G Romano

Istituto Nazionale Tumori "Fondazione Pascale", Napoli, Campania, Italy

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Publications (59)98.25 Total impact

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    ABSTRACT: Markers predictive of treatment effect might be useful to improve the treatment of patients with metastatic solid tumors. Particularly, early changes in tumor metabolism measured by PET/CT with (18)F-FDG could predict the efficacy of treatment better than standard dimensional Response Evaluation Criteria In Solid Tumors (RECIST) response. We performed PET/CT evaluation before and after 1 cycle of treatment in patients with resectable liver metastases from colorectal cancer, within a phase 2 trial of preoperative FOLFIRI plus bevacizumab. For each lesion, the maximum standardized uptake value (SUV) and the total lesion glycolysis (TLG) were determined. On the basis of previous studies, a ≤ -50% change from baseline was used as a threshold for significant metabolic response for maximum SUV and, exploratively, for TLG. Standard RECIST response was assessed with CT after 3 mo of treatment. Pathologic response was assessed in patients undergoing resection. The association between metabolic and CT/RECIST and pathologic response was tested with the McNemar test; the ability to predict progression-free survival (PFS) and overall survival (OS) was tested with the Log-rank test and a multivariable Cox model. Thirty-three patients were analyzed. After treatment, there was a notable decrease of all the parameters measured by PET/CT. Early metabolic PET/CT response (either SUV- or TLG-based) had a stronger, independent and statistically significant predictive value for PFS and OS than both CT/RECIST and pathologic response at multivariate analysis, although with different degrees of statistical significance. The predictive value of CT/RECIST response was not significant at multivariate analysis. PET/CT response was significantly predictive of long-term outcomes during preoperative treatment of patients with liver metastases from colorectal cancer, and its predictive ability was higher than that of CT/RECIST response after 3 mo of treatment. Such findings need to be confirmed by larger prospective trials.
    Journal of Nuclear Medicine 10/2013; · 5.77 Impact Factor
  • J Nucl Med. 2013. 10/2013; J Nucl Med. 2013 Oct 17. [Epub ahead of print].
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    ABSTRACT: Background:Preoperative treatment of resectable liver metastases from colorectal cancer (CRC) is a matter of debate. The aim of this study was to assess the feasibility and activity of bevacizumab plus FOLFIRI in this setting.Methods:Patients aged 18-75 years, PS 0-1, with resectable liver-confined metastases from CRC were eligible. They received bevacizumab 5 mg kg(-1) followed by irinotecan 180 mg m(-)(2), leucovorin 200 mg m(-)(2), 5-fluorouracil 400 mg m(-)(2) bolus and 5-fluorouracil 2400 mg m(-)(2) 46-h infusion, biweekly, for 7 cycles. Bevacizumab was stopped at cycle 6. A single-stage, single-arm phase 2 study design was applied with 1-year progression-free rate as the primary end point, and 39 patients required.Results:From October 2007 to December 2009, 39 patients were enrolled in a single institution. Objective response rate was 66.7% (95% exact CI: 49.8-80.9). Of these, 37 patients (94.9%) underwent surgery, with a R0 rate of 84.6%. Five patients had a pathological complete remission (14%). Out of 37 patients, 16 (43.2%) had at least one surgical complication (most frequently biloma). At 1 year of follow-up, 24 patients were alive and free from disease progression (61.6%, 95% CI: 44.6-76.6). Median PFS and OS were 14 (95% CI: 11-24) and 38 (95% CI: 28-NA) months, respectively.Conclusion:Preoperative treatment of patients with resectable liver metastases from CRC with bevacizumab plus FOLFIRI is feasible, but further studies are needed to define its clinical relevance.British Journal of Cancer advance online publication, 4 April 2013; doi:10.1038/bjc.2013.140 www.bjcancer.com.
