Celecoxib and exemestane versus placebo and exemestane in postmenopausal metastatic breast cancer patients: a double-blind phase III GINECO study.

The aim of this study was to evaluate antitumor effects of cyclooxygenase-2 inhibitors in breast carcinoma and their ability to act synergistically with aromatase inhibitors (AIs). Postmenopausal metastatic breast cancer patients without previous adjuvant AI treatment received exemestane 25 mg/days plus either celecoxib 400 mg twice daily or placebo. The primary endpoint was progression-free survival (PFS). This trial was prematurely terminated (N = 157 of 342 planned) after cardiovascular toxicity was reported in other celecoxib trials. Although no PFS difference was observed between the two arms (9.8 months for both, P = 0.72), a trend favoring celecoxib was observed in 60 tamoxifen-resistant patients (9.6 vs. 5.1 months; P = 0.14) and in 126 patients treated >or=3 months before study termination (12.2 vs. 9.8 months; P = 0.09). No severe adverse events were reported. Cyclooxygenase-2 inhibitors seemingly contribute to reverse endocrine resistance in breast cancer patients, although further study is necessary to allow development of a new therapeutic strategy.

Building a shared patient record for breast cancer management: a French Delphi study.

Before electronic records become operational, patient-held records provide an opportunity to improve communication between patients and healthcare professionals. Our aim was to design the appropriate organization, layout and content for such a shared record for breast cancer management, based on a consensus between the various stakeholders. We therefore conducted a Delphi study within a working group of 48 members, including patients, oncologists, general practitioners, nurses and other professionals. The procedure featured three rounds during which participants' judgements were collected via mailed questionnaires and quantitative and qualitative feedback was provided on a regular basis. These three rounds were followed by an evaluation phase. Forty members (83%) participated in the three rounds. According to the agreement reached, the shared record was expected to include a front summary card, four sections for groups of users authorized to write down or insert information in the record (patient, physicians, medical auxiliaries and other healthcare professionals), and one section for medical imaging files. In addition, the record was to include specific categories of information as subsections within each of the various user sections. The participant satisfaction rate was over 90% for all aspects of the procedure, with the exception of interaction within the working group (79%).

Capecitabine, irinotecan, oxaliplatin (CAPIRINOX) and concomitant irradiation in advanced rectal cancer: the Lyon R-02-01 phase I trial.

AIMS: To determine the feasibility of radiotherapy-associated capecitabine, irinotecan and oxaliplatin administration at five dose levels for the treatment of locally advanced rectal cancer, with or without metastasis. PATIENTS AND METHODS: This was a bicentric phase I trial, including patients with locally advanced rectal cancer, with or without metastasis. Chemotherapy comprised capecitabine (1100, 1300 or 1500 mg/m2/day, every day), irinotecan (30, 40 or 50mg/m2, once per week for 6 weeks) with the addition of oxaliplatin (40 mg/m2 at level 4 or 50 mg/m2 at level 5, once per week for 6 weeks). Radiotherapy at 46 Gy plus a boost of 4 Gy was administered concomitantly. RESULTS: Twelve patients received four levels of dose. As a supplement to radiotherapy, the combination of capecitabine and irinotecan at the respective doses of 1500 mg/m2/day and 50 mg/m2/week was feasible and well tolerated. The addition of oxaliplatin to this combination provoked toxicity (grade 3/4 vomiting, diarrhoea) for two-thirds of the patients. CONCLUSION: A treatment associating radiotherapy (46 Gy+4 Gy) with concomitant chemotherapy comprising capecitabine (1500 mg/m2/day, every day) and irinotecan (50 mg/m2/week, for 5 weeks) was feasible and well tolerated. The addition of oxaliplatin to these doses was prohibitory to the continuation of treatment due to unacceptable toxicity.

[Irradiation of lymph nodes areas in breast cancer]. / Irradiation des aires ganglionnaires dans le cancer du sein.

