Paul Carpentier

Impact of the Learning Curve on Perioperative Outcomes in Patients Who Underwent Robotic Partial Nephrectomy for Parenchymal Renal Tumours

BACKGROUND Robot-assisted partial nephrectomy (RAPN) is an emerging, minimally invasive technique to treat patients with small renal masses. OBJECTIVE To evaluate the impact of the learning curve on perioperative outcomes such as operative times and warm ischaemia times (WIT), blood loss, overall complications, and renal function impairment in patients who underwent RAPN. DESIGN, SETTING, AND PARTICIPANTS We collected prospectively the clinical and pathologic records of 62 consecutive patients who underwent RAPN between September 2006 and November 2009 for renal tumours at a nonacademic teaching institution by a single surgeon with extensive prior robotic experience. INTERVENTIONS The surgeon used transperitoneal RAPN with excision of an adequate rim of healthy peritumour renal parenchyma. MEASUREMENTS Perioperative parameters, pathologic outcome, and short-term outcomes for renal function were recorded. The effects of the learning curve on the previous reported perioperative and functional outcomes was studied. RESULTS AND LIMITATIONS The mean pathologic tumour size was 2.8 +/-1.3 cm. A pelvicaliceal repair was needed in 33 cases (53%). The mean console time was 91 +/-33 min (range: 52-180), with a mean WIT of 20 +/- 7 min (range: 9-40). Warm ischaemia (<20 min) and console times were optimised after the first 30 (p<0.001) and 20 cases (p<0.001), respectively. Pathologic results yielded a positive surgical margin (PSM) rate of 2%. Mean creatinine level changed from a baseline value of 1.02 +/- 0.38 mg/dl to 1.1 +/- 0.7 mg/dl 3 mo after surgery. Estimated glomerular filtration rate changed from a baseline value of 81.17 +/- 29 to 80.5 +/- 29 (millilitres per minute per 1.73 m(2)) 3 mo postoperatively. CONCLUSIONS RAPN is a viable option for nephron-sparing surgery in patients with renal carcinoma. Specifically, in the hands of a surgeon with extensive robotic experience, RAPN requires a short learning curve to reach WIT < 20 min, console times < 100 min, limited blood loss, and acceptable overall complication rates.

The Learning Curve of Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium

BACKGROUND Robot-assisted radical cystectomy (RARC) has evolved as a minimally invasive alternative to open radical cystectomy for patients with invasive bladder cancer. OBJECTIVE We sought to define the learning curve for RARC by evaluating results from a multicenter, contemporary, consecutive series of patients who underwent this procedure. DESIGN, SETTING, AND PARTICIPANTS Utilizing the International Robotic Cystectomy Consortium database, a prospectively maintained and institutional review board-approved database, we identified 496 patients who underwent RARC by 21 surgeons at 14 institutions from 2003 to 2009. MEASUREMENTS Cut-off points for operative time, lymph node yield (LNY), estimated blood loss (EBL), and margin positivity were identified. Using specifically designed statistical mixed models, we were able to inversely predict the number of patients required for an institution to reach the predetermined cut-off points. RESULTS AND LIMITATIONS Mean operative time was 386 min, mean EBL was 408 ml, and mean LNY was 18. Overall, 34 of 482 patients (7%) had a positive surgical margin (PSM). Using statistical models, it was estimated that 21 patients were required for operative time to reach 6.5h and 8, 20, and 30 patients were required to reach an LNY of 12, 16, and 20, respectively. For all patients, PSM rates of <5% were achieved after 30 patients. For patients with pathologic stage higher than T2, PSM rates of <15% were achieved after 24 patients. CONCLUSIONS RARC is a challenging procedure but is a technique that is reproducible throughout multiple centers. This report helps to define the learning curve for RARC and demonstrates an acceptable level of proficiency by the 30th case for proxy measures of RARC quality.

