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To develop a patient decision aid (PtDA) for older women with Stage I, pathologically node negative, estrogen receptor-positive progesterone receptor-positive breast cancer who are considering adjuvant radiotherapy after lumpectomy and to examine its impact on patients' decision making.A PtDA was developed and evaluated in three steps according to the Ottawa Decision Support Framework: (1) needs assessment (n = 16); (2) Pilot I to examine PtDA acceptability (n = 12); and (3) Pilot II, a pretest posttest (n = 38) with older women with estrogen receptor-positive progesterone receptor-positive breast cancer after lumpectomy who were receiving adjuvant radiation therapy. Measures included patients' satisfaction with the PtDA, self-reported decisional conflict, level of distress, treatment-related knowledge, and choice predisposition.The PtDA is a booklet that details each adjuvant treatment option's benefits, risks, and side effects tailored to the patient's clinical profile; includes a values clarification exercise; and includes steps to guide patients towards their decision. On the basis of qualitative comments and satisfaction ratings, all women thought that the PtDA was helpful and informative. In comparison with their baseline scores, patients had a statistically significant (p0.05) reduction in decisional conflict (adjusted mean difference [AMD], -7.18; 95% confidence interval [CI], -13.50 to 12.59); increased clarity of the benefits and risks (AMD, -10.86; CI, -20.33 to 21.49); and improved general treatment knowledge (AMD, 8.99; CI, 2.88-10.28) after using the PtDA. General trends were also reported in the patients' choice predisposition scores that suggested potential differences in treatment decision after PtDA use.This study provides evidence that this PtDA may be a helpful educational tool for this group of women. The quality of care for older breast cancer patients may be enhanced by the use of a tailored PtDA to help patients be better informed about their treatment options.

Summary Rationale: Obesity may contribute to the development and clinical expression of asthma. However, how obesity can influence response to asthma medications is still uncertain. Objectives: To examine the relationship between body mass index (BMI) and the response to an inhaled corticosteroid (ICS), fluticasone propionate, with or without the long-acting b2-agonist salmeterol (LABA). Methods: Achievement of asthma control as defined by the global initiative on asthma guidelines (GINA) was examined in 1242 asthmatic patients not currently using ICS, enrolled in five clinical trials comparing fluticasone propionate and the combination of fluticasone and salmeterol. Results: In both obese and non-obese subjects, fluticasone propionate combined with salmeterol was more effective in controlling asthma than fluticasone alone. However, for both treatments the odds of achieving well-controlled asthma were significantly lower in obese subjects, particularly among those with a BMI of X40kg/m 2 . Reported prevalence of atopy increased with BMI. Age did not influence the effect of obesity in response to asthma medications. Conclusion: Obese patients are less likely than the non-obese to achieve asthma control with an ICS or an ICS combined with a LABA. The causes of such reduced response to asthma medication in obese subjects should be studied, and their implications for asthma therapy determined. & 2007 Published by Elsevier Ltd.

Purpose To evaluate the role of abdominal-pelvic radiotherapy (APR) as adjuvant treatment for uterine papillary serous carcinoma (UPSC). Methods and material The medical records database at the Toronto-Sunnybrook Regional Cancer Centre identified 121 patients with the diagnosis of UPSC between 1980 and 2001. Fifty-nine patients received APR as adjuvant treatment. A retrospective chart review was done to evaluate recurrence rates, sites of failure, and treatment toxicity. Results Of 59 patients who received APR, 30 had advanced-stage disease (Stage III or IV). Eleven had complete surgical staging. Median follow-up was 71 months. Twenty-five of 59 (42%) recurred, with a median time to relapse of 50 months. Five-year disease-free survival was 43%, and 5-year overall survival was 45%. Of the 25 who recurred, only 3 experienced a sole failure outside the irradiated volume. Thirteen women had their treatment interrupted or discontinued because of toxicity. Conclusions This single-institution study reveals that there is a high recurrence rate despite APR, especially among patients with advanced stage disease, and the majority of recurrences continue to be within the irradiated volume. The role of APR remains undefined in early disease but its effectiveness is questionable in advanced disease. Innovative strategies are needed to improve outcome in these patients.

Physician support is required for successful patient recruitment to a large randomized controlled trial (RCT) designed to determine the safety and benefits of short-term hormone replacement therapy (HRT) after breast cancer (BC).A survey was mailed to 1899 Canadian gynaecologists, family physicians, medical, radiation and surgical oncologists to assess willingness to refer patients to an RCT of HRT after BC.Of 538 physicians, 420 (78%) reported that they would be willing to refer a woman after BC to an RCT of HRT versus placebo. Variables predicting willingness to refer included: support for HRT in well women (p = 0.04) and after BC (p = 0.0001); support for clinical trials (p = 0.0001); ongoing BC trials at the physicians' institution (p = 0.003); currently prescribing HRT to women after BC (p = 0.03); and beneficial results in ongoing RCTs of HRT in well women (p = 0.02).An RCT of short-term HRT after BC may be feasible among Canadian physicians.

BACKGROUND The authors evaluated clinical and pathologic factors that predicted for recurrence after patients underwent radical surgery for International Federation of Gynecology and Obstetrics (FIGO) Stage IA2–IB1–2 cervical carcinoma and developed a simple method of scoring those predictive factors to quantify outcome. METHODS An analysis was conducted of a prospective radical surgery cervical carcinoma data base. A Cox proportional hazards regression analysis was done for each of the individual factors to estimate individual risk ratios using all available data for each factor. Stepwise and best-model options were used to identify the best combinations as predictors and to calculate adjusted risk ratios. Based on the information obtained, each patient was assigned a categorical score to predict recurrence. The variables used for the score were dichotomized. The differences between the scores in time to recurrence were evaluated using the log-rank test to compare the time to recurrence curves that were generated with the Kaplan–Meier method. RESULTS Eight hundred seventy-one patients were included in the study, and 66 patients who developed recurrent disease after a median follow-up of 49 months. Tumor size, maximum depth of invasion, pelvic lymph node status, tumor grade, and capillary lymphatic space (CLS) were single predictors for recurrence, and the score, which was based on combinations of these factors, predicted the disease free survival. Maximum depth of invasion, pelvic lymph node status, and CLS were the best combined predictors for recurrence, and they were used to form a second, precise scoring system to predict disease free survival (P < 0.0001; log-rank test). CONCLUSIONS The scoring system based on maximal depth of invasion, CLS, and pelvic lymph node metastases identified four strata of patients with distinct recurrence free survival. The incremental presence of each factor decreased recurrence free survival after patients underwent radical surgery. Patients with the presence of all three factors had a 5-year recurrence free survival rate of 65%. These patients would be suitable for studies of postoperative adjuvant therapy to improve outcome. Cancer 2003;97:1904–8. © 2003 American Cancer Society. DOI 10.1002/cncr.11269

Purpose : To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. Methods and Materials : Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents’ preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. Results : When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. Conclusion : Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making.

Our primary objective was to determine the content and format that is most suitable for educational events targeting patients and carers who are living with advanced cancer. Secondary objectives included examining the differences in information needs between patients and their carers, and providing an estimate of the rate of participation in educational events targeting such patients and carers. Out-patients receiving palliative radiotherapy at Toronto Sunnybrook Regional Cancer Center and their carers were invited to complete the Advanced Cancer Information Needs Survey. One hundred forty-four respondents participated in the survey. The participants identified the management of pain, fatigue, and home palliative care resources as the areas in which information was most needed. Carers displayed greater interest, and the range of topics in which they continue to seek additional information is wider. Thirty-one percent of respondents said they would participate in an educational event. A 'one-on-one' interview approach and short written materials were the preferred sources of information. Our study examined potential content areas and preferred format for proposed educational events targeting patients and carers living with advanced cancer. We also highlighted the reasons for, and potential limitations of this approach. The investment of future effort in evaluating the impact of 1 on 1 interviews and 'short written materials' on the informational needs of patients and carers living with advanced cancer is warranted.