Postoperative radiotherapy after breast surgery increases overall survival by decreasing the local relapse rate. The main site of relapse is the breast or the chest wall. The value of irradiation of the nodal basins is still discussed. It must be emphasized that nodal areas were systematically irradiated in the postmastectomy randomized trials demonstrating a benefit in survival for adjuvant radiotherapy. Axillary relapses are infrequent in case of complete axillary dissection; complementary irradiation could be proposed if the axillary dissection is incomplete or if there is a massive pathologic involvement of the axilla. Its main complication is lymphoedema, which remains the most frequent sequellae of the treatment of breast cancer. Supraclavicular irradiation is logical in case of axillary involvement. Internal mammary nodes are involved in 20 to 40% of the patients, depending of the axillary involvement and location of the tumor inside the breast. Irradiation of the internal mammary basin is difficult: optimal dosimetry required a CT-based simulation. Its benefit remains to be proved. Internal mammary nodes irradiation probably increased cardiovascular mortality. Sophisticated techniques are needed to spare the heart from irradiation. Two large randomized trials (French group, European Organization for Research and Treatment of Cancer [EORTC]) are currently evaluating the possible benefit of internal mammary irradiation.

[Ductal carcinoma in situ: role of the boost]. / Radiothérapie des carcinomes canalaires in situ: impact du complément d'irradiation du lit tumoral.

Ductal carcinoma in situ is defined as breast cancer confined to the ducts of the breast without evidence of penetration of the basement membrane. Local treatment quality represents one of the most prognostic factors as half of recurrences are invasive diseases. The main goal of adjuvant radiotherapy after conservative surgery is to decrease local recurrences and to permit breast conservation with low treatment-induced sequelae. Several randomized trials have established the impact of 50 Gy to the whole breast in terms of local control. Nevertheless, no randomized trial is still available concerning the role of the boost in this disease. In this review, we present updated results of the literature and we detail the French multicentric randomized trial evaluating the impact of a 16 Gy boost after 50 Gy delivered to the whole breast in 25 fractions and 33 days. This protocol will start inclusions in October 2008.

[Patient-held health records: impact on breast cancer follow-up in the Rhône-Alpes region. Project Archimed]. / Le dossier de santé détenu par le patient : impact sur le suivi du cancer du sein dans la région Rhône-Alpes. Projet Archimed.

BACKGROUND: The conditions of use and access to medical records have become an important source of interest in the last decade. In this context, our main objective was to assess the impact of a paper patient-held records, shared with healthcare professionals. METHODS: In the particular case of breast cancer management, we identified the expectations of practitioners and patients. Secondly and according to a Delphi method, we defined the content and size of a medical record, which could be held by the patient. Following these preliminary studies, we conducted a randomized controlled trial, comparing patients with usual follow-up to others holding the new record containing essential information for coordination of care. RESULTS: The patient-held record favoured membership and satisfaction of both patients and health professionals. It was used as a communication tool between physicians and patients, but could also cause anxiety to some patients. Patient quality of life, data confidentiality and costs of care remained identical in the two arms. With its benefits for both patients and healthcare professionals, a new concept of medical records was revealed by this study. CONCLUSION: New models for healthcare organization deeply modify the roles and relationships of all the actors in the healthcare system. Further research on patient-held records is needed to evaluate the full range of its benefits and limits.

French experience with contact X-ray endocavitary radiation for early rectal cancer.

This paper is an overview of the French experience with contact X-ray radiation for rectal cancer. The analysis was mainly carried out on 50 years of experience in Lyon or since 1980 in the Centre Hospitalier Universitaire Lyon Sud. The results obtained in Dijon and Nancy are also reported. In early rectal cancer, contact X-ray radiation can play an important role in three different situations: (1) small T1 less than 2 cm: adjuvant contact X-ray radiotherapy after local excision; (2) T2 N0 or large T1: first-line contact X-ray radiotherapy combined with external beam radiotherapy (+/- chemotherapy) followed by surgery (anterior resection or local excision); (3) early T3 N0 in frail patients: the same approach as for T2 N0 with, in case of clinical complete response, local excision or follow-up.

