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F Boccardo

Publications and source records attributed to F Boccardo.

At least 55 records · Page 3Linked to original sources
PubMed1999

Role of microsurgery in the management of lymphoedema.

BACKGROUND: Microsurgical techniques in the treatment of peripheral lymphoedema proved to be very promising, the authors' clinical experience with derivative and reconstructive lymphatic microsurgical operations was analysed. METHODS: From 1973 to 1997, 843 patients were studied and treated by microsurgical methods, with average follow-up of over 5 years. Microsurgical techniques mostly consisted of derivative lymphatic-venous or lymphatic-capsule-venous anastomoses and reconstructive autologous vein interpositioned grafts (lymphatic-venous-lymphatic-plasty). Ninety percent of patients were operated on at the II-III stage, 3% at the I and 7% at the IV-V stage. Limb volumes were measured using the water displacement technique and lymphoscintigraphy was used to accurately assess the structural and functional status of the lymphatic drainage before and after variable distances of time after microsurgery. More recently, also lymphangio-MR was used to accurately evaluate changes in the lymphoedematous extremity before and after treatment. RESULTS: Postoperatively, all the patients had a reduction of oedema variable above all according to the stage of the pathology at the time of microsurgical operation. Short and long-term results were positive, as concerns both volumetric oedema reduction and arm function, besides the regression of annual incidence of acute lymphangites. The efficacy of microsurgical lymphatic operations has been verified, moreover, by lymphoscintigraphy. CONCLUSIONS: Microsurgical techniques permit, today, the solution of complex clinical patterns not only of secondary but also of primary, unilateral and bilateral, lymphoedemas, at different stages, with better results the more precocious the microsurgical treatment is, with stabilization of the result also at long distance of time from operation.

Adolescent↗
PubMed1998

Frontiers in lymphatic microsurgery.

The Authors report an overview on the modern surgical treatment of peripheral lymphoedema. The aim of lymphatic microsurgical operations is to drain the lymph either toward the venous circulation (lympho-venous shunts) or the lymphatic collectors above the obstacle to the lymph flow, with the interposition of lymphatic or venous grafts (lymphatic-venous-lymphatic plasty). Selection of candidate patients for lymphatic microsurgery is based on an adequate diagnostic investigation, which includes above all lymphoscintigraphy, conventional oil contrast lymphangiography, Doppler venous flowmetry and manometry, and, if necessary (angiodysplasias), an accurate study also of the artery circulation. The clinical outcome of lymphatic microsurgery, assessed by water volumetry and lymphangioscintigraphy, performed at variable distance of time from operations till over 5 years after surgery, shows a significant reduction of edema volume and improvement of lymph flow in all patients and that the more precocious the microsurgical treatment the better the results.

Anastomosis, Surgical↗
PubMed1998

Italian Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group Trials. GROCTA Trials.

