Is There Room for Liposomal Irinotecan in Biliary Tract Cancer? A Meta-analysis of Randomised Trials.

AIMS: The combination of 5-fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX) is widely acknowledged as the standard regimen for second-line treatment in patients with advanced biliary tract cancer. Nanoliposomal irinotecan (nal-IRI) has demonstrated its activity in patients with advanced pancreatic cancer. Recent studies have investigated the activity of nal-IRI in combination with 5-FU/LV for biliary tract cancer. However, the results have been contradictory. We conducted a meta-analysis to assess survival outcomes and response rates in randomised trials investigating the activity of nal-IRI in previously treated biliary tract cancer patients. MATERIALS AND METHODS: We systematically collected potentially relevant findings from PubMed/Medline, the Cochrane library and EMBASE. Abstracts presented at major international oncological meetings were also reviewed. We extracted hazard ratios and 95% confidence intervals for progression-free survival and overall survival, as well as odds ratios and 95% confidence intervals for objective response rate. The outcomes of the accessible randomised studies evaluating the activity of nal-IRI plus 5-FU/LV were analysed. RESULTS: The combination therapy exhibited a statistically significant decrease in the risk of progression (hazard ratio 0.70; 95% confidence interval 0.50-0.97) when compared with 5-FU/LV alone. Additionally, the dual regimen yielded longer overall survival and a higher objective response rate. CONCLUSION: Our meta-analysis showed that nal-IRI plus 5-FU/LV had a superior activity in comparison with 5-FU/LV. Further investigations are required to elucidate the role of nal-IRI in this setting and to identify subgroups of patients who could derive the greatest benefit from its administration.

An Italian multicenter retrospective real-life analysis of patients with brain metastases from renal cell carcinoma: the BMRCC study.

BACKGROUND: The treatment of patients with brain-spread renal cell carcinoma (RCC) is an unmet clinical need, although more recent therapeutic strategies have significantly improved RCC patients' life expectancy. Our multicenter, retrospective, observational study investigated a real-world cohort of patients with brain metastases (BM) from RCC (BMRCC). PATIENTS AND METHODS: A total of 226 patients with histological diagnosis of RCC and radiological evidence of BM from 22 Italian institutions were enrolled. Univariate and multivariate models were performed to investigate the impact of clinicopathological features and multimodal treatments on both overall survival (OS) from the BM diagnosis and intracranial progression-free survival (iPFS). RESULTS: The median OS from the BM diagnosis was 18.8 months (interquartile range: 6.2-43 months). Multivariate analysis confirmed the following as positive independent prognostic factors: a Karnofsky Performance Status >70% [hazard ratio (HR) = 0.49, 95% confidence interval (CI) 0.26-0.92, P = 0.0026] and a single BM (HR = 0.51, 95% CI 0.31-0.86, P = 0. 0310); in contrast, the following were confirmed as worse prognosis factors: progressive extracranial disease (HR = 1.66, 95% CI 1.003-2.74, P = 0.00181) and only one line of systemic therapy after the BM occurrence (HR = 2.98, 95% CI 1.62-5.49, P = 0.029). Subgroup analyses showed no difference in iPFS according to the type of the first systemic treatment [immunotherapy (IT) or targeted therapy (TT)] carried out after the BM diagnosis (HR = 1.033, 95% CI 0.565-1.889, P = 0.16), and revealed that external radiation therapy (eRT) significantly prolonged iPFS when combined with IT (10.7 months, 95% CI 4.9-48 months, P = 0.0321) and not when combined with TT (9.01 months, 95% CI 2.7-21.2 months, P = 0.59). CONCLUSIONS: Our results suggest a potential additive effect in terms of iPFS for eRT combined with IT and encourage a more intensive multimodal therapeutic strategy in a multidisciplinary context to improve the survival of BMRCC patients.

International Tailored Chemotherapy Adjuvant (ITACA) trial, a phase III multicenter randomized trial comparing adjuvant pharmacogenomic-driven chemotherapy versus standard adjuvant chemotherapy in completely resected stage II-IIIA non-small-cell lung cancer.