Addition of oxaliplatin to continuous fluorouracil, l-folinic acid, and concomitant radiotherapy in rectal cancer: the Lyon R 97-03 phase I trial.

PURPOSE: Oxaliplatin could increase the efficacy of fluorouracil (5-FU)/folinic acid chemoradiotherapy in rectal cancer. We tested three dose levels to identify a feasible oxaliplatin dose for combination therapy. PATIENTS AND METHODS: Between February 1998 and April 2000, we included 17 rectal adenocarcinoma patients in a single-center phase I study. Patients had T4 rectal carcinoma, T1-T3 disease with colostomy refusal, or potentially operable T2/T3 M1 requiring local treatment. Pelvic radiotherapy was 45 Gy over 5 weeks, 1.8 Gy/fraction, with concomitant chemotherapy weeks 1 and 5. Chemotherapy was oxaliplatin 80, 100, or 130 mg/m2 2-hour infusion on day 1 followed by L-folinic acid 100 mg/m2/d intravenous bolus, and 5-FU 350 mg/m2/d continuous infusion on days 1 to 5 (FolfoR1). Six patients refusing surgery received additional contact radiotherapy +/- brachytherapy. Dose escalation proceeded if less than two of six patients had dose-limiting toxicity (DLT) at a given dose-level. RESULTS: All except two patients completed treatment; patients at level 1 (prolonged grade 1 thrombocytopenia) and level 3 (prolonged cold-related dysesthesia) had no second chemotherapy course. Median follow-up is 14 months (range, 2 to 28 months). One elderly patient at dose level 1 had DLT asthenia, severe diarrhea and vomiting, and more than 10% weight loss. There were no other DLTs and no severe rectitis or gastrointestinal toxicity. There were objective responses at all doses and no progressions. Eight patients underwent radical surgery after chemoradiotherapy. Two had complete pathologic responses. CONCLUSION: FolfoR1 seems feasible and effective. Dose escalation did not increase toxicity. Although the MTD was not reached in this study, we recommend oxaliplatin 130 mg/m2 for phase II studies because it is the dose determined from studies in metastatic patients with no toxicity when given concurrently with radiation.

Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France.

PURPOSE: To define the role of a 10-Gy boost to the primary tumor in the conservative treatment of early infiltrating breast carcinoma treated by limited surgery and radiotherapy. PATIENTS AND METHODS: Between 1986 and 1992, 1,024 women with early breast carcinoma (< or = 3 cm in diameter) were treated by local excision, axillary dissection, and conventional 50-Gy irradiation given in 20 fractions over 5 weeks and then randomly assigned to receive either no further treatment or a boost of 10 Gy by electrons to the tumor bed. The median follow-up time was 3.3 years as of September 1994. The occurrence of telangiectasia was reported, and the patients were asked to evaluate the cosmetic result. RESULTS: At 5 years, 10 patients of 521 who had received the boost (Kaplan-Meier estimate of local relapse rate, 3.6%) and 20 of 503 who had received no further treatment (Kaplan-Meier estimate of local relapse rate, 4.5%) had developed a local recurrence (P = .044). After adjustment for the main prognostic variables, the relative risk was still significantly lower for the boost group (0.3; range, 0.12 to 0.95). The boost group had a higher rate of grade 1 and 2 telangiectasia (12.4% v 5.9%), but no difference was seen between the two treatment arms in the self-assessment score for the cosmetic result. CONCLUSION: Delivery of a boost of 10 Gy to the tumor bed after 50 Gy to the whole breast following limited surgery significantly reduces the risk of early local recurrence, with no serious deterioration in the cosmetic result. Additional follow-up evaluation will be required to assess the long-term results.

