Publications (17)39.12 Total impact
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Article: Mucinous histology of colon cancer predicts poor outcomes with FOLFOX regimen in metastatic colon cancer.
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ABSTRACT: Mucinous adenocarcinoma (MA) of colorectal cancer seems associated with reduced responsiveness to chemotherapy. The overexpression of markers of resistance to fluorouracil and oxaliplatin has recently been demonstrated. We revised the outcomes of metastatic MA of the colon treated with FOLFOX. From January 2002 to December 2009, we treated 198 patients with metastatic colon cancer, of which 21 (10·6%) had diagnosis of MA and were compared with 42 control patients with non-mucinous adenocarcinoma (NMA). In MA group, three patients [14%; inhibitory concentration 95: ±7·5%] reached partial response, and in NMA group, two patients obtained complete response and 16 obtained partial response with an overall response rate of 43% (inhibitory concentration 95: ±7·6%) with a significant statistical difference (P = 0·027). Median progression-free survival for MA group was 4 months with respect to 8 months for NMA (P = 0·0001); regarding overall survival, we registered a median of 8 months with respect to 18 months for MA and NMA (P = 0·001). In multivariate analysis, MA histology, Eastern Cooperative Oncology Group performance status 2, more than two metastatic sites, and peritoneal metastatic involvement resulted in negative independent prognostic factors. Also in our study, MA is connected to poor prognosis and reduced activity of chemotherapy. In the absence of randomised studies, it may be convenient to analyse this subgroup of patients within the large trials carried out on colorectal cancer.Journal of chemotherapy (Florence, Italy) 01/2012; 24(4):212-6. · 1.08 Impact Factor -
Article: Comparison of short- and medium-term results between laparoscopically assisted and totally laparoscopic right hemicolectomy: a case-control study.
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ABSTRACT: This study aimed to compare the short- and medium-term results obtained by totally laparoscopic right colectomy (TL) with those obtained by laparoscopically assisted right colectomy (LAC) for the treatment of right colon cancer. A retrospective study compared two nonstatistically different groups (50 TL and 50 LAC cases) managed for nonmetastatic malignant tumors. The study outcomes included operative time, length of minilaparotomy, intraoperative complications, postoperative pain, time to resumption of the gastrointestinal functions, permanence of abdominal drain, analgesic therapy duration, postoperative complications, hospitalization time, number of harvested lymph nodes, and distant metastases onset. The mean operative times were 78 ± 25 min (TL group) and 92 ± 22 min (LAC group) (p < 0.05). The findings showed a lower postoperative pain level associated with a reduction in analgesic consumption (p > 0.05) and earlier restoration of digestive function in the TL group than in the LAC group. The mean hospital stays were approximately 5 days (TL) and 7 days (LAC) (p < 0.05). No complications occurred either intra- or postoperatively, and similarly, the TL group experienced no mortality. In comparison, the LAC group had a 30% complication rate (p < 0.05). The complications included one case of intraoperative small bowel lesion, three cases of postoperative respiratory infections, three cases of anastomotic leakage, two cases of intestinal occlusion, three cases of minilaparotomy infection, one case of postoperative femoral neurosis, one case of postoperative heart attack, and one case of postoperative pancreatitis. The mortality rate was 0%. Neither group had a recurrence of the neoplastic disease during a 4-year follow-up period. The findings seem to demonstrate that TL right colectomy is feasible and safe, yielding results comparable with those of the open approach but offering improved postoperative patient comfort. The limits of this retrospective comparative study do not allow definitive conclusions to be drawn despite the encouraging data for the next prospective randomized studies.Surgical Endoscopy 02/2010; 24(9):2085-91. · 4.01 Impact Factor -
Article: Adjuvant treatment of high-risk, radically resected gastric cancer patients with 5-fluorouracil, leucovorin, cisplatin, and epidoxorubicin in a randomized controlled trial.