BACKGROUND: Several strategies have been investigated to improve the 4% survival advantage of adjuvant chemotherapy in early-stage non-small-cell lung cancer (NSCLC). In this investigator-initiated study we aimed to evaluate the predictive utility of the messenger RNA (mRNA) expression levels of excision repair cross complementation group 1 (ERCC1) and thymidylate synthase (TS) as assessed in resected tumor. PATIENTS AND METHODS: Seven hundred and seventy-three completely resected stage II-III NSCLC patients were enrolled and randomly assigned in each of the four genomic subgroups to investigator's choice of platinum-based chemotherapy (C, n = 389) or tailored chemotherapy (T, n = 384). All anticancer drugs were administered according to standard doses and schedules. Stratification factors included stage and smoking status. The primary endpoint of the study was overall survival (OS). RESULTS: Six hundred and ninety patients were included in the primary analysis. At a median follow-up of 45.9 months, 85 (24.6%) and 70 (20.3%) patients died in arms C and T, respectively. Five-year survival for patients in arms C and T was of 65.4% (95% CI (confidence interval): 58.5% to 71.4%) and 72.9% (95% CI: 66.5% to 78.3%), respectively. The estimated hazard ratio (HR) was 0.77 (95% CI: 0.56-1.06, P value: 0.109) for arm T versus arm C. HR for recurrence-free survival was 0.89 (95% CI: 0.69-1.14, P value: 0.341) for arm T versus arm C. Grade 3-5 toxicities were more frequently reported in arm C than in arm T. CONCLUSION: In completely resected stage II-III NSCLC tailoring adjuvant chemotherapy conferred a non-statistically significant trend for OS favoring the T arm. In terms of safety, the T arm was associated with better efficacy/toxicity ratio related to the different therapeutic choices in the experimental arm.

2-weekly docetaxel: issues for clinical practice.

In the phase III trial comparing 2 docetaxel schedules (3-weekly versus 2-weekly) as first-line chemotherapy for CRPC, recently published in The Lancet Oncology, fewer serious adverse events, particularly hematologic toxicities, and longer times on treatment, in favor of the 2-weekly regimen are reported. (1,2,3.)

Development and daily use of an electronic oncological patient record for the total management of cancer patients: 7 years' experience.

BACKGROUND: We describe our experience with an electronic oncological patient record (EOPR) for the total management of cancer patients. METHODS: The web-based EOPR was developed on the basis of a user-centred design including user education and training, followed by continuous assistance; user acceptance was monitored by means of three questionnaires administered after 2 weeks, 6 months and 6 years. RESULTS: The EOPR has been used daily for all in-ward, day hospital and ambulatory clinical activities since July 2000. The most widely appreciated functions are its rapid multipoint access, the self-updated summary of the patients' clinical course, the management of the entire therapeutic programme synchronised with working agendas and oncological teleconsultation. Security and privacy are assured by means of the separate storage of clinical and demographic data, with access protected by login and a password. The questionnaires highlighted appreciation of rapid data retrieval and exchange and the perception of improved quality of care, but also revealed a sense of additional work and a negative impact on doctor-patient relationships. CONCLUSIONS: Our EOPR has proved to be effective in the total management of cancer patients. Its user-centred design and flexible web technology have been key factors in its successful implementation and daily use.

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.

Docetaxel (75 mg m(-2) 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m(-2) for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, < or =75 years, ECOG PS < or =2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77-1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3-4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.

Radiosensitization with chemotherapeutic agents.

The combination of low-dose chemotherapy and thoracic radiotherapy is one of the treatments proposed in an attempt to improve the prognosis of locally advanced non-small cell lung cancer. Chemotherapeutic drugs administered at subtoxic doses act by means of a radiosensitization mechanism. Platinum-derived drugs have been historically used as radiosensitizers, without cumulative unacceptable toxicity. Many new chemotherapeutic agents, which have shown promising results in terms of disease control in advanced non-small cell lung cancer, show also a radiosensitizing activity. However, the optimal dose and timing of such drugs when used concurrently to radiotherapy are unknown. This paper will review the results obtained using new chemotherapeutic drugs as radiosensitizers.

Quality of life in patients with early stage breast carcinoma treated with conservation surgery and radiotherapy. An Italian monoinstitutional study.

