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Biomedical subjects

A Jirillo

Publications and source records attributed to A Jirillo.

At least 19 recordsLinked to original sources

Taking care of older cancer patients: results of a survey addressed to the Chiefs of the Medical Oncology Divisions in Italy.

An open questionnaire on the management of older cancer patients in the Italian Divisions of Medical Oncology was sent to the Chiefs of the units in the last 4 months of the year 2004. One hundred and ninety-nine of 330 (60%) responded. The majority of the Medical Oncologists interviewed agreed that special therapeutic protocols were necessary for elderly cancer patients. Also specific guidelines were believed to be useful. In only a minority of units there were some members specifically dedicated to older patients and the Multidimensional Geriatric (MGE) was used routinely only in 12% of cases. The majority of the physicians interviewed believed that older patients accepted chemotherapy as the younger ones did, or even more (79%). Written informed consent was obtained in the majority of units (70%). Over 63% believed that oral antitumor drugs had a very important role in older patients, while 36% were sceptical or negative. More time and attention should be paid to older patients (87.4%) and more economic resources devoted to them (93.3%). In conclusion, Italian Medical Oncologists are well aware of the increasing number of old cancer patients, of the particular problems concerning drug administration and the need of specific trials and guidelines. The need of close contact with Geriatricians and the adoption of Geriatric tools (MGE) are only perceived by a minority. The majority, however, believes that more time and resources should be available in order to take care of elderly cancer patients.

Aged↗

Adjuvant chemotherapy for elderly patients (> or =70 years) with early high-risk breast cancer: a retrospective analysis of 260 patients.

BACKGROUND: Adjuvant chemotherapy in elderly women is currently perceived as one of the priorities in breast cancer (BC) research and, to date, we lack practical guidelines in this age group. Therefore we performed a retrospective analysis of the actual use of adjuvant chemotherapy according to each negative prognostic factor. PATIENTS AND METHODS: Charts of all consecutive elderly patients aged 70 years or more with operable BC referred to our institution between 1999 and 2003 were reviewed for tumour stage and treatment, and compared with an equal cohort of younger randomly selected postmenopausal patients (control group). RESULTS: A total of 260 elderly patients (mean age 75.6 years, age range 70-97 years) with histological diagnosis of early BC were eligible. Conserving surgery was performed in 54.6% of patients, nodal dissection in 84.6% and sentinel node biopsy in 5.8%. Tumour size was pT2-pT3 in 45.4% of patients; grading was G3 in 27.3%, hormonal status was negative (HR-) in 16.9% and lymph nodes were involved N+ in 36.1%. Of 188 patients presenting one or more risk factors (pT2-3, G3, N+, HR-), 48.4% were not proposed for adjuvant chemotherapy (compared with 7.2% in the control group), 39.8% of those with nodal involvement (compared with 4.3% of controls, P <0.0001) and 22.7% of those who were HR- (compared with 0.0% of controls, P=0.0002). Considering only patients receiving non-anthracycline-based chemotherapy, 20 elderly patients (25.9%) were unable to complete the planned number of cycles (compared with 4.7% of controls, P=0.0002). The 2-year disease-free survival was significantly decreased in N+ HR- patients compared with the remaining elderly patients (49.9% compared with 90.9%, P=0.0006). CONCLUSIONS: Elderly BC patients receive much less adjuvant chemotherapy, according to each prognostic factor. N+ HR- disease probably represents the most reasonable indication. As the toxicity of the CMF regimen frequently caused interruption of treatment, alternative regimens should be assessed in this age class.

Aged↗

A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first-line chemotherapy for women with metastatic breast cancer.