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ABSTRACT: Promising findings obtained using a weekly regimen of 5-fluorouracil (5-FU), epidoxorubicin, leucovorin (LV), and cisplatin (PELFw) to treat locally advanced and metastatic gastric cancer prompted the Italian Group for the Study of Digestive Tract Cancer (GISCAD) to investigate the efficacy of this regimen as adjuvant treatment for high-risk radically resected gastric cancer patients. From January 1998 to January 2003, 400 gastric cancer patients at high risk for recurrence including patients with serosal invasion (stage pT3 N0) and/or lymph node metastasis (stage pT2 or pT3 N1, N2, or N3), were enrolled in a trial of adjuvant chemotherapies; 201 patients were randomly assigned to receive the PELFw regimen, consisting of eight weekly administrations of cisplatin (40 mg/m2), LV (250 mg/m2), epidoxorubicin (35 mg/m2), 5-FU (500 mg/m2), and glutathione (1.5 g/m2) with the support of filgrastim, and 196 patients were assigned to a regimen consisting of six monthly administrations of a 5-day course of 5-FU (375 mg/m2 daily) and LV (20 mg/m2 daily, 5-FU/LV). Disease-free and overall survival were estimated and compared between arms using hazard ratios (HRs) and Kaplan-Meier estimates. All statistical tests were two-sided. The 5-year survival rates were 52% in the PELFw arm and 50% in the 5-FU/LV arm. Compared with the 5-FU/LV regimen, the PELFw regimen did not reduce the risk of death (HR = 0.95, 95% confidence interval [CI] = 0.70 to 1.29) or relapse (HR = 0.98, 95% CI = 0.75 to 1.29). Less than 10% of patients in either arm experienced a grade 3 or 4 toxic episode. Neutropenia (occurring more often in the PELFw arm) and diarrhea and mucositis (more prevalent in the 5-FU/LV arm) were the most common serious side effects. Nevertheless, only 19 patients (9.4%) completed the treatment in the PELFw arm and 85 (43%) patients completed the treatment in the 5-FU/LV arm. Our study found no benefit from an intensive weekly chemotherapy in gastric cancer. The extent of toxicity experienced by the patients in the adjuvant setting suggests that, in gastric cancer, chemotherapy may be more safely administered preoperatively.CancerSpectrum Knowledge Environment 05/2007; 99(8):601-7. · 14.07 Impact Factor -
Article: Residual neurotoxicity in ovarian cancer patients in clinical remission after first-line chemotherapy with carboplatin and paclitaxel: the Multicenter Italian Trial in Ovarian cancer (MITO-4) retrospective study.
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ABSTRACT: Carboplatin/paclitaxel is the chemotherapy of choice for advanced ovarian cancer, both in first line and in platinum-sensitive recurrence. Although a significant proportion of patients have some neurotoxicity during treatment, the long-term outcome of chemotherapy-induced neuropathy has been scantly studied. We retrospectively assessed the prevalence of residual neuropathy in a cohort of patients in clinical remission after first-line carboplatin/paclitaxel for advanced ovarian cancer. 120 patients have been included in this study (101 participating in a multicentre phase III trial evaluating the efficacy of consolidation treatment with topotecan, and 19 treated at the National Cancer Institute of Naples after the end of the trial). All patients received carboplatin (AUC 5) plus paclitaxel (175 mg/m2) every 3 weeks for 6 cycles, completing treatment between 1998 and 2003. Data were collected between May and September 2004. Residual sensory and motor neurotoxicity were coded according to the National Cancer Institute--Common Toxicity Criteria. 