L.F. Da Pozzo

Postoperative Radiotherapy After Radical Prostatectomy: A Randomised Controlled Trial (EORTC Trial 22911)

Summary Background Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We dida randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation withprostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. Methods After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-seepolicy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks).Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positivesurgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-freesurvival. Analysis was by intention to treat. Findings The median age was 65 years (IQR 61–69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74·0%, 98% CI 68·7–79·3

Thermo–Chemotherapy and Electromotive Drug Administration of Mitomycin C in Superficial Bladder Cancer Eradication

Objective: To assess the feasibility and safety of two novel methods for intravesical chemotherapy administration in patients suffering from superficial bladder carcinomas. To draw preliminary considerations concerning the ablative effect on marker lesion using novel approaches compared to standard intravesical chemotherapy. Methods: Eighty patients suffering from single, recurrent, low–stage, low–grade superficial bladder tumor entered a prospective nonrandomized study. Thirty–six of them were treated by means of mitomycin C instillation as a standard procedure. In 29 patients mitomycin C solution was administered in combination with local microwave–induced hyperthermia and in 15 patients the mitomycin C solution was administered according to the electromotive drug procedure. The treatment was scheduled as a short term neo–adjuvant regimen prior to transurethral resection. Feasibility and safety of the different procedures were evaluated on an outpatients basis. The local toxicity induced by different approaches was defined and compared using a subjective questionnaire. Results: Both intravesical chemotherapy administered in combination with hyperthermia and according to the electromotive drug technique appeared to be feasible and safe. Local toxicity induced by thermo–chemotherapy was more severe than that registered for electromotive drug technique and standard intravesical chemotherapy. Local toxicity was always short and self healing without early or delayed major complications. A higher complete response rate on marker lesion was observed after thermo–chemotherapy compared to other administration methods. Conclusion: The intravesical administration of mitomycin C can be safely performed in the form of both thermo–chemotherapy and electromotive drug approach with an increased ablative success rate on small superficial tumor involving only minimal local side effects.

Combination of intravesical chemotherapy and hyperthermia for the treatment of superficial bladder cancer: Preliminary clinical experience

The prevalence of superficial transitional cell carcinoma of the bladder (STCCB) is still increasing in spite of improved adjuvant chemotherapeutic and/or immunoprophylaxis approaches. Thus, there is certainly an urgent need to improve our ability to control this disease. Local hyperthermia has a therapeutical potential for the treatment of many solid tumors, especially when used in combination with other treatments, such as radiation and chemotherapy. In particular, a synergistic or, at least, supra-additive anti-tumor cell killing effect was documented when local hyperthermia was administered in combination with selected cytostatic drugs. Recently, advances in miniaturized technology have allowed the development of a system specifically designed for delivering an endovesical thermo-chemotherapy regimen in humans. In preliminary clinical experiences, insofar mainly carried out as mono-institutional investigations, the combined treatment using this system was demonstrated to be feasible, minimally invasive and safe when performed on out-patient basis. Moreover, the anti-tumoral efficacy seemed to be significantly enhanced when compared with that obtained using intravesical chemotherapy alone for both adjuvant (prophylaxis) and neo-adjuvant (ablative) approaches to superficial bladder cancer.

Five-year results of neoadjuvant cisplatin, methotrexate and vinblastine chemotherapy plus radical cystectomy in locally advanced bladder cancer

Neoadjuvant systemic cisplatin, methotrexate and vinblastine chemotherapy has been used in the treatment of 69 patients with advanced bladder cancer (stages T2-T4 N+/N0 M0). Sixty patients were evaluable for response at a median follow-up of 48 months. Preoperative resection of the tumor was purposely avoided in order to keep a marker lesion. After planned radical cystectomy, pathological complete responses (pCRs) and partial responses (pPRs) were documented in 5 (8.3%) and 29 cases (43.4%), respectively. These patients had a 5-year disease-free survival rate of 80%, which was statistically superior (p = 0.0013) to 35% for the remaining nonresponding patients. One patient (20%) with a pCR died of systemic disease after 14 months, while the remaining 4 patients (80%) are alive and free of disease after a median follow-up of 57 months. A higher percentage of pCRs and pPRs was observed in the group of patients with stage T3b-T4 tumor (pCR 11%, pPR 63%) in contrast to the patients with stage T2-T3a disease (pCR 4.5%, pPR 45.5%), even if no significant difference in the 5-year survival rate was observed between the 2 groups. Patients with a G2 tumor before chemotherapy survived longer (5-year survival rate of 78%) than those with G3 disease (5-year survival rate of 61%), but no significant difference was achieved.

