128 Successful salvage with percutaneous vertebroplasty for cancer patients with painful bony metastases failing palliative radiotherapy

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124 IMPROVEMENT IN PATHOLOGIC REPORTING OF DUCTAL CARCINOMA IN SITU FOLLOWING PUBLICATION OF NSABP-B17

Rakovitch. E., Franssen, E., Pignol, J-P., Ackerman, I., Pritchard, K. Toronto-Sunnybrook Regional Cancer Centre, University of Toronto, Toronto, ON, Canada Purpose: NSABP-B17 was the first trial proving the efficacy of adjuvant radiation (XRT) in reducing the risk of local recurrence following breast-conserving surgery (BCS) for DCIS. In 1995, a correlative pathologic study reported the presence of comedo necrosis and resection margin status as predictors of local recurrence following BCS. Reporting of pathologic features is essential to guide treatment decision-making We have evaluated the impact of NSABP-Bt7 on the completeness of pathologic reporting of DCIS. Methods: A retrospective study of DCIS cases seen from1982 - 2000 was performed. Completeness of pathologic reporting was determined by the proportion of reports containing information on margin status, comedo necrosis, tumour size, nuclear grade and compared among individuals seen from 1982-1995 to those seen from 1996-2000. Differences were compared using Chi-square analyses. Results: Data on 378 patients are reported. Centralized pathology review was performed on 68% of cases seen before 1995 and 69% of cases seen from 1996-2000. There was a significant improvement in the completeness of pathologic reporting from 1996 - 2000 compared to 1982-1995. Fewer reports were missing information on tumor size (15% vs. 48%, p< .01), nuclear grade (2% vs. 49%, p< .01), presence of comedo necrosis (3% vs. 43%, p< .01), high nuclear grade (44% vs. 19%, p< .01), presence of comedo necrosis (63% vs. 33%, p< .01), positive resection margins (20% vs. 11%, p= .03) and presence of comedo subtype (36% vs. 7%, p< .01 ) compared to cases seen from 1982-1995. Conclusion: There has been an improvement in the completeness of reporting of DCIS, but many reports still lack critical pathologic information. Further efforts are required to assess accuracy and improve completeness of pathologic reporting of DCIS. 125 MANAGEMENT OF STAGE IIA, liB, AND IIC TESTICULAR SEMINOMARESULTS OF RADIATION TREATMENT

Chuno. P., Gospodarowicz, M., Panzare/la, T., Bayley, A., Jewett, M., Sturgeon, J., Catton, C., Milosevic, M., Moore, M., Warde, P. Pdncess Margaret Hospital, Toronto, ON, Canada Purpose: In the United States, controversy exists with respect to the volume that should be included in the radiation field for Stage IIA, lib and IIC testicular seminoma. Prophylactic left supraclavicular fossa irradiation (LSCF) has been suggested to reduce relapse rates in these patients. To address this issue, we reviewed patterns of failure and treatment outcome in a cohort of patients with stage II seminoma treated with radiation therapy Materials and methods: Between 1981 and 1999, 93 men with stage II seminoma (IIA, 49; liB, 30; IIC, 14) were treated with radiation therapy (RT) to the para-aortic and ipsilateral (_-i:contralateral) pelvic lymph nodes (dose 25-35Gy). Results: With a median follow up of 8.9 years, the 5-year relapse free rate was 85% (SE 4%). Fourteen men have relapsed, IINBq and IIC-7. The most common sites of relapse were supraclavicular lymph nodes (7), mediastinum/lung (7), bone (4), para-aortic nodes (3). Six patients had multiple sites of relapse. Of the 7 patients with left supraclavicular fossa disease at relapse, 4 were isolated relapses. Two of these were in patients with stage IIC disease who would now be treated with chemotherapy. Eleven of 14 patients were successfully salvaged. Conclusions: Prophylactic LSCF irradiation may have prevented relapse in 2 of 79 patients in stage IINB seminoma, where infradiaphragmatic RT is standard recommended treatment. However, 97% of patients would receive unnecessary left neck RT. 126 PALLIATIVE EFFECTS OF RADIOTHERAPY ON SYMPTOMATIC BONE METASTASES AS REPORTED BY PATIENTS USING THE BRIEF PAIN INVENTORY

Wu, J., Barclay, J. Hamilton Regional Cancer Centre, McMaster University, Hamilton, ON, Canada Background: The self-report Brief Pain Inventory (BPI) is a validated instrument with three 0-10-point pain severity questions and seven functional interference items. There is no literature on bone metastases radiotherapy