55 patients (46%) did not experience any grade of neurological toxicity during chemotherapy and of these none had signs of neuropathy during follow-up. The other 65 patients (54%) had chemotherapy-induced neurotoxicity during treatment and follow-up data are available for 60 of them. Fourteen out of 60 patients (23%) referred residual neuropathy at the most recent follow-up visit, after a median follow up of 18 months (range, 7-58 months): 12 patients had grade 1 and 2 patients grade 2 peripheral sensory neuropathy; 3 patients also had grade 1 motor neuropathy. The remaining 46/60 patients (77%) had no residual neuropathy at the moment of interview: recovery from neurotoxicity had occurred in the first 2 months after the end of chemotherapy in 22 (37%), between 2 and 6 months in 15 (25%), or after more than 6 months in 9 patients (15%). Considering all 120 treated patients, there was a 15% probability of persistent neurological toxicity 6 months after the end of chemotherapy. A significant proportion of patients with advanced ovarian cancer treated with first-line carboplatin/paclitaxel suffer long-term residual neuropathy. This issue should be carefully taken into account before considering re-treatment with the same agents in sensitive recurrent disease.BMC Cancer 02/2006; 6:5. · 3.01 Impact Factor -
Article: Residual neurotoxicity in ovarian cancer patients in clinical remission after first-line chemotherapy with carboplatin and paclitaxel: The Multicenter Italian Trial in Ovarian cancer (MITO-4) retrospective study
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ABSTRACT: Abstract Background Carboplatin/paclitaxel is the chemotherapy of choice for advanced ovarian cancer, both in first line and in platinum-sensitive recurrence. Although a significant proportion of patients have some neurotoxicity during treatment, the long-term outcome of chemotherapy-induced neuropathy has been scantly studied. We retrospectively assessed the prevalence of residual neuropathy in a cohort of patients in clinical remission after first-line carboplatin/paclitaxel for advanced ovarian cancer. Methods 120 patients have been included in this study (101 participating in a multicentre phase III trial evaluating the efficacy of consolidation treatment with topotecan, and 19 treated at the National Cancer Institute of Naples after the end of the trial). All patients received carboplatin (AUC 5) plus paclitaxel (175 mg/m<sup>2</sup>) every 3 weeks for 6 cycles, completing treatment between 1998 and 2003. Data were collected between May and September 2004. Residual sensory and motor neurotoxicity were coded according to the National Cancer Institute – Common Toxicity Criteria. Results 55 patients (46%) did not experience any grade of neurological toxicity during chemotherapy and of these none had signs of neuropathy during follow-up. The other 65 patients (54%) had chemotherapy-induced neurotoxicity during treatment and follow-up data are available for 60 of them. Fourteen out of 60 patients (23%) referred residual neuropathy at the most recent follow-up visit, after a median follow up of 18 months (range, 7–58 months): 12 patients had grade 1 and 2 patients grade 2 peripheral sensory neuropathy; 3 patients also had grade 1 motor neuropathy. The remaining 46/60 patients (77%) had no residual neuropathy at the moment of interview: recovery from neurotoxicity had occurred in the first 2 months after the end of chemotherapy in 22 (37%), between 2 and 6 months in 15 (25%), or after more than 6 months in 9 patients (15%). Considering all 120 treated patients, there was a 15% probability of persistent neurological toxicity 6 months after the end of chemotherapy. Conclusion A significant proportion of patients with advanced ovarian cancer treated with first-line carboplatin/paclitaxel suffer long-term residual neuropathy. This issue should be carefully taken into account before considering re-treatment with the same agents in sensitive recurrent disease.BMC Cancer. 01/2006; -
Article: Long-term survival in locally advanced oral cavity cancer: an analysis of patients treated with neoadjuvant cisplatin-based chemotherapy followed by surgery.
