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Annals of Oncology
801P COMPARISON BETWEEN STANDARD AND REDUCED
VOLUME RADIOTHERAPY IN BLADDER PRESERVATION
TRIMODALITY PROTOCOL FOR MUSCLE INVASIVE BLADDER
CANCER PATIENT
W. Arafat, A. Darwish, G. El Hussiny
Clinical Oncology, University of Alexandria, Alexandria, EGYPT
Invasive bladder cancer is the most common tumor in Egypt. Preservation protocol
consists of transurethral resection followed by concomitant chemo/ radiotherapy. The
induction part of Radiotherapy is usually delivered to the whole pelvis, The role of
omitting pelvic nodal irradiation has not been addressed before.
Aim: To compare the toxicity, pelvic nodal relapse and overall survival of whole
bladder irradiation only to standard technique of whole pelvis irradiation followed by
bladder boost in patients with muscle invasive bladder carcinoma undergoing
bladder preservation protocol.
Material and method: A total of 63 patients with transitional cell carcinoma, stage
T2-3,N0,M0 bladder cancer were subjected to maximal TURB. Then, patients
randomized into two groups: group I (32 patients) to receive whole pelvis
radiotherapy 44Gy followed by 20 Gy bladder boost. While Group II (31 patients)
were randomized to receive whole bladder radiotherapy alone for a total dose of 64
Gy. In both groups, concomittant cisplatin and paclitaxel were given weekly
throughout the whole course of radiotherapy where conventional 2 Gy/ fraction were
used. additionally, 4 cycles of Adjuvant cisplatin and paclitaxel were given after the
end of chemo radiotherapy induction course.
Results: Three patients, two in group I and one in group II discontinued due to
grade 3 toxicity. After a median follow up of 2 years, regional relapse occurred in
7.1% of patients in group I and 10.3% in group II. (p = 1). Distant metastases were
detected in 17.9% of patient in group 1 and 13.8% in group II.(p = 0.73). The 2-year
disease free survival was 60% in group I and 63.3% in group II (p = 0.79). The whole
2-years overall survival was 75% in group I and 79.3% in group II (p = 0.689).
Radiation gastrointestinal (GI) Acute toxicity was higher in group I than in group II
(p = 0.001), while late GI radiation toxicity was comparable in both groups.
Conclusion: treating the bladder only without elective pelvic nodal irradiation, did not
compromise pelvic control rate, but significantly decreased the acute radiation toxicity.
Disclosure: All authors have declared no conflicts of interest.
802P EFFICACY AND PROGNOSTIC FACTORS OF NEOADJUVANT
CHEMOTHERAPY IN RESECTABLE LOCALLY-ADVANCED
MUSCLE-INVASIVE BLADDER CANCER (MIBC) PATIENTS (P)
IN AN OFF-PROTOCOL CLINICAL SETTING
J.L. Cuadra Urteaga 1 , M. Domenech 2 , P. Celiz 1 , J.J. Sánchez 3 , N. Pardo 1 ,
C. Buges 1 , J. Malet 4 , M. Arzoz 5 , J. Areal 5 , A. Font 1
1 Medical Oncology, Catalan Institute of Oncology ICO Badalona Hospital
Germans Trias i Pujol, Medical Oncology, Badalona, SPAIN, 2 Oncology, ALthaia,
Xarxa Assistencial de Manresa, Manresa, SPAIN, 3 Statistics, Autonomous
University of Madrid, Madrid, SPAIN, 4 Urology, ALthaia, Xarxa Assistencial de
Manresa, Manresa, SPAIN, 5 Urology, Hospital Germans Trias i Pujol, Badalona,
SPAIN
Introduction: Although neoadjuvant chemotherapy is a recommended treatment in
MIBC, it has not gained widespread acceptance in clinical practice, due to the lack of
predictive markers of efficacy and the absence of a standard chemotherapy regimen.
Furthermore, since few studies have assessed the role of neoadjuvant chemotherapy
in an off-protocol setting, there may be doubts about its feasibility.
Material and methods: We retrospectively analyzed 124 p with MIBC treated with
neoadjuvant cisplatin-based chemotherapy at two centers from 1991 to 2010. Clinical
and pathological variables were correlated with survival. All patients were classified
as stage cT2-4N0M0 based on TUR (trans-urethral resection) and CT scan findings
and were candidates for neoadjuvant chemotherapy followed by cystectomy.
Results: 10 p (8%) were cT2N0, 83 p (66%) cT3N0, and 31 p (26%) cT4aN0. 60 p
(48%) were treated with CMV (cisplatin, methotrexate and vinblastine) and 64 p
(52%) with cisplatin/gemcitabine (CG). One patient died from treatment-related
toxicity. A complete resection was performed in 109 p (87%). A significant
pathological response (pR) (pT0-1) was obtained in 60 p (48%). Median survival
(MS) and 5-year (5y) survival were 59 months (m) and 50%, respectively. Median
cancer-specific survival (CSS) was not reached and 5y CSS was 64%. 5y overall
survival was similar (50.3% vs 50.9%) in p treated with CMV or CG. In p with a
significant pR, 5y survival was 77%, while for p who did not respond to
chemotherapy (pT3-4NO or N+), it was 8.3%. Only complete resection (HR:3.36,
P = 0.006) and lymphovascular invasion (LVI) (HR:17.29, P < 0.0001) were significant
in the multivariate analysis.