Purpose: To assess the efficacy of Biafine cream in preventing Grade 2 acute radiation dermatitis, according to the National Cancer Institute of Canada skin radiation toxicity criteria in patients undergoing concomitant adjuvant chemotherapy and radiotherapy to the breast. Methods and Materials: Sixty patients participated in this study. Patients were treated with a lumpectomy followed by concomitant chemotherapy and radiotherapy to the breast. Biafine cream was applied daily, starting on the first day and ending 2 weeks post-radiotherapy. Patients underwent weekly skin assessments throughout radiotherapy and at 2 and 4 weeks after treatment. Outcome measures were assessed using a Skin Assessment Questionnaire that was scored according to the National Cancer Institute of Canada skin radiation toxicity criteria and a self-administered questionnaire that evaluated skin symptoms. Results: The maximum skin toxicity observed during the course of treatment was as follows: less than Grade 2 toxicity, 15% (9 patients); Grade 2, 83% (50 patients); Grade 3, 2% (1 patient); Grade 4, 0% (0 patients). The majority of the radiation dermatitis was observed after 3 weeks of radiotherapy. Conclusion: The majority of patients who underwent concomitant chemo- and radiotherapy for breast cancer developed Grade 2 radiation dermatitis with the use of Biafine cream. However, no treatment delays or interruptions were observed because of skin toxicity.

The purpose of this study was to evaluate the short-term effectiveness of a breast self-examination (BSE) teaching program on women’s knowledge about BSE, proficiency in performing BSE, and motivation to perform BSE. The program was developed for delivery by nurses in a breast diagnostic clinic, a clinic designed to meet the need for expeditious management of breast disease, current information about breast cancer risk, surveillance, and counselling. A convenience sample of 68 women attending the clinic in a regional cancer centre participated in a pre- and five month post-teaching program evaluation. The Toronto Breast Self Examination Instrument was used as the evaluation tool. There were statistically significant changes following the teaching program in the areas of knowledge about the correct technique for performing BSE, proficiency performing BSE, and confidence about finding changes when performing BSE. No significant changes were observed in motivation to practise BSE, although group scores did improve following the education. Participants found the video presentation and the review of BSE information pamphlets by the nurse to be the most helpful components of the BSE teaching program.

We conducted a pilot study to examine patients' understanding of their illness and their expectations for palliative radiotherapy for symptomatic metastases. Paricipants were asked to complete a survey consisting of seven questions prior to the initial consultation. Demographic details and information on extent of disease were collected. Patients were asked to score their symptom distress using the modified Edmonton Symptom Assessment System. Sixty patients participated in the pilot study between January and April 1999. Their median age was 68 years (range 46–90). The most common primary tumours were lung, prostate and breast. Twenty-one patients (35%) believed that their cancer was curable. Twelve (20%) expected that palliative radiotherapy would cure their advanced cancer and 23 (38%) believed that palliative radiotherapy would prolong their lives. Twenty-one patients (35%) had concerns about the effectiveness of radiation therapy and twenty (33%) had concerns about the side-effects of radiotherapy. Fifty-two (87%) were not familiar with the concept of radiation treatment. Forty-seven patients (78%) reported that they were not given information about the radiation treatment; 51 (85%) were not satisfied with the information that their own doctors had provided regarding radiation treatment prior to the consultation at our clinic. A significant proportion of the patients in this pilot study had misconceptions regarding their illness and unrealistic expectations from palliative radiotherapy. We plan to provide educational pamphlets for use in referring doctors' surgeries and clinics in order to inform patients of the nature, rationale and anticipated benefits and side-effects of palliative radiotherapy.

Treatment outcomes were documented for 204 adult patients with clinical Stage I-II Hodgkin's disease who were treated with risk-adapted ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) and radiotherapy (RT) at the Toronto-Sunnybrook Regional Cancer Centre between 1984 and 1994. Forty-nine patients with clinical Stage I disease (excluding bulky mediastinal presentations) and 50 patients with a combination of clinical Stage IIA disease, age 50 years or less, and favourable pathology (lymphocyte predominant or nodular sclerosing histology) were identified as low risk and treated with RT alone to 35 Gy. One hundred and five high-risk patients were treated with chemotherapy (86 with ABVD) followed by RT to 25 Gy. The 7-year cause-specific, overall and disease-free survivals were 95%, 90% and 75% respectively for the low-risk cohort, and 91%, 90% and 88% respectively for the high-risk cohort. In-field relapses accounted for 50% of the failures in both groups. Sixteen of 24 (67%) patients with RT failure and 6/14 (43%) with combined modality therapy (CMT) failure were salvaged. Twenty-eight per cent of the patients treated with RT and 21% of those treated with CMT developed hypothyroidism by 7 years. Fatal complications were recorded in 6% of the low-risk patients managed with RT and 8% of high-risk patients managed with CMT. Septic death and second malignancy accounted for the majority of treatment-related fatalities. Risk-adapted therapy emphasizing RT alone for selected patients with favourable prognostic factors and CMT based on ABVD provides excellent long-term disease control. Further treatment refinements, including the wider application of CMT with lower doses of chemotherapy and RT, will be required to reduce the rate of fatal complications to more acceptable levels.

Purpose: To explore the correlation between dose fractionation and local control for the adjuvant radiotherapy of early stage breast cancer. Methods and Materials: A matched-pair analysis of early stage invasive breast cancer treated adjuvantly with two different dose fractionation schedules, 4000 cGy in 16 fractions (Cohort A) vs. 5000 cGy in 25 fractions (Cohort B) was undertaken to compare local control rates. A systematic review of the published experience in similar patient populations was conducted and the reported dose fractionation schedule was converted to a biologic effect dose (BED) based upon the linear quadratic equation. The BED was then used as a basis for comparing reported local control rates with different dose fractionation schemes. Results: The 118 patient pairs were matched from Cohort A and Cohort B using known significant prognostic factors including age, histology, surgical margins, receptor status, lymphvascular space invasion, extensive intraductal disease, lymph node status, and systemic therapy. The local recurrence rate at 5 years for those treated with 4000 cGy (BED = 65 cGy 4 ) and 5000 cGy (BED = 75 cGy 4 ) was 12.7% and 6.8%, respectively, and this difference was not statistically significant ( p = 0.09). Overall survival was 84% at 5 years for both groups. Comparison of the different dose fractionation schemes reported in the literature revealed a highly statistically significant difference between those treated with less than a BED of 75 Cy 4 and those treated with a BED of 75 Gy 4 or greater. Conclusion: Although not statistically significant, there was a trend in the matched pair analysis which suggests that 4000 cGy in 16 fractions (BED = 65 cGy 4 ) provides inferior local control compared to 5000 cGy in 25 fractions (BED = 75 cGy 4 ). Moreover, the literature review demonstrates that a dose control relationship may exist for local control in the adjuvant setting. A dose fractionation schedule equivalent to 5000 cGy in 25 fractions to the whole breast may represent the optimal dose fractionation schedule for local control.