The first GROCTA trial compared 5-year tamoxifen treatment to ten chemotherapy cycles in a group of 504 pre-/post-menopausal, node-positive, ER-positive breast cancer patients. This study also included an arm combining tamoxifen with chemotherapy. Fifteen-year results showed no difference between tamoxifen and tamoxifen plus chemotherapy, while both treatments were significantly superior to chemotherapy alone. A confirmatory study (GROCTA 02) was performed in 244 pre-/perimenopausal patients by comparing 5 years of tamoxifen treatment (plus 2 years of goserelin) to six CMF cycles. No difference has emerged so far between the tamoxifen and CMF arms at a median follow-up time of 62 months. Post-menopausal women were scheduled to receive 3 years of tamoxifen treatment and then to be randomly allocated to further 2 years of tamoxifen or to 2 years of low-dose aminoglutethimide (GROCTA 04B). So far 662 patients have been entered, 375 of whom have been randomized to tamoxifen (n = 188) or aminoglutethimide (n = 187). Preliminary results (median follow-up time 32 months) show no major difference in patients' outcome. A new trial (ITA trial) with a similar design but employing anastrozole in place of aminoglutethimide has been activated in 1998. The GROCTA 03 study investigated the potential superiority of alternating adjuvant chemotherapy over standard CMF. This study, which included 107 node-positive ER-negative pre-menopausal women, was prematurely closed because more patients allocated to the triple alternated chemotherapy appeared to have relapsed and died at the first interim analysis. The use of high-dose chemotherapy (HDC) was explored by the GROCTA 06 trial which included 53 patients with ten or more involved nodes and a maximum age of 55 years. These patients were scheduled to receive three standard CEF cycles followed by one cycle of HDC (cyclophosphamide 5 g/m2; etoposide 1.5 g/m2; cisplatin 150 mg/m2) without any form of bone marrow rescue. This HDC program proved to be feasible but was not superior to CMF-based chemotherapy we had previously employed in a comparable group of patients in previous GROCTA trials. These findings prompted us to explore new HDC programmes with the use of peripheral stem cell support and in addition the possible value of new drugs such as Taxol and vinorelbine. New-generation trials will also explore the value of new prognostic indicators such as tumor proliferative activity, which are prospectively used to allocate patients to different treatment options.

Antineoplastic Agents, Hormonal↗
PubMed1998

Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Liarozole Study Group.

OBJECTIVES: To compare the efficacy of oral liarozole, the first retinoic acid metabolism-blocking agent (RAMBA) to be developed as differentiation therapy for human solid tumors, with that of cyproterone acetate (CPA), an antiandrogen for the treatment of metastatic prostate cancer. Liarozole promotes differentiation of cancer cells by increasing the intratumoral levels of retinoic acid. METHODS: A total of 321 patients with metastatic prostate cancer in relapse after first-line endocrine therapy entered a Phase III international multicenter study (recruitment from February 1992 to August 1994) comparing liarozole (300 mg two times daily) with CPA (100 mg two times daily). RESULTS: Accounting for differences in baseline prognostic factors, the adjusted hazard ratio for survival was 0.74 in favor of liarozole (P = 0.039), indicating a 26% lower risk of death than in patients treated with CPA. Median crude (unadjusted) survival time was the same in the liarozole group as in the CPA group (10.3 months). More patients showed a PSA response (at least 50% reduction in PSA from baseline) when treated with liarozole (20%) than with CPA (4%) (P < 0.001). Prostate-specific antigen (PSA) responders had a median survival benefit of 10 months over nonresponders, irrespective of treatment (hazard ratio 0.43; P = 0.0018). PSA response was apparent within 3 months in approximately 90% of patients who responded. Pain improved more in the liarozole group than in the CPA group (P = 0.03). PSA responders had lower median pain scores than nonresponders (1.7 versus 2.5) and better quality of life (median Functional Living Index-Cancer score 108 versus 98) at end point, ie, treatment discontinuation, as well as throughout the treatment period. Among the most frequently occurring adverse events in the liarozole group were dry skin (51% of patients), pruritus (25%), rash (16%), nail disorders (16%), and hair loss (15%). These adverse events were generally mild to moderate in severity and did not affect the overall quality of life score. There were no detectable effects of either treatment on vital signs such as blood pressure, heart rate, electrocardiogram, and body weight. CONCLUSIONS: Liarozole is superior to CPA in terms of PSA response, PSA progression, and survival, and is capable of maintaining patients' quality of life. The observed adverse events were mild to moderate in nature. These results show that liarozole is a possible treatment option after first-line endocrine therapy has failed.

Aged↗
PubMed1998

[Current status and prospectives of aromatase inhibitors in the treatment of advanced breast cancer].