Surgical Margin Status After Robot Assisted Radical Cystectomy: Results From the International Robotic Cystectomy Consortium

PURPOSE Positive surgical margins at radical cystectomy confer a poor prognosis. We evaluated the incidence and predictors of positive surgical margins in patients who underwent robot assisted radical cystectomy for bladder cancer. MATERIALS AND METHODS Using the International Robotic Cystectomy Consortium database we identified 513 patients who underwent robot assisted radical cystectomy, as done by a total of 22 surgeons at 15 institutions from 2003 to 2009. After stratification by age group, gender, pathological T stage, nodal status, sequential case number and institutional volume logistic regression was used to correlate variables with the likelihood of a positive surgical margin. RESULTS Of the 513 patients 35 (6.8%) had a positive surgical margin. Increasing 10-year age group, lymph node positivity and higher pathological T stage were significantly associated with an increased likelihood of a positive margin (p = 0.010, <0.001 and p <0.001, respectively). Gender, sequential case number and institutional volume were not significantly associated with margin positivity. The rate of margin positive disease at cystectomy was 1.5% for pT2 or less, 8.8% for pT3 and 39% for pT4 disease. CONCLUSIONS Positive surgical margin rates at robot assisted radical cystectomy for advanced bladder cancer were similar to those in open cystectomy series in a large, multi-institutional, prospective cohort. Sequential case number, a surrogate for the learning curve and institutional volume were not significantly associated with positive margins at robot assisted radical cystectomy.

Adjuvant Chemotherapy of Superficial Transitional Cell Bladder Carcinoma:Preliminary Results of a European Organization for Research onTreatment of Cancer Randomized Trial Comparing Doxorubicin Hydrochloride, Ethoglucid and Transurethral Resection Alone

Patients with superficial transitional cell carcinoma of the bladder were entered in a randomized clinical trial to compare the efficacies of transurethral resection alone or followed by bladder instillation of doxorubicin hydrochloride or ethoglucid (Epodyl) for 1 year. Results showed that adjuvant chemotherapy with the selected drugs prolonged the mean interval between recurrences. Mild systemic toxicity and chemical cystitis were observed in 3 and 3 per cent, respectively, of the patients given ethoglucid, and in 5 and 4 per cent, respectively, of those taking doxorubicin.

Lymphadenectomy at the time of robot‐assisted radical cystectomy: results from the International Robotic Cystectomy Consortium

What’s known on the subject? and What does the study add?

Long-term biochemical recurrence rates after robot-assisted radical prostatectomy: analysis of a single-center series of patients with a minimum follow-up of 5 years.

OBJECTIVE To address the long-term biochemical recurrence (BCR)-free survival rates of patients treated with robotic-assisted laparoscopic prostatectomy (RALP) with a minimum follow-up of 5 years. MATERIALS AND METHODS Prospectively collected data of 184 patients treated with RALP at a single institution were analyzed. Kaplan-Meier and life tables analyses targeted the rates of BCR according to pathologic parameters. Cox regression analyses addressed predictors of BCR. RESULTS Median follow-up was 67.5 months. One and 10 patients died of prostate cancer (PCa) and other causes, respectively. Mean time to BCR was 83.8 months. The 3-, 5-, and 7-year BCR-free survival rates were 94%, 86%, and 81%, respectively. These rates were 97%, 93%, and 85% for pT2 disease; 94%, 84%, and 84% for pT3a; and 69%, 43%, and 43% for pT3b (P<.001). The same figures were 97%, 90%, and 88% for Gleason sum 6 or lower; 90%, 86%, and 75% for Gleason sum 7; and 85%, 65%, and 65% for Gleason sum 8-10 (P=.01). At univariable analyses, prostate-specific antigen, pathologic Gleason score, and presence of extracapsular extension, seminal vesicle invasion, and adjuvant radiotherapy were significantly associated with BCR. At multivariable analysis, the presence of seminal vesicle invasion and the presence of Gleason sum 8-10 represented independent predictors of BCR (HR=5.14; P=.004 and HR=3.04; P=.04, respectively). CONCLUSION We report the longest available follow-up in RALP patients. RALP represents an oncologically effective procedure. Our oncological results support the increasing diffusion of RALP for the treatment of organ-confined PCa.