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ABSTRACT: Neoadjuvant chemotherapy has been reported to be extremely active in head and neck cancer but has failed to give a statistically significant improvement in survival. From 1981 to 1994, 33 operable patients with locally advanced oral cavity cancer received cisplatin-based chemotherapy before surgery. Postoperative radiotherapy was performed in high-risk patients. The overall clinical and pathologic complete response rates to neoadjuvant chemotherapy were 48% and 30%, respectively. At a median follow-up of 7.0 years (range, 0.3-15.3+ years), the 5-year and 10-year overall survival rates were 54.5% and 39.5%, and the disease-specific median survival was 6.6 years for all patients (8.3 and 2.3 years for stages III and IV, respectively). The univariate analysis showed a positive relationship between survival and male sex (p = .05), pathologic (p = .02), and clinical (p = .03) complete response. The Cox proportional hazard regression model confirmed the independent prognostic value of the clinical response with a 4.67 (95% CI, 1.70-12.86) hazard ratio. A second primary tumor occurred in six patients (18%), with a median of occurrence of 9 years (range, 7-11 years). This study confirms the prolonged survival expectancy largely exceeding 5 years for selected patients with stage IV and for most with stage III locally advanced oral cavity cancer achieving a clinical and/or pathologic complete response to chemotherapy.Head & Neck 07/2005; 27(6):452-8. · 2.40 Impact Factor -
Article: Cisplatin and escalating doses of paclitaxel and epirubicin in advanced ovarian cancer. A phase I study
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ABSTRACT: Purpose: The combination of paclitaxel and cisplatin is considered the standard regimen for advanced ovarian cancer (AOC). A meta-analysis has shown that the incorporation of anthracyclines into first-line chemotherapy might improve long-term survival by 7-10%. We designed a phase I-II study in patients with AOC using a combination of a fixed dose of cisplatin with paclitaxel and epirubicin both given at escalating doses every 3 weeks. The objectives of this study were to determine both the maximum tolerated dose (MTD) and the antitumor activity of this combination. Methods: Six different dose levels were planned. The starting doses were cisplatin 75 mg/m2, paclitaxel 140 mg/m2, and epirubicin 50 mg/m2. The doses of paclitaxel were escalated in 20-mg/m2 increments, alternating with 20-mg/m2 increments of epirubicin. Ten patients with AOC entered the phase I study. Three patients each were enrolled at level I and level II and four patients at level III, and at each level, 15 courses were administered. Patients received a median of five courses. Results: Nonhematological toxicity was generally mild, except for grade 3 mucositis in one course at levels II and III, and grade 3 vomiting in one course at levels I and III. Hematological toxicities were grade 3-4 neutropenia in 60%, 47% and 60% of courses at levels I, II and III, respectively, and grade 3 anemia in one course at level III. At level III two of four patients developed a dose-limiting toxicity which was grade 4 neutropenia lasting more than 1 week. Conclusions: The MTD was reached at level II with cisplatin 75 mg/m2, paclitaxel 160 mg/m2, and epirubicin 50 mg/m2. The phase II part of the study is currently ongoing.Cancer Chemotherapy and Pharmacology 08/2001; 48(3):255-258. · 2.83 Impact Factor -
Article: Ifosfamide and vinorelbine in advanced pretreated ovarian cancer: a phase II study