This study was designed to evaluate the efficacy and toxicity of dose intensifying DHAP (dexamethasone, cytarabine and cisplatin) salvage chemotherapy by adding mitoxantrone with GM-GSF support in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL). From March 1992 to January 1995, 22 patients with intermediate and high grade (aggressive) NHL refractory or relapsed after adriamycin containing chemotherapy regimens were treated with M-DHAP+GM-CSF, (dexamethasone 40 mg i.v. days 1-4, cisplatin 100 mg/m2 i.v. by continuous infusion over 24 hours on day 1, cytarabine 2 gm/m2, i.v. every 12 hours for 2 doses on day 2, mitoxantrone 10 mg/m2 i.v. on days 3 and 4 and GM-CSF 250-500 microg/m2 s.c. daily beginning day 5 until absolute neutrophil count recovery. Most patients had poor prognostic factors including primary refractory disease (18/22), bulky disease (12/22), elevated LDH (9/22), or bone marrow involvement (8/22). All 22 patients were evaluable. The overall response rate was 41% (CR 23% and PR 18%). There were three toxic deaths, all related to sepsis. Median progression free survival (PFS) and overall survival (OS) rates were 5.2 months and 11.8 months respectively. At the same time of the analysis two patients were alive after high-dose therapy and bone marrow transplant at 34 and 36 months follow-up and two were alive with disease. The maximal acceptable dosage of mitoxantrone was 10 mg/m2 x 2 due to serious hematologic toxicity. Treatment delays and dose reductions compromised delivering the optimal dose intensity of M-DHAP. A poor prognostic group of patients with refractory or recurrent aggressive lymphoma, many of whom were not eligible for high-dose therapy and stem cell transplantation were treated with repeated cycles of dose intensified DHAP with growth factor support. Although M-DHAP had therapeutic activity even in patients considered to have primary refractory disease, myelosuppression was dose limiting and frequently limited the number of cycles. Therefore, if M-DHAP is to be further evaluated, therapeutic results may be improved further by incorporating strategies to reduce myelotoxicity such as the use of growth factors to reduce platelet transfusion requirements or the use of autologous stem cell support after each cycle.

Because of evidence that failure to deliver full dose CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) may compromise the outcome of elderly patients with aggressive non-Hodgkin's lymphoma (NHL), we attempted to deliver full dose CHOP to these patients. The objective of this review was to assess the relative received dose intensity (ARRDI), toxicity and outcome of elderly patients treated with curative intent with CHOP at our centre. Charts were reviewed of all patientsor = 65 years with newly diagnosed aggressive NHL referred to the Toronto-Sunnybrook Regional Cancer Centre (TSRCC) for initial management from 1990-1995 before routine use of G-CSF. Sixty eligible patients were identified. 31 received CHOP +/- radiation (XRT), 9 other curative treatment and 20, palliative treatment. The mean ARRDI calculated on 29/31 patients receiving CHOP was .86; 41%=1.0, 24%=.90-.99, 14%=.75-.89 and 21%=.75. During 141 cycles of CHOP. 17 (12%) episodes of febrile neutropenia (FN) occurred in 14 (45%) patients and other grade 3/4 toxicity occurred in10% of patients. There were 3 (10%) toxic deaths. Sixteen (52%) patients required a total of 29 admissions to hospital for FN (59%) or other causes. Of the 31 patients, 16 (52%) achieved a complete remission (CR), 7 (23%) a partial remission-1 (PR-1), 2 (6%) a partial remission-2 (PR-2), 1 (3%) had no response (NR), 2 (6%) had progressive disease and 3 (10%) were not evaluable (NE). The median progression free survival (PFS) and overall survival (OS) were (16+) months and (24.5) months respectively. We found that physician biases resulted in the selection of; younger patients (median 71 vs. 80 years), patients with a better ECOG performance status (or =2, 13% vs. 50%) and patients with less co-morbid illness (42% vs. 90%) for attempt at curative treatment with CHOP chemotherapy. Age was never the sole reason for offering palliative treatment. In conclusion, a subset of patients over the age of 65 with aggressive NHL, who have a good performance status and minimal co-morbid illness can tolerate full dose CHOP chemotherapy without G-CSF support. Future strategies should emphasize full dose treatment with curative intent with minimization of both hematologic and non-hematologic toxicity. Clinical studies are required to determine whether routine G-CSF support will reduce toxicity or improve outcome in this group of patients.

Providing effective care for individuals with prostate cancer is an important issue for oncology nurses. However, the paucity of empirical work regarding the impact of prostate cancer presents a limitation in designing and implementing appropriate nursing interventions. This article presents the findings from a national survey of 621 Canadian men living with prostate cancer regarding the impact of their disease and the availability of support. The most frequently identified problems included sexual function, side effects, fear of dying, incontinence, anger and pain. Approximately one-third of the respondents experienced a lifestyle change, but relatively few indicated experiencing a negative impact from the changes they experienced. The majority of respondents indicated they had been informed accurately about their treatment, but dissatisfaction was expressed regarding lack of information about emotional reactions, alternative therapies, how to speak with other prostate cancer patients and the availability of counselling and self-help groups. Clearly these results have implications for oncology nurses.

Purpose: To quantify the variability in prostate and seminal vesicle position during a course of external beam radiotherapy, and to measure the proportion of target variability due to setup error. Methods and Materials: Forty-four weekly planning computerized tomography (CT) studies were obtained on six patients undergoing radiotherapy for prostate cancer. All patients were scanned in the radiotherapy treatment position, supine with an empty bladder, with no immobilization device. All organs were outlined on 3-mm-thick axial CT images. Anterior and lateral beam’s eye view digitally reconstructed radiographs and multiplanar reformatted images were generated. The position of the prostate and seminal vesicles relative to the isocenter location as set that day was recorded for each CT study. Target position relative to a bony landmark was measured to determine the relative contribution of setup error to the target position variability. Results: The seminal vesicle and prostate position variability was most significant in the anterior–posterior (AP) direction, followed by cranial–caudal (CC) and mediolateral (ML) directions. Setup error contributed significantly to the total target position variability. Rectal filling was associated with a trend to anterior movement of the prostate, whereas bladder filling was not associated with any trends. Although most deviations from the target position determined at the initial planning CT scan were within 10 mm, deviations as large as 15 mm and 19 mm were seen in the prostate and seminal vesicles respectively. Target position variations were evenly distributed around the initial target position for some patient studies, but unpredictable patterns were also seen. From a simulation based on the observed variability in target position, the AP, CC, and ML planning target volume (PTV) borders around the clinical target volume (CTV) required for target coverage with 95% certainty are 12.4 mm, 10.3 mm, and 5.6 mm respectively for the prostate and 13.8 mm, 8.6 mm, and 3.9 mm respectively for the seminal vesicles. Conclusion: Target position variability is significant during prostate radiotherapy, requiring large PTV borders around the CTV. This target position variability may be potentially reduced by improving the setup accuracy.