[Radiotherapy optimization in breast cancer: filtration, electronic compensation, intensity modulation]. / Optimisation de la radiothérapie du cancer du sein: filtration, compensation électronique, modulation d'intensité

Purpose of radiation treatment after conservative surgery for breast cancer is improvement of long-term local control rate and reduction of heart and pulmonary toxic events for women with long life expectancy. Breast irradiation with intensity modulation might be promising, as results of treatment planning (dose-volume histogram and normal tissue complication probability) showed. Project of our study is to evaluate the advantage of each following techniques: wedged plans, electronic compensation and intensity modulation.

Sphincter preservation in rectal cancer. Endocavitary radiation therapy.

Endocavitary radiation therapy (Endo RT) is performed mainly with a contact x-ray tube. Interstitial brachytherapy is a supplementary method to boost the tumor bed. Only strictly selected patients can be treated for cure by Endo RT. More than 1,000 patients have been treated in Europe and North America since 1950. In T1 N0 adenocarcinoma, the primary local control rate is close to 90%. The overall 5-year survival is between 60% and 90% depending on patient selection. Careful follow-up is necessary because the majority of local failures can be salvaged, usually by radical surgery. The main advantages of Endo RT are a fully ambulatory and simple treatment that can be applied even in frail or elderly inoperable patients, a low risk of complications, and an inexpensive treatment. Results show it is possible to perform curative treatment in patients with more advanced rectal carcinoma. With the combination of external-beam radiation therapy and Endo RT in stage T2-3 N0-1 tumors, the primary local control rate is around 70%, and the incidence of severe radiation toxicity is less than 5%. Overall 5-year survival is between 50% and 70%. Endo RT can also be used as an adjuvant treatment after local excision, in the treatment of villous adenomas, and for palliation of advanced inoperable tumors.

Curative non-surgical combined treatment of squamous cell carcinoma of the oesophagus.

Between April 1982 and June 1989, 65 patients (15 T1, 13 T2, 32 T3, 5 T4) with squamous cell carcinoma of the oesophagus were treated with a curative intent with multimodality combined treatment. A first course of 5-fluorouracil and cisplatin was given during work up, especially if NdYAG laser therapy was used. Irradiation was started 3-4 weeks after induction and two courses of concomitant chemotherapy were given during the radio therapy (aiming at 64 Gy over 7 weeks). Actuarial survival was 79.6% at 1, 36.7% at 3 and 26.7% at 5 years. 5 year survival rates were 56.3% for T1, 29.8% for T2 and 12.9% for T3. All T4 cases died within 16 months. Complete initial disease response was achieved in 76%. Tolerance was good. Thus patients with squamous cell carcinoma of the oesophagus can have long survival and may be cured with combined modality therapy. This treatment may be an alternative to radical surgery when there is a high risk of operative mortality.

Outcome of treatment of upper third vaginal recurrences of cervical and endometrial carcinomas with interstitial brachytherapy.

PURPOSE: To describe an original brachytherapy technique using a dedicated intravaginal template for the treatment of vaginal vault recurrences and to evaluate the results of such a treatment. METHODS AND MATERIALS: Between 1978 and 1993, 78 patients with isolated recurrence of cervical or endometrial carcinoma located in the vaginal vault have been treated in Lyon. Initial treatment was surgery alone in 49 cases and irradiation with surgery in 37 cases. Treatment of the vaginal recurrence was performed with interstitial Iridium 192 brachytherapy combined with pelvic external beam radiation therapy in 34 patients. The tumor was implanted with a dedicated intravaginal plastic template. Six parallel metallic needles were implanted in the vaginal vault and afterloaded with Iridium 192 wires of 4 to 6 cm long. The mucosa of the upper half of the vagina received the same dose as the one encompassing the tumor on the 85% isodose of the Paris system. RESULTS: At 5 years the local control rate was 70% and the overall survival rate 56%. Grade 3 complications occurred in 10% of the cases and only in patients who had received irradiation during the initial treatment of the primary tumor. CONCLUSIONS: This brachytherapy technique makes it possible to perform Iridium 192 implants in a difficult situation with a favorable long-term control rate and an acceptable rate of complications.