BACKGROUND: This randomized phase II study was conducted to evaluate the efficacy of doxorubicin and docetaxel (DOC) administered either as a combination, an alternating or a sequential regimen in women with metastatic breast cancer. Secondary objectives included overall response, time to progression, survival and safety. PATIENTS AND METHODS: Patients with breast cancer (n=123) were randomized to receive doxorubicin and DOC either in combination (60 mg/m2 of each drug), or by alternated or sequential schedule (100 mg/m2 DOC and 75 mg/m2 doxorubicin) every 3 weeks for a maximum of eight cycles as first chemotherapy for stage IV disease. A second randomization allocated patients from each arm to receive prophylactic oral ciprofloxacin or no therapy to prevent febrile neutropenia. RESULTS: Patients received a median of eight cycles. In an intention-to-treat analysis, the overall response was 63%, 52% and 61% in the combination, alternating and sequential schedules, respectively. Corresponding rates of complete response were 15%, 14% and 11%. Grade 4 neutropenia was common in all arms (81%) and, together with febrile neutropenia, was significantly more frequent with the combination. Prophylaxis with ciprofloxacin did not reduce the incidence of febrile neutropenia or infection. Other frequent non-hematological adverse events included alopecia, nausea, vomiting, stomatitis and asthenia. Congestive heart failure only occurred in the combination arm (10%). CONCLUSION: All three schedules are feasible and endowed of good therapeutic activity. In view of the more pronounced toxicity and the risk of cardiac events because of the higher exposure to doxorubicin, the combination should be least favored when treating women with metastatic breast cancer. Prophylaxis with ciprofloxacin was ineffective and is not recommended.

Adolescent↗

Carboplatin and teniposide as third-line chemotherapy in patients with recurrent oligodendroglioma or oligoastrocytoma: a phase II study.

BACKGROUND: This study was a phase II study of third-line chemotherapy with carboplatin plus teniposide in patients with recurrent oligodendroglioma. PATIENTS AND METHODS: Patients with oligodendroglioma progressive or recurrent after surgery, radiotherapy and chemotherapy with PCV (lomustine/procarbazine/vincristine) and temozolomide were treated with 350 mg/m(2) carboplatin on day 1, and 50 mg/m(2) teniposide on days 1-3, every 4 weeks. RESULTS: Response and toxicity were evaluated in all 23 patients enrolled in the study. Two had partial response [8.6%; 95% confidence interval (CI) 1.8% to 28.6%] and 12 stable disease (52.17%; 95% CI 30% to 73%). Median time to progression was 19 weeks (95% CI 11.4-35.0), and 34.8% of the patients (95% CI 20.0% to 61.0%) had progression-free survival at 6 months. Median survival time was 60.7 weeks (95% CI 39.8 to not achieved) and 51% of the patients (95% CI 33.5% to 79.7%) were alive at 12 months. A total of 103 cycles were administered (on average 4.4 per patient; range 1-9). Toxicity was mild and mainly hematological, with grade 4 neutropenia and grade 4 thrombocytopenia in two (8.6%) and three patients (13%), respectively. CONCLUSIONS: Although the response rate of combined carboplatin and teniposide chemotherapy in heavily pretreated oligodendroglial tumors is moderate, the toxicity is manageable, and delay of progression in responders or stable patients may still confer a relevant clinical benefit.

Adult↗

A multicentre, randomized, pharmacokinetic, endocrine and clinical study to evaluate formestane in breast cancer patients at first relapse: endocrine and clinical results. The Italian Trials in Medical Oncology (I.T.M.O.) group.

BACKGROUND: In postmenopausal breast cancer (BC) patients, tamoxifen (TAM) is frequently used in first-line therapy, and for those relapsing under TAM, aromatase inhibitors would be the drug of choice. Formestane, a new aromatase inhibitor, has been demonstrated to be as effective as TAM in first-line therapy. This trial was carried out to investigate the pharmacokinetics and antitumor activity of two formestane doses in BC patients at first relapse, as well as their effects on estrogen levels, evaluated by means of a new analytical method. PATIENTS AND METHODS: One hundred fifty-two postmenopausal BC patients were randomly given formestane 250 mg or 500 mg intramuscularly every two weeks. The blood samples for estrogen measurements were taken on the first day of therapy, at 4 and 10 weeks, and every 12 weeks thereafter. Tumor response was first evaluated after 2.5 months, and then every three months. RESULTS: Seventy-three patients received formestane 250 mg and 79 received 500 mg. After four weeks, plasma estrone, estradiol and estrone sulphate levels were significantly (P < 0.001) suppressed in both groups. The overall response rates were 30% and 40% on 250 mg and 500 mg, respectively. CONCLUSIONS: Both of the formestane doses are effective in reducing plasma estrogen levels in BC patients at first relapse, and the new analytical method improved the quality of results. The antitumor response was highly satisfactory.

