Complementary needs behind complementary therapies in cancer patients.

OBJECTIVE: Although many studies indicate that the use of complementary and alternative medicine by cancer patients is common and widespread, few studies have focused on unmet needs of patients using complementary therapies (CTs). The aim of the present study was to evaluate, through a quantitative approach, possible associations between the use of CTs and the presence of specific unmet needs in cancer patients. METHODS: In six Italian oncology departments, 783 patients were interviewed about CTs use and completed the Needs Evaluation Questionnaire. Patients included in the study had different primary tumor sites and were in different phases of the disease and care process. RESULTS: At the time of the survey, 38.3% of patients were using one or more types of CTs. According to Needs Evaluation Questionnaire, the use of CTs was associated (p < .05) with the need to be more involved in therapeutic choices (40% vs. 31.7%), the need to have a better dialogue with clinicians (44.4% vs. 37.2%), and the need to have more economic-insurance information in relation to their illness (46.1% vs. 36.4%). Statistical significance was confirmed with multivariable analysis for the last two items, whereas three more needs were associated with the use of CTs after adjustment: to receive more explanation on treatments (46.8% vs. 41.0%), to receive more comprehensible information (38% vs. 31.9%), and to receive more attention from nurses (16% vs. 12.1%). CONCLUSIONS: Our study shows interesting differences regarding perceived needs between cancer patients who use and who do not use CTs. Unmet needs that are more expressed in CTs users should be known and, when possible, could be taken into account to improve both psychosocial interventions in the context of conventional care process and the quality of the relationship between patient and medical and nursing staff.

Randomized trial of fenretinide to prevent second breast malignancy in women with early breast cancer.

BACKGROUND: Fenretinide, a vitamin A analogue, has been shown to inhibit breast carcinogenesis in preclinical studies. We determined the efficacy of fenretinide in preventing a second breast malignancy in women with breast cancer. METHODS: We randomly assigned 2972 women, aged 30-70 years, with surgically removed stage I breast cancer or ductal carcinoma in situ to receive for 5 years either fenretinide orally (200 mg/day) or no treatment. The primary end point was the incidence of contralateral breast cancer or ipsilateral breast cancer 7 years after randomization. Other end points considered post hoc were the same outcomes stratified by menopausal status, incidence of distant metastases, overall mortality, and tumors in other organs. The hazards of breast cancer occurrence were determined by Cox proportional hazards regression analysis. Statistical tests were two-sided. RESULTS: At a median observation time of 97 months, there were no statistically significant differences in the occurrence of contralateral breast cancer (P =.642) or ipsilateral breast cancer (P =.177) between the two arms. However, an interaction was detected between fenretinide treatment and menopausal status in both outcomes (P for interaction in both outcomes =.045), with a possible beneficial effect in premenopausal women (contralateral breast cancer: adjusted hazard ratio [HR] = 0.66, and 95% confidence interval [CI] = 0.41-1.07; ipsilateral breast cancer: adjusted HR = 0.65, and 95% CI = 0.46-0. 92) and an opposite effect in postmenopausal women (contralateral breast cancer: adjusted HR = 1.32, and 95% CI = 0.82-2.15; ipsilateral breast cancer: adjusted HR = 1.19, and 95% CI = 0.75-1. 89). There were no statistically significant differences between the two arms in tumors in other organs, incidence of distant metastasis, and all-cause mortality. CONCLUSIONS: Fenretinide treatment of women with breast cancer for 5 years appears to have no statistically significant effect on the incidence of second breast malignancies overall, although a possible benefit was detected in premenopausal women. These studies, particularly the post hoc analyses, are considered exploratory and need to be confirmed.

Risk of endometrial cancer in breast cancer patients under long-term adjuvant treatment with tamoxifen.

AIMS: To evaluate the relative risk of endometrial cancer with respect to the expected underlying incidence in breast cancer patients undergoing long-term adjuvant tamoxifen therapy. METHODS: A total of 1010 postmenopausal breast cancer patients receiving adjuvant tamoxifen and with a first negative endometrial ultrasonography (cutoff for abnormal endometrial thickness >5 mm) were followed by annual transvaginal ultrasonography. Abnormal endometrial thickness prompted an outpatient endometrial biopsy or curettage under anesthesia in the case of cervical stenosis and increasing endometrial thickness. The standardized incidence ratio (SIR) with respect to underlying incidence was determined. RESULTS: A total of 1,010 eligible subjects who had been receiving tamoxifen for an average of 51 months were enrolled and followed for a total of 2,361 patient-years between January 1993 and December 1996. Five cases of endometrial cancer were observed in the study period: 1 was detected at screening, and 4 were diagnosed for vaginal bleeding in the interval between screening examinations. SIR was 4.0 (95% confidence interval, 1.3-9.4) and increased to 4.8 (CI, 1.6-10.5) when the single cancer detected at first screening was considered as incident. CONCLUSIONS: This study adds evidence to the hypothesis that long-term tamoxifen treatment may be responsible for a relevant increase in the risk of developing endometrial cancer. Surveillance based on endometrial ultrasonography was poorly sensitive, but the favorable stage at diagnosis of screen-detected or interval endometrial cancers does not support a more aggressive screening approach.