Endocrine therapy represents one of the most effective instruments for the palliative and adjuvant treatment of breast cancer, in particular in postmenopausal patients. While tamoxifen still forms the treatment of choice during the adjuvant phase and the first-line treatment during the metastatic phase, aromatase inhibitors undoubtedly represent the treatment of choice for patients who do not respond to antiestrogen treatment. These drugs represent a heterogeneous family of compounds able to provide more or less selective inhibition of aromatases by forming an irreversible bond with the catalytic site of the enzymatic complex (type I inhibitors) or using a competitive mechanism (type II inhibitors). Among the type I drugs, 4-hydroxyandrostenedione and hexamestane are those that probably attract greatest clinical interest. These drugs can significantly reduce the circulating levels of estrone and estradiol, and have been shown to be active in 20% of patients pretreated with tamoxifen. Moreover, hexamestane was also effective in patients pretreated with type II inhibitors, of which the parent drug is aminoglutethimide. This drug is still used in the second and third-line treatment of breast cancer but, since it causes collateral effects in a substantial percentage of patients, above all when used at higher doses in combination with hydrocortisone, it will soon be replaced by second and third generation inhibitors, like letrozole, fadrozole, vorozole and anastrozole. These drugs have been shown to be significantly more active than aminoglutethimide, both in vitro and in vivo, and above all more selective. In particular, even at high doses anastrozole has not been found to interfere with steroidogenesis at a corticoadrenal level. Moreover, anastrozole has been shown to be very active even at relatively modest doses given in a single daily dose. Two recent controlled studies, including a total of over 600 patients, recently demonstrated that, if used in second line in patients who no longer responded to adjuvant or palliative tamoxifen therapy, anastrozole is just as effective but probably better tolerated than megestrol acetate. Studies are now in progress or are currently being launched to evaluate the possible value of anastrozole and other third generation inhibitors both as first-line treatment and as adjuvant treatment as an alternative or in combination with tamoxifen.

Aromatase↗
PubMed1997

Intraperitoneal carboplatin with or without interferon-alpha in advanced ovarian cancer patients with minimal residual disease at second look: a prospective randomized trial of 111 patients. G.O.N.O. Gruppo Oncologic Nord Ovest.

From June 1990 to October 1994, 111 advanced ovarian cancer patients with minimal (less than 2 cm) residual disease after platinum-based front-line chemotherapy and second-look laparotomy entered a cooperative randomized study aimed at evaluating the effectiveness and the toxicity of the addition of interferon-alpha2 to carboplatin, both intraperitoneally (ip) administered. Patients were randomized to receive either 3 courses of ip Carboplatin 400 mg/m2 Day 1 q 28 days (54 pts) (CBDCA) or ip interferon-alpha 25 x 10(6) U Day 1 + ip carboplatin 400 mg/m2 Day 2 q 28 days (57 pts) (CBDCA + IFN). Patients treated with interferon experienced more severe (WHO grade 3-4) leukopenia (28% vs 17.1%) and anemia (14% vs 4.2%). Fever (P = 0.000) and flu-like syndrome (P = 0.02) were significantly more frequent in the combination arm. No difference in gastroenteric, neurologic, or renal toxicity was observed. At a median follow-up time of 13 months (range 1-72) 71 patients showed a disease progression (31 CBDCA, 40 CBDCA + IFN) and 44 patients died (21 CBDCA, 23 CBDCA + IFN). Median progression-free survival was 11 months in the CBDCA group and 10 months in the CBDCA + IFN arm. Median survival was 22 and 29 months in CBDCA and CBDCA + IFN arm, respectively. In conclusion, intraperitoneal interferon-alpha does not seem to improve the results achievable with intraperitoneal carboplatin in this subset of patients, while the toxicity and the costs of the combination are consistently higher than with chemotherapy alone.

Adult↗
PubMed1997

Suramin/epidoxorubicin association in hormone-refractory prostate cancer: preliminary results of a pilot phase II study.

