mice with transplanted C57BL/6 X DBA/2F1 tumor were irradiated by a single dose of 60Co localized on the tumor in association with i.p. injections of lyophilized Bacillus Calmette-Guérin. When the animals were sacrificed, tumor parameters (weight, surface area, and volume) were determined. Lung metastases were counted using a binocular magnifying glass. When Bacillus Calmette-Guérin injections were begun the day after the irradiation, tumor growth and the number of lung metastases were significantly decreased in comparison with the control group (p less than 0.01). However, there was no significant difference between the control group, which received radiotherapy alone, and the groups in which Bacillus Calmette-Guérin treatment was started after the 4th day postirradiation. This emphasizes the importance of timing in combined radioimmunological treatment.

Pilot study of neoadjuvant ifosfamide, cisplatin, and etoposide in locally advanced non-small cell lung cancer.

33 patients with locally advanced non-small cell lung cancer entered a study of neoadjuvant chemotherapy to evaluate the response rate with ifosfamide/cisplatin/etoposide and the complete resection rate and safety of surgery following chemotherapy. Chemotherapy with cisplatin 25 mg/m2, ifosfamide 1.5 g/m2, and etoposide 100 mg/m2 was given on days 1-4 of a 21 day cycle and repeated for three cycles. For responders, surgery was done 15-20 days after haematological recovery. Chemotherapy induced 5 complete responses (15%) and 18 partial responses (55%). 77% of the 33 patients had grade 3-4 neutropenia and 60% grade 3-4 thrombocytopenia. 1 patient died with a central nervous system haemorrhage. Thoracotomy was done in 21 patients but resection was only possible in 20 (61%). A complete resection was achieved in 18 patients (55%). Histology was negative for the 5 complete responses. Surgery induced no morbidity. A high response rate may be obtained with ifosfamide, cisplatin and etoposide neoadjuvant chemotherapy allowing a high complete resection rate.

Cancer of the anal canal: report on the experience of 61 patients.

We report our experience on 61 anal canal epidermoid carcinoma bearing patients. The patients are divided into three therapeutic groups: a) 14 patients treated with combined surgery and preoperative radiotherapy (37.8 Gy in 18 fractions and 21 days); b) 28 patients treated with 60Co and electrontherapy (total tumor dose of 60 to 65 Gy); c) 19 patients treated with external cobaltherapy (30 Gy/10 fractions/12 or 15 days) followed 1 to 2 months later by interstitial brachytherapy with Iridium 192 (20 Gy). Local control was observed in 41 out of 61 patients (67.2%). Out of the six patients who underwent salvage abdomino-perineal resection, five were locally cured at 5 years. The overall 5-year survival is 78.6%; the corrected 5-year survival is 88.8%. Analysis of prognosis factors shows a direct relation between local control survival and the loco-regional extension. The 5-year survival was 90.9% in the first therapeutic group, 90.9% in the second group, and 94.7% in the third group. The 5-year survival rates according to the stage and to treatment were as follows: Stage T1 N0 100% in the 1st therapeutic group, 85.7% in the 2nd group, 100% in the 3rd group; for Stage T2 N0 80% in the 1st group, 90.9% in the 2nd group, 90% in the 3rd group; for Stage T3 N0 83.3% in the 1st group, 85.7% in the 2nd group, and 66.6% in the 3rd group. The rates of sphincter preservation were 85.7% in the 2nd group and 94.7% in the 3rd group. These results show the incidence of loco-regional extension on the prognosis and the usefulness of conservative treatments.

Cancer of the uterine cervix: dosimetric guidelines for prevention of late rectal and rectosigmoid complications as a result of radiotherapeutic treatment.