[Cystic lymphangioma: etiopathogenetic and diagnostic considerations apropos of 2 cases]. / Il linfangioma cistico: considerazioni etiopatogenetiche e diagnostiche a proposito di 2 casi.

The authors show two cases of cystic lymphangioma, one located at the neck, the other in the inguinal region, both arising in aged patients. From the study of such cases, the Authors start for studying the etiopathogenetic and histologic aspects, dwell upon the clinics and diagnosis of such neoplasms, and indicate as the sole radical treatment the surgical extirpation.

Worldwide distribution of PSEN1 Met146Leu mutation: a large variability for a founder mutation.

OBJECTIVE: Large kindreds segregating familial Alzheimer disease (FAD) offer the opportunity of studying clinical variability as observed for presenilin 1 (PSEN1) mutations. Two early-onset FAD (EOFAD) Calabrian families with PSEN1 Met146Leu (ATG/CTG) mutation constitute a unique population descending from a remote common ancestor. Recently, several other EOFAD families with the same mutation have been described worldwide. METHODS: We searched for a common founder of the PSEN1 Met146Leu mutation in families with different geographic origins by genealogic and molecular analyses. We also investigated the phenotypic variability at onset in a group of 50 patients (mean age at onset 40.0 +/- 4.8 years) by clinical, neuropsychological, and molecular methodologies. RESULTS: EOFAD Met146Leu families from around the world resulted to be related and constitute a single kindred originating from Southern Italy before the 17th century. Phenotypic variability at onset is broad: 4 different clinical presentations may be recognized, 2 classic for AD (memory deficits and spatial and temporal disorientation), whereas the others are expressions of frontal impairment. The apathetic and dysexecutive subgroups could be related to orbital-medial prefrontal cortex and dorsolateral prefrontal cortex dysfunction. CONCLUSIONS: Genealogic and molecular findings provided evidence that the PSEN1 Met146Leu families from around the world analyzed in this study are related and represent a single kindred originating from Southern Italy. The marked phenotypic variability might reflect early involvement by the pathologic process of different cortical areas. Although the clinical phenotype is quite variable, the neuropathologic and biochemical characteristics of the lesions account for neurodegenerative processes unmistakably of Alzheimer nature.

[Combined diagnosis of breast cancer recurrences after conservative treatment. Critical review of 143 consecutive cases]. / La diagnostica combinata delle recidive intramammarie dopo terapia conservativa. Revisione critica di 143 casi consecutivi.

The diagnostic features are reported of 143 consecutive patients with breast cancer intramammary recurrences observed after conservative treatment, 1984 to 1994. Disease-free interval after surgery was 3.7 years on the average, being longer for the patients receiving postoperative breast irradiation (3.9 vs 3.1 years). The conserved breast was followed-up on a regular basis with palpation and mammography, whereas US and cytology were used only in selected suspicious cases. Palpation, mammography, cytology or US suspected the recurrence in 75, 64, 81 and 77% of cases, respectively. Mammographic false negatives were not explained by breast parenchymal density (Wolfe's pattern) or by breast irradiation, but were likely to be ascribed to the masking effect of surgical scars and distortion. Most failures at cytology were caused by inadequate sampling: when sampling was adequate, cytology exhibited the highest sensitivity (97%). In all, combined palpation + mammography, palpation + cytology and palpation + mammography + cytology diagnosed correctly 97, 98 and 100% of cases, respectively. Palpation should be always combined with mammography in the follow-up of the conserved breast, but US and aspiration cytology should be performed in case of any clinico-radiologic abnormality carrying even a minimal risk of recurrence.

[The combined diagnosis of male breast lesions: a review of a series of 748 consecutive cases]. / Diagnostica combinata delle lesioni mammarie maschili: revisione di una serie di 748 casi consecutivi.