PURPOSE: Previous studies indicate that suramin may be an active agent for treating hormone-refractory prostate cancer. However, antitumour responses were observed in initial experiments only when plasma suramin concentrations were maintained in excess of 250 micrograms/ml. Dose-limiting toxicity, especially neurological toxicity, is directly related to the duration of exposure and sustained plasma drug concentrations of 300 micrograms/ml or more. Combination with other agents such as epidoxorubicin, a drug with demonstrable activity in metastatic prostatic carcinoma, could be more effective and allow reduced suramin doses, while maintaining the suramin antitumor effect; this could make suramin therapy more feasible. On the basis of preclinical synergistic activity for combined suramin/doxorubicin in prostate cancer cell lines, a pilot study in patients with metastatic hormone refractory prostate cancer was performed. MATERIALS AND METHODS: Ten patients with hormone-refractory prostate cancer received a fixed dosing scheme of suramin infusion in combination with weekly epidoxorubicin at 25 mg/m2. Therapy was discontinued for dose-limiting toxicity or progressive disease. RESULTS: None of the ten patients achieved a prostate-specific antigen reduction of more than 50% and no objective responses were observed in any patient. Dose-limiting toxicity was observed in four patients: grade 3 neurotoxicity was observed in three patients and grade 3 nephrotoxicity in one patient. CONCLUSIONS: Suramin/epidoxorubicin association, despite the encouraging preclinical results, was not able to improve the antitumour activity of suramin and showed significant toxicity. The results achieved in our study, although in a small number of patients, seem to suggest that this regimen cannot be recommended for use in the treatment of metastatic hormone-refractory prostate cancer.

Adenocarcinoma↗
PubMed1997

Clinical efficacy and endocrine activity of vorozole in postmenopausal breast cancer patients. Results of a multicentric phase II study.

BACKGROUND: Aminoglutethimide was the first aromatase inhibitor to be used successfully in breast cancer patients. However, this drug also inhibits mineralcorticoid and glucocorticoid synthesis, making co-medication with corticosteroids necessary, and it is often poorly tolerated. The primary objective of this trial was to evaluate the clinical efficacy and tolerability of vorozole, a new non-steroidal oral aromatase inhibitor, in postmenopausal breast cancer patients. The secondary objective was to evaluate the pharmacodynamic activity of the drug. SUBJECTS AND METHODS: Thirty-four postmenopausal patients previously treated with tamoxifen in the adjuvant setting and/ or for advanced disease were treated with vorozole, 2.5 mg once daily. Patients were monitored with respect to treatment efficacy and safety. Hormonal evaluations were performed at baseline and during the course of treatment in order to evaluate the pharmacodynamic efficacy and safety of vorozole. RESULTS: According to UICC criteria, there were seven responders, one complete and six partial, for an overall response rate of 21% (95% confidence interval (CI) 9%-38%). The median duration of response was 9.6 months (95% CI 4.6-0), the median time to progression for the entire group was 4.7 months (95% CI 2.9-6.6) and the median survival time was 29.7 months (95% CI 19.1-0). Tolerability was excellent to good in 97% of the patients. Oestradiol and oestrone levels were suppressed to the limit of detection of the assays used. No effect was observed on the other endocrine parameters. CONCLUSIONS: Our results suggest that vorozole is an effective and safe drug for the treatment of advanced postmenopausal breast cancer following tamoxifen failure.

Aged↗
PubMed1997

Lack of effectiveness of adjuvant alternating chemotherapy in node-positive, estrogen-receptor-negative premenopausal breast cancer patients: results of a multicentric Italian study. The Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group (GROCTA).