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outcomes based on this instrument. Purpose: To determine changes in pain intensity and its functional interference following palliative radiotherapy for painful bbne metastases. Methods: 44 patients (breast 14, prostate 14, unknown 5, lung 4, others 7) were assessed using the BPI before radiotherapy (dose range 8 Gy/l# to 30 Gy/10#). At 4-10 weeks from initial assessment, 26/44 patients completed follow-up BPI for pain intensity, and answered a dichotomized (yes/no) question on "change in quality of life" following radiotherapy. For these 26 patients, 28 different metastatic sites were treated, of which 15 were evaluable for functional interference due to pain. Results: Significant pain reduction was seen following RT in the 28 treated sites, from pre-RT mean '`worst pain" score of 6.8 (SD 2.1) to post-RT mean score of 3.3 (SD 2.5), p 2) in another 18/28 sites. Of these 21 responders, 14 were associated with subjective change in QoL Change in "worst pain" score post-treatment significantly correlated with change in sleeping (r = 0.70, p Conclusion: The degree of reduction in pain intensity following palliative radiotherapy strongly corresponded to improvement in sleeping, walking and general activities. However no subjective change in QoL was felt for one third of the responders. Results of this multi-dimensional evaluation of palliative radiotherapy support a multi-disciplinary approach to patients with painful bone metastases. 127 INTERNATIONAL CONSENSUS ON PALLIATIVE RADIOTHERAPY ENDPOINTS FOR FUTURE CLINICAL TRIALS IN BONE METASTASES

Chow. E. 1, Wu, j.2, Hoskin, p3, Cola, L.4, Bentzen, S.5 Blitzer, p.6 on behaff of the International Bone Metastases Consensus Working Party 1Department of Radiation Oncology, Toronto-SunnybrookRegional Cancer Centre, University of Toronto, Toronto, ON, Canada; 2Department of Radiation Oncology, Hamilton Regional Cancer Centre, McMaster University, Hamilton, ON, Canada; 3Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, Middlesex, UK; 4Department of Radiation Oncology, Community Medical Center, Toms River, NJ, USA; 5Gray Laboratory Cancer Research Trust and the Cancer Centre, Mount Vernon Hospital, Northwood, Middlesex, UK; 6Radiation Therapy Associates, Cape Coral, FL, USA Purpose: To reach a consensus on a set of optimal endpoint measurements for future external beam radiotherapy trials in bone metastases. Methods: An International Bone Metastases Consensus Working Party invited principal investigators and experts on bone metastases to participate in the two surveys and a panel meeting on their preference of choice of optimal endpoints. Results: Consensus has been reached on the following: a) eligibility criteria for future trials; b) pain and analgesic assessments; c) radiation techniques; d) follow-up and timing of assessments; e) parameters at follow-up; f) endpoints; g) re-irradiation and h) statistical analysis. Conclusions: Based on the available literature and the clinical experience of the working party members, an acceptable set of endpoints has been agreed upon for future clinical trials to promote consistency in reporting. It is intended that the Consensus will be re-examined every five years. Areas of further research were identified. 128 SUCCESSFUL SALVAGE WITH PERCUTANEOUS VERTEBROPLASTY FOR CANCER PATIENTS WITH PAINFUL BONY METASTASES FAILING PALLIATIVE RADIOTHERAPY

Chow, E., Cheung, G., Ho/den, L., Vidmar, M., Danjoux, C., Finke/stein, J. Department of Radiation Oncology, Toronto-Sunnybrook Regional Cancer Centre, Toronto, ON, Canada Purpose: To assess prospectively the effectiveness and safety of percutaneous vertebroplasty (PV) in relieving pain, improving functional status and quality of life in cancer patients with painful bone metastases who failed palliative radiotherapy. PV is a minimally invasive procedure in which Polymethyl-methacrylate is injected into the diseased vertebra(e) to relieve pain and / or stabilize the compression fractures. Materials and Methods: Patients with spinal bone metastases who failed palliative radiotherapy were assessed by our interventional neuro-radiologist and orthopedic spine surgeon for the suitability of the intervention. To be eligible for a vertebroplasty, CT and MRI scans must confirm that their pain originated from the bone metastasis or a compression fracture in spine. PV was carried out under local anesthetic as an out-patient procedure. The Edmonton Symptom Assessment Scale (ESAS) assessing pain at the injection site, global pain, nausea, tiredness, depression, anxiety,