The authors reviewed a series of 748 consecutive male patients referred for breast screening; their average age was 50.5 years. A malignant lesion was detected in 20 patients (18 infiltrating ductal carcinomas, 1 intraductal carcinoma and 1 myxosarcoma). Of 18 infiltrating carcinomas, 17 were found in patients over 60 years of age; pT classes were pT1c in 13 patients, pT2 in 2, pT4b in 1, pT4d in 1 and pTx in one patient. Biopsy demonstrated 92 benign lesions (74 gynecomastia cases and 18 other lesions), whereas 636 lesions were considered benign at direct or cancer registry follow-up. Sensitivity was 85% for palpation, 88.8% for mammography, 93.7% for cytology and 100% for US. Specificity was 95.3%, 94%, 95.6% and 97.9%, respectively. Combined palpation and mammography had 100% sensitivity. Sixty-five of 92 benign lesions were submitted to biopsy, even in the absence of suspicion, for psychological/cosmetic reasons. Negative cytology spared unnecessary biopsy in 9 cases, which were fairly suspicious at other exams. To conclude, we confirm the role of this multimodality clinical-instrumental diagnostic approach, with a special emphasis on the role of US. Cytology was as useful to avoid unnecessary open biopsy in men as it is in women. Male breast cancer has the same semiology as female breast cancer, though with a prevalence of opacities with blurred outline and in the absence of scirrhous-stellate patterns. The diagnostic protocol we used to diagnose breast cancer in women seems to be fully indicated also in men.

Prognostic factors for lymphedema after primary treatment of breast carcinoma.

BACKGROUND: Lymphedema of the arm is a serious consequence of breast carcinoma treatment. Postmastectomy lymphedema of the upper limb usually is related to certain risk factors such as axillary surgery, radiotherapy, obesity, venous outflow obstruction, delayed wound healing, and infection. The objective of the current study was to identify the risk factors for secondary lymphedema after breast carcinoma treatment. METHODS: A total of 1278 breast carcinoma patients, all of whom were residents of Florence area, Italy at the time of diagnosis and who were operated on by the same surgeon between 1989 and 1997, were included in the current analysis. The circumference of the upper arm was measured and lymphedema was defined as being present when an increase of > 5% of the sum differences between the two arms was found. The observed cumulative probability of lymphedema occurrence was estimated using the Kaplan-Meier method. The Cox proportional hazards models were fitted to assess the relative excess risk of lymphedema and to check for confusing factors. All patients with lymphedema who were living in the Florence area were referred to a specialist for treatment. RESULTS: Two hundred three cases of lymphedema of the ipsilateral arm were found (15.9%). The right arm was affected in 44.5% of the cases and the left arm in 55.5%. The risk of developing late lymphedema was found to be significantly related to a pathologic T2 classification (hazards ratio [HR] = 1.44; 95% confidence interval [95% CI], 1.06-1.94) and postoperative radiotherapy (HR = 1.35; 95%CI, 1.00-1.83). Patients who had > 30 lymph nodes removed were found to have a borderline increased risk of lymphedema (HR = 1.64; 95% CI, 0.99-2.74). Multivariate analysis identified postoperative radiotherapy (HR = 1.38; 95% CI, 1.02-1.86) and the number of lymph nodes removed (HR = 1.29; 95% CI, 1.04-1.59) to be independent predictors of lymphedema. CONCLUSIONS: The results of the current study demonstrated that the risk of lymphedema was correlated with the use of postoperative radiotherapy and the number of lymph nodes removed.

Screening by ultrasonography for endometrial carcinoma in postmenopausal breast cancer patients under adjuvant tamoxifen.

Seven-hundred thirty-seven asymptomatic postmenopausal breast cancer patients under long-term adjuvant tamoxifen therapy (average, 50 months) were screened by endometrial ultrasonography. Abnormal endometrial thickness (6 mm or larger) was observed in 209 subjects and was significantly associated with patients' age and duration of tamoxifen therapy. Outpatient endometrial biopsy was recommended in presence of abnormal endometrial thickness: 25 subjects refused biopsy, whereas 76 were not biopsied because of cervical stenosis and were followed-up by repeat sonography. Of 108 biopsied subjects, one case of endometrial carcinoma (as expected in the screened cohort according to age-specific incidence rates provided by the regional cancer registry) and one case of endometrial hyperplasia were histologically confirmed, whereas endometrial atrophy was evident in the remaining cases. No other case of endometrial carcinoma has been recorded so far in the studied cohort according to the local cancer registry and no further change of the endometrium has been observed at sonographic follow-up. The cohort will be followed-up by repeat annual endometrial sonography. Thus far, we did not find evidence of increased prevalence of endometrial pathology (carcinoma or hyperplasia) which may be ascribed to tamoxifen therapy. The apparent increase in endometrial thickness observed at sonography might be explained by tamoxifen-induced changes of endometrial stroma and myometrium, misinterpreted as hyperplasia, while causing no real epithelial disease.