AIMS: To evaluate the quality of life (QOL) in patients with early stage invasive carcinoma of the breast treated with conservative surgery and postoperative irradiation. METHODS: A mailed survey to examine QOL was conducted in 227 subjects with breast cancer treated in 1990 and 1994 with conservation surgery plus definitive irradiation. The self-compiled questionnaire was developed based on a series of 38 items assessing six core areas of QOL. Furthermore, the patients were requested to evaluate the degree of information provided by the medical staff concerning the disease, the treatment and related side effects and to evaluate the effects of the treatment on their social, overall QOL, and health status. RESULTS: The questionnaire was completed by 156 patients (68.7%) who had a median age of 56 years (range, 28-75 years) at the time of treatment and 59 years (range, 31-82 years) at the time of the study. The physical condition was reported to be good. Data relating to sexual life were provided by more than 90% of the patients. Some limitations in sexuality, some interference with sexual desire, and some modifications during intercourse were reported by 11, 11, and 10 patients, respectively. The subjective evaluations of the cosmetic results of the therapies were judged good-excellent by 56% of the patients, 12 (8%) only had a negative perception of their body image. Twenty-five percent of the sample declared that they felt tense, 19% nervous, 18% lonely, 27% anxious and 16% depressed. Only six patients (4%) declared that the treatment had had a bad on their social life, and 18 (11%) thought that their health status has been affected by the treatment. A worsening of QOL due to the disease or the treatment was reported by 8% of the responders. The amount of information received concerning the treatment and its side effects was considered sufficient by most of the patients. CONCLUSIONS: The results of the study revealed a satisfactory health-related QOL in patients treated with breast conservation and postoperative irradiation. A preserved favorable body image and lack of a negative impact on sexuality was observed, even though about half of the patients reported a negative judgement on esthetic outcome. Some patients had persistent psychosocial concerns. No significant additional problems attributable to radiation therapy capable of affecting QOL outcomes were reported.

Quality of life after radiotherapy for early-stage testicular seminoma.

BACKGROUND AND PURPOSE: Standard therapy in early-stage testicular seminoma (TS) includes inguinal orchiectomy followed by irradiation (XRT) of the pelvic and para-aortic nodes. Since this treatment is highly effective in controlling the disease and leads to many long survivors, the quality of life (QL) may be impaired by treatment-induced side-effects. The aim of this study was to provide a QL evaluation of patients treated with XRT after orchiectomy for TS. MATERIALS AND METHODS: We used a validated self-completed questionnaire based on a series of 44 items covering all QL fields. The items were grouped into six subscales with standardized scores. The questionnaire was mailed to a consecutive series of 143 patients treated between 1961 and 1995 for TS with no evidence of disease after primary treatment. RESULTS: Ninety-eight questionnaires (68.5%) were returned and are assessable. The median age of the patients was 48 years (range, 26-85 years) at the time of completing the questionnaire, with a median follow-up after completion of treatment of 123 months (range, 15-432 months). The physical and autonomy subscale standardized scores were > or =1 in 83 and 95% of the cases, respectively. Psychological problems were reported by a small percentage of patients, ranging from 13, who reported a depressive condition, to 16%, who declared feeling tense. Of the patients, 86 and 89% have regularly met relatives and friends. The urinary score was above the central point in 99% of the patients. Only 6% of the patients perceived their body image as worsened by treatment. The patients who were more informed about the disease and therapy had a better physical and psychological adjustment. CONCLUSIONS: The QL in our patients resulted as satisfactory, with a maintained body image and few side-effects. The information given to the patients about their disease and its treatment influenced the post-treatment QL adjustment.

Concurrent adjuvant chemotherapy and immediate breast reconstruction with skin expanders after mastectomy for breast cancer.