Does previous robot-assisted radical prostatectomy experience affect outcomes at robot-assisted radical cystectomy? Results from the international robotic cystectomy consortium

OBJECTIVES To evaluate the effect of previous robot-assisted radical prostatectomy (RARP) case volume on the outcomes of robot-assisted radical cystectomy. Little is known regarding the effect of previous robotic surgical experience on the implementation and execution of robot-assisted radical cystectomy. METHODS Using the International Robotic Cystectomy Consortium database, 496 patients were identified who had undergone robot-assisted radical cystectomy by 21 surgeons at 14 institutions from 2003 to 2009. The surgeons were divided into 4 groups according to their previous RARP experience (≤ 50, 51-100, 101-150, and > 150 cases). The overall operative time, blood loss, lymph node yield, pathologic stage, and surgical margin status were compared among the 4 groups using chi-square analysis. RESULTS The mean operative time was 386 minutes (range 178-827). The mean estimated blood loss was 408 mL (range 25-3500). The operative time and blood loss were both significantly associated with previous RARP experience (P < .001). The mean lymph node count was 17.8 nodes (range 0-68). Lymph node yield and increased pathologic stage were significantly associated with previous RARP experience (P < .001). Finally, 34 (7.0%) of the 482 patients had a positive surgical margin. Margin status was not significantly associated with previous RARP experience (P = .089). CONCLUSIONS Previous RARP case volume might affect the operative time, blood loss, and lymph node yield at robot-assisted radical cystectomy. In addition, surgeons with increased RARP experience operated on patients with more advanced tumors. Previous RARP experience, however, did not appear to affect the surgical margin status.

A European Organization for Research and Treatment of Cancer—Genitourinary Group Phase 2 Study of Chemotherapy in Stage T3-4N0-XM0 Transitional Cell Cancer of the Bladder: Evaluation of Clinical Response

From 1986 to 1990 the European Organization for Research and Treatment of Cancer--Genitourinary Group conducted a phase 2 trial of neoadjuvant chemotherapy in patients with stage T3-4N0-XM0 transitional cell carcinoma of the bladder. The objectives were to evaluate the clinical response in relation to the pathological response, and to measure the side effects of chemotherapy. Of 171 patients entered 136 were fully evaluable: 18% had clinical complete remissions, 36% had clinical partial remissions, 39% had no clinical remissions and 10% had unknown response. A selected subgroup of 76 patients underwent cystectomy after 2 or 4 courses of chemotherapy: 2 were not evaluable for pathological response because of preoperative radiotherapy after neoadjuvant chemotherapy, 16 had a pathological complete remission, 7 had a pathological partial remission and 51 had no pathological remission. Comparison of the clinical response or T category only after 2 courses of chemotherapy with the pathological response after 2 or 4 courses of chemotherapy showed that in a number of patients the disease status could be downstaged to pathological complete or partial remission by additional courses of chemotherapy. If the discrepancies between clinical and pathological responses, or between T and P categories, induced by further downstaging after additional chemotherapy were left out, it was shown that clinical complete and partial remissions were a heterogeneous group but nonresponders could be delineated with a 100% accuracy by clinical response evaluation and transurethral resection biopsy only. Furthermore it seems important to establish the number of chemotherapy courses to induce a maximal response of the primary tumor.

Phase 1/2 study of intravesical epirubicin in patients with carcinoma in situ of the bladder

A total of 34 patients with grade 3 carcinoma in situ of the bladder entered a phase 1/2 study with epirubicin to examine the rate of antitumor activity, the type and frequency of local side effects, and the absorption and recovery rates. The selected doses were 30, 50 and 80 mg. Of the patients 22 were evaluable for report of treatment results. A total of 16 patients had a complete remission proved by biopsy and conversion of urine cytology findings. Mean duration of complete remission was 22.4 months (range 7+ to 50+ months). After a mean followup of 35.3 months (range 14 to 59 months) 8 of 16 patients were still in complete remission, 3 died of a myocardial infarction, 3 had recurrent grade 3 carcinoma in situ, 2 had increase to a higher T category (stages T2 and T4a), and 2 had recurrent papillary stage Ta, grade 2 (1) and stage T1, grade 2 (1) transitional cell carcinoma of the bladder. Six of the 22 patients had no response to 1 or 2 treatment courses with a higher dose. Plasma concentrations of epirubicin after instillation were close to the detection limit of the assay (0.5 to 2.0 ng/ml. plasma).

Long‐term evaluation of survival, continence and potency (SCP) outcomes after robot‐assisted radical prostatectomy (RARP)

To report combined oncological and functional outcome in a series of patients who underwent robot‐assisted radical prostatectomy (RARP) for clinically localised prostate cancer in a single European centre after 5‐year minimum follow‐up according to survival, continence and potency (SCP) outcomes.