    British Journal of Cancer 04/2013; · 5.08 Impact Factor
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    ABSTRACT: PURPOSES: Sphincter-saving operation with coloanal anastomosis (CAA) has become an established option for very low rectal cancer, but few studies have compared its functional results and quality of life (QoL) with abdominoperineal resection (APR) showing controversial results. PATIENTS AND METHODS: Patients treated for low rectal cancer with APR or CAA, disease-free after a median follow-up period of 26.5 (8-84) and 52.5 (12-156) months, respectively, were retrospectively reviewed. General and disease-specific changes in QoL and severity of disease were evaluated by Karnofsky scale, EORTC-C30, EORTC-CR38, SF-36, PGWBI, FIQL, PAC-QoL, ICIQ-SF, Stoma-QoL, AMS, Wexner's score and obstructed defecation syndrome (ODS) score. RESULTS: Twenty-six APR patients and 34 CAA patients entered the study. Karnofsky score did not show significant differences. The median Stoma-QoL was 58.2 (45-76.6), indicating a good stoma function in 95 % of patients. EORTC-C30, CR38, PGWBI and SF-36 questionnaires did not show significant differences between the two groups except for sexual function (better after CAA, p = 0.01). Eleven patients after APR and eight after CAA had urinary incontinence, and its severity did not differ significantly. Eighteen of 21 CAA patients complained of faecal incontinence [AMS, 80 (15-120); Wexner, 13 (2-19)] with an impact on their QoL [FIQL: lifestyle, 1.75 (0-4); coping/behaviour, 1.3 (0-3.5); depression, 2.1 (0-5.2); embarrassment, 2 (0-4.6)] and 11 complained of obstructed defecation [7.5 (3-16)] with significant consequences on QoL [PAC-QoL, 30.4 (19.2-80.3)]. CONCLUSIONS: QoL in patients with permanent stoma and in those after CAA did not differ significantly. APR patients had worse sexual function, while most CAA patients had faecal incontinence and sometime obstructed defecation, with important impact on their QoL.
    International Journal of Colorectal Disease 12/2012; · 2.24 Impact Factor
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    ABSTRACT: Pancreaticoduodenectomy (PD) is the gold standard treatment for cancer of pancreatic head in all the cases that are supposed to be resectable. Although the overall survival depends on many heterogeneous factors, the main aim of the treatment must be to achieve a R0 resection with microscopically and macroscopically free margins. As in recent reports vascular involvement does not represent anymore a technical limit, it is mandatory pointing out whether or not vascular resection modifies overall survival and if that is the case vascular invasion should not be considered as an exclusion criterion but as part of a standard resection. The review analysis demonstrated a progressive trend of inversion in the treatment of head pancreatic cancer over the last years. Recently, provided that a R0 resection may be performed, a more aggressive surgical approach has led to consider the possibility of venous and arterial resections. The basis for this new approach has been that the superior mesenteric vein or spleno-portal mesenteric vein invasion is not a measure of the tumor malignancy but merely a consequence of the tumor location. On the contrary, the controversial results in terms of overall survival and local recurrences achieved with major arterial resections are more likely due to a biological aggressivity than to the tumor site. The "artery first" technique seems to be the most promising approach to the problem although it needs further trials to determine whether or not this approach may be beneficial for patients in terms of overall survival and local recurrences.
    Current drug targets 03/2012; 13(6):772-80. · 3.93 Impact Factor
  • European Journal of Surgical Oncology (EJSO). 10/2010; 36(10):1023.
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    ABSTRACT: There is good evidence that radiotherapy is beneficial in advanced rectal cancer, but its application in Italy has not been investigated. We conducted a nationwide survey among members of the Italian Society of Colo-Rectal Surgery (SICCR) on the use of radiation therapy for rectal cancer in the year 2005. Demographic, clinical and pathologic data were retrospectively collected with an online database. Italy was geographically divided into 3 regions: north, center and south which included the islands. Hospitals performing 30 or more surgeries per year were considered high volume. Factors related to radiotherapy delivery were identified with multivariate analysis. Of 108 centers, 44 (41%) responded to the audit. We collected data on 682 rectal cancer patients corresponding to 58% of rectal cancers operated by SICCR members in 2005. Radiotherapy was used in 307/682 (45.0%) patients. Preoperative radiotherapy was used in 236/682 (34.6%), postoperative radiotherapy in 71/682 (10.4%) cases and no radiotherapy in 375 (55.0%) cases. Of the 236 patients who underwent preoperative radiotherapy, only 24 (10.2%) received short-course radiotherapy, while 212 (89.8%) received long-course radiotherapy. Of the 339 stage II-III patients, 159 (47%) did not receive any radiotherapy. Radiotherapy was more frequently used in younger patients (P < 0.0001), in patients undergoing abdominoperineal resection (APR) (P < 0.01) and in the north and center of Italy (P < 0.001). Preoperative radiotherapy was more frequently used in younger patients (P < 0.001), in large volume centers (P < 0.05), in patients undergoing APR (P < 0.005) and in the north-center of Italy (P < 0.05). Our study first identified a treatment disparity among different geographic Italian regions. A more systematic audit is needed to confirm these results and plan adequate interventions.