This paper is the report of a dosimetric study of 41 rectal and rectosigmoid complications after radiotherapeutic treatment (1974-1978) of 287 cervical uterine tumors. Treatment consisted of external irradiation (25 MeV linear accelerator) and intracavitary irradiation (Fletcher-Suit applicator) at different doses depending on tumor stage. Dosimetric measurements were expressed as the maximum rectal dose and mean rectal dose on the anterior surface of the rectum, as proposed by the Groupe Européen de Curiethérapie. Rectal doses were also studied as a function of intracavitary irradiation and intracavitary + external irradiation (maximum rectal and mean cumulative doses for each). The results show a significant difference in the state of the patients with and without complications, based on the dose reaching the rectum. The maximum and the mean cumulative rectal doses serve as one of the primary indicators for predicting complications. These values should therefore be determined before placement of intracavitary sources or, at the latest, before the second intracavitary application. We have shown that there is no fixed threshold dose, but that it varies from one region to another, depending on level of external irradiation. Our results argue in favor of adapting individual patient therapy based on simple precautions, which are adjustable to all treatment modalities. This method could lead to complete elimination of late rectal and rectosigmoid complications arising from radiotherapeutic treatment of cervical uterine cancer.

Exclusive radiation therapy in endometrial carcinoma.

PURPOSE: From 1967 to 1986, 250 patients with endometrial carcinoma were treated with exclusive radiation therapy: 178 with a minimal follow-up of 5 years and 146 with a minimal follow-up of 10 years. The mean age was 68 years, ranging from 53 to 82 years, and the median follow-up duration was 8.5 years (minimum of 5 years and maximum of 23 years). METHODS AND MATERIALS: All the patients received an external beam radiation treatment (45 Gy in 4.5 to 5 weeks to the whole pelvis) followed by a utero-vaginal brachytherapy. RESULTS: At 5 years, the overall survival rate was 58.4% and the disease-free survival rate 55%. At 10 years the overall survival rate was 46.5% and the disease-free survival rate was 45.2%. Without considering deaths from intercurrent disease, the overall survival rate was 76.5% and the disease-free survival rate was 65.8% after 5 years, and 68% and 66%, respectively, after 10 years. The causes of failure were: isolated metastasis: 7.3%, local failure: 24.1% (4.5% with and 19.6% without concomittent distant metastasis). The rates of local control and of survival are related to the tumor stage and the tumor grade. CONCLUSION: The results are discussed according to the literature data and show the ability of exclusive radiation treatment to achieve acceptable results and to be a curative alternative for treating endometrial cancer providing that a correct external beam radiation therapy and a suitable brachytherapy are fulfilled.

Tumorectomy and radiotherapy in early breast cancer: a report on 392 patients.

This study includes 392 patients (231 Stage I and 161 Stage II) treated by tumorectomy followed by radiotherapy. The overall actuarial survival for all the patients is 86.5% at 5 years and 78% at 10 years. The 5-year NED survival is 70.2%. The survival rates are depending on the loco-regional extension: Stage I: 92% survival at 5 years and 84% at 10 years; Stage II: 82% survival at 5 years and 75% at 10 years. The percentage of local recurrences were 13% for all stages (10.6% for Stage I, 16% for Stage II), of lymph node recurrences: 1.5% for all stages, 1.3% for Stage I, 2% for Stage II, of distant metastases: 11.2% for all stages, 8% for Stage I and 16% for Stage II. The loco-regional control rates were analyzed according to the TNM classification and discussed and compared to several literature data. The breast preservation rates were at 5 years 85% for Stage I and 80.9% for Stage II. Cosmetic results are judged as good in 80% by doctors and in 90% by patients themselves with very low complication rates.

Analysis of the results of irradiation in the treatment of tonsillar region carcinomas.

Five year follow-up data are presented for 215 patients with carcinomas of the tonsillar region, all of whom were treated by radiation therapy alone. Data are analyzed retrospectively to determine the factors associated with prognosis. As in many reports in the literature, prognostic factors regarding survival of the patients were: the initial tumor site (tumor extension to the base of the tongue was considered to be a bad prognosis factor); the initial tumor size and lymph node involvement (9.4% 5 year survival for T3N3 vs 73.7% 5 year survival for T1N0 cases); and histological type of differentiation (better prognosis for well differentiated carcinomas than for poorly differentiated tumors). Studies on the biological and volumetric data (the NSD value and target volume were calculated for each case) allowed a statistical and critical correlation between therapeutic results and physical characteristics of the radiation treatment.

Recurrences of rectal cancers: results of a multimodal approach with intraoperative radiation therapy. French Group of IORT. Intraoperative Radiation Therapy.