The objective of this phase I-II study was to determine the efficacy and toxicity of combination chemotherapy with 5-fluorouracil, leucovorin, doxorubicin, methotrexate, and oral etoposide (FLAME) in patients with measurable unresectable or metastatic gastric cancer. Starting doses on the phase I study were as follows: methotrexate 50 mg/m 2 intravenous bolus day 1; leucovorin 20 mg/m 2 intravenous bolus days 2 through 4, starting 24 hours after the methotrexate dose; 5-fluorouracil 325 mg/m 2 intravenous bolus 15 minutes after leucovorin days 2 through 4; doxorubicin 25 mg/m 2 intravenous bolus day 8; and oral etoposide 50 mg/day for 14 days, starting on day 8. A new cycle started on day 28. A total of 42 patients were treated-10 patients in the phase I study and 32 patients in the phase II study. Dose-limiting toxicity was encountered in the phase I study on the second escalation step, when doxorubicin was escalated to 30 mg/m 2 and 5-fluorouracil was escalated to 350 mg/m 2 . In the phase II study 28 patients (109 courses) were evaluable for toxicity. Neutropenia grade 3 or more was dose limiting and was documented in 12 patients (43%) during 22 treatment courses (20%). Neutropenia was associated with febrile neutropenia requiring hospitalization in four patients during five courses of therapy. Grade 3 stomatitis and grade 3 diarrhea was infrequent, documented in two patients (two courses) and three patients (four courses), respectively. All other toxicity was grade 1 and grade 2. The combined objective response rate in 38 evaluable patients entered in both studies was 23.3% (six partial responses and one complete response). Stable disease was documented in 15 patients (39.5%). The median survival for the 42 patients entered in both trials was 6.9 months (95% confidence interval, 5.9-8.5 months). The objective response rate and median survival for the combined group is comparable with that reported for the etoposide, leucovorin, and 5-fluorouracil (ELF), and 5-fluorouracil and methotrexate (FMTX) regimens in a recently reported, multicenter, phase III study.

The objective of this study was to determine whether the addition of concurrent 5-fluorouracil (5-FU) and/or a change in radiation fractionation improves pelvic control and survival or decreases complications in advanced cervical cancer, FIGO stages IB/IIA (>=5 cm) to IVA inclusive. After stratification by pelvic disease extent, 234 of a planned 292 patients were randomized to receive one of four possible treatments: (a) standard external beam pelvic irradiation (RT) 5000 cGy in 25 fractions versus (b) RT as in arm (a) with infusional IV 5-FU 1g/m2 daily in the first and last 4 days of RT, (c) partially hyperfractionated RT, 5280 cGy in 33 fractions, two fractions per day on the first and last 4 days of RT, or (d) arm (c) with the same FU. All were followed with a linear source of intracavitary RT to deliver 40 Gy. The median duration of follow-up for the 221 evaluable patients was 59 months. The 5-year Kaplan-Meier disease-free survival (DFS) in arm (a), (c), (d), and (b), respectively, were 45, 53, 58, and 61%. The differences in survival and pelvic control were not statistically significant. An exploratory subset analysis was performed within stratum 1 and stratum 2 to generate hypotheses for future studies. Only for the 99 patients in stratum 1 (IB/IIA or medial parametrial IIB disease) was the 5-year DFS significantly better (long rank P = 0.05) for standard RT and 5-FU. The DFS was 39% for arm (a), 76% for arm (b), 58% for arm (c), and 65% for arm (d). A multivariate analysis of patient, tumor, and treatment related prognostic factors identified only the use of 5-FU to account for the observed difference. The crude serious late bowel or bladder complication rate was 5.9%. Overall concurrent infusional 5-FU was not beneficial when added to standard RT in this study. The possible benefit for patients in stratum 1 requires exploration in a further randomized trial with appropriate accrual.

Purpose: To determine retrospectively the prognostic significance of airway compromise necessitating tracheostomy in carcinoma of the larynx managed with radical radiotherapy and surgery for salvage (RRSS). Methods and Materials: The charts of 270 patients managed with RRSS at the Toronto-Sunnybrook Regional Cancer Centre between June 1980 and December 1990 were reviewed. Airway compromise necessitating tracheostomy was documented in 26 patients prior to radiotherapy and 3 patients during radiotherapy. Of 29, 27 had T3T4 primaries. Patients have been followed for a median of 5 years. Results: Patients managed without tracheostomy had a 2-year disease-free survival of 74% compared to 41% for those managed with tracheostomy. The adverse impact of airway compromise was more marked in patients with glottic primaries (78% vs. 32%, p = 0.0001) than those with supraglottic primaries (64% vs. 47%, p = 0.18). Tracheostomy was identified in univariate analysis, but not in multivariate analysis, as having a statistically significant impact on local control and local-regional control. Radiotherapy controlled disease above the clavicles in 185 of 267 (69%) evaluable patients. 83% of isolated local-regional failures underwent salvage surgery. Among those managed without tracheostomy, ultimate local-regional control (LRC) was achieved in 161 (94%) of 172 glottic primaries and 54 (81%) of 67 supraglottic primaries. Among those managed with tracheostomy, ultimate LRC was achieved in 9 (69%) of 13 glottic primaries and 12 (80%) of 15 supraglottic primaries. In a subset analysis of 76 patients with T3T4 primaries, there was no statistically significant difference in larynx preservation, disease-free survival, or cause-specific survival between those managed with and without tracheostomy. Conclusion: Airway compromise necessitating tracheostomy is an adverse prognostic factor in patients with carcinoma of the larynx. However, larynx preservation is possible in over 40% of those undergoing tracheostomy and radiotherapy with no compromise of cause-specific survival. The need for pretreatment tracheostomy should not rule out the possibility of RRSS.

Objective:To describe the response to single dose photon stereotactic radiosurgery of arteriovenous malformations (AVMs) so that the probability of success or failure of treatment may be predicted for the individual patient.Method:The obliteration prediction index (OPI) was calculated for AVMs by dividing the marginal dose of radiation in Gray (Gy) by the lesion diameter in centimetres in cohorts of 42 patients treated with the modified linear accelerator at Toronto-Sunnybrook Regional Cancer Centre and 394 patients treated with the gamma unit at the Royal Hallamshire Hospital, Sheffield, United Kingdom. Patients were grouped into ranges by OPI and the proportion of success and failure was calculated for each group. An exponential function [P = 1-A•e(-B-OPI)] was fitted to the data by the least squares method.Results:Despite systematic differences in radiation treatment, that is, marginal doses of 15 and 20 Gy in Toronto and most Sheffield patients with a marginal dose of 25 Gy, the resultant data points exhibited similar behaviour.Conclusion:The function [P = 1-A•e(-B-OPI)] partly describes the biological effect of radiation and is independent of the radiation device used. Radiosurgery centres can use this model to facilitate predictions of successful treatment for individual patients.

Introduction Asthma guidelines have suggested that treatment decisions should be guided by indices of asthma control and not only by disease severity. In adults, symptom-based asthma control parameters have been shown to predict exacerbations and health care services use (HSU). We hypothesize that defining asthma control using parent-reported symptoms alone is not adequate in children. Materials and Methods Cross-sectional data from the population-based asthma in Canada study were reanalyzed. Random-digit dialing was used to produce the final sample, consisting of 1,001 asthmatics: 801 adults (aged 16+) and 200 children (aged 4–15) participating by parental proxy. Weighted frequencies of Canadian guideline defined asthma control parameters, perceived asthma control, HSU and medication use were calculated separately for adults and children. Stratified analyses compared HSU in controlled versus uncontrolled asthmatics. Results Over 90% of parents of asthmatic children believed their child's asthma to be controlled. Only 45% were actually controlled as defined by guideline parameters. Among controlled asthmatics, children reported higher HSU (32% reported 2+ health care encounters versus 17% of adults, P

To determine family physicians' availability to their general practice patients after hours and to explore the characteristics and determinants of after-hours services.Secondary analysis of the 2001 National Family Physician Workforce Survey.Canada.Canadian family physicians and general practitioners currently in practice (n = 10,553).Provision of after-hours care, defined as providing care to all practice patients outside of normal office hours.Sixty-two percent of Canadian family physicians reported providing after-hours service. The lowest rates were found in Quebec (34%) and the highest in Alberta and Saskatchewan (88%). Respondents practising in academic and community clinics, offering selective medical services (emergency care, palliative care, housecalls, after-hours care), or living outside of Ontario or Quebec were more likely to provide after-hours care. Women physicians, those practising in walk-in clinics, or physicians primarily paid by fee-for-service were less likely to do so. Urban versus rural location, organization of practice (solo or group), age of physician, country of graduation, and physician satisfaction were not found to significantly affect the likelihood of providing after-hours services.Knowledge of these factors can be used to inform policy development for after-hours service arrangements, which is particularly relevant today, given provincial governments' interests in exploring alternative payment plans and primary care reform options.