    Techniques in Coloproctology 09/2010; 14(3):229-35. · 1.54 Impact Factor
  • Tecniques in Coloproctology. 07/2010; 14:229-235.
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    ABSTRACT: The standard treatment of CRC patients with hepatic metastases is systemic chemotherapy; however, 5-year survival is disappointingly poor despite recent advances. On the other hand, in patients who undergo immediate radical surgical resection of hepatic metastases, 5-year survival reaches 30-40%. Unfortunately, only 15-20% of patients with hepatic metastases are initially eligible for a radical surgical approach. The majority of patients undergoing liver resection relapse after surgery. For this reason, new onco-surgery approaches have been investigated in recent years and the addition of biological agents to chemotherapy, such as bevacizumab and cetuximab, and the improvements of surgical techniques have opened a new scenario in the management of colorectal liver metastases. Recently, the EORTC trial has demonstrated that perioperative chemotherapy (Folfox regimen) is feasible and improves progression-free survival in patients with resectable liver metastases. Chemotherapy and surgery can finally collaborate. In the unresectable setting, the association of chemotherapy with bevacizumab and cetuximab is particularly promising in improving resectability rate. In particular, K-RAS is a molecular response predictive factor that could be particularly useful in selecting the best treatment option in patients with unresectable liver disease.
    Cancer Chemotherapy and Pharmacology 03/2010; 66(2):209-18. · 2.80 Impact Factor
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    ABSTRACT: In the last years a wide range of new technique offers the possibility to have R0 resection in colorectal cancer. We report our experience about Single Port Laparoscopic Surgery (SPL) for not advanced right colon cancer and about pelvectomy with cilindric Abdominal Perineal Resection (APR) for advanced rectal cancer. SPL offer mainly cosmetic advantages but also quicker recovery. No touch technique with adequate surgical margin and lymphectomy were respected. Operative time of SPL was 85-115 minutes, the incision was 5 cm long. There were no complications. Length of hospital stay was 4-6 days. With advanced pelvic cancer, pelvic exenteration with en-bloc resection is indicated. Then we propose a case of a 55 years old woman with a pelvic recurrence from a metastatic rectal cancer involving the right obturator fossa, the vaginal stump, the right ureter. Modern surgical technique give us the chance to offer the most appropriate oncologic surgical treatment.
    Acta chirurgica iugoslavica 01/2010; 57(3):73-5.
  • Ejso. 01/2010; 36(10):1026-1026.
  • Giovanni Romano, Francesco Bianco, Luisa Caggiano
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    ABSTRACT: Fecal incontinence is a socially devastating problem. The treatment algorithm depends on the etiology of the disease. Large anal sphincter defects can be treated by sphincter replacement procedures: the dynamic graciloplasty and the artificial bowel sphincter (ABS). The best indications for the ABS are lesions of the anal sphincters that are inaccessible to local repair and not responsive to sacral nerve stimulation test or not indicated for such a test. A recent article that published experiences with the ABS showed that this technique had a high rate of morbidity, surgical reinterventions, and explants. Complications leading to explantation included perioperative infections, failure of wound healing, erosion of part of the device throughout the skin or the anal canal, late infection, and mechanical malfunction of the device due to cuff or balloon rupture. The ABS is suitable for well-motivated, selected patients with fecal incontinence of more than one year’s duration and whose condition is affected by an important personal, familial, and/or social disability. KeywordsAnal sphincter-Artificial bowel sphincter-Fecal incontinence
    12/2009: pages 341-347;
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    ABSTRACT: We report a multicentric prospective study which aimed to evaluate Doppler-assisted ligation of the terminal haemorrhoidal arteries (THD) for II and III degree haemorrhoids. A total of 112 patients from five colorectal units, including 81 men, mean age 48 +/- 13 years, with II degree (39) and III degree (73) haemorrhoids were treated by Doppler-guided transanal de-arterialization and anopexy using a new device (THD). The mean operative time was 33.9 +/- 8.8 minutes, and the mean number of ligatures applied was 7.2 +/- 1.5. Postoperatively, 72% of patients did not need analgesics and the other 28% used nonsteroidal antiinflammatory drugs 1-3 times/day for less than 2 days. All the patients were operated as a day case. Early postoperative complications included haemorrhoidal thrombosis (2 patients), bleeding (1) treated by haemostatic suture, dysuria (6) and acute urinary retention (1). After a mean follow-up of 15.6 +/- 6.5 months (range 6-32), 2/105 (20.9%) patients complained of minor bleeding, while mild pain was still present in 4/51 patients (7.8%). There were no statistically significant differences in the sample population regarding the gender or stage of the disease. Tenesmus was cured in 15/17 patients, dyschaezia in 20/22 patients and mucous soiling in 10/10 patients. No new cases of altered defaecation or faecal incontinence were recorded. Overall, 85.7% of patients were cured and 7.1% improved. Residual haemorrhoids were treated by elastic band ligation in nine (8%) patients and by surgical excision in further five patients (4.5%). Doppler-assisted ligation of the terminal branches of the haemorrhoidal arteries for II and III degree haemorrhoids is highly effective and painless. Complications are few and the technique can be performed as a day case.