Conclusions: Neoadjuvant chemotherapy followed by cystectomy is feasible in p
with locally-advanced MIBC. Both CMV and CG are active regimens, with 5-y
survival that compares favorably with surgery alone. p responding to neoadjuvant
chemotherapy have an excellent prognosis, while those who do not respond should
be considered for non-cross-resistant adjuvant chemotherapy.
Disclosure: All authors have declared no conflicts of interest.
803P SELECTIVE BLADDER PRESERVATION BY TRI-MODALITY
THERAPY FOR MUSCLE INVASIVE BLADDER CARCINOMA
A. Darwish 1 , G. Elhussiny 1 ,W.Arafat 2
1 Clinical Oncology, University of Alexandria, Alexandria, EGYPT, 2 Clinical
Oncology, Alexandria International Hospital, Alexandria, EGYPT
Purpose: To access safety, tolerance, local control and survival of transurethral
resection of Bladder tumor (TURB) followed by concomitant cisplatin, paclitaxel and
radiation therapy as selective organ preservation in patients with Muscle Invasive
bladder. Addionally, Surviving and ERCC1 gene expression analysis and response to
treatmentis also studied.
Methods and materials: A total of 63 patients with transional cell carcinoma (TCC),
stage T2–T3, No, Mo bladder carcinoma were enrolled in a protocol of TURP
followed by one daily radiotherapy (2Gy/ fraction for a total dose of 44 GY) with
concomitant cis-platin 15mg/m2/ day,d1-3 weekly and paclitaxel 50mg/m2/day,
weekly.Four weeks later, all patients were evaluated by cytoscopy and biopsy. Patients
with complete response proceeded to consolidation Radiotherapy (2Gy/fr for a total
20GY with concomitant cisplatin and paclitaxel, while those with recurrent tumor
went on to salavage. Cystectomy. Following consolidation or salvage surgery,
all patients went to complete 4 cycles of cisplatin75mg/m2/ day and paclitaxel
175 mg/day every 21 days. RNA extraction from Biopsy before and after treatment
was analysed for survivin and ERCC1 gene expression using real time PCR.
Results: Three patients could not tolerate the treatment and discontinued the
protocol during the induction phase while the remaining sixty patients complete the
induction phase. The complete response after the induction phase was 75%. Eleven
percent of the complete responders developed superficial relapse with a median time
of relapse of 16 months, while 8.9% developed invasive relapse with a median time of
18 months. 2-year disease for survival was 61.7%. Distant metastases we detected in
15.8% the patients. 2year overall survival was 77.2%. RNA was succifully extracted
from 65% of patient, real time PCR for ERCC1 and survivin was done, interpretation
of data will be presented.
Conclusion: Maximal transurethral resection followed by concomitant cis-platin and
paclitaxel, as a bladder preservation therapy, can be considered a valid alternative for
treating selected patients with localized muscle invasive TCC of the bladder. ERCC1
and survivn might be a predictive model of treatment response.
Disclosure: All authors have declared no conflicts of interest.
804P PROGNOSTIC STRATIFICATION OF ADVANCED UROTHELIAL
CARCINOMA (UC) RECEIVING SECOND-LINE SYSTEMIC
THERAPY INCLUDING TIME FROM PRIOR CHEMOTHERAPY
(TFPC) AS A PROGNOSTIC FACTOR
G. Sonpavde 1 , G.R. Pond 2 , T.K. Choueiri 3 , R. Fougeray 4 , G. Niegisch 5 ,
Y. Wong 6 , S.S. Sridhar 7 , W.M. Stadler 8 , C.N. Sternberg 9 , J. Bellmunt 10
1 Medical Oncology, Texas Oncology, Baylor College of Medicine, Webster, TX,
UNITED STATES OF AMERICA, 2 Biostatistics, Ontario Clinical Oncology Group
and McMaster University, Hamilton, CANADA, 3 Medical Oncology, Dana Farber
Cancer Institute, Boston, MA, UNITED STATES OF AMERICA, 4 Statistics, Institut
de Recherche Pierre Fabre, Boulogne, FRANCE, 5 Urologic Oncology, Heinrich
Heine University, Dusseldorf, GERMANY, 6 Medical Oncology, Fox Chase Cancer
Center, Philadelphia, PA, UNITED STATES OF AMERICA, 7 Medical Oncology,
Princess Margaret Hospital, Toronto, ON, CANADA, 8 Medical Oncology,
University of Chicago, Chicago, IL, UNITED STATES OF AMERICA, 9 Medical
Oncology, San Camillo Forlanini Hospital, Rome, ITALY, 10 Medical Oncology,
University Hospital del Mar, Barcelona, SPAIN
Background: Prognostic factors for overall survival (OS) in patients receiving
second-line chemotherapy for advanced platinum-pretreated urothelial carcinoma
(UC) include ECOG performance status (PS) >0, hemoglobin (Hb)