ABSTRACTS OF THE 21st ANNUAL MEETING OF THE ITALIAN ...

Lorenzo Rocchini, Federico Pellucchi, Buthaina Ibrahim,
Carmen Maccagnano, Massimo Freschi, Giuseppe Zanni,
Luca Villa, Giorgio Gandaglia, Paolo Capogrosso,
Niccoló Passoni, Nicola Fossati and Renzo Colombo
I.R.C.C.S. San Raffaele, Universitá Vita-Salute, Milano, Italy
Background: It has been suggested that improved oncologic
outcome can be expected when using a more intensive
schedule for the administration of intravesical chemotherapy.
Patients and Methods: This prospective randomized phase II
study investigated both safety and subjective tolerability of a
novel schedule of chemotherapy administration (3 times per
week for 2 weeks) compared to the standard approach (1 time
per week for 6 weeks) as neoadjuvant treatment of recurrent
low-grade non muscle-invasive bladder cancer (NMIBC). The
secondary endpoint of the study was the definition of complete
tumor response (CR). Between January 2009 and September
2010, 52 consecutive patients diagnosed with recurrent
NMIBC, single tumor smaller than 1 cm in size, with negative
urinary cytology were recruited. All patients underwent
pretreatment video cystoscopy with bladder map including the
location and size of any tumor. Patients were then randomized
to receive within 1 week: a neoadjuvant regimen according to
the standard timing with mitomycin C 40 mg/40 ml saline at
1 instillation per week for 6 weeks (Group 1), or the
experimental adjuvant regimen with mitomycin C 40 mg/40
ml saline at 3 instillations per week for 2 weeks (Group 2).
Seven to ten days after treatment completion, video
cystoscopy with bladder map and biopsy of every residual or
suspicious lesion was performed for all patients. Local and
systemic toxicity were investigated in both groups by means of
a semi-structured questionnaire concerning lower urinary tract
symptoms through three items (nocturia, frequency, dysuria
and urgency) and the SF36 questionnaire being completed at
the time of pre- and post-treatment cystoscopy. Results: The
mean age was 63.4 (range: 34-82) years. All patients
experienced recurrence after transurethral resection and biopsy
for low-grade NMIBC. A total of 24 and 28 patients were
assigned to groups 1 and 2, respectively. Overall, two patients
in Group 2 were unable to complete the scheduled treatment
due to severe lower urinary tract symptoms. Logistic
regression analysis did not document statistical differences
between the two groups in terms of lower urinary tract
symptoms. One-way ANOVA evidenced only one significant
difference between the two groups in terms of SF36 physical
functioning (PF) after treatment (p=0.046). The mean PF
score was 79.8 (standard deviation, 22.3) and 62.5 (standard
deviation, 34.2) in groups 1 and 2, respectively. Overall 15/24
(65.5%) patients in Group 1 and 23/28 (82.1%) in Group 2
showed CR, including the two patients who were unable to
complete the treatment. Due to the limited number of patients
included in this study, we were not able to identify prognostic
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ANTICANCER RESEARCH 31: 1807-1956 (2011)
factors associated with optimal oncologic outcome in a
definitive multivariate analysis. Discussion and Conclusion:
The intensive schedule for intravesical mitomycin C
administration was documented to be well tolerated. When
compared to the standard approach, no difference in terms of
local and systemic toxicity was registered.
84
A NEW MULTIMODAL ANESTHESIOLOGICAL AND
NUTRITIONAL APPROACH IN RADICAL
CYSTECTOMY WITH URINARY DIVERSION BASED
ON ILEAL SEGMENT: A SINGLE-CENTER,
PROSPECTIVE, RANDOMIZED STUDY
Carmen Maccagnano, Antonella Crescenti,
Federico Pellucchi, Lorenzo Rocchini, Vincenzo Scattoni,
Buthaina Ibrahim, Giuseppe Zanni, Andrea Gallina,
Luca Villa and Renzo Colombo
I.R.C.C.S. San Raffaele, Universitá Vita-Salute, Milano, Italy
Aim: To evaluate a new multimodal anesthesiological and
nutritional approach for patients undergoing radical
cystectomy (RC) and urinary diversion with ileal segment
(orthotopic bladder substitution or Bricker ileo-cutaneous
anastomosis). The main endpoints were: (i) to evaluate the
reliability, tolerability and efficacy of intraoperative analgesia
without opium derivatives; (ii) to describe the perioperative
impact of non-administration of standard bowel mechanical
preparation (BMP); and (iii) to report the effects of an early
administration of oral nutrition (ON). Patients and Methods:
Patients were randomized into two groups, three days before
RC. In group I, the patients received standard treatment,
namely administration of BMP with osmotic laxatives during
the day before the operation, antibiotic prophylaxis with
erythromycin and paromomycin, use of opium derivatives for
the intraoperative analgesia, and administration of parenteral
nutrition during the week before the operation. In group II, the
patients received experimental treatment, namely
administration of a standard enema the day before the
operation, intraoperative analgesia without opium derivatives,
and administration of ON with yoghurts and puddings starting
on the third day after the operation. Results: A total of 46
patients were included in the study: 27 patients in group I and
19 patients in group II. The mean age at the time of operation
was 68 years (range, 50-68). Flatus (used as an indicator of
restarting of peristalsis) was reported after a mean time of 3.1
(range, 1-7) days in group I and after 2.3 (range, 2-4) days in
group II. Canalization was observed after 4.5 (range, 1-15)
days in group I and after 6.3 (range 2-11) days in group II.
Surgical wounds were considered to be repaired after 9 (range,
9-19) days in both groups. ON was well tolerated by 98%
(26/27) of patients of group II. Patients in group I were