1. A Comparative Analysis of Quality of Life of Patients Treated by Radical Cystectomy and Sigmoid Neobladder versus Chemoradiation in Muscle Invasive Cancer of Urinary Bladder K. P. Haresh, P. K. Julka, R. Prabhakar, S. Senthamilzelvan, A. Seth, G. K. Rath. All India Institute of Medical Sciences, New Delhi, India

2. PURPOSE Radical cystectomy (RC) and chemoradiation (CTRT) -the present standard treatment options for muscle invasive cancer of urinary bladder (UB) RC has got its own inherent psychosexual issues associated with urinary diversion The new technique of sigmoid neobladder (SNB) provide an artificial bladder fashioned out of sigmoid colon with the patient able to void through their natural urethra. The purpose of our study is to compare the QOL between RC with SNB vs. CTRT.

3. Material and Methods Prospective non-randomized study May 2001 to June 2005 Transitional cell cancer of UB, T2 to T4, N0/N1, M0 N= 30 A modified questionnaire from EORTC-QLQ and bladder symptom score -(Madsen and Iversen, 1983). The patients were directly interviewed. QOL scores were recorded both before treatment and during follow up.

4. S.NO.QUESTIONNAIRESCORE 1.How much would you grade your overall physical health in the past week? 01020253040506070758090100 [Score: till 25=1, 25-50 = 2, 50- 75=3, 75-100=4]1 2 3 4 2.Performance questionnaire: KPS Were you symptomatic in last week? Yes/ no Did you need to put effort for your routine activities ? yes / no Were you able to work in past week ? Yes/ no Did you need any assistance ? yes / no If yes, the assistance type: Occasional / Considerable / Special Care / Hospital Care [KPS score : 0 –20 = 1, 21-50 = 2, 51-80 = 3, 81-100 =4]1 2 3 4 3.How would you grade your mental well being in the past week? 01020253040506070758090100 [Score : till 25=1, 25-50 = 2, 50- 75=3, 75-100=4]1 2 3 4 4.Is the disease / treatment interfering with your family life ? NoMinimalModerateVery much 43211 2 3 4 5.Does the disease / treatment interfere with your social life? NoMinimalModerateVery much 43211 2 3 4 6.Did you have any problem in going out to public ? NoMinimalModerateVery much 43211 2 3 4

5. QUESTIONNAIRE contd… 7.Did the disease / treatment interfere with your sexual life? NoMinimalModerateVery much 43211 2 3 4 8.Did the disease / treatment cause financial problems? NoMinimalModerateVery much 43211 2 3 4 9.Did you suffer any complication due to treatment? NoMinimalModerateVery much 43211 2 3 4 10.Total inpatient hospital stay <10 days11-15 days16-20 days> 20 days 43211 2 3 4 11.How is your sleep in last 1 week ? NormalMinimally altered Moderate insomniaSevere insomnia 43211 2 3 4

6. Bladder / rectal symptom score Did you have ? SCORE 12.Hematuria NeverOccasionallyClots in urineClot retention 43211 2 3 4 13.Frequency >3 h2-3 h1-2 h<1 h 43211 2 3 4 14.Nocturia 0-1x2x3-4x>4x 43211 2 3 4 15.Urgency NoneMildModerateSevere 43211 2 3 4 16.Dysuria NilOcc. Burning Burning >50% of timeFrequent and painful burning 43211 2 3 4 17.Diarrhoea NilOccasionalFrequentWith blood 43211 2 3 4

7. The mean score (as percentage) was calculated for each observation in the two groups separately. Independent t test was performed with the initial individual sample values and the p value was obtained for inter group comparison.

8. Sx pre tmt vs CTRT pre tmt (p value) Sx pre tmt vs Sx post tmt (p value) CTRT pre tmt vs CTRT post tmt (p value) Sx post tmt vs CTRT post tmt (p value) Physical health90.00/84.61 (0.528)90.00/86.46 (0.477)84.61/90.28 (0.607)84.46/90.28 (0.486) Mental health74.16/84.61 (0.175)74.16/89.58 (0.013)84.61/91.67 (0.059)89.58/91.67 (0.525) Family life60.83/67.31 (0.516)60.83/80.21 (0.051)67.31/97.22 (0.020)80.21/97.22 (0.041) Social life79.16/84.62 (0.585)79.16/83.33 (0.438)84.62/97.22 (0.102)83.33/97.22 (0.128) Public life92.50/96.15 (0.821)92.50/87.50 (0.336)96.15/97.22 (0.564)87.50/97.22 (0.350) Sexual life80.83/78.85 (0.953)80.83/43.75 (0.001)78.85/80.56 (1.000)43.75/80.56 (0.008) Financial70.83/75.00 (0.725)70.83/69.79 (0.603)75.00/91.67 (0.071)69.79/91.67 (0.051) Sleep85.83/88.46 (0.857)85.83/94.79 (0.028)88.46/100.00 (0.180)94.79/100.00 (0.379) Hematuria54.16/55.77 (0.733)54.16/100.00 (0.010)55.77/97.22 (0.010)100.00/97.22 (0.292) Frequency57.50/75.00 (0.076)57.50/70.00 (0.429)75.00/75.00 (0.863)70.00/75.00 (0.422) Nocturia52.50/53.85 (0.934)52.20/65.00 (0.589)53.85/72.22 (0.058)65.00/72.22 (0.496) Urgency83.33/84.62 (0.821)83.33/80.00 (0.058)84.62/97.22 (0.157)80.00/97.22 (0.011) Dysuria76.66/88.46 (0.112)76.66/100.00 (0.041)88.46/94.44 (0.180)100.00/94.44 (0.125) Diarrhoea100.00/100.00 (1.000)100.00/95.83 (0.102)100.00/97.22 (0.317)95.83/97.22 (0.887) RESULTS

9. RESULTS contd.. Comparison of pre treatment QOL scores showed that the two groups are very well matched. SNB arm there was a statistically significant improvement in the mental well being and sleep of the patient with treatment There was a significant deterioration in sexual activity in the SNB arm. Bladder symptom scores for hematuria and dysuria showed a significant positive improvement in the SNB arm. The striking feature in the CTRT arm is an improvement in the family life and preservation of sexual activity Bladder symptom scores for hematuria showed a significant improvement in the CTRT arm too. A head on comparison of the post treatment status between two arms showed a highly statistically significant improvement in family life and sexual life in favor of CTRT

10. Chemoradiation yields a slightly better Quality of Life than Radical Cystectomy with Sigmoid Neobladder in the treatment of muscle invasive bladder cancer. Conclusions