BACKGROUND: Immediate breast reconstruction (IBR) by means of skin expander is currently one of the most widely used methods of breast reconstruction in mastectomized patients. However, given that many breast cancer patients usually receive adjuvant chemotherapy, the adoption of IBR raises new questions concerning possible cumulative toxicity. The present study reports our experience in the use of concurrent adjuvant chemotherapy and immediate breast reconstruction with skin expander after mastectomy for breast cancer and the acute cumulative toxicity of the treatments. METHODS: We evaluated a consecutive series of 52 breast cancer patients who have received IBR by skin expander after radical mastectomy and adjuvant chemotherapy concurrently during skin expansion between 1995 and 1998 (IBR/CT group). We identified two series of control patients treated during the same period: 51 consecutive patients undergoing radical mastectomy and IBR without adjuvant chemotherapy (IBR group) and 63 consecutive patients undergoing radical mastectomy and adjuvant chemotherapy without IBR (CT group). For each patient, we evaluated the incidence of surgical complications and chemotherapy's side effects and dose intensity. RESULTS: The interval between surgery and the start of expander inflation was similar in IBR/CT (range 0-19, median 5 days) and IBR groups (range 0-40, median 5 days) and the timing of inflation was not influenced by chemotherapy. The overall incidence of surgical complications in patients undergoing IBR was low: seroma in eight cases, infection in one, skin necrosis in one, expander rupture in two and erythema in three. There were no statistically significant differences in the distribution of complications between the IBR/CT and IBR groups. The dose intensity of chemotherapy was similar between IBR/CT and CT groups, with a median dose intensity of 96% and 95% of the projected dose, respectively. The only statistically significant difference in terms of chemotherapy side effects (p = 0.03) was that stomatitis was more frequent and intense in the CT than in the IBR/CT group. CONCLUSIONS: Concurrent treatment with IBR and adjuvant chemotherapy appears feasible and safe, it does not increase acute surgical complications or chemotherapy side effects, and does not require any changes in dose intensity or the timing of inflation.

p27(kip1) expression in breast carcinomas: an immunohistochemical study on 512 patients with long-term follow-up.

p27(Kip1) (p27), a cyclin-dependent kinase inhibitor, has an important role in the progression of cells from G(1) into S phase of the cell cycle. p27 may act as a tumor suppressor, and several reports suggest that loss of its expression in breast carcinoma is related to tumor progression and poor prognosis. We evaluated p27 immunohistochemical expression in 512 consecutive cases of breast carcinoma with 9 years of median-term follow-up. p27 expression was heterogeneous and frequently less intense than in normal cells. Low p27 expression (<50% of reacting cells) was associated with grade III tumors, N0 status, estrogen receptor-negative status, and low cyclin D1 expression. In the whole series of cases, p27 expression did not predict outcome. In node-negative cases (249 patients), high p27 expression indicated poor prognosis. p27 was not prognostically relevant in the group of 223 patients with pT1 disease or in the group of 154 patients <50 years of age. We also investigated the prognostic value of the combined expression of p27 and cyclin D1, but no differences in survival were seen in this bivariate analysis.

Ocular metastases from breast carcinoma: A multicentric retrospective study.

Breast cancer may affect the eye and orbit by metastatic neoplastic infiltration, uvea being the most common site of presentation. Management of these cases with radiotherapy is usually gratifying with reported response rate of approximately 75%. A retrospective evaluation of cases treated in five Institutions participating in a collaborative radiation therapy group of north-Italy is reported. Fifty-four cases of metastases to the eye or orbit were referred for radiation therapy to the Departments participating in the survey in the period 1977-1995. There were 49 female patients aged between 28 and 75 years (median, 44 years) at presentation of orbital metastasis. Thirty-eight lesions (70%) were metastases to the choroid, 9 involved other parts of the eye, and 7 patients had orbital metastases. Five of the 49 patients had bilateral choroidal metastases. Radiotherapy was employed with megavoltage equipment. The median total dose delivered was 40 Gy (range, 16-60 Gy). All the patients were treated 5 times per week with fraction sizes ranging from 1.8 to 3.0 Gy (median, 2.0 Gy). Of the 43 evaluable eyes, 34 (79%) showed a definite improvement after radiotherapy. There was a stabilization of the process in 4 patients. The rest (11 lesions) were lost to detailed follow-up of the response of the eye metastases. Twelve patients experienced acute transient cheratoconjunctivitis and in a case a subconjunctival haemorrhage was observed; as late side effects, two cases of chataract were observed during a period of observation of 37 and 117 months. A median survival time of 17 months was observed. The goal of irradiation was to improve vision or at least prevent blindness and enucleation. The palliative effect of irradiation was confirmed with a response rate consistent with the data of the literature on this subject.

Biological characterisation of superficial bladder cancer by bivariate cytokeratin 7/DNA analysis, flow cytometric assessment of MIB- 1, and an immunohistochemical study.