Non-Hodgkin's lymphoma (NHL) remains an important complication of associated HIV infection despite advances in antiretroviral therapy (ART), and the optimum chemotherapy regimen for this disease remains to be defined. A dose-escalation trial was performed to determine the maximum tolerated doses of etoposide and doxorubicin as part of the 12-week VACOP-B regimen, supported by filgrastim (r-metHuG-CSF). Patients with aggressive histology HIV-related NHL who were previously untreated with chemotherapy, and who had no active opportunistic infection were eligible for the study. Chemotherapy consisted of cyclophosphamide 350 mg/m2, vincristine 2 mg, bleomycin 10 U/m2; and prednisone 100 mg q2 days x 12 weeks, with increasing doses of doxorubicin 25-50 mg/m2 and etoposide 25-50 mg/m2 intravenously and 50-100 mg/m2 orally. Central nervous system prophylaxis (intrathecal cytarabine 50 mg x 4 doses), antifungal, and Pneumocystis carinii prophylaxis were used, and filgrastim was administered to prevent neutropenic complications. One dose level was expanded to permit the concomitant use of ART. Endpoints were determination of maximum tolerated dose of doxorubicin and etoposide, treatment tolerability, and survival. Forty-seven patients were enrolled, most with diffuse large-cell or immunoblastic NHL. Protocol-defined maximum tolerated dose was not reached and the limits of dose-limiting toxicity were not exceeded, even in patients receiving ART. Thirty-two cycles (4.9%) were delayed6 days because of toxicity; 30 patients (64%) completed all 12 weeks of treatment. After completion of therapy, 14 patients had a complete response (30%), and 4 had a partial response (8%). Median time to progression was 9 months. At 42 months, progression-free survival was 25% and overall survival was 28%.

Purpose: To determine the proportion of patients undergoing palliative radiotherapy (RT) for bone pain who would like to participate in the decision-making process, and to determine their choice of palliative RT regimen (2000 cGy in five fractions vs. 800 cGy in one fraction) for painful bone metastases. Methods and Materials: Eligible patients were approached and all patients agreeing to participate provided written informed consent. Patients’ decisional preferences were studied using a five-statement preference instrument. A decision board was used to help patients decide their preferred palliative RT regimen. Factors influencing patients’ choices were studied using a visual analog scale. Results: A total of 101 patients were enrolled in the study (55 women and 46 men). The preferences for decision-making were as follows: 30 active, 47 collaborative, and 24 passive. Most (55 [76%] of 72) patients favored one fraction of palliative RT (95% confidence interval, 65–86%). Patients were more likely to select the 800 cGy in one fraction because of the convenience of the treatment plan (odds ratio, 1.024; 95% confidence interval, 1.004–1044) but were less likely to choose it because of the chance of bone fracture (odds ratio, 0.973; 95% confidence interval, 0.947–1.000) compared with 2000 cGy in five fractions. Conclusion: Most participating patients preferred to decide either by themselves or with the radiation oncologists which treatment option they preferred. An 800-cGy-in-one-fraction regimen was favored, independent of the treated site. The convenience of the treatment plan and the likelihood of bone fracture were the most important factors influencing patients’ choice.

Conformal radiotherapy requires confidence that the images used for target delineation accurately reflect the pathological dimensions of the target. Radiosurgery, which is a conformal radiotherapy technique, is often used to treat brain metastases. The images of brain metastases can be affected by the method of image acquisition. A prospective study was undertaken to evaluate the effect of delay on CT images of brain metastases selected for radiosurgical treatment. A median delay from contrast administration of 65 min resulted in an increase in the volume of the metastases in 86% of cases when compared with the volumes of the same metastases determined from CT images acquired immediately following the administration of contrast medium. The magnitude of the increase in volume was sufficient to cause radiosurgery planners to select larger collimator sizes for radiosurgery plans based on the delayed CT images in 92% of cases. No significant intraobserver or interobserver variation was found in the group of radiosurgery planners. Differences in image acquisition may account in part for the differences in local control reported in the radiosurgical treatment of brain metastases.

Background. This paper describes the development of the Rapid Response Radiotherapy Program and evaluates the continuing medical education (CME) series, in the form of multidisciplinary monthly Radiation Oncology Palliative Care Rounds at the Toronto Sunnybrook Regional Cancer Centre. Methods. Palliative care rounds were initiated by the multidisciplinary committee in September, 1998. From January, 2000, to June, 2002, attendees used a standard 5- point Likert rating scale to conduct formal evaluations. Results. A total of 203 evaluation forms examining 20 rounds have been collected. Findings indicated that 86.8, 96.0, 87.1, and 90.8% of participants thought the material of the presentation was relevant to their practice, interesting, and instructional. Overall 90.1% of the respondents highly rated the grand rounds (rating of 4 or 5). Conclusion. The grand rounds are an effective CME activity at our hospital.

Practices regarding central nervous system (CNS) prophylaxis and treatment for non-"high-grade" lymphomas are not standardized. We designed a survey to address the CNS surveillance, prophylaxis and treatment (S + P + T) habits of Ontario oncologists, to compare tertiary with community care and gauge interest in a randomized controlled trial (RCT). We mailed 145 questionnaires to oncologists/hematologists registered at the Royal College of Physicians and Surgeons of Ontario between 1980 and 1999. The questionnaire posed questions of S + P + T for a variety of histologies, locations and risk factors. Results showed that 49/77 respondents treated adult NHL, (19 community, 30 tertiary care). Surveillance LP's were commonly done in testicular, orbital, sinus and epidural sites of presentation (76, 69, 71, 80%, respectively), but these were less commonly prophylaxed (45, 33, 29 and 41%). HIV associated NHL received surveillance and prophylaxis by 51 and 33% of respondents. Stage IV disease, increased LDH and extranodal-sites warranted infrequent S + P. IT chemotherapy via LP was the most commonly used form of prophylaxis (74%) or treatment (84%). Twenty percent used systemic agents that cross the blood brain barrier for prophylaxis, and 45% for treatment. A vast heterogeneity of practice within and between tertiary care and community physicians' practices was documented. Ninety percent of physicians indicated willingness to participate in a RCT. In conclusion, CNS surveillance and prophylaxis in non-"high-grade" NHL is highly variable, probably because there are poorly defined risk factors, inconclusive prophylaxis efficacy and the inconvenience/toxicity of therapy. Patients at high risk by International prognostic index criteria are at an increased risk for CNS relapse. A RCT comparing standard chemotherapy with or without CNS prophylaxis in selected patients is needed.