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ABSTRACT: Purpose: The response rate to salvage chemotherapy in advanced ovarian cancer (AOC) has been disappointing in patients who do not respond or relapse after platinum-containing regimens. Ifosfamide (IFO) showed an overall response rate of 20% and vinorelbine (VNR) 15.6%. Trials of the association of these two drugs for AOC have not yet been published. Patients and methods: Between April 1996 and August 1997, 17 patients with AOC were treated with intravenous IFO 2000 mg/m2 per day, days 1 to 3, with mesna uroprotection, and VNR 25 mg/m2 per day, days 1 and 8, every 3 weeks. All patients but one had been heavily pretreated. All patients had been treated with platinum compounds and 16/17 with taxanes. Results: All 17 patients were evaluable for toxicity, and 16 for response (one lost to follow-up). One patient showed a partial response, 12 progressive disease and three stable disease. No complete responses were observed. The main toxicity was neutropenia (grade 3-4 in 82% of patients) with neutropenic fever in 17.6% of patients. In 70.5% of patients (19/59 of courses) VNR was not administered on day 8. In four patients (10/59 courses) the dose was reduced by 25% for persistent leukopenia grade 2-3. Other toxicities were not significant. Conclusions: This combination showed no activity in this set of patients. The poor outcome, as compared with the significant activity reported with the agents used singly, could be ascribed to the patients' characteristics, the low dose intensity of VNR administered and possible cross-resistance between the study drugs and previously used agents.Cancer Chemotherapy and Pharmacology 04/2000; 45(6):513-515. · 2.83 Impact Factor -
Article: A randomized trial comparing alizapride alone or with dexamethasone vs a metoclopramide-dexamethasone combination for emesis induced by moderate-dose cisplatin
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ABSTRACT: To evaluate the antiemetic effectiveness and toxicity of a novel congener of metoclopramide (MCP), alizapride (AZP), 29 patients receiving cisplatin (50 mg/m2) alone or with adriamycin (40 mg/m2) were entered into a randomized cross-over trial comparing moderate-dose AZP (2 mg/kg for 4 doses) administered alone or with dexamethasone (DXM) (8 mg for five doses) vs a standard combination of MCP (1 mg/kg for four doses) and DXM (as above). With the dosage and schedule used, AZP provided only limited antiemetic protection, with less than 10% of the patients free of emesis. The AZP-DXM combination was significantly more effective than AZP alone in reducing the intensity of the emesis (PCancer Chemotherapy and Pharmacology 06/1987; 19(4):335-338. · 2.83 Impact Factor -
Article: Alkaline phosphatase levels as a prognostic factor in metastatic colorectal cancer treated with the FOLFOX 4 regimen: a monoinstitutional retrospective study.
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ABSTRACT: Metastatic colorectal cancer has a heterogeneous behavior, and a set of patients will have minimal response and rapid disease progression. To understand this heterogeneity, studies have evaluated biological and clinical prognostic factors. Alkaline phosphatase seems to be a key prognostic factor, so we have reviewed the outcomes of our patients with respect to alkaline phosphatase levels. Between January 2003 and December 2008, we treated with the FOLFOX 4 regimen 103 consecutive patients with metastatic colorectal cancer. Thirty-two patients had alkaline phosphatase > or =300 U/l. Median time to progression was 4 months for patients with high alkaline phosphatase levels and 8 months for those with low alkaline phosphatase levels. Median overall survival was 8 and 17.5 months, respectively. Only 3 patients in the high alkaline phosphatase group obtained partial response (9.4%) compared to 3 complete responses and 24 partial responses (41.5%) in low alkaline phosphatase group. Toxicity was substantially different, with more grade 3-4 neutropenia, diarrhea and oral mucositis in the high than low alkaline phosphatase group. Alkaline phosphatase is an uncomplicated and potent prognostic factor. Patients with high alkaline phosphatase levels had a poor prognosis.Tumori 97(1):39-42. · 0.86 Impact Factor -
Article: ["Sequential" treatment: is it the best alternative in cholecysto-choledochal lithiasis?].