A total of 238 cases of bladder carcinoma stages Ta, Tis, T1 were submitted prospectively to multiparameter flow cytometry and immunohistochemical study in order to determine the biological aggressiveness of the tumour. DNA index (DI), S-phase fraction (SPF) obtained by bivariate cytokeratin 7/DNA analyses, and the immunohistochemical evaluation of p53 and MIB-1 were studied in relation to the traditional prognostic factors in bladder cancer (stage and grade). the variance analysis results showed that DNA aneuploidy was significantly associated with high stage (p = 0.0001), high grade (p = 0.0001), high SPF value > or = 5.5% (p = 0.0001), MIB-1 positivity > or = 31% (p = 0.0001) and high expression of p53 (staining involving > 50% of cells, p = 0.0001). Even if there was no statistical significance the hypotetraploid class (1.70 < DI < 1.89) showed poor prognostic biomarkers more frequently than the other aneuploid classes. Out of 238 cases, 101 were also submitted to flow cytometric measurement of MIB-1 (fMIB-1) to study the correlation between cell proliferation and DNA content. Data obtained from fresh, 3:1 methanol/acetone fixed samples were compared with values obtained from both cell cycle analysis methods and routine application of the MIB-1 immunostaining in histological sections. fMIB-1 values were positively correlated with SPF values (r = 0.801, p < 0.01) and S+G2M fraction (percentage of cells in S and in G2M phases) (r = 0.763, p < 0.01) but no correlation with paraffin sections was found. A fMIB-1 value > 7% was strongly associated with aneuploidy (p = 0.0001). The determination of DNA content coupled with the study of the epithelial (cytokeratin 7) and proliferative (MIB-1) markers could be useful in providing important information on the biological behaviour of superficial bladder tumours.

Prognostic value of estrogen receptor status can be improved by combined evaluation of p53, Bcl2 and PgR expression: an immunohistochemical study on breast carcinoma with long-term follow-up.

Steroid receptor analysis is the only widely accepted prognostic/predictive marker in breast cancer (BC) treatment. In the present study we evaluated the prognostic role of ER/PgR with p53 and Bcl2, in a series of 277 BC (153 pN1/2, 122 pNO, 2 pNx) with a long-term follow-up (67 months for DFS, 75 months for OS). Our results, besides confirming the usefulness of ER immunohistochemical expression as a prognostic marker, showed that PgR expression alone had a borderline/not significant prognostic value in the whole series (p=0.08 for DFS and p=0.09 for OS), while showed to be prognostic in N+ cases (p=0.02 for DFS and p=0.03 for OS). PgR prognostic value, however, was not independent at the multivariate analysis. By combining ER with PgR, p53 and Bcl2, we showed that ER/p53 and ER/Bcl2 phenotypes had a better discriminant role than ER/PgR phenotype. The ER+/p53+ phenotype was at higher risk of relapse/death as compared with ER+/p53- phenotype. Conversely ER-/p53+ phenotype showed the most unfavourable prognosis. Similar results could be observed concerning ER/Bcl2 phenotypes. Our study showed that the combined evaluation of ER/PgR weakly enhanced the prognostic/predictive power of ER status alone. On the contrary, the combined evaluation of ER/p53 and ER/Bcl2, improved this prognostic/predictive capability and allowed the separation of ER positive and ER negative cases into subgroups with different prognosis.

Quality of life in patients with ductal carcinoma in situ of the breast treated with conservative surgery and postoperative irradiation.

AIM OF THE STUDY: To evaluate the quality of life (QL) in patients with ductal carcinoma in situ of the breast treated with conservative surgery and postoperative irradiation. MATERIAL AND METHODS: A self-completed questionnaire covering many disease-, symptom-, and treatment-specific issues was administered to 106 conservatively treated patients affected by non-infiltrating breast cancer. The questionnaire was based on a series of 34 items assessing five main fields of post-treatment adjustment: physical well being, sexual adaptation, aesthetic outcome, emotional/psychological well being, relational behaviour. Furthermore, the patients were requested to evaluate the degree of information provided by the medical staff concerning surgical procedures and radiation therapy, and to evaluate the effects of the treatment on their social and overall life. RESULTS: The questionnaire was completed by 83 patients (78%), who had a median follow-up of 54.5 months. This final sample had a median age of 50 years (range 29-88) at the time of treatment and 54 years (range 32-94) at the time of study. The patients claimed to be in good physical condition. Data relating to sexual life were provided by 93% of the sample. Some limitations in sexuality, some interference with sexual desire, and some modifications during intercourse were reported by 5, 6, and 5 patients, respectively. The subjective evaluations of the cosmetic results of the therapies were generally good. Only 13 patients (16%) reported the perception of a worsened body image. Forty-six percent of the sample (38 patients) declared that they felt tense, 48% (39 patients) nervous, 29% (38 patients) lonely, 59% (41 patients) anxious, and 41% (34 patients) depressed. Only seven patients (8%) declared that the treatment had had a bad effect on their social life, and 15 (18%) thought that their current life had been affected by the treatment. The amount of information received concerning the disease and treatment (surgery and radiotherapy) was considered sufficient by 79%, 75%, and 79% of the sample, respectively. CONCLUSIONS: This study revealed a good QL in patients treated with breast conservation and postoperative irradiation, with a preserved favourable body image and a lack of negative impact on sexuality. Radiation therapy did not lead to any significant additional problems capable of affecting the QL.