A multicentric randomized trial was performed in premenopausal women with node-positive, estrogen-receptor-negative breast tumors to assess the potential superiority of alternating adjuvant chemotherapy over 'standard' CMF chemotherapy. Between January 1989 and June 1992, 107 patients were entered into the study and randomly allocated to receive either cyclophosphamide 100 mg/m2 per as on days 1-14, methotrexate 40 mg/m2 and 5-fluorouracil 600 mg/m2 intravenously (i.v.) on days 1, 8 (CMF), every 4 weeks for a total of 6 cycles, or the following regimens: CMF as previously; epidoxorubicin 75 mg/m2 i.v. on day 1 and vincristine 0.75 mg/m2 i.v. on days 1, 8 (EV); mitomycin-C 10 mg/m2 i.v. on day 1 and vindesine 2 mg/m2 i.v. on days 1, 8 (MVs). The three regimens were given every 4 weeks for a total of 6 cycles according to the following schedule: CMF, EV, MVs, CMF, EV, MVs. At a median follow up of 48 months (range 30-72), 40 patients have relapsed and 17 have died overall. More patients in the triple-combination arm have relapsed and more have died, the latter difference tending toward statistical significance (p = 0.06). There was no statistical difference in the site of relapse between the two groups. Total duration of adjuvant therapy was similar in the two arms (312 chemotherapy cycles in the triple arm and 308 in the CMF arm). Treatment toxicity was also comparable, although more patients in the triple-combination arm were still regularly menstruating 6 months after the completion of chemotherapy. This study failed to show any advantage ensuing from the use of alternating chemotherapy in patients with early breast cancer.

Adult↗
PubMed1996

Adjuvant chemotherapy plus tamoxifen compared with tamoxifen alone for postmenopausal breast cancer: meta-analysis of quality-adjusted survival.

BACKGROUND: Adjuvant tamoxifen for early breast cancer provides an improvement in relapse-free (RFS) and overall survival (OS), especially for older women. We carried out a meta-analysis to find out whether the benefit of adding chemotherapy to tamoxifen outweighs its costs in terms of toxic effects for postmenopausal patients. METHODS: The meta-analysis of quality-adjusted survival was based on data from 3920 patients aged 50 years or older with node-positive breast cancer randomly assigned in nine trials that compared combination chemotherapy plus tamoxifen with tamoxifen alone. The nine trials were included in the worldwide overview conducted by the early breast cancer trialists' collaborative group (EBCTCG). The quality-adjusted time without symptoms or toxicity (Q-TWiST) method was used to provide treatment comparisons incorporating differences in quality of life associated with subjective toxic effects of treatment and symptoms of disease relapse. FINDINGS: Within 7 years of follow-up the modest benefit of increased RFS and OS for patients who received chemotherapy just balanced the costs in terms of acute toxic side-effects. Chemotherapy-treated patients gained an average of 5.4 months of RFS and 2 months of OS (neither statistically significant), but had to receive cytotoxic treatment for between 2 and 24 months to achieve these gains. No values of preference weights for time spent undergoing chemotherapy and time after relapse gave significantly more Q-TWiST with chemotherapy plus tamoxifen than with tamoxifen alone. INTERPRETATION: Within 7 years of follow-up, adjuvant chemoendocrine therapy did not provide more quality-adjusted survival time than tamoxifen alone for women aged 50 years or older with node-positive breast cancer. Better selection and administration of chemotherapy regimen, different scheduling of chemotherapy and tamoxifen, and appropriate use of patient and tumour characteristics may increase the therapeutic advantage of the combination.

Antineoplastic Agents, Hormonal↗
PubMed1996

Intravesical idarubicin: a dose-finding study.

A total of 12 patients with completely resected, recurrent papillary tumors of the bladder were entered into a dose-finding study using intravesical idarubicin, a new anthracycline agent that has been shown in vitro to be more active than doxorubicin or daunorubicin, its parental compound. Patients were scheduled to receive eight weekly instillations with the following dose levels: 6.5, 12.5, and 20 mg, all of them diluted in 50 ml saline. Each dose level was initially studied in 3 patients. Dose escalation in the individual patients was not allowed so as to avoid undue toxicity and to evaluate the cumulative toxicity induced by each dose level. Overall, 4 patients were withdrawn due to severe local toxicity (chemocystitis) after a median of 2 instillations (range 1-3) and 3 more patients refused to continue treatment due to mild to moderate toxicity after a median of 4 instillations (range 2-4). Both the patients treated with 20 mg idarubicin and 2 of the 6 patients treated with 12.5 mg were withdrawn due to local toxicity. In contrast, no systemic toxicity was encountered at any dose level. We conclude that doses ranging from 6.5 to 12.5 mg and concentrations varying between 0.125 and 0.250 mg/ml are more appropriate for phase II studies, implying repeated instillations. At these doses and concentrations, however, it is unlikely that idarubicin might be more active than doxorubicin or epirubicin, whereas it might be more toxic.