PURPOSE: Prognosis of recurrent rectal cancer remains poor, mainly because of the difficulties of achieving a satisfactory local control. Intraoperative radiation therapy (IORT) allows for the delivery of a complementary single dose to the tumor residues or to the tumor bed and could be useful jn a multimodal treatment. In an attempt to evaluate this interest, a retrospective analysis of patients treated with IORT in six French hospitals has been performed. METHODS AND MATERIALS: Data have been collected in 73 patients (41 men), with a mean age of 62 years, treated with IORT. Initial rectal tumors were large (mean diameter: 45 mm), partially or totally fixed to the contiguous structures in 39%, and with nodal involvement in 50% of the cases. Initial surgery had been a sphincter-sparing surgery in 67%; external radiation therapy had been delivered in 52%, and a chemotherapy had been given in 10% of the patients. Recurrences were isolated (without metastases) in 86%, and were posterior or posterolateral in 55% of the cases. Surgery allowed for a complete macroscopical resection in 57%, a partial resection with gross residual disease in 29%, and no resection in 14% of the recurrences. Intraoperative radiation therapy was delivered in a dose of 10 to 25 Gy (mean 18.5) through localizators of a mean diameter of 75 mm (60 to 110). External radiation therapy, either preoperative or postoperatively was given to 30 patients without prior radiation therapy. Ten patients received additional chemotherapy with 5-fluorouracil. RESULTS: Four postoperative deaths occurred. Postoperative morbidity occurred in 16 patients and some complications were probably related to the IORT procedure. Four long-term complications were observed. Overall actuarial survival occurred in 72.4% of the patients at 1 year, in 44.6% at 2 years, and in 30.6% at 3 years. Twenty-one local failures have been observed. Actuarial local control occurred in 71.3% of the patients at 1 year, 47.7% at 2 years, and 31.3% at 3 years. CONCLUSION: Intraoperative radiation therapy is a complementary treatment for recurrences of rectal cancer. It provides encouraging results, particularly in some selected situations, when patients have not previously been treated with external radiation therapy. Further studies of multimodal treatments are necessary.

Impact of radiotherapy on local control and survival in uterine sarcomas: a retrospective study from the Grup Oncologic Català-Occità.

PURPOSE: In order to provide more information for the clinician and to analyze the impact of radiation therapy on the loco-regional disease-free interval (LRFI), disease-free interval (DFI) and specific overall survival (OS), a multicentric retrospective study of uterine sarcomas has been undertaken using cases reported to the Grup Oncològic Català-Occità (GOCO). PATIENTS AND METHODS: One hundred three patients were selected for this study with a median follow-up period of 49 months. Patients were restaged using the FIGO classification for endometrial adenocarcinoma. Radiotherapy was administered postoperatively to the entire pelvis in 52% of cases (54/103) and was combined with brachytherapy in 24 patients. Mean given dose was 48 Gy, with a 95% confidence interval of 45 to 50 Gy. Variables have been tested for homogeneity between hospitals. Univariate and multivariate analyses have also been carried out. RESULTS: Mean age of the selected patients was 59 years (range 35-84). Stages were distributed as follows: 66 patients (64%) in Stage I; 16 in Stage II (15.5%); 12 in Stage III (11.5%); 9 patients in Stage IVa (9%). Pathological distribution was 41.5% leiomyosarcoma, 39% mixed Mullerian tumours, 16.5% stromal sarcomas, and 2.9% of a miscellaneous group. Overall survival for the entire group was 63.7% and 56% at 2 and 5 years, respectively. Probability of LRFI reached 59.8% at 2 years and 57.4 at 5 years. The DFI at 2 and 5 years were 52.9 % and 48.7%, respectively. The LRFI probability was 41% and 36% at 2 and 5 years, respectively, without radiotherapy and reached 76% at 2 and 5 years among those patients treated with radiotherapy. There was also an increase in DFI probability because of the effect of radiotherapy, from 35% to 68.5% and from 33% to 53% at 2 and 5 years, respectively. The overall survival probability for patients treated with radiotherapy was 76% and 73% at 2 and 5 years, respectively and 51% at 2 years and 37% at 5 years without radiotherapy. Multivariate analysis demonstrated that radiotherapy improved LRFI, DFI, and overall survival. CONCLUSION: We conclude that postoperative radiotherapy in our series of patients diagnosed with uterine sarcoma has an impact on loco-regional and disease-free progression intervals and survival.