Corpus Cavernosum Atypical Metastasis of Renal Cell Carcinoma: Presurgical Therapy and Complete Surgical Resection. Case Report and Review of the Literature

Renal-Cell Carcinoma (RCC) accounts for 2% of all cancers. Metastases are present in up to 30% of patients at diagnosis or appeared during follow up [1]. Atypical RCC metastases are sites, other than chest, liver, bone, adrenal, brain, and nodes, and their presentation is very rare. We describe the case of a 71-years-old male, who was submitted to a left laparoscopic radical nephrectomy for Clear Renal Cell Carcinoma (CRCC). After a 14-year follow-up, MRI scan showed a 5-cm solid lesion of the perineum, that originates from the right corpus cavernosum. A percutaneous trans-perineal biopsy revealed an atypical metastasis of CRCC. To reduce surgical risk during the exeresis of the mass, the patient received 4 cycles of pazopanib as presurgical treatment, with a shrinking of the lesion at follow-up MRI scan. He underwent a complete resection of the residual mass. Histopathology confirmed the diagnosis of atypical corpus cavernosum metastasis of CRCC. Presurgical therapy with Target Molecular Therapy (TMT) is feasible and might have several potential advantages for patients in case of complex metastasectomy.

137 PADUA score accurately predicts the risk and grade of complication and ischemic time in patients who are candidates for nephron sparing surgery

INTRODUCTION AND OBJECTIVES: to prospectively test the Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classification in a cohort of patients submitted to open nephron sparing surgery (NSS) and to correlate the PADUA score to ischemia time. METHODS: from December 2009 and September 2010, 112 consecutive patients were treated with open NSS with the technique of hilar arterial clamping. Tumor were reclassified according to the PADUA classification. Complication were graded according to the modified Clavien system. Univariable and multivariable logistic regression analyses tested the predictive value of PADUA score on overall complication rate and on the ischemic time. RESULTS: Sixty-one patients underwent extraperitoneal NSS through a flank incision, while 51 patients underwent transperitoneal approach. Mean patients age was 61.8 °A 13.3 years. The median tumor diameter was 3.4–1.5 cm. The median PADUA score was 8 (range 6–13). Mean ischemia time was 20–10 min. Overall complication rate was 18.7% (n 21). On univariable analysis, the PADUA score correlated with complication rate (p 0.027) and with increased ischemia time, considered as a continuous variable as well as categorical one (°U 25 min vs 25 min) (p 0.001 and p 0.03, respectively). On multivariable analysis PADUA score achieved the independent predictor status of complication rate, after adjusting for body mass index and surgical approach. Patients with PADUA score 8–9 had a 4-fold risk of complication, while patients with PADUA score 10 had a 15-fold risk compared to those with scores of 6–7 (p 0.013). Moreover. patients with PADUA score 10 had a 6-fold risk of ischemic time 25 minutes (p 0.002). CONCLUSIONS: our study confirms that PADUA score can reliably predict risk complication and ischemic time in patients treated with NSS, independently from the extra or transperitoneal approach. PADUA classification can help the selection of patients who may benefit from additional techniques such as hypothermic procedure.

18 IMPACT OF STAGE MIGRATION ON THE PREVALENCE OF PELVIC LYMPH NODE METASTASES IN PATIENTS UNDERGOING EXTENDED PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER: A 23-YEAR SINGLE INSTITUTION EXPERIENCE

INTRODUCTION AND OBJECTIVE: Locally recurrent gynecological malignancys generally have a poor prognosis and therapeutic optins are limited. We evaluated a series of women undergoing exenterative surgery and urinary diversion for gynecological malignancy. METHODS: All patients who underwent pelvic exenteration for recurrent gynecological malignancy between 1989 and 2001 at Bern University Hospital or Karlsruhe Medical Center were evaluated. Variables assessed included time to recurrence, type of exenteration and urinary diversion, pathological stage, postoperative complications and survival. Cox proportional hazard analysis and Kaplan-Meier survival method and subgroup analysis were performed. RESULTS: Initial therapy prior to recurrence in the 43 evaluated patients was surgery only in 19/43 (44%), in 16/43 (37%) patients surgery was combined with either radiation therapy (23%), chemotherapy (5%) or radio-chemotherapy (9%). Of the remaining 8 patients 5/43 (12%) underwent radiation therapy only and 3/43 (7%) underwent combined radio-chemotherapy. Anterior exenteration was performed in 37 (86%) patients and total exenteration in 6 (14%). Half of the women underwent additional procedures. A continent urinary diversion was constructed in 16 (4 ileal orthotopic bladder substitutes, 2 continent ileal reservoirs, 10 continent ileocecal reservoirs (Mainz-pouch I) and an ileal conduit in 27 patients. The majority of the early postoperative complications were minor and only 2 patients required additional surgical intervention. Four intestinal fistulas were succesfully treated conservatively. Late complications were mainly tumor related. Complication rates related to the urinary diversion were low and there was no difference in complications between continent and incontinent diversion. Overall disease specific 5 year survival rate after exenteration was 33.9 %. This correlated significantly with surgical margin status. CONCLUSIONS: In patients with completely resectable (R0) recurrent cervical cancer of the pelvis, exenteration is a viable option with 5 year survival rates of approx. 43%. Continent urinary diversion did not show higher complication rates than an ileal conduit and should be considered an option even in irradiated patients. This may be of greater significance in younger patients where an intact body image may play an important role on quality of life.