Hyperfractionated radiotherapy alternating with multidrug chemotherapy in the treatment of limited small cell lung cancer (SCLC). Groupe Lyonnais d'Oncologie Thoracique.

From January 1986 through December 1988, 227 patients were included in a multi-institutional pilot study for small cell lung cancer (SCLC). Out of the 211 patients who fully completed the staging procedures, 77 (35%) appeared to have SCLC limited to the thorax. All patients received combination therapy consisting of AVI (Adriamycin, VP-16 and Ifosfamide), except during radiotherapy when the Adriamycin was omitted, plus twice daily fractionated 18 MV radiotherapy. Treatment protocol consisted of 4 initial courses of AVI, followed by 3 courses of radiotherapy alternating with modified chemotherapy (VP-16 and Ifosfamide), completed by 2 courses of initial chemotherapy (AVI). Radiotherapy consisted of 1.5 Gy/fraction, 2 fractions/day, 5 days/week in the first course, and 1.8 Gy/fraction, 2 fractions/day, 5 days/week, in the second and third courses, for a total tumor dose of 51 Gy, felt to be equivalent to 60 Gy at normal fractionation. CT treatment planning was employed to design a treatment consisting of multiport radiotherapy, using AP-PA and laterals or obliques beams. During the first course, the homolateral hemithorax received 9 Gy total dose on days 1, 3, 5. During the third course, 360 degrees arctherapy was generally used to boost the reduced tumor volume to a 51 Gy. Besides chest X ray and CT scan, staging and restaging procedures included fiberoptic bronchoscopy. Response rate after irradiation is 61%, with 46% complete responders and 51% local control. The median survival is 14 months, and disease-free survival 42% at 1 year. Complications consisted of cardiac toxicity in 2 patients, 1 death of acute pulmonary toxicity, and 4 instances of moderate chronic radiation pneumonitis. Thus, high doses of radiation can be delivered combined with chemotherapy using this protocol, with an acceptable toxicity and encouraging results in response rate and local control. A longer follow-up is needed to evaluate the impact of these results on survival.

An original technique of brachytherapy for T1 T2 carcinomas of the mobile tongue.

Twenty-four patients with T1 or T2 (17 T1 N0, 7 T2 N0 not exceeding 3 cm) epidermoid carcinomas from the middle third of the mobile tongue benefit from brachytherapy with "cavaliers-legos" consisting of guide-gutters that are inserted in a rigid support (legos) and covered with a lead plate. Several advantages can be advocated with this technique: easy implantation even with local anaesthetic, no risk of bleeding, good parallelism between Iridium wires, protection of the mandible with the lead plate. Local control was achieved in 22/24 patients (92%). Four patients (16%) developed soft tissue necrosis but only one required surgical intervention and no mandibular necrosis was seen.

Radiation therapy in the conservative treatment of carcinoma of the anal canal.

