Sexual Adjustment and Body Image Scale (SABIS): a new measure for breast cancer patients.

The purpose of this study was to develop and validate a self-report measure of body image and sexual adjustment in breast cancer patients: the Sexual Adjustment and Body Image Scale (SABIS). Three hundred and fifty three women diagnosed with primary breast cancer that had completed initial surgical treatment completed the SABIS and five measures of psychological, psychosocial, and sexual functioning. Psychometric properties of the SABIS were examined and it was found to be a reliable and valid means of assessing body image and sexuality in breast cancer patients following surgery.

How do patient expectancies, quality of life, and postchemotherapy nausea interrelate?

BACKGROUND: Increasing evidence suggests a relation between patient expectancies and chemotherapy-induced nausea. However, this research has often failed to adequately control for other possible contributing factors. In the current study, the contribution of patient expectancies to the occurrence and severity of postchemotherapy nausea was examined using more stringent statistical techniques (namely hierarchical regression) than other similar studies that have relied on bivariate correlations, chi-square tests, and stepwise regression, and further extended upon previous research by including quality of life (QoL) in the analysis. METHODS: In all, 671 first-time chemotherapy patients taking part in a trial comparing antiemetic regimens answered questions regarding their expectancies for experiencing nausea. Patients then completed a diary assessing both the occurrence and severity of their nausea in the 4 days after their first infusion. RESULTS: Stronger expectancies for nausea corresponded with greater average and peak nausea after chemotherapy and this was after controlling for age, sex, susceptibility to motion sickness, diagnosis, and QoL. Interestingly, patients classified as highly expectant (first quartile) experienced significantly greater average and peak nausea than those classified as somewhat expectant, slightly expectant, and not expectant (second, third, and fourth quartiles, respectively), whereas there were no significant differences between these lower levels of expectancy. Furthermore, increases in average nausea led to a significant reduction in QoL after chemotherapy. CONCLUSIONS: Patient expectancies appear to contribute to postchemotherapy nausea and patients that are highly expectant of experiencing nausea appear to be at particular risk. Interventions that target these patients should reduce the burden of nausea and may also improve QoL.

Effect of a nausea expectancy manipulation on chemotherapy-induced nausea: a university of Rochester cancer center community clinical oncology program study.

Several studies have shown that patients' expectancies for the development of nausea following chemotherapy are robust predictors of that treatment-related side effect, and some studies have shown that interventions designed to influence expectancies can affect patients' reports of symptoms. In this randomized, multicenter, Community Clinical Oncology Program trial, we investigated the effect of an expectancy manipulation designed to reduce nausea expectancy on chemotherapy-induced nausea in 358 patients scheduled to receive chemotherapy treatment. Patients in the intervention arm received general cancer-related educational material plus specific information about the efficacy of ondansetron, specifically designed to diminish nausea expectancy. Patients in the control arm received only the general cancer-related educational material. Nausea expectancy was assessed both prior to and following the educational intervention. We observed a significant reduction in nausea expectancy in the intervention group (P=0.024) as compared to the control group (P=0.34). In the intervention group, patients' expectations of nausea assessed prior to the intervention correlated significantly with average nausea (r=0.27, P=0.001), whereas nausea expectancy assessed following the intervention did not (r=0.1, P=0.22). Although the expectancy manipulation reduced patients' reported expectations for the development of nausea, the occurrence of nausea was not reduced. Furthermore, post-intervention nausea expectancy compared to pre-intervention expectancy was less predictive of subsequent nausea. Explanations for these findings include the possibility that the expectancy manipulation was not strong enough, and the possibility that changing nausea expectancies does not change occurrence of nausea.

Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07.

PURPOSE: The randomized, multicenter, phase III protocol C-07 compared the efficacy of adjuvant bolus fluorouracil and leucovorin (FULV) versus FULV with oxaliplatin (FLOX) in stage II or III colon cancer. Definitive analysis revealed an increase in 4-year disease-free survival from 67.0% to 73.2% in favor of FLOX. This study compares neurotoxicity between the treatments. PATIENTS AND METHODS: Neurotoxicity was recorded for all patients using standard adverse event reporting. Patients at select institutions completed a neurotoxicity questionnaire through 18 months of follow-up. RESULTS: A total of 2,492 patients enrolled onto C-07 and 400 patients enrolled onto the patient-reported substudy. Mean patient-reported neurotoxicity was higher with oxaliplatin throughout the 18 months of study (P < .0001). During therapy, patients receiving oxaliplatin experienced significantly more hand/foot toxicity (eg, "quite a bit" of cold-induced hand/foot pain 26% FLOX v 2.6% FULV) and overall weakness (eg, moderate weakness in 27.4% FLOX v 16.2% FULV). At 18 months, hand neuropathy had diminished, but patients who received oxaliplatin experienced continued foot discomfort (eg, moderate foot numbness and tingling for 22.1% FLOX v 4.6% FULV). Observer-reported neurotoxicity was low grade and primarily neurosensory rather than neuromotor. Sixty-eight percent in the FLOX group v 8% in the FULV group had neurotoxicity at their first on-treatment assessment. Time to resolution was significantly longer for those receiving oxaliplatin, and continued beyond 2 years for more than 10% in the oxaliplatin group. CONCLUSION: Oxaliplatin causes significant neurotoxicity. It is experienced primarily in the hands during therapy and in the feet during follow-up. In a minority of patients the neurotoxicity is long lasting.

Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07.

PURPOSE: This phase III clinical trial evaluated the impact on disease-free survival (DFS) of adding oxaliplatin to bolus weekly fluorouracil (FU) combined with leucovorin as surgical adjuvant therapy for stage II and III colon cancer. PATIENTS AND METHODS: Patients who had undergone a potentially curative resection were randomly assigned to either FU 500 mg/m2 intravenous (IV) bolus weekly for 6 weeks plus leucovorin 500 mg/m2 IV weekly for 6 weeks during each 8-week cycle for three cycles (FULV), or the same FULV regimen with oxaliplatin 85 mg/m2 IV administered on weeks 1, 3, and 5 of each 8-week cycle for three cycles (FLOX). RESULTS: A total of 2,407 patients (96.6%) of the 2,492 patients randomly assigned were eligible. Median follow-up for patients still alive is 42.5 months. The hazard ratio (FLOX v FULV) is 0.80 (95% CI, 0.69 to 0.93), a 20% risk reduction in favor of FLOX (P < .004). The 3- and 4-year disease-free survival (DFS) rates were 71.8% and 67.0% for FULV and 76.1% and 73.2% for FLOX, respectively. Grade 3 neurosensory toxicity was noted in 8.2% of patients receiving FLOX and in 0.7% of those receiving FULV (P < .001). Hospitalization for diarrhea associated with bowel wall thickening occurred in 5.5% of the patients receiving FLOX and in 3.0% of the patients receiving FULV (P < .01). A total of 1.2% of patients died as a result of any cause within 60 days of receiving chemotherapy, with no significant difference between regimens. CONCLUSION: The addition of oxaliplatin to weekly FULV significantly improved DFS in patients with stage II and III colon cancer. FLOX can be recommended as an effective option in clinical practice.

Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06.

PURPOSE: The primary aim of this study was to compare the relative efficacy of oral uracil and tegafur (UFT) plus leucovorin (LV) with the efficacy of weekly intravenous fluorouracil (FU) plus LV in prolonging disease-free survival (DFS) and overall survival (OS) after primary surgery for colon carcinoma. PATIENTS AND METHODS: Between February 1997 and March 1999, 1,608 patients with stage II and III carcinoma of the colon were randomly assigned to receive either oral UFT+LV or intravenous FU+LV. RESULTS: Of the total patients, 47% had stage II colon cancer, and 53% had stage III colon cancer. Median follow-up time was 62.3 months. The estimated hazard ratio (HR) for OS of patients who received UFT+LV versus that of patients who received FU+LV was 1.014 (95% CI, 0.825 to 1.246). The estimated HR for DFS was 1.004 (95% CI, 0.847 to 1.190). Cox proportional hazards model analyses with regard to age (< 60 v > or = 60 years), stage, or number of involved nodes (none v one to three v > or = four nodes) revealed no interaction with OS or DFS. Toxicity was similar in the two groups. In the UFT+LV arm, 38.2% of patients experienced any grade 3 or 4 toxic event compared with 37.8% of patients in the FU+LV arm. Primary quality-of-life end points did not differ between the two regimens, although convenience of care analysis favored UFT+LV. CONCLUSION: UFT+LV achieved similar DFS and OS when compared with an intravenous, weekly, bolus FU+LV regimen. The two regimens were equitoxic and generally well tolerated.

Prevalence of complementary and alternative medicine use in cancer patients during treatment.

GOALS OF WORK: To assess complementary and alternative medicine (CAM) therapies being utilized by cancer patients during treatment and communication about CAM usage between the patient and physician. PATIENTS AND METHODS: Newly diagnosed cancer patients receiving chemotherapy or radiation therapy were recruited to complete a CAM survey within 2 weeks after the termination of treatment. Patients were queried on which CAM modalities they utilized and whether or not they were discussed with either their oncologist or primary care physician. MAIN RESULTS: Of the patients surveyed, 91% reported using at least one form of CAM. The most widely used forms of CAM were prayer, relaxation and exercise. CAM users tended to be women chemotherapy patients with at least a high school education. Of the patients using CAM, 57% discussed the use of at least one of these therapies with their oncologist or primary care physician. The most frequent CAM modalities discussed with at least one physician were diets, massage, and herbal medicine. CONCLUSIONS: An overwhelming proportion of cancer patients are using CAM, particularly prayer, relaxation, and exercise. However, patients may not discuss the use of CAMs at all or fully with their physician; if they do, it is most likely to be their oncologist, but not about the most frequently used CAMs. Future research needs to assess effective ways for oncologists to gather information about CAM usage by patients during allopathic treatment and discern ways these therapies may enhance or interfere with traditional cancer treatments.