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ABSTRACT: Laparoscopic cholecystectomy has become the treatment of choice for patients with symptomatic cholelithiasis. About 10-20% of patients with gallbladder stones may also present associated common bile duct stones. The management of the latter remains controversial because many different surgical strategies are available: laparoscopic treatment (laparoscopic common bile duct exploration), sequential endoscopic and laparoscopic treatment (endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy [ERCP/ES] prior to laparoscopic cholecystectomy), inverted sequential endoscopic-laparoscopic treatment (laparoscopic cholecystectomy followed by ERCP/ES), and combined endoscopic-laparoscopic treatment (laparoscopic cholecystectomy with intraoperative ERCP/ES). The aim of this study was to evaluate the efficacy and safety of sequential endoscopic-laparoscopic treatment in patients with cholecystocholedocholithiasis. We retrospectively analyzed the clinical, biochemical and radiological features of 552 patients operated on for cholelithiasis from 1991 to 2001. Common bile duct stones were suspected on the basis of increased serum levels of bilirubin, GOT, GPT, GGT, alkaline phosphatase; presence of jaundice; history of pancreatitis or cholangitis; dilated common bile duct (diameter > 8 mm) or common bile duct stones at hepatobiliary ultrasonography; presence of common bile duct stones at MR-cholangiography or at i.v. cholangiography. In patients with suspected common bile duct stones, preoperative ERCP was performed; if common bile duct stones were confirmed, ES was performed. When common bile duct stones were not suspected preoperatively, laparoscopic cholecystectomy was performed directly. Overall morbidity, mortality and conversion rates in the two groups were evaluated. Of 552 patients admitted for cholelithiasis, 62 (11.3%) underwent preoperative ERCP for suspected common bile duct stones. In 41 patients (66.1%) common bile duct stones were identified and ES with common bile duct stone extraction was performed in 40 patients (clearance: 97.5%). The overall morbidity was 16% (10 cases of post-ERCP acute pancreatitis); no mortality occurred. The conversion rate during subsequent laparoscopic cholecystectomy was 4.8%. In the group of patients with no suspicion of common bile duct stones, the conversion rate was 4.9%. Sequential treatment cannot be considered the best approach for patients with cholecystocholedocholithiasis because of its morbidity rate and the high rate of negative preoperative ERCP findings. Combined endoscopic-laparoscopic treatment seems to present more advantages, especially in term of morbidity, hospital stay and patient compliance and may, in future, be considered the treatment of choice for patients with cholecystocholedocholithiasis.Chirurgia italiana 54(6):785-98. -
Article: Laparoscopic resection of duodenal gangliocytic paraganglioma. A case report.
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ABSTRACT: Paraganglioma is an exceedingly rare tumour of the duodenum that arises in close proximity to the ampulla of Vater. To date a total of 133 cases of duodenal paraganglioma have been reported in the literature; of these, 27 (20%) were histologically gangliocytic paragangliomas. This neoplasm generally behaves in a benign fashion, although instances of recurrence and/or lymph node metastasis have been described. The treatment consists in endoscopic polypectomy or surgical resection in relation to the histological features and the macroscopic extent of the neoplasm. We present a case of a benign duodenal gangliocytic paraganglioma treated by a laparo-endoscopic approach. We report a case of gangliocytic paraganglioma in a 75-year-old woman admitted to the General Surgery Division of Aosta Regional Hospital (Aosta-Italy), complaining of melaena and anaemia. Upper gastrointestinal endoscopy followed by enteroscopy with a video-capsula, revealed a pedunculated neoplasm in the second portion of the duodenum, with ulceration of the overlying mucosa. Multiple biopsies were performed during the endoscopic examination and showed the cellular pattern of benign paraganglioma. After stabilisation of the patient's clinical status, we performed a resection of the neoplasm via a laparoscopic transduodenal approach and a concomitant intraoperative duodenoscopy. The histological features showed a gangliocytic paraganglioma without a malignant cell pattern. The size of the neoplasm was 4 cm. The resection margins were free of neoplastic infiltration. The postoperative stay was 9 days and there were no intraoperative or postoperative complications. The patient is currently in good health without any tumour recurrence. Transduodenal laparoscopic resection with intraoperative duodenoscopy is a valuable treatment for benign gangliocytic paraganglioma of the duodenum which is unresectable by upper gastrointestinal endoscopy. This approach affords the advantages of the minimally invasive technique and fulfils the surgical tenets of the open transduodenal approach, if en bloc resection of the neoplasm with the adjacent duodenal wall is performed.Chirurgia italiana 59(4):551-8. -
Article: [Laparoscopy in abdominal emergencies. Indications and limitations].