Evaluation of sexual life after orchidectomy followed by radiotherapy for early-stage seminoma of the testis.

OBJECTIVE: To explore the changes perceived by patients in their sexual lives after orchidectomy and radiation therapy of the pelvic and para-aortic nodes for early-stage testicular seminoma (ST). PATIENTS AND METHODS: A questionnaire mainly based on two self-completed instruments, previously used to assess the sexual life of patients affected by testicular cancer (the UCLA/RAND sexual module and the Groningen sexual questionnaire) was mailed to a consecutive series of 143 patients treated for ST between 1961 and 1995, and who showed no signs of disease after primary treatment. RESULTS: Ninety-eight questionnaires (69%) were returned and were evaluable. The median age of the patients was 48 years (range 26-85) at the time they completed the questionnaire, with the median follow-up of 123 months (range 15-496). Most of the patients (86%) had been sexually active during the month before completing the questionnaire. Of these patients, 25% reported a low libido and 14% defined their sexual capacity as poor; 14% of the patients avoided sexual contact after treatment because of the disease and/or cancer therapies. After therapy, a minority of the patients found it more difficult to achieve and maintain an erection. Similarly, a few patients reached orgasm less intensely and less frequently. During the period after treatment, 24% reported a low semen volume, 14% premature ejaculation, 2% late ejaculation and 2% an absence of ejaculation. Most of the patients considered the information and counselling given by their physician about the sexual sequelae of therapy to be insufficient. However, the amount of information about the disease and treatment was considered to be good by, respectively, 64% and 61% of the patients. The only variable predictive of sexual adjustment was age at the time of the administration of the questionnaire. CONCLUSION: The sexual adjustment of patients treated with orchidectomy and radiation therapy for early-stage ST is generally good, but a few have negative experiences. Although the main predictive factor is age, communication is an important issue and better information tools could lead to better adjustment.

Patients' opinions, feelings, and attitudes after a campaign to promote the Di Bella therapy.

BACKGROUND: An emotional campaign promoting the Di Bella cancer therapy was launched by the Italian media in 1997. Its effects on patients' hopes, feelings, and decision-making processes were largely unknown. We undertook an investigation of this issue. METHODS: Between Feb 25 and March 31, 1998, a ten-item questionnaire was distributed to 1300 unselected adult patients attending 13 cancer centres throughout Italy. Four expert psycho-oncologists reviewed the design and validity of the contents of the questionnaire. Sociodemographic information was also collected. FINDINGS: 1120 (86%) questionnaires were returned and analysed. The main sources of information were television/radio (62%) and newspapers (26%); only 5% cited doctors. The campaign induced optimism in the patients about the efficacy of the method (ineffective 1%, effective 42%, uncertain 57%), and 53% said their hope of cure was increased. However, 48% felt more confused. 24% do not discuss new treatments with their oncologists, and 20% would like to but cannot. When choosing a treatment, the advice of a trusted doctor was judged more important than scientific progress (53% vs 32%) and 63% would try even unproven treatments in the hope of a cure. Replies to many of the questions were influenced by patients' educational attainment and by the degree of communication with their oncologists. INTERPRETATION: Science cannot prevent the harm caused by such campaigns and their psychological consequences, particularly for less educated patients. When making decisions, patients are looking for hope from the treatment and trust in their doctor, both of which depend on effective doctor-patient communications that therefore need to be improved.