    Colorectal Disease 05/2009; 12(8):804-9. · 2.08 Impact Factor
  • G Romano, F Bianco, L Caggiano
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    ABSTRACT: We report a modified technique of perineal proctectomy using a new reloadable curved cutter stapler, the Contour Transtar (Ethicon Endo-Surgery), to treat full-thickness external rectal prolapse. Between May and July 2008 three female patients were treated. All had a full-thickness external rectal prolapse up to 10 cm in length. The prolapse was initially divided by a linear cutter in anterior and posterior flaps, and resection of the prolapse was performed with a Contour Transtar stapler. There was no mortality or early or late morbidity. Follow-up was 2-4 months. All patients had a bowel movement within 3 days of the operation, oral feeding started immediately and the hospital stay was 5 days in all cases. All patients reported an improvement of constipation and continence. Our procedure may be indicated for full-thickness prolapse with a rectal protrusion up to 10 cm, as it allows a simple resection without any mobilization or dissection of the rectum. The technique is safe, easier and faster to perform than conventional perineal rectosigmoidectomy.
    Colorectal Disease 05/2009; 11(8):878-81. · 2.08 Impact Factor
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    ABSTRACT: Diffusion of laparoscopic surgery in the last 15 years has changed the surgical approach to several diseases. Lapa roscopic surgery has become the gold standard for gallstones, but its application to colorectal surgery, since the first colic resection in 1991, has been very controversial. There are different reasons for this attitude. Pro cedures are more complex, with a relatively long learning curve, which results in an increase in morbidity and mortality. Moreover, there were some initial doubts on its radicality in neoplastic disease, the risk of tumour spread and the adequacy of lymphadenectomy. Open colonic resection has been considered until recently the gold standard for cancer cure because it guarantees adherence to the oncological standard of care. The application of laparoscopic surgery to the treatment of colon cancer will be successfully established only if it also unequivocally reaches this standard of care. In this regard in recent years several prospective multicentre studies investigating the possible advantages of the laparoscopic approach have been re ported: the Clinical Outcome of Surgical Therapy (COST) trial from the US [1], the Medical Research Council’s Conventional versus Laparoscopic Assisted Surgery for Colorectal Cancer (CLASICC) trial from the
    Techniques in Coloproctology 07/2008; 12(2):185-8. · 1.54 Impact Factor
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    ABSTRACT: The aim of the survey was to assess the incidence of anastomotic leaks (AL) and to identify risk factors predicting incidence and gravity of AL after low anterior resection (LAR) for rectal cancer performed by colorectal surgeons of the Italian Society of Colorectal Surgery (SICCR). Information about patients with rectal cancers less than 12 cm from the anal verge who underwent LAR during 2005 was collected retrospectively. AL was classified as grade I to IV according to gravity. Fifteen clinical variables were examined by univariate and multivariate analyses. Further analysis was conducted on patients with AL to identify factors correlated with gravity. There were 520 patients representing 64% of LAR for rectal cancer performed by SICCR members. The overall rate of AL was 15.2%. Mortality was 2.7% including 0.6% from AL. The incidence of AL was correlated with higher age (p<0.05), lower (<20 per year) centre case volume (p<0.05), obesity (p<0.05), malnutrition (p<0.01) and intraoperative contamination (p<0.05), and was lower in patients with a colonic J-pouch reservoir (p<0.05). In the multivariate analysis age, malnutrition and intraoperative contamination were independent predictors. The only predictor of severe (grade III/IV) AL was alcohol/smoking habits (p<0.05) while the absence of a diverting stoma was borderline significant (p<0.07). Our retrospective survey identified several risk factors for AL. This survey was a necessary step to construct prospective interventional studies and to establish benchmark standards for outcome studies.