Purpose. To assess how women with ductal carcinoma in situ (DCIS) perceive their risks of recurrence, dying from breast cancer, and psychological distress compared to women with early stage invasive breast cancer (EIBC). Patients and methods. Eligible patients included those with DCIS or EIBC (T1 or T2, N0) referred to one cancer center between November 1998 and June 1999. Participants completed a self-administered survey regarding their views of their risks of developing recurrent cancer, of dying of breast cancer and the presence of psychological symptoms of distress. Responses were scored and compared between the two groups. Results. In total, 495 patients were screened, 240 found ineligible, 228 patients who agreed to participate. No significant difference between the two groups was observed in perceptions of risk related to the likelihood of developing local recurrence (DCIS: 53%, EIBC 45%, P = 0.14), distant recurrence (DCIS: 36%; EIBC: 39%, P = 0.35) or dying of breast cancer (DCIS: 27%, EIBC 27%, P = 0.5). Both groups expressed similar levels of psychological distress (anxiety, DCIS: 56%, EIBC 54%, P = 0.38; depression, DCIS: 41%, EIBC, 48%, P = 0.17). Conclusions. Despite the excellent prognosis, women with DCIS express serious concerns and report similar psychological morbidity as women with invasive cancer.

Breast cancer patients' utilisation of supportive care has been understudied. In this paper, results from a population-based survey are used to assess the role of physicians and nurses in providing supportive care to women. Participants for this study were women with histologically confirmed invasive breast cancer diagnosed 23-36 months prior to contact about the study, who were randomly selected from the Ontario Cancer Registry. Patients for whom a physician approved contact were sent a survey questionnaire. There were two follow-up mailings. The survey included items related to patients' perceptions of supportive care involvement of oncologists, surgeons, family physicians and nurses. Among 1,119 eligible patients, 65% returned completed questionnaires. A total of 72% of these women reported having talked with an oncologist about one or more supportive care issues; 78% with a surgeon; 73% with a family physician; and 45% with a nurse. Factors linked to seeking supportive care from physicians and/or nurses included: younger age, working status, higher education, additional health insurance beyond that provided by government, higher household income, and receiving chemotherapy. Results indicate that physicians and nurses were providing important supportive care to most women with breast cancer. In a health care context where specialised supportive care services (e.g. help from dietitians, psychologists, social workers) are often unavailable or difficult to access, supportive care remains largely a responsibility of medical and nursing professionals. Even brief interventions may make an important difference to how patients deal with their illness over time.

Purpose: To evaluate the efficacy and toxicity of fractionated stereotactic radiotherapy (FSRT) for vestibular schwannomas in patients treated at two university-affiliated hospitals. Methods and Materials: Thirty-nine patients were treated between April 1996 and September 2000. The median age was 56 years (range: 29–80), and median maximal tumor diameter was 20 mm (range: 9–40). A total of 11 patients had fifth and/or seventh cranial nerve dysfunction before irradiation; 2 patients had only facial weakness, 5 patients had only facial numbness, and 4 patients had both facial weakness and numbness. Thirty-three patients were treated with primary FSRT, and 6 patients were treated for recurrent or persistent disease after previous surgery. All patients were treated with 6-MV photons using a stereotactic system with a relocatable frame. The 39 patients received 50 Gy in 25 fractions over 5 weeks. Median follow-up was 21.8 months (range: 4.4–49.6). Results: Local control was achieved in 37 patients (95%). Two patients experienced deterioration of their symptoms at 3 and 20 months as a result of clinical progression in one case and tumor progression in the other and underwent surgery post FSRT. A total of 19/28 (67.9%) patients preserved serviceable hearing after FSRT. Deterioration of the facial and trigeminal nerves was observed in only 2 patients who were treated with surgery post FSRT. Conclusion: FSRT provided excellent tumor control with minimal morbidity and good hearing preservation in this cohort of patients. Longer follow-up is required to confirm long-term control rates.

Ovarian cancer is the fourth leading cause of cancer-related deaths in women. Ovarian cancer, and its treatment, has a considerable effect on the quality of life of women diagnosed with the disease. Young women diagnosed with ovarian cancer must confront life-threatening illness at a time when many are in the midst of raising children, maintaining a household, and actively engaging in work and career activities. Very little has been reported about the perspectives of young women regarding their experiences with ovarian cancer. This article reports data from 39 women 45 years of age or less concerning the impact of ovarian cancer and its treatment as well as the availability of support. At the time of the study, the women were, on average, 38 years of age and approximately two-thirds were married and had children. About half of the women were working. The most frequently identified problems included side effects (n = 25), fear of recurrence (n = 25), and difficulty sleeping (n = 25). On average, women reported experiencing 10.4 problems since diagnosis. Of those who experienced problems, less than 50% perceived they had received adequate help. Approximately two-thirds of these women experienced a lifestyle change. Quality of life was rated significantly lower following their experience with ovarian cancer. Implications for oncology nurses emerge in areas of assessment, referral, and patient teaching.

In lymphomas an innate defect in the T-cell repertoire could account for the impaired tumour-specific immune response; alternatively, the tumour itself could exert an inhibitory effect on the immune system. To address this issue we analysed the T-cell responses against follicular lymphoma (FL) in identical twins as it can be postulated that their overall T-cell repertoire is identical. While differences between the T-cell response of the patient and the healthy twin would point to a tumour-induced T-cell unresponsiveness, impaired responses in both would point to a defective T-cell repertoire. We demonstrated an impaired tumour-specific proliferation (P = 0.035 and P = 0.013) and cytokine release (P = 0.004 and P = 0.0008) of both peripheral blood and tumour-derived T-cells, respectively, in the FL patient compared with the T-cell response of the healthy twin. Moreover, only syngeneic primed T cells were able to directly lyse unmodified FL cells of the patient. These data support previous findings in murine lymphomas and suggest that inhibitory mechanisms during tumour growth, rather than a defective T-cell repertoire, are responsible for the insufficient T-cell response in lymphoma.

Purpose : The primary objective of this report is to prospectively evaluate pain control provided by palliative radiotherapy for all irradiated patients with bone metastases by using their own assessments. Materials and methods : A prospective database was set up for all patients referred for palliative radiotherapy for bone metastases. Patients were asked to rate their pain intensity using an 11 categorical point scale (0=lack of pain, 10=worst pain imaginable). Analgesic consumption during the preceding 24 h was recorded and converted into equivalent total daily dose of oral morphine. For those who received radiotherapy, follow-up was conducted via telephone interviews at week 1, 2, 4, 8 and 12 post treatment using the same pain scale and analgesic diary. Radiotherapy outcome was initially assessed by pain score alone. Complete response (CR) was defined as a pain score of 0. Partial response (PR) was defined as a reduction of score ≥2 or a≥50% reduction of the pre-treatment pain score. We further analyzed outcomes using integrated pain and analgesic scores. Response was defined as either a reduction of pain score ≥2 with at least no increase in analgesics or at least stable pain score with a ≥50% reduction in analgesic intake. Results : One hundred and five patients were treated with palliative radiotherapy. When response evaluation was by pain score alone, the PR rates at 2, 4, 8 and 12 weeks were 44, 42, 30 and 38%, respectively; while the CR rates were 24, 32, 31 and 29%, respectively. The overall response rate at 12 weeks was 67%. When assessed by the integrated pain and analgesic scores, the response rates were 50, 46, 43 and 43%, respectively. Conclusion : The response rate in our patient population is comparable with those reported in clinical trials. This is important when counselling our patients on the expected effectiveness of radiotherapy outside of clinical trials. Our observations confirm the generalizability of the trials conducted to date. While randomized trials still remain the gold standard of research, observational studies can serve as useful adjuncts to randomized trials to confirm the efficacy and guide the design of new controlled trials.