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drowsiness, appetite, sense of well being and shortness of breath was employed (0 - 10 scale, 0 = absence of symptoms, 10 = worst possible symptoms). Their functional status (Townsend Functional Scale) and daily analgesic consumption were monitored. Telephone follow ups were conducted on day 1, 2, 4, 7 and week 2, 4, 8 and 12 after the procedure. The side effects were recorded. Results: Fifteen patients (10 female, 5 male) with median age 65 years (range 31 - 87) were treated with PV. Their primary cancer sites were: breast, 6; lung, 5; prostate,2; and others, 2. The median pain score at injection site decreased from 10 to 1 (at week 2 and 12) with movement (p < 0.0001 ); decreased from 7 to 0 (at week 2 and 12) at rest (p < 0.0001 ). Most of the pain relief occurred within the 48 hours post procedure. The Townsend Functional Scale (4 levels) demonstrated 1 or 2 level improvement in half of our patients. Their mean total daily morphine equivalent decreased from 287 mg to 194 mg (week 2) and 207 mg (week 12) but was not statistically significant. There was significant improvement in nausea and depression in ESAS. Some patients did report mild discomfort when injection took place during the procedure. One patient developed transient self-reversible tachycardia. The methyl-methacrylate leaked into the spinal canal in one patient which required emergency open surgery to evacuate the cement. The patient made an uneventful recovery with no neurological complications. Conclusion: PV significantly improved pain, mobility and quality of life in cancer patients with bone metastases who failed radiation. The serious complication is relatively rare. Research is ongoing in our biomechanical laboratory to reduce the complications of the procedure. 129 A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF RADIOTHERAPY +/- SINGLE DOSE PAMIDRONATE FOR PAIN RELIEF IN PATIENTS WITH PAINFUL BONE METASTASES

Wono. RKS.1, Franssen, E.2, Danjoux, C.2, Bezjak, A. 1, Loblaw, DA.2, Chow, E.2, Szumacher, E.2, Choo, R.2, Morton, G.2, Levin, W. 1, McLean, M. 1, Hayter, C.2, Wilson, p.2, O'Brien, M.2, Taylor, D.2, Fung, K.2 1princess Margaret Hospital, University of Toronto, Toronto, ON, Canada, 2Toronto-Sunnybrook Regional Cancer Center, University of Toronto, Toronto, ON, Canada Objectives: To determine the effectiveness of radiotherapy +/- single dose pamidronate in providing pain relief for patients with painful bone metastases Materials and Methods: Patients with painful bone metastases (pain score > or = 1 out of 10) of any primary histologies, life expectancy of > 1 month, ability to complete pain and quality of life questionnaires were eligible. Patients with pathological fracture or cord compression at the index site, on or about to start on bisphosphonates, new chemotherapy, serum creatinine >440 micromol/I, hormone therapy na'fve breast and prostate cancer were excluded. Patients were stratified by radiotherapy dose (8Gy in 1 fr. vs. 20Gy in 5 ft.) and randomized between placebo or pamidronate 90mg IV on day I of their radiotherapy. Response criteria were defined based on a combination of pain score and analgesic consumption. A study specific patient diary, Brief Pain Inventory, FACT-G quality of life questionnaires, RTOG toxicity score, physician and patient perception of pain responses were captured. Between 1997 and March 2002, 67 patients were randomized (32 placebo and 35 pamidronate arm). The male: female ratio was 3:1 with a mean age of 68 (+/-9) years. The primary disease sites were prostate 30, lung 21, others 16. Seven patients remain on active follow up. The primary endpoint of interest was time to pain relief at the index site. Secondary endpoints include duration of pain relief, toxicity and quality of life. Conclusions: Our study results will address whether this novel strategy can improve outcomes beyond RT alone for patients with painful bone metastases. Correlation between response as defined (pain and analgesic criteria), with patient perception of response has important implications on refining the clinical relevance of this commonly employed approach in pain trials. 130 THE SUCCESS OF DATA COLLECTION IN THE PALLIATIVE SETTING - TELEPHONE OR CLINIC FOLLOW UP?