Intraoperative radiation therapy in recurrent carcinoma of the uterine cervix: report of the French intraoperative group on 70 patients.

PURPOSE: To evaluate the feasibility and oncologic results of intraoperative radiation therapy (IORT) for recurrent uterine cervical carcinoma in a cohort of patients treated in seven French institutions. METHODS AND MATERIALS: From 1985 to 1993, 70 patients with pelvic recurrences underwent IORT with/ without external radiation therapy (ERT) and chemotherapy (CT). Treatment modalities for recurrence were IORT alone (40 out of 70), IORT + ERT (30 out of 70), additional chemotherapy (20 out of 70). Gross complete resection (CR) was performed in 30 out of 70 cases, partial resection (PR) in 37 out of 70, and unspecified surgery in 3 out of 70. Sixty-five patients had electron beam IORT and 5, 100 KV photon IORT. Mean IORT cone size, electron beam energy, and dose (calculated at the 90% isodose line) were, respectively, 75 mm (40 to 90), 12 MeV (6 to 20), and 18 Gy (10 to 25) after CR and 80 mm (45 to 100), 15 MeV (7 to 24), and 19 Gy (10 to 30) after PR. RESULTS: Mean follow-up after IORT was 15 months (2 to 69). One, 2- and 3-year overall survival rates were 47, 17, and 8%, respectively; median survival was 11 months and local control, 21%. Median survival and local control rates increased after CR (13 months, 27%) vs. PR (10 months, 17%) and when initial treatment consisted of surgery (S) alone (15 months, 25%) vs. radiation therapy (RT +/- S) (10 months, 16%). However, these differences were not statistically significant. No death-related toxicity was observed. Grade 2 or 3 toxicity was observed in 19 out of 70 patients (27%), including 9 not directly IORT-related complications (13%) (three digestive tract fistulas, one rectal stricture, three urinary fistulas, two infections) and 10 directly IORT-related complications (14%) (five neuropathies, four ureteral obstructions, and one rectal stricture). CONCLUSION: This retrospective study demonstrates the feasibility of IORT. The usefulness of IORT still needs to be evaluated in primary treatment of advanced stages of cervical carcinoma.

Exclusive radical radiation therapy in breast carcinoma.

We present the results of 186 breast cancer patients treated initially for locoregional disease by radiotherapy alone, combining cobalt therapy with external electron beam or interstitial iridium implants. According to the TNM classification, the patients were distributed as follows: 3 T1N0, 2 T1N1, 33 T2N0, 36 T2N1, 16 T3N0, 26 T3N1, 6 T3N2, 14 T4N0, 29 T4N1, 9 T4N2 and 12 T4N3. The 5- and 10-year survival rates (52.7% and 36.5%, respectively, for all patients) were directly correlated with the size and location of the breast tumor, and the extent of lymph node involvement. Locoregional recurrence was observed in 39.8% of the cases, metastasis alone in 26.8% of the cases, and a combination of local recurrence and distant metastasis in 14.5% of the cases. The local recurrences and metastases were directly correlated with the extent of locoregional involvement. Late complications and sequelae were mostly minor and occurred in less than 25% of the cases; severe sequelae occurred in no more than 2% of the cases. They depended on the initial tumor volume and the tumor dose. Our results, along with those in the literature, indicate that radiotherapy administered alone is a valid therapeutic option in breast cancer.

Intra-operative radiotherapy in soft tissue sarcomas.