Obesity and breast cancer are common conditions that often coexist. Concerns of relative overdosing of chemotherapy in the large cancer patient have led clinicians to apply empiric dose reductions, 'cap' the body surface area (BSA) at 2 m2, or use ideal rather than actual body weight to calculate BSA. There are no data supporting or refuting these practices and their prevalence is unknown. We sought to determine the distribution of body size and prevalence of obesity in the breast cancer population of our cancer centre, and to determine clinician chemotherapy dosing practices in the era of modern adjuvant chemotherapy.Women with invasive breast cancer receiving systemic therapy at our institution between 1980 and 1998 were identified and their recorded height and weight were used to calculate BSA and body mass index (BMI). We reviewed the first cycle adjuvant chemotherapy dosing practices from 1990-1998. The ideal dose of chemotherapy was calculated based on calculated BSA, and then contrasted with the actual dose received at cycle one. Discrepancies were recorded and categorized, using the largest single drug reduction if more than one drug was reduced.Mean BMI in the systemic therapy population was 26.4 +/- 5.3 kg/m2, 54% were overweight, 2% severely obese and 18% moderately so. Their mean BSA was 1.7 +/- 0.2 m2 and only 5% had a BSAor = 2 m2. In the adjuvant chemotherapy subgroup, most patients receivedor = 85% of their ideal dose. The mean dose reduction was 5.3 +/- 11.3% versus 9.9 +/- 11.3% in the BSA2 andor = 2 m2 groups, respectively (p = 0.02), and 4.3 +/- 8.2% versus 6.7 +/- 13.1% in the BMI25 andor = 25 kg/m2 groups, respectively (p = 0.008). While only 24% of chemotherapy dose reductions ofor = 15% were in the BSAor = 2 m2 group, 76% were in the BMIor = 25 kg/m2 group.Obesity is prevalent in this breast cancer population. BSA is not a sensitive index of large body size. We consistently detected more frequent empiric dose reductions at cycle one of adjuvant chemotherapy, with reductions of greater magnitude in the largest women (BSAor = 2 m2) and those who were overweight (BMIor = 25 kg/m2).

To determine the positive rate of the CAGE questionnaire in an outpatient palliative radiotherapy clinic and to examine the association between problem drinking, pain control, and analgesic consumption, patients referred for palliative radiotherapy were screened with the CAGE questionnaire and asked to rate their symptom distress using the modified Edmonton Symptom Assessment System (ESAS). The latter instrument uses 11-point numeric scales (0 = best, 10 = worst). Their daily analgesic consumption in oral morphine equivalent was recorded. A total of 128 patients participated in the study. Only 9 patients answered one of the four CAGE questions affirmatively (positive group). All the rest answered negatively (negative group). The mean pain intensity at index site/overall pain was 4.97 +/- 3.31/3.27 +/- 2.76 for the negative group and 6.29 +/- 4.42/2.89 +/- 3.37 for the positive group. The mean total daily oral morphine equivalent for the negative and positive group were 112.35 +/- 233.58 mg and 36.82 +/- 58.85 mg, respectively. There was no significant difference found in other symptoms in the modified ESAS between these two groups. The positive rate of the CAGE in patients with advanced cancer attending an out-patient radiotherapy clinic was only 7%, and analyses were limited by the small sample size of those with a positive CAGE. Whether our observed low positive rate of CAGE represents the true prevalence of problem drinking or the CAGE questionnaire is an insensitive tool for screening problem drinking in an outpatient palliative radiotherapy clinic requires further investigation. We did not find a statistically significant worse pain intensity nor higher analgesic consumption in patients who screened positive for CAGE questionnaire.

This paper reports on the results of a survey of utilization of professional supportive care services by women with breast cancer, and on patterns of differential service utilization by sub-groups of patients. Study participants were women with invasive breast cancer diagnosed 23-36 months prior to contact about the study, and randomly selected from the Ontario Cancer Registry. From among 1,119 eligible women sent survey questionnaires, 731 returned completed questionnaires (65%). A total of 31% of respondents reported accessing one or more of the following professionals: social worker, psychologist, psychiatrist, dietitian, physiotherapist. Among those who responded to a question about whether they would have liked specific services, 34% reported that there was at least one professional supportive care service they would have liked to use, but were unable to access. Factors shown to be related to greater utilization of services included: younger age, higher household income, employed or student status, private health insurance coverage, and having received chemotherapy. Overall, there was a surprisingly low utilization of professional specialized supportive care services among women with breast cancer. Policy implications include finding strategies to better inform cancer patients about existing services, and ensuring that a core set of services are available to all patients.

Ovarian cancer is the fourth leading cause of cancer-related death in women. Ovarian cancer and its treatment have a considerable effect on the quality of life of women diagnosed with the disease. Currently, little is known about the perspectives of women regarding their experiences of living with ovarian cancer or the impact of recurrent disease. This article presents data from a national study of Canadian women living with ovarian cancer and describes the impact of the disease and its treatment. In this study, 93 women had recurrent disease, and 170 had not experienced recurrent disease. Women in both groups were similar, ranging in age from 21 to 61 years. Two-thirds of the women were married, and all were white. A greater proportion of the women with recurrent disease reported bowel problems; fears of dying, pain, getting around; and feelings of self-blame. On the average, women with recurrent disease reported experiencing more problems since diagnosis than those without recurrent disease (p = 0.01). The proportion of women who perceived that they received adequate help for their problems ranged from 20% to 85%. Implications for oncology nurses regarding assessment, referral for assistance, and patient education are apparent from the study findings.

Purpose: The use of radical radiotherapy and surgery for salvage (RRSS) in locally advanced squamous cell carcinoma (SCC) of the larynx is controversial. In the absence of randomized studies, it is unclear if RRSS can match the rates of locoregional control and survival reported for primary surgery in this setting. The aim of this study was to compare treatment outcomes of radiotherapy and surgery in comparable patients with CS III–IV SCC of the larynx. Methods and Materials: Eighty-two patients with untreated T2N+M0 or T3T4NM0 SCC of the larynx were treated with a policy RRSS at the Toronto–Sunnybrook Regional Cancer Centre between June 1980 and December 1990. The medical records at presentation were reviewed independently by a panel of three surgical oncologists blinded as to treatment outcome to determine patient suitability for laryngectomy and neck dissection using eligibility criteria adopted by recent clinical trials. Treatment outcomes for surgery-eligible patients were compared to results of comparably staged patients in the surgical literature since 1980. Results: Sixty-three patients (77%) were eligible for study. With a median follow-up of 3 years, radiotherapy controlled the primary in 8/20 evaluable glottic primaries and 21/41 evaluable supraglottic primaries. Forty-five percent of patients surviving 5 years retained a functional larynx. Sixteen of 29 relapsing patients were salvaged with surgery. Disease above the clavicles was controlled in 65% of T3T4N0N+ glottic primaries (compared to a published range of 53% to 79%) and 82% of T3N0 glottic primaries (compared to a published range of 69% to 84%). The 5-year overall survival of patients with T3T4 glottic cancer was 54% compared to a published range of 50% to 63%. The cause-specific survival (CSS) of patients with T3N0 glottic primaries (86% at 1 year and 73% at 2 years) was identical to the only published report of CSS in the surgical literature. Conclusion: A policy of RRSS offers a good chance of laryngeal conservation without compromising ultimate locoregional control or survival when compared to primary laryngectomy and neck dissection in patients with locally advanced carcinoma of the larynx meeting the surgical eligibility of clinical trials.