Wilson. P.. Wong, R., Williams, D., Sharma, N., McLean, M.,.Levin, W., Soban, F., Bezjak, A. [~rincess Margaret Hospital, Toronto, ON, Canada Objective: The usefulness of any research study depends on the quality and quantity of data obtained. Follow up of palliative patients is important but inherently difficult due to the patient population. This study was designed to assess the effectiveness of data collection in our program and to compare

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collection of data by telephone contact and in person. Method: Patients with brain metastases treated with whole brain radiotherapy (WBRT) on an outpatient basis were eligible for follow up data collection. The advanced practice nurse or radiation therapist contacted patients by telephone at one and four weeks following WBRT. A standard data sheet was completed detailing current symptoms, side effects of radiation, steroid dose and whether WBRT had helped symptoms. The patient or a family member answered the questions. A subsequent cohort of patients were telephoned at week 1 but asked to attend an outpatient clinic appointment at week 4, where the same data points are collected. Results: From July 2001 to date 147 patients have been referred to our program for consideration of WBRT for brain metastases. Of these, 107 (73%) actually received a course of WBRT. 85 (79%) were eligible for this followup study. Group A (telephone follow up) consisted of 59 patients collected over a seven month period and group B (clinic follow up) 26 patients accrual still ongoing. Successful contact was defined as obtaining data at week 1 and week 4 - 26 (44%) in group A. The results for group B will be presented. Contact was unsuccessful usually because patients were unavailable, had been admitted to hospital, or were deteriorating clinically. Conclusion: Incomplete outcomes assessment represent a refractory methodological problem in many palliative trials. Continual effort to identity effective ways of acquiring adequate follow up data is essential to facilitate future advances in care for these patients. 131 PHYSICIANS' EXPECTATIONS OF PATIENT'S RESPONSE TO PALLIATIVE RADIATION FOR PAINFUL BONE METASTASES

Wilson. P., Bezjak, A., Pond, G., Williams, D., Sharma, IV., Levin, W., McLean, M., Heath, C., Wong, R. Princess Margaret Hospital, Toronto, ON, Canada Objectives: Informed consent for radiotherapy (RT) typically includes a discussion on expected outcomes. We wanted to assess predictions physicians make when treating patients with palliative RT. Materials and method: Patients referred for RT for painful bone metastases were asked to complete a questionnaire documenting their site of pain, pain score, analgesic intake and ability to perform a specific function that was limited by the pain. Performance status (PS) was recorded. Physicians were asked to predict the degree of improvement and time to response of pain, analgesic intake, PS and ability to perform the specific function. Patients were telephoned at weeks 1, 2, 4, 6, and 8 after RT to complete the same questionnaire. The results were analyzed non-parametrically. Results: The study involved 49 patients (median age 62 years: range 29-89) and 5 physicians. Breast was the primary site in 19 patients (48.8%). Physicians predicted that 6 patients would have little improvement in pain score, 32 moderate improvement and 11 complete response over a time frame of 2 to 6 weeks. At least two physicians had statistically significantly different predictions for pain outcome (p-value=0.045), reduction in analgesics (p Conclusion: Physicians' predictions of a patient's response to treatment are important in informing the patients and communicating expected outcomes of RT. Physicians differ in their predictions. The challenges of correlating physician expectation and observed patient outcome need to be addressed, in order to further patient - physician communication in this area. 132 PRELIMINARY RESULTS OF A PHASE 2 STUDY OF THE ADDITION OF 5% CARBOGEN INHALATION TO RADICAL RADIATION THERAPY IN HYPOXIC CERVICAL CANCER

AQuino-Parsons. C. 1, Lim, P., Green, A. 3, Minchinton, A.2 1Vancouver Cancer Center, Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver, BC, Canada; 2Bntish Columbia Cancer Research Center, Department of Medical Biophysics, British Columbia Cancer Agency, Vancouver, BC, Canada; 3 Vancouver Hospital Health Sciences Center, Department of Respiratory Services, Vancouver, BC, Canada Aim: To assess the outcome of patients with hypoxic cervical tumours treated with radical radiation therapy and concurrent 5% carbogen inhalation. Methods: Women with clinically visible epithelial cervical cancer with a pretreatment median pC2 Results: Between April 1998 and Oct. 30/01,34 eligible patients were treated. The FIGO stage distribution was Ib1:5,1b2:16, 2a:2,2b:10,3b:1. The median size of the tumours was 5cm. With a median followup of 2 years, the 2 year PFS and pelvic PFS was 56% (CI 35-73%) and 74% (CI 5088%). Conclusion: When compared to published reports of a 35% 2 year disease