Administration, Intravesical↗
PubMed1996

Medical treatment of advanced renal cell carcinoma: present options and future directions.

The treatment of patients with metastatic renal cell carcinoma (MRCC) continues to be disappointing. A large number of hormones, chemotherapeutic agents and combinations have been tested with poor and non-reproducible results. Among the immunological treatments investigated in MRCC, the best results have been claimed with interferons (IFNs) and interleukin-2 (IL-2) and, although no randomized studies have shown higher activity than cytotoxic drugs, hormones or even no treatment, many oncologists feel it justified to consider these biologic agents the treatment of choice for this disease. Of patients treated with alpha-IFN, 15-20% achieve an objective remission and 3-5% achieve a long-lasting complete response. No substantial increase of the therapeutic activity of alpha-IFN was produced by combination with chemotherapeutic agents and gamma-IFN or tumour necrosis factor. High doses of IL-2 with or without lymphokine-activated killer cells led to successful results in about 20-30% of patients with 5-10% complete responses. More recently, less toxic regimens with lower doses of IL-2 alone or combined with alpha-IFN produce similar response rates. Many studies have clarified the importance of prognostic factors in patient selection for response and survival during treatments with IFNs and IL-2. Good performance status, a long interval from diagnosis to treatment, and only one site of disease seem to be the most important predictors for survival. Both IFNs and IL-2 appear to possess encouraging antitumour activity in patients with favourable prognostic factors, but further studies are needed to identify the treatment of choice, the optimal dose regimen and route of administration in this subgroup of patients. Patients with poor prognosis should be encouraged to enter controlled studies aimed to evaluate investigational drugs and new therapeutic methods.

Antineoplastic Agents↗
PubMed1996

Risk of new primaries after chemotherapy and/or tamoxifen treatment for early breast cancer.

BACKGROUND: Both chemotherapy and tamoxifen are widely used either alone or in combination as adjuvant treatment following mastectomy. Despite the fact that both of them exhibit carcinogenic properties in experimental models, detailed reports on the incidence of new primaries following chemotherapy and/or tamoxifen in patients with early breast cancer are limited. PURPOSE: To investigate the incidence of new primaries (including opposite breast tumors and skin cancers) in untreated patients and in patients treated with either tamoxifen or chemotherapy or with both modalities. PATIENTS AND METHODS: A total of 1696 patients with early breast cancer, 1286 of whom were treated with either CMF-based adjuvant chemotherapy (n = 410), tamoxifen (n = 656) or with a combination of the two (n = 220) were considered for the present analysis. Patients were operated on between November 1983 and December 1991 and were followed up to June 1994. Detailed information about second malignancies were available for all patients. RESULTS: Overall, 53 new primaries, 19 of them opposite breast tumors, occurred in 53 patients. The actuarial cumulative incidence rates at 5 years were: 3.1% (95% CI: 1.4%-4.8%) in untreated patients; 1.7% (95% CI: 0.0%-3.5%) in tamoxifen-treated patients; 4.2% (95% CI: 1.3%-7.1%) in chemotherapy-treated patients and 2.6% (95% CI: 0.0%-5.2%) in the chemo-tamoxifen group (all groups: P = n.s.; chemotherapy-treated versus tamoxifen-treated: P = 0.01). The corresponding figures, after exclusion of the patients with opposite-breast and skin tumors, were: untreated patients: 2% (95% CI: 0.6%-3.4%); tamoxifen-treated patients: 0.95% (95% CI: 0.0%-2.4%); chemotherapy-treated patients: 2.6% (95% CI: 0.4%-4.8%); chemotherapy plus tamoxifen: 1.65% (95% CI: 0.4%-3.8%); (all groups: P = n.s.; CT versus TAM P = 0.05). Chemotherapy-treated patients showed a risk that was about two-fold that of the one to be expected in the general population. By contrast, a decrease in the total risk was observed in patients treated with tamoxifen. Patients who received chemotherapy and tamoxifen as well as those in the no-treatment group showed a risk which was comparable to that of the general population. CONCLUSIONS: Adjuvant chemotherapy appears to increase the risk of second malignancies. By contrast, tamoxifen seems to exert an overall protective effect in this regard, and it also appears to counteract, at least partially, the carcinogenic effect of chemotherapy. IMPLICATIONS: While there is plenty of evidence that the benefit achieved by adjuvant chemotherapy considerably exceeds the risk of second malignancies, the indiscriminate use of chemotherapy should be avoided, particularly in patients with a low risk of relapse. Moreover, it seems reasonable to prefer tamoxifen over chemotherapy for patients likely to obtain comparable therapeutic benefit from antiestrogenic treatment.