PURPOSE: Radiotherapy is the standard treatment of anal canal carcinoma. We retrospectively analyzed our experience with 108 patients. Special attention was given in evaluating 51 patients who received concomitant chemotherapy with 5-FU-CDDP. METHODS AND MATERIALS: From January 1980 to December 1989, 108 patients with anal canal carcinoma were treated with exclusive radiotherapy at the Centre Hospitalier Lyon Sud. There were 11 men and 97 women, mean age was 65 years (30-86). Histologic types were 94 epidermoid carcinomas, 13 basaloid carcinomas, and one adenocarcinoma. The TNM classification (UICC 87) was: 16 T1 (14.8%), 53 T2 (49%), 33 T3 (39.5%), six T4 (5.5%), 77 N0 (71.3%), 20 N1 (18.5%), nine N2 (8.3%) and two N3 (1.8%). Papillon's radiotherapy technique with a Cobalt direct perineal field was used in 82 patients. Ninety-six patients were treated with an interstitial 192Ir implant with a mean delay of 55 days after the end of the radiotherapy. In 59 patients at least one course of either 5-FU-mitomycin (8) or 5-FU-CDDP was added with at least one course concomitantly to the radiotherapy in 53 patients. RESULTS: A complete response in 104/108 patients (96%) was obtained 2 months after the brachytherapy. A locoregional relapse (local and/or pelvic failure) was seen in 18 patients (16.6%) and inguinal node relapse in nine (8.3%). Eight patients with locoregional recurrence and five with inguinal relapse were salvaged. A systemic failure occurred in six (5.5%) patients. Twenty-nine patients died, 16 of progressive disease. One patient died of treatment related toxicity. The overall 5-year survival was 64% +/- 6 and specific survival 72% +/- 8. None of the patient parameters was found to be statistically significant but there was a trend toward longer 5-year survival in T1-T2 patients and in those with well or moderately differentiated tumors. Noteworthy are the same survival rates for N0 and N1-N3 patients (65 vs. 62%). The objective response and the locoregional failure rates were similar in the patients treated with or without chemotherapy. The difference did not reach statistical significance though it was important for the following parameters: overall survival rates for T1-T2 with and without chemotherapy (94 vs. 61%) and for N1-3 patients (73% vs. 27%). The main prognostic factors in this series were differentiation (5-year overall survival with chemotherapy 95% vs. 27% without chemotherapy p = 0.02) and the response at 3 months after treatment initiation, before brachytherapy implant (5-year overall survival for complete responders and "very good responders" 71% vs. 34% in partial responders p = 0.002). The complications rate was acceptable (Grade III 9%, Grade II 14%). Anal preservation was possible in 85% of the patients (92/108). Nine abdominoperineal resection were performed for recurrence and seven for severe necrosis. The T3-T4 group abdomino perineal resection was 23% while it was 9.2% of the T1-T2 group. CONCLUSION: We confirm that exclusive radiotherapy is the treatment of choice for epidermoid carcinomas of the anal canal. The role of chemotherapy is still unclear.

Intraoperative radiation therapy combined with limited lymph node resection in gastric cancer: an alternative to extended dissection?

PURPOSE: To describe the results of a series of 63 Western patients presenting with gastric adenocarcinoma and treated with surgery and intraoperative radiation therapy (IORT) over a 8-year period and to discuss the role of IORT when combined with limited lymph node dissection. METHODS AND MATERIALS: From 1986 to 1993, 63 patients with gastric adenocarcinoma have been operated in the department of radiation oncology of the Hospices Civils de Lyon. The stage was: I in 17, II in 11, IIIA in 9, IIIB in 20, and IV in 6. The lymph node dissection was considered to be limited in 56 patients and extended in 7. The IORT dose ranged from 12 to 23 Gy (median: 15). Thirty patients also underwent a postoperative external beam irradiation with a standard dose of 44-46 Gy. RESULTS: The postoperative mortality rate was 4.8%. The 5-year overall survival in the entire series was 47% and was 82, 55, 78, 20, and 0% in Stages I, II, IIIA, IIIB, and IV, respectively. Loco-regional relapse occurred in 15 of 63 patients and metastases in 15 of 63. CONCLUSION: In Western patients treated by gastrectomy for adenocarcinoma of the stomach, IORT combined with limited lymph node dissection may provide overall survival similar to that observed after gastrectomy with extended lymph node dissection but with less postoperative mortality.

Endocavitary irradiation for early rectal carcinomas T1 (T2). A series of 101 patients treated with the Papillon's technique.