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ABSTRACT: Laparoscopy, which has been well known as a diagnostic procedure for more than a century, has recently established itself as an important therapeutic procedure in several branches of surgery. In the present study the authors report on 221 patients over a 10-year period (1991-2001), admitted to hospital with a diagnosis of acute abdomen or abdominal trauma. All patients were submitted to emergency laparoscopic surgery; 128 patients (57%) presented acute appendicitis, 40 (18%) acute cholecystitis, 13 (6%) occlusive ileus, 10 (5%) adnexal pathologies, 9 (4%) perforation of abdominal viscera, 3 (1.4%) acute diverticulitis, 3 (1.4%) subdiaphragmatic abscesses, 3 (1.4%) intestinal infarction, 2 (0.8%) other diseases and 10 (5%) abdominal trauma. The operation was completed laparoscopically in 192 cases (87%), while conversion to laparotomy proved necessary in 29 cases (13%). The morbidity of the cases completed laparoscopically was 3%, the mortality 0.5%, and the mean hospital stay 4 days. Advantages of laparoscopy (shorter hospital stay, rapid postoperative recovery and faster return to social activities) emerge from the present study and are confirmed by the literature. The possibility of combining a diagnostic procedure with curative therapy suggests that laparoscopy may have an important role in emergency surgery, demonstrating its efficacy also in acute abdominal syndromes. Nevertheless, emergency laparoscopic surgery is still a technically difficult procedure that needs to be performed by an expert surgical team.Chirurgia italiana 54(2):165-78. -
Article: Mitomycin C and capecitabine combination (MiXe) in heavily pretreated metastatic breast cancer patients. A dose-finding study.
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ABSTRACT: No standard chemotherapy has been defined for metastatic breast cancer patients pretreated with anthracyclines and taxanes. In preclinical studies, mitomycin C (MMC) and capecitabine showed a synergistic effect by up-regulation of thymidine phosphorylase, and both drugs were active against breast cancer with a lack of overlapping toxicity, making their combination a well-tolerated regimen. A dose-finding study was carried out in order to determine the maximum tolerable dose of MMC combined with fixed-dose capecitabine and to describe the dose-limiting toxicities. Twenty-one patients were enrolled, with metastatic breast cancer pretreated at least with anthracyclines and taxanes (3 at dose level I, 15 at dose level II, 3 at dose level III). At dose level III (MMC 12 mg/m2 and capecitabine 1000 mg/m2 days 2-15) dose-limiting toxicities were recorded in 2 patients (G4 thrombocytopenia, neutropenic fever, G4 neutropenia); dose level II (MMC 10 mg/m2 and capecitabine 1000 mg/m2 days 2-15) was extended for a better safety evaluation. No severe toxicity was noted at this dose level, and therefore this dose was recommend for the phase II study. With regard to activity, 4 partial responses and 2 stable diseases (28%) were recorded. Our data show that the combination is feasible, well tolerated and active in this set of patients.Anticancer research 25(6C):4513-7. · 1.73 Impact Factor -
Article: Mitomycin C plus capecitabine (mixe) in anthracycline- and taxane-pretreated metastatic breast cancer. A multicenter phase II study.
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ABSTRACT: Capecitabine is considered the treatment of choice for anthracycline- and taxane-pretreated metastatic breast cancer. Mitomycin C seems to improve the activity of capecitabine by up-regulation of thymidine phosphorylase. Fifty-five women with metastatic breast cancer previously treated with anthracyclinetaxane were treated with mitomycin C 10 mg/m2 on day 1 every six weeks and capecitabine 1000 mg/m2 on days 2-15 every three weeks. An overall response rate of 38% was found, consisting of 3 (5%) complete responses (CR) and 18 (33%) partial responses (PR); 8 patients (14%) had a stable disease (SD) for more than 4 months. The combination was well-tolerated, with the main toxicities being neutropenia, diarrhea and fatigue; other toxicities were of mild to moderate intensity without impairment in the quality of life of the patients. Capecitabine is confirmed as the drug of choice in the treatment of anthracycline- and taxane-pretreated metastatic breast cancer and its combination with mitomycin appears to improve its efficacy.Anticancer research 27(4C):2871-5. · 1.73 Impact Factor -
Article: Differences in transplant-related complications between hematologic malignancies and solid tumors receiving high-dose chemotherapy and autologous peripheral blood stem cell transplantation.