Adult↗
PubMed1996

High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: a randomized study of the Gruppo Oncologico Nord-Ovest.

PURPOSE: The aim of the study was to compare high-versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin as primary chemotherapy for suboptimal stage III and IV ovarian cancer. PATIENTS AND METHODS: One hundred forty-five patients were randomized to receive six courses of cisplatin 50 or 100 mg/m2 plus epidoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2. The two treatment arms were well balanced; all patients had greater than 2 cm and 37.2% had greater than 5 cm of residual disease; 29.6% had stage IV disease. RESULTS: Patients in the high-dose arm received a double dose-intensity and double total dose of cisplatin. The high-dose regimen induced significantly more episodes of leukopenia (47.8% v 32.8%, P = .05), thrombocytopenia (21.7% v 3.2%, P = .003), anemia (37.6% v 12.5%, P = .002), nephrotoxicity (six v one patient), and neurotoxicity (30.4% v 6.3%, P = .002). There were no significant differences in efficacy in terms of clinical response rate (high-dose 57.5% v low-dose 61.1%), pathologic complete response (CR) (9.6% v 18.1%), median survival times (29 v 24 months), and median progression-free survival (18 v 13 months). CONCLUSION: This study shows that doubling the dose-intensity and total dose of cisplatin in combination with epidoxorubicin and cyclophosphamide has significant toxic effects and does not improve clinical outcome in patients with suboptimal ovarian cancer.

Adult↗
PubMed1995

Alternating chemo-radiotherapy in bladder cancer: a conservative approach.

PURPOSE: The aim of this Phase II study was to determine a bladder-sparing treatment in patients with invasive bladder cancer, allowing a better quality of life. Objectives were to test toxicity and disease-free and overall survival of patients given an alternated chemo-radiotherapy definitive treatment. METHODS AND MATERIALS: Seventy-six patients with bladder cancer Stage T1G3 through T4 N0 M0 were entered in the same chemotherapy regimen (Cisplatin 20 mg/mq and 5-Fluorouracil 200 mg/mq daily for 5 days) alternated with different radiotherapy scheduling, the first 18 patients received two cycles of 20 Gy/10 fractions/12 days each; the second group of 58 patients received two cycles of 25 Gy/10 fractions/12 days each (the last 21 patients received Methotrexate 40 mg/mq instead of 5-Fluorouracil). RESULTS: A clinical complete response was observed in 57 patients (81%), partial response in 7 patients (10%), and a nonresponse in 6 patients (9%). At a median follow-up of 45 months, 33 patients (47%) were alive and free of tumor. The 6-year overall survival and progression-free survival was 42% and 40%, respectively. Systemic side effects were mild, while a moderate or severe local toxicity was observed in 14 patients and 13 patients (about 20%), respectively. CONCLUSION: Our conservative combination treatment allowed bladder-sparing in a high rate of patients and resulted in a survival comparable to that reported after radical cystectomy.

Adult↗