PURPOSE: This work is a retrospective analysis of a series of patients treated with endocavitary irradiation stressing the role of transrectal ultrasound (TRUS), which has been used routinely in the staging since 1987. METHODS AND MATERIALS: Between 1977 and 1993, 101 patients with infiltrating adenocarcinomas were treated. Clinical staging was 65 T1 N0 and 36 T2 N0. TRUS used in 36 patients showed: 22 UT1 N0, 10 UT2 N0, and 3 UT2 N1. Contact x-ray was delivered with a 50 kV radiotherapy unit. The median dose was 92 Gy (60-125) in five fractions, 55 days. In 28 patients a boost was given with 192Ir implant delivering a median dose of 25 Gy/21 h. RESULTS: Complete response was observed in all patients at the completion of treatment. Loco-regional failures were seen in 14 patients (local in 7 patients, nodal pararectal in 6 patients, and local + nodal in 1 patient). A curative salvage treatment was attempted in 13 patients and resulted in an ultimate pelvic control rate of 99 patients. Rectal preservation was possible in 92 patients. Overall and specific 5-year survival was 83.3% and 94.4%. No serious complication was observed. TRUS was more sensitive than digital rectal examination to detect involvement of pararectal metastatic nodes (N1). No loco- regional relapse was observed out of 22 UT1 N0. CONCLUSION: Endocavitary irradiation can cure early adenocarcinoma of the rectum without complication. TRUS appears as a significant improvement in the selection of patients amenable to this treatment. If restricted to UT1 N0 tumors, endocavitary irradiation should control locally more than 90% of these patients. Any UN1 is a contraindication for endocavitary irradiation alone.

Primary carcinoma of the gall-bladder: potential for external radiation therapy.

Nineteen patients (14 women, 5 men) received external radiation therapy (ERT) between 1980 and 1988 for gall-bladder carcinoma. Eleven patients had complete resection (cholecystectomy in eight cases), six incomplete gross resection and two only percutaneous transhepatic biliary drainage (PTBD). The modalities of ERT were variable and doses ranged from 30 Gy/10 fractions to 50 Gy/25 fractions. Among 11 patients with complete resection (9/11 with T1 or T2 stages), overall survival was 55% at 48 months and 36% at 60 months, median survival was 48 months and at the time of this report 3/11 patients were alive with no evidence of disease, 54, 65, 76 months after surgery, and eight dead of cancer 8-114 months. Local control was achieved in 66 patients with T1 or T2 stages. All eight patients who had palliative surgery or PTBD died of cancer after 4-20 months with median survival of 6 months. Three complications were noted: one gastric ulcer in the course of ERT (surgical treatment), one duodenal ulcer which occurred 6 months after completion of ERT (medical treatment) and one regressive radiation hepatitis. From this experience it appears that ERT in gall-bladder carcinoma is well tolerated, can obtain local control and prolonged survival after complete resection and good palliation in non-resectable tumors.

Radiation therapy in extrahepatic bile duct carcinoma.

Fifty-one patients with carcinoma of the extrahepatic bile ducts (EHBD) received radiation therapy between January 1980 and December 1988. The location of the tumors was: proximal third, 20 patients; middle third, 23 patients; distal third, 3; diffuse, 5 patients. Thirty-six patients underwent surgery with complete gross resection in 14 (10/14 with positive margins), incomplete gross resection in 12 and only biopsy in 10. Fifteen patients had only biliary drainage without laparotomy after cytologic diagnosis of malignancy in 11/15. Radiation therapy was done with curative intent after complete or incomplete resection (n = 26) and it was palliative in patients who had no resection or only biliary drainage (n = 25). Twenty-five patients received external radiation-therapy (ERT) alone to the tumor and lymph nodes (mean dose 45 Gy/2 Gy per fraction for cure, 35 Gy/10 fractions for palliation), 8 patients had only iridium-192 (192Ir) implant (50-60 Gy at a 1 cm radius for cure, 30 Gy for palliation), 17 patients had both ERT + 192Ir (ERT 42.5 Gy + 192Ir 10-15 Gy for cure; ERT 20 Gy/5 fractions + 192Ir 20-30 Gy for palliation) and one intra-operative irradiation + ERT. The overall survival for the entire group was 55, 28.5 and 15% at 12, 24, 36 months and median survival 12 months. Median survival was 22 months in patients treated with curative intent and only 10 months after palliative treatment (p 0.03). Among patients who had curative treatment, median survival was 27.5 months after complete gross resection and 13 months after incomplete gross resection (p 0.045).(ABSTRACT TRUNCATED AT 250 WORDS)