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ABSTRACT: Multiple factors contribute to transplant-related complications after high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation, including conditioning regimens, number of infused stem cells and clinical characteristics of patient at transplant. We compared the transplant-related complications of 141 patients affected with hematological malignancies with those of 109 patients with solid tumors. The total number of peripheral blood stem cell transplantations performed was 339. High-dose chemotherapy mainly consisted of melphalan-, busulphan- or thiotepa-based regimens. Despite the equal number of infused CD34+ cells, patients with a hematological malignancy showed a slower absolute neutrophil count (days to neutrophils > 0.5 x 10(9)/L, 10.6 +/- 3.6 for hematological malignancies versus 9.1 +/- 1.2 for solid tumors, P < 0.0001) and platelet recovery (days to platelets > 20 x 10(9)/L, 16.4 +/- 9.8 for hematological malignancies versus 12.3 +/- 4.1 for solid tumors, P < 0.0001) than patients with a solid tumor. A significantly higher requirement of red blood cell (3.3 +/- 4.1 versus 2.0 +/- 1.9, P < 0.0029) and platelet units (7.5 +/- 10.4 versus 4.2 +/- 3.4, P < 0.0001) was observed for hematological malignancies than for solid tumors. Five graft failures were documented exclusively in patients with a hematological malignancy. Moreover, such patients displayed a longer duration of mucositis (P < 0.0028) and hospital stay (P < 0.0001), but no difference was observed in terms of febrile episodes. Transplant-related mortality was similar between the two groups. In conclusion, patients with a hematological malignancy overall have more complications than those with a solid tumor.Tumori 89(4):385-90. · 0.86 Impact Factor -
Article: High-dose chemotherapy with mitoxantrone + melphalan and autologous stem cell rescue in metastatic breast cancer patients: a study of feasibility and tolerability.
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ABSTRACT: Hematological and extra-hematological toxicity of mitoxantrone-containing regimens with autologous stem cell rescue was evaluated in 32 metastatic breast cancer patients. The schedule was the final part of two high-dose chemotherapy programs, including an induction phase with three courses of conventional chemotherapy with epirubicin (120 mg/m2) and cyclophosphamide (600 mg/m2) plus three courses of docetaxel (100 mg/m2) and a first high-dose chemotherapy consisting of cyclophosphamide (6000 mg/m2), thiotepa (500 mg/m2) and carboplatin (800 mg/m2) or melphalan (160 mg/m2) plus thiotepa (600 mg/m2). The final second autograft phase included mitoxantrone (60 mg/m2) associated with melphalan (160 mg/m2) and autologous stem cell rescue infusion. The median duration of severe neutropenia and thrombocytopenia was 9 (range, 7-13) and 11.5 (range, 9-29) days. The median number of units of erythrocytes and platelets transfused was 1 (0-11) and 4 (1-9), respectively. Fever for a median of 2 (0-8) days developed in 71.8% of the patients. Mucositis was observed in 81.2% (WHO grade 3-4 in 25%). No acute or late cardiac toxicity was observed. One patient died because of a transplant-unrelated cause. The response according to the program phase showed an increased rate of complete response, from 12.5% at the end of conventional chemotherapy to 21.9% after the first high-dose chemotherapy course, to increase to 43.9% after the treatment with mitoxantrone-melphalan. We conclude that a conditioning regimen with high dose mitoxantrone-melphalan fits well within the high-dose chemotherapy program.Tumori 89(5):492-6. · 0.86 Impact Factor
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- Chirurgia italiana (3)
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Institutions
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2001–2005
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Istituto Regina Elena - Istituti Fisioterapici Ospitalieri
Roma, Latium, Italy
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