Adult↗

Evaluating the impact of radiotherapy on the quality of life of cancer patients by two simple indexes. A pilot study.

The subjective chemotherapy impact (SCI) test has been widely used to evaluate the quality of life in patients receiving chemotherapy. In this study we have tested the SCI questionnaire as an index of the impact of radiotherapy on quality of life. A group of 25 consecutive cancer patients treated with radiotherapy in our centre were tested. In the first item patients were asked to state the number of days they spent with "discomfort". The second item asked them which days they would like to eliminate altogether because of the unbearable symptoms experienced. SCI questions were asked by the same physician before the start of radiotherapy, at the mid point, at the end and 4 months later. A preliminary assessment of validity and reliability of these two indexes provided satisfactory results; data allowed a clear and discriminating differentiation between patients treated with palliative curative radiotherapy and patients who received "adjuvant" treatment (radiotherapy worsened the quality of life in the latter group).

Adolescent↗

Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo.

BACKGROUND: The standard treatment for advanced (stage III and IV) head and neck squamous cell carcinoma (i.e., surgery with postoperative radiotherapy in operable patients and radiotherapy alone in inoperable patients) has had poor results. A series of randomized trials of induction chemotherapy have up to now failed to demonstrate an improvement in survival. PURPOSE: This trial was designed to determine whether intensive induction chemotherapy administered before loco-regional treatment would improve survival of patients with advanced disease. METHODS: Patients had previously untreated, advanced nonmetastatic (stages III and IV) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and paranasal sinuses. The study design was a randomized, multi-institutional, phase III trial. Eligible patients (n = 237) were randomly assigned to receive either initial chemotherapy (cisplatin and infusional fluorouracil) followed by loco-regional treatment (group A, n = 118) or loco-regional treatment alone (group B, n = 119). For operable patients (group A, n = 34; group B, n = 32), loco-regional treatment included resection followed by adjuvant radiotherapy. For inoperable patients, radical irradiation was performed with a planned dose of 65-70 Gy to involved areas. A dose of 45-50 Gy was also planned to the uninvolved neck or postoperatively. The statistical (log-rank) test was performed no earlier than 2 years after the randomization of the last patient. RESULTS: Seventy-one patients (60%) in group A and 67 patients (56%) in group B were considered free of disease after they completed the treatment sequence. The analysis of time to distant metastases showed an advantage for group A patients. (Respective 2- and 3-year values for inoperable patients were 15% and 24% for group A versus 36% and 42% for group B, P = .04; only one operable group A patient had distant metastases after 49 months versus 26% [2 years] and 31% [3 years] for operable group B patients, P = .01.) For inoperable patients, the combined treatment was significantly associated with an increase in complete remission rate (group A, 44%) as compared with radiotherapy alone (group B, 30%) (P = .037). Inoperable patients also benefitted from induction chemotherapy in terms of disease-free survival (49% and 34% for group A versus 28% and 26% for group B; P = .06) and of overall survival (30% and 24% for group A versus 19% and 10% for group B; P = .04). CONCLUSIONS: When all 237 randomly assigned patients were analyzed, there were no significant differences in the two treatment strategies in loco-regional failure or in disease-free or overall survival, although the development of distant metastases was reduced. For operable patients, the only benefit from neoadjuvant chemotherapy was a significant reduction in the incidence of distant metastases. For inoperable patients, neoadjuvant chemotherapy improved local control, decreased the incidence of distant metastases, and improved the complete remission rate and overall survival. IMPLICATIONS: Confirmatory studies with effective chemotherapy regimens delivered for an adequate number of cycles are required.

