Biomedical subjects

Manlio Goetzl

Publications and source records attributed to Manlio Goetzl.

3 recordsLinked to original sources

PubMed2006

Phase I trial of intravesical docetaxel in the management of superficial bladder cancer refractory to standard intravesical therapy.

PURPOSE: Up to 50% of patients treated with intravesical agents for superficial bladder cancer will experience recurrence. Response rates to second-line intravesical therapies range from 20% to 40%. For these high-risk patients, novel agents are necessary to prevent recurrence. Docetaxel is a microtubule depolymerization inhibitor with unique physiochemical properties, making it an excellent candidate for investigation as an intravesical agent. PATIENTS AND METHODS: This phase I trial included patients with recurrent Ta, T1, and Tis transitional cell carcinoma who experienced treatment failure with at least one prior intravesical treatment. Docetaxel was administered as six weekly instillations at a starting dose of 5 mg, with a dose-escalation model used until a maximum tolerated dose (MTD) was achieved. Primary end points were dose-limiting toxicity (DLT) and MTD. Efficacy was evaluated by cystoscopy with biopsy, cytology, and computed tomography imaging. RESULTS: Eighteen patients (100%) completed the trial, and the distribution of stages included six patients with Tis, seven with Ta, and five with T1 disease. No grade 3 or 4 DLTs occurred in 108 infusions, and no patient had systemic absorption of docetaxel. Eight (44%) of 18 patients experienced grade 1 or 2 toxicities, with dysuria being the most common. Ten (56%) of 18 patients had no evidence of disease at their post-treatment cystoscopy and biopsy. None of the patients who experienced relapse had disease progression. CONCLUSION: Intravesical docetaxel exhibited minimal toxicity and no systemic absorption in the first human intravesical clinical trial. This suggests that docetaxel is a safe agent for further evaluation of efficacy in a phase II trial.

Administration, Intravesical↗

PubMed2005

A postoperative prognostic nomogram predicting recurrence for patients with conventional clear cell renal cell carcinoma.

PURPOSE: Few published studies have simultaneously analyzed multiple prognostic factors to predict recurrence after surgery for conventional clear cell renal cortical carcinomas. We developed and performed external validation of a postoperative nomogram for this purpose. We used a prospectively updated database of more than 1,400 patients treated at a single institution. MATERIALS AND METHODS: From January 1989 to August 2002, 833 nephrectomies (partial and radical) for renal cell carcinoma of conventional clear cell histology performed at Memorial Sloan-Kettering Cancer Center were reviewed from the center's kidney database. Patients with von Hippel-Lindau disease or familial syndromes, as well as patients presenting with synchronous bilateral renal masses, or distant metastases or metastatic regional lymph nodes before or at surgery were excluded from study. We modeled clinicopathological data and disease followup for 701 patients with conventional clear cell renal cell carcinoma. Prognostic variables for the nomogram included pathological stage, Fuhrman grade, tumor size, necrosis, vascular invasion and clinical presentation (ie incidental asymptomatic, locally symptomatic or systemically symptomatic). RESULTS: Disease recurrence was noted in 72 of 701 patients. Those patients without evidence of disease had a median and maximum followup of 32 and 120 months, respectively. The 5-year probability of freedom from recurrence for the patient cohort was 80.9% (95% confidence interval 75.7% to 85.1%). A nomogram was designed based on a Cox proportional hazards regression model. Following external validation predictions by the nomogram appeared accurate and discriminating, and the concordance index was 0.82. CONCLUSIONS: A nomogram has been developed that can be used to predict the 5-year probability of freedom from recurrence for patients with conventional clear cell renal cell carcinoma. This nomogram may be useful for patient counseling, clinical trial design and effective patient followup strategies.

Carcinoma, Renal Cell↗

PubMed2002

Partial nephrectomy: the rationale for expanding the indications.

BACKGROUND: We report preliminary results of partial nephrectomy for renal tumors of > or =4 cm in 39 patients with the intent of extending the indications for kidney-sparing surgery. METHODS: From July 1989 to October 2001, 39 patients underwent a partial nephrectomy for renal cortical tumors >4 cm in maximum diameter. Fourteen (36%) had the procedure performed for essential reasons, and 25 (64%) had an elective kidney-sparing operation. We evaluated tumor location and histology, perioperative renal function, and postoperative complications. RESULTS: There were 20 conventional clear-cell (51%), 13 papillary (33%), 4 chromophobe (10%), and 3 oncocytomas (8%) with a median tumor size of 5 cm. After a median follow-up of 13 months, 36 patients had no evidence of disease, 1 patient had died as a result of other causes, and 2 patients who had essential operations were alive with disease. Twenty-three patients (70%) maintained normal postoperative renal function. Of six patients with moderate preoperative renal dysfunction, five (83%) had no change in postoperative renal function and only one patient required short-term dialysis. CONCLUSIONS: With careful patient selection, partial nephrectomy can be effectively used to treat patients with renal cortical tumors >4 cm in diameter. The benefits of this approach include the effective local tumor control while at the same time preserving maximum renal function.

Adult↗