We treated 31 soft tissue sarcoma bearing patients with intraoperative radiation therapy (IORT) with ages ranging from 26 to 71: first curative intent treatment, 16 patients; and recurrent tumors, 15 patients. The tumor site was the pelvis and the retroperitoneal spaces in 13 patients and the limbs or the trunk in 18 patients. The histological type was: malignant histiocytofibroma, 14 patients; liposarcomas, 10 patients; malignant schwanoma, 1 patient; leiomyosarcoma, 2 patients; hemangiopericytoma, 1 patient; embryonic rhabdomyosarcoma, 2 patients; and synovialosarcoma, 1 patient. All the patients were diagnosed without any distant metastatic evolution at the moment of the treatment. All the patients except one underwent a complete surgical excision without any gross residual disease and received an intraoperative radiation single dose of 10 Gy in one case, 12.5 Gy in one case, 13 Gy in one case, 15 Gy in 17 cases, 18 Gy in three cases, 20 Gy in seven cases and 25 Gy in one case. Thereafter the treatment was completed by a postoperative X-ray dose of 45-50 Gy in 4.5-5 weeks for 16 patients. Local control (LC) was obtained in 27 out of 31 patients (87%), with a minimal follow-up duration of 2 years. Eleven out of 31 patients died: seven with local control (one from an intercurrent disease, six from distant metastasis) and four with local failure inside the IORT fields. Twenty patients are alive with no evolutive disease in 19 cases and with a distant metastasis in one case.(ABSTRACT TRUNCATED AT 250 WORDS)

Endometrial carcinoma: a comparative analysis of the therapeutic results and causes of failure after treatment by radiation combined with surgery or radiation therapy alone.

At the present time endometrial carcinoma is considered to be among the most frequent of gynecological tumors and its incidence is now reaching that of cervix carcinoma. In this paper, we present the results of two series of treatment for endometrial carcinoma, one using the combination of surgery and radiation, the second one using radiation treatment alone. Indeed, due to our recruitment criteria between 1968 and 1978 at the Montpellier Cancer Institute, the proportion of patients treated exclusively by physical agents was more or less equal to those receiving combined treatment. In many cases, either because of the poor condition of the patient, or due to local involvement, irradiation alone was used. The report of the results explain the therapeutic failures and show by means of two sequential series how techniques have been developed. Previously treated patients were excluded (44 cases).

A randomized double blind placebo controlled multicenter study of mesalazine for the prevention of acute radiation enteritis.

BACKGROUND AND PURPOSE: Symptoms of acute radiation enteritis (ARE), dominated by diarrhea, occur in more than 70% of patients receiving pelvic irradiation. Eicosanoids and free radicals release have been implicated in the pathogenesis. Mesalazine (5-ASA) is a potent inhibitor of their synthesis in the mucosa and could therefore be of some interest in preventing ARE. PATIENTS AND METHODS: The study was performed in six radiotherapy units in France who agreed on standardized irradiation procedures. One hundred and fifty-three patients planned for external beam radiotherapy to the pelvis > or = 45 Gy for prostate (n = 97) or uterus (n = 54) cancer were randomized on a double blind basis to receive prophylactic 5-ASA (4 g/day Pentasa) or placebo. Patients with concomitant chemotherapy were excluded. Prostate and uterus cancers were chosen since these centropelvic tumors require a similar radiotherapy protocol during the first step of treatment and involve a comparable volume of small intestine. The symptoms of ARE and their severity were assessed every week during irradiation, and 1 and 3 months after its end. All patients followed a low fiber and low lactose diet. End points were diarrhea, use of antidiarrheal agents, abdominal pain, and body weight. Effficacy was evaluated using intention to treat. RESULTS: (means +/- SD) Groups did not differ for age (mean 64 +/- 9 years), sex, tumor site, or irradiation procedure. During irradiation, diarrhea occurred in 69% and 66% of the 5-ASA and placebo groups, respectively (chi2, P = 0.22). Curves of survival without diarrhea did not differ between groups (logrank P = 0.09). Severity of diarrhea did not differ between groups except at d15 where it was significantly more severe in the 5-ASA group (ANOVA P = 0.006). Duration of diarrhea did not differ (22 +/- 15 days in both groups, P = 0.88). Abdominal pain was less frequently reported in the 5-ASA group at d28 (34% vs. 51%, P = 0.048). Use of antidiarrheal agents and body weight did not differ between groups. CONCLUSION: Mesalazine 4 g/day did not decrease the symptoms of ARE.

Decreased nucleic acid synthesis in low-dose-irradiated lymphocytes--effect of TCGF addition.

Flow cytometry was used to evaluate nucleic acid synthesis in irradiated mixed lymphocyte cultures (MLC) compared to nonirradiated control cultures. Two staining methods were used (propidium iodide and acridine orange). We showed that RNA and DNA synthesis are retarded in MLC receiving 0.2 Gy. This effect was reversed by lymphocyte growth factor.