Adult↗

4'epidoxorubicin plus verapamil in anthracycline--refractory cancer patients.

Four patients refractory to doxorubicin (DX) and 9 patients refractory to 4'epidoxorubicin (4'EpiDX) were treated with verapamil (VRP) (120 mg every 6 h for 3 days) plus 4'EpiDX (80 mg/m2 i.v. bolus, together with the 6th VRP administration). Three patients had partial remissions lasting 3, 3.5 and 7 months, respectively. Toxicity grading did not exceed usual levels. The study demonstrates that VRP, when added at conventional doses to 4'EpiDX, can induce objective responses in some patients refractory to anthracyclines.

Adult↗

Factors causing dose variability in drug administration.

The variability of the drug dose actually given to cancer patients was analyzed. Three variability factors were quantitatively examined (body surface calculation, personalized dose calculation, and drug residuum in commercially available vials) and their variability was experimentally measured. A systematic reduction (mean, 7%; range, 2%-15%) and a random variability (4%-5%) of the dose given were demonstrated. These results draw attention to the role of some of the procedures of routine clinical activity in determining the amount of drug actually delivered. The analysis suggests that personalization of doses must be very accurate in both measurement and calculation and that the staff giving the drug needs to be carefully informed about the importance of drug residuum. The variability of the delivered dose can lead to the misclassification of patients in investigations on the dose-response relationship. This factor may be added to pitfalls previously reported to affect this type of retrospective analysis.

Antineoplastic Agents↗

[Peripheral lymphocyte populations in patients treated with pelvic and mediastinal radiotherapy].

Solid tumor bearing patients often show a large variety of immunologic alterations: increase in immune complexes number, reduced NK activity, decreased IL-2 production, T4/T8 reverse and s.o. Most literature data generally concern chemotherapy and/or radiotherapy pretreated patients, so it is difficult to relate the immunological alterations with either antineoplastic treatments or the disease itself. We tried to evaluate any possible alteration of immunological parameters in patients with solid neoplasms who underwent radiotherapy on mediastinum or pelvis. The aim was to detect any variation in peripheral lymphoid sub-populations (even per site of irradiation) and a possible activation of an immune therapy. The evaluable patients were 38 (12 treated with surgery). The minimum dose delivered was 5000 cGys through conventional fractionation. The immunological parameters (T, B, N, T4, T8, H/S) were evaluated before the treatment, at the end and every 2 months during follow-up. Cases were analyzed also per single irradiation volume. No statistically significant variation in immunological parameters was found, although suppressor activity was confirmed as prevailing in immune responsiveness of cancer patients. Thus any significant correlation between immunological state and disease evolution or response to treatment has still to be verified.

Adult↗

Bleomycin, vincristine, mitomycin and cisplatin alternated with cyclophosphamide, 4'-epidoxorubicin and procarbazine in advanced non-small-cell lung cancer.

Thirty-eight patients with histologically confirmed non-small-cell lung cancer were treated with bleomycin, vincristine, mitomycin and cisplatin (BOMP) alternated with cyclophosphamide, 4'-epidoxorubicin and procarbazine (CEP). Twenty patients were randomized to start the treatment with BOMP and 18 with CEP. Patients underwent a median of 4 cycles (range, 1-8). The overall response rate was 36% with 2 clinical complete responses. The median duration of response was 6.5 months, the median survival time was 7.5 months, and 37% of patients survived for more than one year. The comparison between the two arms of this study and between this study and a previous investigation on the effectiveness of BOMP suggests that CEP regimen added to BOMP does not significantly improve patient outcome.

Adult↗

Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial.

From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.

Adult↗