Purpose: To determine the toxicity, maximum tolerated dose (MTD), and clinical effectiveness of a 5-week course of accelerated radiotherapy with delayed concomitant boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN). Methods and Materials: Thirty-five patients with untreated T3T4NM0 or TN2 (> 3 cm) N3M0 SCC of the oral cavity, oropharynx, hypopharynx, or larynx were entered in the study between January 1994 and October 1997. The initial target volume was treated with conventional daily fractions. A small field boost covering gross disease was added as a second daily fraction during the last 2 weeks of the 5-week schedule, using a minimum interfraction interval of 6 h. The study was initiated using 180-cGy fractions to deliver a total dose of 63 Gy over 33–35 days. A classical dose escalation strategy was planned to increase the delivered dose in steps using minimum cohorts of three patients, up to a maximum of 70 Gy in 200-cGy fractions. Results: In the dose escalation study, 4 patients were entered at level 1 (63 Gy), 9 at level 2 (65 Gy), and 8 at level 3 (67 Gy). One patient was withdrawn at level 2 because of unstable angina, and 1 at level 3 because of uncontrolled diabetes. One patient at level 3 failed to complete treatment because of radiation toxicity. RTOG Grade 3 mucositis, dermatitis, or pharyngitis was documented in 1 (25%), 5 (63%), and 7 (100%) evaluable patients at levels 1, 2, and 3, respectively. Grade 4 reactions were documented in 1 patient at each level. One patient at level 3 died 5 weeks post-treatment of unknown causes. Two additional patients at level 3 died of progressive disease and RT toxicity. Sixty-five Gy (level 2) was chosen as the MTD. In the MTD study, 14 additional patients were entered at level 2, providing a total of 22 evaluable patients with a median follow-up of 21 months (range 12–41 months). Grade 3 mucositis, dermatitis, or pharyngitis were documented in 11 (50%), 8 (36%), and 6 (27%) patients, respectively. One patient developed Grade 4 mucositis. A complete response was recorded in 16 (77%). Three of 5 patients with uncontrolled disease and 3 of 3 patients with recurrent disease underwent salvage surgery with no postoperative complications. Radiotherapy controlled disease above the clavicles in 14 (68%). Ultimate locoregional control was achieved in 17 (77%). The disease-free, overall, and cause-specific survival of all patients entered at level 2 was 56%, 76%, and 80%, respectively, at 2 years. Late complications have been limited to 3 patients (trismus, chronic mucosal ulcer, and soft tissue necrosis). Conclusion: A 5-week course of accelerated radiotherapy with delayed concomitant boost can deliver 65 Gy with acceptable toxicity, encouraging rates of complete response, and locoregional control, and no compromise of salvage surgery in patients with locally advanced SCCHN. The regimen is worthy of further study in a Phase III trial.

In order to determine the efficacy and toxicity of the gonadotrophin-releasing hormone agonist Leuprolide in the management of patients with recurrent or metastatic endometrial cancer, we performed a phase II study. Patients were included if there was clinical or radiological documentation of bidimensionally measurable recurrent or metastatic endometrial cancer that was deemed incurable. Treatment was 7.5 mg im every 28 days, and was to continue for at least 2 courses until evidence of disease progression, patient requested withdrawal, or unacceptable toxicity. Twenty-five patients received Leuprolide for recurrent or metastatic endometrial cancer. The median age at study entry was 62 years, and the median time from initial diagnosis to first course of Leuprolide was 25 months. Six patients had received no systemic or radiotherapy prior to study entry, and 2 of these had not previously undergone hysterectomy. Fifteen patients received prior pelvic radiotherapy and 3 patients received prior whole abdominal radiotherapy. Nine of the 25 patients had received prior progestational agents, and 2 had received prior systemic chemotherapy. There were no responders, 8 patients had stable disease for a median 5 months (range 1–8), 14 patients progressed on therapy, and 3 patients were not evaluable for response due to receiving only 1 treatment. One patient experienced a grade 3 toxicity that was possibly attributable to Leuprolide (deep venous thrombosis). The median survival from study entry was 6 months. Twelve patients received progesterone after discontinuing this study, and none responded. Leuprolide does not appear to be a clinically active agent in the treatment of recurrent or metastatic endometrial cancer.

Fifty-four patients with recurrent endometrial carcinoma were identified from a retrospective review of charts of 304 endometrial cancer patients seen between 1983 and 1989 at our center. A review was undertaken to identify the patterns of relapse, to determine the outcome of salvage treatment, to examine the factors predictive of effective salvage, and, if salvage is effective, to assess an alternative strategy to routine adjuvant postoperative pelvic radiotherapy. Forty percent of the entire recurrent population are long-term survivors. Of the 54 relapsing patients, primary therapy had been surgery alone in 32 and surgery and adjuvant radiotherapy (RT) in 22. Isolated pelvic recurrence was the predominate relapse site in those who had not received adjuvant pelvic RT as primary therapy (23 of 32 or 72%). Distant relapse predominated in those who received adjuvant RT (17 of 22 or 77%). Twenty-eight (54%) failed in the pelvis alone, and 26 (46%) had a component of distant failure. Of the 28 with isolated pelvic relapse, 16 had vaginal mucosal disease involvement only and 12 had disease in the parametrium and/or the pelvic sidewall. With a minimum follow-up for the survivors of 5 years, 21 of the 28 with isolated pelvic relapse received radical radiotherapy and 14 or 67% had maintained pelvic control until death or last follow-up. Eleven of 14 (79%) with disease confined to the mucosa had pelvic control, whereas only 3 of 7 (43%) with extramucosal disease were controlled. No patient experienced major treatment-related toxicity. Tumor size, anatomic extent of pelvic recurrence, RT dose, and disease-free interval were examined for prognostic significance for pelvic control and survival by univariate analysis. Only anatomic extent of pelvic recurrence showed a nonstatistically significant trend as a predictor for control with P = 0.08. In conclusion, a significant proportion of patients with disease recurrence confined to the pelvis can be rendered disease-free long-term with maintained pelvic control. A reexamination of the role of routine adjuvant pelvic RT is therefore undertaken in light of these data.

In an effort to determine if differences exist in the treatment and outcome of patients with suboptimally debulked stage IIIc and IV epithelial ovarian cancer between two tertiary-care cancer centers in Canada and the United States, we conducted a comparative study. The records of all patients who underwent treatment for epithelial ovarian cancer at two tertiary-care cancer centers in Canada and the United States between 1987 and 1989 were abstracted onto a common datasheet which was then entered into a computerized database for analysis. Only patients with suboptimally debulked stage IIIc disease (residual tumor diameter1 cm) or stage IV were included in the comparative study. There was a total of 129 evaluable patients (61 Canadian, 68 American). There were no statistically significant differences between the centers in mean age, performance status, histology, grade, or stage distribution. During the period of this study there was no statistically significant difference between the two institutions in the proportion of patients in whom optimal debulking was achieved (Canadian 19%, American 26%). The American patients were heavier than the Canadian patients (Quetelet index 27.3 vs 23.8, P0.006). Primary chemotherapy included a platin-containing regimen in 98 and 93% of Canadian and American patients, respectively. The average number of laparotomies each patient received during her course of illness was 1.7 and 2.5 at the Canadian and the American centers, respectively (P0.0001). Similarly, the American patients received a higher mean number of different chemotherapy regimens and total number of courses of chemotherapy during the course of their disease (3.0 and 12.6) than did the Canadian patients (2.4 and 8.8) (P0.01 and P0.001, respectively). The median survival was 21 months and 20 months in the Canadian and the American patients, respectively (no significant difference), and the 5-year survival was 10% for the Canadian and 11% for the American patients. Despite significant differences in the overall aggressiveness of treatment between the two centers, there was no difference in the survival of these patients. Until effective salvage agents or treatment strategies are realized, "more is not necessarily better."