    Techniques in Coloproctology 06/2008; 12(2):103-10. · 1.54 Impact Factor
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    ABSTRACT: Milligan-Morgan hemorrhoidectomy using radiofrequency dissection (Ligasure) has been proposed instead of conventional diathermy in view of its potential benefits in terms of postoperative anal pain and better hemostatic control, but the medical literature is still controversial. This multicenter, randomized, controlled trial was designed to compare the outcomes between Ligasure and conventional diathermy hemorrhoidectomy in the Milligan-Morgan procedures in a sufficient number of patients. Patients with Grades III and IV hemorrhoids were randomized to two groups: Ligasure hemorrhoidectomy and conventional diathermy. Postoperative anal pain was measured by the Visual Analog Scale (VAS) and the analgesia required. Postoperative complications, wound healing, and return to working activities also were evaluated as secondary outcomes. A total of 273 patients, well matched for age, gender, working activity and grade of hemorrhoids, were randomized to two groups: Ligasure 146, and diathermy 127. The severity of postoperative anal pain was significantly less in the Ligasure group when measured at least 12 hours after defecation (P < 0.01), whereas it was similar at the time of defecation. The Ligasure group had significantly lower requirements for painkiller pills. There were no significant differences in early and late complications. Return to work and normal activities was significantly faster in the Ligasure group. Ligasure hemorrhoidectomy is an effective procedure for Grades III and IV hemorrhoids and facilitates a faster return to work and normal activities by reducing postoperative pain.
    Diseases of the Colon & Rectum 06/2008; 51(5):514-9. · 3.34 Impact Factor
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    ABSTRACT: PurposeObstructed defecation may be treated by stapled transanal rectal resection, but different complications and recurrence rates have been reported. The present study was designed to evaluate stapled transanal rectal resection results, outcome predictive factors, and nature of complications. MethodsClinical and functional data of 123 patients were retrospectively analyzed. All patients had symptoms of obstructed defecation before surgery and had rectocele and/or intussusception. Of them, 85 were operated on by the authors and 38 were referred after stapled transanal rectal resection had been performed elsewhere. ResultsAt a median follow-up of 17 (range, 3–44) months, 65 percent of the patients operated on by the authors had subjective improvement. Recurrent rectocele was present in 29 percent and recurrent intussusception was present in 28 percent of patients. At univariate analysis, results were worse in those with preoperative digitation (P < 0.01), puborectalis dyssynergia (P < 0.05), enterocele (P < 0.05), larger size rectocele (P < 0.05), lower bowel frequency (P < 0.05), and sense of incomplete evacuation (P < 0.05). Bleeding was the most common perioperative complication occurring in 12 percent of cases. Reoperations were needed in 16 patients (19 percent): 9 for recurrent disease. In the 38 patients referred after stapled transanal rectal resection, the most common problems were perineal pain (53 percent), constipation with recurrent rectocele and/or intussusception (50 percent), and incontinence (28 percent). Of these patients, 14 (37 percent) underwent reoperations: 7 for recurrence. Three patients presented with a rectovaginal fistula. One other patient died for necrotizing pelvic fasciitis. ConclusionsStapled transanal rectal resection achieved acceptable results at the cost of a high reoperation rate. Patients with puborectalis dyssynergia and lower bowel frequency may do worse because surgery does not address the causes of their constipation. Patients with large rectoceles, enteroceles, digitation, and a sense of incomplete evacuation may have more advanced pelvic floor disease for which stapled transanal rectal resection, which simply removes redundant tissue, may not be adequate. This, together with the complications observed in patients referred after stapled transanal rectal resection, suggests that this procedure should be performed by colorectal surgeons and in carefully selected patients.
    Diseases of the Colon & Rectum 01/2008; 51(2):186-195. · 3.34 Impact Factor

Publication Stats

490 Citations
98.25 Total Impact Points

Institutions

  • 2009–2012
    • Istituto Nazionale Tumori "Fondazione Pascale"
      Napoli, Campania, Italy
    • Azienda Ospedaliera S. G. Moscati
      Avellino, Campania, Italy
  • 2010
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
      Milano, Lombardy, Italy
  • 2008
    • Università degli Studi di Bari Aldo Moro
      Bari, Apulia, Italy
  • 2007
    • Santo Spirito Hospital, Casale Monferrato
      Casale, Piedmont, Italy
  • 1994–2004
    • University of Naples Federico II
      Napoli, Campania, Italy
  • 2002–2003
    • Sapienza University of Rome
      Roma, Latium, Italy
  • 2001
    • Universita' degli Studi "Magna Græcia" di Catanzaro
      Catanzaro, Calabria, Italy
  • 1988–1993
    • Second University of Naples
      • Faculty of Medicine and Surgery
      Napoli, Campania, Italy